244 matching studies

Sponsor Condition of Interest
Study to Evaluate the Safety and Efficacy of the Coadministration of Ibrexafungerp (SCY-078) With Voriconazole...
Scynexis, Inc. Invasive Pulmonary Aspergillosis
Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis. expand

Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.

Type: Interventional

Start Date: Jan 2019

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

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or...
National Cancer Institute (NCI) Lung Adenocarcinoma Lung Large Cell Carcinoma Resectable Lung Non-Small Cell Carcinoma Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage IB Lung Squamous Cell Carcinoma AJCC v7
This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have... expand

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Type: Interventional

Start Date: Aug 2014

open study

AMPLATZER PFO Occluder Post Approval Study
Abbott Medical Devices Stroke Patent Foramen Ovale
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting. expand

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

Type: Interventional

Start Date: Jan 2018

open study

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
Michael Roth Scleroderma, Systemic Interstitial Lung Disease
A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD). expand

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).

Type: Interventional

Start Date: Nov 2017

open study

Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment...
Strata Oncology Cancer Adult Solid Tumor Lymphoma
Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary... expand

Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does not require additional procedures but rather uses surplus, or leftover tumor specimens for molecular profiling.

Type: Observational [Patient Registry]

Start Date: Nov 2016

open study

Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)
Oxford Immunotec Tuberculosis
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture expand

The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture

Type: Observational

Start Date: Nov 2019

open study

PREVENTion of Clot in Orthopaedic Trauma
Major Extremity Trauma Research Consortium Blood Clot Trauma
The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots in patients who sustain trauma. expand

The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots in patients who sustain trauma.

Type: Interventional

Start Date: Apr 2017

open study

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients...
Entasis Therapeutics Acinetobacter Baumannii-calcoaceticus Complex Hospital-acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia Bacteremia Colistin Resistant ABC
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC (Acinetobacter baumannii-calcoaceticus Complex) hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is... expand

This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC (Acinetobacter baumannii-calcoaceticus Complex) hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin treatment.

Type: Interventional

Start Date: Apr 2019

open study

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin)...
National Cancer Institute (NCI) Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage IB2 Cervical Cancer AJCC v6 and v7 Stage II Cervical Cancer AJCC v7
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA... expand

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Type: Interventional

Start Date: Jan 2016

open study

Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or...
M.D. Anderson Cancer Center Carcinomatosis Elevated Serum CA-125 Tumor Antigen High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma
This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body. Certain... expand

This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body. Certain characteristics in the DNA of these patients may affect how well they respond to treatment. Learning how adavosertib affects DNA in tumor cells may help doctors plan effective treatment.

Type: Interventional

Start Date: Feb 2016

open study

Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been...
National Cancer Institute (NCI) EGFR Exon 19 Deletion Mutation EGFR NP_005219.2:p.L858R Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage II Lung Non-Small Cell Cancer AJCC v7 Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by... expand

This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: Aug 2014

open study

Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are...
Scynexis, Inc. Invasive Candidiasis Mucocutaneous Candidiasis Coccidioidomycosis Histoplasmosis Blastomycosis
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal... expand

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

Type: Interventional

Start Date: Apr 2017

open study

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Duke University Lactating Women on Select DOI Breastfed Infants of Mothers on Select DOI
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying.... expand

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Type: Observational

Start Date: Oct 2018

open study

Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation...
Alung Technologies Acute Exacerbation of COPD
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation... expand

This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.

Type: Interventional

Start Date: Feb 2018

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

Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer...
Infinity Pharmaceuticals, Inc. Breast Cancer Renal Cell Carcinoma
MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase... expand

MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

Type: Interventional

Start Date: Oct 2019

open study

SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in...
The University of Texas Health Science Center, Houston Acute Ischemic Stroke
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging... expand

SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well. The second aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. This will be evaluated by comparing the outcomes in patients with discordant imaging profile and assessing if thrombectomy outcome rates and treatment effect will differ in patients with discordant imaging profiles (favorable CT/unfavorable perfusion imaging and unfavorable CT/favorable perfusion imaging).

Type: Interventional

Start Date: Oct 2019

open study

Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory...
University of Minnesota Acute Respiratory Distress Syndrome
A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation. expand

A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.

Type: Interventional

Start Date: Apr 2016

open study

A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms...
Novartis Pharmaceuticals Alzheimer's Disease
The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms... expand

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Type: Interventional

Start Date: Nov 2015

open study

Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial...
Daiichi Sankyo, Inc. Atrial Fibrillation
When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation. Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves... expand

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation. Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter. Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter. The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.

Type: Interventional

Start Date: Mar 2017

open study

Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical...
M.D. Anderson Cancer Center Atypical Endometrial Hyperplasia FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The... expand

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.

Type: Interventional

Start Date: Sep 2015

open study

Brain Oxygen Optimization in Severe TBI, Phase 3
University of Michigan Brain Injuries, Traumatic
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by... expand

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.

Type: Interventional

Start Date: Aug 2019

open study

Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Texas Woman's University Multiple Sclerosis Gait Disorders, Neurologic Cognitive Impairment
The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific... expand

The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.

Type: Interventional

Start Date: May 2018

open study

Riluzole in Spinal Cord Injury Study
AOSpine North America Research Network Spinal Cord Injury
The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after... expand

The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

Type: Interventional

Start Date: Oct 2013

open study