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NCT ID: NCT03301051 Completed - Influenza Clinical Trials

Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

Start date: August 31, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants

NCT ID: NCT03300635 Completed - Fibromyalgia Clinical Trials

Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

Start date: September 5, 2015
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a world widely common syndrome, characterized by widespread pain, often accompanied by general fatigue, soreness, and abnormal sensations (like "pins and needles"). The reasons and the mechanisms (pathogenesis) of FM are still poorly understood. Efficacious therapies cannot be developed without understanding the pathophysiological mechanisms of the disease or syndrome. FM patients suffer from pain and sense of weakness and fatigue in the muscles, and often report difficulty in relaxing their muscles. So far, the studies on muscle activation in fibromyalgia (mostly using surface electromyography) have shown some unusual functioning, a kind of overuse, but the results have been somewhat contradictory. FM symptoms share some features with small fibre neuropathy, which is a disease or abnormality of small nerve fibres with a diverse aetiology. Recently, several research groups have shown (studying both the electrical function of superficial nerves and nerve endings of skin samples) that up to 50% of the FM patients with severe symptoms have small fibre neuropathy: their small nerves do not function properly and small nerve fibre density in their skin is reduced. However, as this phenomenon is common but not a rule, it might be rather a consequence of some underlying mechanisms of the syndrome, creating even more symptoms. The aim is to investigate whether there would exist metabolic changes in FM patients that would create pain and lead to functional changes and damage in small nerve fibres. The investigators also aim to explore the muscle function particularly in distressed situations and at rest. The hypothesis is that a towards-overuse-altered function would create unfavourable metabolic changes. Third, the aim is to investigate some psychological factors (such as tendency to get anxious or distressed) to find out, if there is any association between them and muscle function. The FM patients as well as healthy control subjects will be recruited at Helsinki University Hospital Pain Clinic and from primary care at Vantaa Health Care Centre. The voluntary test subjects will attend 1. A muscle function examination of 30 minutes with electromyography using surface electrodes, including mentally distressing tasks and relaxing periods. At the same session, the subject will reply to some questionnaires regarding their symptoms and measuring some psychological factors. Actual pain level will be assessed. 2. A glucose tolerance test, with other blood samples 3. A bicycle ergometer exercise test of 20 - 30 minutes, with both physiological and chemical (blood samples) recordings. Actual pain level will be assessed as well. At this stage, 40 patients and 20 healthy control subjects will be recruited.

NCT ID: NCT03300427 Completed - Heart Failure Clinical Trials

The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients

TurkuPET
Start date: July 5, 2018
Phase: Phase 4
Study type: Interventional

This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.

NCT ID: NCT03298542 Completed - Clinical trials for Pre-Symptomatic Type 1 Diabetes

A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes

Start date: October 16, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).

NCT ID: NCT03295786 Completed - Parkinson Disease Clinical Trials

Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease

Start date: September 26, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the patients will receive monthly infusions with placebo and two-third of the patients will receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.

NCT ID: NCT03290846 Completed - Obesity Clinical Trials

Secretin Activates Human Brown Fat and Induces Satiation.

GUTBAT
Start date: August 2, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

15 healthy males will be studied with PET/CT, using FDG to investigate glucose metabolism, and radiowater to investigate perfusion. One scan will be performed in controlled cold exposure, to see whether subjects have cold activated brown adipose tissue. Two scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. PET/CT scans will be analysed blinded. 20 healthy males will also be studied with fMRI, in order to investigate brain activity responses to appetizing versus bland foods. This study will be conduced on the same patients as the PET/CT study, but additional subjects with same inclusion and exclusion criteria will be recruited. Two fMRI scans will be performed in room temperature conditions, where all subjects are blinded and randomised to receive placebo and secretin hydrochloride. fMRI scans will be analysed blinded.

NCT ID: NCT03280537 Completed - Nasal Polyps Clinical Trials

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

POLYP 2
Start date: November 21, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

NCT ID: NCT03276598 Completed - Hypertension Clinical Trials

A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

GENRES
Start date: November 25, 1999
Phase: Phase 4
Study type: Interventional

Blood pressure variation and the risk of essential hypertension have an important genetic component. In most cases susceptibility to essential hypertension is likely determined by the action of more than one gene. The identification of genes causing susceptibility to hypertension is important, since it would give new tools for the diagnosis and enable better etiological classification and specific treatment of the disease. The innovation of this study is to use the response to antihypertensive therapy as an intermediate phenotype. In the study, each subject uses one of four antihypertensive drugs, each as a monotherapy in a rotational fashion, for 28 days in a randomized order. The antihypertensive drugs to be tested include a thiazide diuretic, a beta-adrenergic antagonist, an angiotensin-II receptor antagonist and a calcium channel blocker. The drugs that are selected for the study are "typical" representatives of their groups and long-acting, and the dosages are sufficient but well tolerable.

NCT ID: NCT03276130 Completed - Haemophilia A Clinical Trials

Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

MIND
Start date: October 30, 2018
Phase:
Study type: Observational

The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.

NCT ID: NCT03274934 Completed - Well-being Clinical Trials

The Effectiveness of the Mobile-based Youth COMPASS Program to Promote Adolescent Well-being and Life-control

YouthCOMPASS
Start date: September 21, 2017
Phase: N/A
Study type: Interventional

The aim of this randomized control trial is to examine effectiveness of individually tailored web- and mobile-based Acceptance- and Commitment Therapy interventions to promote adolescents' well-being and life-control and subsequently support their successful transition from basic education to upper secondary education. Our additional aim is to examine to what extent the effectiveness of the intervention varies according to intervention intensity and according to risk for school failure. The five-week structured intervention is delivered using the novel web-and mobile-based program Youth COMPASS following the principles of the Acceptance and Commitment Therapy (ACT). The Internet context is assumed to be particularly motivating for youth who enjoy spending time online using different social media. Internet-based interventions have several advantages; they can include more information and treatment components than traditionally delivered treatments and that intervention programs are accessible at any time and at any place. Another unique aspect of the Youth COMPASS is the fact that it is individually-tailored. Each participant have an individually assigned online coach who provides support and encouragement, reminds about Youth COMPASS, sends individualized feedback, and recommends different exercises. The study hypothetizes that the Youth COMPASS is more effective than school counseling as usual. More specifically, the Youth COMPASS is expected to be more effective when it is combined with face-to-face support than when support and feedback are provided only via the Internet. Also, the Youth COMPASS with no face-to-face support (online only) is expected to be more effective than receiving only regular school counseling. Finally, the Youth COMPASS is expected to be more effective for students at risk for school failure than for students without risk for school failure, especially when at risk-adolescents receive more intensive support (i.e., both online and face-to-face support).