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Набира участници

Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors

Portal Hypertension Cirrhosis Varices, Esophageal

This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria: 1. effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease), 2. liver stiffness measurements under 25 kPa, and 3. absence of varices as confirmed by endoscopy Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being \

Начало: 20.01.2025 Край: 31.12.2031 Възраст: от 18 г.

Australia, China, Hong Kong +2 Chinese University of Hong Kong NCT06549673

Набира участници

Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

Nociceptive Pain Axial Back Pain

The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are: * Does ULF neuromodulation reduce chronic low back pain? * What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation? Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will: * Be randomly assigned to either the study device or to conventional medical treatments * Undergo standard surgical procedures to place the study device if assigned to the device arm * Attend regular clinic visits over 24 months for checkups and data collection

Начало: 17.01.2025 Край: 01.04.2029 Възраст: от 22 г. Лечение

Australia Presidio Medical, Inc NCT06763653

Набира участници Фаза 1

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed. ABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Начало: 16.01.2025 Край: 01.11.2031 Възраст: от 18 г. Лечение

Australia, Israel, Japan +2 AbbVie NCT06667687

Набира участници Фаза 3

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Non Small Cell Lung Cancer

ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

Начало: 15.01.2025 Край: 01.03.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Estonia +6 ETOP IBCSG Partners Foundation NCT06284317

Набира участници Фаза 2

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Acute Myeloid Leukemia

This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms/kilogram/day \[μg/kg/day\]), used in combination with venetoclax and azacitidine, to determine the dose for Part 2. This determined dose, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2 in 2 cohorts (TP53 mutated and TP53 wild type). Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.

Начало: 14.01.2025 Край: 11.02.2030 Възраст: от 18 г. Лечение

Australia, United States Stemline Therapeutics, Inc. NCT06456463

Набира участници Фаза 1

Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

Advanced Solid Tumor

This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Начало: 13.01.2025 Край: 01.06.2028 Възраст: от 18 г. Лечение

Australia, United States BioNTech SE NCT06750185

Набира участници Фаза 2

An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures

Focal Onset Seizure Primary Generalized Epilepsy

An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures

Начало: 10.01.2025 Край: 01.07.2025 Възраст: 18–75 г. Лечение

Australia, Spain, United States Praxis Precision Medicines NCT06908356

Набира участници Фаза 1

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Locally Advanced Solid Tumor

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Начало: 10.01.2025 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia, China Innovent Biologics (Suzhou) Co. Ltd. NCT06349408

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis

Arthritis, Psoriatic

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Начало: 09.01.2025 Край: 18.10.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +19 Janssen Research & Development, LLC NCT06807424

Набира участници Фаза 2

A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

Moderate to Severe Glabellar Lines

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Начало: 09.01.2025 Край: 01.10.2025 Възраст: от 18 г. Лечение

Australia Chongqing Claruvis Pharmaceutical Co., Ltd. NCT06481475

Набира участници Фаза 2/3

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Non-small Cell Lung Cancer

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Начало: 07.01.2025 Край: 01.03.2030 Възраст: от 18 г. Лечение

Australia, Belgium, China +12 BioNTech SE NCT06712316

Набира участници Фаза 4

International Care Bundle Evaluation in Cerebral Hemorrhage Research

Intracerebral Hemorrhage Intracerebral Haemorrhage Intraventricular Hemorrhage Stroke +1

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.

Начало: 07.01.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia, Canada, Hong Kong +5 Region Skane NCT06429332

Набира участници Фаза 3

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Breast Cancer

The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: * HR-positive (breast cancer cells that need estrogen or progesterone to grow) * HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface); * locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body) * who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease. Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Начало: 06.01.2025 Край: 29.12.2037 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +25 Pfizer NCT06760637

Набира участници Фаза 2

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Начало: 03.01.2025 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +14 Loxo Oncology, Inc. NCT06588478

Набира участници Фаза 2

Evaluation of BTV100 in Subjects With Dry Eye Disease

Dry Eye

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Начало: 31.12.2024 Край: 15.02.2026 Възраст: от 18 г. Лечение

Australia, Taiwan BioTheraVision, Inc. NCT06543303

Набира участници Фаза 1/2

HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies

Advanced Solid Tumor Malignancies

The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044. HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.

Начало: 30.12.2024 Край: 31.10.2027 Възраст: 18–75 г. Лечение

Australia Hanx Biopharmaceuticals (Wuhan) Co., Ltd. NCT06649708

Набира участници Фаза 1

Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.

Начало: 30.12.2024 Край: 30.08.2027 Възраст: 18–75 г. Лечение

Australia, China Innovent Biologics (Suzhou) Co. Ltd. NCT06613009

Набира участници Фаза 2

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

Treatment Resistant Depression

This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Начало: 30.12.2024 Край: 30.03.2026 Възраст: 18–65 г. Лечение

Australia, Canada, United Kingdom +1 atai Therapeutics, Inc. NCT06524830

Набира участници Фаза 2

A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

MTAP-deleted NSCLC

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).

Начало: 26.12.2024 Край: 29.11.2030 Възраст: 18–99 г. Лечение

Australia, Brazil, Canada +13 Amgen NCT06593522

Набира участници Фаза 2

A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Focal Segmental Glomerulosclerosis Glomerulonephritis Minimal Lesion

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Начало: 19.12.2024 Край: 16.02.2028 Възраст: 16–75 г. Лечение

Argentina, Australia, Brazil +18 Sanofi NCT06500702

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