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NCT ID: NCT05520905 Recruiting - Hiv Clinical Trials

TelePrEP for At-risk Youth in Colorado

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

Youth represent the largest proportion of new HIV infections in Colorado, reflective of their inadequate access and uptake of pre-exposure prophylaxis(PrEP)for HIV prevention. Colorado's 2019 HIV/AIDS Prevention Program state-wide review of PrEP barriers showed PrEP eligible individuals do not access PrEP services due to lack of interest, not wanting referral to a navigator, and low estimation of HIV risk. The overall goal is to provide youth at higher risk for HIV with an effective youth informed telemedicine delivery of PrEP (TelePrEP) that addresses PrEP barriers and contributes to ending the HIV epidemic in Colorado. The primary objective will be proportion of youth retained on PrEP 12 months after initiation. The hypotheses are that a TelePrEP model for youth will be acceptable and feasible and will result in successful initiation, persistence and retention on oral PrEP.

NCT ID: NCT05537038 Recruiting - Tuberculosis Clinical Trials

Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers

Start date: April 18, 2023
Phase: Phase 1
Study type: Interventional

This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule.

NCT ID: NCT05539430 Recruiting - Pancreatic Cancer Clinical Trials

Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

Start date: April 18, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

NCT ID: NCT05546606 Recruiting - Clinical trials for COPD Acute Exacerbation

CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

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

The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

NCT ID: NCT05597878 Recruiting - Prostate Cancer Clinical Trials

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Start date: April 18, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.

NCT ID: NCT05601817 Recruiting - Heart Failure Clinical Trials

Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure

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

This research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal health, quality of life, and shorter survival. Therefore, the investigators propose to test the effect of a dual-component intervention comprised of a virtual reality-based cognitive restoration intervention and computerized cognitive training on cognitive function and overall health among 172 older adults with HF who experience mild cognitive impairment.

NCT ID: NCT05611931 Recruiting - Endometrial Cancer Clinical Trials

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

XPORT-EC-042
Start date: April 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

NCT ID: NCT05639647 Recruiting - Clinical trials for Gram-negative Bacterial Infections

Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections

Start date: April 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: - 9 months to less than 18 years of age - Hospitalized - Suspected/known to have a gram-negative infection - Receiving intravenous (iv, given directly into a vein) antibiotics - Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. - Participants will receive either ATM-AVI or best available therapy (BAT). - Both therapies will be given through a vein. - Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. - The iv dose of ATM-AVI will be based on the participant's weight and kidney function. - The study doctor will determine the iv dose of BAT. - During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. - Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. - Participants will receive a maximum of 14 days of ATM-AVI treatment. - After discharge from the hospital, 1 study visit may be required. - Depending on the participant's response, the study duration will be from 33 to 50 days. - The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

NCT ID: NCT05644834 Recruiting - HIV Prevention Clinical Trials

Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her

IFE4Her
Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The overarching objective for the pilot study is to test the feasibility of using a mobile medical unit as a delivery mode combined with enhanced Pre-exposure Prophylaxis (PrEP) messaging to increase awareness of PrEP and access to PrEP medical services among women living in public housing.

NCT ID: NCT05650996 Recruiting - Clinical trials for Distal Radius Fracture

Impact of Early ADL Participation on Outcomes Post DRF

Start date: April 18, 2023
Phase: Phase 1
Study type: Interventional

This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated conservatively in a cast. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.