+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Search Bar & Filters

Found 6 Actively Recruiting clinical trials

C

Actively Recruiting

This research focuses on men suspected of having prostate cancer and aims to compare two approaches for deciding when to perform prostate biopsies after MRI scans. The study evaluates whether biopsies guided by shared decision-making based on prostate cancer risk estimation differ in detecting significant cancer compared to biopsies performed routinely after MRI. Researchers seek to improve diagnosis while reducing unnecessary biopsies and have enrolled 600 patients from multiple hospital districts for this randomized trial. Participants undergo biparametric MRI bpMRI scans interpreted by an experienced urologist using specific scoring systems. Men are randomly assigned to two groups in the control group, all men receive biopsies after MRI in the intervention group, biopsies are done only after a shared decision process considering individual risk. Biopsies involve systematic and targeted samples depending on MRI findings. Men without biopsies or with negative results enter a five-year follow-up with regular PSA tests. During the study, participants undergo MRI scans, prostate biopsies when indicated, and follow-up PSA testing every six months for five years. Researchers assess the proportion of men with clinically significant prostate cancer Gleason 43 or higher at baseline, biopsy complications, anxiety levels through questionnaires, and biopsy rates. Long-term follow-up continues for 15 years using health records and registries to monitor outcomes beyond the initial study period.

Age: 18Years +MALEPhase Not Applicable
4 locations
C

Actively Recruiting

This research evaluates the use of drug-coated balloons DCB compared to drug-eluting stents DES in patients with stable coronary artery disease CAD or acute coronary syndrome ACS who are at high risk of bleeding. The study aims to test whether using DCB with a shorter dual antiplatelet therapy DAPT regimen is not worse than using DES with a longer DAPT duration. If the DCB strategy is found not inferior, its superiority over DES will be further assessed. Participants will receive either a DCB or a DES during percutaneous coronary intervention PCI. The DCB group uses the SeQuent Please device combined with a tailored antithrombotic regimen based on patient stability and oral anticoagulation use. The DES group involves implantation of various CE-marked drug-eluting stents alongside individualized antithrombotic treatment. Treatment regimens vary between stable patients and those with ACS, with differences in DAPT duration and lifelong therapies. Throughout the study, participants are monitored for major adverse cardiac events MACE and bleeding episodes using the BARC classification over 12 months as the primary outcome. Additional outcomes include mortality, revascularization events, myocardial infarction, stroke, and bleeding tracked up to 36 months. The study uses a randomized, triple-blind design to compare these treatments with ongoing safety and efficacy assessments.

Age: 18Years +All GendersPhase Not Applicable
14 locations
C

Actively Recruiting

This research evaluates treatment methods for older adults aged 65 years or older who have displaced distal radius fractures caused by low-energy injuries. It compares casting without prior closed reduction to casting after closed reduction to see if they provide equivalent results in wrist pain and disability after 12 months. The study is a randomized controlled trial including 532 participants and led by Tampere University Hospital, focusing on the Patient-Rated Wrist Evaluation PRWE score as the primary measure. Participants are randomly assigned to one of two groups one receiving a dorsal cast without reduction right after the initial x-ray, and the other undergoing closed reduction under local anesthesia followed by casting. Both groups have their casts removed after 5 weeks and are encouraged to resume normal wrist use without restrictions. An observational group receiving standard care without randomization is also followed remotely. Follow-up visits occur at 3 and 12 months, with radiographs taken at 3 months only. Participants will attend follow-up appointments in person or remotely, completing questionnaires and wearing accelerometer wristbands if remote. Data is collected via the REDCap system. Outcomes measured include wrist function, pain, quality of life, and adverse events. Patients with ongoing symptoms may receive physiotherapy for up to one year and further evaluation if needed. A 5-year follow-up is planned as an exploratory endpoint to monitor long-term results.

Age: 65Years +All GendersPhase Not Applicable
10 locations
N

Actively Recruiting

Researchers are evaluating the outcomes of a nonoperative management approach for rectal cancer in patients who have a complete clinical response after neoadjuvant therapy. This prospective, non-randomized, single-arm international trial aims to establish a unified protocol and compare the oncological results and organ preservation rates with practices worldwide. The study focuses on disease-free survival two years after starting nonoperative management as the primary endpoint. Patients with confirmed complete clinical response after standard neoadjuvant treatment undergo nonoperative surveillance involving clinical examinations, laboratory tests, and imaging such as digital rectal exams, endoscopy, rectal MRI, and body CT scans. This single treatment arm follows a watch-and-wait approach to monitor for local regrowth or distant spread, avoiding surgery unless cancer recurs. Follow-up visits occur every three months for the first two years and every six months for the next three years. Participants will be closely monitored through clinical assessments and imaging to detect any recurrence or metastases. Researchers will measure survival outcomes, organ preservation rates, quality of life, and treatment-related complications up to five years. Data are collected securely and pseudonymously, with costs of follow-up covered by the healthcare system. The study may end at a center if local recurrence exceeds 30% after complete clinical response.

Age: 18Years +All GendersPhase Not Applicable
13 locations
S

Actively Recruiting

Urothelial cancers of the bladder and upper urinary tract cause significant illness and death worldwide, with over 600,000 new cases and 200,000 deaths annually. Patients often present with hematuria blood in urine, leading to many cystoscopiesan invasive bladder examination. However, only about 10% of these cystoscopies result in a cancer diagnosis. This observational study aims to evaluate whether urine tumor DNA utDNA testing can replace many cystoscopies in diagnosing urothelial cancer, potentially improving patient quality of life and reducing healthcare costs and workload in urology centers. The study involves collecting urine samples by mail, which will be analyzed without knowledge of patients cancer status. Patients scheduled for cystoscopy to rule out urothelial cancer will be included, and a random subsampling process will balance cancer-positive and cancer-negative groups. The study will follow patients to compare the sensitivity and specificity of utDNA testing against cystoscopy and urine cytology, assessing the potential to avoid invasive procedures. Participants will provide informed consent and submit urine samples by mail. Researchers will monitor outcomes such as test accuracy, time to diagnosis, adverse events related to cystoscopy, and the number of cystoscopies potentially avoided. Follow-up will extend up to 10 years to evaluate long-term diagnostic outcomes and safety. The study duration includes diagnostic workup and extended monitoring to measure the effectiveness of utDNA testing in clinical practice.

Age: 18Years - 100YearsAll Genders
8 locations
S

Actively Recruiting

Researchers are investigating whether a simple home exercise program can help people with advanced chronic kidney disease CKD. The study also includes an observational part without any exercise program to understand the links between cardiovascular and kidney health, exercise ability, and negative health outcomes. The study focuses on patients over 40 years old who have severe kidney impairment and are at high risk for death, heart problems, hospital visits, and bone fractures. Participants in the study are randomly assigned to either receive education from a physiotherapist on how to perform physical training and exercise regularly at home at least three times a week, or to continue with their usual care without the exercise program. The study tracks outcomes over several years, with a focus on hospitalizations, mortality, major cardiovascular or cerebrovascular events, emergency visits, walking distance, kidney replacement therapy, and compliance with the exercise program. During the study, researchers will collect data on physical tests like the six-minute walk and maximal oxygen uptake, quality of life, bone fractures, blood tests, and X-rays. These measurements will occur at multiple time points up to the end of 2031. The study aims to understand how frailty and physical and psychological capabilities relate to health events and treatment outcomes in patients with advanced CKD.

Age: 40Years +All GendersPhase Not Applicable
3 locations