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Found 12 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating two treatment approaches for patients with acute atrial fibrillation or atrial flutter when rhythm control is desired. The study compares conventional acute cardioversion performed within 48 hours in the emergency department to elective delayed cardioversion performed approximately one week later in an out-patient clinic. The goal is to see if these arrhythmias can be safely managed with an elective timing approach. Participants are randomly assigned to either immediate cardioversion in the emergency department or to an elective delayed cardioversion after discharge. All patients receive anticoagulation treatment according to guidelines, with extra precautions such as transesophageal cardiac ultrasound if needed before delayed cardioversion. Patients in the elective group can choose early cardioversion if symptoms become unmanageable before the scheduled out-patient visit. Participants undergo follow-up visits including a cardiologist assessment about one week after enrollment and further assessments one month later with an ECG to check heart rhythm. Quality of life and symptom monitoring occur during the first week and one month after the clinic visit. Patients are then followed up for up to five years to monitor any medical interventions related to atrial fibrillation or flutter. New antiarrhythmic drugs like flecainide are not used during the first month.

All GendersPhase Not Applicable
4 locations
C

Actively Recruiting

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.

Age: 75Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

This research focuses on patients undergoing laparoscopic colorectal surgery for various conditions. It aims to evaluate heart rate variability HRV parameters, such as RMSSD, before and after surgery to understand how surgical effects and possible complications impact these measurements and relate to specific adverse outcomes. Participants receive standard colorectal surgery followed by monitoring using the PulseOn device to measure HRV after the operation. The study specifically examines changes in HRV within three days post-surgery to assess recovery and complications. During the study, participants HRV is tracked before and after surgery, with data collected via the PulseOn device. Researchers monitor HRV changes and complications to evaluate recovery quality. The total participation involves preoperative and postoperative assessments focused on physiological monitoring within the first few days after surgery.

Age: 18Years - 100YearsAll GendersPhase Not Applicable
1 location
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
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Actively Recruiting

Researchers are evaluating the use of mobile-device assisted management of hypertension combined with screening for hidden atrial fibrillation in patients who recently experienced an ischemic stroke or transient ischemic attack TIA. The trial aims to compare this approach to standard care in reducing cardiovascular risks. The study focuses on detecting atrial fibrillation, a key treatable risk factor, and improving blood pressure control, both important for preventing recurrent strokes. Participants are randomly assigned in a 21 ratio to either the standard diagnostic work-up and treatment group or an intervention group. The intervention involves 3 weeks of continuous ECG monitoring to detect hidden atrial fibrillation and monthly self-monitoring of blood pressure for one week with self-adjustment of blood pressure medications guided by a mobile device application. The control group receives usual follow-up and hypertension management without these additional technologies. During the 12-month study period, researchers will measure the incidence of new atrial fibrillation cases and changes in average blood pressure. Secondary outcomes include new cardiovascular events and healthcare costs up to 36 months. Participants will undergo regular assessments and follow-up to monitor these outcomes, with safety and adherence tracked throughout the study.

Age: 40Years +All GendersPhase Not Applicable
4 locations
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Actively Recruiting

Healthy Volunteer

Endometriosis is a long-lasting condition where tissue similar to the lining inside the uterus grows outside it, causing pain and fertility problems for many women of reproductive age. This research aims to find specific RNA and protein markers in endometriosis tissue and normal uterine lining to help develop new treatments and diagnostic tools. The study also seeks to identify markers that predict disease progression and infertility through a detailed 10-year follow-up. Participants include women aged 19 to 48 years either with surgically confirmed endometriosis or healthy women without endometriosis confirmed by laparoscopy during sterilization. The study involves collecting tissue samples during surgery by laparoscopy or laparotomy for analysis of hormone metabolism and gene expression. Healthy volunteers are also included to provide comparison samples. During the study, researchers will collect samples during surgery and follow participants annually for up to 10 years using questionnaires about pain symptoms, fertility, and treatments. The study measures hormone levels and gene expression in tissues and blood, and tracks pain recurrence after surgery. This long-term follow-up aims to better understand disease behavior and support development of personalized treatment options.

