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NCT02442687
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twicedaily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared toplacebo in patients with biopsy-proven nonalcoholic steatohepatitis Inclusion Criteria:1. Age 18 years2. Provision ...
NCT02442453
Effect of Scaling and Root Planing Along With Topical Application of Commercially Available Curcuma Longa Gel on Superoxide Dismutase and Malondialdehyde Levels in Saliva of Chronic Periodontitis Patients
Chronic Periodontitis Periodontitis is initiated by microbial biofilm but its progression is mediated by anabnormal host response to biofilm microorganisms.In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygenspecies (ROS) play an important role. Imbalance between antioxidant defe...
NCT02442245
The Effect of XSurge Supplementation on Biomarkers and Performance From High Intensity Resistance Exercise
Exercise Performance Recovery Part one of this study will consist of baseline (BL) testing, 28 days of dailysupplementation with XSurge, and an exercise protocol. The acute exercise protocol consistsof five visits, of which, the first visit will consist of maximal strength testing. Theremaining visits will consist of p...
NCT02442050
Del Nido Cardioplegia Randomized Trial
Cardiac Perfusion The use of a modified depolarizing cardioplegia solution in adult cardiac surgery wouldallow for prolonged re-dosing intervals while providing equivalent myocardial protection.The use of del Nido solution has been used extensively in congenital heart surgery for over25 years. The primary objective is ...
NCT02442440
Anisodamine Critically Ill SeptIc Shock
Septic Shock Anisodamine has been widely used in China for its pharmacological effect on improvingmicrocirculation during shock. It has been reported that anisodamine is effective inreducing mortality rate in children with meningitis. however, its effectiveness in patientswith septic shock has not been systematically i...
NCT02442284
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Chronic Hepatitis C This is a study to evaluate the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir andDasabuvir with or without Ribavirin in US veterans with genotype 1 chronic hepatitis C virusinfection. Inclusion Criteria:1. US military veteran currently receiving healthcare through the Veterans HealthAdmin...
NCT02442778
Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Agitation in Patients With Dementia of the Alzheimer's Type Patients with agitation secondary to dementia of the Alzheimer's type. The diagnosis ofprobable Alzheimer's disease (AD) will be based on the '2011 Diagnostic Guidelines forAlzheimer's Disease' issued by the National Institute on Aging (NIA)-Alzheimer's Associ...
NCT02442817
Linagliptin and Mesenchymal Stem Cells: A Pilot Study
Schizophrenia The purpose of the present study is to gather pilot data on the effects of linagliptin onthe concentration of the long and short forms of SDF1- (stromal cell-derived factor alpha)in humans, and to demonstrate the feasibility of such a study in patients with psychosis inour setting. Inclusion Criteria:- M...
NCT02442180
Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid
Alcoholic Hepatitis Steroid is the treatment of choice in patients with severe alcoholic hepatitis. However,null- or partial responder of steroid treatment is recommended to consider livertransplantation. The yearly demand for liver transplants far exceeds the supply of availableorgans and alcoholic liver disease has b...
NCT02442427
"Palivizumab Therapy for RSV-bronchiolitis"
Respiratory Syncytial Virus-bronchiolitis There is a growing body of literature suggesting that monoclonal antibody could beefficacious in infants with RSV-bronchiolitis, well tolerated with no or clinicallyinsignificant adverse effects."The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in dia...
NCT02442037
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
Ulcerative Colitis Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stemcell (UC-MSC) in patients with active ulcerative colitisrandomized, single blind,controlled prospective study. Inclusion Criteria:- The diagnosis of active UC must have been confirmed by endoscopic and histolog...
NCT02442960
Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis
Ulcerative Colitis This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment givenorally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one oftwo cohorts in up to two clinical sites. Treatment will be given for 8 weeks and studyduration will be 12 weeks. 1. Age ...
NCT02442141
Peri-operative NIRS Monitoring In Infants
Anesthesia The purpose of this research study is to examine the effects of routine anesthesia on infantbrain oxygen levels. The investigators do not know how anesthesia effects blood flow in thebrain of infants during surgery. This study will help the investigators detect possibleblood flow changes in the brain for inf...
NCT02442154
Early Tracheostomy Versus Standard of Care in Patients With Severe Head Injury
Severe Head Injury Severe head injury is associated with airway compromise and poor respiratory effort. InMulago Hospital intubation is the mainstay intervention and then patients are subjected tothe wait and see strategy of delayed or no tracheostomy, very few undergo earlytracheostomy, and some patients are left with...
NCT02442544
Prebiotic Fiber Supplement in T1DM Children
Type 1 Diabetes The gut microbiome is increasingly recognized as a contributor to disease states. In type 1diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability,inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gutmicrobiota and could potentia...
NCT02442791
GLP-1 Analogs for Neuroprotection After Cardiac Arrest
Cardiac Arrest Experimental studies and previous clinical trials suggest neuroprotective effects of GLP-1analogs in various degenerative neurological diseases, and in hypoxic brain injuries inexperimental designs. This study is designed as a safety and feasibility study with patientsrandomized 1:1 to receive GLP-1 anal...
NCT02442752
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
Pediatric Gastroesophageal Reflux Disease The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD)[after daily administration for 7 days] and safety [after daily administration for 8 weeks]of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, withacid-related dis...
NCT02442024
Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
Diabetes Mellitus The investigators aimed at evaluating the metabolic effects of the inversion of the typicalItalian sequence of food ingestion at the main meals in type 2 diabetic patients. Inclusion Criteria:- Well-controlled type 2 diabetes- HbA1c 48-58 mmol/mol (6.5-7.5%)- Treatment with metformin or diet only- ...
NCT02442232
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
Hemodynamic Responses to Propofol The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses topropofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphismson biomarkers r...
NCT02442583
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors
Colorectal Cancer Interview colorectal cancer survivors and use this input to create a brochure intended toguide reduction of sedentary behaviors in this population. Have colorectal cancer survivorsreview and comment on a draft of the brochure. A third group of colorectal cancer survivorswill wear an Actigraph activity...
NCT02442622
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
de Quervain's Disease To determine if the addition of Astym treatment to traditional therapy produces a morepositive outcome then traditional therapy alone for the treatment of de Quervain'stenosynvitis. Two groups will be examined with one group receiving traditional therapy andthe other group receiving traditional th...
NCT02442193
Individual Placement and Support for Patients With Offending Histories
Employment, Supported The overall aim of the study is to assess the feasibility of conducting a RandomizedControlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support(IPS) in improving employment rates and associated psychosocial outcomes in forensicpsychiatric populations. Inclusion Criteri...
NCT02442804
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
Stroke The purpose of this study is to determine whether pomegranate supplements improve cognitivefunctioning following stroke. Inclusion Criteria:- Suffered an ischemic stroke and admitted to LLUMC Rehabilitation Institute forinpatient care- Fluent in English- Between the age of 18 and 89 years oldExclusion Criteri...
NCT02442596
Abdominal SepsiS Study: Epidemiology of Etiology and Outcome
Intra-Abdominal Infections The aim of the project is to perform a multinational, prospective, observational study onIAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be givento epidemiology and outcomes. Inclusion Criteria:- Adult (18 yrs. of age)- IAI treated with percutaneous or sur...
NCT02442999
The SNORES Randomized Clinical Trial
PCOS Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present forfertility treatment to evaluate the impact of screening for obstructive sleep apnea. Inclusion Criteria- Females 18 - 50 years old.- Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinologyinferti...
NCT02442557
Safety and Dose-finding Study of DC-TAB in Healthy Subjects
Multiple Sclerosis The purpose of this study is to determine safety and appropriate dose of DC-TAB forselective immune tolerance induction in humans. Inclusion Criteria:- Caucasian- Signed the written informed consent form before first screening procedure- Age 18 years and 55 years- In general good health in the ...
NCT02442219
A Blood Based Diagnostic Test for Coeliac Disease
Coeliac Disease Persons with coeliac disease treated with a gluten free diet will be asked to give blood fora new diagnostic blood test. In this test investigators will use multimerized HLA bound todifferent gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (alongwith other relevant T-cell-mark...
