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NCT ID: NCT02154126 Completed - Diabetes Mellitus Clinical Trials

PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

PRECISE
Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

NCT ID: NCT02153294 Completed - Clinical trials for Ventilator-free Days

PRotective VENTilation in Patients Without ARDS

PReVENT-NL
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this national multicentre randomized controlled trial is to compare a ventilation strategy using lower tidal volumes and higher respiratory rates with a ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated and ventilated intensive care unit (ICU) patients without Acute Respiratory Distress Syndrome (ARDS) at start of ventilation. Participating centres in The Netherlands will include a total of 952 adult patients admitted to intensive care units without ARDS. Patients are randomized and ventilated with either a strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day 28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90. Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives, and neuromuscular blocking agents, incidences of ICU delirium and ICU acquired weakness, patient-ventilator asynchrony and the need for decreasing of instrumental dead space.

NCT ID: NCT02153190 Completed - Clinical trials for Type 1 Diabetes Mellitus

Hybrid Artificial Pancreas in Home Setting

AP Hybrid
Start date: May 2014
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

NCT ID: NCT02152592 Completed - Clinical trials for Postoperative Pain After Ambulatory Surgery

Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

Start date: October 2007
Phase: Phase 4
Study type: Interventional

the primary objective of this study is to assess and compare the efficacy, safety and benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful day-case surgery. We hypothesize that ambulatory patients postoperatively treated with oxycodone/paracetamol will achieve better pain relief with equal side effects compared to patients treated with paracetamol/naproxen. Our second goal is to assess analgesic adherence in the outpatient setting. Endpoints: Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: - side-effects/ adverse effects of study medication - patient satisfaction with pain treatment - compliance to study medication Study design: Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial (RCT) at our pre-assessment clinic. Subjects will be enrolled by a study nurse and will be randomized into one of three study treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are assigned to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch CR oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol 1000 mg orally four times a day for 48 hours postoperatively. Recovery after discharge will be assessed using a diary for up to 48 hours after surgery. Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea, vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore, compliance to the use of the study medication will be assessed by checking whether the patients took the study medication as prescribed and if any other pain medication was used. Compliance will be assessed three times a day and patients will be divided into three groups according to medication use: always = full compliance, sometimes = partial compliance, or never = no compliance. Finally, overall satisfaction with the postoperative pain treatment will be assessed (score 0-10).

NCT ID: NCT02151994 Completed - Clinical trials for Hypertension and Chronic Heart Failure

Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses

NCT ID: NCT02151409 Completed - Healthy Clinical Trials

Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.

NCT ID: NCT02150603 Completed - Clinical trials for Heart Defects, Congenital

Patient-Reported Outcomes in Adults With Congenital Heart Disease

APPROACH-IS
Start date: April 2013
Phase: N/A
Study type: Observational

The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

NCT ID: NCT02150486 Completed - Myocardial Injury Clinical Trials

Myocardial Injury and Postoperative Complications

MICOLON
Start date: June 2012
Phase: N/A
Study type: Observational

To determine whether perioperative myocardial injury is associated with adverse outcome in patients scheduled for major abdominal surgery.

NCT ID: NCT02150343 Completed - Rhinoconjunctivitis Clinical Trials

Phase II HDM-SPIRE Safety and Efficacy Study

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

NCT ID: NCT02149654 Completed - Clinical trials for Aortic Valve Stenosis

Engager Align Post-market Clinical Study

Start date: May 2014
Phase:
Study type: Observational [Patient Registry]

Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment. Design Prospective non-randomized, non-interventional, multicenter, single-arm, post-market study. 250 Patients will have the Engager bioprosthesis implanted. Patients will be followed at 1 month, 6 months, and 12 months after the procedure. The recruitment period will be approximately 12 months, so the total study duration will be 24 months.