Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass SurgeryApr 2013
The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression. (FEC-TH)Apr 2013
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
A randomised control trial to determine whether a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course for the prevention of surgical site infection following lower limb amputation surgeryMar 2013
The primary objective is to establish if a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course in preventing surgical site infection in patients undergoing lower limb amputation.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-BasedMar 2013
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant.
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) TrialMar 2013
This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure (DESYRE)Mar 2013
This study is designed to assess the following hypothesis: "early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event)".
Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation (REP0211)Mar 2013
The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D) patients.
Mortality Following Surgery for Proximal Femoral Fractures (HipMo)Mar 2013
Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)Mar 2013
Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces. Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures. Primary hypothesis: In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
CE-US in Renal TransplantationFeb 2013
Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction. Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.
Hip Fractures Treated With Uncemented Arthroplasties (HUA)Feb 2013
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)Feb 2013
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.Feb 2013
The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement
Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery (THER-6)Feb 2013
The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane, in the urinary bladder and sublingually. Shivering will be graded by visual inspection. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
Safety of Spinal Anesthesia in Patients With Tibial Shaft FractureFeb 2013
There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.
Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques (MALTA)Feb 2013
One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent ImplantationFeb 2013
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.
Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)Feb 2013
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
Changes of cytokines and regulatory T cells in renal transplant recipients after switch to the mTOR inhibitor Everolimus. A Single center trial, non-blinded, non-randomized.Feb 2013
Changes of cytokines in renal transplant recipients after switch of immunosuppression from CNI (calcineurin inhibitor) to the mTORi (mTOR inhibitor) Certican.
Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial ProphylaxisFeb 2013
Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance. The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior to the skin incision significantly reduces the risk of SSI, but the correct time point of drug administration remains unclear. Most studies recommend application of SAP directly prior to skin incision. Other studies, however, suggest that this is too late and more time between administration of the SAP and skin incision is necessary for optimal SSI prevention. A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes prior to skin incision. Due to the obvious importance of this controversy, we want to answer this question with a clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room located in front of the actual operating theatre, where the patient gets anesthesia. Therefore, the application of SAP will take place early, approximately between 75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre, which on average occurs later (approximately within the last 30 minutes before skin incision). We test the hypothesis that strategy A is more effective in preventing SSI than strategy B. We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at each study site and 2500 per study group). All patients will be followed in the hospital for SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as hip endoprosthesis or meshes). We expect this study to be completed within approximately 3 years.
The effects of n-3 polyunsaturated fatty acids on glomerular filtration rate, proteinuria, fibrosis and inflammation in the kidney transplant and cardiovascular risk markers in kidney transplant recipients: a randomized double blinded placebo controlled intervention study.Feb 2013
To study the glomerular filtration rate in kidney transplant recipients receiving supplementation of n-3 polyunsatturated fatty acids compared to placebo.
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)Feb 2013
This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.
Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant RecipientsJan 2013
The purpose of this study is to assess the pharmacokinetics (PK) efficacy and safety of Belatacept in stable pediatric renal transplant recipients.
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart FailureJan 2013
The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.
Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)Jan 2013
One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line
Kinematics of Obese Patients Perambulation (MARCHOBESE)Jan 2013
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)Jan 2013
The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.
A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract SurgeryJan 2013
This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.
Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ TransplantationJan 2013
The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described. Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.
IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser TrabeculoplastyJan 2013
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients. The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)Jan 2013
60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.
PRevention of Macular EDema After Cataract Surgery (PREMED)Jan 2013
Cystoid macular edema (CME) is a swelling of the central and most important part of the retina. It is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. However, no randomised controlled clinical trial (RCT) has compared all the currently existing preventive interventions and no study has been conducted to investigate whether combining different preventive strategies has an additional effect. Therefore, the investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM). This is a non-inferiority trial and for that reason our null hypothesis states that all treatment options are equally effective. The outcomes of this RCT will be of benefit to all cataract surgeons.
