Search Clinical Trials
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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 (we1 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 |
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 rec1 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 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-a1 expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
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 a1 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 |
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Johns Hopkins University
Atrial Fibrillation
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous
Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an
AF-sensing Smart Watch (AFSW) in parti1 expand
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk. Type: Interventional Start Date: Jul 2023 |
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 tha1 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 |
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
Weill Medical College of Cornell University
Emphysema
HIV
The purpose of this study is to determine if doxycycline will reduce progression of
emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity
of emphysema, six minute walk distance, patient reported outcomes, ratio of forced
expir1 expand
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections. Type: Interventional Start Date: Aug 2022 |
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 the1 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 |
Neuromodulation of the Fear Extinction Circuit Using Temporally and Anatomically Specific TMS in Hu1
The University of Texas Health Science Center, Houston
PTSD
This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS)
impacts fear circuits. The overarching objectives are to understand how varying TMS
parameters affect targeted brain regions in order to optimize its impact on enhancing
fear extinction memory consolidation in1 expand
This study aims to explore the mechanisms of how transcranial magnetic stimulation (TMS) impacts fear circuits. The overarching objectives are to understand how varying TMS parameters affect targeted brain regions in order to optimize its impact on enhancing fear extinction memory consolidation in a population with known fear extinction deficiencies: post-traumatic stress disorder (PTSD). 250 subjects will take part in this research study across UTHealth Houston. The study will include preliminary screenings, baseline visits, and experimental visits across four days Type: Interventional Start Date: Feb 2022 |
Fear and Avoidance in PTSD Patients
The University of Texas Health Science Center, Houston
Post Traumatic Stress Disorder
The purpose of this research study is to study how the brain learns to avoid certain
stimuli or situations using an experimental paradigm. The big goal is to measure brain
responses and subject's feelings and expectations when they are learning to actively
avoid experimental stimuli, and how fear e1 expand
The purpose of this research study is to study how the brain learns to avoid certain stimuli or situations using an experimental paradigm. The big goal is to measure brain responses and subject's feelings and expectations when they are learning to actively avoid experimental stimuli, and how fear extinction learning and monetary cost can change how and when subjects are to avoid. Type: Interventional Start Date: Sep 2021 |
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. Ho1 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 |
Advancing Discussions Using a Video-based Support Tool About End-of-life Care
The University of Texas Health Science Center, Houston
Traumatic Injury
The purpose of this study is to evaluate the effectiveness and implementation
considerations of a video aid to improve communication and patient-centered outcomes in
older injured adults expand
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults Type: Interventional Start Date: Mar 2025 |
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P21
The University of Texas Health Science Center, Houston
Acute Kidney Injury
The central hypothesis of this research study is that perioperative administration of the
proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney
injury (AKI) following cardiac surgery by activation molecular pathways for kidney
protection. The investigators propose a1 expand
The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 2 days perioperatively. Our study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine. Type: Interventional Start Date: Jan 2025 |
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression
The University of Texas Health Science Center, Houston
Bipolar II Disorder
Depression, Bipolar
Suicidality
The purpose of the study is to assess the safety and acceptability of up to two
sequential administrations of 25 mg psilocybin with additional therapeutic support in
decreasing suicidality in patients with Bipolar Disorder (BD II) depression. expand
The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression. Type: Interventional Start Date: Mar 2025 |
Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program
Ultragenyx Pharmaceutical Inc
Glycogen Storage Disease Type Ia
The main objective of this observational study is to evaluate the long-term safety and
effectiveness of DTX401 for at least 10 years after DTX401 administration. expand
The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration. Type: Observational Start Date: Nov 2024 |
A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande1
The University of Texas Health Science Center, Houston
Stroke
The purpose of this study is to investigate the feasibility of a mobile
telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke
survivors with community health worker (CHW) at-home support and to estimate the
functional health, mental health (depression), and careg1 expand
The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities. Type: Interventional Start Date: Mar 2025 |
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Takeda
Plaque Psoriasis
The main aim of this study is to check the side effects of TAK-279 and how well it is
tolerated in participants with moderate-to-severe plaque psoriasis.
All participants will be assigned to study treatments of TAK-279 and will be treated with
TAK-279 if the participants meet the study rules.
Par1 expand
The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times. Type: Interventional Start Date: Sep 2024 |
Helix Research Network
Helix, Inc
Genetic Predisposition to Disease
Genetics Disease
The Helix Research Network ("HRN") is a network of academic, public, and/or private
healthcare organizations that are committed to advancing medical research and improving
human health through large-scale genomics research and acceleration of the integration of
genomic and other omics data into cli1 expand
The Helix Research Network ("HRN") is a network of academic, public, and/or private healthcare organizations that are committed to advancing medical research and improving human health through large-scale genomics research and acceleration of the integration of genomic and other omics data into clinical care. Type: Observational Start Date: Sep 2021 |
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night1
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 prescr1 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 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolesc1
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 to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pe1
AbbVie
Episodic Migraine
A migraine is a moderate to severe headache on one side of the head. A migraine attack is
a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light
and sound, or other symptoms. A number of treatments are available for adults with
migraine but there are limited approve1 expand
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Type: Interventional Start Date: May 2023 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved1 expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |