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Набира участници

CCM OPEN HF Registry

Heart Failure

The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.

Начало: 01.11.2025 Край: 01.08.2036 Възраст: от 18 г.

United States Impulse Dynamics NCT07112924

Набира участници

Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.

Appendicitis Acute Gangrenous Appendicitis

PHASE II-III CLINICAL TRIAL TO EVALUATE THE SAFETY, EFFECTIVENESS AND EFFICIENCY OF DISCHARGE TO OUTPATIENT SURGERY IN PATIENTS WITH ACUTE GANGRENOUS APPENDICITIS UNDERGOING EMERGENCY SURGERY.

Начало: 01.11.2025 Край: 01.11.2027 Възраст: от 14 г.

Spain Fundación Pública Andaluza para la gestión de la Invest NCT07521969

Набира участници

COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)

Ulcerative Colitis, Pediatric Inflammatory Bowel Diseases Crohn Disease

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is: Are the newer medications used to treat IBD just as safe and effective for treating IBD in children. Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.

Начало: 01.11.2025 Край: 01.09.2028 Възраст: 1–18 г.

United States University of North Carolina, Chapel Hill NCT07198113

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Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.

Pulmonary Hypertension Due to Left Heart Disease Pulmonary Hypertension (PH) Heart Failure

Previous data from our group showed reduced BMPR2 isoform A in pulmonary hypertension associated with left heart disease (PH-LHD) of valvular origin. Focusing on dysregulation of the BMPR2-activin pathway, a key regulator of vascular homeostasis, this project uses a multimodal approach combining molecular biology, advanced cardiac imaging, and histology. Its aim is to determine the role of the BMPR2-activin pathway in the development and regression of PH-LHD. We will conduct a prospective observational study with 1-year follow-up in 150 heart failure patients of different etiologies undergoing hemodynamic assessment. Clinical parameters, biomarkers, molecular profiles, and hemodynamic/echocardiographic variables will be analyzed. A nested substudy in 40 heart transplant candidates will include thoracic CT for vascular morphometric analysis and histological correlation in explanted hearts versus healthy controls. We will also assess reversibility of vascular remodeling one year after transplantation. Results may redefine PH-LHD classification, enable phenotypic precision-medicine models, guide targeted therapies such as activin inhibitors, and refine transplant criteria in combined pulmonary hypertension.

Начало: 01.11.2025 Край: 31.12.2028 Възраст: от 18 г.

Spain Hospital General Universitario Gregorio Marañon NCT07537517

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Oral Microbiome in Carotid Atherosclerosis

Atherosclerosis Cardiovascular Disease Atherosclerosis of Artery Carotid Artery Plaque Periodontitis +1

The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke. Researchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke. The study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project. The main questions the study aims to answer are: Do people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture? Are the bacteria found in vulnerable plaques different from those in stable plaques? Are similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body? What participants will do: Have their oral health checked before surgery, including an exam of gum disease and tooth infections. Provide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery). Have preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility. All samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type. The study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care. Researchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability. The results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.

Начало: 01.11.2025 Край: 01.11.2029 Възраст: от 18 г.

Hungary Semmelweis University Heart and Vascular Center NCT07296965

Набира участници Фаза 1/2

FACE Phase II (a Stage II Trial)

MCI Subjective Cognitive Decline (SCD) Mild Behavioral Impairment

How to ensure adherence to computerized cognitive training in unsupervised circumstances (e.g., at-home, self-administered) in older adults at risk for Alzheimer's disease (AD) or AD related dementia (AD/ADRD) is understudied. The objective of the R33 study is to test a novel facial expression-based personalization engine (FPE) for monitoring and modulating real-time effective engagement, with an ultimate goal of enhancing long-term adherence in unsupervised cognitive training in older adults at risk for AD/ADRD. Here, Effective engagement is defined as the extent to which someone is actively engaged and performing with significant attention and enjoyment while training, addressing a balance between adherence and cognitive gains/plasticity from the training. Based on previous work, the hypotheses include that (1) mental fatigue revealed in facial expressions will reflect a trainee's degree of effective engagement, which can be modified by modulating task novelty; (2) the proposed FPE will ensure the effective engagement in cognitive training by monitoring trainee facial expressions and modulating training in response, promoting the trainee's long-term adherence to the training and cognitive plasticity. A Stage II intervention efficacy study will be conducted to compare effective engagement and adherence in unsupervised cognitive training between training programs with vs. without FPE in older adults at risk for AD/ADRD. The proposed FPE may assist in monitoring and improving effective engagement and adherence in older adults with unsupervised cognitive training. In the current application, FPE in a cognitive training program called speed of processing training will be tested. However, such FPE may be embedded to any computerized cognitive training in future studies to help address adherence related issues.