NCT02442635
Yoga During Chemotherapy Study
Cancer This proposal aims to expand non-pharmacologic options for the control of symptoms duringchemotherapy using yoga practices. It is particularly focused on sleep disturbance with asecondary focus on fatigue. Inclusion Criteria:- 18-65 years of age- Have a Karnofsky Performance Status Score of 60 or above- Diagn...
NCT02442609
Internet for Anesthesia Information : a Patient Questionaire
Anaesthesia Patients need information for perioperative period and internet may be an interestingalternative.This study analysed by questionaire what does patient look on internet:information of perioperative period and specifically for anesthesia. Questionaire (8questions) are distributed to the patient before surgery...
NCT02442973
Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002
Pregnancy Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) areonly two dimensional. The Accuro is a three dimensional handheld ultrasound device. Thisdevice uses sound waves to create pictures of the spine in three dimensions. This may allowthe physician to view the spine in more ...
NCT02474758
[Trial of device that is not approved or cleared by the U.S. FDA]
NONE NONE NONE
NCT02474823
Neck Grasp as a Predictor of Sleep Apnea
Obstructive Sleep Apnea A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor),showed a positive maneuver (unable to wrap hands completely around neck) to be 100%predictive of sleep apnea in a sleep clinic population. The investigators now would like tocompare ESAP to other tests used t...
NCT02474407
A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat)
Refractory Epilepsy This is a multi-center, open-label, crossover, pharmacokinetic, bioavailability studyinvolving adolescents and adults with refractory (drug-resistant) epilepsy Inclusion Criteria:- Diagnosis of refractory epilepsy- Body weight 26 to 111 kilogram (kg) inclusive- Other inclusion criteria applyExclu...
NCT02474836
Determination of Biological Activity of Three Allergen Extracts
Hypersensitivity Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenicand non-allergenic components. Many factors such as the variability, differences inextraction process and subsequent handling of allergens can affect the final composition,potency, and stability of allergen prep...
NCT02474771
[Trial of device that is not approved or cleared by the U.S. FDA]
NONE NONE NONE
NCT02474017
An Open Study to Assess the Robustness of the CRC749 Inhaler
Asthma To confirm the robustness of the CRC749 inhaler. Inclusion Criteria:1. Males and females at least 12 years of age.2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD andstable treatment.3. Spirometry following salbutamol showing FEV1 40% of predicted normal and FEV1/FVCratio <0.7 f...
NCT02474940
MS Symptom Management Study
Multiple Sclerosis People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, availabletreatments provide inadequate relief for the majority of these individuals. There remains anurgent need for additional treatment options for MS-related symptoms. The purpose of thisstudy is to see if alternati...
NCT02474160
Collection and Storage of Tissue and Blood Samples From Patients With Cancer
Malignant Neoplasm This research trial collects and stores tissue and blood samples from patients with cancer.Collecting and storing samples of tissue and blood from patients with cancer to study in thelaboratory may help scientists create new and better models to learn about cancer and totest new cancer drugs. Inclusi...
NCT02474212
: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
Venous Thromboembolism To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin inpostoperative cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparinis administered either as a continuous intravenous infusion or subcutaneous bolus oncedaily.After informed consent, 80 elective...
NCT02474979
Reduced Pressure for Less Pressure Ulcers
Pressure Ulcer Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerablecosts for society. The present study will evaluate the effect of the Continuous BedsidePressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patientswill be conducted in a geriatric s...
NCT02474004
Gait Analysis Meniscal Repair
Lesion of the Medial Meniscus In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of theknee adduction moment (KAM) during walking. Other researches found out that an increase ofthe KAM is an important factor contributing to degeneration joint disease of the knee(osteoarthritis). Today...
NCT02474992
The Kanyakla Study: a Social Network Intervention for Promoting Engagement and Retention in HIV Care
HIV The purpose of this randomized controlled trial is to compare a social network-basedbehavioral intervention known as microclinics to standard HIV clinical care alone in helpingpatients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent toclinic appointments. The study is designed to ev...
NCT02474602
Phototherapy Applied in Association With Strength Training
Muscle Development in Association to Phototherapy The effects of phototherapy has been widely studied by some research groups. Theinvestigators know that there are positive results with light application to improve muscleperformance and delay fatigue. However, there are few studies showing its effects onmuscular traini...
NCT02474563
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
Multiple Myeloma The purpose of this study is to assess the 2-year progression-free survival rate. Inclusion Criteria:- Participants who are nave to chemotherapy for multiple myeloma and not eligible forautologous stem cell transplantation- Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal ...
NCT02474615
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
Mandibular Hypoplasia Thirty teeth twelve patients, two female and a male, who had persistent periradicularlesions were selected to participate in this study. The lesions were diagnosed withcone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging SciencesInternational LLC).In patients with two teeth to b...
NCT02474173
Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer
Estrogen Receptor Negative This phase Ib trial studies the side effects and best dose onalespib when given togetherwith paclitaxel in treating patients with triple negative breast cancer that has spread toother places in the body and usually cannot be cured or controlled with treatment(advanced). Onalespib works by blo...
NCT02474628
Consistencies in Responses to Sodium Bicarbonate?
Sports Nutritional Physiological Phenomena Intervention studies do not account for high within-individual variation potentiallycompromising the magnitude of an effect. Repeat administration of a treatment allowsquantification of individual responses and determination of the consistency of responses.The investigators ai...
NCT02474199
Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
Liver Transplant Recipient This research study is for liver transplant recipients and their respective living donors.The purpose of this study is:1. To see if it is safe for liver recipients to receive one dose of donor reactive Tregulatory cells (Tregs)2. To see if the Tregs allows a liver recipient to take less, or c...
NCT02474953
A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
Healthy This study is investigating the pharmacokinetic profile (i.e. the way the product isprocessed by the body) of a proprietary curcumin formulation compared to an unformulatedcurcumin product. Subjects will take a single dose of either the proprietary formulation orcomparator product and the blood levels of curcum...
NCT02474238
Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy
Angle Closure Glaucoma No single type of laser or set of laser parameters is appropriate for all type of irides.Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was consideredas the gold standard for iridotomy. It, however, is less effective and causes somecomplication such as iris hemorrhage...
NCT02474576
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
Dupuytren Disease The efficiency of percutaneous aponeurotomy in the treatment of Dupyutrens disease is wellknown. However, the duration of the clinical improvement after aponeurotomy is not wellknown.This study aims primarily at measuring the incidence rate of local relapse ofDupuytrens-induced finger flessum, within ...
NCT02474589
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
Smallpox Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety andtolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects. Inclusion Criteria:- 18 to 80 years old, inclusive- Available for clinical follow-up for the duration of the study- Able and willing to give ...
NCT02474511
the Influence of General Anesthesia on Tumor Metastasis and Recurrence
Tumor Recurrence and Metastasis The purpose of this study was to investigate whether general anesthesia will affect thepostoperative recurrence and metastasis of malignant tumor. Inclusion Criteria:- ASA I - III Primary liver cancer tumor is single and diameter is less than 3centimeter There is no major vascular invas...
NCT02474277
How Well Does the 30-Second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients
Acute Disease The aims are to identify predictive indicators of hospitalized elderly medical patients'need for rehabilitation and to validate (known group validity) the Chair Stand Test Inclusion Criteria:- Can speak and understand Danish- Can report personal data- Within the first 48 hours of admission are able to ...
NCT02474667
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
Delayed Graft Function A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study ofBB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased DonorKidney.The major objective is to demonstrate the safety and efficacy of BB3 in reducing theseverity of delayed graft func...
NCT02474459
Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
Parkinson's Disease The purpose of this study is to test the use of a clinical decision support tool forpostoperative care of Parkinson's disease patients who are treated using deep brainstimulation (DBS). The central hypothesis is that the use of a DBS clinical decision supportsystem for individual patient management ...
NCT02474303
Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal
HIV/AIDS Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities torethink HIV prevention and treatment strategies, especially for key populations such asFemale Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has thepotential to have a profound population-le...
NCT02474316
Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients
Chronic Hepatitis B This is a prospective, randomized, multicenter, open-label study. After more than 24 weeksNA treatment, HBeAg positive CHB patients who achieved HBV DNA<1000copies/ml but HBeAbnegative, will be randomized (1:1) into 2 study arms as follows:Arm A: Peginterferon alfa-2a 180g /wk plus NA 1 piece qd for...
