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NCT ID: NCT06212947 Recruiting - Hypochondroplasia Clinical Trials

A Multicenter Multinational Observational Study of Children With Hypochondroplasia

Start date: November 27, 2023
Phase:
Study type: Observational

This study will assess growth over time and the clinical course of HCH in children by collecting growth measurements and other variables of interest.

NCT ID: NCT06211283 Completed - Clinical trials for Food-drug Interaction

Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.

Start date: September 11, 2023
Phase: Phase 1
Study type: Interventional

to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions.

NCT ID: NCT06209424 Recruiting - Physical Inactivity Clinical Trials

Modified Breath Test to Determine Anabolic Sensitivity Across Physical Activity States

BTLP
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels

NCT ID: NCT06208735 Not yet recruiting - Clinical trials for Non-Hodgkin's Lymphoma

CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies

Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed/refractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion. The primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies. The secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201. Exploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.

NCT ID: NCT06208657 Not yet recruiting - Childhood Cancer Clinical Trials

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

NCT ID: NCT06208553 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits

Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to test the procedures for implementing quality indicator toolkits for hip and knee replacement rehabilitation in clinical settings. The main questions it aims to answer are: - Are the EQUIP (for patients) and QUICK (for clinicians) toolkit resources feasible (accessible, acceptable, usable) in real world clinical settings? - Are study procedures including recruitment and retention, informed consent, clinical site tracking, audit and feedback, training and data collection feasible? - What effect does toolkit implementation have on patient experiences, quality of care and patient-reported outcomes? Participants will be asked to provide consent at time of discharge from rehabilitation to have their clinical records audited and to complete an online questionnaire about their physical function, quality of care they received, and overall rehabilitation experience and satisfaction. Rehabilitation providers will also be asked to complete a questionnaire on their adherence to ten post-acute rehabilitation quality indicators after a 3-month baseline period and 6-month implementation phase.

NCT ID: NCT06208488 Recruiting - Clinical trials for Healthy Adult Participants

A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants

Start date: November 22, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.

NCT ID: NCT06208306 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

AERIFY-4
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: - The study duration will be up to 72 weeks - The treatment duration will be up to 52 weeks - A follow-up period of 20 weeks will be conducted - The number of on-site visits will be 7 and the number of phone contacts will be 5

NCT ID: NCT06208215 Recruiting - Clinical trials for Congenital Hyperinsulinism

RZ358 Treatment for Congenital Hyperinsulinism

sunRIZE
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

NCT ID: NCT06208150 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

MonumenTAL-6
Start date: January 22, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).