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Prospective, pharmacokinetic study for determination of the relationship between lean body weight and anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin in morbidly obese patients after bariatric surgery.

Primary objective: prospective evaluation of the relationship between lean body weight and anti-Xa activity of 5700 IU nadroparin 4 hours after subcutaneous administration in morbidly obese patients.Secundary objectives: - Correlation between other…

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…

The effects of ceasing opioid, benzodiazepine, or Z-hypnotic drug use on measures of driving performance and postural balance.

The aim of this study is primarily to investigate the effects of a withdrawal intervention on measures of driving performance in a clinical population that uses benzodiazepines, Z-hypnotics, or opioid analgesics chronically. As a secondary objective…

An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated with the Investigational PI3K* Inhibitor, GS-9820

To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.

A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…

Avoiding tacrolimus under- and overexposure by using a new dosing algorithm for pediatric renal transplant recipients

To minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3, 7 and 10 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-based approach.…

Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)

The primary objective of the study is to assess the effect of missed doses of atomoxetine and OROS methylphenidate in ADHD patients who are stable on pharmacotherapy based on the patient*s daily behavior as assessed by the Daily Parent Report of…

A Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus (TEMSR) Regimens in Subjects With Relapsed, Refractory Mantle Cell Lymphoma

Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…

Diarrhea during use of the oral angiogenesis inhibitors sunitinib and sorafenib

To identify what might be the cause of the occurrence of diarrhea during the use of angiogenesis inhibitors sunitinib and sorafenib in patients with a malignancy.

Effect of the plasma substitutes Gelofusine and Hydroxyethyl Starch 130/0.4 combined with lactated ringer's solution on the coagulation system

The main objective in this study is to examine if there is a difference in coagulation between Ringerlactaat/Gelofusine® priming and Ringerlactaat/HES 130/0.4 priming after coronary artery bypass graft (CABG), by measuring the thorax drain…

Pharmacokinetics of the addition of an acidic beverage to posaconazole co-administered with a proton pump inhibitor in GVHD patients

to investigate whether the bioavailability of posaconazole in graft-versus-host-disease (GVHD) patients, adversely affected by the coadministration of proton pump inhibitors (PPIs), can be restored by an acidic beverage

OPEN LABEL EUROPEAN STUDY TO SUPPORT THE EARLY IDENTIFICATION OF PATIENTS WITH CHRONIC NEUROPATHIC LOW BACK PAIN IN PRIMARY CARE AND TO ASSESS THE EFFECTIVENESS AND TOLERABILITY OF PREGABALIN IN THIS POPULATION.

Primary Objectives1. To raise awareness and enhance the diagnosis of patients with chronic low back pain (CLBP) with a neuropathic pain component who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain in a primary…

Two-arm, randomized, open-label, phase IIIb study investigating the safety of a 3 hour i.p. infusion of catumaxomab with and without prednisolone premedication in patients with malignant ascites due to epithelial cancer

Primary objective:The primary objective of the study is to compare the 3 hour i.p. infusion of catumaxomab with prednisolone to catumaxomab without prednisolone by demonstrating superiority for safety and non inferiority for efficacy.Secondary…

The effect of prewarming on hypothermia during orthopaedic surgery and related postoperative complications.

In this present study we will assess the effect of a pre-warming intervention before surgery, in order to decrease the temperature gradient from core to periphery and thereby minimize redistribution hypothermia under anesthesia, on (I) the…

Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

The potential for risperidone to induce hyperprolactinemia in pediatric patients is well known.However, the effects of drug-induced serum prolactin elevations on growth and sexual maturation havenot been as well characterized in pediatric…

Ketanest in Intensive Care Unit Patients

Compare induction of anaesthesia using etomidate versus ketanest on hemodynamics, as well as microcirculatory consequences in patients admitted to the ICU and in need of ventilatory support.

HepZero study: Heparin Free dialysis with Evodial: A prospective multicenter, open, randomized, controlled clinical study with parallel groups

Primary objective:- To determine the effectiveness of Evodial, as compared with standard of care in terms of successful treatments during the first heparin free dialysis treatment. If the non-inferiority of Evodial is demonstrated, the superiority…

Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already…

*Pre-operatieve Iron* use as blood sparing technique in Orthopedic Surgery.

In this research we will investigate if i.v. iron therapy can become a method of blood saving therapy for orthopedic surgery and can replace erytropoietin.

ULTRASOUND-GUIDED SAPHENOUS NERVE BLOCK:
A DOSE-FINDING STUDY IN HEALTHY VOLUNTEERS

The general aim of the present study is to identify the minimum local anaesthetic dose (ED95) of mepivacaine in healthy volunteers.