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NCT ID: NCT02017782 Completed - Clinical trials for Acute Changes in Respiratory Outcomes

Controlled Human Exposure to Indoor Air, Dust and Ozone

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

The aim of the study is to provide information which may help to improve the quality of the life of persons exposed to indoor environments in Danish dwellings. The experiment will document if dust and ozone contribute to deterioration of indoor air quality and to the occurrence of symptoms and health effects. The study is aimed at testing the hypothesis that the presence of ozone potentiate the health and comfort effects of dust exposure in the indoor environment. Testing this hypothesis will be based on the following questions: Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause unwanted health effects either by themselves or by interaction? If so, does the presence of ozone potentiate the expected irritative effects of dust? The challenge of these hypotheses will be made as a controlled experiment on humans in a climate chamber under controlled exposure conditions. This controlled human experiment should be able to substantiate the findings from the intervention studies. Furthermore, they ideally reflect something relevant to the general public and therefore should have maximum public appeal and application possibilities.

NCT ID: NCT02017769 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

MRI in Diagnosing and Monitoring CIDP

Start date: May 2014
Phase: N/A
Study type: Observational

We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin

NCT ID: NCT02017626 Completed - Fish Allergy Clinical Trials

FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units: To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects. The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.

NCT ID: NCT02017171 Completed - Clinical trials for Coronary Artery Disease

A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes

Start date: February 2014
Phase: Phase 3
Study type: Interventional

Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease. Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for three years, during which they will be followed through periodical visits. To prevent any possible bias, neither the participants nor the clinical staff knows who is taking allopurinol and who is taking the placebo. Kidney function will be measured at the beginning and at the end of the treatment period to see whether patients taking allopurinol experience a slower loss of kidney function over time as compared to those taking the inactive pill. If this trial is successful, the reduction in health problems resulting from the prevention or delay of kidney function loss due to the use of allopurinol would have a major impact on the lives of type 1 diabetic patients as well as on society at large, significantly reducing the human and financial costs associated with diabetic kidney disease. Because of the emphasis on early intervention, the proposed trial, if successful, will establish a new paradigm in treatments to slow or prevent progression towards end stage kidney disease in type 1 diabetes far beyond anything achieved to date.

NCT ID: NCT02015897 Completed - Breast Cancer Clinical Trials

Effect of Physical Therapy on Breast Cancer Related Lymphedema

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

The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

NCT ID: NCT02015364 Completed - Clinical trials for Deep Vein Thrombosis

Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization

Start date: February 2014
Phase: N/A
Study type: Interventional

Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture. Type of study Randomized, controlled trial (RCT). 130 patients will be included. Time schedule Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed. Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups: 1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3. 2. The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle. Treatment protocol for the two groups is similar concerning orthose, removal of wedges and weight-bearing. The only difference is that patients in the intervention group are instructed to do ankle exercise. Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12 months. The study's primary endpoint is at the 12 month mark. Population Patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint). Number of patients 65 patients will be included in each group (a 130 patients in total).

NCT ID: NCT02015247 Completed - Hip Dysplasia Clinical Trials

Functional Capacity After Computer Assisted Periacetabular Osteotomy in Patients With Hip Dysplasia

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

Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by genetic and intrauterine factors, such as mechanical (rump presentation and oligohydramnios) and hormonal factors1. To ease the passage through the birth canal, the hip joint is quite mobile perinatally. Postnatally, the laxity of the ligaments will subside and the femoral head will normally position itself deeply in the acetabulum2. The theory is that if the femoral head does not migrate sufficiently into the acetabulum, dysplasia may develop because the matrice to stimulate acetabular growth is not correctly positioned. Normally, at birth the femoral head sits deep in the acetabulum held by surface tension of the synovial liquid. The growth and the hemispherical morphology of acetabulum are dependent on the presence of a normally growing and correctly placed spherical femoral head that works as a convex matrice. If for some reason the normal development is disturbed pre- or postnatally, pathologic relations may develop between the femoral head and the acetabulum3, leading to hip dysplasia. Purpose of this research project is to investigate if the correction of the acetabulum is accurately performed when the surgeon use navigation equipment during PAO.

NCT ID: NCT02014311 Completed - Clinical trials for Coronary Artery Disease

CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion

CATCH2
Start date: October 2013
Phase: N/A
Study type: Interventional

The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge. The following main hypothesis will be tested: - Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

NCT ID: NCT02014298 Completed - Burn Scars Clinical Trials

Non Ablative Fractional Laser Treatment of Burn Scars

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

BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel mature burn scars. OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn scars after NAFL-treatment. HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and functional appearance. METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment Scale; 1 = normal skin, 10 = worst imaginable scar).

NCT ID: NCT02013843 Completed - Hypertension Clinical Trials

Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.

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

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life and concentration of fasting blood lipids and glucose during one year of treatment.