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NCT ID: NCT06285318 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma (RRMM)

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

REALiTEC/TAL
Start date: December 18, 2023
Phase:
Study type: Observational

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.

NCT ID: NCT06284915 Recruiting - Healthy Volunteers Clinical Trials

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

Start date: March 19, 2024
Phase: Phase 3
Study type: Interventional

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

NCT ID: NCT06283966 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

THARROS
Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

NCT ID: NCT06280391 Recruiting - Bronchiectasis Clinical Trials

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

Start date: February 20, 2024
Phase: Phase 2
Study type: Interventional

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: - The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. - The treatment duration will be up to 24-52 weeks. - The follow-up duration will be 20 weeks. - Site/phone visits are at a monthly interval.

NCT ID: NCT06279143 Recruiting - Skin Diseases Clinical Trials

The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes

dOCT-pBCC
Start date: April 4, 2024
Phase:
Study type: Observational

The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area. The Hypotheses: - The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used. - The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used. - The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used. - D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC. - The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure. - The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure. - Delineation of periocular BCC tumour extension is possible using both D-OCT probes

NCT ID: NCT06277401 Recruiting - Knee Discomfort Clinical Trials

Exercise in Patients With Hypermobile Joints and Knee Pain

HIPEr-Knee
Start date: February 21, 2024
Phase: N/A
Study type: Interventional

Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

NCT ID: NCT06273475 Recruiting - Stroke Clinical Trials

Robot-Assisted Training Versus Standard Training in Ischemic Stroke

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation. The main hypothesis of the study is: Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training.

NCT ID: NCT06271304 Recruiting - Bipolar Disorder Clinical Trials

Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

BLUES
Start date: April 5, 2024
Phase: N/A
Study type: Interventional

The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder. When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days. After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).

NCT ID: NCT06269198 Recruiting - Clinical trials for Postoperative Complications

Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System

WARD-SX-RCT-II
Start date: October 31, 2023
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery. Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy.

NCT ID: NCT06268873 Recruiting - Clinical trials for Chronic Kidney Disease and Hypertension

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Start date: March 29, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.