225 matching studies

Sponsor Condition of Interest
Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus...
CytoDyn, Inc. Coronavirus Disease 2019
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease. expand

The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

Type: Interventional

Start Date: Apr 2020

open study

Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects...
Pfizer Dermatitis, Atopic
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib,... expand

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying Phase 3 study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country

Type: Interventional

Start Date: Mar 2018

open study

Reducing Lung CongestIon Symptoms in Advanced Heart Failure
V-Wave Ltd Heart Failure
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV... expand

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Type: Interventional

Start Date: Sep 2018

open study

Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
The University of Texas Health Science Center, Houston Epilepsy
The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety,... expand

The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety, quality of life, sleep, and seizure frequency.

Type: Interventional

Start Date: Jun 2020

open study

Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade...
Merck Sharp & Dohme Corp. Neuromuscular Blockade
This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex is superior... expand

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.

Type: Interventional

Start Date: Jul 2019

open study

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
The George Washington University Biostatistics Center Obstetrical Complications Hemorrhage Labor and Delivery
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery. expand

A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Type: Interventional

Start Date: Mar 2018

open study

Chronic Hypertension and Pregnancy (CHAP) Project
University of Alabama at Birmingham Hypertension
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is... expand

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

Type: Interventional

Start Date: Jun 2015

open study

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular Mitral Valve Regurgitation
Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the... expand

Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device. Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Type: Interventional

Start Date: Oct 2017

open study

Comparison Of Radiation Exposure To Patients During Endoscopic Retrograde Cholangiopancreatography (ERCP)...
The University of Texas Health Science Center, Houston Pancreatic Cancer
Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training. Research design: This is... expand

Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training. Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training. Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future. Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.

Type: Observational

Start Date: Nov 2015

open study

Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Boehringer Ingelheim Idiopathic Pulmonary Fibrosis
The main objectives of this study are: - Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)... expand

The main objectives of this study are: - Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF) - Determine the difference in change in Quality of Life (QoL) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF) - Determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)

Type: Interventional

Start Date: Nov 2018

open study

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
COMPASS Pathways Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression expand

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Type: Interventional

Start Date: Jan 2019

open study

Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
The University of Texas Health Science Center, Houston Spinal Cord Injuries
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury. expand

The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.

Type: Interventional

Start Date: Jun 2020

open study

Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active...
Gilead Sciences Inflammatory Bowel Disease
The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease. Results of this study may be pooled with the results of a separate study being conducted in participants with... expand

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease. Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

Type: Interventional

Start Date: Jul 2017

open study

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active...
Gilead Sciences Crohn's Disease
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete... expand

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

Type: Interventional

Start Date: Oct 2016

open study

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Seattle Genetics, Inc. Small Cell Lung Cancer Non-small Cell Lung Cancer, Squamous Non-small Cell Lung Cancer, Non-squamous Head and Neck Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma
This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer. expand

This trial will study ladiratuzumab vedotin (LV) to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

Type: Interventional

Start Date: Oct 2019

open study

Timing of Inguinal Hernia Repair in Premature Infants
Vanderbilt University Medical Center Inguinal Hernia Premature Birth of Newborn
The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia. expand

The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.

Type: Interventional

Start Date: Jun 2013

open study

Multi-arm Optimization of Stroke Thrombolysis
University of Cincinnati Acute Ischemic Stroke
The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS)... expand

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.

Type: Interventional

Start Date: Oct 2019

open study

Early Feasibility Study: Fetoscopic NEOX Cord 1K® Myelomeningocele (MMC) Repair
The University of Texas Health Science Center, Houston Spina Bifida Fetus Risk Myelomeningocele
The purpose of this study is to test the feasibility of surgically covering myelomeningocele spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect, prevention... expand

The purpose of this study is to test the feasibility of surgically covering myelomeningocele spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect, prevention of cerebral spinal fluid leakage and wound dehiscence will be assessed at birth and at 12 months of age.

Type: Interventional

Start Date: Feb 2020

open study

D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
PolyPid Ltd. Surgical Site Infection Sternal Infection Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac... expand

Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.

Type: Interventional

Start Date: Dec 2019

open study

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
University of Texas Southwestern Medical Center Peripheral Arterial Disease
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software,... expand

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.

Type: Observational [Patient Registry]

Start Date: Jan 2013

open study

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Ra Pharmaceuticals Immune Mediated Necrotizing Myopathy
The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks. expand

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

Type: Interventional

Start Date: Dec 2019

open study

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Intercept Pharmaceuticals Liver Cirrhosis, Biliary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational... expand

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

Type: Interventional

Start Date: Dec 2014

open study

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders...
EBR Systems, Inc. Heart Failure
This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy. expand

This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

Type: Interventional

Start Date: Jan 2018

open study

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
Novartis Pharmaceuticals Sickle Cell Disease (SCD)
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit. expand

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

Type: Interventional

Start Date: Mar 2019

open study

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
Lundbeck Northera Ltd. Symptomatic Neurogenic Orthostatic Hypotension
To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with... expand

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)

Type: Interventional

Start Date: Feb 2016

open study