nct_id stringlengths 11 11 | brief_title stringlengths 7 300 | brief_summary stringlengths 0 4.99k | detailed_descriptions stringlengths 0 31.8k | official_title stringlengths 16 598 ⌀ | conditions stringlengths 0 11k | interventions stringlengths 0 3.18k | eligibility_criteria stringlengths 0 19.6k ⌀ | minimum_age stringclasses 304
values | maximum_age stringclasses 448
values | gender stringclasses 4
values | healthy_volunteers stringclasses 3
values | design_details stringlengths 0 1.17k | primary_outcome_measures stringlengths 75 136k | secondary_outcome_measures stringlengths 0 185k | keywords stringlengths 0 18.8k | mesh_terms stringlengths 0 8.39k | arms_and_interventions stringlengths 0 109k | structured_text stringlengths 539 193k |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00170157 | Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer | RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of ... | OBJECTIVES:~I. To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone.~II. To specifically examine whether concomitant AA therapy + MDX-010 can be used to prolong the progression-free interval in... | A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer | Prostate Adenocarcinoma, Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage III Prostate Cancer, Stage IV Prostate Cancer | * Drug: Bicalutamide
* Drug: Flutamide
* Drug: Goserelin Acetate
* Drug: Ipilimumab
* Drug: Leuprolide Acetate
* Other: Pharmacological Study
| Inclusion Criteria:~NOTE: All values must be obtained =< 14 prior to study entry~Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the exclusion of central nervous system (CNS) metastases; includes post radical p... | 18 Years | null | Male | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Progression-free at 18 Months | PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart. | 18 months from the start of AA therapy |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response | Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over). | 3 months |
| Ipilimumab, Leuprolide, Goserelin, Bicalutamide, Flutamide, Antineoplastic Agents, Immunological, Antineoplastic Agents, Immune Checkpoint Inhibitors, Molecular Mechanisms of Pharmacological Action, Fertility Agents, Female, Fertility Agents, Reproductive Control Agents, Physiological Effects of Drugs, Antineoplastic A... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiand... | Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the am... | |
NCT04083300 | Cancer, Physical Activity and Quality of Life- a Longterm Follow up | This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on cancer-related stress reactions and emotional reactivity between the intervention and control group. Secondary objectives is to inves... | Major improvements in cancer detection and treatment lead to longer life expectancy among cancer survivors. This may in turn lead to more late effects and many have to deal with long-term consequences of the disease and its' treatment. Returning to everyday life and to work is often an important part of returning to no... | 6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time. | Cancer, Rehabilitation, Stress Disorder, Fatigue, Quality of Life, Physical Activity | Inclusion Criteria:~Stage I-III disease~Scheduled for neo/adjuvant or curative treatment (i.e. chemotherapy, radiation therapy or hormonal therapy or any combination of these therapies)~Exclusion Criteria:~On-going psychiatric condition~Lack of fluency in Norwegian~A previous diagnosis of cancer | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study. | | 2021 |
| Objectively measured physical activity from diagnosis to 6-8 years follow up. | | 2022 |
| The context between change in physical activi... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study | Experiences of the follow up. | 2021 |
| Cancer, Physical Activity and Quality of Life- a Longterm Follow up
Study Overview
=================
Brief Summary
-----------------
This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on... | |||||
NCT04594265 | Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure | We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure. | Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure | Ketosis, Heart Failure | * Dietary Supplement: KetoneAid KE4 Pro Monoester
* Dietary Supplement: Science in Sport Go Enegy
| Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%~Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients are studied in a randomized single-blind cross-over design.
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output (L/min) | Change in Cardiac output measured by Swann-Ganz Catherization during study period, | 3 hours - Area under the curve |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction | Change in LVEF measured by echocardiography during study periode | 3 hours - Area under the curve |
| Blood Ketones | Change in blood Ketones measured by venous blood samples | 3 hours |
| Blood pH | Chan... | Hemodynamics | Heart Failure, Heart Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone Monoester<br>Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) | Dietary Supplement: KetoneAid KE4 Pro Monoester<br>* A dietary supplement containing ketone monoester.<br>|
| Placebo Comparato... | Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Study Overview
=================
Brief Summary
-----------------
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
Official Title
-----------------
Weight-Adjusted D... | |
NCT00805831 | Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis | The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the ... | Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis | Vascular Disease, Atherosclerosis | * Device: HDH
| Inclusion Criteria:~Patient age above 18 (men and woman)~Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm~Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm~The abdominal aneurysm neck is longer than 1.5 cm~Patient's physical co... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events. | | within 1 month |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete the anastomosis | | during the surgery |
| sutureless vascular bypass | Atherosclerosis, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aortic anastomosis surgery will be conducted using HDH device. | Device: HDH<br>* sutureless vascular anastomosis<br>|
| Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Study Overview
=================
Brief Summary
-----------------
The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft),... | |
NCT00606606 | Reducing Adverse Drug Events in the Nursing Home | Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting. However, the residents of nursing homes are at increased risk for experiencing adverse drug events. This risk is incre... | This study was conducted in two large, academic long-term care facilities located in Connecticut and Ontario, Canada. The two facilities have a combined total of 1,229 beds. Patients residing in areas of the facilities related to short-term care (e.g., subacute care, hospital-level care, or rehabilitation) were not inc... | Reducing Adverse Drug Events in the Nursing Home | Adverse Drug Events | * Other: Clinical Decision Support
| Inclusion Criteria:~prescriber at the study facilities~Exclusion Criteria:~not a prescriber at the study facilities | null | null | All | Accepts Healthy Volunteers | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse drug events | | March 2002 - February 2005 |
| Drug-Related Side Effects and Adverse Reactions, Chemically-Induced Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I - Intervention units<br>nursing home units, provided HIT CDS intervention | Other: Clinical Decision Support<br> <br> * Other names: CDS;|
| No Intervention: C - control units<br>nursing home units, not provided the HIT CDS intervention ... | Reducing Adverse Drug Events in the Nursing Home
Study Overview
=================
Brief Summary
-----------------
Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting. How... | ||
NCT02328339 | Tea and Forearm Blood Flow | The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design. | Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation.~Less is known however about its effects in other vascular beds. The study will... | Forearm Blood Flow Response to Acute Consumption of Black Tea | Vascular Function | * Other: Tea
* Other: Placebo
| Inclusion Criteria:~Males and post menopausal (> 1 years) females~Aged ≥ 45 and ≤ 75 years~Body mass index (BMI) of ≥ 18.0 and ≤ 35.0 kg/m2~Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, ... | 45 Years | 75 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forearm blood flow response to acetylcholine | Does tea ingestion change mean forearm blood flow response to acetylcholine when compared to placebo | During acetylcholine infusion 120-140 min after first tea/placebo intake |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forearm blood flow response to sodium nitropusside | Does tea ingestion change mean forearm blood flow response to sodium nitropusside when compared to placebo | During sodium nitropusside infusion 170-190 min after first tea/placebo intake | ... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black tea<br>Approximately 400 mg total polyphenols in 240 ml hot water (loading dose; 2 hours before the start of measurements; t=0) and 130 mg total polyphenols in 120 ml hot water (maintenance dose just before start of the measurements;... | Tea and Forearm Blood Flow
Study Overview
=================
Brief Summary
-----------------
The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design.
Detailed Description
-----------------
Epidemiological stu... | ||
NCT04711629 | Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease | Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.~The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychol... | The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.~The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MW... | Clinical Characteristics of Chronic Obstructive Pulmonary Patients Who Continue to Smoke | Copd, Smoking | * Other: Clinical Tests
| Inclusion Criteria:~Smoker COPD Patients who smoker~Exclusion Criteria:~Not volunteer to participate the study | 18 Years | 90 Years | All | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Smoker COPD Ex Smoker COPD
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity | Six minutes walk test | 6 minutes |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Functions | Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second dur... | copd, smoking | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoker COPD<br>Patients who continue to smoke | Other: Clinical Tests<br>* Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital An... | Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease
Study Overview
=================
Brief Summary
-----------------
Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they... | |
NCT04535986 | A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD | The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). | A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD | Chronic Obstructive Pulmonary Disease | * Drug: Ensifentrine
* Drug: Placebo
| Inclusion Criteria:~Informed Consent~Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF).~Age and Sex~Age: Patient must be 40 to 80 years of age inclusive, at... | 40 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Square (LS) Mean Change From Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 | Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24 | Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 i... | COPD | Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Disease, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Ensifentrine Nebulized Suspension; 3 mg BID | Drug: Ensifentrine<br>* Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks<br>|
| Placebo Comparator: Arm 2<br>Placebo Neb... | A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease ... | |
NCT00126451 | A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED) | This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) crite... | A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer. | Breast Cancer, Colorectal Cancer, Non-small-cell Lung Carcinoma | * Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
* Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles
| Inclusion Criteria:~Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer~Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.~Has a measurable, positron emission tomography (PET) as... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria. | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days. | | |
| Vorinostat, Antineoplastic Agents, Histone Deacetylase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Intervention/Treatment |
| --- |
|Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)|nan|
|Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles|nan|
| A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)
Study Overview
=================
Brief Summary
-----------------
This is an investigational study to determine the response rate of relapsed/r... | ||
NCT03637088 | Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo) | Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on pulmonary artery pressure and right heart function (Echo). | Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, (six-minute walk test) 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.~Randomly assigned to the order of testing, the participants will be tested under simulated ... | Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise | Pulmonary Hypertension | * Device: Simulated Altitude (FiO2: 15.1%)
* Device: Shamed Hypoxia (FiO2: 20.9)
| Inclusion Criteria:~Informed consent~PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a (pulmonary artery wedge pressure) PAWP ≤15 mmHg during right heart catheterization at the time of initial diagnosis~PH class 1 (PAH) or 4 (CTEPH)~Stable condition, on the s... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Including a baseline assessment and assessments under simulated altitude and normoxia.
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic assessment under hypoxia (FiO2: 15.1) | Pulmonary artery pressure measured by echo (TTE) | 2 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic assessment of the right heart under hypoxia (FiO2: 15.1) | Right heart functions measured by echo (TTE) (fac, d-shaping, kinetic etc.) | 2 hours |
| Simulated altitude, Pulmonary artery pressure, Echocardiography, Right heart function | Hypertension, Pulmonary, Hypertension, Hypoxia, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases, Signs and Symptoms, Respiratory | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Order air-hypoxia<br>The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator (A... | Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo)
Study Overview
=================
Brief Summary
-----------------
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to ... |
NCT02688153 | EDWARDS INTUITY Valve System CADENCE Study | The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass. | This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitan... | A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment | Aortic Valve Disease, Aortic Stenosis | * Device: EDWARDS INTUITY
* Device: Stented aortic bioprostheses
| Inclusion:~≥18 years of age~aortic stenosis / mixed aortic stenosis and aortic insufficiency~SAVR+CABG (1-4 distal anastomoses)~Log. EuroSCORE ≥6~NYHA Class ≥II~Exclusion (i.a.):~pure aortic insufficiency~pre-existing prosthetic heart valve or ring~congenital true bicuspid / unicuspid aortic valve~LVEF <20% | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Subject Time Spent on Cardiopulmonary Cross Clamp | Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal bloo... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years. | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality ... | Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY | Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EDWARDS INTUITY<br>EDWARDS INTUITY Valve System, Model 8300A | Device: EDWARDS INTUITY<br>* To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR ... | EDWARDS INTUITY Valve System CADENCE Study
Study Overview
=================
Brief Summary
-----------------
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
Det... |
NCT00575003 | Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis | The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients. | Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis | Perennial Allergy to House Dust Mite and/or Cat | * Drug: CYT003-QbG10
| Inclusion Criteria:~Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens~Exclusion Criteria:~Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments.~Us... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life | | on 4 occations over 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the vaccine by collection of adverse events | | at each visit |
| Dust Mite Allergy, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Rhinitis, Nose Diseases, Respiratory Tract Diseases, Respiratory Hypersensitivity, Otorhinolaryngologic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>|
| Placebo Comparator: 2<br> | Drug: CYT003-QbG10<br>* 6 subcutaneous injections<br>|
| Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.... | ||
NCT04056728 | A Phase IV Study to Assess the Safety of EupentaTM Inj | A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine} | A Prospective, Open-label, Interventional Phase IV Study to Assess the Safety of EupentaTM Inj. {Fully Liquid Pentavalent Vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [Recombinant-deoxyribonucleic Acid])-Haemophilus Influenzae Type b Conjugate Vaccine} | Hepatitis B, Diphtheria, Haemophilus Influenzae Type B Infection, Tetanus, Pertussis | * Biological: Eupenta Inj.
| Inclusion Criteria:~Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study~A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination~In good health as determined... | 6 Weeks | 8 Weeks | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any immediate reactions reported from the study after EupentaTM Inj. Vaccination | | first 30 minutes after each study vaccination |
| Incidence of solicited local and systemic adverse events (AEs) | | baseline(pre-vaccination)... | Blood-Borne Infections, Hepatitis, Liver Diseases, Influenza, Human, Hepatitis B, Whooping Cough, Tetanus, Diphtheria, Haemophilus Infections, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Infections, RNA Virus Infections, Respiratory Tract Infections, Orthomyxoviridae Infections, Respiratory Trac... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eupenta Inj.<br> | Biological: Eupenta Inj.<br>* fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine sing... | A Phase IV Study to Assess the Safety of EupentaTM Inj
Study Overview
=================
Brief Summary
-----------------
A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [r... | |||
NCT01994811 | Eastern Caribbean Health Outcomes Research Network (ECHORN) | The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean. | The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad & Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and... | Eastern Caribbean Health Outcomes Research Network (ECHORN) | Cancer, Cardiovascular Disease, Diabetes | Inclusion Criteria:~Greater than or equal to 40 years of age~English or Spanish language speaking~Resident of island at least 10 years~Able to provide informed consent~Non-institutionalized at the time of data collection~Stable contact/residential information~No plans to relocate from island within the next 5 years | 40 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of non-communicable diseases | Prevalence of non-communicable diseases, including cancer, heart disease and diabetes. | 5 years |
| cancer, cardiovascular disease, diabetes | Cardiovascular Diseases | Eastern Caribbean Health Outcomes Research Network (ECHORN)
Study Overview
=================
Brief Summary
-----------------
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabet... | ||||
NCT04545879 | Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique | Investigators recruited 10 trimethylamine N-oxide (TMAO) producers to test the effect of garlic juice containing allicin on gut microbiota modulation and TMAO production. | Trimethylamine N-oxide (TMAO) was recently discovered as a novel and independent risk factor for promoting atherosclerosis while it is generated from dietary carnitine through the metabolism of gut microbiota for decades. Allicin, the major compound in raw garlic juice, is a naturally antimicrobial phytochemical found ... | Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique | Atherosclerosis | * Dietary Supplement: Raw garlic juice containing allicin
| Inclusion Criteria:~Age 20-65 years old~Healthy subjects with TMAO producing ability~Exclusion Criteria:~Exposure to antibiotics, probiotics, or carnitine supplements within the previous month~Have a history of chronic diseases including, diabetes mellitus, myasthenia gravis, chronic renal disease, hyperparathyroidism,... | 20 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine TMAO level (ppm) | Quantitation of plasma and urine TMAO level by LC-MS | 6 months |
| Compositional analysis of gut microbiota (% of different bacteria species) | Next-generation sequencing and bioinformatics | 6 months |
| Antioxidants, Allicin, Anti-Infective Agents, Hypolipidemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Lipid Regulating Agents, Protective Agents, Physiological Effects of Drugs, Hypoglycemic Agents, Free Radical Scavengers | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raw garlic juice<br>Raw garlic juice treatment group | Dietary Supplement: Raw garlic juice containing allicin<br>* Fresh garlic juice containing around 48mg allicin for 7 days<br>|
| Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique
Study Overview
=================
Brief Summary
---------... | ||
NCT03863873 | Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome | This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate idiopathic carpal tunnel. They were randomly divided into two groups. Group 1: patients received ultrasound-guided platelet-rich plasma injection and group 2 patients received ultrasound-guided corticosteroid injection... | Intervention:~PRP Injection Group(PRP-inj-G) - This group included 49 patients (40 females and 9 males). Their age ranged from 20 to 60 years.~PRP Preparation: 16 ml of blood was obtained from each patient using special PRP kits (GD medical pharma, Dutch company). The blood was collected on citrated tubes with a mixing... | Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome | Carpal Tunnel Syndrome | * Procedure: Platelet-Rich Plasma Injection Group
| Inclusion Criteria:~Patients with mild-to-moderate idiopathic CTS with clinical manifestations failed to respond to conservative treatment ( such as splint, medications, Physical therapy) for at least 3 months and they were diagnosed by electrophysiological study and musculoskeletal ultrasound.~Exclusion Criteria:~Diab... | null | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement | The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain)... | Carpal Tunnel Syndrome, Platelet-rich plasma | Carpal Tunnel Syndrome, Syndrome, Disease, Pathologic Processes, Median Neuropathy, Mononeuropathies, Peripheral Nervous System Diseases, Neuromuscular Diseases, Nervous System Diseases, Nerve Compression Syndromes, Cumulative Trauma Disorders, Sprains and Strains, Wounds and Injuries | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP Injection Group<br>PRP Preparation: 16 ml of blood was obtained from each patient using special PRP kits (GD medical pharma, Dutch company). The blood was collected on citrated tubes with a mixing ratio of 9:1 by volume. Tubes und... | Platelet-Rich Plasma in the Treatment of Patients With Idiopathic Carpal Tunnel Syndrome
Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial in a cohort of Egyptian patients suffered from mild to moderate idiopathic carpal tunnel. They were randomly divided into two g... | |
NCT02996682 | Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis | The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis. | A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis | Hepatitis C Virus Infection | * Drug: SOF/VEL
* Drug: RBV
| Key Inclusion Criteria:~Chronic HCV-infected males and non-pregnant/non-lactating females~Treatment naive or treatment experienced individuals~Child-Pugh-Turcotte Score 7-12 at screening~Note: Other protocol defined Inclusion/Exclusion criteria may apply. | 20 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatme... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With SVR at 24 Weeks ... | Communicable Diseases, Hepatitis, Hepatitis C, Virus Diseases, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Velpatasvir, RNA Virus Infections, Ribavirin, Sofosbuvir, Antiviral Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Anti-Infective Agents, Decompensated Cirrhosis | Anti-Infective Agents, Ribavirin, Sofosbuvir-velpatasvir drug combination, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antiviral Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOF/VEL<br>SOF/VEL for 12 weeks | Drug: SOF/VEL<br>* 400/100 mg FDC tablet administered orally once daily<br>* Other names: Epclusa®;|
| Experimental: SOF/VEL + RBV<br>SOF/VEL + RBV for 12 weeks | Drug: SOF/VEL<br>* 400/100 mg FDC tablet a... | Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/ve... | |
NCT05043155 | Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia | A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impact and importance of vaccination among cancer survivors. | Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia | Covid19, Vaccination Refusal, Survivorship | Inclusion Criteria: Female cancer survivors or care-taker undergoing national covid 19 vaccine -~Exclusion Criteria: Male, not cancer survivors~- | null | null | Female | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination refusal | Number of cancer survivors refuse vaccine | 8 months |
| Reason for Refusal of Vaccine | Number of cancer survivors refuse vaccine | 8 months |
| Covid19, Vaccination, Gynaeoncology cancer, Cancer survivor | COVID-19, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases | Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia
Study Overview
=================
Brief Summary
-----------------
A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impa... | |||||
NCT03985189 | Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma | The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety... | A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study | Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma | * Drug: ME-401
| Inclusion Criteria:~[Phase 1 study (DLT evaluation)]~Patients aged 20 years or older at the submission of the written informed consent form~Patients with relapsed or refractory B-cell NHL~Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.~Patients who have undergone Bruton's tyrosin... | 20 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events (TEAEs) | | Up to approximately 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401 | | Up to approximately 2 years |
| [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax) | | Up to approximately 2 years |
| [Phase 1 study (DLT eva... | Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ME-401<br>ME-401 administered orally | Drug: ME-401<br>* [Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at C... | Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Re... | ||
NCT00000732 | Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine | To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood, and how long AZT remains in the blood) changes from day-to-day in the same patient. Also to determine whether the pharmacokinetics of AZT is changed by sulf... | AZT has been effective in treating some patients with AIDS, and SMX/TMP is an antibiotic combination which is useful in preventing or treating Pneumocystis carinii pneumonia (PCP), which is an important cause of disease and death in patients with AIDS. It is important to know how drugs interact in patients because addi... | Evaluation of the Interaction Between Low Dose Trimethoprim/Sulfamethoxazole and Zidovudine | HIV Infections | * Drug: Sulfamethoxazole-Trimethoprim
* Drug: Zidovudine
| Inclusion Criteria~Prior Medication:~Allowed:~Zidovudine (AZT) for patients with AIDS.~AIDS related complex (ARC). The presence of any one of the following findings within 12 months prior to entry and the absence of a concurrent illness or conditions other than HIV infection to explain the findings:~Fever of > 38.5 C d... | 18 Years | 50 Years | All | No | Primary Purpose: Treatment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Sulfamethoxazole-Trimethoprim | Zidovudine, Trimethoprim, Sulfamethoxazole, Trimethoprim, Sulfamethoxazole Drug Combination, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Antiviral Agents, Anti-Infective Agents, Anti-HIV Agents, Anti-Retroviral ... | | Intervention/Treatment |
| --- |
|Drug: Sulfamethoxazole-Trimethoprim|nan|
|Drug: Zidovudine|nan|
| Evaluation of the Interaction Between Low Dose Sulfamethoxazole-Trimethoprim and Zidovudine
Study Overview
=================
Brief Summary
-----------------
To determine if the pharmacokinetics of low doses of zidovudine (AZT) (that is, how fast AZT reaches the blood, what concentration of AZT is attained in the blood... | |
NCT01902641 | Muscle Relaxation for Short Procedures | Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as p... | Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study | Sore Throat, Intubating Conditions, Fasciculations, Postoperative Myalgia, Patient Satisfaction | * Drug: Succinylcholine
* Drug: Rocuronium/Sugammadex
* Drug: Rocuronium
| Inclusion Criteria:~age > 18 yr~scheduled for elective rigid bronchoscopy~Exclusion Criteria:~known neuromuscular disease~significant hepatic or renal dysfunction~family history of malignant hyperthermia~known allergy to one of the drugs used in this protocol~pregnancy or breastfeeding | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubating condition | scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing | After induction of general anaesthesia (after 3-5... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasciculations | Fasciculations were graded by the investigator on the following four-point scale~0 = no fasciculations~= mild, fine fasciculations of the eyes, neck, face or fingers, without limb movement~= moderate fasciculations occurring a... | succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures | Rocuronium, Succinylcholine, Neuromuscular Nondepolarizing Agents, Neuromuscular Blocking Agents, Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Neuromuscular Depolarizing Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Succinylcholine<br>Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy. | Drug: Succinylcholine<br>* Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and... | Muscle Relaxation for Short Procedures
Study Overview
=================
Brief Summary
-----------------
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. Th... | |
NCT05249855 | Balneotherapy and Anxiety During SARS-CoV-2 Pandemic | Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state. | Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.~A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer ... | Balneotherapy and Anxiety During SARS-CoV-2 Pandemic | D001452 | * Behavioral: Psychological measurement
| Inclusion Criteria:~enrolled in balneological treatment~Exclusion Criteria:~not enrolled in the balneological treatment | null | null | All | No | Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Anxiety | Low level of anxiety | 10 days |
| balneology, anxiety, fear of SARS-CoV-2, resilience, general trust | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Longitudinal Study<br>A longitudinal study of anxiety over the balneological treatment. | Behavioral: Psychological measurement<br>* Psychological assessment<br>|
| Balneotherapy and Anxiety During SARS-CoV-2 Pandemic
Study Overview
=================
Brief Summary
-----------------
Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxie... | ||
NCT04106622 | Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location | To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart.~To investigate whether the accessory pathway location can predict the high risk nature of the accessory pathway | The Wolf-Parkinson-White (WPW) syndrome is a clinical entity characterized by the presence of ≥1 accessory pathways between the atria and the ventricles pre-disposing patients to arrhythmias. Anterograde conduction through the accessory pathway leads to preexcitation of the ventricles and a delta wave in the ECG. The p... | Accessory Pathway Antegrade Effective Refractory Period Among Wolff Parkinson White Patients: the Risk in Relation to the Location | Wolff-Parkinson-White Syndrome | * Procedure: electrophysiological study
| Inclusion criteria:~all patients with WPW admitted to Assuit university hospital and subjected to invasive EPS~Exclusion criteria:~heart failure~cardiomyopathy | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the antegrade refractory period during invasive EPS done for the patients | the values will be correlated to the site of the AP diagnosed be EPS.. according to the previous studies and the current guidelines, if the refractory period is < 250 ... | Wolff-Parkinson-White Syndrome | Parkinson Disease, Pre-Excitation Syndromes, Wolff-Parkinson-White Syndrome, Accessory Atrioventricular Bundle, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases, Pathological Condit... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wolff Parkinson White patients<br>The investigators will decide the location of the AP by:~- Invasively: if the patient is subjected to (EPS)~• There are different locations of AP To assess whether the AP is of high risk or not, for all patients the Ant... | Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location
Study Overview
=================
Brief Summary
-----------------
To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart. To investigate whe... | ||
NCT00720057 | Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain. | To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain. | A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain | Toothache | * Drug: Naproxen Sodium ER (BAYH6689)
* Drug: Placebo
| Inclusion Criteria:~Healthy, ambulatory, male and female volunteers between 16 to 45~Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction~No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain re... | 16 Years | 45 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Pain Intensity Difference (SPID) | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (S... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Pain Relief (TOTPAR) | Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain re... | Dental Pain, Analgesia | Naproxen, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Gout Suppressants, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharm... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen sodium ER (BAYH6689)<br>single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. | Drug: Naproxen Sodium ER (BAYH6689)<br>* Analgesic efficacy in dental pain; per ... | Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Study Overview
=================
Brief Summary
-----------------
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Official Title
----... | |
NCT05502003 | The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients | The aim of this study is to evaluate the effect of telerehabilitation-based high-intensity interval upper extremity exercise training on biochemistry parameters and disease symptoms in fibromyalgia patients. It has been reported that substances such as serotonin and tryptophan are found at abnormal levels in the seroto... | Fibromyalgia is a chronic musculoskeletal disease of unknown etiology accompanied by symptoms such as pain, hyperalgesia, sleep disorders, fatigue and mood disorders. It has been suggested that a defect in the serotonergic system is involved in the pathophysiology of the disease. The serotonergic system has been associ... | Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia | Fibromyalgia | * Other: High Intensity Interval Training
* Other: Moderate Exercise Training
| Inclusion Criteria:~Participants diagnosed with fibromyalgia according to the American College of Rheumatology 2016 criteria.~Participants between the ages of 18-65~Participants who do not use a drug that will affect the treatment results~Participants who volunteer~Exclusion Criteria:~Infection~Fever~Any known advanced... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of serum free tryptophan | Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen.The analysis will be completed by following the manufacturer's instructions of ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold Assessment | Pressure pain threshold assessment will be done with an algometer. | 6 weeks |
| Evaluation of Grip Strength | Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer). | 6 weeks |
... | fibromyalgia, high intensity interval training, telerehabilitation, tryptophan | Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Neuromuscular Diseases, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training<br>With the arm ergometer given to the participants, a telerehabilitation-based upper extremity aerobic exercise program will be applied. Maximum Heart Rate (MHR) will be determined by the formula '220-age'... | The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients
Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of telerehabilitation-based high-intensity interval upper extremity exercise training on biochemistry parameters and disease symptoms in... |
NCT00720668 | The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma | This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome. | It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. Th... | The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma | Hepatitis B, Hepatocellular Carcinoma | * Procedure: radiofrequency ablation
| Inclusion Criteria:~Age 18 - 75 years~HBV carrier with HCC~After percutaneous radiofrequency ablation;~No history of encephalopathy, ascites refractory to diuretics or variceal bleeding~No HCV or HIV co-infection~No previous treatment of HCC~No previous treatment of HBV except Lamivudine~Exclusion Criteria:~Patient com... | 18 Years | 75 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Exacerbation of chronic hepatitis B after RFA | | one week, one month, one year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | | 1, 3, 5-year |
| mortality | | one month |
| hepatitis B, hepatocellular carcinoma, radiofrequency ablation, reactivation | Hepatitis A, Hepatitis B, Hepatitis B, Chronic, Carcinoma, Carcinoma, Hepatocellular, Hepatitis, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Infections, Enterovirus Infections, Picornaviridae Infections... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patient with hepatocellular carcinoma after radiofrequency ablation | Procedure: radiofrequency ablation<br>* radiofrequency ablation for HCC<br>* Other names: RFA;|
| The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
Study Overview
=================
Brief Summary
-----------------
This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatect... | |
NCT05421338 | A Study in Healthy Men to Test How BI 456906 is Processed in the Body | This trial is intended to examine the basic pharmacokinetics of BI 456906 and total [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity. | A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 456906 (C-14) Administered Subcutaneously to (Otherwise) Healthy Male Volunteers With Normal Body Weight, Overweight or Obesity | Healthy | * Drug: BI 456906 (C-14)
| Inclusion Criteria:~Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ele... | 18 Years | 65 Years | Male | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_urine, 0-tz) | | up to 7 weeks |
| Fraction of [14C]-radioactivity excre... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte (Cmax) | | up to 22 days |
| Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz) | | up to 22 days |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 456906 (C-14)<br> | Drug: BI 456906 (C-14)<br>* BI 456906 (C-14)<br>|
| A Study in Healthy Men to Test How BI 456906 is Processed in the Body
Study Overview
=================
Brief Summary
-----------------
This trial is intended to examine the basic pharmacokinetics of BI 456906 and total [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single su... | |||
NCT00577135 | Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study) | Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduced blood flow throughout the body, congestion of blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics are often used to address the problem of f... | Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Heart failure symptoms include shortness of breath, swelling, and fatigue. Standard treatment for the swelling associated with heart failure includes the use of diuretic medications, such as furosem... | Diuretic Optimal Strategy Evaluation in Acute Heart Failure (The DOSE-AHF Study) | Heart Failure | * Drug: Furosemide-Q12 hour bolus
* Drug: Furosemide-Continuous Infusion
* Drug: Furosemide-Low Intensification
* Drug: Furosemide-High Intensification
| Inclusion Criteria:~Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month~Current diagnosis of heart failure, as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary v... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Well Being, as Determined by a Visual Analog Scale | Global Visual Analog Scale Scale Range 0-7200; higher score is better | Measured at 72 hours |
| Change in Serum Creatinine | | Measured at baseline and 72 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | | baseline and 96 hours |
| Proportion of Patients Free of Congestion | | Measured at 72 hours |
| Dyspnea, as Determined by Visual Analog Scales | Global Visual Analog Scale Scale Range 0-2400; higher score is better | ... | Loop Diuretics, Furosemide, Fluid Overload, Cardio Renal Failure | Furosemide, Diuretics, Sodium Potassium Chloride Symporter Inhibitors, Natriuretic Agents, Physiological Effects of Drugs, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q12 hour bolus<br>Furosemide-Q12 hour bolus | Drug: Furosemide-Low Intensification<br>* 1x oral dose<br>* Other names: Loop diuretic;Drug: Furosemide-High Intensification<br>* 2.5x oral dose<br>* Other names: loop diuretic;|
| Experimental... | Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
Study Overview
=================
Brief Summary
-----------------
Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduce... |
NCT04820712 | Surgical Therapy and Survival in HCC/ C.F. Zhang et al. | This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of surgery. The SEER database, which is one of the most comprehensive and authoritative databases concerning cancer, was used to... | The SEER data contain no identifiers and are publicly available for studies of cancer-based epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from Institutional Review Board approval and the need for informed consent was waived. The submitted magazine requires registration on the ... | Surgical Therapy and Survival in Young Patients With Stage I-II Hepatocellular Carcinoma: A Retrospective Cohort Study | Hepatocellular Carcinoma, Surgery | Inclusion Criteria:~Patients were diagnosed with colorectal cancer only;~Patients with simultaneous metastasis of liver and lung cancer cells;~Patients without metastasis resection;~whether they underwent palliative primary tumor resection was known;~Their cause of death was known;~Their survival time were known and gr... | 18 Years | 45 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival was defined as the duration between the surgery and death or the last follow-up | 2004.1.1-2013.12.31 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific survival | Cancer-specific survival was defined as the period between the surgery and death due to cancer to reduce the impact of life-threatening comorbidities. | 2004.1.1-2013.12.31 |
| Neoplasms, Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases | Surgical Therapy and Survival in HCC/ C.F. Zhang et al.
