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NCT ID: NCT05207865 Active, not recruiting - Migraine Clinical Trials

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Start date: March 15, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.

NCT ID: NCT05207722 Active, not recruiting - Clinical trials for Metastatic HER2 Positive Gastroesophageal Junction Cancer

CYNK-101 in Combination With Trastuzumab and Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Start date: April 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen. Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone. The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.

NCT ID: NCT05207397 Active, not recruiting - Alzheimer Disease Clinical Trials

Lactate for Energy and Neurocognition

LEAN
Start date: April 12, 2023
Phase:
Study type: Observational

The investigator has shown that improved cardiorespiratory fitness following an aerobic exercise program elicits cognitive benefit in elderly subjects and memory improvement in Alzheimer's disease (AD). The physiological mechanism may be related to exercise-mediated change in circulating factors that permeate the brain. The response to each individual bout of exercise (i.e. the acute exercise response) may differ between subjects and be key to driving brain benefit. In young populations, the acute response to exercise can last hours and affect brain glucose metabolism. However, the field knows little about this acute exercise response in AD. Most exercise intervention trials designed to prevent and slow AD, including our own (AG033673; AG034614; AG043962; AG049749; AG053952), assess biomarkers at two fasting time points: pre- and post-intervention. The acute exercise response in the brain and periphery likely varies between subjects and diagnoses and provide key information regarding mechanisms of benefit. Our primary goals are to characterize the acute exercise response to exercise in the brain (glucose metabolism) and periphery (biomarker response) in aging and AD. The investigator will identify relationships between exercise-related factors (i.e. heart rate, biomarkers) and change in brain metabolism and cognition. Understanding these mechanistic relationships will provide specific targets that can be used in future trials to develop individualized exercise prescriptions and maximize benefit. Accumulating evidence suggests that the exercise-related metabolite lactate is an understudied effector of brain health. Lactate is an essential fuel for neuronal function. It is supplied to neurons through glucose metabolism in nearby glia and from peripheral blood, since the brain is permeable to lactate. A drop in cerebral glucose metabolism is a marker of AD. Thus, supplying neurons directly with lactate for oxidation may supplement energy requirements in AD, as has been suggested with ketones. Importantly, circulating lactate levels rise during exercise. Repeated increases in systemic lactate (acute exercise response) may transiently spare glucose by providing an alternative fuel. With routine exercise, acute responses may elicit adaptations that facilitate the use of lactate beyond that which occurs during acute exercise and contribute to brain benefits observed during chronic exercise interventions. In younger populations, higher exercise intensity evokes a greater lactate response compared to lower intensities and elicits cognitive benefit. The investigator will achieve these goals through the following aim: Aim 1. Examine differences in lactate metabolism between diagnosis groups and the effect of lactate on cognitive performance. Increased blood lactate can reflect increased production or decreased uptake. This has never been compared in ND and AD. The investigator will use a "lactate clamp" procedure, where lactate is infused to concentrations that match those found during exercise, to characterize lactate turnover. The investigator will characterize cognitive performance following lactate infusion, independent of exercise factors. The investigators hypothesize that ND subjects (n=12) will use lactate more efficiently (greater uptake) than AD individuals (n=12). The investigator further hypothesize that cognitive performance will acutely improve after lactate infusion in ND and AD subjects. The overall goal is to characterize lactate metabolism, and its relationships with cognition. The KU ADC is a recognized leader in the study of exercise and metabolism in aged and AD populations, and puts the investigator in a strong position to successfully achieve these aims.

NCT ID: NCT05207098 Active, not recruiting - Clinical trials for Head and Neck Cancer

A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy

Start date: December 22, 2021
Phase:
Study type: Observational

The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.

NCT ID: NCT05206994 Active, not recruiting - Adolescent Behavior Clinical Trials

Evaluation of the Close to Home Program in California

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Investigators propose to rigorously evaluate the Close to Home (C2H) model via a cluster-matched control trial across 18 diverse communities (9 C2H, 9 control) in California via collection and analyses of social network, school-based and social media data. Close to Home is a primary prevention community mobilization model implemented in 10 communities across California that engages community members across multiple sectors and social networks to strengthen community connections and shift social norms regarding sexual violence (SV), but has never been rigorously evaluated. C2H moves beyond criminal justice, lobbying, or school-based curricular approaches, taking a true community-level and community-led approach. This is a five-year project, funded by the Centers for Disease Control and Prevention (CDC) for 3 years with competitive awards for years 4 and 5, and is conducted in partnership with the California Department of Public Health (CDPH) and ValorUs (formerly CALCASA). The University of California, San Diego (UCSD) and CDPH partnership is uniquely poised to conduct the first rigorous evaluation of C2H in California at this time.

NCT ID: NCT05206448 Active, not recruiting - Infertility Clinical Trials

Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation

CLC II
Start date: October 26, 2020
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair step dosing of letrozole similar to standard of care. Half of the participants will receive letrozole and CC in combination, while the other half will receive letrozole alone.

NCT ID: NCT05205915 Active, not recruiting - Clinical trials for Major Depressive Disorder

Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

NCT ID: NCT05205551 Active, not recruiting - Clinical trials for Heart Transplant Rejection

Prospera Test Evaluation in Cardiac Transplant (ProTECT)

ProTECT
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

NCT ID: NCT05205512 Active, not recruiting - Hodgkin Lymphoma Clinical Trials

Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial

Start date: September 14, 2022
Phase: N/A
Study type: Interventional

This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.

NCT ID: NCT05205005 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes

Start date: May 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The prevalence of type 2 diabetes (T2D) continues to increase in the US, with 26.8 million adults carrying a diagnosis. Importantly, T2D is widespread in the Veteran population. This epidemic of T2D also contributes to the staggering rates of cardiovascular disease and cardiovascular mortality. Lifestyle modifications, including increased physical activity, are recommended as first-line therapy for the management of T2D. Unfortunately, patients with T2D exhibit diminished vascular adaptations to exercise. The proposed project will test the overall hypothesis that degradation of the endothelial glycocalyx, a characteristic feature of T2D, precludes shear stress mechanotransduction and consequent exercise-induced vascular adaptations. As such, the investigators pose that restoration of the endothelial glycocalyx via dietary supplementation of glycocalyx precursors will potentiate vascular adaptations to exercise in Veterans with T2D.