A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.Dec 2012
Determine the 3-year graft failure rate in patients testing positive for HLA Ab at baseline or within 3 years of randomization who receive an optimized anti-rejection medication intervention with prednisone, Tac and MMF (‘treatment’), compared to a control group who test positive for HLA Ab at baseline or within 3 years post-randomization who remain on their established immunotherapy and whose clinicians are not aware of their Ab status.
Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based ImmunosuppressionDec 2012
To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B])
Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant RecipientsNov 2012
This study aims to assess the effects of early insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.
The effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgeryNov 2012
To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery
Acupuncture Trial for Post Anaesthetic Recovery and Postoperative PainOct 2012
In the present study, the investigators want to evaluate if press needle acupuncture applied prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve fast-track anaesthesia in the PACU after general surgery.
Are phrophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial.Oct 2012
The principal question is whether a single dose of antibiotic prior to donating a kidney reduces infections within 30 days of surgery.
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral FracturesSep 2012
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation. A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants. The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgerySep 2012
To determine if a single dose of intravenous iron given to patients with anaemia prior to major open abdominal surgery, reduces the need for peri-operative blood transfusion (the peri-operative period is defined as from randomisation to the trial until 30 days following operation)
Immunogenicity of repeated dose 13-valent pneumococcal conjugate vaccine compared to the existing recommended protocol of pneumococcal polysaccharide vaccine in adult kidney and liver transplant patientsAug 2012
To show the non-inferiority of Prevenar 13 compared to pneumovax
BE-RELACs-Trial: Biomarkers Explaining RELevance of ACute RejectionsAug 2012
To explore a number of biomarkers from plasma, serum and renal tissue to describe the impact of different strategies for immunosuppression (Belatacept, Cyclosporine) on the immune-system that may explain differences in long-term outcome.
A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation.Aug 2012
The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in T1D patients. The safety of reparixin in the specific clinical setting will be also evaluated.
Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)Aug 2012
The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter) - during induction of general anesthesia, - during a leg raising test in the Intensive Care Unit
Prospective, Randomized, open label, European, multicenter study of the efficacy of the linezolid-rifampin combination versus standard of care in the treatment of Gram-positive prosthetic hip joint infectionJul 2012
The main objective is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus standard of care therapy in the treatment of Gram-positive prosthetic Hip joint infection with one-stage surgical treatment.
Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)Jul 2012
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia. A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.
A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft FunctionJul 2012
Primary Objective: • Phase 0: To determine the receptor occupancy of OPN305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN305 to be used in Part A of the study. • Part A: to select the optimal single IV dose of OPN305 for Part B of the study in ECD/DCD/SCD(CIT>18h) kidney transplantation patients. The primary endpoint for this objective is: o The incidence of DGF on Day 7 defined as the need for dialysis in the 7 days post-transplantation (dDGF) in patients receiving an ECD/DCD/SCD(CIT>18h) kidney transplantation • Part B: to extend the evaluation whether the optimal dose of OPN305 from Part A can reduce the incidence of DGF • Parts A and B: to evaluate whether OPN305 can reduce the incidence of DGF defined as the use of dialysis in the 7 days following transplantation (dDGF) o Note that all three active doses may contribute to this endpoint if similar in efficacy in Part A.
Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgeryJun 2012
Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgery
Personal monitoring of liver transplant patients infected with Hepatitis C Virus. Pilot study to compare the evolution of Hepatitis C by receiving immunosuppression with tacrolimus in combination with Mycophenolate Mofetil or Everolimus.Jun 2012
Compare the evolution of hepatitis C recurrence as determined by progression of liver fibrosis (F ? 2, as ranked by ISHAK) a year post-liver transplantation in patients receiving low dose tacrolimus in combination with mycophenolate mofetil vs everolimus.
Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing SurgeryMay 2012
The nurses at Roswell Park Cancer Institute are conducting a study to see if the way patients wash before surgery and the soap they use will help reduce the rate of surgical site infection. Every gynecology surgical patient scheduled for abdominal surgery will be given a "Bathing Bundle" to use for washing the night before and the morning of their surgery. The "Bathing Bundle" contains an antimicrobial skin cleanser solution (chlorhexidine gluconate solution 4.0% [CHG]) and disposable wash clothes for the patient to bathe or shower with the night before and the morning of surgery. There are specific instructions in the "Bathing Bundle" that you will need to follow. Research has shown that CHG has helped to reduce the level of bacteria on the skin surface for some patients. The current preoperative standard of care instructs the patient to use an antibacterial soap instead of the skin cleanser provided in the "Bathing Bundle". Our research will compare patients that use the "Bathing Bundle" with 4% chlorhexidine gluconate to patients that use the standard of care anti-bacterial soap.
Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia (NICOM-MAP)May 2012
Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.
Air Barrier System for the Prevention of Surgical Site Infection (ABS)May 2012
The main objective of this research study is to determine whether the ABS can reduce the potential for surgical site infection during total hip replacement, spinal fusion, or lower extremity bypass grafting procedures. These procedures were chosen because each is a long-duration procedure which involves implantation of prosthesis.
Influence of obesity and gastric bypass on medication absorption: pharmacokinetic studyMay 2012
To evaluate the influence of obesity and a gastric bypass on the absorption of drugs
Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac DeathApr 2012
The primary objective of this study is to evaluate the safety and efficacy of BB3 compared to placebo in improving renal function in the immediate post-transplant period in patients who have received DCD (Donor after Cardiac Death) kidney transplantation.
A Single Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after TransplantationApr 2012
To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.
Improvement of Needle Visibility in Ultrasound Guided Regional AnaesthesiaApr 2012
Needle tip visualization, although fundamental to the safety and efficacy of ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is most marked at steep insertion angles. Studies in patients with UGRA demonstrate that echogenic needle designs have the potential to offer improved visibility and accuracy. Our study pursues another approach. We use (for differentiation) echogenic nerve block needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization Technology®). We will compare UGRA with ANV® against standard UGRA without using this SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks as part of their routine anesthetic management are included. This work represents the first randomized controlled double blinded clinical trial of ANV® in patients undergoing UGRA. We hypothesize, that we can decrease the time without needle visualization (Loss of needle time in percentage of procedure time) during in-line regional anaesthesia. Furthermore we will record quality of visibility, duration of procedure and insertion angle of the needle.
Comparison of Different Propofol Formulations With or Without Remifentanil (PropofolRemi)Apr 2012
The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.
BEL114424: A Phase 2 Pilot, Single Centre, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Belimumab plus Standard of Care versus Placebo plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation.Apr 2012
The primary objective of this study is to assess the safety and tolerability of belimumab 10 mg/kg (or placebo) administered in addition to standard of care at transplantation (Day 0), Day 14, Day 28 and every 4 weeks through Week 20.
12 month, multi-center, open-label, prospective, randomized, parallel group study investigating a standard regimen in de novo kidney transplant patients versus a Certican® based regimen either in combination with Cyclosporin A or TacrolimusMar 2012
To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard group at month 12 post-transplantation in renal transplant patients.
Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical CancerMar 2012
Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.
Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin SuturesFeb 2012
In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.
The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantationFeb 2012
To examine the possible renal graft protective effects of treatment with eplerenone in kidney transplanted patients in addition to a standard regimen, including studies in the progression of proteinuria and glomerular filtration.
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance (HYPNOC)Jan 2012
The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted(concerning cardiac stratum; in cooperation with "Immundiagnostik AG")
Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil AnesthesiaJan 2012
The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.
General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)Jan 2012
Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder TumorsJan 2012
This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.
Efficacy and safety of selective vitamin D receptor activation with paricalcitol for reduction of proteinuria in kidney transplant recipients: a randomized controlled trialJan 2012
Difference in urinary protein to creatinine ratio (UPCR) between paricalcitol and placebo study group patients.
