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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Karuna Therapeutics
Alzheimer Disease
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult
participants with mild to severe Alzheimer's Disease (AD) with moderate to severe
psychosis related to AD. expand
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. Type: Interventional Start Date: Sep 2024 |
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
RECORDATI GROUP
Post-Bariatric Hypoglycemia
The Total duration of trial participation for each participant with post-bariatric
hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
- 19 weeks for the Core Phase. It is composed of:
- a Screening period: a maximum of 3 weeks
- a Run-in p1 expand
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment). Type: Interventional Start Date: Jan 2024 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezo1
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of the1 expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 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 |
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Merck Sharp & Dohme LLC
Essential Thrombocythemia
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared
with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET)
participants for whom cytoreductive therapy is indicated. Its primary objective is to
compare bomedemstat to hydroxyurea with respe1 expand
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR. Type: Interventional Start Date: Jul 2024 |
Bionic Pancreas in CFRD
Jaeb Center for Health Research
Cystic Fibrosis-related Diabetes
This multi-center randomized controlled trial (RCT) will compare efficacy and safety
endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP)
versus a control group using their usual care insulin delivery method and continuous
glucose monitoring (CGM) during a 13-week1 expand
This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system. Type: Interventional Start Date: Sep 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or
1305-0023).
The goal of this study is t1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or 1305-0023). The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: Sep 2024 |
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
The University of Texas Health Science Center at San Antonio
Parkinson Disease
This study aims to determine the effects of aerobic exercise as a primer to add-on
virtual reality (VR)-based rehabilitation on balance, postural control and
neuroplasticity (ability of brain to adapt in structure and function) in individuals with
Parkinson's disease (PD). This study will utilize t1 expand
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment). Type: Interventional Start Date: Feb 2024 |
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD
The University of Texas Health Science Center at San Antonio
Parkinson's Disease
This project will provide preliminary data on the feasibility and effects of exercise and
VR on motor behavior and neuroplasticity in PD. Results from this work will provide
insight into whether combination interventions utilizing AE and VR have parallel effects
on cognition, gait, and neuroplastic1 expand
This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD. Type: Interventional Start Date: Nov 2022 |
Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
The University of Texas Health Science Center at San Antonio
Atrophy of Muscle Due to Disuse
Rehabilitation
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral
leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation
(Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to
address their aims:
- Demonstrat1 expand
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation (Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to address their aims: - Demonstrate the sex-specific effects of skeletal muscle disuse (Phase 1) - Identify key molecular determinates of susceptibility of skeletal muscle atrophy (Phase 1) - Map the early, sex-specific molecular time-course of rehabilitation (Phase 2) - Determine if disused and healthy muscle respond similarly to exercise (Phase 2) Healthy, middle-age men and post-menopausal women (50-65 years) will be recruited from the greater Houston/Galveston area. This under-represented research demographic demonstrate few negative metabolic or phenotypic signs of advanced age, but are at increased risk of being hospitalized and experiencing accelerated loss of lean mass and muscle function that parallels a much older population. The goal of this study is to characterize phenotypic and molecular skeletal muscle changes in middle-aged men and women during critical periods of disuse and rehabilitation and ultimately direct the development of targeted and effective prevention and treatment strategies. Type: Interventional Start Date: Aug 2021 |
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures
Xenon Pharmaceuticals Inc.