Study Overview
=================
Brief Summary
-----------------
This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of sur... | ||||
NCT00974571 | Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) | This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control. | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis | Perennial Allergic Rhinitis | * Drug: montelukast sodium
* Drug: Comparator: cetirizine
* Drug: Comparator: placebo
| Inclusion Criteria:~Patient has a documented clinical history of perennial allergic rhinitis~Patient is a nonsmoker~Patient is in good general health~Exclusion Criteria:~Patient is hospitalized~Patient is a woman who is <8 weeks postpartum or is breast-feeding~Patient is a current or past abuser of alcohol or illicit d... | 15 Years | 85 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Daytime Nasal Symptoms Score | Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Sc... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nighttime Symptoms Score | Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Cong... | Histamine H1 Antagonists, Anti-Asthmatic Agents, Leukotriene Antagonists, Cetirizine, Montelukast, Respiratory System Agents, Hormone Antagonists, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Cytochrome P-450 CYP1A2 Inducers, Cytochrome P-450 Enzyme Inducers, Molecular Mechani... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>montelukast | Drug: montelukast sodium<br>* montelukast 10 mg tablet orally once daily at bedtime for 6 weeks<br>|
| Active Comparator: 2<br>cetirizine | Drug: Comparator: cetirizine<br>* cetirizine 10 mg tablet orally once daily at b... | Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Study Overview
=================
Brief Summary
-----------------
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an acti... | ||
NCT02218840 | Behavioral Pharmacology Associated With Cigar Smoking | Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This study will be evaluating the behaviors of cigar smokers and the short term effects of cigar smoking.~A cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are small cigars with filters that res... | This study seeks to better understand dependence behaviors in small and large cigar smokers. All recruited cigar smokers will be self-defined as users on ≥ 1 day(s) per week for the past 6 months. They will not be currently using any other type of tobacco product for the past 6 months. Study subjects will smoke their o... | Behavioral Pharmacology Associated With Cigar Smoking | Cigar Smoking | * Other: Smoking topography
| Inclusion Criteria:~Willing to voluntarily sign the IRB approved informed consent form (ICF)~Willing to complete all the requirements of the study~Male or Female, ≥ 18 years of age~Female subjects must be either:~Surgically sterile defined as having had a hysterectomy, bilateral oophorectomy, or tubal ligation, amenorr... | 18 Years | 99 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Beharioral/Self-Reported Aspects of Cigar Smoking | Characterize and quantify dependence, withdrawal relief, cravings, puff topography | 4 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate smoking exposure | Identifying smoking puff topography and laboratory markers of exposure (nicotine, NNAL, breath CO, and cotinine). | 4 weeks |
| cigar smoker, smoking, behavioral pharmacology, smoking topography | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Behavioral<br>Evaluation of cigar smoking topography | Other: Smoking topography<br>* Evaluation of cigar smoking topography<br>|
| Behavioral Pharmacology Associated With Cigar Smoking
Study Overview
=================
Brief Summary
-----------------
Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This study will be evaluating the behaviors of cigar smokers and the short term effects of cigar smoking. A cigar... | ||
NCT04616833 | [Trial of device that is not approved or cleared by the U.S. FDA] | [Trial of device that is not approved or cleared by the U.S. FDA] | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Trial of device that is not approved or cleared by the U.S. FDA]
Study Overview
=================
Official Title
-----------------
[Trial of device that is not approved or cleared by the U.S. FDA]
Participation Criteria
=================
Ages Eligible for Study
-----------------
Minimum Age:
Maximum Age:
Study... | ||||||||||||||
NCT01016041 | A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial | Instead of treating in-stent restenosis, the best strategy for patients is preventing in-stent restenosis. Recent advances in the understanding of the cellular mechanism responsible for smooth muscle cell proliferation (neointimal hyperplasia), together with improvement in stent coating and eluting technology have prov... | A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial | Stable Angina, Unstable Angina, Acute Coronary Syndrome | * Device: everolimus stent
* Device: paclitaxel stent
| Inclusion Criteria:~Any patient from 18 to 85 years with lesions feasible for PCI treatment.~Exclusion Criteria:~Dual antiplatelet therapy contraindication,~Participation in other trials,~No informed consent. | 18 Years | 85 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the study is the composite end point of: all death, non fatal myocardial infarction, target vessel revascularization at 1 year. | | 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up. | | 12 months |
| drug-eluting stent, stable angina, ACS, MACE, safety, stent thrombosis | Paclitaxel, Everolimus, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, MTOR Inhibitors, Protein Kinase Inhibitors, Enzyme Inhibitors, Immunosuppressive Agents, Immunologic Factors, Physiological Effect... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus stent<br> | Device: everolimus stent<br>* stenting<br>|
| Active Comparator: paclitaxel eluting<br> | Device: paclitaxel stent<br>* stenting<br>|
| A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial
Study Overview
=================
Brief Summary
-----------------
Instead of treating in-stent restenosis, the best strategy for patients is preventing in-stent restenosis. Recent advan... | |
NCT01738035 | The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease | The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin ... | NEFECON is an add-on treatment to other medications for nephropathy symptoms and kidney function, including ACEI and/or ARBs. Rigorous blood pressure control will be achieved over a 6-month Run-in Phase in which ACEI and/or ARB will be dosed to target a blood pressure of <130/80 mm Hg and UPCR <0.5 g/g. Patients who co... | A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease | Primary IgA Nephropathy | * Drug: NEFECON
* Other: Placebo
| Screening Inclusion Criteria:~Female or male patients ≥18 years~Biopsy-verified IgA nephropathy~Urine protein creatinine ratio ≥0.5 g/g OR urine protein ≥0.75 g/24hr~Estimated GFR (using the CKD-EPI formula) OR measured GFR ≥50 mL/min per 1.73 m2 OR ≥45 mL/min per 1.73m2 for patients on a maximum recommended or maximum... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine protein creatinine ratio | | 9 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin creatinine ratio | | 9 months |
| Change from baseline in 24 hour albuminuria | | 9 months |
| Change from baseline in estimated GFR | | 9 months |
| IgA nephropathy | Budesonide, Anti-Inflammatory Agents, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Asthmatic Agents, Respiratory System Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEFECON 8 mg/day<br>NEFECON 8 mg/day (2 active + 2 placebo capsules daily) for 9 months | Drug: NEFECON<br>* All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maxi... | The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease
Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA ne... |
NCT01564680 | Lornoxicam vs. Paracetamol After Lower Abdominal Surgery | Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.~Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly a... | Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial | Postoperative Pain | * Other: placebo
* Drug: Paracetamol
* Drug: Lornoxicam
| Inclusion Criteria:~lower abdominal surgery~Exclusion Criteria:~body weight more than 150% of their ideal body weight~history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulc... | 18 Years | 69 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively. | 24 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively | 24 hours |
| Incidence of side-effects | incidence of side... | Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine | Acetaminophen, Lornoxicam, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Antipyretics, Anti-Inflammatory Agents, Non-Steroidal, Anti-Inflammatory Agents, Antirheumatic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lornoxicam<br>Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively | Drug: Lornoxicam<br>* 16 mg at skin closure and 8 mg 12 hours postoperative<br>* Other names: xefo;|
| Placebo Comparator: Contr... | Lornoxicam vs. Paracetamol After Lower Abdominal Surgery
Study Overview
=================
Brief Summary
-----------------
Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lowe... | |
NCT02548832 | Bezafibrate Plus Berberine in Mixed Dyslipidemia | Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for class... | The aim of this study is to evaluate the effect of berberine plus bezafibrate administration on the lipid profile of patients with mixed dyslipidemia.The investigators will conduct a double-blind randomized pilot clinical trial with parallel groups in men and women aged 30-60 years old with diagnosis of mixed dyslipide... | Effect of Berberine Plus Bezafibrate Administration on the Lipid Profile of Patients With Mixed Dyslipidemia: A Pilot Clinical Trial | Mixed Dyslipidemia | * Drug: Berberine
* Drug: Bezafibrate
* Drug: Berberine plus Bezafibrate
| Inclusion Criteria:~A. Men and women~B. Accomplished age 30 to 60 years~C. Diagnosis of mixed dyslipidemia established to meet the following criteria:~Total cholesterol > 5,17 mmol/l.~Triglycerides > 1,7 mmol/l.~D. BMI of 25 kg / m^2 to 39.9 kg / m^2, weight stable over the past three months, defined as a variability i... | 30 Years | 60 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides After 90 Days | The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method. | 90 days |
| Total Cholesterol After 90 Days... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (BW) After 90 Days | The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | 90 days |
| Body Mass Index (BMI) A... | Berberine, Bezafibrate | Bezafibrate, Hypolipidemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Lipid Regulating Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine<br>Berberine 500 mg with breakfast, meal, and dinner. | Drug: Berberine<br>* Berberine 1500 mg, each 24 h for 90 days~1 Berberine capsule 500 mg for breakfast.~1 Berberine capsule 500 mg for lunch.~1 Berberine capsule 500 mg for ... | Bezafibrate Plus Berberine in Mixed Dyslipidemia
Study Overview
=================
Brief Summary
-----------------
Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to incr... |
NCT00419991 | Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection | Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms and provides activity against emerging multi-drug resistant pathogens. The purpose of this protocol is to determine the linkage between time related clinical measures of infection response and time to bacterial eradication in p... | Tigecycline, a glycylcycline antibiotic and an analog of the tetracycline minocycline, demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant gram-positive, gram-negative, anaerobic, and atypical bacteria. It is being developed as an agent that overcomes tetracycline-resistance mechani... | An Open-Label Noncomparative, Multicenter, Clinical Trail Measuring Time Related Clinical Response Factors in Relation to Time to Bacterial Eradication With Tigecycline Treatment in Patients With Catheter Infection | Staphylococcal Infections | * Drug: Tigecycline
| Inclusion Criteria:~Male or female patients, 18-85 years of age and a weight of > 45 kilograms.~Patients with intravascular catheters and a blood culture that is positive for gram-positive cocci in clusters. Patients will be subsequently excluded from the study analysis if they do not have a culture-positive infection ... | 18 Years | 85 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to bacterial eradication | | 7-14 days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of Tigecycline in patients with intravascular catheter infections | | 7-14 days |
| Tigecycline, Staphylococcal Infections, Catheter | Tigecycline, Anti-Bacterial Agents, Anti-Infective Agents, Protein Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1 Tigecycline<br> | Drug: Tigecycline<br>* All patients will receive tigecycline infusions approximately every 12 or 24 hours. The usual regimen of tigecycline is (an initial intravenous (IV) dose of 100 mg followed by 50 mg approximate... | Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Study Overview
=================
Brief Summary
-----------------
Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms and provides activity against emerging multi-drug resistant pathogen... |
NCT01909843 | ALX-0171 Safety Study in Adults With Hyperresponsive Airways | This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways.~This phase I study is an exploratory study and serves to evaluate the occur... | A Phase I, Single-centre, Open Label Study to Evaluate the Potential Occurrence, Reversibility and Prevention of Bronchoconstriction as Individual Response to Escalating Doses Followed by Repeated Doses of ALX-0171, Administered by Oral Inhalation to Adults With Hyperresponsive Airways | Respiratory Syncytial Virus Infection | * Biological: ALX-0171
| Inclusion Criteria:~Adult male and female subjects aged 18-60 years (both included).~Subjects must demonstrate a PC20 (concentration of the agonist in the inhaled substance leading to a fall in FEV1 of ≥20.0% of personal best at same visit) response to methacholine (MCh) concentrations of > 1 mg/mL and ≤ 8 mg/mL at scr... | 18 Years | 60 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation | | Within a period of 8 hou... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of bronchoconstriction events | | Day 1 to Day 7 |
| The frequency of use of β2-agonist for the treatment of study drug/procedure induced bronchoconstriction | | Day 1 to Day 7 |
| Safety markers | between others: physical exa... | Gontivimab, Antiviral Agents, Anti-Infective Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALX-0171 Oral inhalation<br> | Biological: ALX-0171<br>* Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4... | ALX-0171 Safety Study in Adults With Hyperresponsive Airways
Study Overview
=================
Brief Summary
-----------------
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations ... | ||
NCT03672136 | Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients | The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients. | The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectable stage III NSCLC patients, whether this regimen can improve PFS. | Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients：An Exploratory Single-Arm Phase II Clinical Trail | Carcinoma, Non-Small-Cell Lung | * Drug: Anlotinib
* Other: Concurrent Chemoradiotherapy
| Inclusion Criteria:~Patients voluntarily participate in this study, signed informed consent.~Patients pathologically diagnosed as locally advanced (IIIB / IV) unresectable non-small cell lung cancer, with measurable lesions; IIIa3 patient: Multiple stations lymph node metastasis detected by mediastinoscope, other lymph... | 18 Years | 75 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | 2 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 2 years |
| ORR | Objective Response Rate | 2 years |
| DCR | Disease Control Rate | 2 years |
| Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent Chemoradiotherapy+Anlotinib<br>Radiotherapy: Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy. If radiotherapy and chemotherapy are conducted in the same day, chemotherapy shou... | Concurrent Chemoradiotherapy Combination With Anlotinib for Unresectable Stage III NSCLC Patients
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether concurrent chemoradiotherapy combination with Anlotinib is safe, effective in the treatment of unresectabl... | |
NCT04076384 | Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions | The study will develop and evaluate the effectiveness of a team-based follow-up program in general practice (GP) among people with chronic conditions. | The epidemic proportion of lifestyle related non-communicable diseases is a worldwide challenge and public health problem resulting in significant hospitalization rates, mortality and morbidity, and huge personal and societal costs. This project involves research for better public health and health outcomes acknowledgi... | Effectiveness of a Team-based Follow-up Program in General Practice: Protocol of a Mixed-method Complex Intervention Trial Among People With Chronic Conditions | Diabetes Type 2, COPD | * Behavioral: Guided Self-Determination
* Behavioral: Standard care
| Inclusion Criteria:~Aged between 20-80 years with FINDRISC score ≥15~Body Mass Index ≥ 30~Manifest T2DM (HbA1c ≥48 mmol/mol (6,5%))~Positive smoking status (risk for COPD)~Manifest COPD (spirometry value: FEV1/FVC < 0,7).~Exclusion Criteria:~Severe somatic disease (cancer, end stage renal disease)~Severe psychiatric di... | 20 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure (PAM-13) | The Patient Activation Measure instrument capture patient's knowledge, skills and confidence for self-management living with chronic conditions.It has four response categories with scores from 1 to 4: stro... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Blood glucose | 12 months |
| Problem Areas in Diabetes Scale (PAID-5) | The Problem Areas in Diabetes Scale measures negative emotions related to living with diabetes. The scores are on a 5-point Likert scale ranging from 0 (not a pr... | Diabetes Mellitus, Type 2, Chronic Disease, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team-based consultations<br>Guided Self-Determination | Behavioral: Guided Self-Determination<br>* Structured team-based consultations<br>|
| Experimental: Standard care<br>Standard consultation | Behavioral: Standard care<br>* Standard co... | Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
Study Overview
=================
Brief Summary
-----------------
The study will develop and evaluate the effectiveness of a team-based follow-up program in general practice (GP) among people with chronic conditions... | |
NCT05424978 | Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an | Objective: To observe the practical application of the standardized green channel treatment system for stroke in Xi 'an in the real world. Methods: Clinical data and information of patients with acute ischemic stroke who received standardized green channel treatment for stroke were collected, and a multicenter observat... | The standardized green channel treatment system for acute ischemic stroke includes: Triage nurse triage timely, rapid assessment emergency doctor, suspected stroke the green channel, immediately start in the green channel of stroke accompanied by doctors and nurses stroke patients improve CT examination, intravenous th... | Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an | Acute Ischemic Stroke, Thrombolysis, Endovascular Treatment | * Other: Standardized green channel treatment methods for stroke
| Inclusion Criteria:~18 years old;~Consistent with the diagnosis of acute ischemic stroke;~24 hours from onset to enrollment;~Informed consent~Exclusion Criteria:~Patients who refuse to receive intravenous thrombolysis or intravascular intervention (including intravascular mechanical thrombolysis and arterial thrombolys... | 18 Years | 100 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of function independent | Rate of modified Rankin Scale(mRS) score less than 3 at 90 days | 90 days after onset |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality | 90-day mortality rate | 90 days after onset |
| Rate of stroke recurrence | 90-day stroke recurrence rate | 90 days after onset |
| Rate of cerebral hemorrhage and pneumonia | Incidence of cerebral hemorrhage and pneumoni... | Stroke, Ischemic Stroke, Cerebral Infarction, Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Pathologic Processes, Brain Infarction, Brain Ischemia, Infarction, Necrosis | | Intervention/Treatment |
| --- |
|Other: Standardized green channel treatment methods for stroke|The measures include six measures: timely triage by triage desk nurses; Rapid evaluation by emergency room physician; If stroke is suspected, the green channel for nosocomial stroke should be activated immediately. Stroke... | Application of Standardized Green Channel Treatment System for Ischemic Stroke in Xi 'an
Study Overview
=================
Brief Summary
-----------------
Objective: To observe the practical application of the standardized green channel treatment system for stroke in Xi 'an in the real world. Methods: Clinical data and... | ||
NCT05282420 | Ranibizumab Versus Aflibercept for CRVO in Young Patients. | this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old | This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.~Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will ... | Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients. | Non-Ischemic Central Retinal Vein Occlusion With Macular Edema | * Procedure: intravitreal injection of Ranibizumab
* Procedure: intravitreal injection of Aflipercept
* Drug: Ranibizumab
* Drug: Aflibercept
| Inclusion Criteria:~patients younger than 50 years with macular edema due to non-ischemic CRVO~Exclusion Criteria: Other conditions that might affect the macula as~diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,~patients with ischemic type ... | null | 50 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\0.1 ml afl... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity BCVA | change BCVA after injection | at 12 months post-injection |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of macular edema | change in central subfield macular thickness CST on OCT | at 12 months post-injection |
| non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept | Ranibizumab, Aflibercept, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab group<br>Ranibizumab injection monthly for 3 successive months | Procedure: intravitreal injection of Ranibizumab<br>* intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genent... | Ranibizumab Versus Aflibercept for CRVO in Young Patients.
Study Overview
=================
Brief Summary
-----------------
this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients youn... |
NCT02757079 | Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders | The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15. | This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During open label treatment phase, all patients will be administered NP... | Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders - | Sleep Disorders, Neurodevelopmental Disorder | * Drug: NPC-15
| Inclusion Criteria:~Female or male patients aged 6 to 15 years.~Patients with neurodevelopmental disorder diagnosed by using DSM-5.~Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months~Patients who are out-patient, not hospitalized patient.~Signed informed con... | 6 Years | 15 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency with electronic sleep diary at week 10. | Sleep latency is a common endpoint in sleep disorders. In addition, it has been used in a randomized clinical study of sleep disorders of children with neurodevelopmental disorders. | 10 ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency with electronic sleep diary at week 26. | To assess the efficacy of this drug in detail | 26 weeks |
| Abnormal behavior checklist Japanese version | To assess effects of this drug on neurodevelopment disorders | Week 10, 26 |
... | Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5 | Melatonin, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Central Nervous System Depressants | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-15 Granule<br>NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed. | Drug: NPC-15<br>* NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks ... | Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
Detailed Descript... |
NCT03969615 | SuperNO2VA™ and General Anesthesia Postoperative Care | The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively i... | SuperNO2VA™ and General Anesthesia Postoperative Care: Comparing the Incidence, Severity, and Duration of Postoperative Oxygen Desaturation Between SuperNO2VA™ and Standard of Care, a RCT | Hypoxemia, Acute Respiratory Failure | * Device: SuperNO2VA nasal positive airway pressure devic
* Device: Supplemental oxygen
| Inclusion Criteria:~Age 18 years of age or older~Patients scheduled for general anesthesia with a supraglottic device or ETT~American Society of Anesthesiology (ASA) Physical Status I-IV (E)~Has provided written informed consent~BMI > 35 kg/m2 or documented Obstructive Sleep Apnea~Exclusion Criteria:~Inability to give ... | 18 Years | null | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute) | Within 90 minutes of extubation between the two study groups. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway maneuvers | Compare the number of airway interventions including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with ETT or SGA insertion performed by anesthesia providers | Within 90 minutes... | Respiratory Insufficiency, Hypoxia, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplemental oxygen<br>5lpm of supplemental oxygen via a nasal cannula or face mask | Device: Supplemental oxygen<br>* 5lpm of supplemental oxygen<br>* Other names: face mask;|
| Experimental: SuperNO2VA nasal positive airway pressure... | SuperNO2VA™ and General Anesthesia Postoperative Care
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating devic... | ||
NCT05333536 | Effects of Strength Training on Freestyle Swimming Performance and Core Muscles Strength in Swimmers | To compare the effectiveness performance and core muscles of Strength Training . strength in swimmers on freestyle swimming | There is lack of literature on strength training on freestyle swimming performance, core muscles strength in swimmers, kicking, and stroke rate. With the help of this study the swimming performance of individual s will improve. | Effects of Strength Training on Freestyle Swimming Performance and Core Muscles Strength in Swimmers | Sports Physical Therapy | * Other: Experimental: Experimental group exercises
* Other: No Intervention: Control group
| Inclusion Criteria:~Competitive swimmers~male gender~Experience of more than a year of swimming~Exclusion Criteria:~Individuals with associated neuromuscular conditions and any injuries to lower limbs.~Spinal injuries have been excluded in the study. | 18 Years | null | Male | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups , comparison group a control and b experimental
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50 meter Swimming Test | Done by stop watch, changes will be assessed accordingly: First week Pre test and post test in 6th week which will be last week of work | 6th week |
| Core muscle strength test | Determine by stop watch .Used for moni... | Stroke rate, Free style, Stability ball, Core strength | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group exercises<br>Experimental performs Strengthening exercises of core.10 reps , 3 sets of each.Prone plank(10 sec hold)(18) ,Side plank (8 sec hold),Bridging (8 sec hold)(19),Bird dog (10 reps ,3 sets),Leg drop (10 reps, 3 ... | Effects of Strength Training on Freestyle Swimming Performance and Core Muscles Strength in Swimmers
Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness performance and core muscles of Strength Training . strength in swimmers on freestyle swimming
Detailed Description
-------... | ||
NCT04237233 | Intense Monitoring Study on Tyvyt | The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma. | Intense Monitoring Study on Sintilimab Injection (Tyvyt®) | Relapsed or Refractory Classical Hodgkin's Lymphoma | Inclusion Criteria:~Patients must be able to understand and voluntarily sign the informed consent form (ICF).~Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.~Patients must have agreed to use Tyvyt® to treat the target indica... | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of known adverse drug reactions | | During the actual Tyvyt treatment time. |
| Occurrence of new adverse drug reactions | | During the actual Tyvyt treatment time. |
| Association, risk factors, severity and incidence of immune-... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | | During the actual Tyvyt treatment time. |
| Intense Monitoring Study on Tyvyt
Study Overview
=================
Brief Summary
-----------------
The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical ... | ||||||
NCT01512940 | Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients. | Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive pro... | Since the acceptance of surgical procedures to achieve a sustainable weight loss, many different procedures has been tried with variable success. Among them , various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal r... | Laparoscopic Greater Curvature Plication for Weight Loss and Resolution of Diabetes and Other Comorbidities. | Obesity | * Procedure: Laparoscopic Greater Curvature Plication
| Inclusion Criteria:~Subject is willing to give consent and comply with evaluation and treatment schedule;~18 to 65 years of age (inclusive);~Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may i... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent excess weight loss | The percent excess weight loss at 3-years from the time of surgery. The primary analysis will include all available data at the 3-year follow-up. | 3 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of comorbidities | The following comorbidities will be assessed at regular intervals: diabetes, dyslipidemia, liver dysfunction, and hypertension. Measures will include glycosylated hemoglobin, triglycerides, low-density lipoprotein... | obesity, Laparoscopic Greater Curvature Plication, Percent Excess weight Loss, comorbidities, BMI, Bariatric Surgery | Obesity, Overweight, Overnutrition, Nutrition Disorders, Body Weight | | Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Greater Curvature Plication|The greater curvature of the stomach is separated from the greater omentum. At least two rows of at least five continuous stitches will be placed about the greater curvature of the stomach starting at or near the angle of His and en... | Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.
Study Overview
=================
Brief Summary
-----------------
Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesopha... |
NCT02839720 | Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma | This pilot phase II trial studies how well selumetinib works in treating patients with neurofibromatosis type 1 and cutaneous neurofibromas. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. | PRIMARY OBJECTIVE:~I. Determine if selumetinib sulfate (selumetinib) can result in shrinkage of cutaneous neurofibromas.~SECONDARY OBJECTIVE:~I. Assess the effect of selumetinib on target inhibition in cutaneous neurofibroma(s) excised prior treatment and on treatment with selumetinib for analysis of percent inhibition... | Pilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (CNF) | Cutaneous Neurofibroma, Neurofibromatosis Type 1, Optic Nerve Glioma | * Other: Laboratory Biomarker Analysis
* Drug: Selumetinib Sulfate
| Inclusion Criteria:~Patients be >= 18 years old at the time of enrollment and must have a documented germline neurofibromatosis 1 (NF1) mutation in a Clinical Laboratory Improvement Act (CLIA) certified laboratory or a diagnosis of NF1 based on clinical National Institutes of Health (NIH) consensus criteria; in additio... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Best Response of Cutaneous Neurofibromas in Participants With at Least One Restaging Evaluation | Average percent change in volume of target cutaneous neurofibromas from baseline. Cutaneous neurofibromas measured with calipers and volum... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Number of Cutaneous Neurofibromas | At the time of each response evaluation (baseline and then after every 4 cycles), the number of cutaneous neurofibromas (cNFs) that are greater than 4mm as measured with a caliper were counted ... | Neurofibromatoses, Neurofibromatosis 1, Neurofibroma, Optic Nerve Glioma, Nerve Sheath Neoplasms, Neoplasms, Nerve Tissue, Neoplasms by Histologic Type, Neoplasms, Neoplastic Syndromes, Hereditary, Neurocutaneous Syndromes, Nervous System Diseases, Heredodegenerative Disorders, Nervous System, Neurodegenerative Disease... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (selumetinib sulfate)<br>Patients receive selumetinib sulfate PO twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients who exp... | Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma
Study Overview
=================
Brief Summary
-----------------
This pilot phase II trial studies how well selumetinib works in treating patients with neurofibromatosis type 1 and cutaneous neurofibromas. Selumetinib may stop th... | |
NCT04406402 | L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols | Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/ obese and T2DM subjects. | The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese ... | The Effects of Different Acute Nutritional Protocols and Lifestyle Modification on Circulating L-arginine and Asymmetric Dimethylarginine (ADMA) in Obese and Type 2 Diabetic Subjects | Diabetes Mellitus, Type 2, Obesity, Arginine, Asymmetric Dimethylarginine | * Behavioral: Acute dietary protocols and lifestyle modification
| Inclusion Criteria:~obese and/ or T2DM subjects~Exclusion Criteria:~type 1 diabetes~insulin-treated T2DM~active coronary disease (recent [≤ 6months] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting~individuals with significant impairment in liver enzymes (≥ 2.5 the up... | 40 Years | null | All | No | Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum L-arginine change | Change in arginine levels (absolute and relative) (µmol/l) | For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) change | Change in BMI levels (Kg/m2) | From baseline to 12 weeks for lifestyle modification phase |
| Glycated hemoglobin (HbA1c) change | Change in HbA1c levels (%) | From baseline to 12 weeks for lifestyle modificatio... | Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute glucose tolerance test<br>A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water) | Behavioral: Acute dietary protocols and lifestyle modification<br>* The investigators tested the effects on serum Arg and AD... | L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols
Study Overview
=================
Brief Summary
-----------------
Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not ... | |
NCT02192619 | National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup | The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.~Prospective population-based non-interventional and non-randomized multicenter registry. | collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence~documentation of efficacy and safety of the first line and salvage therapy in APL including~documentation of minimal residual disease (MRD)~correlation of clinical outcomes with chosen therapy~collecti... | National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup | Newly-diagnosed APL (de Novo or Therapy-related), Relapsed APL | * Other: observational
| Inclusion Criteria:~newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis~or relapsed APL, within 12 months of diagnosis of relapse~confirmed by the presence of the translocation t(15; 17)~and / or confirmed by the detection of the fusion transcript of PML/RARa~Exclusion Criteria:~none | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiological parameters | | yearly follow up for 5 years |
| diagnostic quality indicators | | yearly follow up for 5 years |
| type of therapy | | yearly follow up for 5 years |
| response, recurrence and time of death and resulting ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission (CR) and CRm | | yearly follow up for 5 years |
| treatment related mortality (TRM) | | yearly follow up for 5 years |
| cumulative incidence of relapse (CIR) | | yearly follow up for 5 years |
| grade IV toxicities | ... | APL, acute promyelocytic leukemia, AML M3 | Leukemia, Leukemia, Promyelocytic, Acute, Neoplasms by Histologic Type, Neoplasms, Leukemia, Myeloid, Acute, Leukemia, Myeloid | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational<br> | Other: observational<br> <br> |
| National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Study Overview
=================
Brief Summary
-----------------
The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally... | |
NCT05447650 | Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT) | Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD). | The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.~U... | Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial. | Nonexudative Age-related Macular Degeneration, Age-Related Macular Degeneration, Dry Age-related Macular Degeneration | * Device: i-Lumen(TM) AMD
* Device: i-Lumen(TM) AMD Sham
| Key Inclusion Criteria:~Age ≥50 years.~Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy~Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye~Key Exclusion Criteria:~History and... | 50 Years | null | All | No | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Device Effects | Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study | Through study completion, Month 12 timepoint |
| AMD, Dry AMD | Retinal Degeneration, Retinal Diseases, Eye Diseases, Macular Degeneration, Geographic Atrophy | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-Lumen AMD Active<br>Active transpalpebral microcurrent stimulation therapy | Device: i-Lumen(TM) AMD<br>* Transpalpebral microcrurrent stimulation<br>|
| Sham Comparator: i-Lumen AMD Sham<br>Sham transpalpebral microcurrent stimulation t... | Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (... | |
NCT01259713 | Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia | The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction. | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission-Induction Chemotherapy for Acute Lymphoblastic Leukemia ... | Invasive Fungal Disease | * Drug: Liposomal amphotericin B
* Drug: Placebo
| Inclusion Criteria:~Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at least 10 days of neutropenia defined as an absolute neutrophil count < 500 cells/mm^3 or 0.5 × 10^9 cells/L~Subjects with lymphoblastic lymphoma or any malignancy other than ALL are NOT eligible for this study.~Age ≥... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL) | Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader | | During remission-induction chemotherapy (average 7 weeks) |
| Percentage of Participants Diagnosed With Proven or Probable IFIs According to the ... | Ambisome, ALL, invasive fungal infection, prophylaxis, liposomal amphotericin B, Invasive fungal infection prophylaxis | Amphotericin B, Liposomal amphotericin B, Amebicides, Antiprotozoal Agents, Antiparasitic Agents, Anti-Infective Agents, Anti-Bacterial Agents, Antifungal Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal amphotericin B<br>Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy | Drug: Liposomal amphot... | Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia
Study Overview
=================
Brief Summary
-----------------
The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal in... | |
NCT00135174 | Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study | The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time. | Specific objectives :~To determine the incidence of complications occurring in the first year after implantation of a pacemaker.~To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation.~To determine which baseline (patient and pacemaker relate... | Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The FOLLOWPACE Study | Arrhythmia, Heart Diseases | Inclusion Criteria:~Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study.~Exclusion Criteria:~Patients are not eligible if they refuse to sign informed consent on use of personal medical data.~P... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacemaker, routine, follow-up, complications, Quality of Life | Heart Diseases, Cardiovascular Diseases | Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study
Study Overview
=================
Brief Summary
-----------------
The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an ap... | ||||
NCT02442986 | Neurological Outcome in Surgical and Non-surgical Septic Patients | Systemic inflammation and sepsis cause multi organ failure including severe neurologic impairment in the course of disease. Neurologic failure typically presents as critical-illness-polyneuropathy/-myopathy and septic encephalopathy during sepsis and is associated with an increased mortality rate.~Clinical parameters t... | All patients with severe sepsis and septic shock and fulfilling the inclusion criteria should be screened for the study on two surgical (septic surgical patients), one medical intensive care unit (septic non-surgical patients) and one neurological intensive care unit (non-septic patients) at the university hospital of ... | Prospective Observational Study: Comparison of Neurological Outcome in Septic Surgical, Septic Non-surgical and Non-septic Patients on ICU | Critical-Illness, Polyneuropathy, Myopathy, Septic Encephalopathy | Inclusion Criteria:~Fulfilling criteria for severe sepsis or septic shock~Exclusion Criteria:~Diagnosis of cerebrovascular disease (pre-existing)~Advanced dementia~Diagnosis of pre-existing other neuromuscular disease~High-dose glucocorticosteroid therapy (> 300 mg Hydrocortisone/die)~Pre-existing renal replacement the... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Septic Encephalopathy | EEG, MRT, CSF (cerebrospinal fluid) | day 7 |
| Critical-Illness-Polyneuropathy and -myopathy | ENG | day 7 |
| Septic Encephalopathy (28) | Clinical observation. | day 28 |
| Critical-Illness-Polyneuropathy and -myo... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 28-day survival (observation time 100 days) | Survival after 28 days. | day 28 |
| - Time of respirator-therapy | In days cumulative. | 1 year |
| - Dosage of vasopressors (cumulative) | In days cumulative. | observation time 100 days |
