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Found 16 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the BETTER4U project, which aims to prevent obesity by improving weight management through personalized interventions powered by modern monitoring tools and artificial intelligence. This pilot study is part of an international effort involving 28 partners across Europe, Israel, and Australia, running from November 2023 to October 2027. The study focuses on assessing the usability, feasibility, and acceptability of the BETTER4U mobile app and intervention platform before they are used in a larger randomized controlled trial. The study involves two groups: "end-users" from the general population who will use a smartwatch and the BETTER4U app for 21 days to monitor behaviors like eating, physical activity, sleep, and environmental factors; and "implementers," healthcare professionals who will test the intervention platform and app for 7 days using synthetic and self-recorded data. End-users' data is collected passively via the wearable devices and self-reports through the app, while implementers provide feedback and assist in validating AI algorithms. Participants will be monitored through wearable devices, online questionnaires, and platform usage metrics. Researchers will gather data on system usability, acceptability, feasibility, and intervention appropriateness using standardized scales at the end of each group’s participation. The study will last three weeks for end-users and one week for implementers, with outcomes guiding further development and optimization of the BETTER4U tools for future larger trials.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
7 locations
B

Actively Recruiting

Researchers are studying how the ability to manage emotions and changes in brain activity caused by stress relate to the risk of relapse in smokers trying to quit. The trial looks at how these factors, along with stress responses, affect cravings, sticking to abstinence, and reactions to a smoking cessation program. The study focuses on smokers aged 18 to 60 who smoke at least 10 cigarettes daily and want to quit. The study is divided into three phases. First, participants smoke as usual while baseline assessments of emotion regulation, brain activity using quantitative electroencephalography (qEEG), stress hormones, and cravings are collected before and after a stress task. Second, participants abstain from smoking for 24 hours, during which the same measures plus withdrawal symptoms and cue-induced cravings are assessed. Finally, participants take part in a computerized smoking cessation program called Flexiquit for 6 months. This avatar-led program provides motivational support, education, coping strategies, relapse prevention, and emotion regulation training, with adherence monitored throughout. Participants are evaluated before quitting and during follow-up visits at 3 and 6 months to confirm abstinence through biochemical tests. Researchers monitor smoking lapses and time to relapse. They also assess changes in emotion regulation, brain activity, stress responses, withdrawal symptoms, and cravings throughout the study. The goal is to identify patterns that predict relapse risk and improve smoking cessation outcomes.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
1 location
B

Actively Recruiting

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare blood cancer recognized as a distinct disease since 2008. There is currently no agreed-upon best treatment for BPDCN, and because the disease is so uncommon, international collaboration is needed to collect detailed information on how BPDCN presents, is diagnosed, and responds to different treatments. The study aims to build a large global database of BPDCN patients, examine disease characteristics and outcomes across various treatments, identify factors that affect prognosis, and develop treatment recommendations based on collected data. This study is an international registry collecting both past and new patient data from multiple centers worldwide. Participating centers gather detailed patient information through questionnaires, including patient and disease characteristics, treatment details, outcomes, causes of death, and the timing of data collection. The registry does not involve any experimental treatments but focuses on collecting comprehensive clinical data to better understand BPDCN. Participants provide informed consent if enrolled prospectively, and data quality is managed by the Immune Oncology Research Institute. Researchers will analyze overall survival over five years as a key outcome. This registry supports ongoing monitoring and data collection to improve knowledge about BPDCN and guide future treatment strategies.

All Genders
20 locations
B

Actively Recruiting

Benign prostatic hyperplasia (BPH) is a common condition affecting men, especially as they age, with up to 90% of men experiencing it by age 80. This research aims to create an ongoing international registry to collect and analyze demographic and clinical data from men with BPH who receive either medical therapy or surgical treatments. The registry helps track treatment patterns and outcomes worldwide to better understand the effectiveness and complications related to various BPH treatments. The registry collects detailed baseline information including patient-reported symptoms, sexual health, quality of life, urinary flow, and laboratory values such as prostate-specific antigen and testosterone. It also records any complications like bleeding, infections, incontinence, strictures, ejaculation issues, and erectile dysfunction. This data is gathered over a three-year period with no set endpoint, allowing for long-term follow-up and analysis of real-world treatment results. Participants provide medical records which are securely stored and accessed only by authorized users. The study monitors symptoms using standardized scores and quality of life measures, along with clinical tests such as post-void residual urine volume. Regular audits ensure data accuracy, and the registry’s technology supports future integration with patient portals and electronic medical records. The study duration is planned for at least three years, with possible extensions to continue follow-up and research.

Age: 18Years +MALE
26 locations
B

Actively Recruiting

Researchers are evaluating two different interventions to manage cognitive symptoms caused by long COVID. This experimental study involves adults aged 25 to 60 who report cognitive difficulties following COVID-19 infection and meet the WHO Long COVID criteria. The study aims to better understand how these treatments affect cognition and quality of life in people with post-COVID cognitive symptoms. Participants will be randomly assigned to one of two groups. One group will receive active transcranial direct current stimulation (tDCS) combined with cognitive training using the digitalized Categorization Program. The other group will receive cognitive training with sham (placebo) tDCS. Both groups will participate in 15 one-hour sessions over three weeks, with two tDCS sessions plus cognitive training each session for the active group and cognitive training with sham tDCS for the control group. Throughout the study, participants will undergo neuropsychological assessments and quality of life questionnaires before and after the intervention. Functional near-infrared spectroscopy (fNIRS) will be used to measure brain function pre- and post-treatment. Outcome measures include various cognitive tests and questionnaires administered at multiple time points over the six-week period. The study will monitor changes in cognition and quality of life to evaluate the effects of the interventions.