Age: 19Years - 48YearsFEMALE
4 locations
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Actively Recruiting

Researchers are evaluating a health psychological group rehabilitation program for patients diagnosed with Chronic Fatigue Syndrome MECFS, a condition marked by long-lasting fatigue, cognitive difficulties, and issues with standing up orthostatic intolerance. The study aims to improve overall functioning and illness management by exploring group therapy effects and comparing treated patients with a control group receiving health counseling. The study includes two groups one receives eight group rehabilitation sessions over four months focusing on stress management, pacing, coping, emotional support, and autonomic nervous system concerns. The control group attends six sessions over three months on health, lifestyle, and wellbeing counseling covering sleep, nutrition, and daily activities. Participants are randomly assigned to either group. Participants will undergo psychological and psychiatric assessments, laboratory tests, and autonomic nervous system antibody measurements before and after the intervention, plus a three-month follow-up. Outcomes include disability and autonomic symptom assessments, anxiety and depression scales, sense of coherence, fatigue severity, and patient health questionnaires. The total study duration includes rehabilitation and follow-up periods, with progress evaluated at multiple time points.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

This research evaluates the effects of nature-based therapies on patients undergoing stroke rehabilitation in a hospital ward. It aims to compare the outcomes of patients receiving additional outdoor therapy sessions with those performing conventional indoor rehabilitation tasks. The study is randomized and controlled, focusing on stroke rehabilitation, and monitors physical, psychological, and microbiological changes during the recovery process. Participants are randomly assigned in a 21 ratio to either an intervention group or a control group. The intervention group attends three therapy sessions per week outdoors, including individual visits with a research worker, group sessions, and sessions with a family member or volunteer. The control group is advised to perform simple indoor rehabilitation activities. Blood and microbiome samples are collected before the interventions and again after 4 weeks and 3 months post-discharge. Throughout the study, questionnaires assessing mood, quality of life, and functional deficits are administered at baseline, after 4 weeks, and 3 months after discharge. Physiological measures evaluate autonomic nerve function. The study also tracks mood and quality of life changes in participating family members. Primary outcomes focus on functional ability within 30 days, while secondary outcomes assess quality of life, rehabilitation impact, psychological effects, microbiome changes, and autonomic nervous system activity over up to 120 days.

Age: 18Years +All GendersPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are comparing two treatments for intra-articular proximal tibia fractures in patients aged 65 and older. The study evaluates knee function and pain one year after treatment using either locking plate osteosynthesis ORIF or primary total knee replacement TKR. These fractures are common in the elderly and often come with complications like osteoporosis and risk of losing independent walking ability. The study addresses the need to compare traditional ORIF treatment with TKR as a primary option, as no randomized controlled trials have done so before. The study involves two treatment groups. One group receives osteosynthesis with locking plates through incisions based on the fractures shape, with possible use of bone transplantation and additional fixation. Post-surgery, patients follow a weight-bearing schedule starting with limited weight for six weeks. The other group undergoes total knee replacement within two weeks of fracture, using a medial parapatellar approach with prosthesis tailored for stability and bone condition. Patients in this group are allowed full weight bearing as tolerated after surgery. Participants undergo assessments at multiple points up to 10 years, including knee function, pain, physical performance, quality of life, satisfaction, and any reoperations. The main outcome measure is knee function at 12 months. Researchers will use these evaluations to compare the effects of both treatments. The study lasts for many years with follow-ups to monitor long-term results and safety.

Age: 65Years +All GendersPhase Not Applicable
8 locations
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Actively Recruiting

This research aims to evaluate the effects of nature-based rehabilitation methods on adults who have recently experienced an acute stroke. The study investigates how therapeutic activities conducted in natural environments may influence recovery, mood, cognitive functions, and psychological well-being. Participants include adults recovering from stroke with additional concerns such as stress, post-traumatic stress disorder, depression, anxiety, and loneliness. Participants are randomly assigned to one of two groups during a four-week period. The intervention group takes part in individual and group therapeutic sessions held in nearby natural settings, involving specially designed ergotherapeutic, physiotherapeutic, and neurocognitive tasks within a psychotherapeutic framework. The control group is encouraged to maintain light physical activity one to three times a week, with or without company, but does not participate in organized sessions. Weekly contact is maintained by research staff for all participants. Throughout the study, participants undergo assessments including the PROMIS questionnaire to measure patient-reported outcomes, mood evaluations using the GAD7 scale, and neurocognitive function assessments with the COMET questionnaire. These evaluations occur over the four-week study period. Researchers monitor participant adherence and progress through regular contact and encourage engagement in outdoor activities. The total participation duration is four weeks, with the primary focus on the impact of nature interventions on health and well-being after stroke.

Age: 18Years +All GendersPhase Not Applicable
1 location

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