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Набира участници

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Cardiac Arrest, Out-Of-Hospital Hypothermia, Induced Hypoxia-Ischemia, Brain

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

Начало: 05.08.2022 Край: 31.03.2028 Възраст: 2–17 г. Лечение

Australia, Canada, New Zealand +2 University of Michigan NCT05376267

Набира участници Фаза 3

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

Embryonal Rhabdomyosarcoma Fusion-Negative Alveolar Rhabdomyosarcoma Spindle Cell/Sclerosing Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Начало: 04.08.2022 Край: 30.06.2030 Възраст: до 21 г. Лечение

Australia, Canada, New Zealand +1 Children's Oncology Group NCT05304585

Набира участници Фаза 1/2

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

KRAS P.G12C

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.

Начало: 03.08.2022 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia, China, France +7 D3 Bio (Wuxi) Co., Ltd NCT05410145

Набира участници Фаза 3

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

Breast Cancer Breast Cancer Female Breast Conserving Surgery Mastectomy

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.

Начало: 27.07.2022 Край: 01.07.2028 Възраст: от 18 г. Превенция

Australia, Hong Kong, New Zealand +1 Monash University NCT05072314

Набира участници Фаза 2/3

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Mucopolysaccharidosis II

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

Начало: 21.07.2022 Край: 01.12.2027 Възраст: 2–25 г. Лечение

Argentina, Australia, Belgium +12 Denali Therapeutics Inc. NCT05371613

Набира участници

Otoferlin Gene-mediated Hearing Loss Natural History Study

Sensorineural Hearing Loss, Bilateral

This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.

Начало: 14.07.2022 Край: 01.02.2029 Възраст: до 44 г.

Australia, Germany, Spain +4 Akouos, Inc. NCT05572073

Набира участници Фаза 1/2

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

LGLL - Large Granular Lymphocytic Leukemia Primary Cutaneous Gamma-Delta T-Cell Lymphoma Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma Hepatosplenic T-cell Lymphoma +9

This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas

Начало: 13.07.2022 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, France, Germany +6 Dren Bio NCT05475925

Набира участници

Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

Erectile Dysfunction

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Начало: 11.07.2022 Край: 21.05.2026 Възраст: от 22 г. Лечение

Australia Rigicon, Inc. NCT05574868

Набира участници

The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

Crohn Disease

The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.

Начало: 08.07.2022 Край: 01.07.2028 Възраст: 18–80 г. Превенция

Australia Austin Health NCT05469607

Набира участници

INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)

Kidney Failure

The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.

Начало: 06.07.2022 Край: 01.08.2026 Възраст: от 18 г. Лечение

Australia, Canada The University of Queensland NCT04932148

Набира участници Фаза 4

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Solid Tumors

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Начало: 05.07.2022 Край: 31.07.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +14 Pfizer NCT05203172

Набира участници Фаза 3

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

Medulloblastoma, Childhood Cognitive Impairment

The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents treated for a brain tumour will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children/adolescents aged 7 years to 21 years and 11 months who have completed treatment for a brain tumour, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?

Начало: 01.07.2022 Край: 30.11.2027 Възраст: 7–21 г. Поддържаща грижа

Australia, Canada Donald Mabbott NCT05230758

Набира участници Фаза 3

A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

Niemann-Pick Disease, Type C

A pivotal, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Niemann Pick disease type C (NPC). The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care. Following this randomized, double-blind, placebo-controlled "Parent Study", an extension phase is conducted for (1) patients who completed the "Parent Study" and (2) patients who are enrolled directly into the Extension Phase. Currently, the Extension Phase provides patients with 3 years of open-label treatment.

Начало: 30.06.2022 Край: 01.12.2030 Възраст: от 4 г. Лечение

Australia, Czechia, Germany +5 IntraBio Inc NCT05163288

Набира участници Фаза 2

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma of the Head and Neck Head and Neck Cancer

Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014). The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including: 1. Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy; 2. Provision of immediate information about pathological response and 3. Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response. The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.

Начало: 28.06.2022 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia Queensland Health NCT05025813

Набира участници Фаза 1/2

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Advanced Solid Malignancies

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

Начало: 24.06.2022 Край: 11.08.2027 Възраст: 18–130 г. Лечение

Australia, Germany, South Korea +4 AstraZeneca NCT05417594

Набира участници Фаза 3

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

Cystic Fibrosis

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Начало: 21.06.2022 Край: 30.06.2030 Възраст: 1–11 г. Лечение

Australia, Canada, France +6 Vertex Pharmaceuticals Incorporated NCT05422222

Набира участници Фаза 1

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer

This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.

Начало: 17.06.2022 Край: 01.11.2031 Възраст: от 18 г. Лечение

Australia, Germany, Hungary +5 BioNTech SE NCT05142189

Набира участници Фаза 1/2

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Locally Advanced Solid Tumor Metastatic Solid Tumor

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.

Начало: 09.06.2022 Край: 01.01.2028 Възраст: от 12 г. Лечение

Australia, Belgium, Canada +12 Nuvalent Inc. NCT05384626

Набира участници

Longitudinal Bladder Cancer Study for Tumour Recurrence

Urothelial Bladder Cancer

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Начало: 08.06.2022 Край: 31.08.2026 Възраст: от 18 г.

Australia, United States Pacific Edge Limited NCT05080998

Набира участници Фаза 1

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors

Locally Advanced or Metastatic Solid Tumors

This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Начало: 07.06.2022 Край: 28.02.2028 Възраст: от 18 г. Лечение

Australia, China Antengene Therapeutics Limited NCT05205109

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