Age: 25Years - 60YearsFEMALEPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating the effects of exercise with blood flow restriction (BFR) in patients who have a complete tear of the anterior cruciate ligament (ACL). The study aims to find out whether adding BFR to standard conservative treatment offers any extra benefits, and whether using a knee brace helps the ACL heal on its own. This is a randomized clinical trial comparing bracing with BFR to bracing with sham BFR (a placebo version) to see if BFR adds value to usual treatment. Participants will use a knee brace for six weeks with specific adjustments at different stages to control knee motion and weight bearing. During this time, they will follow a detailed exercise program. The intervention group will perform exercises with BFR applied, while the control group will do the same exercises with a sham BFR. Exercises progress through phases, starting with isometric muscle contractions and gradually including movements like squats, step climbing, and treadmill walking. Home-based exercises are also provided through an electronic platform that monitors compliance and guides proper exercise execution. Participants will undergo initial assessments including MRI, strength measurements, swelling, pain, and functional scales. Strength, swelling, and pain will be reassessed at two and four weeks, with all initial measures repeated at the end of 12 weeks. The study monitors the participants closely throughout the intervention to evaluate changes and the safety of treatments over the full 12-week period.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
2 locations
F

Actively Recruiting

This observational study aims to gather clinical data on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO Aortic Arch Stent Graft System for treating aortic aneurysms. It focuses on assessing early mortality, safety outcomes, device failure, and procedural and hospitalization information in patients treated according to standard care. The study includes participants who have been implanted with these devices since February 2019 or are indicated for implant according to device instructions. Participants will receive treatment as part of their usual care without additional interventions from the study. The study design includes two arms and collects data prospectively or retrospectively in an open-label, multi-center setting. Follow-up will continue for up to five years to monitor long-term safety and device performance. During the study, researchers will collect information on mortality within 30 days, safety throughout the study period, and any device failures. Clinical data, hospitalization details, and procedural outcomes will be recorded. Participants must provide informed consent and be available for follow-up visits, with ongoing assessment of their health status and renal function as deemed necessary by their physician.

Age: 18Years +All Genders
18 locations
I

Actively Recruiting

Researchers are evaluating the effects of beta-blocker use in adults undergoing transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis. This multicenter, randomized clinical trial focuses on patients already receiving beta-blockers, randomly assigning them to either continue or stop the medication at least 72 hours before and for 7 days after TAVI. The main goal is to compare the rates of permanent pacemaker implantation within 7 days after the procedure, with additional outcomes including death, cardiogenic shock, and various heart rhythm abnormalities tracked over 12 months. Participants will be randomly assigned in a 1:1 ratio to either continue beta-blockers or stop them 72 hours before TAVI and resume at least 7 days after. The TAVI procedure involves selecting the access site, valve type, and anesthesia based on the operator's decision. Standard antithrombotic and antibiotic treatments are given according to hospital protocols. After TAVI, patients receive post-procedure care including ECG, blood tests, and echocardiography. If needed, beta-blockers may be restarted earlier for safety reasons, and any changes in medication or crossover between groups will be recorded. Participants undergo screening up to 3 months before TAVI, including medical history, medication review, ECG, echocardiography, and blood tests. Follow-up visits occur at discharge, 7 days, 30 days, and 12 months post-TAVI to monitor outcomes, adverse events, and heart function. Data on permanent pacemaker implantation, mortality, arrhythmias, and conduction blocks are collected during this period. The study prioritizes patient safety with continuous monitoring and includes detailed documentation and reporting of all events throughout the study duration.

Age: 18Years +All GendersPhase 4
2 locations
P

Actively Recruiting

Emergency laparotomy is a high-risk surgery often performed on elderly patients who tend to have reduced physiological reserve, frailty, and multiple health conditions. Researchers are evaluating the effect of a structured postoperative physiotherapy program on patients aged 65 years and older undergoing emergency laparotomy. The study aims to assess how this physiotherapy impacts functional recovery and clinical outcomes in this vulnerable population. This multicenter randomized controlled trial enrolls patients aged 65 and above who have emergency laparotomy at two hospitals in Cyprus and Greece. Participants are randomly assigned to either a structured five-day postoperative physiotherapy program involving progressive mobilization, supervised exercises, respiratory training every two hours, and family-supported self-practice, or to usual postoperative care that includes general mobilization and basic breathing instructions without structured progression or monitoring. Participants will be monitored for functional recovery using validated measures during their hospital stay and at 30 and 90 days after discharge. Researchers will also assess secondary outcomes such as postoperative complications, pulmonary complications, length of hospital stay, mortality, and health-related quality of life. The study will follow participants closely to record these outcomes and compare results between the two groups according to intention-to-treat analysis.

Age: 65Years +All GendersPhase Not Applicable
1 location
P

Actively Recruiting

Researchers are studying whether taking probiotics can reduce brain inflammation, improve thinking skills, and change brain activity in people aged 65 to 85 with mild Alzheimer's Disease. This early phase 1 trial compares patients who receive a probiotic capsule to those who receive a placebo, focusing on people with mild cognitive impairment as measured by specific mental tests. Participants will take a probiotic capsule containing a blend of five types of beneficial bacteria or a placebo. The study lasts 16 weeks, during which the effects on inflammation, brain function, and gut bacteria will be monitored. The probiotic contains 20 million CFU of several Lactobacillus and Bifidobacterium strains. Throughout the study, blood tests will measure inflammation markers at the start and end of the trial. Cognitive tests, brain activity measurements, analysis of gut microbiome, and dietary habit assessments will also be performed. Researchers will carefully monitor participant safety and study progress over the 16 weeks to understand how probiotics might affect mild Alzheimer's Disease.

Age: 65Years - 85YearsAll GendersEarly Phase 1
1 location

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