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Набира участници Фаза 2

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm Acute Myeloid Leukemia Post Cytotoxic Therapy Acute Myeloid Leukemia, Myelodysplasia-Related

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Начало: 25.09.2024 Край: 31.03.2027 Възраст: 18–59 г.

Canada, Puerto Rico, United States National Cancer Institute (NCI) NCT05554406

Набира участници Фаза 3

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

Head and Neck Squamous Cell Carcinoma

This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

Начало: 25.09.2024 Край: 01.07.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Merus B.V. NCT06525220

Набира участници Фаза 2

A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

Gram-negative Bacterial Infection

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

Начало: 25.09.2024 Край: 25.04.2027 Възраст: до 39 г.

Argentina, India, Israel +2 Pfizer NCT06462235

Набира участници Фаза 1

A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)

Congenital Myasthenic Syndrome CMS

The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function. After the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the double-blinded treatment period. Participants will then enter the follow-up period. After the follow-up period, participants may enrol in the active-treatment period, where they will receive open-label ARGX-119. The full duration of the study is approximately 38 months.

Начало: 24.09.2024 Край: 24.01.2028 Възраст: от 18 г.

Canada, France, Italy +3 argenx NCT06436742

Набира участници Фаза 1/2

Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

Gastroesophageal Junction Gastroesophageal Adenocarcinoma Esophageal Neoplasms Esophageal Cancer

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Начало: 20.09.2024 Край: 12.09.2029 Възраст: от 18 г.

Brazil, Chile, China +9 Merck Sharp & Dohme LLC NCT06469944

Набира участници Фаза 1

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

Metastatic Solid Tumor Advanced Solid Tumor Non-small Cell Lung Cancer SMARCA4-Deficient Tumor

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.

Начало: 19.09.2024 Край: 01.10.2027 Възраст: от 18 г.

France, Germany, Japan +3 Eli Lilly and Company NCT06561685

Набира участници Фаза 1

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

Solid Tumor Advanced Solid Tumor Solid Tumor, Adult Metastatic Tumor +24

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Начало: 19.09.2024 Край: 01.05.2029 Възраст: от 18 г.

United States NiKang Therapeutics, Inc. NCT06586957

Набира участници

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Claudication Peripheral Artery Disease

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

Начало: 16.09.2024 Край: 31.05.2029 Възраст: от 40 г.

United States University of Oklahoma NCT03845036

Набира участници

Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program

Kidney Transplant; Complications Obesity

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.

Начало: 16.09.2024 Край: 01.04.2026 Възраст: от 18 г.

United States Virginia Commonwealth University NCT06688825

Набира участници Фаза 2

Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma

This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.

Начало: 16.09.2024 Край: 20.03.2030 Възраст: от 65 г.

United States City of Hope Medical Center NCT06042569

Набира участници Фаза 3

Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

Social Anxiety Disorder (SAD)

This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-4 and choose to enter the distinct open-label extension phase of the study.

Начало: 16.09.2024 Край: 01.04.2027 Възраст: 18–65 г.

United States VistaGen Therapeutics, Inc. NCT06615557

Набира участници

Evaluation of Unstained

Teen Pregnancy Prevention

The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the legal system. The primary research questions it aims to answer are: * Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months? Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Начало: 16.09.2024 Край: 14.09.2028 Възраст: 14–22 г.

United States The Policy & Research Group NCT06574139

Набира участници

The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)

Anterior Cruciate Ligament Reconstruction

The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.

Начало: 15.09.2024 Край: 01.01.2028 Възраст: 18–45 г.

Israel Assaf-Harofeh Medical Center NCT06493851

Набира участници Фаза 2

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

Acute Myeloid Leukemia

This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.

Начало: 13.09.2024 Край: 31.12.2027 Възраст: 18–59 г.

Canada, Puerto Rico, United States National Cancer Institute (NCI) NCT05554393

Набира участници

Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women

Gestational Hypertension

The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are: * Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation? * Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers? * Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure? Participants will: * Complete baseline and follow-up in-person appointments; * Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy; * Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.

Начало: 12.09.2024 Край: 01.09.2028 Възраст: от 18 г.

United States Weill Medical College of Cornell University NCT06647511

Набира участници Фаза 1

MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer Colorectal Cancer

The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Начало: 12.09.2024 Край: 01.03.2029 Възраст: от 18 г.

Canada, China, France +6 Eli Lilly and Company NCT06586515

Набира участници Фаза 3

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

Metastatic Dedifferentiated Liposarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 +2

This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.

Начало: 11.09.2024 Край: 30.06.2026 Възраст: от 18 г.

Canada, Puerto Rico, United States National Cancer Institute (NCI) NCT06422806

Набира участници Фаза 2

A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma

Advanced Melanoma

The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.

Начало: 10.09.2024 Край: 01.09.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06594991

Набира участници

mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders

Bipolar Disorder

Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning. Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims: Aim 1. To establish a machine learning algorithm using GPS/location data for predicting prospective declines in social participation in Veterans with BD. Aim 2. To establish machine learning algorithms using GPS/location data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy. Aim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.

Начало: 10.09.2024 Край: 30.09.2027 Възраст: от 18 г.

United States VA Office of Research and Development NCT06204705

Набира участници

Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer

Esophageal Cancer (EsC)

The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and are closely correlated with morbidity and mortality. The investigators' primary objective is to identify potential factors and conditions that could be influenced and modified to enhance the disease outcome. Main questions: 1. What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied? 2. What is the time course of the changes during and after treatment? 3. Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease? Patients will undergo a detailed physical and nutritional assessment, non-invasive imaging tests and several questionnaires in addition to the usual pre- and post-operative examinations.

Начало: 10.09.2024 Край: 10.09.2034 Възраст: от 18 г.

Hungary Semmelweis University NCT06713993

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