Panacea: A foundation model for clinical trial search, summarization, design, and recruitment
Paper β’ 2407.11007 β’ Published
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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
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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 β₯ 45 and β€ 75 years~Body mass index (BMI) of β₯ 18.0 and β€ 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) β₯ 25 mmHg along with a (pulmonary artery wedge pressure) PAWP β€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 β₯ 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:~β₯18 years of age~aortic stenosis / mixed aortic stenosis and aortic insufficiency~SAVR+CABG (1-4 distal anastomoses)~Log. EuroSCORE β₯6~NYHA Class β₯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
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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
---------... |
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CTGOV
π€ [Panacea Model] β’ π» [Github Repo] β’ π [Panacea Paper]
This repo contains ctgov data used in "Panacea: A foundation model for clinical trial search, summarization, design, and recruitment".
Load the dataset
pip install -U datasets fsspec
from datasets import load_dataset
ds = load_dataset('linjc16/ctgov', split='train')
Citation
If you find our work useful, please consider citing Panacea:
@article{lin2024panacea,
title={Panacea: A foundation model for clinical trial search, summarization, design, and recruitment},
author={Lin, Jiacheng and Xu, Hanwen and Wang, Zifeng and Wang, Sheng and Sun, Jimeng},
journal={arXiv preprint arXiv:2407.11007},
year={2024}
}
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