NCT02474706
Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli
Urinary Tract Infections Background Information: Infections caused by extended-spectrum -lactamase (ESBL)-producingEscherichia coli are becoming increasingly common owing to incorrect use of antibiotics andcross-transmission in healthcare establishments. These give rise to major problems instandard clinical practice: p...
NCT02474472
Postoperative Analgesia Investigation
Pain The primary objective of the study is to compare the efficacy of standard local anestheticbupivicaine and liposomal bupivicaine in postoperative pain control both in magnitude andduration in patients undergoing sternotomy, thoracotomy, thoracoabdominal, and laparotomyincisions. Inclusion Criteria:- 18 years-old o...
NCT02474329
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's Disease
Parkinson's Disease Background: Long-term management of Parkinson's disease (PD) does not reach its fullpotential due to lack of knowledge about disease progression. The Real-PD study aim toevaluate the feasibility and compliance of usage of wearable sensors in PD patients in reallife. Moreover, an explorative analysis...
NCT02474498
EMD and/or Bone Substitute for the Treatment of Class II Furcations
Periodontal Disease To clinically evaluate the treatment of mandibular class II furcation defects with enamelmatrix derivative (EMD) and/or a bone substitute graft make of beta tricalciumphosphate/hydroxyapatite (TCP/HA). Inclusion Criteria:- Males and females, between 18-75 years of age;- Presence of a mandibular mo...
NCT02474927
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation
Lung Transplant Rejection The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safetyand efficacy of combination therapy with carfilzomib, plasma exchange and intravenousimmunoglobulins for AMR after lung transplantation and elucidate important clinical andimmunologic phenotypes and mecha...
NCT02474264
The Link Between BRCA Mutation and Endothelial Function
BRCA1 Gene Mutation This study evaluates the effect of BRCA1&2 mutations on cardiovascular diseases by tocomparing the endothelial function of male BRCA mutation carriers with that of age matchednon-BRCA mutation carriers. Inclusion Criteria:- Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 muta...
NCT02474524
Self-Management and Recovery Technology Psychosocial Intervention Trial
Schizophrenia This project is a component of a broader research program referred to as "Self-Managementand Recovery Technology (SMART): Use of online technology to promote self-management andrecovery in people with psychosis", which has been funded by the Victorian Department ofHealth Mental Illness Research Fund (MIRF...
NCT02474901
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Human Immunodeficiency Virus (HIV) The goal of this study is to determine if there is a difference in shedding (primaryobjective) and in immunogenicity and safety (secondary objectives) between HIV-positive andHIV-negative children and young adults who are receiving the quadrivalent live-attenuatedinfluenza vaccine (QL...
NCT02474732
Usability Study for the Beactive Brace Instructions for Use
Lower Back Pain FDA requires that the user's guide be provided with any over-the-counter (OTC) medicaldevice. It is beneficial to demonstrate that the user's guide for a new medical device isbroadly comprehensible where the device will be provided without prescription and directphysician counseling. Therefore, a popula...
NCT02474875
Explain Pain in Fibromyalgia Patients
Fibromyalgia Education of pain physiology is described as an educational session or sessions describingthe neurobiology and neurophysiology of pain, and pain processing by the nervous system.There is compelling evidence that an educational strategy addressing neurophysiology andneurobiology of pain can have a positive ...
NCT02474849
Pharmacokinetic Study Comparing Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects
Healthy Volunteers This study will compare nicotine delivery, heart rate, puffing parameters and productsatisfaction in healthy subjects either using several different types of electroniccigarettes or smoking a conventional cigarette. Inclusion Criteria:1. Prior to study start, subjects must be daily users of newer gen...
NCT02474108
Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
Atrial Fibrillation This study evaluates the safety and efficiency of surgical prevention of atrial fibrillationin patients with valvular heart disease and left atrium enlargement Inclusion Criteria:- rheumatic mitral valve lesion- the absence a history of AF- sinus rhythm- left atrium size more than 6.0 cmExclusio...
NCT02474134
Comparison Study of PF530 and Betaferon in Healthy Subjects
Multiple Sclerosis The purpose of this study is to compare the safety, tolerability, and blood levels of twointerferon beta-1b products, Betaferon and PF530, in healthy volunteers. Inclusion Criteria:- Females of childbearing potential must agree to use two effective methods of birthcontrol, practice complete abstinen...