|... | sepsis, weaning failure, polyneuropathy, encephalopathy | Brain Diseases, Polyneuropathies, Sepsis-Associated Encephalopathy, Critical Illness, Disease Attributes, Pathologic Processes, Central Nervous System Diseases, Nervous System Diseases, Neuromuscular Diseases, Peripheral Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic Shock or severe sepsis<br>Septic patients on ICU with severe sepsis or septic shock. | |
| Non-Septic, Surgical Patients<br>Non-septic patients after surgical treatment and anesthesia on ICU. | |
| Non-Septic, Non-Surgical Patients<br>Patients wi... | Neurological Outcome in Surgical and Non-surgical Septic Patients
Study Overview
=================
Brief Summary
-----------------
Systemic inflammation and sepsis cause multi organ failure including severe neurologic impairment in the course of disease. Neurologic failure typically presents as critical-illness-polyne... | ||
NCT01956435 | Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study | This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or left) will be treated. Treatments with the Xtrac Excimer laser will be performed twice weekly for 12 weeks using the typical vitiligo protocol. O... | Methods: This pilot study will consist of 10 adult subjects with symmetric IGH on the lower legs. After enrollment, 5 lesions of IGH on each leg will be selected by either Dr. Jennifer Gordon or Dr. Ammar Ahmed and marked. Subjects will be randomized to which extremity (right or left) will be treated. Treatments with t... | Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study | Idiopathic Guttate Hypomelanosis | * Device: Excimer Light Treatment
| Inclusion Criteria~Diagnosis of idiopathic guttate hypomelanosis on the bilateral lower extremities with at least 5 lesions on each leg that are overall symmetric as determined by study personnel~Patients must be 18 years or older~Patients may be from any ethnicity but are required to be English-speakers~Patients must ... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcome | Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Impr... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Self-reported Assessment of Re-pigmentation for Treated Lesions | Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using a scale from 1 - 4 with 1 being the least amount of re-pigm... | Hypopigmentation, Pigmentation Disorders, Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Excimer Light Treatment Right Leg, Control Left Leg<br>Excimer light treatment will be performed on the right leg of every subject, no treatment on the left or control leg of the subject. | Device: Excimer Light Treatment<br>* Excimer light treat... | Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
Study Overview
=================
Brief Summary
-----------------
This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or lef... | |
NCT05070988 | Oral Health Related Quality of Life of Patients With Rare Diseases: a Qualitative Approach | The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of expertise at Necker Hospital in Paris by semi-structured interviews. | To date, few studies have used the qualitative method to analyze the oral health-related quality of life and the oral health care pathways of patients with rare diseases, all health sectors combined. The quantitative studies carried out using standardized questionnaires offer only a partial view of how patients feel, b... | Oral Health Related Quality of Life of Patients With Rare Diseases Followed at Necker Hospital: a Qualitative Approach | Rare Diseases | * Other: Semi-structured interview
| Inclusion Criteria:~Minor and adult patients with rare diseases aged of at least 6 years old and followed at the Necker Enfant Malades Hospital, Paris~Patients with the 3 most frequent rare diseases of each rare disease Necker reference center participating in the study (10 centers : Chronic And Malformative Disorders ... | 6 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life assessment | Qualitative method from a semi-structured interview. | Day 0 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of oral health care pathways | Description from the semi-structured interviews. | Day 0 |
| Inequalities in access to oral health care | Description of inequalities in access to oral health care. Description from the semi-structur... | Rare diseases, Oral health-related quality of life, Qualitative method | Rare Diseases, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rare diseases<br>Children and adult patients with rare diseases and followed at the Necker Enfant Malades Hospital, Paris | Other: Semi-structured interview<br>* Semi-structured interview with the investigating doctor of the study lasting 30 minutes to ... | Oral Health Related Quality of Life of Patients With Rare Diseases: a Qualitative Approach
Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to assess the oral health-related quality of life of patients with rare diseases and followed in the rare disease centers of exp... | |
NCT04773574 | Physiologic Ocular Changes During Pregnancy in Women With High Myopia. | The prevalence of myopia is seemingly increasing, and it is one of the major causes of blindness. High myopia is defined as a refractive error with spherical equivalent exceeding -6 diopters and/or the axial length longer than 26.5 mm. The global prevalence of high myopia is estimated to rise from 2.7% of the world pop... | There are few studies of posterior ocular changes during pregnancy. A recent meta-analysis showed that the choroidal thickness and retinal vascular density were increased during pregnancy especially in the 3rd trimester. From the literature review, there is only one publication of physiologic ocular changes during preg... | Physiologic Ocular Changes During Pregnancy in Women With High Myopia. | High Myopia, Pregnancy Related | * Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
| Inclusion Criteria:~age > 18 years~high myopia: spherical equivalent > 6 diopters and/or axial length > 26.5 mm~singleton pregnancy~clear ocular media~written inform consent~Exclusion Criteria:~high risk pregnancy such as pre-eclampsia, gestational diabetes mellitus, hyperthyroidism and asthma.~history of retinal disea... | 18 Years | null | Female | Accepts Healthy Volunteers | Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Choroidal thickness was measured by optical coherence tomography | 40 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vascular density | Percentage of retinal vascular density was measured by optical coherence tomography angiography | 40 weeks |
| Retinal nerve fiber layer thickness | Retinal nerve fiber layer thickness was measured by optical cohere... | choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature, high myopia, pregnancy | Myopia, Refractive Errors, Eye Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal pregnant women with high myopia<br>Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth. | Device: Corneal topog... | Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
Study Overview
=================
Brief Summary
-----------------
The prevalence of myopia is seemingly increasing, and it is one of the major causes of blindness. High myopia is defined as a refractive error with spherical equivalent exceeding -6 d... |
NCT04251832 | Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff | Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. Ultrasound guided percutaneous lavage (UGPL or barbotage or irrigation) of calcific tendinopathy is indicated when conservative treatments (physiotherapy, nonsteroidal anti-inflammatory drugs) have failed. Our hypothesis is that l... | Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. It is characterized by calcium phosphate crystal deposition in the rotator cuff. Its pathogenesis and etiology remains unclear and the mechanisms leading to this pathological mineralization are still largely unknown. This disorder... | Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff | Sodium Thiosulfate, Calcific Tendinitis, Shoulder Pain | * Drug: Sodium Thiosulfate
| Inclusion Criteria:~Age over 18 years old;~Pain for more than 3 months;~Worsening of symptoms with activities above shoulder level;~Minimum one the 3 following impingement positive clinical tests: Yocum, Hawkins or Neer;~Calcification > 5 mm in size on the standard anteroposterior radiographs;~Type A calcification acco... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the calcific deposit | Evaluated using a semi-quantitative score as followed: 0: no change or minimal changes; 1: decrease size of the calcification less than 50%; 2: decrease of the calcification between 50 and 90%; 3: more than ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale pain at rest | Visual Analogue Scale minimum:0 - no pain maximum:10 - extreme pain | 1 week, 1 month and 3 months |
| Visual Analogue Scale pain at during activities | Visual Analogue Scale minimum:0 - no pain maximum:10... | Antidotes, Protective Agents, Physiological Effects of Drugs, Antioxidants, Molecular Mechanisms of Pharmacological Action, Antitubercular Agents, Anti-Bacterial Agents, Anti-Infective Agents, Chelating Agents, Sequestering Agents, Sodium thiosulfate | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided percutaneous lavage with STS<br>Ultrasound guided percutaneous lavage with a single needle technic. A total of 10 mL of lidocaine 1% will be injected in the subcutaneous tissues, the subacromial bursa and over the surface... | Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff
Study Overview
=================
Brief Summary
-----------------
Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. Ultrasound guided percutaneous lavage (UGPL or barbotage or irrigation) o... | |
NCT03356951 | Gait Analysis Following Total Ankle Replacement and Subtalar Fusion | Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiota... | Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months. | Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation | Ankle Osteoarthritis | * Procedure: TAR through anterior approach and subtalar fusion
* Procedure: TAR through lateral approach and subtalar fusion
| Inclusion Criteria:~Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a... | 20 Years | 80 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait analysis | Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs | 1 day |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analog Scale) | Differences in Pain Scores on the Visual Analog Scale | 1 day |
| AOFAS | Differences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score | 1 day |
| Short Form Health Survey (SF-12) | Di... | Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lateral approach group<br>TAR through lateral approach and subtalar fusion | Procedure: TAR through lateral approach and subtalar fusion<br>* Simultaneous total ankle replacement through lateral approach and subtalar fusion<br>* Other names: Zimmer TM (... | Gait Analysis Following Total Ankle Replacement and Subtalar Fusion
Study Overview
=================
Brief Summary
-----------------
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoart... | ||
NCT00059267 | Prevention of Recurrent Hepatitis B After Liver Transplantation | Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies foun... | Prevention of Recurrent Hepatitis B After Liver Transplantation | Hepatitis B, Cirrhosis, Acute Liver Failure, Hepatocellular Carcinoma | * Drug: HBIG, Epivir, Hepsera
| null | 13 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adefovir dipivoxil, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antiviral Agents, Anti-Infective Agents | | Intervention/Treatment |
| --- |
|Drug: HBIG, Epivir, Hepsera|nan|
| Prevention of Recurrent Hepatitis B After Liver Transplantation
Study Overview
=================
Brief Summary
-----------------
Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results o... | ||||
NCT03294512 | Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform | The purpose of this study is to create a smartphone app that delivers the educational content of the current Intermountain MAWDS* program and allows patients to enter and track their MAWDS data within the app; and to determine if a broad-scale project can be conducted within the limits of currently available technology... | The Intermountain Heart Institute will collaborate with Savvysherpa Inc to develop a sensor-based digital platform based on MAWDS. (MAWDS is Intermountain's acronym that stands for Medications, Activity, Weight, Diet, Symptoms; used across Intermountain Healthcare to represent the most important concepts and skills to ... | Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study) | Heart Failure | * Behavioral: MAWDS data entry on app
| Inclusion Criteria:~Male or female > 18 years of age~Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures~Documentation of heart failure of any etiology, using standard of care criteria for diagnosis, and based on clinical assessment of the P... | 18 Years | null | All | No | Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients utilizing the app. | Data will be collected that shows the number of patients engaging with the app. | 3 months |
| Heart Failure, Heart Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Failure Patients<br>Patients who are seen at Intermountain Medical Center with heart failure, based on the Intermountain-specific Heart Failure Identification and Risk Stratification, will be screened for this study. The Principal In... | Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a smartphone app that delivers the educational content of the current Intermountain MAWDS* prog... | ||
NCT02202421 | T-ABA Group Based Early Intervention For Parents of Children With ASD | This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a form of behavior therapy used to promote skill de... | This is a ten week study. The child will be randomized to one of two treatment groups. Assignment is chosen by chance (like flipping a coin). The two treatment groups are T-ABA (Targeted Applied Behavior Analysis) with parent training and T-ABA with parent training and individual child sessions. For both groups, study ... | Targeted Applied Behavior Analysis (T-ABA) Group Based Early Intervention for Parents of Children With Autism Spectrum Disorder (ASD) | Autism | * Behavioral: Targeted Applied Behavior Analysis (T-ABA)
| Inclusion Criteria:~Clinical DSM-5 diagnosis of Autism Spectrum Disorder (299.00).~Age 2.0 (24 months) to 5.99 (71 months) at time of consent.~If participant is using neuropsychiatric medication and/or receiving therapy (PT, OT, speech, ABA, etc.), these must be stable two weeks prior to their study participation and t... | 24 Months | 71 Months | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in child utterances | The primary objective of this study is to determine whether T-ABA with parent training and individual child sessions is superior to T-ABA with parent training alone in improving child utterances as calculated by ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child communication | To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in increasing the number of child utterances as measured using the LENA Pro language collection device.... | Applied Behavior Analysis, Autism | Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Neurodevelopmental Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T-ABA Parent Training Only<br>Participants in the T-ABA Parent Training Only group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-... | T-ABA Group Based Early Intervention For Parents of Children With ASD
Study Overview
=================
Brief Summary
-----------------
This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with indi... |
NCT05517577 | An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes | This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia. | Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in... | Effectiveness of an Integrated Community-based Intervention Package in Improving Maternal, and Neonatal Health Outcome in Jimma Zone, Southwest Ethiopia: a Cluster Randomized Controlled Trial | Integrated Community-based Intervention Package, Breastfeeding, Exclusive, Morbidity;Newborn, Complementary Feeding, Knowledge, Attitudes, Practice, Food Security, Birth Preparedness and Complication Readiness Plan, Neonatal Care, Health Care Seeking Behavior, Delivery Care, Postnatal Care | * Behavioral: Behaviour Change Communication and Male involvement intervention
| Inclusion Criteria:~Pregnant women in the third trimester~Live in the selected cluster~Exclusion Criteria:~Serious illness or clinical complications requiring hospitalization~Maternal death~Newborn death~Stillbirth~Twin gestation~Preterm birth (at <37 weeks) | 15 Years | 49 Years | Female | Accepts Healthy Volunteers | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 i... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal care practices | Prevalence of neonatal care practices | At month one after delivery |
| Feeding practice | prevalence of early initiation and exclusive breastfeeding | At month one after delivery |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal morbidity | Prevalence of neonatal morbidity | At month one after delivery |
| Maternal morbidity | Prevalence of maternal morbidity | At month one after delivery |
| Birth preparedness and complication readiness plan | Proportion o... | community-based intervention,, maternal,, neonatal,, infant,, health outcome,, randomized controlled trial | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>An integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They wi... | An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes
Study Overview
=================
Brief Summary
-----------------
This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, South... | |
NCT03587675 | Diagnosis of EIB in Young Elite Athletes (13-18 y) | The investigators recently observed airway inflammation and increased damage-associated molecular pattern (DAMP) level in sputum of children (age 11-12y) and adolescents (18-23y) from elite sport programs in Belgium with increased risk of bronchoconstriction upon extreme exercise. They here want to validate these findi... | State of the art Physical exercise, though absolutely beneficial for human well-being, is a well-known trigger to induce bronchoconstriction. Aretaeus of Cappadocia described the first cases of asthma triggered by exercise, already in the second century AD. Exercise can provoke bronchoconstriction in subjects with pre-... | Validation Screening Protocol for the Diagnosis of Exercise-induced Bronchoconstriction in Young Elite Athletes (13-18 y) | Exercise Induced Bronchospasm, Athletes, Adolescent | * Diagnostic Test: EVH test
| Inclusion Criteria:~high-school elite athletes from 'topsportschool' or 'future team'~from following disciplines: swimming, basket, volley or foot ball~performing at least 12 h sport a week~or~healthy recreational control subjects~performing less than 6 hours sport/week~Exclusion Criteria:~- acute infection in four wee... | 13 Years | 18 Years | All | Accepts Healthy Volunteers | Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: adolescents from different athletic disciplines and recreational adolescents will be tested for atopy, exercise-induced bronchospasm measured by EVH and biomarkers for EIB will be studied in blood and induced sputu... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of athletes with exercise-induced bronchospasm | measured by positive EVH test: at least 10% drop in FEV1% between 5-20' after EVH | 2 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of questionnaire to predict positive EVH test | AQUA questionnaire+additive questions (n=5) | 2 years |
| use of blood biomarker to predict positive EVH test | blood CC16 levels measured by ELISA | 3 years |
| use of sputum biomarker to ... | Bronchial Spasm, Asthma, Exercise-Induced, Bronchial Diseases, Respiratory Tract Diseases, Asthma, Respiratory Hypersensitivity, Exercise-Induced Allergies, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EVH in high-school elite athletes<br>EVH-test, skin prick test, sputum induction in all subjects Interventional but no drug or device tested | Diagnostic Test: EVH test<br> <br> * Other names: nasal lavage;|
| Diagnosis of EIB in Young Elite Athletes (13-18 y)
Study Overview
=================
Brief Summary
-----------------
The investigators recently observed airway inflammation and increased damage-associated molecular pattern (DAMP) level in sputum of children (age 11-12y) and adolescents (18-23y) from elite sport program... | |
