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NCT ID: NCT01938248 Completed - Stroke Clinical Trials

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

ARTESiA
Start date: May 2015
Phase: Phase 4
Study type: Interventional

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

NCT ID: NCT01937377 Completed - Stroke Clinical Trials

GLORIA-AF Registry Program (Phase II/III)

Start date: September 2, 2013
Phase:
Study type: Observational

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

NCT ID: NCT01934322 Completed - Clinical trials for Vulnerable Populations

Case Management for Frequent Users of the Emergency Department

Start date: June 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED). Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more isolated and live alone. They report more chronic medical conditions, have a higher mortality rate and consume more healthcare resources. In the literature, interventions aimed at improving the management of ED-FU have demonstrated several positive outcomes, but there are still some knowledge gaps. The proposed project tests the hypotheses that case management intervention as compared with standard emergency care - is a more efficient use of healthcare resources and reduces ED attendance, - is cost-saving and - improves quality of life, - altogether leading to favorable cost-utility ratio.

NCT ID: NCT01933971 Completed - Clinical trials for Healthy Male Subjects

Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®

Start date: June 2007
Phase: Phase 1
Study type: Interventional

Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same active content as Neupogen®. BK0023 is expected to have the same tolerability profile and clinical effects as Neupogen® in controlling myelo-toxicity induced by chemotherapy given for the treatment of solid and haematological tumours. It is worth noting that the production and manufacturing procedures allow to have a reduction of drug cost thus it is likely to have pharmacoeconomic advantages. The study is aimed at investigating the pharmacodynamic equivalence and the pharmacokinetic bioequivalence of the new BK0023 injectable formulation of filgrastim 0.3 mg/mL by Bio-Ker S.r.l. vs. the comparator (Neupogen® 0.3 mg/mL, Dompé Biotec S.p.A., Italy). Healthy male subjects will receive test and reference at the doses of 2.5 and 5 µg/kg/day for 7 consecutive days and at the dose of 10 µg/kg/day for 5 consecutive days according to a randomised cross-over design. Pharmacodynamics, pharmacokinetics and safety of BK0023 injectable formulation 0.3 mg/mL and of Neupogen® 0.3 mg/mL, administered in 2 consecutive periods with a wash-out of at least 28 days elapsing between the last injection of period I and the first of period II, are compared. Study design: Single and multiple escalating dose, double-blind, randomised, two-way cross-over, pharmacodynamic and pharmacokinetic bioequivalence study.

NCT ID: NCT01933945 Completed - Clinical trials for Carcinoma, Hepatocellular

Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

OPTIMIS
Start date: October 28, 2013
Phase:
Study type: Observational

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

NCT ID: NCT01931566 Terminated - Clinical trials for Mild Cognitive Impairment Due to Alzheimer's Disease

Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset

TOMMORROW
Start date: August 1, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone compared with placebo to delay the onset of MCI-AD in cognitively-normal participants who are at high-risk for developing MCI within 5 years.

NCT ID: NCT01931371 Active, not recruiting - Anal Fistula Clinical Trials

Anal Fistula Plug Versus Endorectal Advancement Flap

AFPERAF
Start date: May 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

NCT ID: NCT01931215 Completed - Postoperative Pain Clinical Trials

Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

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

Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common. Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects. With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine. The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.

NCT ID: NCT01930695 Completed - Heart Failure Clinical Trials

Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

Pre-CRAFT
Start date: August 2013
Phase:
Study type: Observational

The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.

NCT ID: NCT01928459 Completed - Clinical trials for Advanced Solid Tumors

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Start date: October 2013
Phase: Phase 1
Study type: Interventional

To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.