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NCT ID: NCT06065033 Withdrawn - COVID-19 Clinical Trials

Exercise Interventions in Post-acute Sequelae of Covid-19

Start date: September 9, 2023
Phase: N/A
Study type: Interventional

The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC. The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.

NCT ID: NCT06057636 Withdrawn - Breast Cancer Clinical Trials

Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study

Start date: September 8, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two hypnotic interventions for Black women with advanced cancer pain in preparation for a well-powered phase III study. The investigators plan to enroll 30 adult Black women with advanced cancer pain in a 2-arm pilot randomized controlled trial (RCT). The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial. It is hypothesized that at least 75% of participants in both study arms will complete study requirements. The secondary aims will be to evaluate the participant's experience with the intervention and to determine the effect size of the intervention on pain severity.

NCT ID: NCT06046274 Withdrawn - Clinical trials for Advanced Endometrial Cancer

GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer (cancer of the womb). The main questions the study aims to answer are: - How well acasunlimab in combination with pembrolizumab works against endometrial cancer - What are the potential side effects participants may experience when they are treated with acasunlimab in combination with pembrolizumab Participants will receive both acasunlimab and pembrolizumab. All participants will receive active drug; no one will receive placebo. participants will participate in 1 of 2 cohorts. A participant will receive study treatment up to a maximum of 24 months. The study duration (including screening, treatment, and follow-up) for each participant will be about 39 months.

NCT ID: NCT06041373 Withdrawn - Atrial Fibrillation Clinical Trials

Verily Watch Cardio (AF and ECG) Study

Start date: November 2023
Phase:
Study type: Observational

This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.

NCT ID: NCT06036511 Withdrawn - PTSD Clinical Trials

Connectivity Changes Associated With Ketamine Assisted Psychotherapy for PTSD

CONCHKAP
Start date: December 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the effects of Ketamine Assisted Psychotherapy [KAP] on individuals with Post Traumatic Stress Disorder [PTSD]. The main questions it aims to answer are: 1. Does KAP improve symptoms of PTSD? 2. What changes in brain network connectivity are seen with KAP?

NCT ID: NCT06032247 Withdrawn - Clinical trials for Anterior Cruciate Ligament Injuries

Bilateral Versus Unilateral Strength Training After ACLR

BUST
Start date: August 31, 2023
Phase: N/A
Study type: Interventional

After rehabilitation completion, there remains large deficiencies between the operative (OP) and non-operative (NOP) limbs in lower-limb outcomes (e.g., size, strength, and function) and these deficits can persist for years. Therefore, further specialized training protocols, such as the ones in the present study, are required to determine if these deficits can be lessened. The proposed project will evaluate the effect of 8-weeks of single-leg and double-leg lower-body resistance training on musculoskeletal function in individuals with a previous anterior cruciate ligament (ACL) reconstruction (ACLR) in a randomized control trial. The study will recruit 30-40 males and females between 18-35 years of age that have undergone a previous ACLR. Participants will be randomized to either the single-leg/unilateral (UL) or double-leg/bilateral (BL) training groups. Training will occur three times per week for 8-weeks. The UL group will participate in exercises such as split squats, single-leg deadlifts, or single-leg squats. The BL group will utilize exercises such as double-leg squats, conventional deadlifts, and leg presses. One week prior to (PRE) and one week after (POST) the training program, all participants will undergo a testing battery. Musculoskeletal ultrasound will measure quadriceps and hamstrings muscle cross-sectional area (mCSA), fascicle length (FL), and pennation angle (PA) of both OP and NOP limbs. Strength will be assessed through maximal voluntary isometric contractions (MVIC) for the quadriceps and hamstrings, and one-repetition maximum tests for single-leg leg extensions, leg curls, and leg press. Lower-limb function will be assessed through single-leg and double-leg jumps on a dual force plate system for jump height, impulse, rate of force development, and peak force. Data will be analyzed via separate mixed-factorial analyses of variance for the within-subjects factor of leg (OP vs. NOP) and time (PRE vs. POST) and the between-subjects factor of biological sex (male vs. female) and group (UL vs. BL). Post-hoc analyses will include lower-order ANOVAs and t-tests as pairwise comparisons when significance is detected. Significance will be established at p≤0.05. The results of this study will assist practitioners, coaches, sport scientists, and most importantly, the athletes, in the development of post-rehabilitative strength training protocols designed to reduce between-limb discrepancies.

NCT ID: NCT06030050 Withdrawn - Chronic Pain Clinical Trials

Animal Assisted Intervention for Hemodialysis Outpatients

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to understand if and how an animal-assisted intervention [AAI] using therapy dogs can support hemodialysis [HD] patients' treatment adherence and enhance their well-being. The main objectives are: - Objective 1: Determine if the AAI impacts patients' HD treatment adherence (primary outcome is number of unplanned missed treatments no due to hospitalization). - Objective 2: Evaluate if the AAI impacts patients' psychosocial well-being (secondary outcomes are stress, pain, mood, QOL). - Objective 3: Examine potential mechanistic biomarkers that underpin human-animal bonding (hormones tied to stress and bonding). (exploratory aim) - Objective 4: Understand patients' subjective experiences of the AAI. Participants will be asked to engage in several research tasks, including: - assessments - therapy dog visits - monthly blood draws - focus group Researchers will compare how the treatment group (those who receive 2 dogs visits per week) and the control group (those who receive 0 dog visits per week) to see if the AAI impacts treatment adherence and psychosocial well-being.

NCT ID: NCT06017323 Withdrawn - Clinical trials for Metastatic Pancreatic Cancer

Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma

ProglumidePanc
Start date: October 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I open labelled study to treat patients with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with gemcitabine and nab-paclitaxel given days 1, 8, and 15 every 28 days, and proglumide. This is a phase 1 study with 3+3 design, enrolling3-12 patients over 2 planned dose levels of proglumide(maximum 6 patients per dose level). Proglumide will be tested at the daily dose of 1200 mg orally (PO) given as 400mg three times daily (TID) (dose level 1) or 1600 mg orally(PO) given as 800 mg twice a day (BID) (dose level 2). All cycles are 28 days. Patients will be monitored for safety and toxicity by laboratory blood testing and physical examinations.

NCT ID: NCT06006442 Withdrawn - Clinical trials for Evaluate the Association of Vaping With Seizures

Vaping-Related Seizures - A Prospective Study

Start date: September 2023
Phase:
Study type: Observational

This case-crossover study evaluates the association between vaping and seizures in patients of a large academic medical center who admits to vaping and hav a planned ambulatory EEG ordered.

NCT ID: NCT06006286 Withdrawn - Clinical trials for Metastatic Hepatocellular Carcinoma

A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

Start date: August 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

To learn about the safety and tolerability of atezolizumab, bevacizumab, and ADI-PEG 20 when given in combination to patients with locally advanced or metastatic liver cancer