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NCT ID: NCT01543477 Completed - Pregnancy Clinical Trials

Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

PASCO II
Start date: July 7, 2010
Phase:
Study type: Observational

The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacritâ„¢ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacritâ„¢ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

NCT ID: NCT01535261 Completed - Macular Edema Clinical Trials

Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

CRYSTAL
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The present study will provide additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images will be analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring will be assessed in Year 2. The results of this open-label study will provide long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

NCT ID: NCT01531894 Completed - Cancer Clinical Trials

Continuation Study of the Oral AKT Inhibitor GSK2110183

Start date: February 8, 2012
Phase: Phase 2
Study type: Interventional

This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.

NCT ID: NCT01530412 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

Start date: June 2007
Phase: N/A
Study type: Interventional

Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband. Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required. The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.

NCT ID: NCT01530139 Completed - Clinical trials for Dietary Modification

Strategies for Personalised Nutrition

Food4Me
Start date: August 2012
Phase: N/A
Study type: Interventional

The concept of personalised nutrition emerged following the sequencing of the human genome in 2000. It was hoped that with the identification of gene nutrient interactions, an individual's response and susceptibility to particular diets would be better understood and therefore appropriate dietary modifications could be made to optimise health and lower disease risk. Then Food4Me aims to study the development of personalized nutrition at three levels and determine whether providing more personalised dietary advice leads to better compliance and health outcomes compared to standard population advice. The hypotheses to be tested in the Food4Me study are as follows: - Personalisation of dietary advice assists and/or motivates consumers to eat a healthier diet and follow a healthier lifestyle (in comparison with "impersonal" [conventional] dietary advice). - Personalisation based on individualised biochemical (phenotypic) and/or genetic information is more effective in assisting and/or motivating study participants to make, and to sustain, appropriate healthy changes to their usual (habitual) diet and lifestyle.

NCT ID: NCT01529697 Completed - Asthma Clinical Trials

Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

INCA
Start date: February 2012
Phase: N/A
Study type: Interventional

Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified. In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.

NCT ID: NCT01527812 Completed - Clinical trials for Fractured Neck of Femur

Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

Start date: December 2009
Phase: N/A
Study type: Interventional

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

NCT ID: NCT01526369 Completed - Clinical trials for Metastatic Breast Cancer

A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

TH V THL
Start date: February 13, 2012
Phase: Phase 3
Study type: Interventional

The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

NCT ID: NCT01523587 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Start date: March 5, 2012
Phase: Phase 3
Study type: Interventional

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

NCT ID: NCT01521923 Completed - Clinical trials for Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

C-early
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.