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Набира участници Фаза 3

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic Inflammatory Demyelinating Polyneuropathy

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

Начало: 21.08.2024 Край: 12.01.2029 Възраст: от 18 г.

Argentina, Belgium, Brazil +20 Sanofi NCT06290141

Набира участници

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Начало: 21.08.2024 Край: 31.10.2026 Възраст: от 18 г.

South Korea Starmed NCT06358391

Набира участници Фаза 3

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

HPV-Related Squamous Cell Carcinoma

The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.

Начало: 19.08.2024 Край: 01.08.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06563479

Набира участници Фаза 2

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Acute HIV Infection

A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.

Начало: 19.08.2024 Край: 06.09.2028 Възраст: 18–70 г.

Brazil, Peru, United States National Institute of Allergy and Infectious Diseases ( NCT05719441

Набира участници Фаза 1

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

Alzheimer Disease

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.

Начало: 15.08.2024 Край: 01.02.2027 Възраст: 50–85 г.

Japan, United Kingdom, United States Eli Lilly and Company NCT06297590

Набира участници Фаза 1

Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors

Metastatic Pancreatic Neuroendocrine Tumor Pancreatic Neoplasm Stage III Pancreatic Neuroendocrine Tumor AJCC v8 Stage IV Pancreatic Neuroendocrine Tumor AJCC v8 +1

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

Начало: 14.08.2024 Край: 14.12.2026 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT05687123

Набира участници Фаза 2

Working Out M0 Bipolar Androgen Therapy

Prostate Cancer

The WOMBAT study will test if BAT can prolong the time it takes for nmCRPC prostate cancer to become detectable in other areas of the body (metastatic disease). Approximately 69 participants over the age of 18 with castrate resistant prostate cancer, no evidence of metastatic disease (M0) on conventional imaging (WBBS and CT scan at screening) and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia. Participants will receive continuous androgen deprivation therapy with LHRH agonists/antagonists. The study intervention will be IM testosterone enthanate, injected on day 1 of each 56-day cycle. Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle. Both LHRH and agonist/antagonist and darolutamide are supplied through the PBS as standard of care medications. Administration of both testosterone and darolutamide will continue until disease progression, beyond disease progression, unacceptable toxicity, death, withdrawal of consent or study Sponsor termination of the study. Primary objective (endpoint) is to determine the metastasis-free survival (time from commencing BAT to evidence of metastases or death)

Начало: 14.08.2024 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia Australian and New Zealand Urogenital and Prostate Canc NCT06594926

Набира участници

J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations

HIV Contingency Management Justice Involved Populations Status Neutral Interventions +2

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system. The main question it aims to answer is: • Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community? Participants on the study will be: * Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

Начало: 13.08.2024 Край: 30.06.2028 Възраст: от 18 г.

United States University of Chicago NCT06477588

Набира участници

SuperSaturated Oxygen Comprehensive Observational Registry

STEMI - ST Elevation Myocardial Infarction AMI

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Начало: 13.08.2024 Край: 31.03.2029 Възраст: от 18 г.

United States TherOx NCT06438315

Набира участници

Sleep Mechanisms Of Regulating Emotions

Insomnia Depression

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.

Начало: 12.08.2024 Край: 01.06.2027 Възраст: 18–65 г.

United States Stanford University NCT06373718

Набира участници Фаза 2

Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer

Borderline Resectable Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Adenocarcinoma Stage I Pancreatic Cancer AJCC v8 Stage II Pancreatic Cancer AJCC v8 +1

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Начало: 06.08.2024 Край: 31.12.2027 Възраст: от 18 г.

United States Emory University NCT06423326

Набира участници Фаза 1

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Advanced Chronic Myeloid Leukemia Philadelphia Chromosome-Positive Acute Myeloid Leukemia

To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

Начало: 06.08.2024 Край: 01.01.2029 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06401603

Набира участници Фаза 4

Anesthesia and Non-small Cell Lung Cancer Recurrence

Non-small Cell Lung Cancer Surgery Anesthesia

There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.

Начало: 05.08.2024 Край: 31.12.2028 Възраст: от 19 г.

South Korea Samsung Medical Center NCT06330038

Набира участници Фаза 1

Study of STP938 in Advanced Solid Tumours

Solid Tumor

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Начало: 02.08.2024 Край: 01.05.2027 Възраст: от 18 г.

France, United Kingdom, United States Step Pharma, SAS NCT06297525

Набира участници

Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes

Type 1 Diabetes Diet Intervention Glucose Control

The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.

Начало: 01.08.2024 Край: 31.12.2027 Възраст: 18–70 г.

China Yang Tao NCT06273631

Набира участници

Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients

Pneumonia Next-generation Sequencing Microbiome Antimicrobial Resistance

Monitoring of antimicrobial resistance (AMR) based on metagenomics analyses in pneumonia patients is critical for optimizing clinical diagnosis and treatment and improving clinical prognosis. This study is designed to ask the following key questions: 1. What is the microbiome maps of patients with severe pneumonia and mild pneumonia ? 2. How many pathogen resistance genes are carrying in severe pneumonia and mild pneumonia ? 3. What is the genetic diversity of key pathogens detected in severe pneumonia and mild pneumonia during 2019-2025?

Начало: 01.08.2024 Край: 30.09.2026

China Shanghai General Hospital, China NCT06566898

Набира участници Фаза 2

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

Extensive-stage Small-cell Lung Cancer

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Начало: 01.08.2024 Край: 31.12.2026 Възраст: 18–80 г.

China Second Hospital of Shanxi Medical University NCT06536868

Набира участници

RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana

Hiv Serious Mental Illness

The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence. The investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention. The investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change. Enabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.

Начало: 01.08.2024 Край: 01.12.2027 Възраст: 18–65 г.

Botswana New York University NCT05807867

Набира участници

Predictive Algorithms for Critical Rehabilitation Outcomes

Intensive Care Mechanical Ventilation Rehabilitation Algorithms

An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.

Начало: 01.08.2024 Край: 30.12.2026 Възраст: 18–90 г.

China Wuhan University NCT06532994

Набира участници Фаза 2

Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...

Small Cell Carcinoma of the Bladder Small Cell Carcinoma of the Urinary Tract Squamous Cell Carcinoma of the Bladder Squamous Cell Carcinoma of the Urinary Tract +4

Background: Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU. Objective: To test SG, either alone or combined with atezolizumab, in people with rare GU tumors. Eligibility: Adults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor. Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm. All participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle. Blood and urine tests, imaging scans, and other exams will be repeated during study visits. Treatment may continue for up to 5 years. Follow-up visits will continue for 5 more years.

Начало: 01.08.2024 Край: 01.11.2028 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT06161532

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