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Набира участници Фаза 3

A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

Clostridioides Difficile Associated Disease

The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly works or clearly doesn't. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years. During this time, participants will have 3 planned clinical visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study. Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.

Начало: 10.12.2025 Край: 07.06.2029 Възраст: от 65 г.

Argentina, Japan, United Kingdom +1 Pfizer NCT07282665

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Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause

Genitourinary Syndrome of Menopause

Chronic hypoestrogenism in postmenopausal women significantly impacts the urogenital epithelium, leading to Genitourinary Syndrome of Menopause (GSM) and increasing susceptibility to gynecological infections due to vaginal pH elevation. Therapies using the Erbium:YAG (Er:YAG) 2940nm laser and low dose topical estrogen have demonstrated efficacy in improving vaginal trophism and restoring microbiota balance. This randomised, double-blind clinical study aims to assess the effects of combining Er: YAG laser therapy with vaginal estriol compared with estriol therapy alone in postmenopausal women with GSM. Sixty patients will be recruited and randomly assigned to two groups. All participants will receive low-dose topical estrogen therapy (estriol cream ) for 14 days, followed by twice-weekly applications until completing three laser sessions at four-week intervals. Group 1 (Sham) will receive the laser with minimal fluence (0.5J/cm²) applied to maintain blinding (auditory cues) below the threshold for biological tissue, while Group 2 , will undergo active laser treatment. Inclusion criteria include age 45-70 years, vaginal pH ≥5, absence of hormone therapy or energy-based intimate treatments for 180 days, and moderate vaginal atrophy symptoms (SCORE \>4). Exclusion criteria include abnormal cervicalvaginal cytology in the last six months, corticosteroid therapy within 90 days, and BMI ≥35kg/m². Assessments will occur at Baseline, 30 days after each laser session and 4 months after the third laser application. The primary outcome is the Vaginal Health Index (VHI), while secondary outcomes include GSM symptom evaluation via the Visual Analog Scale, vaginal microbiota analysis through 16S gene sequencing, and quality-of-life and sexual health questionnaires. Statistical analysis of the groups will be performed using SPSS version 22.0. For analytical statistics, repeated measures ANOVA will be used for continuous data, and non-parametric tests for repeated measures, such as the Friedman test, when appropriate. A p-value \

Начало: 10.12.2025 Край: 31.12.2026 Възраст: 45–70 г.

Brazil University of Nove de Julho NCT06873971

Набира участници Фаза 3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Major Depressive Disorder (MDD) Depression in Adults Depression - Major Depressive Disorder Depression Disorders +2

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

Начало: 10.12.2025 Край: 08.05.2027 Възраст: 18–85 г. Лечение

Australia, Czechia, Germany +5 Cybin IRL Limited NCT06793397

Набира участници Фаза 1

A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

Psoriatic Arthritis Axial Spondyloarthritis

To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.

Начало: 10.12.2025 Край: 14.09.2028 Възраст: от 18 г.

Bulgaria, Germany, Poland +1 UCB Biopharma SRL NCT07290036

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A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany

Indolent Systemic Mastocytosis

This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM. The study is designed to follow each participant up to a maximum of 24 months.

Начало: 09.12.2025 Край: 01.12.2028 Възраст: от 18 г.

Germany Blueprint Medicines Corporation NCT07255638

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The Impact of Image-Assisted Colonoscope on Patient Experience, Physician Workload, and Examination Quality

Colorectal Cancer Screening Colonic Polyps/Colonoscopy/Colorectal Neoplasms Difficult Colonoscopy Colonoscopy-Related Discomfort

Colonoscopy is the cornerstone for colorectal cancer screening, diagnosis, and post-treatment surveillance. Procedural quality is influenced by patient anatomy, particularly variations in colonic configuration such as sigmoid redundancy, looping, and low-lying transverse colon. These features prolong insertion time, increase patient discomfort, and elevate physician workload. Evidence suggests that prior CT imaging can provide objective and individualized information on colonic anatomy-such as redundancy, angulation, and tortuosity-potentially predicting procedural difficulty. However, existing studies are mainly retrospective or descriptive, lacking prospective randomized evidence on clinical utility. This single-blind, randomized controlled trial evaluates whether image-assisted colonoscope insertion, based on pre-existing abdominal/pelvic CT scans, can improve cecal intubation time, enhance patient experience, reduce operator workload, and improve overall examination quality compared with standard colonoscopy.

