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NCT ID: NCT02361619 Completed - Healthy Volunteers Clinical Trials

Dabigatran in an Interaction Probe Drug Cocktail

D-cocktail
Start date: February 2015
Phase: Phase 1
Study type: Interventional

Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.

NCT ID: NCT02357589 Completed - Cholecystolithiasis Clinical Trials

3D vs 2D HD Laparoscopy in Cholecystectomy

Start date: January 2015
Phase: N/A
Study type: Interventional

The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).

NCT ID: NCT02357511 Completed - Blood Pressure Clinical Trials

Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

Start date: February 2015
Phase: N/A
Study type: Interventional

The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

NCT ID: NCT02353286 Completed - Clinical trials for Biliary Tract Diseases

Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent

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

Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. The primary end points are feasibility of endoscopic insertion with the novel implantation device and stricture or leak resolution as well as clinical treatment success.

NCT ID: NCT02352090 Completed - Contraception Clinical Trials

Synthetic vs Natural Estrogen in Combined Oral Contraception

SYLVI
Start date: April 1, 2015
Phase: Phase 4
Study type: Interventional

The main objective of the study is to compare the metabolic effects of natural estradiol and synthetic ethinylestradiol used in combined oral contraception in healthy women. A progestin-only preparation will be used in comparison. The main goal is to study the effects on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels, markers of coagulation and chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters.

NCT ID: NCT02350608 Completed - Blood Pressure Clinical Trials

Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients

Start date: March 2015
Phase: N/A
Study type: Observational

Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

NCT ID: NCT02348632 Completed - Clinical trials for Obstructive Sleep Apnea

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

NCT ID: NCT02348619 Completed - Clinical trials for Obstructive Sleep Apnea

"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

OSA
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

NCT ID: NCT02348593 Completed - Narcolepsy Clinical Trials

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

NCT ID: NCT02348489 Completed - Clinical trials for Leukemia, Myeloid, Acute

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Start date: March 19, 2015
Phase: Phase 3
Study type: Interventional

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.