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NCT ID: NCT06291285 Recruiting - Healthy Volunteers Clinical Trials

A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

Start date: February 27, 2024
Phase: Phase 1
Study type: Interventional

This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day.

NCT ID: NCT06291246 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Expediting Access to Services for Equity (EASE)

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

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism. The main questions it aims to answer are: - Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism? - Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism? - Does Family Navigation improve caregiver well-being? Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

NCT ID: NCT06291233 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth

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

The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs. Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).

NCT ID: NCT06291155 Recruiting - Type 2 Diabetes Clinical Trials

Renal Mechanism of SGLT2 Inhibition

Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years. Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study: Consent and Screening: - Laboratory tests to determine baseline health - Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys Month 0: - Study entry kidney MRI (day 0) - Study entry kidney biopsy (within 30 days of MRI) - Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply Month 3: - Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication - Review of systems Month 6: - Follow-up kidney MRI - Follow-up kidney biopsy Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs). Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.

NCT ID: NCT06291090 Recruiting - Opioid Use Disorder Clinical Trials

A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.

NCT ID: NCT06290934 Recruiting - Ulcerative Colitis Clinical Trials

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

SWIFT
Start date: March 27, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12

NCT ID: NCT06290869 Recruiting - Smoking Cessation Clinical Trials

Tobacco Education and Lung Health Study (TEAL)

TEAL
Start date: February 22, 2024
Phase: Phase 3
Study type: Interventional

Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes. Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.

NCT ID: NCT06290687 Not yet recruiting - Clinical trials for Muscle Invasive Bladder Carcinoma

Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

Start date: August 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

NCT ID: NCT06290648 Recruiting - Mental Illness Clinical Trials

Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings

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

The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question[s] it aims to answer are: 1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure). 2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes) Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

NCT ID: NCT06290622 Not yet recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL

Start date: June 30, 2024
Phase: Phase 1
Study type: Interventional

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.