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NCT ID: NCT01191424 Completed - Asthma Clinical Trials

A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

ADONE
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.

NCT ID: NCT01191268 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.

NCT ID: NCT01189981 Completed - Clinical trials for Congenital Heart Disease

Effect of eHealth Encouragements to Intensive Exercise in Adolescents With Congenital Heart Disease

PReVaiL
Start date: October 2010
Phase: Phase 2
Study type: Interventional

All over the world 0.8 % of all live children are born with a Congenital Heart Disease (CHD) due to genetic end environmental causes. Advanced treatment and care has enhanced survival substantially, and adults with CHD are a growing population requiring continuous monitoring and care. Presently 25% of young adults acquire complicating Cardio Vascular Diseases (CVD) in young adulthood amongst other co-morbidities. It is known that adolescents with CHD are not as physical fit (PF) as their cardiac capability allows, most likely for reasons concerning safety, ability plus inactive everyday life. However, in 2006 The European Society of Cardiology states, that regular exercise at recommended levels can be performed and should be encouraged in all patients with CHD. Training programmes in hospitals have an effect on PF and Quality of Life (QoL) for the few, as most adolescents' find it impossible to fit into everyday life. It is the investigators hypothesis that an eHealth intervention, to facilitate intensive exercise in the patients' neighbourhood environs, may improve physical fitness more efficiently than standard lifestyle education. The purpose of the study is to create evidence to recommend an efficient, fun and safe cardiac rehabilitation programme to adolescents with CHD. Primary outcome measure Cardiopulmonary exercise capacity: Online V02 max bicycle test Secondary outcome measure Level of physical exercise: Actigraph and Questionnaire Tertiary outcome measure Quality of Life: PedsQl Prevail is a national prospective, randomized clinical trial including 216 adolescents aged 13-16 years, who have had cardiac surgery in childhood owing to complex CHD. The patients included are all recommended to be as physical active as their healthy peers and pursue the principle guideline from The National Board of Health: "All children and young people must be physically active for at least 60 minutes a day, preferably longer". Patients with mental retardation and FEV1 at baseline < 80% of predicted are excluded. The risk of participating in the purposed trial is not regarded as higher than everyday daily living. Results will be interpreted according to affiliation to health related fitness clusters.

NCT ID: NCT01188356 Completed - Atrial Arrhythmia Clinical Trials

EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

EMERALD
Start date: March 2010
Phase:
Study type: Observational

The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

NCT ID: NCT01187095 Completed - Infertility Clinical Trials

Involuntary Childlessness and Stress Management

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

Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding. Psychosocial intervention might have a soothing and healing effect on both behavior as well on physical matters. Hence, the investigators would like to investigate whether Expressive Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy rate for couples who are going through fertility treatment.

NCT ID: NCT01187082 Completed - Overactive Bladder Clinical Trials

Grouptraining for Overactive Bladder in Adults

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

Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder. The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).

NCT ID: NCT01187069 Completed - Type 2 Diabetes Clinical Trials

A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care

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

A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour changes. In Denmark, the tendency is that nurses in general practice provide a large part of type 2 diabetes care. Observational studies support Self-determination Theory by finding autonomous motivation and perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes. Hence, research is needed to develop and test interventions that are autonomy supportive. Aim To develop a training course for practice-nurses in autonomy support in patients with type 2 diabetes, and to evaluate the effect on patient outcomes. Methods The development of the intervention was based on literature research and expert meetings. The intervention is evaluated in a cluster randomised controlled trial with 40 Danish general practices, - where nurses, before enrolment in the study, provided consultations to patients with type 2 diabetes, - and about 2500 patients with type 2 diabetes, identified in a Diabetes Database. The patients will be followed 15 months from nurse-participation in the course. Data will be obtained from registers and patient-questionnaires. The hypothesis is that patients with type 2 diabetes regardless of education level, age, and gender will benefit from the intervention.

NCT ID: NCT01186744 Completed - Psoriasis Clinical Trials

A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

NCT ID: NCT01185119 Completed - Healthy Clinical Trials

Effect of GLP-1 on Glucose Metabolism in CNS Assessed by PET

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

10 healthy men will be PET-scanned (CNS) twice in random order with infusions of placebo or Native GLP-1 during hyperglycemic clamp to uncover the metabolic effects of GLP-1 in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.

NCT ID: NCT01184716 Completed - Healthy Clinical Trials

The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

VitMaD
Start date: September 2010
Phase: N/A
Study type: Interventional

Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.