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NCT ID: NCT05627557 Recruiting - Clinical trials for Childhood Idiopathic Nephrotic Syndrome

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

INShore
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

NCT ID: NCT05627141 Recruiting - Muscle Damage Clinical Trials

Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Skeletal muscle fatigue is an inevitable phenomenon in the training and competition routine for many crossfit athletes, which can impair their physical performance and predispose them to musculoskeletal injuries. Thus, strategies and/or therapies that minimize fatigue and accelerate muscle recovery are extremely relevant for everyone involved with sport. The aim of the present study is to investigate and compare the effects of photobiomodulation, cryotherapy combined with compression, and massage as isolated therapies for muscle recovery after a protocol of induced muscle damage and fatigue in Crossfit athletes. This is a randomized, double-blind, crossover, sham-controlled clinical trial. Will be recruited 60 male participants, adults, aged between 18 and 40 years, Crossfit practitioners. They will be randomly allocated into 3 groups of 20 participants per therapy, each crossed between effective and sham every 15 days. The primary outcome will be muscle performance in functional test (free squat) and knee extensor torque in maximal voluntary isometric contraction (MVIC). Secondary outcomes will be evaluated by the levels of muscle damage via creatine phosphokinase (CPK) and inflammatory process via blood C-reactive protein (CRP); and delayed onset muscle pain via numerical verbal scale (0-10). All outcomes will be evaluated at baseline, 24h and 48h after induction of muscle damage and fatigue. Data will be analyzed and compared intra and inter groups with a significance level of 5%.

NCT ID: NCT05627037 Recruiting - Dental Implants Clinical Trials

Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

Start date: November 2022
Phase: N/A
Study type: Interventional

The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up

NCT ID: NCT05626088 Recruiting - Ulcerative Colitis Clinical Trials

A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil

Start date: April 10, 2023
Phase:
Study type: Observational

The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis [UC] and Crohn's Disease [CD]).

NCT ID: NCT05625997 Recruiting - Clinical trials for Calcified Lesions in Small Coronary Vessels

Shockwave IVL + DCB

Start date: June 16, 2023
Phase:
Study type: Observational

Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions. This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.

NCT ID: NCT05625399 Recruiting - Melanoma Clinical Trials

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

RELATIVITY-127
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

NCT ID: NCT05624554 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Start date: March 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nemtabrutinib compared to investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) or bendamustine plus rituximab (BR) in participants with previously untreated CLL/SLL without 17p deletion and/or tumor protein (TP) 53 mutation. The primary hypothesis is that nemtabrutinib is superior to FCR/BR with respect to progression-free survival (PFS).

NCT ID: NCT05624450 Recruiting - Clinical trials for Viral Lung Infection and Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05622929 Recruiting - Clinical trials for Cardiovascular Diseases

Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control

SAPPHIRE-LDL
Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.

NCT ID: NCT05622708 Recruiting - Clinical trials for Non-radiographic Axial Spondyloarthritis

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

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

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.