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An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment...
Bristol-Myers Squibb
Lupus Nephritis
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared
with placebo with regard to measures of kidney function in participants with lupus nephritis
(LN).
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The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN). Type: Interventional Start Date: Apr 2019 |
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).
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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 |
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.
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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 |
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
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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 |
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 |
Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases...
NovoCure Ltd.
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
The study is a prospective, randomized controlled phase III trial, to test the efficacy,
safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic
radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to
supportive treatment... expand
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Type: Interventional Start Date: Jul 2016 |
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.
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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 |
GB001 in Adult Subjects With Chronic Rhinosinusitis
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Chronic Rhinosinusitis Without Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the
efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with
placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without
nasal... expand
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP). Type: Interventional Start Date: Apr 2019 |
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 |
Radiation Therapy and Cisplatin With or Without Triapine in Treating Patients With Newly Diagnosed Stage...
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 |
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 |
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development...
University College, London
Huntington's Disease
HDClarity will seek at least 1200 research participants at different stages of Huntington's
disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of
biomarkers and pathways that will enable the development of novel treatments for HD. The
secondary... expand
HDClarity will seek at least 1200 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development. Type: Observational Start Date: Jan 2017 |
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 |
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 |
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 |
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 |
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing...
Leading BioSciences, Inc
Ileus
Post-Operative Adhesions
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and
tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal
adhesions in subjects undergoing elective bowel resection.
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The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection. Type: Interventional Start Date: Oct 2019 |
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 |
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 |
Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES...
The University of Texas Health Science Center, Houston
Osteo Arthritis Knee
The purpose of this study is to determine the feasibility, safety, and preliminary efficacy
of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee
osteoarthritis(OA)
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The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee osteoarthritis(OA) Type: Interventional Start Date: Aug 2019 |
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The purpose of this study is to compare the efficacy, safety, and durability of two different
strategies to treat participants with a history of sub-optimal adherence and control of their
HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care... expand
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC). Type: Interventional Start Date: Mar 2019 |
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 |
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.
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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 |
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 |
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous...
Clovis Oncology, Inc.
Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to determine how patients with metastatic castration-resistant
prostate cancer, and evidence of a homologous recombination gene deficiency, respond to
treatment with rucaparib.
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The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib. Type: Interventional Start Date: Feb 2017 |