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NCT ID: NCT06037265 Active, not recruiting - Clinical trials for Chronic Kidney Disease Stage 5

PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with poor/difficult vascular access. The PortIO device may be inserted into the proximal or distal tibia or the proximal humerus in adults, and provides up to 60 days of intraosseous vascular access for delivery of fluids and medications.

NCT ID: NCT05988853 Active, not recruiting - Clinical trials for Nosocomial Infection

Biosafety of Musical Instruments in the ICU

Start date: March 27, 2023
Phase:
Study type: Observational

This study investigates the efficacy of the institutional disinfection protocol for musical instruments in the ICU of the music therapy service of the University Hospital Fundación Santa Fe de Bogotá (FSFB), Colombia.

NCT ID: NCT05952869 Active, not recruiting - Clinical trials for Hypercholesterolemia

A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

Start date: August 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

NCT ID: NCT05883943 Active, not recruiting - Clinical trials for Venous Insufficiency of Leg

Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

Start date: April 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.

NCT ID: NCT05857722 Active, not recruiting - Mood Disorders Clinical Trials

Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement

JC
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to test the effectiveness of an emotion regulation intervention called Jóvenes Capibara in a Venezuelan migrant and internally displaced population sample of youth between the ages of 18 through 30 delivered within a 10-day boot-camp entrepreneurship program. The main questions it aims to answer are: (a) Is Jóvenes Capibara feasible and acceptable among IDP and Venezuelan migrant youth aged 18-30 in Colombia?; (b) Is delivery of Jóvenes Capibara within entrepreneurship training feasible and acceptable among facilitators?; (c) Is Jóvenes Capibara associated with improved mental health, daily functioning, and labor market outcomes in Colombian and Venezuelan youth who receive the YRI compared with control youth? Participants will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. Measures will be taken at baseline, post-intervention, and at 6-month post-intervention follow-up. The comparison group will receive the intervention one year after youth in the experimental condition. The researchers will compare the experimental group and the waitlist control group to determine the effects of Jóvenes Capibara on mental health, daily functioning, and labor market outcomes.

NCT ID: NCT05766501 Active, not recruiting - HIV Infection Clinical Trials

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Start date: March 17, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

NCT ID: NCT05743881 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Start date: February 15, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to <24 months.

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: NCT05603845 Active, not recruiting - Severe Asthma Clinical Trials

Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

iOUTRUN
Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

NCT ID: NCT05569954 Active, not recruiting - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).