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NCT ID: NCT06042803 Recruiting - Breast Feeding Clinical Trials

UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk

UmbrelLACT
Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are: - What is the concentration of maternal medicines in human milk? - What is the (estimated) intake and exposure in the breastfed infant? Participants will be asked to - fill out a questionnaire regarding medical data of the mother and child - track medication intake for 3 days - collect milk samples during 24 hours - optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child - fill out a questionnaire regarding the general health of the child.

NCT ID: NCT06042205 Recruiting - Hernia Clinical Trials

TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Start date: July 4, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS

NCT ID: NCT06041269 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)

Start date: August 31, 2023
Phase: Phase 2
Study type: Interventional

RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

NCT ID: NCT06038370 Recruiting - Chronic Pain Clinical Trials

Self-induced Cognitive Trance for Chronic Pain Management

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

The need to find complementary approaches, based on a holistic perspective of the human being, takes on its full meaning in a political context that recommends efficient health programs. Self-induced cognitive trance is one of these complementary approaches, which induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether learning self-induced cognitive trance can improve the quality of life of people with chronic pain. Participants will participate in two times two days workshop aiming at learning how to self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12 months afer the last workshop will be caried out were outomes will be assessed. Furthmore, questionnaires related to the phenomenology of self-induced cognitive trance will be adeministrered. Investigators also proceeded to interveiwes after the second workshop to gather qualitative information.

NCT ID: NCT06037915 Recruiting - Child Clinical Trials

Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.(Flowkid)

Start date: November 28, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to evaluate possible differences in airway responses and interventions during intravenous anesthesia for direct laryngoscopy in children when comparing two oxygenation methods (conventional low flow oxygen supplementation via nasopharyngeal tube versus Nasal High Flow Therapy with the OptiflowTM system ).

NCT ID: NCT06035159 Recruiting - Depression Clinical Trials

The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems

e-PMG
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

With this study the investigators aim to examine through a mixed method study the feasibility, usability and satisfaction with the developed online tool for perinatal mental health problems. This will be done through a pre- and post measurement of depressive and anxiety symptoms and the use of the tool itself. In addition, a qualitative thematic analysis will be conducted on the clarity, understandability and user-friendliness of the tool.

NCT ID: NCT06034743 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

BaxHTN
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

NCT ID: NCT06032546 Recruiting - Clinical trials for Human Immuno-deficiency Virus (HIV) Disease

A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382

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

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). Approximately 140 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06030570 Recruiting - Low Back Pain Clinical Trials

Effect of an Interdisciplinary Spine Rehabilitation Program

PROGRESS
Start date: August 22, 2023
Phase:
Study type: Observational

The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.