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Набира участници Фаза 2

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Начало: 03.01.2025 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +14 Loxo Oncology, Inc. NCT06588478

Набира участници Фаза 3

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma (CSCC)

This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works

Начало: 02.01.2025 Край: 03.05.2030 Възраст: от 18 г. Лечение

Australia, United States Regeneron Pharmaceuticals NCT06585410

Набира участници

External Pancreatic Stent in Pancreaticojejunostomy

Pancreatic Fistula

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Начало: 01.01.2025 Край: 01.07.2026 Възраст: 18–75 г.

Egypt Minia University NCT06743516

Набира участници Фаза 2

Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease

High-Risk Oral Precancerous Disease

The goal of this study is to understand the safety, tolerability, and potential efficacy of an injected immune therapy called RP2 to treat oral precancer conditions and prevent progression to an oral cancer. The name of the study drug involved in this study is: -RP2 (a genetically modified live Herpes Simplex V-1 strain)

Начало: 01.01.2025 Край: 01.01.2029 Възраст: от 18 г.

United States Glenn J. Hanna NCT06623110

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Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children

Myopia Strabismus Eye Health

This project proposes to conduct a prospective, multicenter registry study in rural China to evaluate, under real-world conditions, the implementation effectiveness of an integrated child eye health service model centered at the county level and coordinated across county, township, village, and school tiers. The target population will include all children and adolescents within participating counties, and the primary exposure will be the annual coverage and implementation intensity of this service model. The study will focus on its impact on clinical outcomes such as refractive error correction rates and referral rates following eye disease screening, while also examining annual trends in disparities in access to different eye care services. Through long-term and systematic observation, the project aims to clarify the sustained effects of this eye health service model on improving the management of pediatric eye diseases, enhancing visual function, and promoting health equity, thereby providing evidence-based support for optimizing the rural child eye care system in China.

Начало: 01.01.2025 Край: 31.12.2028 Възраст: 3–18 г.

China Zhongshan Ophthalmic Center, Sun Yat-sen University NCT07547748

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OBESE-HFpEF: Towards Preventing Obesity Related HFpEF

Heart Failure and Preserved Ejection Fraction Obesity (Disorder) Heart Failure

Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart becomes stiffer. This makes it harder for the heart to fill with blood, which can lead to shortness of breath during physical activity. In the Netherlands, 15% of the population has obesity. In South Limburg, this is even higher at 19%. Among people with HFpEF, obesity is much more common: about 50% of these patients have obesity. Life expectancy in people with HFpEF is poor, and current treatment mainly focuses on reducing symptoms. Early recognition and treatment of risk factors, such as obesity, are therefore very important. This study includes about 250 people with obesity. Using a heart ultrasound and tests of blood and fat tissue, we will look for early signs of HFpEF and study the effects of weight loss. The measurements will be repeated after 1 and 2 years. The goal of this study is to better understand how obesity contributes to HFpEF and how weight loss affects the heart. This research may help improve future treatments for patients with HFpEF.

Начало: 01.01.2025 Край: 01.01.2029 Възраст: от 35 г.

Netherlands Zuyderland Medisch Centrum NCT07539766

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Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study

Inflammatory Bowel Diseases

Crohn's disease (CD) is a nonspecific chronic inflammatory condition characterized by a protracted course with alternating periods of relapse and remission. Even patients who achieve deep remission remain prone to recurrence and require long-term follow-up. While various monitoring methods are available, endoscopy plays a primary role in the management and diagnosis of CD; however, its relative invasiveness and the need for bowel preparation limit the feasibility of continuous monitoring. In contrast, transabdominal intestinal ultrasound offers advantages such as non-invasiveness, absence of radiation, good patient tolerance, and low cost, making it suitable for long-term monitoring. However, most studies have focused on exploring its concordance with disease activity and endoscopic findings, with only a limited number of studies examining its clinical significance for long-term prognosis. Therefore, we conducted a multicenter prospective study involving 18 months of follow-up in CD patients who achieved deep remission. Based on the follow-up results, patients were divided into relapse and non-relapse groups. Stratified analysis was performed according to the Montreal classification to compare color Doppler ultrasound parameters between the two groups and within each stratum, and to establish a predictive model.

Начало: 01.01.2025 Край: 01.01.2029 Възраст: 18–70 г.

China Nanfang Hospital, Southern Medical University NCT07539727

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Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer

Gastric Cancer (GC) Siewert Type III Adenocarcinoma of Esophagogastric Junction Siewert Type II Adenocarcinoma of Esophagogastric Junction

Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues. Rising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques). Each method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL. No consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied. Systematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.

Начало: 01.01.2025 Край: 01.06.2029 Възраст: от 18 г.

Russia P. Herzen Moscow Oncology Research Institute NCT07441785

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Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

Congenital Heart Disease (CHD) Univentricular Heart

This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.

Начало: 01.01.2025 Край: 01.06.2027

Indonesia Sisca Natalia Siagian NCT07535203

Набира участници

Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis

Endometrioma Ultrasound Therapy; Complications Quality of Life Pelvic Pain

The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management. The main questions it aims to answer are: 1. \- Does sclerotherapy significantly reduce pelvic pain compared to expectant management? 2. \- Does sclerotherapy improve quality of life as measured by the EHP-5 score? Researchers will compare the sclerotherapy group to the expectant management group to determine whether the intervention leads to greater improvement in pain and quality of life. Participants will: * Be randomly assigned to one of two groups: (1) Sclerotherapy group: undergo ultrasound-guided puncture and alcohol sclerotherapy; (2) Control group: expectant management * Complete quality of life and pain assessments at baseline and after 6 months * Provide blood and urine samples for biomarker analysis (e.g., cortisol, IL-6, hsCRP, catecholamines) * Undergo ovarian reserve assessments (AMH, antral follicle count) * Be followed for adverse events, recurrence, fertility outcomes, and treatment-related costs The study will follow an intention-to-treat and per-protocol analysis approach.

Начало: 01.01.2025 Край: 31.12.2027 Възраст: 18–45 г.

Spain Hospital Universitari de Bellvitge NCT06955221

Набира участници

Dental Communication and Social Media: Legal and Ethical Framework

Professional Ethics Health Communication Social Media

This observational study explores the legal and ethical boundaries of dental communication on social media, analyzing Italian regulatory evolution. Through surveys involving dental professionals and patients, it assesses awareness of advertising regulations and the impact of digital communication on the patient-practitioner relationship. The research identifies knowledge gaps regarding deceptive advertising and highlights the need for transparent, deontologically compliant digital practices to protect public health.

Начало: 01.01.2025 Край: 01.01.2027 Възраст: от 18 г.

Italy University of Roma La Sapienza NCT07550153

Набира участници Фаза 2

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer

Unresectable Locally Recurrent Rectal Cancer

Research Objectives and Principles: Through a prospective study, explore the effectiveness and safety of stereotactic body radiation therapy (SBRT) in the treatment of unresectable locally recurrent rectal cancer (ULRRC), providing high-level evidence for the use of SBRT in ULRRC treatment. Primary Objective: 1-year local progression-free survival (LPFS) . Secondary Objectives: R0 resection rate and overall survival (OS), 2-year LPFS and OS, and side effects of the treatment. Study Design: A single-arm, open-label, prospective phase II study. Study Population and Expected Enrollment: Patients with unresectable locally recurrent rectal adenocarcinoma, with an expected enrollment of 40 patients. Scheduled Visits and Duration: December 2024 to November 2027. Trial Duration: December 2024 to November 2027. Intervention: SBRT for unresectable locally recurrent rectal cancer. Statistical Hypothesis: Enrolled patients are those with unresectable recurrent rectal cancer. Based on previous literature reports and retrospective clinical data from our center, it is hypothesized that the 1-year LPFS for patients with unresectable locally recurrent colorectal cancer who do not receive SBRT is 20%, while the 1-year LPFS for those receiving SBRT intervention is 40%. Using Simon's optimal two-stage study design, a single-arm study, with α set at 0.05 and 1-β at 0.80, and an expected loss to follow-up rate of 10%.

Начало: 01.01.2025 Край: 30.11.2026 Възраст: 18–75 г.

China Sixth Affiliated Hospital, Sun Yat-sen University NCT07297004

Набира участници Фаза 2

Evaluation of BTV100 in Subjects With Dry Eye Disease

Dry Eye

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

Начало: 31.12.2024 Край: 15.02.2026 Възраст: от 18 г. Лечение

Australia, Taiwan BioTheraVision, Inc. NCT06543303

Набира участници

The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles

Ventricular Arrythmia

We believe that the design of the Optrell™ mapping catheter with TRUEref technology allows for faster and more accurate mapping not only due to narrow electrode spacing but also due to the ability to achieve simultaneous contact of multiple bipoles with the surface of the papillary muscle. Simultaneous mapping of multiple sites on the same surface will allow operators to appreciate small activation differences that typically exist between neighboring sites during papillary muscle ventricular arrhythmias. In addition, the position of the Optrell™ mapping catheter on the papillary muscle allows the mapping catheter to move with the papillary muscle rendering a more accurate allocation of the activation time to the surface of the papillary muscle. We also believe that optimal positioning between the Optrell™ mapping catheter and papillary muscles can be assisted by using intracardiac echocardiography. The goal of the study is to explore the utility and superiority of a specific mapping catheter, the Optrell™ mapping catheter with TRUEref.

Начало: 30.12.2024 Край: 30.12.2028 Възраст: 18–75 г.

United States Northwell Health NCT07541092

Набира участници Фаза 1

Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.

Начало: 30.12.2024 Край: 30.08.2027 Възраст: 18–75 г. Лечение

Australia, China Innovent Biologics (Suzhou) Co. Ltd. NCT06613009

Набира участници Фаза 2

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

Treatment Resistant Depression

This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Начало: 30.12.2024 Край: 30.03.2026 Възраст: 18–65 г. Лечение

Australia, Canada, United Kingdom +1 atai Therapeutics, Inc. NCT06524830

Набира участници Фаза 1/2

HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies

Advanced Solid Tumor Malignancies

The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044. HX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.

Начало: 30.12.2024 Край: 31.10.2027 Възраст: 18–75 г. Лечение

Australia Hanx Biopharmaceuticals (Wuhan) Co., Ltd. NCT06649708

Набира участници Фаза 1/2

Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

Advanced Lung Adenocarcinoma

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Начало: 27.12.2024 Край: 01.09.2027 Възраст: от 18 г.

United States The University of Texas Health Science Center at San An NCT06516887

Набира участници

A Long-term Follow-up Study of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)

Locally Advanced Unresectable or Metastatic Gastric Cancer

This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1/CTLA-4 bispecific antibody for marketing, Cadonilimab may confer long-term survival benefits.

Начало: 26.12.2024 Край: 31.12.2040

China Akeso NCT07547787

Набира участници Фаза 2

A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

MTAP-deleted NSCLC

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).

Начало: 26.12.2024 Край: 29.11.2030 Възраст: 18–99 г. Лечение

Australia, Brazil, Canada +13 Amgen NCT06593522

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