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NCT ID: NCT06353438 Not yet recruiting - Aging Clinical Trials

Hydraulic Resistance and Older Adults

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

The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are: - Does the use of hydraulic exercise equipment decrease fall risk in older adults? - Does the use of hydraulic exercise equipment improve function in older adults? Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).

NCT ID: NCT06353282 Not yet recruiting - Adolescents Clinical Trials

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Start date: July 1, 2025
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

NCT ID: NCT06352866 Not yet recruiting - Multiple Myeloma Clinical Trials

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion.

NCT ID: NCT06352840 Not yet recruiting - Endometriosis Clinical Trials

Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain

Start date: April 2024
Phase: N/A
Study type: Interventional

The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP). The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.

NCT ID: NCT06352723 Not yet recruiting - Epilepsy Clinical Trials

Cenobamate in the Intensive Care Unit

CENOBITE
Start date: April 2024
Phase: Early Phase 1
Study type: Interventional

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH. Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

NCT ID: NCT06352645 Not yet recruiting - Clinical trials for Plaque Induced Gingivitis

Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser

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

The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.

NCT ID: NCT06352372 Not yet recruiting - Epilepsy Clinical Trials

Safety and Efficacy of tPBM for Epileptiform Activity in Autism

tPBM
Start date: April 2024
Phase: Phase 2
Study type: Interventional

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.

NCT ID: NCT06352359 Not yet recruiting - Clinical trials for Advanced Solid Tumor

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

Start date: June 30, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg.

NCT ID: NCT06352073 Not yet recruiting - Clinical trials for Eosinophilic Esophagitis

Dupilumab for Eosinophilic Esophagitis With Severe Strictures

DESTRICT
Start date: April 2024
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab. Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses. Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed. At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test.

NCT ID: NCT06351761 Not yet recruiting - Atrial Fibrillation Clinical Trials

WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

WIBOFA
Start date: May 2024
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation