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Филтри 1
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Намерени 4,436 изпитвания Стр. 161 от 222
Набира участници Фаза 1
IKS014 in Advanced Solid Tumors That Express HER2
Breast Cancer Gastric Cancer Gastroesophageal-junction Cancer

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Начало: 14.09.2023 Край: 01.09.2027 Възраст: от 18 г. Лечение
Australia, New Zealand, Singapore +1 Iksuda Therapeutics Ltd. NCT05872295
Набира участници Фаза 2/3
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Systemic Sclerosis Associated Interstitial Lung Disease Scleroderma, Systemic

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Начало: 13.09.2023 Край: 12.07.2029 Възраст: от 18 г. Лечение
Argentina, Australia, Belgium +14 GlaxoSmithKline NCT05878717
Набира участници Фаза 3
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
Polycystic Ovary Syndrome Reproductive Medicine

The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.

Начало: 12.09.2023 Край: 01.12.2027 Възраст: 18–35 г.
France University Hospital, Lille NCT03059173
Набира участници Фаза 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Community-acquired Pneumonia

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Начало: 09.09.2023 Край: 31.07.2028 Възраст: от 18 г. Лечение
Argentina, Australia, Belgium +14 Biotest NCT05722938
Набира участници
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Invasive Candidiasis

The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are: * Compare the desirability of outcome ranking in children with uncomplicated candidemia randomized to 7 additional days of antifungal therapy (standard-course) versus no additional antifungal therapy (short-course) after already receiving 7 days of echinocandin therapy. * Compare the 14-day desirability of outcome measure for subjects with a negative and those with a positive T2Candida® biomarker at day 7 of therapy within randomized groups. Participants meeting eligibility criteria will be approached and consented between day 5 and 7 of primary systemic antifungal therapy. On day 7 of primary systemic antifungal therapy, inclusion and exclusion criteria will again be reviewed for consented patients and those still eligible will be randomized 1:1 to the two study arms. Researchers will compare no additional antifungal therapy (short-course) versus 7 additional days of systemic antifungal therapy (standard-course) in pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy to see if shorter durations are as effective as longer durations in treating uncomplicated candidemia.

Начало: 08.09.2023 Край: 30.06.2032 Възраст: от 120 г. Лечение
Australia, United States Arkansas Children's Hospital Research Institute NCT05763251
Набира участници Фаза 1
A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
Non-alcoholic Steatohepatitis

This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, and D and in participants with a history of NASH or presumed NASH in Part C.

Начало: 08.09.2023 Край: 15.06.2025 Възраст: 18–65 г. Лечение
Australia Inipharm Australia Pty Ltd NCT05945537
Набира участници Фаза 3
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Metastatic Breast Cancer

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Начало: 08.09.2023 Край: 28.12.2032 Възраст: от 18 г. Лечение
Argentina, Australia, Belgium +25 Hoffmann-La Roche NCT05894239
Набира участници Фаза 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Начало: 07.09.2023 Край: 01.08.2030 Възраст: от 18 г. Лечение
Argentina, Australia, Belgium +22 Gilead Sciences NCT06051617
Набира участници
Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA
Dental Implant

This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.

Начало: 05.09.2023 Край: 31.03.2027 Възраст: от 18 г.
United Kingdom Barts & The London NHS Trust NCT06086873
Набира участници Фаза 1
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
Relapsed Malignant Solid Neoplasm

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Начало: 05.09.2023 Край: 01.06.2027 Възраст: от 18 г.
India Aurigene Discovery Technologies Limited NCT05865002
Набира участници Фаза 1
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
B-cell Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma +1

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).

Начало: 05.09.2023 Край: 01.09.2028 Възраст: от 18 г. Лечение
Australia, Canada, Italy +2 Iksuda Therapeutics Ltd. NCT05365659
Набира участници
The Effect of Water Carbonation on Orthostatic Tolerance
Orthostatic Hypotension Syncope Vasovagal Syncope

The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers. Orthostatic tolerance refers to the ability to maintain an adequate blood pressure when standing. In some individuals blood pressure can fall when standing, predisposing to dizzy spells or fainting episodes. Drinking water can boost blood pressure and making fainting episodes less likely. However, it is not clear whether the carbonation of the water has any further impact on the blood pressure response. This is important because it may be that carbonated water expands the stomach (gastric distension), provoking an increase in sympathetic activity. The increase in sympathetic nervous system activity boosts blood pressure. Resolving this question would have important implications for patients with syncope. This study will test whether carbonated water will have any further impact on blood pressure than the already known effect of non-carbonated water.

Начало: 01.09.2023 Край: 01.04.2027 Възраст: 19–50 г.
Canada Simon Fraser University NCT05621460
Набира участници Фаза 2
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)
Schwannomatosis Schwannomas Pain, Chronic

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe

Начало: 31.08.2023 Край: 30.11.2027 Възраст: от 18 г.
United States Massachusetts General Hospital NCT05684692
Набира участници Фаза 3
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
Ph+ ALL

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

Начало: 31.08.2023 Край: 31.10.2028 Възраст: от 18 г. Лечение
Australia, China Ascentage Pharma Group Inc. NCT06051409
Набира участници Фаза 3
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC)

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Начало: 31.08.2023 Край: 31.05.2029 Възраст: от 18 г. Лечение
Argentina, Australia, Belgium +21 Ipsen NCT06016842
Набира участници Фаза 1
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumor

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design

Начало: 30.08.2023 Край: 01.06.2030 Възраст: от 18 г.
United States Pliant Therapeutics, Inc. NCT06270706
Набира участници Фаза 1/2
Study of AVZO-021 in Patients With Advanced Solid Tumors
Advanced Solid Tumor HR+/HER2- Breast Cancer HR+, HER2-, Advanced Breast Cancer CCNE1 Amplification +5

This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).

Начало: 30.08.2023 Край: 31.01.2030 Възраст: от 18 г. Лечение
Australia, United States Avenzo Therapeutics, Inc. NCT05867251
Набира участници Фаза 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

Начало: 30.08.2023 Край: 31.10.2026 Възраст: от 4 г. Лечение
Argentina, Australia, Bulgaria +18 Teva Branded Pharmaceutical Products R&D LLC NCT06052267
Набира участници Фаза 1
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Advanced Urothelial Carcinoma Oral Drug Administration Open Label

The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.

Начало: 24.08.2023 Край: 30.01.2028 Възраст: от 18 г.
United States Flare Therapeutics Inc. NCT05929235
Набира участници Фаза 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma Advanced Biliary Tract Carcinoma Advanced Bladder Carcinoma Advanced Breast Carcinoma +40

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

Начало: 23.08.2023 Край: 01.01.2027 Възраст: от 18 г.
United States Mayo Clinic NCT05969860
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