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Assessment of CCM in HF With Higher Ejection Fraction
Impulse Dynamics
Heart Failure
Heart Failure With Preserved Ejection Fraction
Heart Failure With Mid Range Ejection Fraction
Heart Failure With Moderately Reduced Ejection Fraction
Diastolic Heart Failure
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac
Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and
≤60%. expand
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤60%. Type: Interventional Start Date: Feb 2022 |
Comparing Tissue Adhesives in Port Site Closure
The University of Texas Health Science Center, Houston
Dermatitis, Contact
This is a multi-center randomized controlled trial to evaluate two different methods of
reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate. expand
This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate. Type: Interventional Start Date: Jun 2022 |
Financial Coaching and Lifestyle Intervention for Diabetes Prevention in Low-income Families
The University of Texas Health Science Center, Houston
Weight Loss
The purpose of this study is to compare the effect on weight and metabolic outcomes of an
enhanced intervention, comprised of evidence-based financial coaching plus a lifestyle
intervention vs. the lifestyle intervention alone expand
The purpose of this study is to compare the effect on weight and metabolic outcomes of an enhanced intervention, comprised of evidence-based financial coaching plus a lifestyle intervention vs. the lifestyle intervention alone Type: Interventional Start Date: May 2023 |
Does BMI Influence Pain Follow vNOTE Surgery
The University of Texas Health Science Center, Houston
Obese
Surgery
Pain, Postoperative
Overweight and obesity are increasing dramatically worldwide and contribute substantially
to the burden of morbidity and mortality. Obesity was considered in the past a relative
contraindication for abdominal and pelvic laparoscopy surgeries due to the morbidity that
is associated with it. Vaginal... expand
Overweight and obesity are increasing dramatically worldwide and contribute substantially to the burden of morbidity and mortality. Obesity was considered in the past a relative contraindication for abdominal and pelvic laparoscopy surgeries due to the morbidity that is associated with it. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain. Type: Observational [Patient Registry] Start Date: Feb 2022 |
A Telerehabilitation Program for SCI
The University of Texas Health Science Center, Houston
Incomplete Spinal Cord Injury
This study evaluates a remotely supervised, home-based therapeutic program to improve
upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord
injury (iSCI). expand
This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI). Type: Interventional Start Date: Jul 2021 |
Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
The University of Texas Health Science Center, Houston
Blood Coagulation Disorders, Inherited
Thrombotic Disorder
The objective of this study will be to assess the coagulation system in-vitro in a
variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin
generation assay. expand
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay. Type: Observational Start Date: Oct 2002 |
Generic Database of Very Low Birth Weight Infants
NICHD Neonatal Research Network
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
The Generic Database (GDB) is a registry of very low birth weight infants born alive in
NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline
data on both mothers and infants, and the therapies used and outcomes of the infants. The
information collected is not specific... expand
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials. Type: Observational Start Date: Jan 1987 |
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic...
The University of Texas Health Science Center, Houston
Gestational Diabetes
Type2 Diabetes
Pregnancy in Diabetic
The purpose of this study is to investigate whether automation of glucose monitoring data
to facilitate the total number of recommended and completed SMBG checks improve clinical
outcomes for women living with gestational and type 2 diabetes during pregnancy? This is
a RCT expand
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT Type: Interventional Start Date: Nov 2019 |
RECOVER-ENERGIZE Platform Protocol
Duke University
Long COVID
Long Covid19
Long Covid-19
This is a platform protocol designed to be flexible so that it is suitable for a range of
interventions and settings within diverse health care systems and community settings with
incorporation into clinical COVID-19 management programs and treatment plans if results
achieve key study outcomes.
This... expand
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC. Type: Interventional Start Date: Jul 2024 |
Strategy for Improving Stroke Treatment Response
Translational Sciences, Inc.
Ischemic Stroke
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding
trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal
antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. expand
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. Type: Interventional Start Date: Mar 2024 |
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 participants... 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 |
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic...
