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NCT ID: NCT05731128 Recruiting - Colitis Ulcerative Clinical Trials

A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype. Screening period: 2 to up to 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

NCT ID: NCT05716100 Recruiting - Clinical trials for Focal Onset Seizures

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

Start date: May 9, 2023
Phase: Phase 3
Study type: Interventional

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

NCT ID: NCT05712200 Recruiting - Clinical trials for Atrial Fibrillation (AF)

Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

LILAC-TIMI 76
Start date: December 27, 2022
Phase: Phase 3
Study type: Interventional

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

NCT ID: NCT05705349 Recruiting - HIV-1 Infection Clinical Trials

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

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

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

NCT ID: NCT05704738 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-ASTRO
Start date: April 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

NCT ID: NCT05702034 Recruiting - Clinical trials for Ischemic Stroke; Ischemic Attack, Transient

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

LIBREXIA-STROK
Start date: February 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

NCT ID: NCT05696717 Recruiting - Clinical trials for MSA - Multiple System Atrophy

Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy

CYPRESS
Start date: June 27, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

NCT ID: NCT05695950 Recruiting - Dermatomyositis Clinical Trials

A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis

GALARISSO
Start date: February 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM).

NCT ID: NCT05694052 Recruiting - Sleep Disturbance Clinical Trials

Impact of a Multifaceted Intervention of Environment Control in the ICU to Optimize Quantity and Quality of Sleep

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

In critically ill patients, sleep and circadian rhythms are markedly disturbed, including sleep deprivation and disruption, as well as altered sleep architecture, and loss of normal oscillations of Melatonin and Cortisol. These alterations have been associated with delirium, fatigue, and higher mortality. In addition, sleep disturbances may remain after hospital discharge, and they have been associated with psychological comorbidities, which may contribute to the low quality of life observed in ICU survivors. Patient factors for sleep deprivation in ICU are the type/severity of underlying illness, the pathophysiology of the acute illness, pain, and stress/anxiety. Factors associated with the ICU, such as exposure to inadequate levels of light and noise, or inflexible schedules of daily care activities, have also been reported to have a major role in sleep disturbance. A limited number of studies have evaluated interventions targeting sleep optimization in the ICU, using strategies like eye masks and/or earplugs to isolate patients from their environment, the application of a dynamic light system that ensures light at night and higher levels of light at daytime to restore circadian rhythm, or auditory masking, to avoid intense cortical stimuli secondary to annoying noises. These strategies have been reported to have some positive impacts on sleep in ICU but this has only been assessed by qualitative instruments. In addition, they have been tested as isolated interventions, and not as part of a more comprehensive approach. The goal of this project is to determine the impact of a multifaceted intervention of environmental control in the ICU, based on dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities, on quantity and quality of sleep, assessed by polysomnography and other semi-quantitative methods, compared to standard care. In addition, the effect of both strategies on delirium, circadian rhythm biomarkers, and long-term neuropsychological outcomes will be compared. This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. After obtaining informed consent, patients will be randomized to receive a multifaceted intervention of environmental control or standard care. And this protocol will be applied from enrollment until ICU discharge, with a follow-up before hospital discharge and at 6 months.

NCT ID: NCT05689788 Recruiting - Clinical trials for Non-specific Chronic Neck Pain

High-intensity Laser Therapy for Neck Pain

Start date: March 31, 2024
Phase: N/A
Study type: Interventional

Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. High-intensity laser therapy (HILT) is a recent treatment proposed to reduce musculoskeletal pain; however, there are few studies that prove its effects in reducing neck pain. The aim of this randomized clinical trial is to evaluate the effect of high-intensity laser therapy on pain intensity in patients with chronic nonspecific neck pain. The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Participants will be employers and volunteer students with non-specific chronic neck pain. Participants will be randomized and allocated into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (simulated HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment, at the end of treatment, and 12 weeks after treatment (follow-up). The main results will be the differences in pain pressure threshold (ΔPPT), intensity of pain at rest (ΔRPI) and intensity of pain on movement (ΔMPI). Secondary outcome measures, on the other hand, will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND).