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NCT ID: NCT06395636 Not yet recruiting - Appendicitis Clinical Trials

Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients

i-DETECT
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.

NCT ID: NCT06395519 Recruiting - Breast Cancer Clinical Trials

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

ERADIC8
Start date: May 2024
Phase: Phase 1
Study type: Interventional

This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.

NCT ID: NCT06395506 Not yet recruiting - Breast Cancer Clinical Trials

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

THRIVE
Start date: June 30, 2024
Phase: N/A
Study type: Interventional

The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.

NCT ID: NCT06395467 Not yet recruiting - Clinical trials for Alcohol Use Disorder

12-Step Facilitation/MET/CBT (InTEGRA) vs. MET/CBT for Youth With Alcohol and Other Drug Use Disorder

InTEGRA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with alcohol and other drug [AOD] use disorder (hereafter substance use disorder), that compares two different active psychosocial interventions designed to address adolescent substance use disorder. Participants are recruited from our clinical settings and the community at two sites: one in the metro Boston, Massachusetts (MA) area and the other in the metro Farmington, Connecticut (CT), area. Study aims and hypotheses are as follows: 1. To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA), which integrates 12-Step Facilitation (TSF) with Motivational Enhancement Therapy/Cognitive Behavioral Therapy (MET/CBT) relative to gold standard MET/CBT alone (N = 294). It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer substance-related negative consequences. 2. Investigate the personal recovery capital (PRC) and social recovery capital (SRC) mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time (e.g., PRC: motivation, self-efficacy, coping; SRC: 12-step involvement; social network changes). 3. Investigate moderators of InTEGRA's effects on outcomes across one-year follow-up (e.g., effect of age, network support for AOD use; psychiatric severity; age composition of 12-step meetings on substance use and substance-related consequences). It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. 4. Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design.

NCT ID: NCT06395441 Not yet recruiting - Clinical trials for Malignant Solid Neoplasm

Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

NCT ID: NCT06395402 Not yet recruiting - Clinical trials for Neuroendocrine Tumors

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

LUMOD-ID
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: - Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan - Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry) - Undergo blood tests for 4 to 8 weeks after each Lutathera treatment - Complete patient reported outcome questionnaires - Visit the clinic for follow-up about every 8 weeks.

NCT ID: NCT06395376 Completed - Aging Clinical Trials

Adaptive Stress Response: The Hot Yoga Study

Start date: February 11, 2023
Phase: N/A
Study type: Interventional

This is a small intervention study which is aimed at characterizing what is known as the adaptive stress response (also know as "hormesis") in women aged 30-45 years. Participants will perform Bikram Yoga in a room heated to 104°F (40°C) which is often referred to as "Hot Yoga". The hypothesis of this study is that a protective and health-promoting adaptive stress response can be induced in living humans by performing exercise in a hot environment. The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?

NCT ID: NCT06395350 Completed - Healthy Volunteers Clinical Trials

Spire Health Remote Patient Monitor Human Factors Summative Study Protocol

Start date: September 4, 2019
Phase: N/A
Study type: Interventional

This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use conditions. This summative testing is the culmination of several preliminary analyses including a formative usability evaluation via Cognitive Expert Review Panel and is intended to assess the effectiveness of control measures put in place to reduce/eliminate use-related hazards or potential use errors.

NCT ID: NCT06395324 Not yet recruiting - Clinical trials for Microbial Colonization

Fiber Effectively Educates & Directs the Microbiome Study

FEEDMe
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The FEEDMe Study is a single-group, open label pilot study exploring how diverse, commercially available foods rich in arabinose influence the gut microbiome in adults from diverse populations.

NCT ID: NCT06395285 Not yet recruiting - ROSAH Clinical Trials

Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients

Start date: May 20, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.