Search Clinical Trials
Sponsor Condition of Interest |
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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 |
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 |
The Neural Code and Dynamics of the Reading Network.
The University of Texas Health Science Center, Houston
Epilepsy
Brain Tumor
The purpose of this study is to compare organization of normal brain function as detected
using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to
patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including
Brodmann Areas) and functional significance... expand
The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas. Type: Interventional Start Date: Aug 2022 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
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 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 to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis...
Amgen
Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in
monotherapy and combination therapy treatment in adolescent subjects. expand
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects. Type: Interventional Start Date: Apr 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 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 |
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Neurona Therapeutics
Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
This clinical trial is designed to test whether a single stereotactic intracerebral
administration of inhibitory nerve cells into subjects with drug-resistant mesial
temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure
frequency). expand
This clinical trial is designed to test whether a single stereotactic intracerebral administration of inhibitory nerve cells into subjects with drug-resistant mesial temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure frequency). Type: Interventional Start Date: Jun 2022 |
AlloSure Lung Assessment and Metagenomics Outcomes Study
CareDx
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
ALAMO is a prospective, multi-center, perspective, registry of patients receiving
LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung
(dd-cfDNA) to detect a spectrum of rejection... expand
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic). Type: Observational [Patient Registry] Start Date: Oct 2021 |
Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals...
Pfizer
Sickle Cell Disease
This registry is an observational study designed to evaluate the effect of Oxbryta in
individuals with SCD in a real-world setting. expand
This registry is an observational study designed to evaluate the effect of Oxbryta in individuals with SCD in a real-world setting. Type: Observational [Patient Registry] Start Date: Nov 2021 |
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 |
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-approved... 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 |
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 is a prospective, randomized,... 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 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 |
Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease
UniQure Biopharma B.V.
Huntington's Disease
This is the first study of AMT-130 in patients with early manifest HD and is designed to
establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase I/II, randomized,
multicenter, multiple dose, double-blind, imitation surgery, first-in-human (FIH) study.
Cohort 3 participants will receive... expand
This is the first study of AMT-130 in patients with early manifest HD and is designed to establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase I/II, randomized, multicenter, multiple dose, double-blind, imitation surgery, first-in-human (FIH) study. Cohort 3 participants will receive either high or low dose (1:1 randomization). Participants enrolled in Cohort 3 will also receive an immunosuppression regimen consisting of dexamethasone, sirolimus, and rituximab. Type: Interventional Start Date: Sep 2019 |
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). expand
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 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke or high
risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6
months after the event, and (2)... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
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. We are interested... 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 |
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 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved...
The University of Texas Health Science Center, Houston
Cancer Prevention
The purpose of this study is to enhance the current TSSC multilevel intervention
delivered in Cameron and Hidalgo counties by adding additional components including an
educational module on the risks of alcohol intake and its connection to cancer, as well
as developing training and referral systems... expand
The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors. Type: Interventional Start Date: May 2024 |
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
The University of Texas Health Science Center, Houston
Food Insecurity in Post Partum Women
The purpose of this study is to compare the short-term and long term impacts of Food is
the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding
rates, mental health status, rates of home cooking, and rationing coping strategies
relative to FBM-In Person among food insecure,... expand
The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations. Type: Interventional Start Date: Jan 2024 |
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version...
The University of Texas Health Science Center, Houston
In Utero Procedure Affecting Fetus or Newborn
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved
fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery expand
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery Type: Interventional Start Date: Apr 2024 |
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