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Намерени 3,079 изпитвания Стр. 110 от 154

Активно (без набиране) Фаза 3

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Type 2 Diabetes Obesity Overweight Obstructive Sleep Apnea

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Начало: 11.07.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +5 Eli Lilly and Company NCT05929079

Активно (без набиране) Фаза 1

Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

Melanoma Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma High Grade Serous Adenocarcinoma of Ovary +13

AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody. This is a dose escalation study to identify the maximum toxicity dose (MTD) or the recommended phase 2 dose (RP2D).

Начало: 11.07.2023 Край: 31.07.2026 Възраст: от 18 г. Лечение

Australia OncoC4, Inc. NCT05858736

Активно (без набиране) Фаза 1/2

A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

Advanced Solid Tumors With MAPK Pathway Mutations

This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.

Начало: 10.07.2023 Край: 01.04.2028 Възраст: от 18 г. Лечение

Australia, China, United States D3 Bio (Wuxi) Co., Ltd NCT05886920

Активно (без набиране) Фаза 3

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Obesity Overweight Osteoarthritis, Knee Obstructive Sleep Apnea

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Начало: 10.07.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +9 Eli Lilly and Company NCT05929066

Активно (без набиране) Фаза 3

A Study of Zigakibart in Adults With IgA Nephropathy

IgA Nephropathy Immunoglobulin A Nephropathy

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Начало: 06.07.2023 Край: 25.01.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Novartis Pharmaceuticals NCT05852938

Активно (без набиране) Фаза 1/2

An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias

Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease

The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.

Начало: 03.07.2023 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia, Canada, Germany +6 Alpine Immune Sciences, Inc. NCT05757570

Активно (без набиране) Фаза 2

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Uveal Melanoma

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Начало: 03.07.2023 Край: 30.04.2030 Възраст: от 18 г. Лечение

Australia, Canada, France +4 IDEAYA Biosciences NCT05907954

Активно (без набиране)

First-line Treatment for Femoroacetabular Impingement Syndrome

Femoroacetabular Impingement Syndrome

There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise intervention to usual first-line care in patients with FAIS. The main hypothesis it aims to investigate are: 1. 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 2. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. 3. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.

Начало: 01.07.2023 Край: 01.07.2027 Възраст: 18–50 г. Лечение

Australia, Denmark University of Aarhus NCT05927935

Активно (без набиране) Фаза 2/3

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Advanced Non-Small Cell Lung Cancer

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Начало: 30.06.2023 Край: 05.02.2032 Възраст: от 18 г. Лечение

Australia, Canada, Georgia +8 Regeneron Pharmaceuticals NCT05785767

Активно (без набиране) Фаза 3

Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy

Symptomatic Neurogenic Orthostatic Hypotension MSA - Multiple System Atrophy

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Начало: 27.06.2023 Край: 01.01.2028 Възраст: от 30 г. Лечение

Argentina, Australia, Brazil +14 Theravance Biopharma NCT05696717

Активно (без набиране) Фаза 1/2

A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

Metastatic Urothelial Carcinoma Urothelial Neoplasms

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.

Начало: 23.06.2023 Край: 31.05.2027 Възраст: от 18 г. Лечение

Australia, Canada, Chile +9 Merck Sharp & Dohme LLC NCT05845814

Активно (без набиране) Фаза 2

A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

Recurrent Wheezing Wheezing Lower Respiratory Illness

This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing

Начало: 20.06.2023 Край: 30.09.2026 Възраст: 6–72 г. Лечение

Australia, Hungary, Poland +1 OM Pharma SA NCT05857930

Активно (без набиране) Фаза 1

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

Relapsed Non-Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Relapsed Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia +10

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."

Начало: 20.06.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia, China, New Zealand +1 BeOne Medicines NCT05828589

Активно (без набиране) Фаза 1

Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma

Ewing Sarcoma

New drug efficacy in ES has been disappointing in the last decades and no new drugs have been successfully introduced up to now in front line treatment. Among the tested drugs, early clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors (TKI) with anti-angiogenic activities are among the most efficient and may be beneficial in the treatment of patients with ES. Several TKI have been and are currently being tested as single-agent in patients with relapsed/refractory ES with encouraging results in phase II trials. Regorafenib has shown promising activity in Ewing sarcoma relapse setting, Nevertheless, regorafenib has never been combined with the intensive chemotherapy VDC/IE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy. The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy. It consists of a phase Ib that will only recruit patients with multi-metastatic (other than lungs/pleura only) ES, that present the highest unmet medical need (2 year EFS: 33%, similar to patients with relapse/refractory ES).