Focal Onset Seizures
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled
study that will evaluate the clinical efficacy, safety and tolerability of XEN1101
administered as adjunctive therapy in focal-onset seizures. expand
The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures. Type: Interventional Start Date: Nov 2022 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Proteas1
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) develo1 expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Pr1
Plus Therapeutics
Glioma
This is an open-label, multicenter, Phase 1 study to establish the safety and
efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via
intraventricular catheter) for recurrence glioma in patients who received a prior
treatment of 186RNL. expand
This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL. Type: Interventional Start Date: Dec 2024 |
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
The University of Texas Health Science Center at San Antonio
Carcinoma, Hepatocellular
This is an observational, prospective cohort study that will recruit a diverse sample of
84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma
(HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment
tools with participants 65 yea1 expand
This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants. Type: Observational Start Date: Sep 2019 |
DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
ECOG-ACRIN Cancer Research Group
Gliosarcoma
Recurrent Glioblastoma
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic
resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for
early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI
may help evaluate changes in the bl1 expand
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment. Type: Interventional Start Date: Jul 2017 |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymp1
Children's Oncology Group
B Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy
versus (vs.) standard chemotherapy alone in protecting the liver in patients with
leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the
treatment of acute lymphoblastic leukem1 expand
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients. Type: Interventional Start Date: Aug 2023 |
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metas1
Tvardi Therapeutics, Incorporated
Hepatocellular Carcinoma
The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability
of TTI-101 orally administered as a single agent to participants with locally advanced or
metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum
tolerated dose (MTD) and/or reco1 expand
The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TTI-101 as a single agent. The primary objectives of Cohort A Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 as a single agent in participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohort A Phase 2 are to assess response, progression, survival, and pharmacokinetics. The primary objectives of Cohorts B and C Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, or unresectable HCC and to determine the MTD and/or RP2D of TTI-101 when used in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C). The primary objectives of Cohorts B and C Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohorts B and C Phase 2 are to assess response, progression, survival, and pharmacokinetics. Type: Interventional Start Date: Mar 2023 |
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion N1
Children's Oncology Group
Embryonal Rhabdomyosarcoma
Fusion-Negative Alveolar Rhabdomyosarcoma
Spindle Cell/Sclerosing Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This
phase III trial aims to maintain excellent outcomes in patients with very low risk
rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24
weeks of vincristine and dactinomycin (1 expand
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved. Type: Interventional Start Date: Aug 2022 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in1 expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Transformative Research in Diabetic Nephropathy
University of Pennsylvania
Diabetic Nephropathies
Diabetic Glomerulosclerosis
This is a prospective, observational, cohort study of patients with a clinical diagnosis
of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to
collect, process, and study kidney tissue and to harvest blood, urine and genetic
materials to elucidate molecular pathways an1 expand
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol. Type: Observational Start Date: Dec 2016 |
The Effects of Bariatric Surgeries on Glucose Metabolism
The University of Texas Health Science Center at San Antonio
Post Bariatric Surgery
Gastric Bypass
Sleeve Gastrectomy
Hypoglycemia After Gastric Bypass
The purpose of this study is learn the effect of gastric bypass surgery and sleeve
gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after
eating. expand
The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating. Type: Interventional Start Date: Jul 2015 |
Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer
The University of Texas Health Science Center at San Antonio
Lung Neoplasm
Create a living biobank of PDOs from Stage I-III lung cancer patients. expand
Create a living biobank of PDOs from Stage I-III lung cancer patients. Type: Observational Start Date: Oct 2018 |
Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (1
The University of Texas Health Science Center at San Antonio
Alcohol Use Disorder
This study is testing a new treatment called IR-TMS (image-guided, robot navigated
transcranial magnetic stimulation) to see if it can help people who drink too much
alcohol to reduce the amount they drink. Participants will be placed into one of three
groups, each receiving a slightly different ve1 expand
This study is testing a new treatment called IR-TMS (image-guided, robot navigated transcranial magnetic stimulation) to see if it can help people who drink too much alcohol to reduce the amount they drink. Participants will be placed into one of three groups, each receiving a slightly different version of this treatment. The study involves going through a few sessions of IR-TMS, having brain scans (MRI), providing blood and urine samples, and answering questions about their drinking and mental health. These activities are part of the study and aren't usually part of regular treatment for alcohol use. IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain. The goal is to see if this treatment can help reduce the urge to drink. There are other options, like sticking with therapy or medication, which are less intense but have been used for a longer time. Type: Interventional Start Date: Feb 2025 |
Genomic Predictors of Recurrent Pregnancy Loss
Yale University
Recurrent Pregnancy Loss
The overall goals of this proposal are to determine the genetic architecture of recurrent
pregnancy loss (RPL) and to discover genomic predictors of RPL. expand
The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL. Type: Observational Start Date: Sep 2021 |
Chromosome 18 Clinical Research Center
The University of Texas Health Science Center at San Antonio
Chromosome Aberrations
Growth Hormone Deficiency
Hypomyelination
Our vision, that of the researchers at the University of Texas Health Science Center at
San Antonio, is that every person with a chromosome 18 abnormality will have an
autonomous and healthy life. Our mission is to provide families affected by chromosome 18
abnormalities with comprehensive medical1 expand
Our vision, that of the researchers at the University of Texas Health Science Center at San Antonio, is that every person with a chromosome 18 abnormality will have an autonomous and healthy life. Our mission is to provide families affected by chromosome 18 abnormalities with comprehensive medical and educational information. Our goals are to provide definitive medical and education resources for the families of individuals with chromosome 18 abnormalities; perform and facilitate groundbreaking clinical and basic research relating to the syndromes of chromosome 18; and to provide treatments to help these individuals overcome the effects of their chromosome abnormality. Type: Observational Start Date: Sep 1993 |
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