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NCT ID: NCT02058160 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

LixiLan-L
Start date: January 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes

NCT ID: NCT02058147 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

LixiLan-O
Start date: February 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes

NCT ID: NCT02048618 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

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

- 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 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 GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

NCT ID: NCT02048592 Recruiting - Cystic Fibrosis Clinical Trials

Impact of Immunonutrition on the Patients With Cystic Fibrosis

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The primary objectives: To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis 1. Safety of immunonutrition 2. The effect of immunonutrition on parameters of oxidative stress 3. The effect of immunonutrition on the inflammatory parameters 4. The effect of immunonutrition on nutrition status Hypothesis The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has been shown to positively modulate oxidative stress in the different clinical setting however it has not yet been evaluated inpatients with cystic fibrosis who frequently need some support by means of enteral nutrition. We anticipate that the substitution of routine enteral nutrition by immunonutrition will result in improving of oxidative stress parameters.

NCT ID: NCT02041507 Active, not recruiting - Pain Clinical Trials

Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening

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

The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer. Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm, P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy. Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the proximal colon. In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy. We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy. Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues. Several secondary outcomes will also be analysed.

NCT ID: NCT02029885 Recruiting - Hypertension Clinical Trials

Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

WAVE_IV
Start date: August 2014
Phase: N/A
Study type: Interventional

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

NCT ID: NCT02029495 Terminated - Psoriatic Arthritis Clinical Trials

Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic Arthritis

AMVISION-1
Start date: March 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

NCT ID: NCT02025244 Recruiting - Clinical trials for Other Specified Disorders of Esophagus, Stomach or Duodenum

EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors

Start date: November 2010
Phase: N/A
Study type: Interventional

Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner surface. The prognosis and treatment of these tumors depend on their correct diagnostics and mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics of Upper gastrointestinal Submucosal Tumors.

NCT ID: NCT02025049 Terminated - Pancreatitis Clinical Trials

DP-b99 in the Treatment of Acute High-risk Pancreatitis

Start date: December 2013
Phase: Phase 2
Study type: Interventional

Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease.

NCT ID: NCT02023437 Completed - Cataract Clinical Trials

Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

Start date: December 2013
Phase: Phase 4
Study type: Interventional

This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as "A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure".