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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: NCT05722015 Active, not recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Start date: February 14, 2023
Phase: Phase 3
Study type: Interventional

This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

NCT ID: NCT05630755 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 Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

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

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued BIC/FTC/TAF at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, 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; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

NCT ID: NCT05630547 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Start date: December 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

NCT ID: NCT05595304 Active, not recruiting - Elderly Clinical Trials

Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age With Deficient Removable Prostheses

Start date: November 3, 2020
Phase: Phase 3
Study type: Interventional

Title: Evaluation of the impact on general functionality of the application of an immediate prosthetic functionalization protocol, in patients with deficient removable prostheses, compared with the conventional treatment that is delivered at the secondary level of the health system, to people over 70 years of age. Introduction: Sarcopenia and malnutrition are closely involved in frailty. To prevent them it is important to assess oral function. "Oral fragility" manifests with specific signs or symptoms, among which are loss of occlusion due to tooth loss and chewing difficulty. To recover from it, it is important to restore function by placing a dental prosthesis in the event of tooth loss. In Chile, a large percentage of patients who are referred to secondary care to perform new prosthetic treatment, lives in conditions of less oral functionality and enters waiting lists that can take years, with a silent impact on general functionality. Falls are a public health problem with a significant economic cost, being the second cause of death worldwide. One of the causes is sarcopenia and it has been studied that the decrease in the number of teeth and the occlusal posterior support region may be risk factors for decreased gait speed, an objective measurement of fall risk. It has been studied that the decrease in the number of teeth causes a reduction in: total muscle mass, walking speed and lower quality of life. Hypothesis: The recovery of immediate functionality in deficient prostheses in patients 70 years of age and older will have a positive and rapid impact on general functionality and on their assessment of oral health related quality of life. General objective: To evaluate the impact on general functionality of the application of an immediate prosthetic functionalization protocol in patients with deficient removable prostheses, compared with conventional treatment, at the secondary level of the health system, in patients over 70 years of age. Methodology: randomized, double-blind clinical trial with two groups of 62 patients each: experimental and control. The intervention will consist of recovering prosthetic function in one session, before conventional rehabilitation vs. the control group that will receive conventional rehabilitation. Measurements will include manual grip strength measurements, made with a Jamar dynamometer, timed up and go test, before and after prosthetic treatments and quality of life related to oral health through Ohip 7sp. Descriptive statistics will be applied, through the registration of frequency and contingency tables. To compare hand grip strength, the Pearson's Correlation will be used; for risk of pre and post fall, the t-test will be applied for 2 related samples; for quality of life before and after intervention, Chi2 will be used; changes in grip strength, fall risk and quality of life, between the different groups according to the Eichner index, one-way ANOVA will be applied, for related samples. Results: A short-term improvement is expected in patients whose functionality will be recovered, which, being a simple technique of competence of the general dentist, could be applied in primary care, without loss of valuable time before attention is achieved, at the secondary level for rehabilitation with new prostheses.

NCT ID: NCT05562830 Active, not recruiting - Clinical trials for Urothelial Carcinoma

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

Start date: November 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

NCT ID: NCT05522296 Active, not recruiting - Mpox Clinical Trials

Break-through Infection Following Mpox vaccinatIon

REMAIN
Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.

NCT ID: NCT05475691 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Longitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin America

RegistrAME
Start date: August 17, 2022
Phase:
Study type: Observational [Patient Registry]

The natural history of SMA patients has changed, due to the improvements in treatment and technological advances. The systematic collection of data from routine clinical practice in multiple Latin American countries, harmonized to an internationally aligned core data set, is important to advancing the understanding the natural history of disease in the region and the influence of different drug treatments on patient outcomes. These data are critical to improving the care of these patients. So far, clinical trials regarding therapeutic approaches for SMA patients only cover a subgroup of the broad spectrum of severity of SMA. Thus, there is a strong need to monitor the full range of treated and untreated SMA patients in a real-world context.The aim of this study is to set up a regional healthcare provider (HCP) entered registry. The planned SMA registry will provide an online platform to collect longitudinal data on SMA patients across Latin America to achieve a better understanding of the clinical characteristics of SMA patients, the natural history of the disease, the use of DMTs and patients' outcomes, as well as to support further research projects and regional data generation.

NCT ID: NCT05446870 Active, not recruiting - Ovarian Carcinoma Clinical Trials

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

Start date: July 25, 2022
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.

NCT ID: NCT05421598 Active, not recruiting - Asthma Clinical Trials

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

TIDE-asthma
Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: - The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. - The randomized treatment duration will be up to approximately 60 weeks. - The scheduled number of visits will be 13.