Bayer
Prevention of Ischemic Stroke
Acute Non-cardioembolic Ischemic Stroke
High-risk Transient Ischemic Attack
Researchers are looking for a better way to prevent an ischemic stroke which occurs when
a blood clot travelled to the brain in people who within the last 72 hours had:
- an acute stroke due to a blood clot that formed outside the heart (acute
non-cardioembolic ischemic stroke), or... expand
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. Type: Interventional Start Date: Jan 2023 |
TSC Biosample Repository and Natural History Database
National Tuberous Sclerosis Association
Tuberous Sclerosis
Lymphangioleiomyomatosis
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that
scientists can request to use in their research. The samples we collect are all linked to
clinical data in the TSC Natural History Database. The TSC Natural History Database
captures clinical data to document... expand
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively. Type: Observational [Patient Registry] Start Date: Jan 2016 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and...
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world patient... expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric...
Hoffmann-La Roche
Atypical Hemolytic Uremic Syndrome
This study aims to evaluate the efficacy and safety of crovalimab in pediatric
participants with aHUS. expand
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS. Type: Interventional Start Date: Nov 2021 |
Humidity in Incubators for Tiny Infants
The University of Texas Health Science Center, Houston
Extremely Premature Infant
The objective of the study is to assess 2 different initial incubator humidification
protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit
(NICU). The hypothesis is that a higher starting humidity decreases dehydration and
results in no difference in survival or morbidity.... expand
The objective of the study is to assess 2 different initial incubator humidification protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared. Type: Interventional Start Date: Jun 2024 |
Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea...
CinPhloro Pharma, LLC
Irritable Bowel Syndrome With Diarrhea
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help
reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea
(IBS-D) in adult patients. The main questions it aims to answer are:
- To evaluate the efficacy of CIN-103 on symptoms of... expand
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are: - To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo. - To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo Participants will attend the following visits: - Screening Period (1 Visit) - Baseline Period (1 Visit) - Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation. - 12-Week Treatment Period (5 Visits) - Study drug taken twice daily by mouth. - Will complete daily diaries and other PROs as described in the protocol. - Follow- Up Period (1 Visit) Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability. Type: Interventional Start Date: Dec 2023 |
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
Cesarean Delivery
General Anesthesia
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
investigate the indications, mode of airway management, predisposing factors, and
obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for
cesarean delivery. expand
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Type: Observational Start Date: Feb 2024 |
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator)...
Merck Sharp & Dohme LLC
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic
obstructive pulmonary disease (COPD). The goal of the study is to learn if people who
take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take
placebo. expand
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo. Type: Interventional Start Date: Mar 2023 |
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic...
Edwards Lifesciences
Aortic Valve Insufficiency
Aortic Valve Stenosis
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk
with a failing aortic bioprosthetic valve. expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve. Type: Interventional Start Date: Nov 2023 |
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of...
Major Extremity Trauma Research Consortium
Post Operative Surgical Site Infection
The overall objective is to compare the effect of Vancomycin and Tobramycin powder
combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation
infections of tibial plateau and tibial pilon fractures at high risk of infection
(collectively considered the "study injuries"). expand
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries"). Type: Interventional Start Date: May 2021 |
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Emalex Biosciences Inc.
Tourette Disorder
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and
tolerability of ecopipam tablets in children, adolescents and adults in the treatment of
Tourette's Disorder (TD). The study includes an open-label period followed by
double-blind, placebo-controlled, randomized withdrawal... expand
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period. Type: Interventional Start Date: Jan 2023 |
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular...
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke
Yale University
Intracerebral Hemorrhage
Ischemic Stroke
Spironolactone
The purpose of this research study is to determine whether blood pressure treatment
regimens with spironolactone are better than blood pressure treatment regimens without
spironolactone at lowering blood pressure in stroke survivors. expand
The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors. Type: Interventional Start Date: Mar 2021 |
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