A 12 month, multi-center, open-label, randomized, controlled study to evaluate efficacy/safety and evolution of renal function of everolimus in co-exposure with tacrolimus in de novo liver transplant recipientsJan 2012
To demonstrate that an immunosuppressive regimen based on everolimus (EVR) in co-exposure with tacrolimus (TAC) has superior efficacy compared to tacrolimus alone on estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver transplant recipients.
an open-label, single-arm, multicenter trial to determine safety and efficacy of eculizumab in the prevention of Antibody Mediated Rejection (AMR) in sensitized recipients of a kidney transplant from a deceased donorDec 2011
To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
A 3-month, multicenter, randomized, open label study to evaluate the impact of early vs delayed introductioN of EVERolimus on WOUND healing in de novo kidney transplant recipients (NEVERWOUND study)Dec 2011
The primary objective of the study is to compare the proportion of patients without wound complications related to initial transplant surgery (i.e. lymphorrea, fluid collections, wound dehiscence, wound infections, incisional hernia) between the delayed everolimus arm and the immediate everolimus arm, between randomization and 3 months after transplantation.
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the CervixDec 2011
Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.
A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancerDec 2011
Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?
The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group TrialDec 2011
To confirm the rate of acute kidney graft rejection in the study population under standard immunosuppressive therapy in order to corroborate historical renal transplantation statistics and generate reference ranges for future clinical research within The ONE Study.
Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic PlethysmographyNov 2011
The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.
Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.Nov 2011
To investigate whether hyperbaric oxygen therapy in patients with open fracture of tibia grade II and III decreases the rate of surgical complications (necrosis, dehiscence, infection).
A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.Nov 2011
Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)Oct 2011
The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.
Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade (SFINX)Oct 2011
The main aim of the present study is to assess whether sugammadex has a positive effect on the post-operative alertness of the patients, to assess the nature, magnitude and the time of onset of this effect and if a clinically relevant effect has been observed to enable the sample size calculation for a formal well-powered efficacy study.
Cyp3A4 metabolism before and after surgery induced weight loss in morbidly obese patients, using midazolam as a model drugSep 2011
To compare midazolam pharmacokinetics in morbidly obese patients before/during a gastric bypass and 0.5-2 year after surgery.
Eliminate Risk of Cardiac Surgical Site Events (ERASE)Aug 2011
The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient (TUFEV)Aug 2011
This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.
Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal SurgeryAug 2011
The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.
A pilot, explorative study to identify contrast-enhanced ultrasound (CE-US) patterns that characterize acute allograft rejection and other causes of acute allograft dysfunction in renal transplant recipientsJun 2011
To identify the patterns of kidney graft perfusion that are associated with key patterns of renal involvement that may be detected in patients with acute allograft dysfunction.
The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney TransplantationMay 2011
The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.
Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cmMay 2011
Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms of overall survival and disease-free survival. This has prompted some authors to suggest that PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous experience, some tumors (with deep locations, which were included as "central HCC") may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the investigators conducted a study that included a consecutive series of patients with single resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational AnaesthesiaApr 2011
The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood LossMar 2011
The main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells)
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years (HYPOPANX)Mar 2011
This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients.Mar 2011
The principal objective is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body. This is called pharmacokinetics (PK). The results will then help to decide how much Modigraf in future should be given to children and young people following transplantation.
A 3-Armed Prospective Randomized Controlled, Open-Labeled Phase III Trial to Evaluate Late Introduction of Cyclosporine or Everolimus versus a 5-day Delay of Cyclosporine in Combination with MMF in Liver Transplant Recipients with MELD-Scores≥25Feb 2011
The primary objective of the trial is to investigate the influence of CNI-free-“bottom up” immunosuppression compared to CNI-containing “bottom-up” immunosuppression and 5-day Cyclosporine delay and their influence on renal function at 12 months measured by estimated GFR using the abbreviated MDRD formula
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal MupirocinFeb 2011
Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft SurgeryFeb 2011
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients. The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney TransplantationFeb 2011
The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation
A Comparison of Infection Rates Between Two Surgical SitesDec 2010
Does the use of chlorhexidine scrub prior to cutaneous surgery on the face increase the chances of toxicity to the eyes or ears? In addition, does the us eof chlorhexidine scrub on the face prior to cutaneous surgery decrease the chances of a post-operative wound infection?
Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, patient-masked trial.Nov 2010
To determine the beneficial effect of a single dose of 150 µg clonidine as an adjuvant to chirocaine in retrobulbar block.
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal SurgeryOct 2010
The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection.
Phase III Randomized Study of Standard Versus Extended Pelvic Lymphadenectomy During Radical Cystectomy in Patients With Muscle-Invasive Urothelial Carcinoma of the BladderOct 2010
To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy.
Single center, open-label, cross-over study in maintenace kidney allograft recipients to evaluate the bioavailability of CellCept® (Mycophenolate mofetil) in comparison to Myfortic® (Enteric- coated mycophenolate sodium) in combination with a proton pump inhibitor without co-medication.Oct 2010
The objective of this pharmacokinetic trial is to analyze, whether the concomitant administration of a proton pump inhibitor influences the bioavailability of mycophenolic acid, applied as either mycophenolat mofetil or enteric-coated mycophenolic acid.
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder CancerSep 2010
This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery (SSI)Sep 2010
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section.
Covering of the Abdominal Wall in Laparotomies: Differences in Surgical Site Infections Between an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs at Technische Universität München (BaFo)Aug 2010
BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the numbers of surgical site infections in two different techniques of covering the abdominal wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™ Steri-Drape™ Wound Edge Protector.
Comparison Study of Narrow Band Imaging Versus White Lite Resection in Patients With Bladder Tumors/CancerAug 2010
The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant PatientsJul 2010
This study will investigate the blood pressure lowering efficacy of nebivolol among renal transplant recipients who are on calcineurin inhibitors which are believed to contribute to hypertension by SNS activation and decreased prostaglandin and nitric oxide production. Hypotheses: Nebivolol is more beneficial than metoprolol in favorably affecting markers of oxidative stress in hypertensive renal transplant patients. Nebivolol has a better impact than metoprolol on kidney function among hypertensive renal transplant patients
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site InfectionsJun 2010
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.
Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal TransplantationJun 2010
This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK, JC, CMV, EBV) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.
An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis versus Placebo in High Risk Surgical Subjects with Intra-abdominal Infections - A Multicentre, Randomized, Double-Blind StudyMar 2010
To assess the incidence of invasive candidiasis at EOT and to assess the time to invasive candidiasis at EOT
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with a Fresh Unilateral Hip Fracture, Status Post Surgical FixationMar 2010
To investigate the effect of AMG 785 compared to placebo on functional healing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy hip fractures.
An international, multi-centre, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.Mar 2010
The primary objective is to evaluate the incidence of post-operative delirium (POD, diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia, with Xenon or Sevolfurane, for a period of four days post-surgery
A randomized trial of Rituximab in induction therapy for living donor renal transplantationMar 2010
Can the addition of rituximab to a minimalist immunosuppressive regimen allow further reduction in immunosuppression?
The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of Prograf and AdvagrafMar 2010
The objectives of this study are 1) To determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics 2) To compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural RepairMar 2010
The objective of this study is to evaluate the safety and efficacy of Evicel for use as an adjunct to dura sutures in elective cranial surgery to provide watertight closure.
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone SystemMar 2010
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody SyndromeDec 2009
In this trial, a drug called eculizumab will be tested for its ability to prevent CAPS after kidney transplantation in patients with a prior history of CAPS. Eculizumab is an inhibitor of the complement system, which is believed to be important in generating the inflammatory environment that leads to diffuse clotting of blood vessels in CAPS.
Fondaparinux population pharmacokinetic to morbid obese patients in post-operatory bariatric surgeryNov 2009
To evaluate pharmacodynamics parameters (absorption and elimination half life, clearance, distribution volume and their variability) of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients (BMI >40kg/m2) with a daily subcutaneous injection of fondaparinux 2,5 mg during at least 5 days following a bariatric surgery
Prospective multicentric evaluation of a bladder preservation strategy using a combination of neoadjuvant chemotherapy with intensified MVAC (Méthotrexate + vinblastine + adriamicine + Cisplatine) and optimal bladder transurethral resection in patients with a localized muscle infiltrative urothelial carcinoma (protocol ReChiVe)Nov 2009
The 5 years bladder preservation rate in patients with a localized infiltrative bladder treated with a double optimal transurethral bladder resection (TURB) combined with a neoadjuvant chemotherapy.
Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis (ABCAL)Nov 2009
The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.
Open-label, randomised multicentre study of CAMPATH-1H versus basiliximab induction treatment and sirolimus versus tacrolimus maintenance treatment for the preservation of renal function in patients receiving kidney transplantsNov 2009
The primary aims of the 3C Study are to investigate, in people receiving a kidney transplant, whether: 1) using Campath-1H as induction therapy (i.e. given around the time of transplant surgery) reduces the incidence of acute rejection of the kidney transplant at 6 months after surgery, compared to standard basiliximab-based induction therapy; and 2) whether sirolimus-based maintenance immunosuppression (i.e. the drugs they have to take every day to prevent their body's immune system from attacking ('rejecting') the transplant) improves the function of their kidney transplant, compared to using tacrolimus-based maintenance therapy at 2 years after transplantation.
Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed Head and Neck CancerSep 2009
This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
Clipping Versus No Hair Removal and the Risk of Surgical Site InfectionsSep 2009
The objective of this study is to determine whether hair clipping is non-inferior to no hair removal in preventing superficial, deep, and organ space surgical site infections (SSI) in patients undergoing various general surgical procedures, evaluated after surgery by an assessor blinded to treatment allocation.
Pilot study of Lapatinib (Tyverb®) in néoadjuvant treatment for patients with locally bladder carcinoma before cystectomySep 2009
The primary objective of the study is to evaluate the effect at a molecular level, of 3 weeks of neoadjuvant lapatinib, in locally advanced muscle-invasive transitional cell carcinoma of the bladder. A comparison of tissue from the original biopsy and cystectomy after lapatinib will allow this to occur. This effect will be evaluated by studying proliferation and apoptotic markers as well as the phosphorylation of proteins which are components of the egf signalling pathway.
Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney TransplantationJun 2009
This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (GERD-BPD)Jun 2009
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)May 2009
In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
Factors Influencing Anesthetic Drug Requirement (PosoAnes)May 2009
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).
Influence of Muscle Relaxation on a Closed-loop Anesthesia System (Drone-Curare)Apr 2009
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
A prospective, randomized, open label blinded end point (probe), cross-over study to compare the effects of telmisartan and losartan on metabolic profile of renal transplant patientsMar 2009
To compare the short-term effects of telmisartan and losartan on insulin sensitivity in kidney transplant recipients with stable renal function and concomitant treatment with steroids and/or calcineurin inhibitors.
Mycophénolate sodic in graded increased doses in the first 3 months of renal transplantation _ Pharmacokinetic descriptive Pilot studyMar 2009
Describe the pharmacokinetics of the MYFORTIC ® ( MPA) with graded increased doses first 3 months of the renal transplantation
Radical Trachelectomy for Cervical CancerDec 2008
The primary objective of this study is to longitudinally assess quality of life, sexual functioning, symptoms, and satisfaction with healthcare decisions in women who have undergone abdominal radical trachelectomy for cervical cancer. The secondary objectives are: To determine long-term fecundity and pregnancy outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, to determine short- and long-term operative outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, and to determine disease-free and overall survival in women who have undergone abdominal radical trachelectomy for cervical cancer.
Impact of the administration of systemic glucocorticoids on inflammatory response and clinical evolution of patients diagnosed with moderate-severe bronchiolitisNov 2008
To investigate the immunogenicity of two different dosages of IC43 in mechanically ventilated ICU patients at day 14 after first vaccination
Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)Oct 2008
Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)Sep 2008
The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.
A study assessing in vivo hepatic and intestinal CYP3A4/5 and PGP activity in kidney transplant recipients and its relationship with genetic and non-genetic variables and the pharmacokinetics and metabolism of Tacrolimus.Sep 2008
To asses in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients.
VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcomeSep 2008
Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo?
A 24-month extension to a 12-month, open-label, randomised, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipientsJul 2008
To characterise the general and renal-specific glomerular filtration rate (GFR) (MDRD) safety profile, up to 36 months post transplantation, of renal transplant patients treated with AEB071 in combination with Certican® (CNI free) versus a standard CNI-based regimen.
A prospective, randomized, double dummy, double blind, multinational, multicenter trial comparing the safety and efficacy of sequential (intravenous/oral) moxifloxacin 400 mg once daily to intravenous piperacillin/tazobactam 4.0/0.5 g every 8 hours followed by oral amoxicillin/clavulanic acid tablets 875/125 mg every 12 hours for the treatment of subjects with complicated skin and skin structure infections (RELIEF Study).Feb 2008
The objective of this study is to compare the efficacy and safety of two sequential (IV/PO) treatment regimens for the treatment of adult subjects with cSSSIs: Moxifloxacin, 400 mg IV every 24 hours followed by moxifloxacin 400 mg PO every 24 hours, and Piperacillin/tazobactam, 4.0/0.5 g administered IV three times daily followed by oral amoxicillin/clavulanic acid tablets, 875/125 mg twice daily.
A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery.Jan 2008
The primary Efficacy Objective is to demonstrate that a single dose of V710 administered prior to cardiothoracic surgery will reduce the proportion of adult patients who acquire S. aureus bacteremia and/or S. aureus deep sternal wound infections through postoperative Day 90.
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathyJan 2008
To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX)
A prospective randomized study of antibiotic prophylaxis for renal transplantation: short term vs standard treatmentJan 2008
Superiority of single dose - same incidence of infectious complications
Efficacy and safety of Alefacept in combination with Tacrolimus, Mycophenolate Mofetil and Steroids in de-novo kidney transplantation – a multicenter, randomized, double-blind, placebo controlled, parallel group studyDec 2007
The primary objective of this study is to evaluate the efficacy and safety of alefacept in a kidney transplant population. Data suggests that 12 weeks of treatment with alefacept in combination with tacrolimus, mycophenolate mofetil (MMF) and steroids may be more effective than and as safe as a combination therapy of tacrolimus with MMF and steroids. Effectiveness will be measured as the occurrence of and time to biopsy proven acute rejection at six months assessed locally.
Hepatic and intestinal CYP3A4/5 activity in renal transplantation.Oct 2007
To asses in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients at different time-points and in different clinical settings after renal transplantation.
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder (GERD)Aug 2007
The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.
A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.Aug 2007
To compare the safety and efficacy of a programmed introduction of a Sirolimus-based, Calcineurin inhibitor free, maintenance immunosuppressive regime, three months after renal transplantation in recipients of a non-heart-beating donor kidney graft on: graft function as determined by eGFR and biopsy proven acute rejection rates at twelve months post randomization to programmed Sirolimus introduction
Simple Versus Radical Hysterectomy for Stage I Cervical CancerJul 2007
The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.
Primary fungal profilaxis with Liposomal Amphotericin B at the dose of 10 mg/kg a week in adult patient undergoing orthotopic liver transplantation and high risk for postoperative fungal infection: a prospective studyJun 2007
The main objective of the trial is to evaluate the safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks
A randomized,open-label,multicenter, parallel-group study of belatacept-based corticosteroid-free regimens in renal transplantMay 2007
To assess the rate of AR in different corticosteroid-free belatacept-based immunosuppressive regimens in de novo renal transplant subjects by 6 months post-transplant
The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without DiabetesApr 2007
Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high. The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.
An open study to investigate the effect of 4 instead of 2 daily dosing mycophenolate mofetil (MMF) in renal transplant patients on diarrheaMar 2007
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure.
A multicenter, single-arm, open, conversion study from a cyclosporine (CYA) based immunosuppressive regimen to a tacrolimus modfied release, FK506E (MR4), based immunosuppressive regimen in kidney transplant subjectsJan 2007
Primary objective is to assess the changes in kidney function in kidney transplant subjects converted from a CyA-based immunosuppressive regimen to a tacrolimus modified release, FK506E (MR4), based immunosuppressive regimen.
Randomised Trial of Anti-CD20 in C4d+ Chronic Allograft NephropathyOct 2006
To determine whether anti-CD20 therapy can stabilise or improve renal function and/or proteinuria in patients with C4d+, chronic (humoral) rejection in whom standard therapeutic approaches have failed.
Prevention of Surgical Site InfectionsJul 2006
The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.