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NCT ID: NCT01372657 Terminated - Cataract Clinical Trials

Intraocular Lens (IOL) Calculation Improvement

Start date: April 2011
Phase: N/A
Study type: Observational

Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.

NCT ID: NCT01370863 Terminated - Clinical trials for Gastroesophageal Reflux Disease

An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

Start date: December 2, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

NCT ID: NCT01368666 Terminated - Clinical trials for Aortic Valve Replacement

Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark

CAVALIER
Start date: February 23, 2010
Phase: N/A
Study type: Interventional

The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

NCT ID: NCT01367769 Terminated - Thrombosis Clinical Trials

Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis

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

Background: Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late phase CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. The inflammatory process of the vessel wall associated with perivascular angiogenesis at the time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may important in the development of post-thrombotic syndrome (PTS). Therefore the investigators will test the value of CEUS to detect venous perivascular vascularization and inflammation in patients with acute DVT or SVT. Aims: To determine the presence and degree of venous perivascular vascularization and inflammation assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without thrombosis. Expected results: The investigators hypothesize that venous perivascular vascularization and inflammation assessed by contrast agent enhancement can be quantified and will be significantly more pronounced in the perivascular tissue of the thrombotic vein than in the non affected vein and in controls, and will correlate with level of inflammatory markers and leg volume. Significance: These results would provide new information on the pathophysiological concept of thrombosis and thrombus resolution. It might help to better understand the pathophysiologic mechanisms that promote the development of chronic venous insufficiency and PTS.

NCT ID: NCT01366729 Terminated - Clinical trials for Stroke Gait Rehabilitation

Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs

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

Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait. To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke. This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes. Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation. Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation. Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented.The intervention will continue for five weeks or until patients have reached FAC 5 (independent walkers on all surfaces). Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed "up and go" test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale. Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids

NCT ID: NCT01362868 Terminated - Healthy Subjects Clinical Trials

Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

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

The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

NCT ID: NCT01345630 Terminated - HIV-1 Clinical Trials

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

MODERN
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

NCT ID: NCT01318993 Terminated - Crohn's Disease Clinical Trials

Open-Label Extension Study of GSK1605786A

SHIELD-3
Start date: April 2011
Phase: Phase 3
Study type: Interventional

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

NCT ID: NCT01316939 Terminated - Crohn's Disease Clinical Trials

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

SHIELD-2
Start date: May 2011
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.