Начало: 16.06.2023 Край: 01.10.2027 Възраст: 2–50 г. Лечение

Australia, Denmark, France +3 Gustave Roussy, Cancer Campus, Grand Paris NCT05830084

Активно (без набиране)

10°C vs 4°C Lung Preservation RCT

Lung Transplant Organ Preservation

Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting \~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (\~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Building on pre-clinical research suggesting that 10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network, Medical University of Vienna and Puerta de Hierro Majadahonda University Hospital. Donor lungs meeting criteria for direct transplantation and with cross clamp times between 6:00pm - 4:00am were intentionally delayed to an earliest allowed start time of 6:00am and a maximum preservation time from donor cold flush to recipient anesthesia start time of 12 hours. Lungs were retrieved and transported in the usual fashion using a cooler with ice and transferred to a 10°C temperature-controlled cooler upon arrival to transplant hospital until implantation. The primary outcome of this study was incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72h, with secondary endpoints including: recipient time on the ventilator, ICU Length of Stay (LOS), hospital LOS, 30-day survival and lung function at 1-year. Outcomes were compared to a contemporaneous conventionally transplanted recipient cohort using propensity score matching at a 1:2 ratio. 70 patients were included in the study arm. Post-transplant outcomes were comparable between the two groups for up to 1 year. Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible. In the current study design, the investigators will conduct a multi-centre, non-inferiority, randomized, controlled trial of 300 participants to compare donor lung preservation from the time of explant to implant at \~10°C in X°Port Lung Transport Device (Traferox Technologies Inc.) vs a standard ice cooler. When eligible donor lungs become available for a consented recipient, the lungs will be randomized to undergo a preservation protocol using either 10°C (X°Port Lung Transport Device, Traferox Technologies Inc.) or standard of care. The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.

Начало: 09.06.2023 Край: 22.11.2026 Възраст: 18–80 г. Лечение

Australia, Belgium, Canada +4 University Health Network, Toronto NCT05898776

Активно (без набиране) Фаза 3

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Breast Cancer

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

Начало: 07.06.2023 Край: 30.03.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +15 Hoffmann-La Roche NCT05646862

Активно (без набиране) Фаза 1

A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Melanoma Urothelial Carcinoma Renal Cell Carcinoma Non-small Cell Lung Cancer +2

Safety study of RC198 in Subjects with Solid Tumors.

Начало: 05.06.2023 Край: 31.12.2024 Възраст: от 18 г. Лечение

Australia, China RemeGen Co., Ltd. NCT05867303

Активно (без набиране) Фаза 2

Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy

Myelodysplastic Syndromes Acute Myeloid Leukemia

The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is relapsed/refractory to hypomethylating agents (HMAs) treatment. Responding patients are eligible to continue treatment until loss of response/disease progression.

Начало: 05.06.2023 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, France, Germany GCP-Service International West GmbH NCT05583552

Активно (без набиране) Фаза 1/2

Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS)

PANS Pediatric Acute-Onset Neuropsychiatric Syndrome

This study investigates the effectiveness of a medicinal cannabis extract (NTI164) with 0.08% THC in treating children with pediatric acute-onset neuropsychiatric syndrome (PANS) over a period of 18 to 54 weeks. Participants, aged 18 to 54, will start with a daily dose of 5mg/kg, gradually increasing to a maximum of 20mg/kg over four weeks. After reaching their maximum tolerated dose, they will maintain this dose for eight weeks, with an option to extend up to 54 weeks. The study will measure the treatment\'s efficacy using questionnaires on emotional and behavioral changes, and verify the results with whole blood RNA sequencing to assess immune dysfunction.

Начало: 02.06.2023 Край: 01.12.2025 Възраст: 1–17 г. Лечение

Australia Fenix Innovation Group NCT06621888

Активно (без набиране) Фаза 3

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer EGFR Exon 20 Mutations

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.

Начало: 01.06.2023 Край: 15.02.2028 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +16 ArriVent BioPharma, Inc. NCT05607550

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