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NCT ID: NCT01626196 Completed - Routine Colonoscopy Clinical Trials

Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation

Start date: February 2012
Phase: N/A
Study type: Observational

Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing. This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).

NCT ID: NCT01625520 Completed - Clinical trials for Medullary Thyroid Cancer

SOM230 Alone or in Combination With RAD001 in Patients With Medullary Thyroid Cancer

Start date: February 2012
Phase: Phase 2
Study type: Interventional

A mono centre study to evaluate the efficacy of SOM230 in patients with progressive metastatic or postoperative persistent medullary thyroid cancer.

NCT ID: NCT01625390 Completed - Clinical trials for Hemophilia A, Hemophilia B

A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process. The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months. Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

NCT ID: NCT01625338 Completed - Chronic Hepatitis C Clinical Trials

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

NCT ID: NCT01625182 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Start date: December 22, 2012
Phase: Phase 3
Study type: Interventional

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

NCT ID: NCT01624870 Completed - Clinical trials for Aortic Valve Stenosis

CoreValve Advance-II Study: Prospective International Post-market Study

Advance-II
Start date: October 2011
Phase:
Study type: Observational

The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.

NCT ID: NCT01624506 Completed - Clinical trials for Gastroesophageal Reflux

Observational Study of Anti-Reflux Surgery

Start date: January 2010
Phase:
Study type: Observational

The Anti-Reflux Surgical Study has been established to: - Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice - Track the clinical course of patients from pre-operative assessment to three years post-surgery

NCT ID: NCT01624350 Completed - Anorectal Fistulas Clinical Trials

A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas

Start date: September 2012
Phase: N/A
Study type: Observational

This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas. The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.

NCT ID: NCT01624142 Completed - Clinical trials for Severe Familial Hypercholesterolemia

Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

TAUSSIG
Start date: June 1, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

NCT ID: NCT01623570 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP

Start date: March 2011
Phase: N/A
Study type: Interventional

The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH women. This open-label monocentric, randomized comparative trial, to receive the two different standard clinical practice treatments: - 1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH) - 2 vials of Menopur: (vials/powder hMG 75IU). Follicular development were monitored until the protocol hCG requirement is met and a single injection of hCG was administered. Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm), pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25 nanomole/Liter (nmol/L).