Начало: 31.10.2025 Край: 31.08.2028 Възраст: 60–89 г.

United States Stanford University NCT07130669

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Decoding Emotional Dynamics in Bipolar Disorder

Bipolar Disorder I or II Healthy (Controls)

The goal of this neuroimaging study is to investigate how emotional states fluctuate in people with bipolar disorder (BD) compared to healthy controls, and to understand the neural mechanisms driving mood instability. The main questions it aims to answer are: * Can emotional states be decoded from fMRI brain activity using machine learning? * Do individuals with BD show more unstable emotional state trajectories (e.g., high metastability, low fractal scaling) than healthy controls? * Does amplifying positive emotions stabilize brain and emotional dynamics in BD? Researchers will compare individuals with bipolar disorder (BD-I or BD-II, currently depressed or mixed state) to healthy controls without psychiatric history to see whether the BD group shows greater fluctuations in emotional brain activity and whether positive emotion regulation strategies normalize this instability. Participants will: * Complete self-report questionnaires on mood, emotion regulation, anxiety, and daily functioning. * Recall and provide short descriptions of personal positive and negative memories to be used in the MRI task. * Undergo fMRI scanning, including: * Resting-state scans * A Think and Regulate Affective States Task (TReAT) where they recall autobiographical memories, rate emotions, and practice amplifying positive mood. * Structural and diffusion MRI for brain mapping. * Receive physiological monitoring (heart rate, respiration) during scanning. * Complete post-scan surveys on emotional state and task experience. This research will help clarify how the brain supports or disrupts emotional regulation in bipolar disorder and may inform the development of personalized, neurobiologically informed treatments for mood instability.

Начало: 30.10.2025 Край: 01.11.2028 Възраст: 18–65 г.

United States Laureate Institute for Brain Research, Inc. NCT07221864

Набира участници Фаза 3

A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer

Breast Cancer

A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.

Начало: 30.10.2025 Край: 02.02.2028 Възраст: от 18 г.

China, France, Italy +3 AstraZeneca NCT07205822

Набира участници

Optimizing Care Transition Process for Older Colorectal Surgery Patients

Colorectal Surgery Care Transition Older Adults (65 Years and Older)

The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.

Начало: 30.10.2025 Край: 01.12.2027 Възраст: от 65 г.

United States Massachusetts General Hospital NCT06752031

Набира участници Фаза 4

Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination

Diabetes Mellitus Type 2 DM

The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

Начало: 30.10.2025 Край: 30.06.2026 Възраст: 18–80 г.

Pakistan Nabiqasim Industries (Pvt) Ltd NCT06862739

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Well-being in IBS: Strengths and Happiness (WISH) 2.0

Irritable Bowel Syndrome

The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.

Начало: 30.10.2025 Край: 01.08.2028 Възраст: от 18 г.

United States Massachusetts General Hospital NCT06866106

Набира участници Фаза 3

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

Breast Neoplasms

This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.

Начало: 30.10.2025 Край: 01.09.2030 Възраст: от 18 г. Лечение

Australia, Belgium, China +9 BioNTech SE NCT07173751

Набира участници Фаза 2

Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)

Pompe Disease

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.

Начало: 30.10.2025 Край: 08.08.2027 Възраст: от 18 г.

Belgium, Denmark, France +6 Shionogi NCT07123155

Набира участници Фаза 3

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

Respiratory Syncytial Virus Infections

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.

Начало: 29.10.2025 Край: 14.12.2026 Възраст: 18–59 г.

China GlaxoSmithKline NCT07220109

Набира участници Фаза 2

A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

Atrial Fibrillation

A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

Начало: 28.10.2025 Край: 09.09.2027 Възраст: от 18 г.

Canada, China, Germany +4 Novartis Pharmaceuticals NCT07217067

Набира участници

Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation

Hypertension Cardiovascular Diseases Vascular Diseases

This observational study will assess the long-term effectiveness of the RDN procedure for lowering blood pressure in Medicare patients with uncontrolled hypertension. This research will be conducted using de-identified electronic health records (EHR) and administrative health insurance claims data. Patients are enrolled through the submission of claims or encounter data to CMS.

Начало: 28.10.2025 Край: 01.06.2029 Възраст: от 18 г.

United States Medtronic Vascular NCT07174622

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An Open-label Prospective Study to Evaluate the Efficacy and Safety of Pegfilgrastim in Triple-Negative Breast Cancer Patients Receiving AC Regimen Following Paclitaxel and Carboplatin as Neoadjuvant Therapy

Triple-Negative Breast Cancer

This open-label, prospective, single-arm clinical study aims to evaluate the efficacy and safety of pegfilgrastim in preventing febrile neutropenia (FN) among patients with triple-negative breast cancer (TNBC) receiving anthracycline/cyclophosphamide (AC) chemotherapy following neoadjuvant paclitaxel/carboplatin therapy. In the Keynote-522 regimen, paclitaxel and carboplatin are administered prior to the AC phase, which may increase cumulative myelosuppression and subsequently elevate the risk of FN during AC. Despite this clinical concern, real-world evidence supporting the prophylactic use of pegfilgrastim in Korean patients undergoing this regimen remains insufficient. A total of 40 adult TNBC patients will be enrolled. Pegfilgrastim 6 mg will be administered subcutaneously once per cycle on Day 2 of each AC cycle (Cycles 1-4), approximately 24 hours after chemotherapy completion. The primary objective is to assess the incidence of FN during the four AC cycles. Secondary objectives include hospitalization due to FN, incidence of Grade 4 neutropenia, delays or dose reductions in chemotherapy due to neutropenia, and evaluation of hematologic and non-hematologic toxicities. This study is descriptive in nature and does not involve hypothesis-testing sample size calculations. The sample size of 40 was determined based on feasible drug supply and is expected to provide clinically meaningful insight when compared with existing real-world data, in which the FN risk during AC without prophylactic G-CSF is historically reported at approximately 20-25%. The findings from this study may offer essential clinical evidence supporting the preventive use of pegfilgrastim during the AC phase in TNBC patients treated with the paclitaxel/carboplatin-leading neoadjuvant regimen.

Начало: 28.10.2025 Край: 27.10.2026 Възраст: 19–70 г.

South Korea Yonsei University NCT07525869

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OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels

Cardiac Failure Graft Rejection

This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.

Начало: 28.10.2025 Край: 01.01.2032 Възраст: 18–99 г.

United States Inova Health Care Services NCT06939751

Набира участници Фаза 3

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

Idiopathic Pulmonary Fibrosis (IPF)

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

Начало: 27.10.2025 Край: 15.02.2032 Възраст: 40–80 г.

China Sunshine Lake Pharma Co., Ltd. NCT07082842

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CORE (Cognitive Optimization Through Rehabilitation and Education) Study

Mild Traumatic Brain Injury; Concussion

Mild traumatic brain injury (mTBI) affects millions of individuals worldwide every year. It has long been thought that the vast majority of individuals who sustain a mTBI experience natural recovery with little or no intervention and return to baseline functioning within days to weeks of injury. However, recent large studies have demonstrated that a substantial number of individuals experience prolonged symptoms (e.g., cognitive impairment, headaches, affective symptoms). These symptoms, termed "Persistent Post-concussive Symptoms" (PPCS) are associated with significant functional disability and reduced quality of life (QOL) and can last for years post-injury. While PPCS can include affective, cognitive, and somatosensory/vestibular symptoms, objective and subjective cognitive symptoms - particularly in the domains of attention, memory, processing speed, and executive function - are among the most commonly reported following mTBI. There is currently no gold-standard intervention to address these symptoms. To address this gap, our research group developed a brief cognitive rehabilitation intervention called Tools for Rehabilitation and Cognitive Care (or On-TRACC). The goals of this clinical trial are: AIM 1: Compare the efficacy of On-TRACC to a psychoeducation control on reduction of self-reported cognitive post-concussive symptoms (Aim 1.1) and overall neurobehavioral post concussive symptoms and (Aim 1.2) following treatment and at 3-month follow-up (Aim 1.3) in a randomized clinical trial of community-dwelling adults with mTBI. AIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory strategy use, self-management skills, and quality of life at post-treatment and 3-month follow-up. Exploratory AIM 3: Compare the efficacy of On-TRACC and psychoeducation on: primary and secondary outcomes at 6-months post-treatment and (Aim 3.1) explore whether engaging in On-TRACC leads to subsequent engagement in care by assessing whether there is a different level of participation in optional intervention booster sessions in the post-intervention period (Aim 3.2). All participants will: * Complete a series of assessments * Complete 6 treatment sessions via telehealth (either On-TRACC or psychoeducation) All participants will have the option of: * Attending weekly "Booster Sessions" between 3 and 6-months post-treatment * Completing neuropsychological assessments at 2 timepoints during the study

Начало: 27.10.2025 Край: 01.09.2029 Възраст: от 18 г.

United States University of Washington NCT06859996

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