NCT02858635 | Molecular Genetics of Suicidal Behavior | Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress ... | Transversal study:~1500 patients with a personal history of suicide attempt will be recruited. Clinical, biological and neuropsychological assessments will be performed. The first objective of the study is to replicate the results already obtained regarding the association between serotonergic system genes and suicidal... | Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System | Suicidal Behaviour | * Other: Clinical and neuropsychological assessment, Blood and saliva samples
| Inclusion Criteria:~personal history of suicide attempt~French Caucasian Western Europe and specifically have all four grandparents from a country in Western Europe (for genetics purposes)~able to understand nature, aims, and methodology oh the study~do not emphasize to leave during the time-study.~Exclusion Criteria:~... | 18 Years | 65 Years | All | No | Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of suicide attempt | occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit | up to 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suicidal ideation | suicidal ideation will be assessed by scale for suicidal ideation (SSI) self-assessments (with a smartphone) by Likert scales, 5 times per day during 7 days. | up to 7 days |
| number of suicide attempt | assessed by clini... | Suicidal behaviour, Impulsivity, Genetics, Serotonin | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suicide attempters<br>Clinical and neuropsychological assessment. Blood and saliva samples in order to answer objectives study. | Other: Clinical and neuropsychological assessment, Blood and saliva samples<br>* Clinical and neuropsychologi... | Molecular Genetics of Suicidal Behavior
Study Overview
=================
Brief Summary
-----------------
Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and st... | |
NCT04125459 | Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout | Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. Gout is typically a... | Assessing the Role of the NLRP3 Inflammasome in Driving Inflammation in Affected Joints of Patients With Intercritical Gout | Gout | * Procedure: Joint Biopsy
| Inclusion Criteria:~Adult patients with gout diagnosed by a Rheumatologist.~patients with a history of at least two gout attacks in the target joint~Patients with a target joint amenable to biopsy. Target joint defined as:~Joint that has been affected by acute gout attack at least twice in the 12 months prior to enroll... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NLRP3 Inflammasome Role in Driving Inflammation in Intercritical Gout | To investigate the role of the NLRP3 inflammasome in driving inflammation in intercritical gout. Specifically, this will be accomplished via measuring caspase-1 activity a... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcrystal Correlation | Correlate NLRP3 activity with the presence of microcrystals in the synovium | Up to 2 months |
| Immune Cell Infiltration in the Inflamed Joint Correlation | Correlate NLRP3 activity with the presence of infiltratio... | Gout, Arthritis, Joint Diseases, Musculoskeletal Diseases, Crystal Arthropathies, Rheumatic Diseases, Purine-Pyrimidine Metabolism, Inborn Errors, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with Gout<br>This arm will be getting a biopsy as well as a blood draw | Procedure: Joint Biopsy<br>* a synovial biopsy of a joint that has been affected by a gout attack<br>|
| Controls<br>These individuals will not be getting a joint biops... | Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout
Study Overview
=================
Brief Summary
-----------------
Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patien... | |||
NCT00632021 | Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study) | Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provi... | After hospital discharge, many people experience difficulty in managing their medication regimens. This can be due to medication dosing changes, challenges in adjusting new medications with those that were taken previously, inadequate discharge instructions from hospital personnel, and inadequate follow-up. Difficulty ... | Pharmacist Intervention for Low-Literacy in Cardiovascular Disease | Acute Coronary Syndrome, Heart Failure | * Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
| Inclusion Criteria:~Admitted to a participating study hospital~Diagnosis of acute coronary syndromes or heart failure~Exclusion Criteria:~Too ill to participate~Corrected visual acuity worse than 20/200~Severe hearing impairment~Patient is not being discharged to their home~No regular telephone number~Not fluent in Eng... | 18 Years | null | All | No | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Medication Errors as Determined by Interview and Medical Chart Review | Number of clinically important medication errors per patient | Measured at Day 30 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Unplanned hospitalizations and Emergency Department visits | Measured at Day 30 |
| Low Health Literacy, Medication Errors, Cardiovascular Disease, Pharmacist, Care Transition | Acute Coronary Syndrome, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia, Vascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Patients will receive usual care at hospital discharge, which generally includes physician reconciliation of medications and a nurse-provided explanation of how to take medications at the time of discharge. | |
| Experimental: 2<br... | Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study)
Study Overview
=================
Brief Summary
-----------------
Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health ... |
NCT01719796 | Effect of TAP Block on Ventilatory Function Following Abdominal Surgery | Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery. | Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery. | Laparotomy | * Procedure: Regional analgesia infusion
| Inclusion Criteria:~laparotomy~Exclusion Criteria:~below 18, pregnancy, prisoners | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity | | 72h |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum forced expiratory flow | | 72h |
| analgesic consumption | | 72h |
| pain | resting pain, assessed using VAS | 72h |
| diaphragmatic course | using ultrasonography | 72h |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral TAP catheter<br>Ultrasonography guided bilateral TAP catheter insertion. | Procedure: Regional analgesia infusion<br> <br> |
| No Intervention: No TAP catheter<br> | |
| Effect of TAP Block on Ventilatory Function Following Abdominal Surgery
Study Overview
=================
Brief Summary
-----------------
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investig... | |||
NCT02183766 | GOS Prebiotic Effect in Children Constipation | Some prebiotics are useful for improving symptoms related to constipation, but clinical trials including infants and older children are scarce. A double-blind, placebo-controlled, crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides (GOS) on functional constipation in children and ad... | Constipation is a common symptom in the pediatric clinics. It is usually defined in terms of difficulty of passage of faeces, faecal consistency and frequency of evacuation. A diet containing high amounts in fiber can promote beneficial effects constipation therapy. Beside the fiber, functional foods, such as prebiotic... | Effect of the Prebiotic 4'Galactooligosaccharides in Children and Adolescents With Functional Constipation | Constipation | * Dietary Supplement: Galactooligosaccharide prebiotic
* Drug: Maltodextrin
| Inclusion Criteria:~Functional constipation defined by Rome III criteria~Consent form signed by parent or guardian~Exclusion Criteria:~Patients with systemic, genetic or neurological diseases.~Lactose intolerance~Laxative use~Probiotic use~Antibiotic use during the study | 4 Years | 16 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of constipation improvement after GOS use in children compared to use of placebo. | | within 30 days of GOS use. |
| Constipation, Signs and Symptoms, Digestive | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>6 mL once a day diluted in juice during 30 days. | Drug: Maltodextrin<br>* 6 mL once a day<br>* Other names: Placebo;|
| Active Comparator: Galactooligosaccharide prebiotic<br>6 mL once a day diluted in juice during 3... | GOS Prebiotic Effect in Children Constipation
Study Overview
=================
Brief Summary
-----------------
Some prebiotics are useful for improving symptoms related to constipation, but clinical trials including infants and older children are scarce. A double-blind, placebo-controlled, crossover clinical trial was... | ||
NCT03971422 | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG). | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | * Drug: Rozanolixizumab
* Other: Placebo
| Inclusion Criteria:~Study participant must be ≥18 years of age, at the time of signing the informed consent~Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations~Study participant has a confirmed positive ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quan... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43 | The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG. The MG-ADL targeted symptoms and disability across ocular... | gMG, UCB7665, generalized myasthenia gravis, rozanolixizumab | Rozanolixizumab, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosage Regimen 1<br>Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period. | Drug: Rozanolixizumab<br>* Rozanolixizumab will be administered b... | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Study Overview
=================
Brief Summary
-----------------
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with... | |
NCT01837355 | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis | Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have differen... | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1) | Pulmonary Inflammation, Cystic Fibrosis, Microbiota | * Dietary Supplement: Lactobacillus rhamnosus
* Dietary Supplement: Placebo
| Inclusion Criteria:~moderate to severe CF disease~Exclusion Criteria:~acute gastroenteritis 2 weeks prior to inclusion~chronic disease other than CF (except CF associated disorders)~oral or parenteral antibiotics 2 weeks prior to inclusion~systemic steroids 4 weeks prior to inclusion~any probiotic intake | 6 Years | 20 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at w12 and w24 in fecal calprotectin levels | Baseline, week 12 change from baseline, week 24 change from week 12 | Baseline, week 12, week 24 |
| Change from baseline at w12 and w24 in pulmonary calprotectin levels | Bas... | Pneumonia, Cystic Fibrosis, Fibrosis, Inflammation, Pathologic Processes, Pancreatic Diseases, Digestive System Diseases, Lung Diseases, Respiratory Tract Diseases, Genetic Diseases, Inborn, Infant, Newborn, Diseases, Respiratory Tract Infections, Infections | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo once daily for 12 weeks | Dietary Supplement: Placebo<br> <br> |
| Experimental: Lactobacillus rhamnosus<br>lactobacillus rhamnosus once daily for 12 weeks | Dietary Supplement: Lactobacillus rhamnosus<br> <br> |
| Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis
Study Overview
=================
Brief Summary
-----------------
Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatm... | |||
NCT04063930 | The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia | To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia. | Patients with type 2 diabetes and nephropathy, especially patients with impaired kidney function, frequently encounter hyperkalemia as an adverse effect of RAAS blocking treatment. Consequently, RAAS blocking treatment is reduced or discontinued, which in turn impairs prognosis in terms of long-term renal and cardiovas... | A Randomized, Double-blind, Placebo Controlled, Parallel, Multicenter Study of the Effects of 12-weeks of Sodium Zirconium Cyclosilicate (Lokelma) on Albuminuria (UACR) in Patients With Type 2 Diabetes and Hyperkalemia | Type 2 Diabetes Mellitus With Kidney Complications | * Drug: LOKELMA 5 GM Powder for Oral Suspension
* Drug: Placebos
| Inclusion Criteria:~Provision of informed consent prior to any study specific procedures~Female and/or male patients with type 2 diabetes aged 18-85 years~Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history).~Chronic (at least 1 month) stable RAAS bl... | 18 Years | 85 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary albumin creatinine ratio (UACR) | Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment | 12 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated glomerular filtration rate (eGFR) | Change in eGFR mL/min/1.73 m2 (CKD-EPI formula) from baseline to end of treatment | 12 weeks |
| Urinary sodium | Change in urinary sodium levels (mmol per liter) in one 24h urine collection from ... | Hyperkalemia, Renin angiotensin system | Albuminuria, Diabetes Mellitus, Diabetes Mellitus, Type 2, Hyperkalemia, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Proteinuria, Urination Disorders, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogeni... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lokelma<br>Sodium zirconium cyclosilicate Lokelma® 5 g, powder (Astra Zeneca)~After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolve... | The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia
Study Overview
=================
Brief Summary
-----------------
To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patie... |
NCT04097977 | Networked-Based Recovery With User Involvement | Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety and depression. Overall, mental health problems represent the greatest health burden among adolescents. This means... | Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety and depression. Overall, mental health problems represent the greatest health burden among adolescents. This means... | Networked-Based Recovery With User Involvement for Young People With Mental Illness: A Nonrandomized Clinical Trial | Psychiatric Hospitalization | * Other: An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties.
| Inclusion Criteria:~Young adults aged 18 - 30 years~Diagnosed with a mental disorder~Have experienced hospitalization~Exclusion Criteria:~Cognitive deficit~Patients who did not consent to participation~Hospitalized for less than a week | 18 Years | 30 Years | All | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The project is designed as a non-randomized intervention study with a control group.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mental health status. | Mental health status is valid and reliable indicator of the patients self-reported mentale state and well-being. Mental status is assessed using the standardized Short Form Health Survey (SF-36). Scores range ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of function. | The young adults' level of function is assessed using the Global assessment of functioning (GAF). Scores range from 0 to 100, with higher scores indicating better health. | At baseline and after 4 months. |
| Ch... | User involvement, Patient-reported outcomes, Networked-based recovery | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: RENEW in a psychiatric ward<br>Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group that will form the basis of real user involvement. | Other: An educational support ... | Networked-Based Recovery With User Involvement
Study Overview
=================
Brief Summary
-----------------
Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety a... | |
NCT04533750 | Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin | This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the e... | PRIMARY OBJECTIVE:~I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT).~SECONDARY OBJECTIVES:~I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy.~II. To estimate the rates... | Phase I Trial With Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients With Stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) | Advanced Head and Neck Squamous Cell Carcinoma, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oropharyngeal (p16-Negative) Car... | * Radiation: Intensity-Modulated Radiation Therapy
* Drug: Peposertib
| Inclusion Criteria:~Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration;~Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplas... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity | | Up to 28 days after the end of intensity-modulated radiation therapy (IMRT) |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute toxicity | Will be as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 | Up to 3 months from IMRT completion |
| Incidence of late toxicity | Will be as measured by CTCAE v5.0. | More than 3... | Peposertib, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (peposertib, IMRT)<br>Beginning 60-90 minutes before each radiation treatment, patients receive peposertib PO QD and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity. | R... | Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Study Overview
=================
Brief Summary
-----------------
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation ther... | |
NCT03788668 | Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients | Aim of the study~To determine the exact role of hyoid bone suspension surgery in splinting lateral pharyngeal wall in the era of the lateral pharyngoplasty | Before recruitment of the patients, they will be subjected to detailed history taking and full ear nose throat examination. Body mass index and neck circumference will be measured. All the patients will undergo sleep study and the following parameters will be documented: Apnea hypopnea index (AHI), lowest O2 saturation... | Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients | Obstructive Sleep Apnea | * Procedure: Hyoid suspension
| Inclusion Criteria:~Adult patients of both sexes between 18-60 years old.~Moderate to severe obstructive sleep apnea diagnosed by sleep study with apnea hypopnea index (AHI) > 15/h.~Body mass index (BMI) <35.~Refusing or intolerable to use continuous positive airway pressure.~Lateral pharyngeal wall collapse diagnosed ... | 18 Years | 60 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index (AHI) | Number of apneas and hypopneas recorded during sleep is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in b... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day time sleepiness will be assessed using Epworth sleepiness score (ESS) | Decrease in this parameter indicate better outcome it is a questionnaire to assess the sleepniess during day time by assessment the chance of dozing during different d... | Hyoid suspension, Barbed reposition pharyngoplasty | Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoid suspension with barbed reposition pharyngoplasty<br> | Procedure: Hyoid suspension<br>* Hyoid suspension will be done with barbed reposition pharyngoplasty<br>|
| No Intervention: barbed reposition pharyngoplasty<br> | |
| Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients
Study Overview
=================
Brief Summary
-----------------
Aim of the study To determine the exact role of hyoid bone suspension surgery in splinting lateral pharyn... |
NCT05349877 | Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial. | Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health o... | Efficacy of a Brief, Self-guided, On-line, Writing Intervention to Improve Mental Health Outcomes Among Sexual and Gender Minorities: a Randomized Controlled Trial. | Depression, Anxiety, Psychological Distress, Social Phobia, Post Traumatic Stress Disorder, Suicidal Ideation, Sex, Unsafe, Discrimination, Social, Behavior, Risk, Self Esteem | * Behavioral: Expressive writing
* Behavioral: Self-affirmation
* Behavioral: Placebo
| Inclusion Criteria:~Self-identity as sexual and gender minority.~Being older than 16 years old.~Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed.~Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms.~Currently living... | 16 Years | 100 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, clinical trial assessing the efficacy of a brief, unsupervised, self-guided psychological intervention targeting sexual and gender minorities' mental health.
Masking: Tri... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline depression at 3 and 6 moths after the intervention. | Assessed using the Center for Epidemiologic Studies - Depression (CES-D). CES-D is composed of 20 items. The final score ranges from 0 to 60 points. Originally, the cut... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention. | Wagnild and Youngs's Resilience Scale that has presented the following scoring for the total score: 25-100 = Very low, 101-115 = Low, 116-130 = On the lo... | Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Suicidal Ideation, Phobia, Social, Behavioral Symptoms, Trauma and Stressor Related Disorders, Mental Disorders, Suicide, Self-Injurious Behavior, Phobic Disorders, Anxiety Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expressive writing<br>Participants will be invited to join three writing activities, lasting 20 minutes daily in D1, D3, and D5 of the same week. For example, to write about a difficult or painful experience related discrimination and thei... | Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.
Study Overview
=================
Brief Summary
-----------------
Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stres... | ||
NCT02142907 | Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast | In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving surgery followed by radiation therapy to the intact b... | Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I , stage II of breast carcinoma. Fifty patients of histologically proven post lumpectomy cases of carcinoma bre... | Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast | Breast Cancer, Adverse Effect of Radiation Therapy | Inclusion Criteria:~Unicentric primary breast cancer with invasive ductal histology.~Stage T1, T2, N0, N1, M0 -~Exclusion Criteria:~Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.~Skin involvement.~History of prior primary malignancy.~History of prior irradiation to chest~Pa... | 20 Years | 75 Years | Female | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation toxicities- acute and early-late | Acute toxicity will be assessed at at 1 month. Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale~Pigmentary change scale:~0 = None~= Transitory , slight~= Permanent , marked... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome and local control iii) Local control | Cosmetic assessment will be done using Harvard/NSABP/RTOG breast cosmesis grading scale. | 6 months to 5 years |
| Breast conservative surgery, boost radiation, acute toxicity, cosmesis, local control | Breast Neoplasms, Neoplasms, Neoplasms by Site, Breast Diseases, Skin Diseases | Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast
Study Overview
=================
Brief Summary
-----------------
In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of t... | |||
NCT01397968 | Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures | This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.~Also to evaluate the safety and tolerability of YKP3089. | A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures | Partial Epilepsy | * Drug: YKP3089
* Drug: Placebo
| Inclusion Criteria:~Diagnosis of treatment resistant partial epilepsy;~History of epilepsy for at least 2 years;~Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.~Currently treated on a stable dose of :~1 - ... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days | Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% Responder Rate | Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline. | 1... | partial onset seizures, treatment resistant, partial epilepsy | Cenobamate, Anticonvulsants | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YKP3089<br> | Drug: YKP3089<br>* Capsule, dose to be titrated Tablet, dose to be titrated<br>* Other names: cenobamate;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule Placebo tablet<br>|
| Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully control... | |
NCT05118386 | Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults | Gates MRI-RSM01-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of ADA, and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy ad... | Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide.~RSM01, a monoclonal antibody targeting RSV, may potentially provide an effective method to protect infants from RSV disease based on its poten... | A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults | RSV Infection | * Drug: RSM01
* Other: Placebo
| Inclusion Criteria:~Participant must be 18 to 49 years of age inclusive, at the time of signing the informed consent~Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests~Body mass index (BMI) 18 to 29.9 kg/m2 (inclusive)~Both males and fem... | 18 Years | 49 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled study of RSM01. The study will be conducted in 2 parts: A Dose Escalation Phase (28 participants) with 4 dosing cohorts, followed by an Expansion Phase... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unsolicited adverse events (AEs) through Day 151 | To characterize the safety and tolerability of a single dose of RSM01 | 151 days |
| Number of serious adverse events (SAEs) and AE of special interest (AESIs) through Day 151 | To ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of safety laboratory parameters Grade 1 and above through Day 151. | To characterize safety laboratory parameters following RSM01 administration | 151 days |
| Area under the capillary blood-concentration time curve from zero to infini... | Infections, Respiratory Syncytial Virus Infections, Pneumovirus Infections, Paramyxoviridae Infections, Mononegavirales Infections, RNA Virus Infections, Virus Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSM01<br>Participants will be randomized to receive different dose levels of RSM01. Participants will be randomized in a ratio of 6:1 where for every 6 participants receiving active drug (RSM01) 1 participant will receive Placebo. | Drug: ... | Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Study Overview
=================
Brief Summary
-----------------
Gates MRI-RSM01-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics,... | |
NCT00026533 | Thalidomide in Treating Patients With Thyroid Cancer | RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor.~PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer. | OBJECTIVES:~Determine the antitumor activity of thalidomide, in terms of tumor response and duration of response, in patients with metastatic follicular, papillary, or medullary thyroid carcinoma that is unresponsive to systemic radioiodine.~Compare the differences in antitumor activity of this drug in patients with me... | Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas | Head and Neck Cancer | * Drug: thalidomide
| DISEASE CHARACTERISTICS:~Histologically confirmed follicular, papillary, insular, or medullary thyroid carcinoma~Must meet criteria for 1 of the following:~Unresectable, distantly metastatic tumor that does not concentrate radioactive iodine~Follicular or papillary thyroid carcinoma with a large distant tumor burden th... | 18 Years | 120 Years | All | No | Primary Purpose: Treatment
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, insular thyroid cancer | Thalidomide, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Leprostatic Agents, Anti-Bacterial Agents, Anti-Infective Agents, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Growth Inhibitors, Antineoplastic Agents | | Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|
| Thalidomide in Treating Patients With Thyroid Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid ca... | |
NCT04883697 | Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique | A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. | A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower v... | Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap | Macular Holes | * Other: vitrectomy with ILM peeling and ILM flap technique
| Inclusion Criteria:~Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020~Age 18 or older~Exclusion Criteria:~Age <18 | 18 Years | 105 Years | All | null | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | best corrected distance visual acuity | change between visual acuity 2-6 months postoperative to baseline |
| macular hole closure | closure of the macular hole assesed with OCT | 2-6 months postoperative |
| Retinal Perforations, Retinal Diseases, Eye Diseases | | Intervention/Treatment |
| --- |
|Other: vitrectomy with ILM peeling and ILM flap technique|outcomes after vitrectomy with ILM peeling and ILM flap technique for macukar hole repair are assessed|
| Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique
Study Overview
=================
Brief Summary
-----------------
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.
Detail... | |||
NCT03693300 | A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer | This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks [q4w] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). Thi... | This is a Phase II, open-label, multi-centre study to determine safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) monotherapy in participants with unresectable Stage III NSCLC who have not progressed following definitive, platinum-based sCRT. Approximately, 150 participants will be treated with the study drug i... | A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6) | Non-small Cell Lung Cancer (NSCLC) | * Drug: Durvalumab
| Inclusion criteria:~Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.~Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.~Provision of signed and dated writt... | 18 Years | 130 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 3 and Grade 4 Treatment-related Adverse Events (TRAEs) | Safety and tolerability of Durvalumab as defined by Grade 3 and Grade 4 TRAEs following IV infusion administration was assessed. | Up to 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | The efficacy of Durvalumab (MEDI4736) treatment in terms of PFS. PFS was defined as the time from the first date of treatment until the date of objective disease progression based on Investigator's assessment ... | Stage III Non-Small Cell Lung Cancer, Durvalumab, IV infusion immunoglobulin G (IgG), Antibody-dependent cellular cytotoxicity, Complement-dependent cytotoxicity, Monotherapy | Antineoplastic Agents, Immunological, Antineoplastic Agents, Durvalumab | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WHO/ECOG PS 0 to 1 Cohort<br>100-120 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug ... | A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Study Overview
=================
Brief Summary
-----------------
This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI47... |
NCT02741583 | Kyrgyz Asthma Rehabilitation at High Altitude | prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control. | Low altitude baseline measurements will be performed in Bishkek. Participants will then either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).~The rehabilitation programs in high or low altitude will be identically performed and will comprise~asthma education and awareness~instruction... | Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial | Effect of High Altitude | * Other: altitude rehabilitation program
* Other: rehabilitation program
| Inclusion Criteria:~diagnosed with atopic or non-atopic Asthma for at least 3 months~partly controlled on regular or on demand inhaled therapy according to guidelines.~asthma variability in peak expiratory flow > 10%/day and/or a reversible airflow obstruction in spirometry~History of asthma consisting of variable symp... | 18 Years | 80 Years | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily peak-flow variability | | assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements |
| change in asthma control questionnaire score | | baseline to week 3 and 15 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced expiratory volume in 1 second (FEV1) | | baseline to week 3 and 15 |
| average peak flow over 2 days | | baseline to week 3 and 15 |
| spirometric values (Forced vital capacity (FVC), FEV1/FVC) | | from baseline to week 3 and 15 | ... | Altitude Sickness, Respiration Disorders, Respiratory Tract Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: altitude rehabilitation program<br>3 weeks rehabilitation program at high altitude (3200m) | Other: altitude rehabilitation program<br>* altitude exposure<br>|
| Active Comparator: rehabilitation program<br>3 weeks rehabilitation program a... | Kyrgyz Asthma Rehabilitation at High Altitude
Study Overview
=================
Brief Summary
-----------------
prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.
Detailed D... | |
NCT04034771 | The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol | This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion. | 38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bi... | The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT | TBI (Traumatic Brain Injury) | * Drug: Melatonin 10 MG Oral Tablet
* Drug: Propofol
* Drug: Placebo oral tablet
| Inclusion Criteria:~Age group from 18 to 65~Both sexes~Patients on a mechanical ventilation and need sedation~Patients who are vitally stable~Exclusion Criteria:~Gastro intestinal tract impractabililty~Pregnant female~Vitally unstable patients who cannot tolerate propofol infusion | 18 Years | 65 Years | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of sedation | observe the effect of the oral administration of 10 mg melatonin on decreasing the dose of propofol infusion in a mechanically ventilated patient with a traumatic brain injury using bispectral index | 6 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Arterial blood pressure | measuring Blood pressure in mmgh just before and after start of propofol infusion and every hour for successive 6 hours | 6 hours |
| Heart rate | | Measuring the heart rate as beats per minutes just before and af... | melatonin | Propofol, Melatonin, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol and melatonin<br>propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission. | Drug: Melatonin 10 MG Oral Tablet<br>* Melatonin tablets<br>* Other names: circadian;Drug: Propofol<br>* propofol am... | The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol
Study Overview
=================
Brief Summary
-----------------
This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.
Detai... |
NCT02895399 | Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers | Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevale... | Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock | Human Papillomavirus Viruses | * Other: Cervico-Vaginal Smears analysis
| Inclusion Criteria:~Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )~Having already had sexual intercourse~Having given after information , consent to the ... | 20 Years | 65 Years | Female | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and distribution of Human Papillomaviruses genotypes | | At the time of inclusion (baseline) |
| | Intervention/Treatment |
| --- |
|Other: Cervico-Vaginal Smears analysis|Cervico-Vaginal Smears analysis|
| Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers
Study Overview
=================
Brief Summary
-----------------
Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the inte... | |||||
NCT05178004 | Microbiome and Immune Profiling in Infant With Cow's Milk Allergy | Non-IgE-mediated cow's milk allergy (CMPA) is associated to gastrointestinal symptoms, and its cause remains poorly understood, limiting the identification of specific markers to help with the diagnosis.~Using a non-invasive method, the aim of this study is to identify new protein markers as well as to profile the bact... | STUDY DESIGN~Study description:~This observational study will involve the analysis of clinical data, stool, urine and serum (if available) samples that will be collected from infants with suspected or confirmed non-IgE-mediated CMPA. Clinical data will be collected from the medical notes of the patients with the writte... | Profiling Stool Cytokines and Microbiome of Infants With Non-IgE-mediated Cow's Milk Protein Allergy Could Explain Its Pathophysiology and be Used as a Non-invasive Diagnostic Method (Melina Study) | Cow Milk Allergy | * Other: Faecal and Urine sample collection
| Inclusion criteria~Infants ≤4 months (prior to weaning)~Infants born at term (≥37and ≤42weeks), by uncomplicated normal birth or caesarean section and appropriately grown for gestational age.~Exclusion criteria for study population and controls~Infants who present with pre-existing risk factors for altered intestinal p... | null | 16 Weeks | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome profiling | Gut bacterial diversity in infants with non-IgE-mediated CMPA compared to control groups, assessed by 16s rRNA sequencing (at baseline and throughout the study period). | 32 months |
| Faecal metabolites | The concentra... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of clinical symptoms | Evaluation of the condition's severity based on the symptom diary | 32 months |
| Inflammatory markers and clinical symptoms | Correlation between levels of inflammatory proteins and severity of clinical symp... | Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity, Hypersensitivity, Immediate | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-IgE-mediated CMPA<br>Infants with mild, moderate and severe non-IgE-mediated cow's milk protein allergy | Other: Faecal and Urine sample collection<br>* This is an observational study.<br>|
| IgE-mediated CMPA<br>Infants with IgE-mediated CMPA | Oth... | Microbiome and Immune Profiling in Infant With Cow's Milk Allergy
Study Overview
=================
Brief Summary
-----------------
Non-IgE-mediated cow's milk allergy (CMPA) is associated to gastrointestinal symptoms, and its cause remains poorly understood, limiting the identification of specific markers to help with... | ||
NCT05151757 | Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model by Non-physician Graders in Vietnam | This study aims to develop a training course for screening glaucoma using fundus images obtained during diabetic retinopathy screening by non-physician graders. The study also aims to test this training course among non-physician graders in Vietnam | Background:~According to the International Diabetes Federation (IDF), the prevalence of diabetes will increase by 51% from 463 million in 2019 to 743 million in 2045 among adults between the ages of 20-79 years. This increase is projected to be 15% in Europe, 33% in North America, 74% in South East Asia and 143% in Afr... | Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model During Diabetic Retinopathy Screening by Non-physician Graders in Vietnam | Training Group, Sensitivity | * Other: A standard image training set
| Inclusion Criteria:~Inclusion Criteria of graders:~A minimum of 42 non-physician and non-optometrist graders (mostly nurses with and without ophthalmic experience) who are currently involved in the Orbis CAFÉ diabetic retinopathy screening in Vietnam.~12 Ophthalmologists in Vietnam taking part as DR graders in the CAFÉ... | 20 Years | 60 Years | All | Accepts Healthy Volunteers | Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: This is a before and after study in which non physician graders will undergo testing on the standard image set at baseline, and then complete a training course. They will then undergo a post course test on the stand... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the sensitivity, specificity, area under the curve (AUC) of non-physician graders before and after training on a glaucoma test course in Vietnam. | The primary outcome is to assess change before and after training in the diagnostic a... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the sensitivity, specificity, area under the curve (AUC) of trained non-physician graders with general ophthalmologists on a test course in Vietnam. | Performance of the non-physician graders on the standard image set after the cours... | Screening, Glaucoma, Non physician graders, Fundus images | Glaucoma, Ocular Hypertension, Eye Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: To test the effectiveness of a training course to improve graders ability to detect glaucoma<br>Study design: This is an uncontrolled interventional experimental before and after study in which a minimum of 42 non-physician graders shall b... | Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model by Non-physician Graders in Vietnam
Study Overview
=================
Brief Summary
-----------------
This study aims to develop a training course for screening glaucoma using fundus images obtained during diabetic retinopathy screening by non-phy... |
NCT01149304 | Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity | To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR) brachytherapy. | A preventive effect of pentoxifylline, ursodeoxycholic acid and low dose low molecular weight heparin on pathological processes in healthy tissue after irradiation is described in clinical studies on percutaneous liver irradiation and on bone marrow transplantation. However, data remains inconclusive.~This exploratory ... | Evaluation of the Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity After Brachytherapy of Liver Metastases From Colorectal Carcinoma, Assessed in a Prospective Randomised Trial | Colorectal Cancer, Liver Metastases, Irradiation Damage, Radiation Induced Liver Disease | * Drug: Pentoxifylline
* Drug: Ursodeoxycholic Acid
* Drug: Enoxaparin
| Inclusion Criteria:~Age 18 to 80~If female, postmenopausal or surgically sterilized~Liver metastases from colorectal carcinoma scheduled for a CT/MRI-guided single-fraction interstitial HDR brachytherapy~Non-cirrhotic liver~Life expectancy longer than 6 months~willing and able to undergo all study procedures~Having vol... | 18 Years | 80 Years | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDR-brachytherapy isodose (measured in Gy) that corresponds to the metastases without enhancement of Gd-EOB-DTPA in MR imaging using an axial T1 THRIVE sequence. | The primary variable is the HDR-brachytherapy isodose that encloses liver tissu... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the HDR brachytherapy isodose that corresponds to damaged live tissue as defined by missing Gd-EOB-DTPA enhancement in MR imaging and liver-specific laboratory values. | To evaluate the relation between hepatocyte dysfuncti... | brachytherapy, liver metastases, irradiation, radiation induced liver disease, dosimetry | Enoxaparin, Pentoxifylline, Ursodeoxycholic Acid, Anticoagulants, Fibrinolytic Agents, Fibrin Modulating Agents, Molecular Mechanisms of Pharmacological Action, Phosphodiesterase Inhibitors, Enzyme Inhibitors, Platelet Aggregation Inhibitors, Radiation-Protective Agents, Protective Agents, Physiological Effects of Drug... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Medication group with patients receiving the study medication according to the study protocol for 8 weeks after HDR brachytherapy. | Drug: Pentoxifylline<br>* Pentoxifylline is given for 8 weeks since the evening of the day of i... | Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity
Study Overview
=================
Brief Summary
-----------------
To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and enoxaparin provides a protective effect on the liver parenc... |
NCT04980885 | A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia | This is a open label, phase Ib/II study. All patients are diagnosed with AML, Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine in subjects with AML. | A Phase Ib/II Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia | Acute Myeloid Leukemia | * Drug: AK117
* Drug: Azacitidine
| Inclusion Criteria:~Age ≥18 years (at the time consent is obtained).~Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).~Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3，and 0~2 are required for ... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite complete remission rate （complete remission + complete remission with incomplete count recovery） | Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per Europ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CR Without Minimal Residual Disease (CR MRD-) | The rate of CR MRD- is the percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2017 criteria. | Approximately 6 months |
| Duration of complete resp... | Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Enzyme Inhibitors, Azacitidine | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK117+Azacitidine<br>Phase Ib: Subjects will receive different doses of A117 in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28 day cycle;~Phase II: Subjects will receive AK117 at the recommended Phase 2 dose in... | A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia
Study Overview
=================
Brief Summary
-----------------
This is a open label, phase Ib/II study. All patients are diagnosed with AML, Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to ... | ||
NCT03882060 | Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients | This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization... | The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial | Pediatrics, Moyamoya Disease, Cerebrovascular Disorders | * Drug: erythropoietin
* Drug: Normal saline
| Inclusion Criteria:~Pediatric Moyamoya patients scheduled for the first revascularization surgery~Exclusion Criteria:~Hypersensitivity or contraindication to rHuEPO~History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis~Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-ve... | null | 18 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative <12 month Angiogenesis | Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor) | <12 month after revascularization operation |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week | Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no) | up to 1 week |
|... | Epoetin Alfa, Hematinics | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rHuEPO<br>recombinant human erythropoietin 500 U/kg IVS x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) | Drug: erythropoietin<br>* Recombinant human erythropoietin (500 U/... | Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO w... | ||
NCT00933114 | Functional Imaging of Tumor and Normal Tissue | Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including... | Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up. | The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer | Head and Neck Cancer | * Procedure: MRI and PET imaging
| Inclusion Criteria:~Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0)~Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx~Curative intent concurrent chemoradiation~Age > 18 years~Karnofsky Performance Status > 60~Abl... | 18 Years | 80 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permeability, perfusion, diffusion and glucose metabolism | | At end of 1 week of radiation therapy |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationships between baseline and treatment induced changes in vascular permeability, perfusion, interstitial space, glucose metabolism, and saliva production to identify prognostic and predictive parameter(s) for treatment | | 1 year of com... | DCE MRI, PET, Perfusion, Permeability, Cancer of the head and neck, Head, Neck neoplasms | Head and Neck Neoplasms, Neoplasms by Site, Neoplasms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Functional Imaging<br>Functional imaging with MRI and PET | Procedure: MRI and PET imaging<br>* Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy<br>|
| Functional Imaging of Tumor and Normal Tissue
Study Overview
=================
Brief Summary
-----------------
Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that... | |
NCT00924937 | CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention | The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease. | Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturate... | Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease | Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline, Diabetes Mellitus, Metabolic Syndrome | * Behavioral: Mediterranean Diet
* Behavioral: Low Fat Diet
| Inclusion Criteria:~Informed Consent~Clinical: Unstable coronary disease with documented vessel/myocardial damage~Acute Myocardial Infarction~Revascularization~Exclusion Criteria:~Age < 20 or > 75 years (or life expectancy lower than 5 years).~Patients already planned for revascularization.~Patients submitted to revasc... | 20 Years | 75 Years | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. | Combined apparition of hard card... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis. | Data from clinical and/or diagnostic tests will be analyzed | Seven Years |
| Concentration of LDL cholesterol. | Concentrati... | Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet | Pathologic Processes, Myocardial Infarction, Angina, Unstable, Metabolic Syndrome, Infarction, Cognitive Dysfunction, Ischemia, Necrosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Cognition Diso... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Fat Diet<br>Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids) | Behavioral: Low Fat Diet<br>* Low fat diet: <30% fat (12% MUFA; 6-8%PU... | CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events... |
NCT05678114 | Inositol Treatment in Different Type of PCOS Phenotype | Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria) | The Effect of Inositol Treatment in Women With PCOS of Different Phenotype | Polycystic Ovary Syndrome | * Dietary Supplement: Myo-inositol
| Inclusion Criteria:~women with PCOS of any phenotype~Exclusion Criteria:~hormonal treatment (such as contraceptive pill)~use of supplements containing myo-inositol~severe co-morbidities | 18 Years | 45 Years | Female | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regularization of the menstrual cycle | Number of women with regular/altered menstrual cycle | Change from baseline number of women with irregular menstrual cycle at 4 months |
| Inositol, Vitamin B Complex, Vitamins, Micronutrients, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperandrogenic PCOS<br> | Dietary Supplement: Myo-inositol<br>* Myo-inositol (4g/die)<br>|
| Experimental: Non-hyperandrogenic PCOS<br> | Dietary Supplement: Myo-inositol<br>* Myo-inositol (4g/die)<br>|
| Inositol Treatment in Different Type of PCOS Phenotype
Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)
Official Title
-----------------
The Effect of Inositol Treatme... | |||
NCT05181176 | Effect of Coffee and Tea Consumption on Adolescent Weight Control | Introduction: The influence of tea or coffee supplementation on body weight in adolescents has never been tested. The aim of the present study was to investigate the effect of tea and coffee consumption on body weight and body fat in an obese adolescent population.~Methods: Randomized clinical trial, parallel group stu... | Patient Population The participants were recruited at the at the Obesity Clinic in the Pediatric Gastroenterology Unit at Dana Dwek Children's Hospital from January 2018 and December 2020. The Obesity Clinic is a tertiary referral center for children and adolescent with obesity and its complication. Adolescents aged 12... | Effect of Coffee and Tea Consumption on Adolescent Weight Control - a Randomized Clinical Trial | Body Weight | * Dietary Supplement: Coffee
* Dietary Supplement: Green tea
* Dietary Supplement: Herbal tea (placebo)
| Inclusion Criteria:~Adolescents aged 12-17 years with BMI in the 95th percentile or higher were eligible for the study.~Exclusion Criteria:~Exclusion criteria included major medical, chronic use of medication that may affect study outcomes or regular intake of some tea or coffee (individual for whom the intervention wo... | 12 Years | 17 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial, parallel group study comparing 3 weight loss interventions comprised of a similar dietary recommendation with either coffee (coffee group), tea (tea group) or placebo (h... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect tea and coffee consumption on body weight | change in BMI Z score | 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect tea and coffee consumption on body fat | change in fat percentage analysis using bio electrical impedance analysis | 6 months |
| Obesity | Body Weight | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coffee<br>The coffee group was instructed to consume 2 cups of coffee a day, the amount that was previously described as beneficial in epidemiological studies and safe for children and adolescence. Each cup of coffee contains 250 ml of cof... | Effect of Coffee and Tea Consumption on Adolescent Weight Control
Study Overview
=================
Brief Summary
-----------------
Introduction: The influence of tea or coffee supplementation on body weight in adolescents has never been tested. The aim of the present study was to investigate the effect of tea and coff... |
NCT01737736 | Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy | The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.~The secondary objectives is measure time from ICA clamping to algorithm asymmetry det... | null | Stroke | * Device: Neurokeeper stroke detector
| Inclusion Criteria:~Age > 18 years old.~Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.~Exclusion Criteria:~General anesthesia~Selective carotid artery shunting.~Previous major hemispheric stroke.~Any known major hemispheric lesion.~Significant movement disorder.~Local sku... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological detrioration detection | The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients under... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from deterioration to detection | The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection | |
| Stroke | Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing cartoid endarterectomy surgery<br> | Device: Neurokeeper stroke detector<br>* Electrophisoloigcal monitoring<br>|
| Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy
Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to cl... | ||
NCT05102032 | Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery | Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's recovery. Currently, minimally invasive surgical procedures combined with multimodal analgesia are commonly used to increase the quality of postoperative period... | Introduction About 43,000 hysterectomies were performed in France in 2016 half of them as a laparoscopic procedure. Compared to vaginal hysterectomy, laparoscopic surgery decreases postoperative pain and hospital length of stay [PubMed ID: 25524534 ]. Laparoscopic hysterectomy is also the most common surgical technique... | Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery | Uterus Disease | * Procedure: mini invasive approach
* Procedure: Conventional approach
| Inclusion Criteria:~programmed to laparoscopic hysterectomy~stable ASA score <3~no contraindication to take nonsteroidal anti-inflammatory drugs~absence of chronic pain~perfect understanding of post-operative psycho-motor assessment~presence of an attendant~distance between home and hospital allowing a possible quick r... | 18 Years | 80 Years | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immediate postoperative recovery | determined by the Post Operative Quality of recovery scale PQRS (pain score, PONV and cognitive recovery) | 6th post-operative hour |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative intensity of nociceptive stimulation | measured by the intraoperative opioids consumption (remifentanil) according to the Analgesia Nociception Index (ANI) in microgram. | 4th induction hour |
| postoperative pain intensity: Ve... | post operative recovery, laparoscopic hysterectomy, mini invasive surgery, low pressure laparoscopy | Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional approach<br>Conventional approach to laparoscopic hysterectomy | Procedure: Conventional approach<br>* laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation press... | Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery
Study Overview
=================
Brief Summary
-----------------
Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's... |
NCT04996511 | Day Case Colectomy: Optimizing Short Stay-surgery. | HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology. | Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated. | Day Case Colectomy: Optimizing Short Stay-surgery. | Monitoring, Physiologic | * Device: PulseOn
| Inclusion Criteria:~• Colorectal resection for any pathology~Exclusion Criteria:~• Arrhytmias likely to cause problems with HRV measurements | 18 Years | 100 Years | All | No | Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability (HRV) change | Reliability of HRV parameters | 3 days |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colorectal Surgery Patients<br> | Device: PulseOn<br>* Postoperative HRV measurement<br>* Other names: Emfit QS;|
| Day Case Colectomy: Optimizing Short Stay-surgery.
Study Overview
=================
Brief Summary
-----------------
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.
Detailed Description
-----------------
Patients scheduled for colorectal surgery are recruited to the stu... | |||
NCT05666492 | Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction. | SARS COV-19 has resulted in prolonged olfactory dysfunction in many patients. The investigators aim to compare the effect of topical platelet-rich plasma (test) vs saline (placebo) in patients with covid-related post-viral olfactory dysfunction. | The investigators hypothesize that the use of topical PRP will improve smell identification, threshold, and smell-related quality of life in comparison to a placebo.~This study will provide critical information for a promising new treatment of olfactory dysfunction with the highest level of evidence, in a randomized, p... | Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction. | Olfactory Disorder, Olfaction Disorders | * Other: Platelet rich plasma
* Other: Saline
| Inclusion Criteria:~Adult patients suffering from either post-viral or post-COVID smell loss of any duration, without a history of nasal surgery, nasal polyposis, chronic rhinosinusitis, or intranasal tumors~Patients who are post-COVID must report at least a positive home test on history~Patients with post-viral etiolo... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a placebo-controlled randomized control trial
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PRP on smell identification | Investigate the effect of topical PRP on olfaction via smell identification testing using a brief smell identification test (B-SIT). The change in smell identification with PRP or placebo over time will ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural course of covid related olfactory dysfunction | Investigate the natural course of post-COVID / post-viral olfactory dysfunction in patients treated with placebo for the study by comparing the smell test. | 12 months from clinic visit |... | Olfaction, Smell | Olfaction Disorders, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less than 12 months PRP- Test<br>Patients randomized into the less than 12 months PRP arm will receive 3 doses of topical PRP each month apart and their sense of smell will be assessed during each visit followed by a monthly remote assessm... | Platelet Rich Plasma for the Management of Post-Viral Olfactory Dysfunction.
Study Overview
=================
Brief Summary
-----------------
SARS COV-19 has resulted in prolonged olfactory dysfunction in many patients. The investigators aim to compare the effect of topical platelet-rich plasma (test) vs saline (place... |
NCT03178292 | Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy | To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL. | Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause... | Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy (PCNL) | Percutaneous Nephrolithotomy, Infection, Sepsis, Antibiotics | * Drug: Levofloxacin
* Drug: Placebo
| Inclusion Criteria:~Stones ≥ 2.5 cm and/or hydronephrosis~Sterile mid urine stream~Exclusion Criteria:~Patients with a stent, nephrostomy tube or indwelling catheter~Uncontrolled Diabetes mellitus~Renal failure~Fever before surgery~Concomitant bladder stone or tumour~Patients with active UTI~Contralateral renal/ureteri... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference | SIRS if patient h... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone. | Preoperative urine (MSU),intraoperative renal pelvic urine and extracted stone culture and sensitivity. | 1 yea... | Levofloxacin, Ofloxacin, Anti-Infective Agents, Urinary, Anti-Infective Agents, Anti-Bacterial Agents, Topoisomerase II Inhibitors, Topoisomerase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Cytochrome P-450 CYP1A2 Inhibitors, Cytochrome P-450 Enzyme Inhibitors | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levofloxacin<br>Levofloxacin 500 mg daily for 5 days | Drug: Levofloxacin<br>* Levofloxacin 500Mg daily for 5 days<br>* Other names: Levofloxacin 500Mg;|
| Placebo Comparator: Placebo<br>Placebo tab daily for 5 days | Drug: Placebo<br... | Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy
Study Overview
=================
Brief Summary
-----------------
To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after ... | |
NCT01818050 | Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™) | Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Studies have shown that the conventional tubular type... | Fifty patients that meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study.~Initial visit:~Written informed consent will be obtained~Complete history and physical will be performed and the patients baseline liver function tests and imaging results will be ass... | Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™) | Bile Duct Stricture | * Other: Liver Function Tests
| Inclusion Criteria:~All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.~One or more biliary stents may be placed during the procedure depending... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary stent patency | | At 90 days after stent placement |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Function Test improvement | | 90 days |
| Constriction, Pathologic, Pathological Conditions, Anatomical | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wing stent arm<br>There is only one arm in this study. Intervention: checking liver function tests to evaluate stent patency | Other: Liver Function Tests<br>* LFTs will be checked periodically after Wing stent placement to evaluate stent patency... | Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)
Study Overview
=================
Brief Summary
-----------------
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.