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NCT ID: NCT02415959 Completed - Clinical trials for Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

NCT ID: NCT02410031 Completed - Acne Vulgaris Clinical Trials

Risk Minimisation Study for Diane-35 and Its Generics

Start date: June 26, 2015
Phase: N/A
Study type: Observational

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist. Specifically, the following objectives will be addressed: - Investigate whether physicians have received any educational material related to Diane-35 or its generics - Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card - Assess physicians' knowledge and understanding of key safety information pertaining to the following areas: - Contraindications relevant to thromboembolism - Risk factors for thromboembolism - Signs and symptoms of thromboembolism

NCT ID: NCT02409979 Completed - Abdominal Pain Clinical Trials

Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes

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

Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.

NCT ID: NCT02386618 Completed - Colorectal Cancer Clinical Trials

Endoscopic Treatment for Local Residual Neoplasia

Start date: October 2013
Phase: N/A
Study type: Interventional

Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.

NCT ID: NCT02380586 Completed - Clinical trials for Obstetric Anesthesia Care

Obstetric Anaesthesia And Analgesia Month Attributes - International

OBAAMA-INT
Start date: November 2015
Phase: N/A
Study type: Observational

A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic.

NCT ID: NCT02378688 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of the study are: - To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD) - To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

NCT ID: NCT02375412 Completed - Clinical trials for Major Abdominal Surgery

Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome

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

The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic nervous system could complicate the postoperative course in the patient undergoing surgery. Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the autonomic nervous system.

NCT ID: NCT02351076 Completed - Clinical trials for Foramen Ovale Patent

Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.

Start date: August 2014
Phase: N/A
Study type: Observational

The aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system ( Cardiox TM) in young stoke patients ( age under 55 years).

NCT ID: NCT02342704 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

REVEAL
Start date: November 2014
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).

NCT ID: NCT02337608 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

ORIGIN
Start date: December 2014
Phase: Phase 2
Study type: Interventional

- Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment. - During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.