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Recruiting Phase 2/3

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Colitis, Ulcerative

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Начало: 30.05.2022 Край: 14.08.2031 Възраст: 2–17 г. Treatment

Australia, Belgium, Canada +10 Bristol-Myers Squibb NCT05076175

Recruiting Phase 4

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Complicated Urinary Tract Infection Infection Pediatric Infectious Disease

Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes. This multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient/ED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.

Начало: 30.05.2022 Край: 16.05.2028 Възраст: 3–18 г. Treatment

Australia, New Zealand Murdoch Childrens Research Institute NCT04876131

Recruiting

Post Market Clinical Follow Up of ResMed Mask Systems

Obstructive Sleep Apnea

Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

Начало: 26.05.2022 Край: 01.06.2027 Възраст: 18–100 г. Treatment

Australia ResMed NCT05262439

Recruiting Phase 2

Intraoperative Tumor Margin Identification With ICG Dye Imaging

Benign Neoplasm Malignant Neoplasm

In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.

Начало: 25.05.2022 Край: 01.04.2030 Възраст: от 18 г.

United States Massachusetts General Hospital NCT04752137

Recruiting

WiserAD: The Effect of a Structured Online Intervention on Antidepressant Deprescribing in Primary Care

Depression

The use of antidepressants (ADs) is increasing globally, including within Australia, which has one of the highest rates of AD prescribing. Despite clear benefits for many people, there is reason to believe that the ongoing use of these medications is often not properly monitored or stopped (deprescribed) when a person returns to better Mental health. This trial sets out to test how well an online support tool (WiserAD) can help patients and their general practitioner to manage the careful and appropriate reducing and stopping of antidepressants, in primary care patients.

Начало: 25.05.2022 Край: 07.08.2025 Възраст: 18–75 г. Treatment

Australia University of Melbourne NCT05355025

Recruiting Phase 2

The Communicate Study Partnership

Aboriginal Health Cultural Safety Access to Interpreters Healthcare Provider Training

The vision of the Communicate Study Partnership is to ensure more Aboriginal patients receive culturally safe healthcare in their first language. The Communicate Study Partnership will implement and evaluate creative ways to embed cultural safety training and increase use of Aboriginal Interpreters and Aboriginal Health Practitioners at Northern Territory Top End hospitals. Quantitative outcomes (interpreter uptake, outcomes including leave against medical advice, costs) will be measured using time-series analysis. Qualitative outcomes derived from interviews with patient, healthcare provider and interpreter participants, will be informed by decolonising theory and participatory approaches. Successful project implementation will improve experience of care and health outcomes for Aboriginal people, build Aboriginal workforce, and improve healthcare provider satisfaction.

Начало: 23.05.2022 Край: 31.12.2026 Health services research

Australia Menzies School of Health Research NCT05629416

Recruiting Phase 1

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

Chronic Myeloid Leukemia Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive Cml

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

Начало: 22.05.2022 Край: 01.12.2027 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +11 Enliven Therapeutics NCT05304377

Recruiting Phase 2

MK-7075 (Miransertib) in Proteus Syndrome

Proteus Syndrome

Background: Proteus syndrome is a rare overgrowth disorder. Most people begin to have symptoms between 6 months and 2 years of age. There are very few living adults with this disease. There is also no known treatment for it. Researchers want to see if a new drug can slow down or stop overgrowth in people with Proteus syndrome. Objective: To learn if miransertib is a safe and effective treatment for Proteus syndrome. Eligibility: People ages 3 and older with Proteus syndrome. Design: Participants will be screened with a medical checkup. They will answer questions about their medical history and current health. They will have a physical exam with vital signs. They will have an electrocardiogram to measure their heartbeat. They will give blood and urine samples. They will repeat the screening tests during the study. Participants will take a miransertib pill once a day. They will bring their empty pill bottles with them to the NIH when they visit. If they can t swallow a pill, researchers will try to find other ways for them to take the drug. Participants will have X-rays, ultrasounds, and imaging scans. Photos may be taken of their feet and other parts of the body that have or develop signs of Proteus syndrome. Participants will have lung function tests to measure how much and how fast air moves out of their lungs. Participants will complete surveys about their levels of pain, physical functioning, and quality of life. Participants may have additional tests performed to assess their individual disease. They may have consultations with other specialists. Participation lasts about 4 years. Participants will have 20-30 visits at the NIH....

