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Набира участници Фаза 2

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Pulmonary Fibrosis Progressive Pulmonary Fibrosis Pulmonary Fibrosis Secondary to Systemic Sclerosis Pulmonary Fibrosis, Interstitial Lung Disease +6

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Начало: 03.04.2024 Край: 01.06.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +11 Avalyn Pharma Inc. NCT06329401

Набира участници Фаза 1/2

A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

Cystic Fibrosis Lung Respiratory Infections, Recurrent, Chronic Pseudomonas Aeruginosa

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

Начало: 01.04.2024 Край: 01.06.2026 Възраст: от 12 г. Лечение

Australia, United States Respirion Pharmaceuticals Pty Ltd NCT06016088

Набира участници Фаза 1/2

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion

Immunoglobulin Light Chain (AL) Amyloidosis

Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world. Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration. 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Начало: 01.04.2024 Край: 01.09.2031 Възраст: от 18 г. Лечение

Australia, France, Greece +3 AbbVie NCT06158854

Набира участници Фаза 3

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

Heart Failure Systemic Inflammation

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

Начало: 01.04.2024 Край: 08.01.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Bulgaria +12 Novo Nordisk A/S NCT06200207

Набира участници

Fluid Administration and Fluid Accumulation in the Intensive Care Unit

Fluid Accumulation Fluid Therapy Fluid Overload

The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients.

Начало: 01.04.2024 Край: 01.09.2025 Възраст: от 18 г.

Denmark, Finland, Iceland +7 Nordsjaellands Hospital NCT06258616

Набира участници Фаза 2

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

Начало: 29.03.2024 Край: 04.08.2027 Възраст: 18–75 г. Лечение

Australia, Belgium, Bulgaria +18 Takeda NCT06254950

Набира участници Фаза 3

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Immunoglobulin A Nephropathy IgAN

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Начало: 29.03.2024 Край: 19.07.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +24 Alexion Pharmaceuticals, Inc. NCT06291376

Набира участници

Zenith LAA Occlusion System

Atrial Fibrillation Left Atrial Appendage Stroke

Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique. Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm

Начало: 28.03.2024 Край: 31.12.2025 Възраст: от 18 г. Устройства

Australia, New Zealand AuriGen Medical Ltd NCT05951101

Набира участници Фаза 1/2

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)

Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia

The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort). All participants will receive active trial intervention. Four dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).

Начало: 26.03.2024 Край: 31.05.2030 Възраст: от 18 г. Лечение

Australia, France, Germany +6 Terns, Inc. NCT06163430

Набира участници Фаза 2

Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

Начало: 21.03.2024 Край: 30.06.2032 Възраст: от 18 г. Лечение

Australia, Canada, Japan +1 Juno Therapeutics, Inc., a Bristol-Myers Squibb Company NCT06297226

Набира участници

The Osteoarthritis Prevention Study

Osteoarthritis, Knee

The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.

Начало: 21.03.2024 Край: 31.07.2029 Възраст: от 50 г. Превенция

Australia, United States Wake Forest University NCT05946044

Набира участници Фаза 3

A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Neoplasms, Head and Neck

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)

Начало: 21.03.2024 Край: 26.10.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 GlaxoSmithKline NCT06256588

Набира участници

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

Immunosuppression Vaccine Response Impaired

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are: 1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens? 2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.

Начало: 20.03.2024 Край: 01.12.2027 Възраст: от 18 г. Превенция

Australia Central Adelaide Local Health Network Incorporated NCT06262776

Набира участници Фаза 3

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

Low Grade Serous Ovarian Cancer

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Начало: 18.03.2024 Край: 09.02.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +12 Verastem, Inc. NCT06072781

Набира участници Фаза 3

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

Diabetic Ketoacidosis

The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).

Начало: 14.03.2024 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia The George Institute NCT05752279

Набира участници Фаза 3

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Начало: 13.03.2024 Край: 01.02.2029 Възраст: 18–80 г. Лечение

Argentina, Australia, Belgium +23 89bio, Inc. NCT06318169

Набира участници Фаза 3

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Начало: 13.03.2024 Край: 12.07.2028 Възраст: 2–17 г. Лечение

Australia, Belgium, Brazil +12 Janssen Research & Development, LLC NCT05923073

Набира участници Фаза 4

Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone

Patient-Controlled Analgesia

POPCORN trial will compare the side effects and effectiveness of Morphine versus Oxycodone medication when prescribed for use as patient controlled analgesia (PCA) for pain relief for paediatric patients after-surgery. This trial is embedded into routine patient care using the hospital electronic medical record (EMR). Participants will be randomly assigned to either medication after they enrol in the study. The main questions the POPCORN trial aims to answer are: * 1\. Is there a difference in the usage of medication to treat nausea and vomiting for those who received oxycodone PCA versus morphine PCA for post-surgery pain relief? * 2\. Is there a difference in side effects or pain relief needed between the two groups? Study activities are as follows: * Participants enrolled to study during their pre-operative consultation * Participants are randomly assigned to morphine or oxycodone * No further study-specific activities expected from participant after enrolment and randomisation * Participant receives routine medical care as planned * Clinicians record assessments as per routine care in electronic medical record (EMR) * EMR data are extracted as trial data

Начало: 13.03.2024 Край: 19.03.2027 Възраст: 6–18 г. Лечение

Australia Murdoch Childrens Research Institute NCT06186141

Набира участници

Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Lung Neoplasm

Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.

Начало: 12.03.2024 Край: 31.01.2025 Възраст: 45–77 г. Друго

Australia phenoMapper, LLC NCT06158971

Набира участници Фаза 1/2

Study of AZD0754 in Participants With Metastatic Prostate Cancer

Metastatic Prostate Cancer

The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.

Начало: 12.03.2024 Край: 24.11.2026 Възраст: 18–130 г. Лечение

Australia, Spain, United States AstraZeneca NCT06267729

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