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Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Johns Hopkins University
SARS-CoV 2
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the
risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or
oropharyngeal viral shedding.
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To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding. Type: Interventional Start Date: Jun 2020 |
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy...
The University of Texas Health Science Center, Houston
Parkinson's Disease
The purpose of this study is to select the safest and most effective number of repeat doses
of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the
progression of Parkinson's disease (PD).
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The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD). Type: Interventional Start Date: Nov 2020 |
Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention...
The University of Texas Health Science Center, Houston
Behavior, Risk
The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV
(NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing
Homelessness (YEH).
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The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH). Type: Interventional Start Date: Oct 2019 |
The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With...
Brigham and Women's Hospital
Heart Failure
Central Sleep Apnea
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy
(NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced
ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy
(GDMT),... expand
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA). Type: Interventional Start Date: Apr 2019 |
Genetic Risks for Bicuspid Aortic Valve Disease
The University of Texas Health Science Center, Houston
Bicuspid Aortic Valve
Unicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but
very little is known about the genetic causes or risk factors for adverse outcomes.
Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years
old... expand
Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies. Type: Observational [Patient Registry] Start Date: Mar 2012 |
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Duke University
Stroke, Ischemic
Motor Activity
Upper Extremity Paralysis
This research study is to find out if brain stimulation at different dosage level combined
with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation
technique is called transcranial direct current stimulation (tDCS). The treatment uses direct... expand
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one. Type: Interventional Start Date: Sep 2019 |
Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
The University of Texas Health Science Center, Houston
Major Depressive Disorder
Treatment Resistant Depression
We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients with
treatment refractory depression (TRD). Data from the University of Bonn indicates that
surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients... expand
We propose a clinical study of medial forebrain bundle DBS as a treatment in 10 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Activa® systems manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 65 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB. Type: Interventional Start Date: Nov 2013 |
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Johns Hopkins University
Coronavirus
Convalescence
Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control
(SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day
28.
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Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28. Type: Interventional Start Date: Jun 2020 |
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
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The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression Type: Interventional Start Date: Jan 2019 |
Child to Adult Neurodevelopment in Gene Expanded Huntington's Disease
Peggy C Nopoulos
Huntington's Disease
Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of
cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat
(CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized
as a neurodegenerative... expand
Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. However, recent evidence suggests that abnormal brain development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed during development and through life. In animal studies, the HTT gene has been shown to be vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In addition, studies in adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD subjects) have significant changes in the structure of their brain, even up to 20 years before onset of clinical diagnosis. How far back these changes are evident is unknown. One possibility is that these brain changes are present throughout life, due to changes in brain development,though initially associated with only subtle functional abnormalities. In an effort to better understand the developmental aspects of this brain disease, the current study proposes to evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD - those who have a parent or grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive tests, behavioral assessment, and physical and neurologic evaluation. Subjects that are gene-expanded (GE) will be compared to subjects who are gene non-expanded (GNE). Changes in brain structure and/or function in the GE group compared to the GNE group would lend support to the notion that this disease has an important developmental component. Type: Observational Start Date: Jul 2005 |
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)
COMPASS Pathways
Treatment Resistant Depression
The primary objective of this study is to assess the long-term efficacy of psilocybin with
respect to use of new antidepressant treatment, hospitalisations for depression, suicidality,
and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)... expand
The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001). Type: Observational Start Date: Jul 2020 |
Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
The University of Texas Health Science Center, Houston
Complete Spinal Cord Injury
Incomplete Spinal Cord Injury
Acquired Brain Injury
Multiple Sclerosis
The purpose of this study is to develop an algorithmic-based evaluation and treatment
approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological
conditions.
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The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions. Type: Interventional Start Date: Mar 2016 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7
weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will
complete... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Aug 2017 |
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
The University of Texas Health Science Center, Houston
Congenital Diaphragmatic Hernia
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal
Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia
(CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will
determine... expand
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention. Type: Interventional Start Date: Dec 2015 |
Computer Aided Polyp Detection (C3PO) Trial
The University of Texas Health Science Center, Houston
Colonic Polyp
Computer aided detection (CADe) algorithms have been developed to overcome human errors and
assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to
investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against... expand
Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes. Type: Observational Start Date: Jun 2020 |
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After...
The University of Texas Health Science Center, Houston
Essential Tremor
The purpose of this study is to elucidate the structural connectivity of the
dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt
stimulation
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The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation Type: Interventional Start Date: Mar 2021 |
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
ColubrisMX
Rectal Adenoma
Rectal Polyp
Rectal Lesion
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing
transanal endoluminal procedures in the rectum and distal colon (up... expand
This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: 1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). 2. To validate a program for training surgeons and their teams to successfully use the ELS System. Stage 1 Objective: To evaluate the safety of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum (up to 12 cm from the anal verge). Type: Interventional Start Date: Oct 2020 |
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices
Atrial Fibrillation
Stroke
Bleeding
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation... expand
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Type: Interventional Start Date: Jul 2020 |
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant,...
ImmunoGen, Inc.
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab
soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant
high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose
tumors express... expand
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. Type: Interventional Start Date: Dec 2019 |
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Seagen 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.
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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 |
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
Alliance for Clinical Trials in Oncology
CDK Gene Mutation
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
NTRK Family Gene Mutation
PI3K Gene Mutation
This phase II trial studies how well genetic testing works in guiding treatment for patients
with solid tumors that have spread to the brain. Several genes have been found to be altered
or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these... expand
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. Type: Interventional Start Date: Aug 2019 |
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
Brickell Biotech, Inc.
Axillary Hyperhidrosis
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
by an overactive cholinergic response of the sweat glands.
Current therapies have limited... expand
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis. Type: Interventional Start Date: Dec 2020 |
Cycled Phototherapy
NICHD Neonatal Research Network
Hyper Bilirubinemia
Premature Infant
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among
extremely premature infants (< 750 g BW or <27 weeks GA).
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Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA). Type: Interventional Start Date: Jul 2020 |
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... 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 |
An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in...
Hoffmann-La Roche
Huntington Disease
This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in
participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or
Genentech-sponsored studies in the Huntington's disease (HD) in the development program for
RG6042.... expand
This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042. Type: Interventional Start Date: Apr 2019 |