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A randomized, double-blind, placebo-controlled phase IIIa study of bIAP, an anti-inflammatory moiety, in patients undergoing combined aortic valve replacement and coronary artery bypass grafting.

Primary Objective:The objective of this study is to determine the efficacy of bIAP as a prophylactic agent against inflammation-mediated complications from more invasive cardiac surgery, aortic valve surgery and CABG with cardiopulmonary-bypass time…

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intra Ocular Lens Replacement with Phacoemulsification.

The co-primary objectives of this study are to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on: • Intraoperative pupil diameter.• Pain during…

Effect of low-dose esketamine on postoperative delirium in patients undergoing noncardiac surgery.

Primary Objective:In this pilot study, the authors aim is to investigate whether esketamine reduces the incidence of POD in elderly patientspresenting for noncardiac surgery.Secondary Objective(s):To examine whether esketamine has an effect on the…

Effect of pre-operative Simvastatin use on fibrinolytic activity during surgery. A randomized clinical pilot study

The purpose of this clinical pilot study is to generate quantitative evidence that the oral administration of 80 mg Simvastatin per day, three weeks before surgery and one week thereafter, will have a significant effect on fibrinolytic activity…

Efficacy of post-operative pain management with intralesional ropivacaine after subacromial decompression

The researchquestions of this study are:1. What is the efficacy of treatment of postoperative pain after subacromial decompression with a subacromial catheter with ropivacaine versus placebo?2. What are the differences in costs per patient and in…

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery

Primary objective: to demonstrate that tezosentan, in patients undergoing cardiac surgery with cardiopulmonary bypass, reduces the incidence of clinically relevant right ventricular failure resulting in difficult separation from bypass or need for…

Pre-incisional bupivacaine infiltration of trocarincisions, reduction of postoperative pain in laparoscopic cholecystectomy?

The purpose of this study is to monitor whether preicncisional bupivacaine (bupivacaïne 0,5% with epinefrine 1:200.000), infiltration in trocarcincisions reduces postoperative wound pain in patients undergoing laparoscopic cholecystectomy.

Pre-incisional bupivacaine infiltration trocarincions, reduction of postoperative pain?

The purpose of this study is to monitor whether preicncisional bupivacaine (bupivacaïne 0,5% with epinefrine 1:200.000), infiltration in trocarcincisions reduces postoperative wound pain.

Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized controlled study

Primary outcome parameter is the amount of intra- and postoperative transfusions required. Secondary outcome parameters include intra- and postoperative blood loss, operation time, and postoperative complications and the outcome of…

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

1. To determine the efficacy of QPI-1002 to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of a donation after brain death (DBD) older donor kidney.2. To assess the safety and tolerability of QPI-…

Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantation

To study the potential of alkaline phosphatase to protect against ischemia-reperfusion injury in living donor kidney transplantation.

Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma

This study has been transitioned to CTIS with ID 2024-514927-40-02 check the CTIS register for the current data. To evaluate the efficacy of TXA to prevent surgery for cSDH

Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery.

Primary Objective: This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestrogen for postmenopausal women undergoing POP surgery. In this trial, the perioperative use of oestrogen is considered superior to…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

The efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomised controlled trial

The objective of this study is to investigate whether BTA injection in the pelvic floor muscle is an effective treatment for patients with chronic pelvic pain and pelvic floor hypertonicity.

Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates

This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer

This study has been transitioned to CTIS with ID 2023-509360-24-00 check the CTIS register for the current data. Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ…

Less opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial.

In this prospective, double-blind, randomized controlled trial, we investigate the hypothesis that regional anesthesia provided by WCI with ropivacaine will reduce pain postoperatively (as measured with COMFORT behavior scale and Numeric Rating…

A randomised sham controlled trial of vertebroplasty for painful chronic osteoporotic vertebral fractures

To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related…