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Found 5 Actively Recruiting clinical trials

H

Actively Recruiting

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Age: 75Years +All GendersPhase Not Applicable
25 locations
C

Actively Recruiting

Researchers are studying complications after closing a temporary loop ileostomy in patients who had surgery for rectal cancer. The study aims to answer two main questions whether the choice of anastomotic method affects recovery after surgery, and if using a mesh to close the stoma site can reduce hernias. This is a prospective randomized trial involving multiple centers to explore these surgical techniques. Participants are randomly assigned to receive either a stapled anastomosis using a linear staple device or a hand-sewn anastomosis with a running monofilament suture. Additionally, there is an optional randomization to close the stoma site either with a lightweight mesh placed under the muscle or with a long-lasting suture. The skin and fascia are closed with running monofilament sutures, including a pursestring technique for the skin. During the study, researchers will monitor participants for postoperative bowel obstruction within 30 days and for stoma site hernias over 2 years. They will also assess other complications and hospital stay length within 30 days. Participants will undergo follow-up visits to evaluate these outcomes and ensure proper recovery. The total participation timeline includes short-term and long-term monitoring to capture relevant surgical results.

All GendersPhase Not Applicable
11 locations
C

Actively Recruiting

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

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

Actively Recruiting

This research aims to assess the safety and performance of PexyEazy, a new device designed to treat grade II and III hemorrhoids using the mucopexy method. Hemorrhoidal disease occurs when hemorrhoidal cushions slide down in the anal canal, causing symptoms like bleeding, leakage, itching, and pain. Traditional surgery for severe hemorrhoids often involves long recovery and complications, so this study explores a less invasive, semi-automatic approach that can be done on awake patients in under 10 minutes. The PexyEazy device folds the mucosa above the hemorrhoids and applies sutures using a semi-automatic system, lifting the hemorrhoids back to their normal position. This procedure improves venous drainage and reduces swelling. The device includes an examination proctoscope, handle with depth setting piston, light shuttle, mucopexy device with three operating areas, and a battery pack. The study involves 35 patients, with the first 6-10 undergoing the procedure under general anesthesia and the rest awake. Follow-ups occur after 1 week, 3 months, and 1 year. Participants will have clinical examinations, questionnaires on quality of life and hemorrhoid symptoms, and monitoring of pain, complications, and use of pain relief drugs at follow-up visits. The study measures surgical results, device validation, surgery duration, pain presence, anesthesia needs, and perioperative complications immediately after the procedure. Long-term outcomes include symptom changes, clinical outcomes, quality of life, and sick leave duration, documented up to one year after treatment.

Age: 18Years - 84YearsAll GendersPhase Not Applicable
3 locations
R

Actively Recruiting

Researchers are conducting a randomized, placebo-controlled, double-blind clinical trial to evaluate treatments for patients who experience in-hospital cardiac arrest and require adrenaline according to current guidelines. The study aims to determine whether adding vasopressin and steroids to adrenaline improves survival rates compared to adrenaline alone. The trial is expected to run for 3 to 4 years and will enroll about 1400 patients. Patients who have a cardiac arrest in the hospital and meet criteria for adrenaline administration will be randomly assigned to receive either adrenaline combined with vasopressin and steroids or adrenaline with a placebo sodium chloride. The intervention group receives vasopressin during CPR cycles and methylprednisolone during the first cycle, followed by hydrocortisone infusion for up to seven days in the ICU for those with post-resuscitation shock. The control group receives sodium chloride as a placebo during CPR and in the ICU at similar schedules. Participants will be monitored closely with survival at 30 days as the primary outcome measure. The study includes informed consent procedures for hospitalized men over 18 and women over 50 years old, excluding certain groups based on capacity to consent, pregnancy potential, and prior enrollment. The trial uses quadruple masking and randomization to ensure unbiased results, with data collected throughout the treatment and follow-up periods.

Age: 18Years +All GendersPhase 3
2 locations