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A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment...
InSightec
Movement Disorders
Neurology
Parkinsons Disease
This registry is a prospective, multicenter, international, single arm, observational
post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years.
The proposed registry will enroll 60 subjects and will be conducted at approximately 10
centers worldwide. expand
This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide. Type: Observational [Patient Registry] Start Date: Jan 2023 |
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Women With a PI3K Alteration and HR+/Her2-...
SynDevRx, Inc.
HR+/HER2-negative Breast Cancer
Metastatic Breast Cancer
This is a Phase 1b/2, open-label, parallel-arms pilot study in post-menopausal women with
hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an
alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or
AKT1 mutation, designed to determine... expand
This is a Phase 1b/2, open-label, parallel-arms pilot study in post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy. The purpose of this study is: - to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat, - to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and - to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population. Type: Interventional Start Date: Aug 2022 |
Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors
InSightec
Glioblastoma
Glioma
Liquid Biopsy
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain
barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects
with suspected Glioblastoma brain tumors expand
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for liquid biopsy in subjects with suspected Glioblastoma brain tumors Type: Interventional Start Date: Aug 2022 |
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Johns Hopkins University
Gram-negative Bacteremia
The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is
a multi-center, randomized clinical trial that hypothesizes that early transition to oral
antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is
as effective but safer than remaining... expand
The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment. Type: Interventional Start Date: Feb 2024 |
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Massachusetts General Hospital
Cognitive Impairment
Dementia
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is
an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking
and memory problems. Alzheimer's disease and other dementias leave signatures on brain
scans or in the blood called biomarkers.... expand
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss. Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated. The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function. Type: Observational Start Date: Sep 2021 |
Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells
University of Illinois at Chicago
Mesenchymal Stromal Cells
Cornea
Safety
Corneal Defect
This study is a longitudinal assessment using a classic dose-escalation study design to
assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic
mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted
at Illinois Eye and Ear Infirmary located... expand
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use digital conjunctival and corneal photography and corneal Scheimpflug Imaging, densitometry, and pachymetry for assessment of safety and corneal wound healing. Type: Interventional Start Date: Mar 2021 |
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
University of Maryland, Baltimore
Typhoid and/or Cholera Vaccination
This is an open-label, non-randomized study. The purpose of this study is to better
understand how vaccines against typhoid fever and cholera affect the normal immune system
and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy
and/or esophagogastroduodenoscopy (EGD))... expand
This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine. Type: Interventional Start Date: Nov 2018 |
Recovery and Outcomes From Stroke
University of Cincinnati
Intracerebral Hemorrhage
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral
hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations
of motor and cognitive function at baseline, 3 months and 6 months to determine
predictors of recovery, progressive cognitive... expand
The investigators will perform follow-up on 500 cases of deep and lobar intracerebral hemorrhage to perform advanced neuroimaging before 45 days post stroke, and evaluations of motor and cognitive function at baseline, 3 months and 6 months to determine predictors of recovery, progressive cognitive or functional impairment. Type: Observational Start Date: Aug 2017 |
Cardiopulmonary Bypass Induced Red Blood Cell Lysis
University of Maryland, Baltimore
Cardiopulmonary Bypass
Cardiac Surgery
Kidney Injury, Acute
Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury,
limits will be set for safe levels of pfH following the use of CPB. These results will be
compared to existing laboratory-based methods for determining red blood cell damage to
predict CPB assist device safety.... expand
Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB. Type: Observational Start Date: Mar 2022 |
Diagnostic Stewardship for Ventilator Associated Pneumonia
University of Maryland, Baltimore
Ventilator Associated Pneumonia
The goal of this pragmatic cluster-randomized crossover trial is to test if less
unnecessary antibiotics are prescribed when the lab reports respiratory culture test
results in a specific way for patients who have respiratory cultures obtained, but do not
meet clinical criteria for ventilator associated... expand
The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for patients who have respiratory cultures obtained, but do not meet clinical criteria for ventilator associated pneumonia (VAP). The main question it aims to answer is: Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit (ICU)? Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results. Type: Interventional Start Date: Aug 2023 |
The Effects of Exercise on Quality of Life and Fluid Dynamics in Patients With Aortic Dissection
University of Maryland, Baltimore
Aortic Dissection
Aerobic exercise and physical activity improve patient health in patients in a variety of
aspects of life and disease. It also improves patients' mental well-being and quality of
life. However, the safety of this physical activity and its potential benefits remain
uncertain for patients after aortic... expand
Aerobic exercise and physical activity improve patient health in patients in a variety of aspects of life and disease. It also improves patients' mental well-being and quality of life. However, the safety of this physical activity and its potential benefits remain uncertain for patients after aortic dissection, a tear in the main blood vessel delivering blood to all of the body's organs. The goal of this study is to facilitate the translation of pre-clinical findings by the Principal Investigator and published literature that demonstrates light to moderate exercise is safe and beneficial in patients with thoracic aortic dissection. This will be accomplished by using both imaging-based analyses of aortic wall responses to a 3- month exercise program, patient surveys of quality of life metrics, functional fitness assessments, and clinical outcomes. Type: Interventional Start Date: May 2023 |
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 |
Rare and Atypical Diabetes Network
University of South Florida
Diabetes Mellitus
Diabetes Mellitus Progression
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Disease
RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study
of atypical diabetes.
The objective of this study is to define new forms of diabetes and the unique mechanisms
underlying these forms of atypical diabetes. The specific aims are to:
1. Identify and enroll... expand
RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes. Type: Observational Start Date: Sep 2020 |
Spinal Cord Injury Registry - North American Clinical Trials Network
Robert G. Grossman, MD
Spinal Cord Injury
The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting
de-identified data from patients admitted through the Emergency Department of a NACTN
center at the time of injury with an initial (first time) spinal cord injury (SCI).
Information will be collected on the natural history... expand
The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care. Type: Observational Start Date: Jul 2005 |
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