Search trials – HealthDB

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Намерени 4,781 изпитвания Стр. 170 от 240

Not yet recruiting

Searching Patterns In the Robustness of Immunological FVIII Tolerance

Hemophilia A Hemophilia A, Congenital

Children with hemophilia A lack clotting factor VIII (FVIII) due to a genetic mutation. It is well known that administration of FVIII concentrate leads to immunological tolerance for the FVIII protein in the majority of children. In 30% of these children tolerance is not achieved leading to the development of anti-FVIII antibodies (i.e. inhibitors). Our knowledge on the underlying immunological mechanisms leading to tolerance is limited. Recently, Non-Factor Therapy (NFT) has become available for prevention of bleeding in patients with hemophilia, i.e. prophylaxis. Currently, many children with severe hemophilia A use NFT as the subcutaneous administration of NFT is very convenient. In children on NFT prophylaxis, intravenous FVIII concentrate is exclusively used on-demand for treatment of bleeding. As NFT is very effective in the prevention of bleeds, patients may not be exposed to the deficient FVIII protein for periods up to a year or longer. It is currently not known how robust immunological tolerance is in the absence of exposure to a deficient antigen. The infrequent exposure to FVIII, enabled by NFT, provides an opportunity to study the immunological tolerance mechanisms for FVIII in children with hemophilia A. The aim of SPIRIT is to investigate the mechanisms of the immunological tolerance to FVIII in patients with hemophilia A aged younger than 18 years using NFT for prophylaxis. In this observational cohort study, children (aged \

Начало: 01.05.2026 Край: 01.03.2029 Възраст: до 18 г.

Netherlands Academisch Medisch Centrum - Universiteit van Amsterdam NCT07539402

Not yet recruiting

ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY

Myocardial Infarction (MI) Sudden Cardiac Death Due to Cardiac Arrhythmia

Although advances in treatment and patient management have considerably improved post-infarction prognosis, the risk of sudden cardiac death remains a major concern. Sudden cardiac death (SCD) is defined as an unexpected death occurring within one hour of the onset of symptoms, often of arrhythmic origin. In patients who have survived a myocardial infarction, sudden death represents a persistent threat. This risk is often associated with complications such as left ventricular dysfunction, malignant ventricular arrhythmias, and structural alterations of the myocardium, all of which can favor the development of fatal cardiac events. Among the risk factors identified, reduced left ventricular ejection fraction, a history of ventricular arrhythmias and the presence of extensive scarring of the myocardium are particularly significant. Assessing the risk of SCD in post-infarction patients is crucial to determining appropriate prevention strategies, such as implanting automatic implantable defibrillators (ICDs). Assessment tools are varied, but currently only left ventricular ejection fraction (LVEF) \< 35% is identified and validated. However, this risk stratification is unsatisfactory, particularly in view of SCD in patients with a history of myocardial infarction and a moderately impaired LVEF (between 35 and 50%). Although the initial treatment of myocardial infarction is essential for the patient's immediate survival, managing the risk of sudden death in the long term remains a major clinical challenge. A multiparametric approach is needed to optimize prognosis and prevent premature death in these patients.

Начало: 01.05.2026 Край: 01.05.2033 Възраст: 18–80 г.

France University Hospital, Clermont-Ferrand NCT07545512

Not yet recruiting Phase 3

Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

Advanced/Metastatic Breast Cancer HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.

Начало: 01.05.2026 Край: 01.04.2031 Възраст: 18–75 г.

China Sun Yat-sen University NCT07543536

Not yet recruiting

Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

Colon Neoplasms Locally Advanced Colon Cancer 3D Reconstruction

The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.

Начало: 01.05.2026 Край: 01.05.2031 Възраст: от 18 г.

Fundació d'investigació Sanitària de les Illes Balears NCT07528937

Not yet recruiting

Host Response and Pathogen Genomics in Childhood Respiratory Infection

Pneumonia

A major challenge in children's infections is that it is difficult to work out which bug is making them unwell. Tests can find the bugs that are present though there can be more than one. Some bugs may just be bystanders and not actually making the child sick. Children still receive antibiotics because it is not always clear that they don't need them. This project explores whether measuring how the body is reacting to the bugs gives precise information about which bug is actually making them sick. It will investigate children in intensive care who are suspected of having a chest infection. This study uses a novel technology called "metagenomics" to detect any bacteria or viruses in the lung. Alongside this, investigators will measure how the lungs respond to the bugs through further tests of cells and proteins collected from the lung fluid. This fluid will be tested to see if the response is due to bacteria or viruses. Collecting lung fluid samples requires that children are sedated and intubated, having a breathing tube in place. This means that only children intubated in intensive care are eligible. Extra samples of lung fluid and blood will be collected when being taken for routine clinical care. If these tests work, they have the potential to give rapid and accurate information about what type of infection is taking place in the lung. This means the correct antibiotics can be given to children who need them and avoid the harms of giving them to children who do not. This can reduce cost, improve patient outcomes and help limit the development of antibiotic resistance.

Начало: 01.05.2026 Край: 01.03.2027 Възраст: до 16 г.

Guy's and St Thomas' NHS Foundation Trust NCT07545096

Not yet recruiting

Investigation of the Effect of Screen Time Before Sleep on Posture Disorders and Dynamic Balance

Postural Disorders Balance Problems

The widespread use of electronic devices such as smartphones, tablets, and laptops has significantly increased screen exposure, especially before sleep. Prolonged screen use may contribute to poor posture by promoting forward head posture, rounded shoulders, and other musculoskeletal problems. In addition, screen exposure before sleep may negatively affect sleep quality and neuromuscular performance, which may in turn influence postural control and balance.

Начало: 01.05.2026 Край: 01.05.2027 Възраст: 18–35 г.

Turkey (Türkiye) Saglik Bilimleri Universitesi NCT07541963

Not yet recruiting

Exercise-Targeted Smart Lifestyle Management

M-health Metabolic Syndrome Lifestyle Alteration Lifestyle (Sedentary Behavior and Physical Activity) +1

To investigate the effects of simple dietary management and diet combined with exercise capacity-targeted intelligent lifestyle management on improving metabolic indicators in patients with overweight/obesity and metabolic syndrome.

Начало: 01.05.2026 Край: 01.06.2027 Възраст: 20–60 г.

China National Center for Cardiovascular Diseases NCT07535333

Not yet recruiting Phase 2

Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5

High-Risk Neuroblastoma

This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.

Начало: 01.05.2026 Край: 01.04.2032 Възраст: 12–21 г.

Israel Shaare Zedek Medical Center NCT07537400

Not yet recruiting

Prophylactic Anti-epileptic Regimen in Traumatic Brain Injury

Antiepileptic Efficacy and Safety Brain Injuries

To evaluate the effectiveness and safety of anti-epileptic drugs in the prevention of early and late post-traumatic seizures among patients with trauma brain injury

Начало: 01.05.2026 Край: 30.06.2027 Възраст: 18–75 г.

Assiut University NCT07535736

Not yet recruiting

Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair

Hernia Incisional

Thousands of patients worldwide undergo abdominal surgery every day; 2-11% of laparotomies will progress to an incisional hernia, particularly midline laparotomies, which are associated with higher hernia rates, reaching up to 70% in obese patients (1,2). Long-term recurrence after incisional hernia repair is close to 30% after primary repair and may increase to 70% in cases of iterative (redo) surgery (3). The main risk factors for incisional hernia formation or recurrence include surgical site infection, surgical technique, respiratory insufficiency (COPD), as well as overweight and obesity, the prevalence of which is rapidly increasing. Midline incisional hernias are the most frequent and represent a significant public health issue. In abdominal wall surgery, some teams perform so-called tension-free repairs, whereas others favor repairs under tension. The tension-free concept may be associated with a lower recurrence rate. However, this intuitive concept has never been mechanically defined, using perioperative pressure measurements or surface tension assessment. Few studies have investigated abdominal pressure and muscle tension measurements in relation to abdominal wall surgery. The aim of this study is to evaluate a protocol for measuring abdominal pressures during open repair of midline incisional hernia.

Начало: 01.05.2026 Край: 01.07.2028 Възраст: от 18 г.

France Centre Hospitalier Universitaire de Nice NCT07531615

Not yet recruiting Phase 1

External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL

Diffuse Large B Cell Lymphoma

The purpose of this clinical trial is to assess the safety and tolerability of ration therapy followed by receiving epcoritamab or glofitamab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Начало: 01.05.2026 Край: 01.05.2031 Възраст: от 18 г.

United States University of Utah NCT07528352

Not yet recruiting

Serratus vs ESP Block for Postoperative Pain in Unilateral Breast Surgery

Post Operative Pain Opioid Use

This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia. The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.

Начало: 01.05.2026 Край: 01.08.2026 Възраст: 18–65 г.

Turkey (Türkiye) Engin Çetin NCT07541040

Not yet recruiting Phase 2

An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

Hypertension (HTN)

The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols.

Начало: 01.05.2026 Край: 30.11.2031 Възраст: от 18 г.

Novartis Pharmaceuticals NCT07543120

Not yet recruiting

Transforming Adolescent Perception and Mental Health Through Meditation and Cognitive Reappraisal A Mixed Method Study

Meditation Cognitive Reappraisal Emotional Regulation

This study will evaluate how a comprehensive meditation-based program, Inner Engineering, supports teens ages 15-18 in becoming more joyful, focused, resilient, and better equipped to manage stress and thrive. Through this study, researchers will examine whether practices like meditation, yoga, and cognitive reframing can help adolescents view and respond to challenges with greater clarity and balance. The study will assess mental and physical impacts through self-report, physiological, and neuroimaging methods.

Начало: 01.05.2026 Край: 01.03.2028 Възраст: 15–18 г.

Beth Israel Deaconess Medical Center NCT07173608

Not yet recruiting

First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation

Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater

The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients. The main questions it aims to answer are: * Does the treatment with the TRICENTO G2 TVSTR improve symptoms of severe tricuspid regurgitation? * Is the treatment with the TRICENTO G2 TVSTR safe? Participants will: * Undergo a minimally invasive procedure for the implantation of the TRICENTO G2 Bioprosthesis using the TRICENTO G2 Delivery System * Visit the clinic for a baseline visit, the procedure itself, 30 days, 3 months, 6 months and 1 year after the procedure

Начало: 01.05.2026 Край: 01.11.2027 Възраст: от 18 г.

Medira GmbH NCT07536724

Not yet recruiting

Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Panama

Knee Cartilage Lesions

The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee. This study will include males and females between the ages of 22 and 60.

Начало: 01.05.2026 Край: 01.08.2027 Възраст: 22–60 г.

Panama Nanochon, Inc. NCT07542184

Not yet recruiting

Areola Preservation in NSM With Nipple Involvement

Breast Cancer Ductal Carcinoma In Situ, DCIS Invasive Breast Carcinoma

Background: During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation. Purpose: This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery. Study Plan: This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group: The nipple is removed. A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved. A new nipple is created during the same operation using a local skin flap technique (purse-string suture). All patients will have immediate breast reconstruction. We plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications. What We Will Measure (Exploratory Endpoints): Safety \& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis). Early Effectiveness: The rate of cancer returning in the breast/chest wall area within 3 years (local recurrence). Patient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery. Why This Study is Important: This is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.

Начало: 01.05.2026 Край: 15.01.2030 Възраст: от 18 г.

China Second Affiliated Hospital, School of Medicine, Zhejian NCT07544134

Not yet recruiting

Transdiagnostic Dimensional Profiling of Neurodevelopmental Disorders

Neurodevelopmental Disorder (Diagnosis)

In recent years, the growing awareness of the multifactorial nature of neurodevelopmental disorders has stimulated interest in transdiagnostic approaches aimed at investigating underlying etiological mechanisms beyond traditional diagnostic categories. In this context, the present study seeks to provide a transdiagnostic profiling of both domain-general cognitive functions (attention, working memory, executive control) and domain-specific functions (phonological awareness, rapid naming, vocabulary, reading) underlying the main neurodevelopmental disorders in a large sample of preschool and school-age children (3-11 years), through the use of CRAB (Computerized Reading-related Assessment Battery). CRAB is a digital platform specifically developed by SUPSI and the Université de Genève to integrate, within a single testing environment, the assessment of the main domain-general and domain-specific cognitive functions underlying neurodevelopmental disorders. In particular, participating families will receive an email containing a link to access the CRAB platform, which will not include their personal data but rather a code provided by the staff of IRCCS Medea. A screen will open displaying several game-like tasks designed to measure both domain-general and domain-specific cognitive functions, which must be completed by the participating subject. The main objective is to obtain a fine-grained and multidimensional mapping of cognitive profiles prior to the standard diagnostic process, in order to identify early patterns of (a)typical or at-risk functioning.

Начало: 01.05.2026 Край: 30.01.2030 Възраст: 3–11 г.

IRCCS Eugenio Medea NCT07544199

Not yet recruiting

Psychoemotional Status and Functional Gastrointestinal Disorders

Functional Dyspepsia Irritable Bowel Syndrome

This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and/or irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.

Начало: 01.05.2026 Край: 01.05.2028 Възраст: от 18 г.

Russia Center of New Medical Technologies NCT07539051

Not yet recruiting

Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units

User Experience Usability Acceptability Satisfaction

Frailty is not related exclusively to age, but represents a state of increased biological and clinical vulnerability characterized by reduced functional reserve and greater susceptibility to adverse events, even in response to minor stress factors. In patients with complex conditions, such as severe acquired brain injuries, early detection and prompt treatment of clinical deterioration are essential to reduce the risk of acute readmission, complications, and in-hospital mortality. Many of these events are potentially predictable and preventable, given the presence of appropriate monitoring systems. Advanced care models, including early warning systems, have been developed to support healthcare professionals in identifying patients at risk by detecting significant changes in physiological parameters. In recent years, technological innovations-particularly in the fields of robotics and telemedicine-have created new opportunities to enhance clinical monitoring, enabling continuous data collection and more timely, proactive interventions. Social assistive robots are emerging as promising tools in healthcare settings. These systems can support clinicians and nurses in routine monitoring activities, help reduce workload, and facilitate more efficient and personalized care. By integrating robotic assistance with digital health platforms, it is possible to improve the quality and responsiveness of patient management, especially in high-complexity environments such as neurorehabilitation units. This study focuses on the use of an innovative robotic telemedicine system based on the integration of the MOVER-L prototype with the ROB.IN.CARE platform, promoted by Item Oxygen (Bari, Italy). The system is designed to continuously monitor patients' clinical conditions, collecting vital parameters and identifying early signs of deterioration. It supports healthcare professionals by providing real-time data and alerts, enabling earlier and more targeted interventions. The study is a low-intensity interventional clinical trial conducted in a Neurorehabilitation Unit. Patients with varying levels of clinical severity, classified according to the Glasgow Coma Scale, are enrolled and divided into two groups: a control group receiving standard care and an experimental group monitored using the robotic system in addition to usual care. The primary objective of the study is to evaluate the feasibility, usability, safety, and reliability of this robotic telemedicine solution in a real clinical setting. In addition, the study assesses its acceptability among both patients and healthcare professionals. These aspects are measured using validated tools, including the System Usability Scale (SUS) and the Health and Safety Executive Stress Scale (HSE), to understand the impact of the technology on user experience and workload. The integrated MOVER-L/ROB.IN.CARE system combines robotic assistance with continuous monitoring of vital signs and advanced software architecture. The platform incorporates predictive algorithms designed to stratify clinical risk and assess patient severity. It utilizes established clinical scoring systems, such as the Modified Early Warning Score (MEWS) for early detection of clinical deterioration, the quick Sequential Organ Failure Assessment (qSOFA) for sepsis risk evaluation, and the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for the assessment of acute kidney injury. By enabling early identification of clinical worsening, the system aims to improve the timeliness and effectiveness of healthcare interventions, optimize clinical workflow, and reduce the risk of adverse events and complications. Ultimately, this study explores whether robotic telemedicine can represent a safe, feasible, and valuable tool to enhance the management of fragile patients in neurorehabilitation settings.

Начало: 01.05.2026 Край: 01.11.2026 Възраст: от 18 г.

Ernesto Losavio NCT07496346

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