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NCT ID: NCT01783444 Completed - Breast Cancer Clinical Trials

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

BOLERO-6
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT01780935 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

OCTAVE
Start date: June 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

NCT ID: NCT01777022 Completed - Pregnancy Clinical Trials

Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

AFFIRM
Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth. The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial. The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01770808 Completed - Clinical trials for Digestive System Disorders

A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort

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

Digestive discomfort includes gastrointestinal symptoms such as abdominal pain, altered bowel habit, flatulence and bloating and can sometimes result from slower intestinal transit and other digestive irregularities. The objective of this study is to investigate the effect of consuming Aquamin (as AquaCal and AquaPT) on digestive discomfort and symptoms amongst adults without diagnosed gastrointestinal disorders.

NCT ID: NCT01767155 Completed - Endometrial Cancer Clinical Trials

Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

ZoptEC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.

NCT ID: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01759524 Completed - Clinical trials for Post Operative Analgesia Duration.

To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade

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

Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone produces analgesia. When administered centrally its effects are predominantly due to its alpha 2 activity. When administered peripherally it prolongs the analgesia through its vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another possibility is that it prolongs analgesia of peripheral nerve blocks due to a hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major concern with the lower limb blocks is the risk of falls associated with prolonged motor blockade during early mobilisation. Clonidine has been shown to intensify and prolong the motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine are associated with longer analgesia but with more side effects. Clonidine in a dose of 90 mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block in patients under going semi elective foot/ankle procedures.

NCT ID: NCT01757977 Completed - Clinical trials for Performance and Safety of an Airway Management Device

A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DLâ„¢ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

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

The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.

NCT ID: NCT01757509 Completed - Parkinson's Disease Clinical Trials

A Randomized Controlled Feasibility Trial to Determine the Effectiveness of Set Dancing for People With Parkinson's Disease

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

The aim of this study is to investigate if set dancing is beneficial and feasible for those with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that: - Participants will be able to partake fully in the intervention without reporting adverse events. - There will be evidence of gains in functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease who participate in eight weeks of set dancing classes compared to a control group.