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NCT ID: NCT01478672 Completed - Diabetes Clinical Trials

Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

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

The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

NCT ID: NCT01478425 Completed - Allergic Rhinitis Clinical Trials

Efficacy and Tolerability of a Topical Microemulsion in Patients With Allergic Rhinitis Due to Sensitization to Pollen

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Study design: Randomized, controlled, double-blind, parallel, multicentre multinational clinical trial, to show superiority of an active therapy as compared to a control therapy on intermittent or persistent Allergic Rhinitis. Primary objective: 1. To show that a topical microemulsion is superior to a sterilized saline solution to prevent deterioration in the health related quality of life, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen. Secondary objectives 2. To explore the effect of a topical microemulsion, as compared to a sterilized saline solution, for the prevention of nasal and ocular symptoms in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen. 3. To explore the effect of a topical microemulsion, as compared to a sterilized saline solution, in the utilization of symptomatic medications, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen. 4. To assess the patient's satisfaction with a topical microemulsion treatment, as compared to a sterilized saline solution, in patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen. 5. To assess the safety of a topical microemulsion, as compared to a sterilized saline solution, administered to patients with intermittent or persistent allergic rhinitis due to sensitization to birch, olive tree or grass pollen. This is a clinical investigation study of a Class 1 medical device product. This is a prospective study of an active medical device versus a control medical device. It was considered feasible to recruit 10 patients patients per center, and therefore the study should be conducted in 10 centers. To get treatment balance within each center, a total of 100 patients should be recruited.

NCT ID: NCT01478230 Completed - Tobacco Dependence Clinical Trials

An Exploratory Study Comparing Two Nicotine Inhalers

Start date: November 2011
Phase: Phase 0
Study type: Interventional

Subjects will be screened within 28 days before the first study treatment to confirm that they meet the requirements to participate in the trial. They will return to the site for two treatment visits, at least 12 hours each, and at least one day in between visits. At each visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11 hours. The investigator (or an appropriate delegate at the investigator site) will obtain informed consent from each subject. Blood samples will be drawn on a special schedule. The total predicted amount of blood sampled from each subject is 174 mL over the whole study. Subjects will be required to follow specific smoking and dietary restrictions and rate their urges to smoke, general liking of the product, and how easy the product is to use.

NCT ID: NCT01477125 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Working Memory Training in Adults With ADHD

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

The purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50).

NCT ID: NCT01476475 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: - The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives: - To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or ≤6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.

NCT ID: NCT01476423 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Start date: January 2004
Phase: N/A
Study type: Observational

This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.

NCT ID: NCT01475825 Completed - Clinical trials for Hypercholesterolemia

A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol

FOCUS FH
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo. Secondary Objectives: - Determine whether there are qualitative differences between the safety profiles of the 2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and the overall study population - Determine whether there are qualitative differences between the tolerability of the 2 dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population - Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1, Cohort 2, and the overall study population - Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic lipid levels in Cohort 2 compared to placebo - Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients with FH and inadequately controlled LDL-C who complete the primary efficacy assessment visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label Continuation Period

NCT ID: NCT01475591 Completed - Clinical trials for Musculoskeletal Pain

Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care

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

The aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. The aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. Randomization will be done at each primary health care centre after screening to 1) Multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. The investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. The research and implementation will be performed in a close cooperation with Luleå University of Technology.

NCT ID: NCT01474850 Completed - Clinical trials for Mechanical Ventilation

Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

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

The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.

NCT ID: NCT01474772 Completed - Clinical trials for Diabetic Peripheral Neuropathy

Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

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

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.