Начало: 20.05.2022 Край: 01.07.2028 Възраст: 3–99 г.

United States National Human Genome Research Institute (NHGRI) NCT04316546

Recruiting

SELUTION4BTK Trial

Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Начало: 19.05.2022 Край: 30.07.2032 Възраст: от 18 г. Treatment

Austria, France, Germany +7 M.A. Med Alliance S.A. NCT05055297

Recruiting Phase 2

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Acute Respiratory Failure Hypercoagulability Fibrinolysis Shutdown

Patients with coronavirus disease (COVID) and non-COVID acute respiratory failure (ARF) may be at an increased risk of thrombosis due to increased clot formation and decreased clot lysis. This two stage study aims to utilise bedside coagulation technology to detect patients at increased risk and guide tPA treatment to maximise efficacy and safety through a personalised approach.

Начало: 18.05.2022 Край: 01.12.2026 Възраст: 18–75 г. Treatment

Australia South West Sydney Local Health District NCT05540834

Recruiting Phase 2

Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

Oropharyngeal Squamous Cell Carcinoma

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Начало: 16.05.2022 Край: 01.06.2032 Възраст: от 18 г.

United States University of Florida NCT05268614

Recruiting

Clinical Utility and Gait Analysis of NextAR System AUS

Total Knee Arthroplasty

This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.

Начало: 15.05.2022 Край: 01.05.2026 Възраст: от 18 г.

Australia Medacta International SA NCT05863741

Recruiting

The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial

Diabetes Mellitus, Type 2 Pregnancy in Diabetic Child Obesity Child Development

The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.

Начало: 11.05.2022 Край: 01.05.2026

Australia, Canada Mount Sinai Hospital, Canada NCT05025852

Recruiting Phase 1/2

Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

B-cell Malignancy Non-Hodgkin Lymphoma Mantle Cell Lymphoma Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma +5

This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts

Начало: 06.05.2022 Край: 31.01.2029 Възраст: от 18 г.

China BeiGene NCT05294731

Recruiting Phase 2

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Fibrodysplasia Ossificans Progressiva (FOP)

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

Начало: 05.05.2022 Край: 20.01.2033 Възраст: 2–99 г. Treatment

Argentina, Australia, Brazil +14 Incyte Corporation NCT05090891

Recruiting Phase 2

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Urothelial Carcinoma

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Начало: 03.05.2022 Край: 14.04.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +9 Seagen, a wholly owned subsidiary of Pfizer NCT04879329

Recruiting

Real World Data Collection on the Synergy Cervical Disc

Cervical Disc Degeneration

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.

Начало: 01.05.2022 Край: 01.12.2029 Възраст: от 21 г.

Australia Synergy Spine Solutions NCT05305430

Recruiting Phase 1/2

Microbial Restoration in Inflammatory Bowel Diseases

Fecal Microbiota Transplantation Crohn Disease Inflammatory Bowel Diseases Microbiome

This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.

Начало: 01.05.2022 Край: 01.04.2026 Възраст: 18–70 г. Treatment

Australia St Vincent's Hospital Melbourne NCT04970446

Recruiting

High Frequency RF Current Effects on Muscle Pain and Function

Transcutaneous Electric Nerve Stimulation Chronic Low-back Pain Hamstring Injury Muscle; Injury, Quadriceps (Thigh) +3

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).

Начало: 30.04.2022 Край: 31.12.2029 Възраст: 18–65 г.

Greece Aristotle University Of Thessaloniki NCT05345015

Recruiting Phase 3

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Seizures Lennox Gastaut Syndrome

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Начало: 28.04.2022 Край: 01.12.2028 Възраст: 4–55 г. Treatment

Argentina, Australia, Colombia +12 SK Life Science, Inc. NCT05219617

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