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NCT ID: NCT05052996 Active, not recruiting - HIV-1 Infection Clinical Trials

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Start date: October 5, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

NCT ID: NCT05052723 Active, not recruiting - Pancreatic Cancer Clinical Trials

Cabozantinib and Pembrolizumab in Metastatic Pancreas

Start date: January 4, 2022
Phase: Phase 2
Study type: Interventional

This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.

NCT ID: NCT05052281 Active, not recruiting - Prenatal Stress Clinical Trials

Promoting Healthy Brain Development: Wellness for 2 Study

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

The "Promoting Healthy Brain Project" (PHBP) is part of the Lurie Children's Hospital Strategic Research Initiative on Perinatal Origins of Childhood Disease: Research & Prevention at the Maternal-Fetal Interface. The overall purpose of the PHBP is to test whether reducing maternal stress during pregnancy is associated with improved neurodevelopment in the first year of life. This will be tested via a randomized controlled trial (n = 100) of a technology and mindfulness enhanced prenatal stress-reduction intervention (Mothers and Babies; MB).

NCT ID: NCT05052268 Active, not recruiting - Clinical trials for Advanced Solid Tumor

XTX202 in Patients With Advanced Solid Tumors

Start date: January 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

NCT ID: NCT05051124 Active, not recruiting - Hypertension Clinical Trials

Peers and Technology for Adherence, Access, Accountability, and Analytics

PT4A
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.

NCT ID: NCT05050942 Active, not recruiting - Clinical trials for Gastro-enteropancreatic Neuroendocrine Tumor

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

SORENTO
Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

NCT ID: NCT05050916 Active, not recruiting - Clinical trials for Vitamin D Deficiency

The Investigation of Vitamin D and Menstrual Cycles Trial, the inVitD Trial: A Phase II Randomized Trial

Start date: March 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Background: About 1.5 million U.S. women of reproductive age are estimated to be infertile. Many more have difficulty getting pregnant. Menstrual cycles are an indicator of a woman s general health. Menstrual cycle changes may predict difficulties in getting pregnant. Researchers want to see what role vitamin D may play in menstrual cycle health. Objective: To examine the effect of vitamin D supplementation on the hormones that come from the brain and the ovary during a menstrual cycle. Eligibility: Women aged 19-40 who have spontaneous menstrual cycles (are not taking any hormones) less than 50 days in length. Design: Participants will fill out a screening survey about their demographics and health history. It will take 5-10 minutes to complete. Participants will have 3 study visits. Participants who are deficient and move to Phase 2 will receive a 5000 IU dose of vitamin D supplements. Participants who are sufficient will receive placebo. If they are vitamin D deficient, they will not get the placebo. They will take the capsules by mouth, once per week, for 3 menstrual cycles (or about 90 days). Participants will have physical exams. Their height, weight, body fat percentage, blood pressure, and waist-hip ratio will be measured. They will give blood samples. They will have self-administered vaginal and oral swabs. Participants will keep a daily menstrual diary. They will do daily home ovulation testing. They will collect urine at home. Some women may collect menstrual blood at home. Participants will fill out an online survey. It will ask about their health, diet, and physical activity; birth control use; pregnancy history; menstrual cycle; smoking and drinking habits; education; and occupation. It will take 20-30 minutes to complete. Participation will last for four menstrual cycles (about 4 months).

NCT ID: NCT05050240 Active, not recruiting - Healthy Lifestyle Clinical Trials

BATokines as Biomarkers of Brown Fat in Humans

Start date: October 12, 2021
Phase: N/A
Study type: Interventional

Brown adipose tissue (BAT) burns excess calories to produce heat in response to environmental cold. Rapidly growing evidence from rodent and human studies suggests that the presence and activation of brown fat are far more beneficial for whole body metabolism and cardiometabolic health than previously appreciated. Despite the clear associations between brown fat and metabolic health, we lack both: cost-effective means of detecting brown fat in humans as well as comprehensive insights into how brown fat facilitates metabolism on a molecular level in humans. Emerging evidence suggests that the benefits of brown fat activation are mediated, at least in part, by secretion of specific molecules into the bloodstream which signal to metabolically active organs such as skeletal muscle, liver and brain. A number of these so-called brown adipokines (or BATokines) have now been discovered in mice and shown to positively impact glucose homeostasis, liver and muscle function. Human deep-neck brown fat biopsies reveal that >1000 molecules could potentially be secreted from brown fat, and >400 are released by human brown fat cells in a dish, representing a major opportunity for discovery of high translational value. Here, we aim to identify a screen of first potential blood biomarkers of brown fat in healthy young humans. This will be achieved by analyzing plasma proteins in subjects with 'inactive brown fat' (warm) and 'activated brown fat' (3-hr cold exposure, cooling vests) using high-throughput technologies (SOMAscan and O-link) to identify temperature-sensitive brown fat-enriched molecules. This preliminary data will guide a larger follow up study in which we envision studying lean and obese (insulin sensitive and insulin resistant) subjects of various age groups and race/ethnicity. Human BATokines identified here will become primary targets for manipulation in experimental animals to assess their therapeutic potential against obesity, T2D, and associated diseases. Additionally, since current methods of brown fat detection in human rely on deep neck biopsies or costly 18-FDG-PET/CT scans, identification of blood biomarkers of brown fat would offer a cost-effective and non-invasive alternative for prediction of metabolic health in humans.

NCT ID: NCT05050227 Active, not recruiting - Depression Clinical Trials

Improving Depression Management

IDMPC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PC-MHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting and pilot testing PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT).

NCT ID: NCT05049993 Active, not recruiting - Avascular Necrosis Clinical Trials

Pyrocarbon Clinical Follow-up Study

PYC CFS
Start date: October 27, 2021
Phase:
Study type: Observational

The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).