NCT02474121
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
Peripheral Arterial Disease This study will continue to evaluate the performance of the MarrowStim PAD Kit to treatsubjects with critical limb ischemia (CLI) caused by severe PAD. Inclusion Criteria:- Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterialdisease- Unsuitable for revascula...
NCT02474069
Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis
Moderate to Severe Plaque-type Psoriasis This study is designed to support the optimal use of secukinumab by providing data to refineguidance on dosing flexibility in patients with psoriasis. The purpose of the study is toexplore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patientswho had ...
NCT02474082
Study of Secukinumab Compared to Fumaderm in Adults With Moderate to Severe Psoriasis.
Psoriasis This is a randomized, controlled, multicenter, open-label study with blinded assessment ofthe efficacy of subcutaneous secukinumab compared to Fumaderm, in 200 adults with moderateto severe plaque type psoriasis who are candidates for systemic therapy. The study consistsof 2 periods: a screening period of at ...
NCT02474914
Sandostatin in the Prevention of Postoperative Complications After Pancreaticoduodenectomy
Periampullary Carcinoma Resectable pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benignand malignant pancreatic and periampullary diseases. Despite improved surgical technique andpostoperative care, the mortality rate after PD is high reaching up to 30%, due to highincidence of p...
NCT02474719
Transfer and Ultrafiltration In Peritoneal Dialysis
End-stage Renal Disease The aim of this study is to demonstrate the efficiency of an adapted and "alternate"peritoneal dialysis scheme in terms of sodium extraction and purification compared to anadapted conventional peritoneal dialysis scheme. Inclusion Criteria:- Patients hospitalized in the Nephrology department of...
NCT02474043
A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin
Hepatitis C The goal of this study is to evaluate the effectiveness of a brief, computerized behavioralintervention for promoting screening for hepatitis C and reducing risky behavior for peoplewho inject drugs (PWID). Inclusion Criteria:- Age 18 or over- English-speaking- Reports injection of illicit drugs in the p...
NCT02474862
Healthy Expectations - A Program for Pregnant Women Experiencing Depressive Symptoms
Depressive Symptoms This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP)in comparison to a Postpartum Prep Program (PPP) comparison group for pregnant womenexperiencing depressive symptoms. In addition to assessing changes in depressive symptoms,the investigators will examine other...
NCT02474446
Getting Vitamin D Dosing Right
Vitamin D Status The investigators want to make sure that people get the right dose of Vitamin D treatment.They will therefore investigate how skin colour, body mass index, ethnicity, vitamin Dbinding protein and genetic variation affect the response to a standard course of vitamin Din young adults, as a prelude to fur...
NCT02474485
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
Coronary Artery Disease AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded toevaluate two strategies of in stent restenosis treatment: Implantation of drug elutingbioresorbable stent scaffold Absorb vs. balloon angioplasty with drug eluting balloonSequent Please. Inclusion Criteria:- ...
NCT02474888
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
Granulomatosis, Wegener's The aim of the investigators' study is to evaluate whether monitoring serum rituximab levelscould be an interesting tool in the follow-up of ANCA-associated vasculitis patients.All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis orthe relapse of a known ANC...
NCT02474693
Salt Sources Study
Dietary Sources of Sodium Intake The Centers for Disease Control and Prevention conducted an observational cross-sectionalstudy to obtain information about the amount of sodium consumed from various sources(including sodium from processed and restaurant foods, sodium inherent in foods, and saltadded at the table and du...
NCT02474056
The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock
the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients We hypothesis that in various situation when the effective blood volume decreased the venousvolume flow characteristics change according to the fluid resuscitation Inclusion Criteria:- age >...
NCT02474095
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Head and Neck Carcinoma This randomized pilot clinical trial studies alternate schedules for acupuncture-liketranscutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia)caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is aprocedure in which mild electric currents...
NCT02474654
Implementation of a Pain Management Protocol for Total Knee Arthroplasty
Knee Replacement, Total Study question: Is there an ideal combination of intraoperative long acting analgesics(periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) tooptimize post-operative functional recovery, decrease overall narcotic consumption andenable faster 'readiness to disch...
