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PrEP My Way: A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women

HIV/AIDS

PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. Preliminary testing of PrEP My Way in Kisumu, Kenya found it to be highly feasible and acceptable, but PrEP use as an oral medication was lower than expected. Now that newer PrEP formulations are becoming available, the team is adding choice of PrEP formulation (i.e., oral tenofovir/emtricitabine, injectable cabotegravir-long acting \[CAB-LA\], or dapivirine ring) as well as choice of adherence support from peers (e.g., SMS \[short message service\], routine check-ins and/or WhatsApp groups) to the intervention. The study team will then test the effectiveness of the augmented PrEP My Way intervention (with and without testing for gonorrhea and chlamydia due to cost concerns) on PrEP persistence in women with ongoing HIV prevention needs (i.e., self-reported desire for PrEP, self-reported HIV risk, condomless sex, and/or multiple sexual partners). The team will also track implementation, service, and client metrics per Proctor's framework and determine cost-effectiveness of the intervention

Начало: 03.03.2025 Край: 01.12.2028 Възраст: 16–24 г.

Kenya Massachusetts General Hospital NCT06566430

Набира участници Фаза 2

Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment

Non-small Cell Lung Cancer

This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.

Начало: 03.03.2025 Край: 01.10.2028 Възраст: от 18 г. Лечение

Australia, South Korea, Spain +3 BioNTech SE NCT06841055

Набира участници

Optimizing the Timing of rTMS to Enhance the Administration of Insomnia Treatment

Insomnia

Repetitive transcranial magnetic stimulation (rTMS) has shown to be a promising technique for improving insomnia symptoms and sleep quality. However, the impact of circadian rhythmicity on rTMS sessions and its potential influence on insomnia therapy remains unclear. Moreover, the effect of rTMS on objective sleep parameters is not fully established. The objective of this pilot study is to establish key feasibility and preliminary data that would be used for an R-level grant application focused on optimizing rTMS therapy for insomnia. The investigators will acquire feasibility data from ten adults with Insomnia disorder. Participants will receive ten sessions rTMS over two weeks, either in the morning or evening. Sleep parameters will be assessed before, during, and after completion of rTMS and brain cortical excitability will be collected before rTMS treatment. The investigators aim to 1) evaluate the impact of circadian timing of rTMS sessions on subjective and objective sleep outcomes, 2) assess the time course of improvements in sleep outcomes, and 3) examine the association between sleep outcomes and cortical excitability. The overarching goal of this work is to optimize rTMS therapy for insomnia by investigating the impact of circadian timing on rTMS sessions and assessing potential variations in subjective and objective measures of sleep.

Начало: 01.03.2025 Край: 30.09.2026 Възраст: 25–45 г.

United States Stanford University NCT06656533

Набира участници

EIM Via the Myolex mScan as an ALS Biomarker

Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.

Начало: 01.03.2025 Край: 30.05.2027 Възраст: от 18 г.

United States Beth Israel Deaconess Medical Center NCT06491732

Набира участници

Epidural Electrical Stimulation in Spinal Cord Injury

Spinal Cord Injuries (SCI)

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES. Participants will: Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory function assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.

Начало: 01.03.2025 Край: 31.12.2026 Възраст: 16–60 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT07105878

Набира участници

Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

Lung Cancer, Non-Small Cell

The goal of this multicenter observational study is to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) for patients with central lung cancer when compared with video-assisted thoracic surgery (VATS) approach, both of which have been already applied to these patients in minimally invasive surgical techniques as part of their regular medical care recently. The main question it aims to answer is: Are RATS sleeve lobectomy associated with similar or even better long-term survival and perioperative outcomes for patients with central lung cancer when compared with the VATS approach?

Начало: 01.03.2025 Край: 31.12.2027 Възраст: от 18 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT06687408

Набира участници Фаза 2

Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ

Gastric Adenocarcinoma Gastro-esophageal Junction Adenocarcinoma

This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before. After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles). Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.

