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NCT ID: NCT01288066 Active, not recruiting - Osteoarthritis Clinical Trials

Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System

Epoca H vs T
Start date: September 2011
Phase: N/A
Study type: Interventional

The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.

NCT ID: NCT01271517 Active, not recruiting - Clinical trials for Diabetes Mellitus Type 1

Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis

BAS
Start date: September 2005
Phase: Phase 4
Study type: Interventional

Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis. This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.

NCT ID: NCT01268397 Active, not recruiting - Wrist Fracture Clinical Trials

Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

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

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

NCT ID: NCT01228682 Active, not recruiting - SIADH Clinical Trials

Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

Start date: October 2010
Phase: N/A
Study type: Observational

A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice. A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.

NCT ID: NCT01208766 Active, not recruiting - Multiple Myeloma Clinical Trials

Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

HO95
Start date: January 2011
Phase: Phase 3
Study type: Interventional

Study phase: phase III Study objective: - Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT) - Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation - Comparison of single versus tandem high dose Melphalan with ASCT Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive Study design: Prospective, multicenter, intergroup, randomized Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.

NCT ID: NCT01208675 Active, not recruiting - Clinical trials for Mild Cognitive Impairment

The Swedish BioFINDER Study

Start date: September 2010
Phase:
Study type: Observational

The present study aims at combining biochemical methods with various types of imaging techniques to identify the pathophysiology of Alzheimer's disease (AD). The main interest is to find markers associated with the very early steps in the pathology of this disease. The investigators shall thus screen for i) molecules in cerebrospinal fluid (CSF) and plasma specific for AD, and ii) brain imaging markers (e.g. MRI and PET) that correlate to detailed clinical assessments. Biomarkers of interest would then be useful to: 1. Enable accurate detection of the disease early on. Such biomarkers need to specifically reflect the very early pathophysiology of AD and distinguish it from disorders with similar symptomatology, such as other types of dementia and major depression. The sensitivity and specificity of these biomarkers in combination with clinical assessment should be of at least 90%. 2. Enable prediction of the course of events of the disease, such as the disease rate in individual patients. Biomarkers that can predict the pattern of future symptoms will be extremely valuable. 3. Allow monitoring of early effects of new disease-modifying therapies (so-called surrogate biomarkers). Currently clinical therapeutic trials for AD require large patient groups together with long-term treatment. Both size of the groups and treatment time will be reduced with the help of surrogate biomarkers. 4. Study the pathogenesis of the disease. Biomarkers can be used to investigate in detail early alterations in AD patients. For instance, changes in the levels of certain molecules in CSF together with genetic predisposition could then be correlated to clinical signs and changes detectable by brain imaging. This can lead to identification of new therapeutic targets that could easily be monitored in future trials.

NCT ID: NCT01163825 Active, not recruiting - Alzheimer's Disease Clinical Trials

Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

NsG0202
Start date: January 2008
Phase: Phase 1
Study type: Interventional

Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the degeneration of these neurons correlates with the cognitive decline in these patients. The objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the potential benefits of targeted gene therapy with the safety of a retrievable implantable device. The study is an open label, single centre, 12-month, dose-escalation phase Ib study in patients with mild to moderate AD. The primary objective is safety and tolerability, while secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily living (ADL), positron emission tomography (PET) imaging and electroencephalography (EEG).

NCT ID: NCT01161329 Active, not recruiting - Stroke Clinical Trials

Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

Start date: September 2009
Phase: Phase 1
Study type: Interventional

Chronic conditions such as stroke are associated with physical disability and an economic burden for the family and the society. A medical approach is often not sufficient to address the bio-psychological process of chronic disease. Behavioural medicine approaches are often needed to improve the treatment outcomes. Those approaches have often successfully been used together with physical activity to change health behaviour in inactive individuals and in pain management. In this project the combined approach of behavioural medicine principles and physical training will be tried on patients who have had a stroke one year ago where it has yet only been used scarcely. As the study focus on the individuals' ability to function and be active the primary outcome measure is disability. The aim of the study are in a randomized controlled study evaluate if a high intense functional exercise program as an group intervention under three months can influence functional, psychosocial, anthropometric and biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome variables will be analyzed: 1. level of physical activity, motor function and balance 2. depression and health-related quality of life 3. body mass index (BMI), metabolic risk profile, inflammation status 4. number of falls, fall-related self-efficacy and outcome expectations

NCT ID: NCT01121952 Active, not recruiting - Clinical trials for Talo-crural Joint Dysfunction

The Effect of Manipulation on Dysfunction of the Talo-crural Joint

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

The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.

NCT ID: NCT01117363 Active, not recruiting - Obesity Prevention Clinical Trials

Effect of Three Weeks Consumption of Rye Porridge Breakfast

Start date: March 2010
Phase: N/A
Study type: Interventional

Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current study is to investigate whether this effects remains at regular consumption. A secondary aim is to compare the orocecal transit time (OCTT) between the two breakfasts.