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NCT ID: NCT04624204 Recruiting - Clinical trials for Small Cell Lung Cancer

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

NCT ID: NCT04610840 Recruiting - Urolithiasis Clinical Trials

The Use of Direct Puncture Technique With Mini-PCNL

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

- A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy. - 60 patients - Inclusion criteria: 1. all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study 2. ASA scale 1-3 3. Solitary stone up to 2.5 cm 4. Single access to the caliceal system - Exclusion criteria: 1. Active infectious process 2. Coagulopathies 3. Abnormalities of the urinary system

NCT ID: NCT04609904 Recruiting - Asthma Clinical Trials

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

LOGOS
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

NCT ID: NCT04608825 Recruiting - Clinical trials for Post Cardiac Arrest Syndrome

Intensive Care Unit Management After Cardiac ARrest in Russia

ICAR-RUS
Start date: November 11, 2020
Phase:
Study type: Observational

The purpose of this study is to study the prevalence of post cardiac arrest syndrome (PCAS) among ICU patients, to analyze the effectiveness of intensive care, to assess the factors associated with death and the development of severe neurological deficits.

NCT ID: NCT04607421 Recruiting - Neoplasms Clinical Trials

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: - has spread to other parts of the body (metastatic); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. Participants in this study will receive one of the following study treatments: - Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. - Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. - Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

NCT ID: NCT04603807 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

NCT ID: NCT04601584 Recruiting - ALL Clinical Trials

GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

Start date: October 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.

NCT ID: NCT04600544 Recruiting - Clinical trials for Genetic Predisposition to Disease

Russian Disc Degeneration Study

RuDDS
Start date: October 16, 2020
Phase:
Study type: Observational [Patient Registry]

The main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. Diverse biological samples (whole blood, plasma, disc tissue) along with MRI imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. It will lay the groundwork for the development of early diagnostics of DDD and its personalized treatment. The study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. It is planned to recruit patients within 36 months.

NCT ID: NCT04596631 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

PIONEER TEENS
Start date: November 2, 2020
Phase: Phase 3
Study type: Interventional

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

NCT ID: NCT04595929 Recruiting - Gastric Cancer Clinical Trials

Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-

GASPACCO
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.