Начало: 28.02.2025 Край: 31.12.2027 Възраст: 18–75 г.

China Cancer Institute and Hospital, Chinese Academy of Medic NCT06808971

Набира участници Фаза 3

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Schizophrenia

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Начало: 28.02.2025 Край: 29.10.2026 Възраст: 18–65 г.

Japan, United States Otsuka Pharmaceutical Development & Commercialization, NCT06894212

Набира участници Фаза 2

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

Primary Myelofibrosis Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.

Начало: 28.02.2025 Край: 17.03.2028 Възраст: от 18 г.

Canada, France, Germany +3 GlaxoSmithKline NCT06517875

Набира участници Фаза 1

ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

Solid Tumors EGFR Exon 20 Insertion Mutations NSCLC EGFR-mutated NSCLC

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

Начало: 27.02.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Canada, United States ORIC Pharmaceuticals NCT06816992

Набира участници Фаза 1/2

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Small Cell Lung Cancer

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Начало: 27.02.2025 Край: 17.01.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Chile +9 Merck Sharp & Dohme LLC NCT06780137

Набира участници

Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

Cancer of Breast Trastuzumab Emtansine Trastuzumab Deruxtecan

Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea

Начало: 26.02.2025 Край: 30.09.2029 Възраст: от 19 г.

South Korea Seoul National University Hospital NCT06928818

Набира участници Фаза 1

A Study of HS-20110 in Participants With Advanced Solid Tumors

Solid Tumors

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Начало: 26.02.2025 Край: 30.09.2027 Възраст: от 18 г.

China, United States Hansoh BioMedical R&D Company NCT06892379

Набира участници Фаза 3

Reducing Breathlessness With Dronabinol in COPD Patients

COPD Breathlessness Cannabis

This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).

Начало: 26.02.2025 Край: 01.10.2026 Възраст: от 18 г.

Denmark Vejle Hospital NCT06473701

Набира участници

Identifying Patterns in the Breath of Individuals With Breast Cancer

Breast Cancer

Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection. Women with mammogram-confirmed breast tissue density undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results. The primary goal of this project is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's cavity ring-down spectrometer to further develop Breathe BioMedical's technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women aged 40 to 74. Secondarily, this project aims to identify patterns of VOCs that are either over- or under-represented in participants with breast cancer when compared to the breath profiles of participants without breast cancer. This project will also assess performance characteristics of the technology (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This project aims to understand intra-subject variability by exploring differences in breath signatures before and after definitive management of breast cancer, including surgical resection.

Начало: 25.02.2025 Край: 01.12.2027 Възраст: 40–74 г.

United States Breathe BioMedical Inc NCT06512350

Набира участници Фаза 3

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

Extensive-Stage Small Cell Lung Cancer

The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.

Начало: 25.02.2025 Край: 05.09.2031 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +23 Bristol-Myers Squibb NCT06646276

Набира участници

A Postmarketing Study of LEQEMBI in South Korean Participants With Alzheimer's Disease

Alzheimer's Disease

The primary purpose of this study is to evaluate safety of LEQEMBI in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in patients treated with LEQEMBI.

Начало: 24.02.2025 Край: 30.09.2029 Възраст: от 19 г.

United States Eisai Korea Inc. NCT06810960

Набира участници Фаза 3

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

Non-small Cell Lung Cancer

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.

Начало: 24.02.2025 Край: 01.12.2028 Възраст: от 18 г.

China Sichuan Baili Pharmaceutical Co., Ltd. NCT06838273

Набира участници

The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

Osteoarthritis (OA) of the Knee

Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

Начало: 24.02.2025 Край: 30.06.2028 Възраст: 45–85 г.

Taiwan Shin Kong Wu Ho-Su Memorial Hospital NCT06702046

Набира участници

Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device

Breast Cancer, Metastatic Breast Cancer Invasive Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up. The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up

Начало: 24.02.2025 Край: 30.11.2026 Възраст: от 18 г.

France ScreenCell NCT06807502

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