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NCT ID: NCT05782244 Recruiting - Clinical trials for Traumatic Brain Injury

Sildenafil for Microvasculopathy in Chronic TBI

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

Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.

NCT ID: NCT05827952 Recruiting - Clinical trials for Caregivers With Toddler Receiving Early Intervention

The Effect of Self-efficacy and Relationship Through Behavior Modification by Hybrid Mode

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

The past literature supports the use of digital media as a medium to provide ongoing interventions for families caring for children with difficulties and the opportunity to intervene directly through caregivers, and to combine the advantages of hybrid physical and online interventions, applying different modes of teaching and interacting, satisfying the need for high frequency supervision and feedback for habit building, responding to difficulties and adjusting settings appropriately and immediately, in addition to providing timely assistance, by In addition to providing timely assistance, by changing parents' behavioral patterns and skills, it can increase the caregiver's level of implementation, thus establishing subtle changes and learning in daily life, promoting the quality of interaction and relationship building, and therefore providing intervention. The study aims to use the new specific model of behavior modification-"Atomic Habit" as the basis for behavior change intervention, combining parental self-identification and children's play participation to establish good thinking and behavior patterns of caregivers, to increase self-identification and reduce stress, and to improve relationships and reduce conflict.

NCT ID: NCT05836597 Recruiting - Clinical trials for Functional Dyspepsia

Functional Dyspepsia Treatment Using Virtual Reality

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

The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.

NCT ID: NCT05844891 Recruiting - Asthma in Children Clinical Trials

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

TEACH-ER
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom), featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.

NCT ID: NCT05848284 Recruiting - Clinical trials for Tricuspid Regurgitation

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

VISTA-US
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

NCT ID: NCT05858008 Recruiting - Clinical trials for Mild Cognitive Impairment

Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment

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

This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.

NCT ID: NCT05858346 Recruiting - Clinical trials for Social Anxiety Disorder

Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

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

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with social anxiety disorder and comorbid posttraumatic stress via a randomized controlled trial of TBT and an existing DST. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

NCT ID: NCT05888389 Recruiting - Anesthesia Clinical Trials

Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH

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

A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for chronic subdural hematoma.

NCT ID: NCT05899166 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

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

The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: - Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? - Does a ketogenic diet improve diabetes control? - Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? - What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. - Diabetes care devices will be connected for cloud-based data collection. - Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. - During five study visits held at at baseline, 1, 5, 9 and 24 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. - Children and their caregivers will participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. Comparison will be made between a ketogenic vs standard diet.

NCT ID: NCT05899387 Recruiting - Breast Cancer Clinical Trials

Seroma of the Mammary Gland

SerMa
Start date: April 1, 2024
Phase:
Study type: Observational

The study is designed as international, prospective, multicenter non-AMG/MPG study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.