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NCT ID: NCT06312124 Recruiting - Surgery Clinical Trials

A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Start date: March 8, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.

NCT ID: NCT06312059 Recruiting - Growth Clinical Trials

Goat or Cow Milk Based Infant Formula GMS

Start date: December 14, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).

NCT ID: NCT06312020 Recruiting - Sjogren's Syndrome Clinical Trials

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Start date: May 9, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

NCT ID: NCT06311838 Recruiting - Opioid Use Disorder Clinical Trials

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness

Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

NCT ID: NCT06311799 Recruiting - Diabetes Clinical Trials

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

FIMPreg
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study team after they are done.

NCT ID: NCT06311786 Completed - Healthy Volunteer Clinical Trials

A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants

Mass Balance
Start date: April 8, 2024
Phase: Phase 1
Study type: Interventional

The main goal of this study is to learn how [14C]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants.

NCT ID: NCT06311760 Recruiting - Clinical trials for Healthy Participants Study

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants

Start date: April 9, 2024
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.

NCT ID: NCT06311708 Recruiting - Clinical trials for Arrhythmogenic Right Ventricular Cardiomyopathy

Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

RIDGE
Start date: January 31, 2023
Phase:
Study type: Observational

This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

NCT ID: NCT06311682 Recruiting - Atopic Dermatitis Clinical Trials

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

TRAPEDS 2
Start date: June 10, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

NCT ID: NCT06311656 Recruiting - Healthy Clinical Trials

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants

Start date: March 19, 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B and C include optional groups.