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NCT ID: NCT05268744 Completed - Clinical trials for Autism Spectrum Disorder

Micronutrient Supplementation in Children With ASD

Start date: November 14, 2022
Phase: Phase 2
Study type: Interventional

An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

NCT ID: NCT05268393 Completed - type1diabetes Clinical Trials

Feasibility Trial of a Mindfulness Based Intervention in Youth With Type 1 Diabetes

BREATHE-T1D
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

Type 1 diabetes (T1D) is one of the most common chronic illnesses of childhood. The involved treatment regimen, including daily insulin administration/pump management, frequent blood glucose checks, and careful track-ing of food intake, places a high-stress burden on patients and their families. Adolescence is a particularly risky time for T1D management given a marked decline in treatment adherence and glycemic control. Over 80% of adolescents with T1D have poor glycemic control (A1c >7.5%), and one significant risk factor is the increase in negative affectivity, including depression and anxiety symptoms, that distinguish adolescents with T1D. Elevated depression and anxiety symptoms affect 40% of teens with T1D. Preliminary data support the notion that negative affectivity contributes to diminished treatment adherence and worsening of glycemic control, partially through the effects of negative affectivity on stress-related behavior such as maladaptive eating behavior (e.g., dietary restriction, uncontrolled eating patterns, and insulin omission for weight control). There is no gold-standard approach to address the poor glycemic control seen in adolescents with T1D. The creation of novel, targeted interventions, tailored for the developmental needs of adolescents with T1D and the particular burdens of coping with their chronic illness, are needed. Mindfulness-based interventions delivered to adolescents without T1D, including the team's preliminary work in teens with depression and weight-related disorders, have shown promise in treating negative affectivity, maladaptive eating behavior, and health outcomes. A mindfulness-based approach may be well-suited for adolescents with T1D, but given that the mechanisms of association among negative affectivity, stress-related behavior, and self-care are unique to individuals with T1D, interventions must be specifically tailored for this population. The goal of this study is to, therefore, adapt an existing 6-session mindfulness-based intervention, Learning to BREATHE, for use with adolescents with T1D (BREATHE-T1D). The first specific aim of the study is to adapt BREATHE for adolescents with T1D and to adapt a relevant and credible health education comparison curriculum (HealthEd-T1D). The second aim is to carry out a 2-way pilot randomized controlled trial to evaluate the feasibility and acceptability of BREATHE-T1D and HealthEd-T1D. The result of the current study will be a feasible and acceptable mindfulness intervention and comparison curriculum that can be evaluated in an efficacy trial. The multidisciplinary study team contributes complementary areas of expertise in adolescents with T1D, behavioral intervention development, negative affectivity and maladaptive eating behavior, adolescent mindfulness-based intervention, qualitative data analysis, and delivery of behavioral health interventions via telehealth. The study's innovative approach will enable the investigators to establish a feasible/acceptable intervention tailored for adolescents with T1D, leading to a future proposal for a full-scale efficacy trial.

NCT ID: NCT05268302 Completed - Dengue Clinical Trials

Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4)

Start date: February 28, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.

NCT ID: NCT05268185 Completed - COVID-19 Clinical Trials

The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19)

BOOSTED
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

While both heterologous (mixing) and homologous (matching) vaccine regimens are now considered standard of care, post-vaccination complications and long-term effects of the different vaccination regimens have not been thoroughly studied. There is a pressing need to investigate the longitudinal effects of the mixing and matching vaccine-booster approaches. This study proposes to utilize the existing digital infrastructure of the COVID-19 Citizen Science (CCS) study on the Eureka Research Platform to perform a systematic and prospective randomized trial comparing mixing versus matching approaches. Eligible CCS participants will have the opportunity to be randomly assigned to a recommendation of receiving either the Pfizer or Moderna booster vaccine. Long-term effects will be monitored through the participants' completion of their regular weekly CCS follow-up surveys on symptoms and infection. This randomized trial aims to mitigate the effect of confounding variables and provide more conclusive evidence on each regiment to guide booster recommendations.

NCT ID: NCT05268055 Completed - Cultural Competency Clinical Trials

Sign Here: How to Conduct Informed Consent With Deaf Individuals

Start date: May 3, 2023
Phase: N/A
Study type: Interventional

The goal of this research is to create a training film for hearing healthcare providers to teach them how to competently and sensitively interact with Deaf patients. In Year 1, focus groups will be facilitated to elicit feedback that will inform video production of the training film. In Year 2, film production will take place, as well as an RCT to test the feasibility and preliminary efficacy of the new training intervetion.

NCT ID: NCT05268029 Completed - Huntington Disease Clinical Trials

Making HD Voices Heard

Start date: March 23, 2022
Phase:
Study type: Observational

The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.

NCT ID: NCT05268016 Completed - Plaque Psoriasis Clinical Trials

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis

Start date: March 24, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.

NCT ID: NCT05267652 Completed - Clinical trials for Acute Respiratory Failure

Pragmatic Trial Examining Oxygenation Prior to Intubation

PREOXI
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. One-in-ten emergency tracheal intubations is complicated by life-threatening hypoxemia. Administering supplemental oxygen prior to induction and intubation ("preoxygenation") decreases the risk of life-threatening hypoxemia. In current clinical practice, the most common methods for preoxygenation are non-invasive positive pressure ventilation and facemask oxygen. Prior trials comparing non-invasive positive pressure ventilation and facemask oxygen for preoxygenation have been small and have yielded conflicting results. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to preoxygenation could improve the care clinicians deliver and patient outcomes.

NCT ID: NCT05267470 Completed - Clinical trials for Squamous-Cell Non-Small-Cell Lung Cancer

A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

FORTITUDE-201
Start date: March 29, 2022
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

NCT ID: NCT05267301 Completed - Cholesterol Clinical Trials

AlmegaPL CV Health Open Label Study

Start date: May 11, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the effectiveness of Almega PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA), on improving blood markers associated with heart health of iwi customers.