Clinical Trials Logo

Filter by:
NCT ID: NCT01493414 Completed - Myelofibrosis Clinical Trials

INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

JUMP
Start date: August 16, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.

NCT ID: NCT01492504 Completed - Hepatitis C Clinical Trials

Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

Start date: February 7, 2012
Phase:
Study type: Observational

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

NCT ID: NCT01485926 Completed - Breast Cancer Clinical Trials

A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients.

TCHL Phase II
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The primary objective: -To assess the efficacy of TCH and TCHL in neo-adjuvant treatment of HER-2 positive breast cancer, using pathological complete response (pCR) as the primary endpoint (Phase II). Secondary objectives: - To assess the clinical response rate and overall response rate for docetaxel and carboplatin with trastuzumab alone or trastuzumab combined with lapatinib in HER-2 positive breast cancer. - To assess the relationship between drug exposure and adverse events. - To examine potential molecular and pharmacological markers of response to trastuzumab and lapatinib - To assess Disease-free Survival (DFS) and Overall Survival (OS) - To determine if prophylactic Loperamide significantly reduces the number of diarrhoea -related adverse events.

NCT ID: NCT01485159 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Airflow Limitation in Cardiac Diseases in Europe

ALICE
Start date: October 2011
Phase: N/A
Study type: Observational

This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.

NCT ID: NCT01482650 Completed - Clinical trials for Performance and Safety of an Airway Management Device

Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The investigators have performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia. This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA. The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA. A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).

NCT ID: NCT01480063 Completed - Multiple Sclerosis Clinical Trials

An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

LIBERATE
Start date: April 16, 2012
Phase:
Study type: Observational

The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

NCT ID: NCT01476956 Completed - Clinical trials for Rheumatoid Arthritis

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

Start date: October 2011
Phase:
Study type: Observational

Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies. Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum. Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months). Patients will be followed for 2 years.

NCT ID: NCT01467323 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

Start date: April 1998
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

NCT ID: NCT01467128 Completed - Clinical trials for Adverse Drug Reactions

Adverse Drug Event Prevention Using Structured Pharmacist Review

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem. A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.

NCT ID: NCT01467102 Completed - Clinical trials for Chronic Postoperative Pain

euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study

PAIN-OUT
Start date: July 2011
Phase: N/A
Study type: Observational

This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP). Research Questions - What is the incidence of chronic post surgical pain (CPSP) in Europe? - What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management? - What are the difference in incidence and risk factors in different European countries?