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NCT ID: NCT04112511 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy

Start date: March 1, 2015
Phase:
Study type: Observational

The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias. Specifically the investigational questions are: 1. Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy? 2. Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy? 3. Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy? 4. Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy? 5. Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?

NCT ID: NCT04109612 Completed - Clinical trials for Cerebrovascular Disorders

Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-

SUN4P
Start date: July 17, 2019
Phase:
Study type: Observational [Patient Registry]

The main objectives of the proposed project are: 1. To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement 2. To develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management. 3. To evaluate patients' and physicians' experiences and their impact on stroke management. 4. To assess severe negative impact of stroke on the life of survivors including quality of life and disability 5. To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach 6. To evaluate the value of care focusing on health outcomes compared with total costs of achieving them

NCT ID: NCT04108884 Completed - Atrial Fibrillation Clinical Trials

RedStroke - Reducing Europe's Stroke Incidence

RedStroke
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients. The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.

NCT ID: NCT04105426 Completed - Tinnitus Clinical Trials

A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effectiveness of antioxidant supplementation in idiopathic tinnitus patients. To investigate this, a double-blind, randomized, and placebo-controlled clinical trial was conducted to assess the impact of a multivitamin-multimineral supplement with phytochemicals combined with a-lipoic acid supplements on serum oxidative stress, serum antioxidant capacity and tinnitus parameters in patients with idiopathic tinnitus. Subjective, idiopathic, non-pulsatile tinnitus ("tinnitus") is perception of sound without the presence of an external acoustic stimulus. Causes of idiopathic tinnitus remain unknown and the pathological mechanisms are not fully understood. Currently, effective therapies for tinnitus remain limited. Previous research has demonstrated that oxidative stress is possibly involved in the pathogenesis of idiopathic tinnitus and some studies have shown beneficial effects of antioxidant therapy in tinnitus patients. Moreover, many studies have shown the beneficial effect of antioxidant supplementation on the reduction of oxidative stress and the increase of endogenous antioxidant enzymes and antioxidant capacity. Seventy patients with idiopathic tinnitus were enrolled based on certain inclusion and exclusion criteria. Subsequently, they were informed regarding the aims, methods, anticipated benefits, and potential hazards of the study, and were provided with the information leaflet of the study. Each patient who agreed to take part in the study, signed an informed consent form, a copy of which was given to them. Participants were allocated to either antioxidant or placebo group. Randomisation was conducted by someone who was not involved in the study and blinding was strictly maintained to researchers and participants. The antioxidant group received one multivitamin and multimineral tablet with grape seed extract once a day together with one tablet of alpha-lipoic acid twice a day, whereas the placebo group received identical placebo tablets. Supplements were kindly donated by Lamberts. The intervention lasted 3 months. Both groups kept their usual medical treatment and their diet and exercise habits stable during the intervention. Patients were assessed after randomisation according to the following tools: - Medical history - Audiometric and Tinnitus assessment: Basic audiometric tests, pitch match, loudness match, minimum masking level (MML) - Tinnitus questionnaires: Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI) and Visual Analogue Scale (VAS) - anthropometrics: body weight , height, Body Mass Index, waist and hip circumferences - Nutrition and physical activity evaluation - Adherence to the Mediterranean dietary pattern (MedDietScore) - Psychological assessment - Biochemical measurements: Complete blood count, lipid profile, glucose, electrolytes, liver enzymes, thyroid hormones - Vitamin laboratory tests - Oxidative stress assessment in serum samples: Total Antioxidant Capacity (TAC), Superoxide Dismutase (SOD) activity and Oxidized LDL are quantified. Compliance and any side effects were checked with a weekly telephone contact with the patients. The consumption of tablets was checked with a diary completed by patients. At the end of the intervention, all baseline parameters were assessed.

NCT ID: NCT04098484 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Biological Adaptations of Strength Training.

Start date: April 2, 2019
Phase: N/A
Study type: Interventional

A two-trial repeated measures design will be employed in this investigation. Both the control trial and the exercise trial will last for 3 months. During a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. This range of measurements will be repeated the ended each month for both trials. Control trial succeeds exercise trial. An exercise intervention program will take place in the second trial, three times a week.

NCT ID: NCT04093024 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

InPedILD®
Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).

NCT ID: NCT04089566 Completed - Clinical trials for Muscular Atrophy, Spinal

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

DEVOTE
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).

NCT ID: NCT04086706 Completed - Colonoscopy Clinical Trials

Retroflexion In The Ascending Colon Is A Costless Endoscopic Maneuver Increasing Adenoma Detection Rate

Start date: June 1, 2017
Phase:
Study type: Observational

Missing polyps during colonoscopy is considered an important factor for interval cancer appearance especially in the ascending colon (AC). Aim of the study: To evaluate the contribution of retroflexion to adenoma detection in the AC. Patients-Methods: Prospective observational study included consecutive patients with complete colonoscopy between June 2017 and June 2018. The AC was examined in two phases. The first phase included two forward views from the hepatic flexure to the cecum and the second phase a retroflexion in the cecum, inspection till the hepatic flexure then redressing to forward view and reinsertion to the cecum.

NCT ID: NCT04085458 Completed - Hemophilia A Clinical Trials

Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

Start date: September 23, 2019
Phase: Phase 4
Study type: Interventional

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

NCT ID: NCT04081818 Completed - Metabolic Syndrome Clinical Trials

A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. Recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. This condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response. Previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients. In addition, there is strong evidence that obesity is inversely associated with vitamin D levels. The major cause of vitamin D deficiency in humans is the lack of adequate sun exposure. Unfortunately, very few foods, i.e. mushrooms, naturally contain vitamin D and foods that are fortified with vitamin D are inadequate to satisfy vitamin D requirements. The last decade, mushrooms have attracted the research interest as functional foods with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. Edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure. Thus, the purpose of this study is to determine the effects of nutritious mushrooms in adults with Metabolic Syndrome. More specifically, 100 participants will be allocated to two groups, namely intervention group (N=50) and control group (N=50). Vitamin D2-enhanced mushrooms by UV-B will be provided as a snack to the intervention group, whereas the control group will not consume the snack. The intervention will last 3 months.The effects of the intervention will be evaluated via clinical and laboratory markers. Personal and family history, anthropometric, demographic data, body composition, dietary habits, physical activity and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as metabolomic profiles will be assessed in blood samples pre- and post- intervention. Both groups will receive standard nutritional counselling throughout the intervention and will be encouraged to report any adverse effects they may experience during the intervention.