NCT02474641
Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
Early-Stage Breast Carcinoma Hypofractionation with simultaneous integrated boost has been investigated in a few trialsand appears to be safe and feasible.Investigators initiated this multicenter two-armed phase III prospective trial to analysethe non-inferiority of hypofractionation with simultaneous integrated boost ...
NCT02474537
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
Hepatic Impairment This is a phase I, multi-center, open-label, single oral dose, parallel group study toevaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impairedhepatic function and non-cancer subjects with normal hepatic function.The study populationwill be healthy male and postmenopausa...
NCT02474251
Brain Sleep Clearance of Amyloid-Beta Peptides
Obstructive Sleep Apnea The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta(A), in the brain is the initiating event in Alzheimer's disease (AD), however, themechanisms involved are not well understood. Recent studies support the hypothesis that Adynamics in the brain are influenced...
NCT02474290
Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML
Acute Myeloid Leukemia The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis ofleukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITDpositive acute myeloid leukemia (AML). Inclusion Criteria:- FLT3-ITD Positive AML- Allo-HSCT RecipientsExclusion Criteria:...
NCT02474680
Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
Major Depressive Disorder 1 This is a non-randomized, single-case design of pharmacogenetic implementation in a mentalhealth patient population of subjects taking antipsychotics and/or antidepressants. Inclusion Criteria:- Must be taking either an anti-depressant or an anti-psychotic medication- Must provide informed...
NCT02474745
Study of the Type of Pushing at Delivery
Delivery The objective of this randomized clinical trial is to assess and compare the effectivenessof directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs.directed open-glottis pushing (pushing during a prolonged exhalation) during the secondstage of labor. The study hypothesis is that ope...
NCT02474433
Same-day Cervical Preparation With Misoprostol Before Hysteroscopy
Cervical Preparation Prior to Hysteroscopy This is a randomized trial, assessing Misoprostol efficacy in cervical preparation severalhours prior to hysteroscopy, comparing the different routes of administration(PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease ofdilatation, time requ...
NCT02474355
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
Lung Cancer The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a realworld setting in adult patients with advanced or metastatic, epidermal growth factorreceptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who havereceived prior EGFR-tyrosine kinase inhibitor (T...
NCT02474368
Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck
Recurrent Head and Neck Carcinoma This research study seeks to gain new knowledge about the addition of a carefully targeted"boost" dose of radiation as a possible treatment for recurrent or metastatic head or neckcancer. The name of the study intervention involved in this study is stereotactic bodyradiotherapy, which ...
NCT02474550
Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma
Diffuse Large B Cell Lymphoma This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL)treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators willprospectively collect clinical data and treatment outcome of patients with DLBCL who useprophylactic pegylat...
NCT02474381
Autologous Endothelial Progenitor Cells Treatment of Diabetic Foot
Diabetic Foot The vascular pathologic basis of diabetic foot include arterial obstruction andmicro-circulation defects.The latest technology of arterial reconstruction can only rebuildblood flow of anterior,posterior tibial artery and peroneal artery.Endothelial progenitorcells have been proved to integrate into damage...
NCT02474342
Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease
Rotator Cuff Disease The purpose of this study is to evaluate safety and efficacy of Autologous Adipose TissueDerived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease. Participants should meet all the inclusion criteria. Patients must consent in writing toparticipate in the study by signing and dat...
NCT02474394
Effects of Videolaryngoscope on Intraocular Pressure
Intubation Complication This study is designed to compare the effects of the McGrath Series 5 video laryngoscope andMacintosh laryngoscope on intraocular pressure during laryngoscopy. Inclusion Criteria:- American society of anesthesiologist physical status I- Non-ophthalmic elective surgery under general anesthesiaE...
NCT02474784
[Trial of device that is not approved or cleared by the U.S. FDA]
NONE NONE NONE
NCT02474186
Phase II Study for Solid Metastatic Tumors
Breast Cancer 1. To induce immunity-mediated tumor response outside the radiation field (abscopaleffect) after chemo-radiation of a metastatic site in metastatic breast cancerpatients.2. To monitor the induction of a T cell response.3. To explore the role of PET scanning to assess tumor responses/abscopal effect. Inclu...