Search Clinical Trials
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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 |
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion:...
Exact Sciences Corporation
Colorectal Cancer
The primary objective of this study is to collect de-identified, clinically-characterized
stool and whole blood specimens for use in developing and evaluating the performance of
new biomarker assays for the detection of colorectal cancer (CRC). expand
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC). Type: Observational Start Date: Dec 2018 |
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity...
NeuraStasis, Inc
Stroke, Ischemic
Upper Extremity Paresis
This is a single-center, pilot study of up to 25 subjects with residual upper extremity
deficits at least six months after an ischemic stroke. The purpose of the study is to
evaluate the initial clinical safety, device functionality, and treatment effect of
non-invasive electrical stimulation of the... expand
This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study. Type: Interventional Start Date: Mar 2024 |
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After...
Northwell Health
Essential Tremor
The purpose of this study is to elucidate the structural connectivity of the
dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt
stimulation expand
The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation Type: Interventional Start Date: Dec 2021 |
Complex Adult Deformity Surgery (CADS)
International Spine Study Group Foundation
Adult Spinal Deformity
Scoliosis
Kyphosis
Sagittal Imbalance
Evaluate surgical treatment outcomes and identify best practice guidelines for complex
adult spinal deformity (ASD) patients, including radiographic and clinical outcomes,
surgical and postoperative complications, risk factors for and revision surgery rates,
and the role of standard work to improve... expand
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. Type: Observational [Patient Registry] Start Date: Jul 2018 |
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
The George Washington University Biostatistics Center
Short Cervical Length
This protocol outlines a randomized trial of 630 women evaluating the use of micronized
vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth
in women carrying twins and with a cervical length of less than 30 millimeters. expand
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Type: Interventional Start Date: Nov 2015 |
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement...
The University of Texas Health Science Center, Houston
Depression in Old Age
The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week
social engagement program aimed at reducing depression and increasing social engagement
among seniors who are transitioning out of Adult Protective Services (APS) for either
elder abuse or self-neglect. expand
The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of Adult Protective Services (APS) for either elder abuse or self-neglect. Type: Interventional Start Date: Aug 2023 |
intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
The University of Texas Health Science Center, Houston
Chronic Stroke
The purpose of this study is to Investigate the feasibility of a high-quality, high-dose,
high-intensity upper extremity therapy program and to assess the treatment effects of a
high-quality, high-dose, high-intensity upper extremity therapy program on functional
outcomes, motor impairment, and quality... expand
The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life Type: Interventional Start Date: Mar 2023 |
A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis...
Regeneron Pharmaceuticals
Hemophilia B
This study is focused on males who have Hemophilia B and who need regular preventive
treatment with factor IX protein (FIX) replacement therapy to prevent and also to control
their bleeding events. The aim of the study is to gather at least 6 months of information
on bleeding events for each individual... expand
This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individual participant while they continue to use their usual FIX replacement therapy. There is no experimental treatment being tested in this study. The study is informational, and part of a larger program to understand and treat Hemophilia B with a potential experimental new therapy in the future. There is no obligation to agree to taking part in this future study. The study is looking to answer several other research questions to help understand each participant's individual disease characteristics, including: - How often to use FIX replacement therapy, both on a regular basis (prophylaxis) and as needed to treat bleeding events - Measurement of FIX activity (factor IX is a clotting factor) by different laboratories using different types of tests in Hemophilia B participants - Possible complications from the FIX replacement therapy the patient receives (usual standard of care will continue to be used) - How quality of life is affected by Hemophilia B - How joint health is affected by Hemophilia B - How often the participant visits the emergency room, urgent care center, physician's office, hospital, or has a telemedicine visit as a result of bleeding events - Whether the body makes antibodies (a protein produced by the body's immune system) against the FIX replacement therapy you receive, which could make the drug less effective or could lead to side effects Type: Observational Start Date: Jan 2024 |
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 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled into... expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease...
The University of Texas Health Science Center, Houston
Alzheimer Disease
The purpose of this study is to assess acceptability, and safety of providing tDCS to
ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for
ADRD-related symptoms, mainly behavioral symptoms. expand
The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms. Type: Interventional Start Date: Apr 2023 |
Effects of Pioglitazone on Stress Reactivity and Alcohol Craving
The University of Texas Health Science Center, Houston
Alcohol Use Disorder
The purpose of this study is to examine the effects of pioglitazone on stress-induced
relapse risk in a laboratory model and to examine the effects of pioglitazone on
drinking, stress/anxiety, and alcohol craving in the natural environment expand
The purpose of this study is to examine the effects of pioglitazone on stress-induced relapse risk in a laboratory model and to examine the effects of pioglitazone on drinking, stress/anxiety, and alcohol craving in the natural environment Type: Interventional Start Date: May 2022 |
TRISCEND II Pivotal Trial
Edwards Lifesciences
Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
Heart Valve Diseases
Cardiovascular Diseases
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid
valve replacement system expand
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system Type: Interventional Start Date: Apr 2021 |
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally...
The University of Texas Health Science Center, Houston
Adults With Ulcerative Colitis
The purpose of the study is to evaluate the efficacy and safety of lyophilized
PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage.
This study will also include longitudinal analyses of recipient's gut microbiota taxonomy
and metagenomics to determine potential... expand
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration. Type: Interventional Start Date: Sep 2020 |
Solution Temperature and Fluid Deficit During Hysteroscopy
The University of Texas Health Science Center, Houston
Surgery
Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as
septum, synechiae, polyp and intrauterine fibroids. The complication rate is estimated as
0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative
hysteroscopy intravascular absorption... expand
Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as septum, synechiae, polyp and intrauterine fibroids. The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy intravascular absorption (OHIA) syndrome refers to fluid overload complications from operative hysteroscopies and is considered a major complication. Report describing the clinical association between irrigation fluid temperature to intravasation rate itself or the risk of fluid overload are limited mainly to theoretical models. Due to the aforementioned, we aim to evaluated the role of temperature on absorption of the irrigation solution in hysteroscopic surgery. Type: Interventional Start Date: Dec 2023 |
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
Anthony Johnson
Congenital Diaphragmatic Hernia
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal
Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic
Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients)
will determine the feasibility of UTHealth's... expand
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention. Type: Interventional Start Date: Dec 2015 |
Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft
Gustavo Oderich
Complex Abdominal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Aortic Arch Aneurysm
Aortic Arch Dissection
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch
and customized physician-specified stent-graft with a combination of fenestrations and/or
branches to repair aortic aneurysm. expand
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm. Type: Interventional Start Date: Mar 2014 |
Nourishing the Community Through Culinary Medicine- Acres Homes
The University of Texas Health Science Center, Houston
Diabetes
Elevated Body Mass Index
The purpose of this study is to to implement adapted virtual Culinary Medicine (CM)
curriculum among target population, to assess if program participation improves
participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors
above standard of care, to assess if program participation... expand
The purpose of this study is to to implement adapted virtual Culinary Medicine (CM) curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of HbA1c, Body Mass Index, Blood Pressure, HDL, LDL and Triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous CM classes. Type: Interventional Start Date: Nov 2023 |
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
The University of Texas Health Science Center, Houston
Breast Cancer
Cervical Cancer
The purpose of this study is to increase early detection and prevention of breast and
cervical cancer through education and navigation and to increase breast and cervical
cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas. expand
The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas. Type: Interventional Start Date: Feb 2020 |
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal...
The University of Texas Health Science Center, Houston
Anesthesia
The purpose of this study is to assess and compare conditions for tracheal intubation
obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg
succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy,
vocal cord view, vocal cord opening,... expand
The purpose of this study is to assess and compare conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy, vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal intubation in order to assess intubation conditions, to compare efficiency and success rate of tracheal intubation between two induction agents and to determine the rate of patient awareness during induction and post-operative recall of paralysis. Type: Interventional Start Date: Sep 2023 |
Lifestyle Improvement for Teens With Bariatric Surgery
The University of Texas Health Science Center, Houston
Obesity, Adolescent
Bariatric Surgery Candidate
The purpose of this study is to Conduct a proof of concept study to assess feasibility,
acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported
healthy lifestyle behavioral intervention among adolescent patients, their families, and
their clinical team. expand
The purpose of this study is to Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team. Type: Interventional Start Date: Mar 2022 |
The Will Erwin Headache Research Center - Cluster Headache Study
The University of Texas Health Science Center, Houston
Cluster Headache
Cluster Headaches and Other Trigeminal Autonomic Cephalgias
Paroxysmal Hemicrania
SUNCT
Hemicrania Continua
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal
Neuralgia is a prospective, multicenter, observational research network for subjects with
Cluster Headache and/or Trigeminal Neuralgia. expand
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia. Type: Observational Start Date: May 2016 |
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
The University of Texas Health Science Center, Houston
Spinal Cord Injuries
The purpose of this study is to see if it's possible to reach high cardiovascular
intensity training parameters (exercise at a rate that elevates heart rate to the level
recommended for improving strength and endurance) while walking in a wearable robotic
exoskeleton. This study will also evaluate... expand
The purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. This study will also evaluate if exercising at high intensity will lead to improvement in walking ability. Participants in this study will be asked to attend 5 walking training sessions using Ekso exoskeleton. There will be two additional sessions, one before and one after the five training sessions. At these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments. Type: Interventional Start Date: Oct 2021 |
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis
The University of Texas Health Science Center, Houston
Sepsis
Severe Sepsis
Septic Shock
Multi-organ Failure
This is an observational study to understand the changes in alveolar dead space in
medical critically ill patients with severe infection (severe sepsis) requiring
mechanical ventilation and the possibility to predict multi-organ failure.
The measurement of alveolar dead space used to require sophisticated... expand
This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure. The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention. Type: Observational Start Date: Dec 2016 |
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