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A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR01
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Marengo Therapeutics, Inc.
Advanced Solid Tumors
Genital Neoplasm, Female
Urogenital Neoplasms
Lung Neoplasm
Neoplasms by Site
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and
preliminary clinical activity of STAR0602 as a single agent administered intravenously in
participants with advanced solid tumors that are antigen-rich. expand
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich. Type: Interventional Start Date: Jan 2023 |
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
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James P. Rathmell, MD
Painful Diabetic Neuropathy
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks. expand
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Type: Interventional Start Date: Sep 2022 |
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promo1
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University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I
(tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve
sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection
(Exploratory Aim 3), and to explore the c1 expand
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions. Type: Interventional Start Date: Oct 2024 |
A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Ga1
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Regeneron Pharmaceuticals
Eosinophilic Gastritis (EoG)
Eosinophilic Duodenitis (EoD)
Eosinophilic Gastrointestinal Disease (EGID)
Eosinophilic Gastroenteritis
This study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/im1 expand
This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
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University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-D1 expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
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Endotronix, Inc.
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate s1 expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. - Treatment Arm (Group 1) - Active Control Arm (Group 2) - Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy. Type: Interventional Start Date: Nov 2023 |
iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Rural Families
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University of Kansas Medical Center
Weight Loss
Pediatric Obesity
The purpose of this study is to assess whether providing a parent-only group program
before providing a parent and child group program works better than the parent and child
group program alone. expand
The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone. Type: Interventional Start Date: Apr 2023 |
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