Search Clinical Trials
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Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
COMPASS Pathways
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants
with treatment-resistant depression (TRD) expand
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) Type: Interventional Start Date: Jan 2023 |
Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
Vanderbilt University Medical Center
Lupus Erythematosus, Systemic
A phenome-wide association study (PheWAS) identified an association between a variant in
the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A,
and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this
gene encodes for increased NMDA receptor... expand
A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population. Type: Interventional Start Date: Aug 2018 |
Contingency Management for Cannabis Use for Persons With HIV
The University of Texas Health Science Center at San Antonio
Marijuana
HIV Infections
The purpose of this study is to determine the feasibility and impact of 28-days of
monitored abstinence from cannabis use on symptoms of depression and anxiety, pain,
sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation
among PLWH and who use cannabis regularly (weekly... expand
The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse. Type: Interventional Start Date: Aug 2021 |
Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
The University of Texas Health Science Center, Houston
Smoking Cessation
Nicotine Addiction
Schizophrenia
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive
transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for
smoking cessation. Smoking and brain functional connectivity changes will be assessed at
baseline, different stages of rTMS... expand
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups. Type: Interventional Start Date: Jun 2022 |
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 disease. However,... 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 |
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With...
Pfizer
Crohn's Disease
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy,
safety, and tolerability of oral etrasimod as therapy in adult participants with
moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at
least 1 of the current therapies for CD... expand
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment. Type: Interventional Start Date: Jan 2020 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is that... expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large
study conducted in community-dwelling older adults without cardiovascular disease (CVD)
or dementia will demonstrate the... expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
The University of Texas Health Science Center, Houston
Treatment-resistant Bipolar Depression
The overall objective of the investigators is to assess the therapeutic efficacy and
tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells
(MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant
bipolar depression patient (TRBD). expand
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD). Type: Interventional Start Date: Apr 2022 |
Post Market Clinical Evaluation of Gamma 4
Stryker Trauma and Extremities
Femoral Fracture
This is a prospective, multi-center, non-randomized, post-market clinical investigation
of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
It is anticipated that a total of 100 subjects will be enrolled at five sites. Total
duration of enrollment, 12 month follow-up... expand
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up and analysis is expected to take approximately 30 months. The clinical investigation has been designed to follow the surgeon's standard of care for subjects treated with a cephalomedullary nail for femoral fractures or and deformities, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months. Type: Observational Start Date: Mar 2023 |
A Study of SGN-B6A in Advanced Solid Tumors
Seagen Inc.
Carcinoma, Non-Small Cell Lung
Squamous Cell Carcinoma of Head and Neck
HER2 Negative Breast Neoplasms
Esophageal Squamous Cell Carcinoma
Esophageal Adenocarcinoma
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with
pembrolizumab, with or without chemotherapy, to find out whether it is safe for people
who have solid tumors. It will study sigvotatug vedotin to find out what its side effects
are. A side effect is anything the drug... expand
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. - Part A of the study will find out how much sigvotatug vedotin should be given to participants. - Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. - Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. - Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. - In Parts C and D, participants will receive sigvotatug vedotin with either: - Pembrolizumab or, - Pembrolizumab and carboplatin, or - Pembrolizumab and cisplatin. Type: Interventional Start Date: Jun 2020 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
Rapport Therapeutics Inc.
Focal Onset Seizures
This is a clinical research study for an investigational drug called RAP-219 in patients
with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219
works and is safe in patients with Refractory Focal Epilepsy. expand
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. Type: Interventional Start Date: Oct 2024 |
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Astellas Pharma Global Development, Inc.
Hot Flashes
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most
common symptoms which bother women in menopause. This study will follow women going
through menopause who have hot flashes and night sweats that cause them bother. They will
be starting a non-hormonal therapy prescribed... expand
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both. They will receive prescriptions for the non-hormonal therapy from their HCP for up to 1 year. This real-world study will provide information on outcomes from various non-hormonal therapies. The study sponsor (Astellas) will not decide which therapy the women receive. However, the sponsor will provide instructions on when the women visit their clinic, and what is recorded during the study. Some of the visits will be in-person, but most will be virtual. The virtual visits can be carried out at home using a smartphone, tablet or computer. The main aim of the study is to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment. The study will also check the women's sleep patterns, their productivity at work, and their general well-being before and after starting treatment. The overall safety of the non-hormonal therapies will also be examined. Type: Observational Start Date: Nov 2023 |
Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Hope Biosciences
Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the
potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences
adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional
outcomes, and neuroinflammation after traumatic... expand
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury and/or hypoxic-ischemic encephalopathy in adults. Type: Interventional Start Date: Apr 2024 |
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent...
Amgen
Atopic Dermatitis
The primary objective of this study is to describe the long-term safety and tolerability
of rocatinlimab in participants with moderate-to-severe AD. expand
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD. Type: Interventional Start Date: May 2023 |
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe...
Eli Lilly and Company
Atopic Dermatitis
Eczema
The main purpose of this study is to measure the effect, safety and how well the body
absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with
moderate-to-severe atopic dermatitis (AD). expand
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD). Type: Interventional Start Date: Oct 2022 |
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active...
argenx
Active Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
This study's purpose is to measure the treatment response from efgartigimod PH20 SC
compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing
myopathy (IMNM), or certain other subtypes... expand
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/. Type: Interventional Start Date: Oct 2022 |
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all follow-up... expand
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint. Type: Interventional Start Date: Jan 2023 |
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric...
Denali Therapeutics Inc.
Mucopolysaccharidosis II
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active
(standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa
(DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement
therapy (ERT) for mucopolysaccharidosis type II (MPS... expand
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria. Type: Interventional Start Date: Jul 2022 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination...
Epizyme, Inc.
Relapsed/Refractory Follicular Lymphoma
Follicular Lymphoma
Refractory Follicular Lymphoma
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the
disease has come back after a period of improvement after that follows a treatment
regimen and 'refractory' when treatment no... expand
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. Type: Interventional Start Date: Jun 2020 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 25-45% expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive...
Alliance for Clinical Trials in Oncology
Intracranial Meningioma
Recurrent Meningioma
NF2 Gene Mutation
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor
GSK2256098, and capivasertib work in treating patients with meningioma that is growing,
spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098,
capivasertib, and abemaciclib may stop the... expand
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Aug 2015 |
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide...
Novo Nordisk A/S
Type 2 Diabetes
This study will look at how well CagriSema helps people with type 2 diabetes lower their
blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not
yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that
doctors may prescribe in some... expand
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years. Type: Interventional Start Date: Jan 2024 |