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Намерени 3,079 изпитвания Стр. 2 от 154

Само по покана

Spatial Transcriptomics in Kidney Transplantation

Transplant Complication Kidney Injury

The study is an investigator-led, prospective, longitudinal, observational cohort study. The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology. By utilising new spatial technologies, the investigators aim to: * Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes * Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney * Develop refinements to histological kidney rejection diagnostic and scoring classification * Correlate of spatial and refined biopsy scoring features to clinically important outcomes

Начало: 03.04.2024 Край: 01.01.2035 Възраст: 18–75 г.

Australia Western Sydney Local Health District NCT06288425

Само по покана

Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation

Respiration, Artificial Ventilators, Mechanical

The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.

Начало: 15.02.2024 Край: 31.03.2026 Възраст: от 22 г. Лечение

Australia, France, Netherlands +1 Liberate Medical NCT05759013

Само по покана

5-SENSE Score Validation Study

Epilepsy Intractable

The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.

Начало: 09.01.2024 Край: 01.06.2027 Възраст: от 15 г.

Australia, Canada, Czechia +7 Duke University NCT06138808

Само по покана

A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies

Hematologic Malignancy Solid Malignancy

This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies

Начало: 22.11.2023 Край: 01.08.2038 Възраст: от 18 г.

Australia, Canada, Germany +1 CRISPR Therapeutics AG NCT06208878

Само по покана Фаза 2

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Kidney Transplant Rejection

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Начало: 25.10.2023 Край: 01.12.2029 Възраст: 18–100 г. Лечение

Australia, Brazil, Canada +5 Eledon Pharmaceuticals NCT06126380

Само по покана Фаза 2/3

HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

Erythropoietic Protoporphyria

This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.

Начало: 31.08.2023 Край: 01.06.2028 Възраст: от 12 г. Лечение

Australia, United States Disc Medicine, Inc NCT05883748

Само по покана Фаза 3

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

Cystic Fibrosis

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).

Начало: 11.08.2023 Край: 30.07.2029 Възраст: от 1 г. Лечение

Australia, Canada, France +6 Vertex Pharmaceuticals Incorporated NCT05844449

Само по покана Фаза 2

A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

Growth Hormone Deficiency

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Начало: 01.08.2023 Край: 01.04.2028 Възраст: 5–14 г. Лечение

Australia, United States Lumos Pharma NCT05796440

Само по покана

The Effect of OSA on Brain Waste Clearance

Obstructive Sleep Apnea Dementia Cognitive Impairment

Recent ground-breaking research has shown that clearance of toxic neuro-metabolites from the brain including the proteins β-Amyloid (Aβ) and tau that form dementia causing plaques and tangles is markedly impaired when sleep is disturbed. This suggests that dementia risk may be increased in people with sleep disorders such as obstructive sleep apnea (OSA). Longitudinal studies have linked OSA with a 70-85% increased risk for mild cognitive impairment and dementia. Despite this strong link, little is known about the OSA-specific mechanistic underpinnings. It is not fully understood as to how sleep disturbance in OSA inhibit brain glymphatic clearance. However, it is known that OSA inhibits slow wave sleep, profoundly activates sympathetic activity, and elevates blood pressure - particularly during sleep. These disturbances have, in turn, been shown to independently inhibit glymphatic function. Previous studies have attempted to sample human cerebrospinal fluid (CSF) involved in glymphatic clearance for dementia biomarkers during sleep. However, these studies were severely limited by the need for invasive CSF sampling. To address this problem, a set of newly available, highly sensitive blood based SIMOA assays will be used to study glymphatic function in people treated for severe OSA who undergo CPAP withdrawal. Furthermore, novel methods will be utilized to capture changes in slow wave sleep, blood pressure and brain blood flow together with sleep-wake changes in blood levels of excreted neuro-metabolites to define the pathophysiological mechanisms that inhibit brain cleaning in OSA.

Начало: 18.07.2023 Край: 01.04.2026 Възраст: 35–65 г. Друго

Australia Woolcock Institute of Medical Research NCT05606991

Само по покана Фаза 2/3

A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia

Achondroplasia

TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.

Начало: 21.06.2023 Край: 01.03.2039 Възраст: 3–15 г. Лечение

Australia, Canada, Denmark +5 Ascendis Pharma Growth Disorders A/S NCT05929807

Само по покана

Transition of Care in Type 1 Diabetes Mellitus

Transition Type 1 Diabetes Mellitus

This research project seeks to address the question of how to improve the transition of patients with type 1 diabetes mellitus from the paediatric to the adult health service at RNSH and Mona Vale Community Health Centre (seeking the perspectives of patients, families, and staff)?

Начало: 09.06.2023 Край: 09.06.2028 Възраст: от 16 г.

Australia Northern Sydney and Central Coast Area Health Service NCT06113588

Само по покана Фаза 2

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

Autism Spectrum Disorder

ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.

Начало: 01.06.2023 Край: 01.12.2027 Възраст: 12–46 г. Лечение

Australia, Canada, United States MapLight Therapeutics NCT05889273

Само по покана Фаза 3

An Open-label Study of XEN1101 in Epilepsy

Focal Epilepsy Tonic-Clonic Seizures

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

Начало: 25.04.2023 Край: 01.06.2033 Възраст: от 12 г. Лечение

Argentina, Australia, Belgium +18 Xenon Pharmaceuticals Inc. NCT05718817

Само по покана

A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

Osteoarthritis, Knee

This is an observational study of the long term safety and efficacy of ICM-203.

Начало: 16.03.2023 Край: 01.12.2028 Възраст: 50–80 г.

Australia ICM Co. Ltd. NCT05752032

Само по покана Фаза 3

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to

Atopic Dermatitis Eczema

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \

Начало: 09.03.2023 Край: 01.04.2029 Възраст: 6–18 г. Лечение

Argentina, Australia, Brazil +10 Eli Lilly and Company NCT05735483

Само по покана

A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)

Hemophilia A

The BMN 270 clinical development program consists of multiple interventional studies designed to assess the safety and efficacy of a single infusion of BMN 270 for at least 5 years post-infusion. This long-term follow-up study is needed to help further understand the long-term safety of BMN 270 beyond 5 years and to assess the durability of efficacy.

Начало: 01.01.2023 Край: 01.01.2040 Възраст: от 18 г.

Australia, Belgium, Brazil +9 BioMarin Pharmaceutical NCT05768386

Само по покана Фаза 2/3

Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

Hereditary Angioedema Hereditary Angioedema Type I Hereditary Angioedema Type II Hereditary Angioedema Types I and II +12

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll participants from Study PHA022121-C201 (NCT04618211), Study PHA022121-C306 (NCT06343779) and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.

Начало: 28.12.2022 Край: 01.06.2027 Възраст: от 12 г. Лечение

Argentina, Australia, Brazil +21 Pharvaris Netherlands B.V. NCT05396105

Само по покана Фаза 3

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

Начало: 30.11.2022 Край: 01.08.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +14 Ionis Pharmaceuticals, Inc. NCT05667493

Само по покана Фаза 3

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

Kidney Disease, Chronic Renal Transplant Failure Heart Failure Kidney Failure +1

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR\

Начало: 08.11.2022 Край: 01.07.2027 Възраст: от 18 г. Превенция

Australia, Belgium, Germany +3 University Medical Center Groningen NCT05374291

Само по покана Фаза 3

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Progressive Pulmonary Fibrosis

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Начало: 06.09.2022 Край: 01.06.2026 Възраст: от 40 г. Лечение

Argentina, Australia, Belgium +14 United Therapeutics NCT04905693

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