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NCT ID: NCT05635019 Active, not recruiting - Obesity Clinical Trials

FoodRx for Obesity Treatment

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.

NCT ID: NCT05634811 Active, not recruiting - Lyme Disease Clinical Trials

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Start date: December 12, 2022
Phase: Phase 3
Study type: Interventional

This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: - are healthy - are age 5 through 17 - have not been diagnosed with any form of Lyme disease in the past - have not received any vaccines for Lyme disease in the past Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group. Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo. Everyone participating in this study will: - get the shots in a clinic or in a hospital office - receive a total of 4 shots - receive the first 3 shots within 6 months - receive the last shot about 1 year afterwards - need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

NCT ID: NCT05634746 Active, not recruiting - Clinical trials for Eosinophilic Esophagitis

24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.

NCT ID: NCT05634551 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status

Start date: February 9, 2023
Phase:
Study type: Observational

To better understand your feelings and expectations about immunotherapy

NCT ID: NCT05634226 Active, not recruiting - Single-ventricle Clinical Trials

Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan

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

This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.

NCT ID: NCT05633355 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-Orbit
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

NCT ID: NCT05633316 Active, not recruiting - Infertility, Female Clinical Trials

Automated Intracytoplasmic Sperm Injection (ICSIA)

ICSIA
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs. This study will evaluate survival and fertilization rates of oocytes handled via ICSIA and compare to survival and fertilization rates of oocytes which are manually injected with sperm.

NCT ID: NCT05631093 Active, not recruiting - HIV-1 Infection Clinical Trials

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

Start date: February 20, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

NCT ID: NCT05630937 Active, not recruiting - Clinical trials for Unresectable Hepatocellular Carcinoma (HCC)

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy

Start date: November 13, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy. The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment. The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.

NCT ID: NCT05630885 Active, not recruiting - HIV-1-infection Clinical Trials

A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

The study is being conducted to determine if cenicriviroc mesylate (CVC) will decrease vascular inflammation as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging of the aorta.