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NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01896167 Completed - Migraine Clinical Trials

Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia

Start date: April 2013
Phase: N/A
Study type: Interventional

In this study the investigators will investigate the following hypothesis - that hypoxia induce migraine headache and migraine aura - the aura phase is associated with a spreading reduction in cerebral blood flow - the migraine headache is associated with dilatation of intra- and extracerebral arteries - the migraine headache is associated with changes in brain metabolism - the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.

NCT ID: NCT01895868 Completed - Clinical trials for Ultrasound Simulation

Long-terms Effects of Simulation-based Ultrasound Training: A Randomized Trial

Start date: July 2013
Phase: N/A
Study type: Interventional

The clinical effects of simulation-based ultrasound training has not yet been explored. To examine the long-term effects of training, we plan to conduct a trial, where half of all new residents are randomized to simulation-based training and the other half to traditional clinical training only. The effects are assessed after two months of practice by evaluating two ultrasound scans performed by the residents. These scans are subsequently evaluated by a blinded consultant gynecologist and rated using the Objective Structured Assessment of Ultrasound Skills, which has been validated in previous studies.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895283 Completed - Bethlem Myopathy Clinical Trials

The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy

Start date: September 2013
Phase: N/A
Study type: Interventional

Muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist. Previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training. The study consists of two test days, a 10-week training period and five blood tests. Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring. The training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. The patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength. We will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the Principal investigator. We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.

NCT ID: NCT01895231 Completed - Iron-deficiency Clinical Trials

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

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

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

NCT ID: NCT01895218 Completed - Clinical trials for Postpartum Haemorrhage

Treatment of Women After Postpartum Haemorrhage

PP-01
Start date: June 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

NCT ID: NCT01895205 Completed - Clinical trials for Severe Postpartum Haemorrhage

Treatment of Women After Severe Postpartum Haemorrhage

PP-02
Start date: June 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue

NCT ID: NCT01892943 Completed - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Start date: August 2013
Phase: N/A
Study type: Observational

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON). Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed. The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey. Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

NCT ID: NCT01892254 Completed - Clinical trials for Polycystic Ovary Syndrome

Incretin Effect in PCOS Women

Start date: June 2013
Phase: Phase 4
Study type: Interventional

This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin. The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.