Начало: 09.12.2025 Край: 28.05.2026 Възраст: 18–80 г.

China DONG WU NCT07541924

Набира участници Фаза 1/2

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

Bladder Cancer Urinary Bladder Neoplasms

Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

Начало: 09.12.2025 Край: 28.02.2029 Възраст: от 18 г.

Austria, Belgium, Canada +9 Merck Sharp & Dohme LLC NCT07222488

Набира участници Фаза 2/3

Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.

Начало: 09.12.2025 Край: 11.03.2034 Възраст: от 18 г. Лечение

Australia, France, Japan +4 Pfizer NCT07226999

Набира участници Фаза 1

An Open-label Study of AZD0120 in Adults With Multiple Sclerosis

Multiple Sclerosis

This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.

Начало: 09.12.2025 Край: 07.12.2028 Възраст: 18–60 г. Лечение

Australia, Canada, Germany +2 AstraZeneca NCT07224373

Набира участници Фаза 2

A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia

Severe Hypertriglyceridemia

The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.

Начало: 08.12.2025 Край: 01.08.2027 Възраст: от 18 г.

Canada, China, Japan +1 Eli Lilly and Company NCT07269210

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Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO]

Glioblastoma Multiforme

Glioblastoma multiforme (GBM WHO IV) is the most common and aggressive primary brain tumor in adults, carrying a poor prognosis with a median survival of 12-16 months. The annual incidence is approximately 5 per 100,000 (roughly 600 cases annually in Poland), predominantly affecting individuals in their prime productive years. The standard of care consists of maximal safe resection followed by the Stupp protocol (60 Gy fractionated radiotherapy and temozolomide chemotherapy). Routine surgical management relies on contrast-enhanced MRI. Gross total resection (GTR) is defined as the complete removal of the contrast-enhancing lesion. Although GTR improves progression-free survival (PFS) and overall survival (OS), local recurrence at the operative site occurs in up to 51% of patients within a year. This rapid regrowth is driven by glioblastoma stem cells infiltrating the surrounding non-enhancing brain tissue. Consequently, standard contrast-enhanced MRI lacks the sensitivity required to define true tumor boundaries for optimal patient outcomes. To overcome this, positron emission tomography (PET-CT) using amino acid tracers like 18F-fluoroethyl-L-tyrosine (18F-FET) offers a promising alternative. Unlike 18-FDG, which is obscured by physiologically high glucose uptake in healthy brain tissue, 18F-FET provides high specificity and sensitivity for glial tumors. Crucially, studies show that MRI contrast enhancement overlaps with only 58% of the hypermetabolic area identified by 18F-FET. While "supramarginal" resections based on FLAIR MRI abnormalities (assumed to contain infiltrating stem cells) improve PFS by roughly 2 months, the FLAIR sequence cannot definitively distinguish active tumor infiltration from standard peritumoral edema. This proposed experiment carries significant innovative value: it aims to use the fusion of 18F-FET PET and contrast-enhanced MRI to precisely guide both primary surgical resection and postoperative radiotherapy. By redefining the primary target volume to include the area of true biological tumor activity rather than just the MRI-enhancing mass (incorporating it into GTV, CTV, and PTV planning), the procedure directly targets residual glioblastoma stem cells. While PET has been evaluated for radiotherapy planning in recurrent GBM, high-quality data regarding its use for primary surgical planning is lacking. This study aims to fill that crucial gap in the literature.

Начало: 08.12.2025 Край: 31.08.2032 Възраст: 18–70 г.

Poland Copernicus Memorial Hospital NCT06466031

Набира участници Фаза 3

Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

Gastric Cancer MSI-H Metastatic Cancer Advanced Cancer

CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm).

Начало: 08.12.2025 Край: 15.05.2028 Възраст: от 18 г.

France Centre Leon Berard NCT06346197

Набира участници Фаза 2

Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer

Non Small Cell Lung Cancer (NSCLC)

The aim of this Phase 2 study is to investigate the efficacy and safety of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) infusion in patients undergoing VATS (Video-Assisted Thoracoscopic Surgery) or RATS (Robotic-Assisted Thoracoscopic Surgery) resection of Stage I-II non-small cell lung cancer (NSCLC).

Начало: 08.12.2025 Край: 01.09.2026 Възраст: от 18 г.

United States Integro Theranostics NCT07276789

Набира участници Фаза 1

A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer

Metastatic Prostate Cancer (mCRPC)

This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.

Начало: 08.12.2025 Край: 18.06.2027 Възраст: 18–100 г.

Japan Novartis Pharmaceuticals NCT07174063

Набира участници

Factors Associated With Breast Cancer Risks and Outcomes

Breast Cancer

The purpose of this study is to learn more about risks and outcomes of breast cancer in people with different backgrounds. Tissue and blood will be collected from participants for research purposes. Participants will complete questionnaires during their standard medical care. The study will not provide treatment for cancer or any other condition.

Начало: 08.12.2025 Край: 08.12.2031 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT07294703

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A Study to See Whether Taking a Mix of Vitamins Can Help Adults Recover Better After Surgery for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome

Carpal Tunnel Syndrome (CTS) is a common condition that causes numbness, tingling, pain, and weakness in the hand due to compression of the median nerve at the wrist. It can affect daily activities, work performance, and quality of life. While surgery is effective in severe cases, many patients with mild to moderate CTS are initially treated with non-surgical options such as splinting and medications. However, the effectiveness of oral supplements for CTS remains uncertain. This clinical study aims to evaluate whether an oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B complex can safely reduce symptoms and improve hand function in patients with Carpal Tunnel Syndrome. These supplements are believed to have antioxidant, anti-inflammatory, and nerve-protective properties, which may help reduce nerve irritation and improve nerve recovery. Participants in this study will be randomly assigned to receive either the oral supplement combination or a comparator treatment. The study is single-blinded, meaning participants will not know which treatment they are receiving. Symptoms such as pain, numbness, and hand function will be assessed over a defined follow-up period using clinical evaluation and standardized questionnaires. The main hypothesis of this study is that patients receiving the oral combination of alpha-lipoic acid, Vitamin E, and Vitamin B will experience greater improvement in symptoms and functional outcomes compared to those who do not receive the combination, without significant side effects. The results of this study may help determine whether this oral supplement combination can be used as an effective and safe conservative treatment option for patients with Carpal Tunnel Syndrome, potentially reducing the need for invasive procedures.

Начало: 08.12.2025 Край: 31.01.2027 Възраст: от 18 г.

Malaysia Hospital Universiti Sains Malaysia NCT07312123

Набира участници Фаза 1/2

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.

Начало: 08.12.2025 Край: 18.06.2030 Възраст: 28–4383 г.

Japan, United States Amgen NCT07134088

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Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients

IBD (Inflammatory Bowel Disease) Colonoscopy Colonoscopy: Bowel Preparation

The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.

Начало: 08.12.2025 Край: 01.10.2026 Възраст: 18–75 г.

China Changhai Hospital NCT07335705

Набира участници Фаза 2

Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma

B-Cell Non-Hodgkin Lymphoma Burkitt Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified +5

This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.

Начало: 07.12.2025 Край: 31.05.2030 Възраст: от 18 г.

United States University of Washington NCT07097363

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Pathways to Perinatal Mental Health Equity

Perinatal Anxiety Perinatal Depression Social Determinants of Health (SDOH) Peer Support +3

Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.

Начало: 05.12.2025 Край: 01.10.2030 Възраст: 18–70 г.

United States University of Massachusetts, Worcester NCT06790641

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