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NCT ID: NCT02576509 Completed - Clinical trials for Hepatocellular Carcinoma

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT02576171 Completed - Clinical trials for Social Anxiety Disorder

Group Therapy Supported Internet-based CBT for Adolescents With Social Anxiety Disorder - A Feasibility Trial

SoFT
Start date: October 15, 2015
Phase: N/A
Study type: Interventional

The primary objectives of this study is to test the feasibility and efficacy of group-therapy supported internet-delivered CBT for adolescents (13 - 17 years) with social anxiety disorder. Investigators will conduct an open trial with N = 30 participants. Participants will be assessed at baseline, immediately after treatment and at a 6-month follow-up.

NCT ID: NCT02573233 Completed - Asthma Clinical Trials

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

EXPEDITION
Start date: January 27, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

NCT ID: NCT02573194 Completed - Obesity Clinical Trials

The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake

Start date: August 2015
Phase: N/A
Study type: Interventional

Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion adults being overweight. Consumption of foods that can affect appetite by increasing satiety could regulate the total energy intake and thus body weight. There is data suggesting that the macronutrient composition of the foods and especially protein content may have a potent role on satiety. However, the type of protein appears to play a role in satiety possibly due to the different balance of the amino acid profile. The research project is dedicated to identify the source (animal or plant) and the optimized protein quantity needed to accelerate satiation, suppress appetite and extend satiety until hunger appears again. It is hypothesized that the consumption of animal derived protein-enriched meals will induce a reduction in hunger through the impact on gut hormones and peptides that are closely related to the short-term regulation of food intake.

NCT ID: NCT02572024 Completed - Clinical trials for Resistant Hypertension

The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)

BAT
Start date: November 2015
Phase: N/A
Study type: Interventional

Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted. Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy. Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension. Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study. This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria. The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.

NCT ID: NCT02571777 Completed - Asthma Clinical Trials

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

NCT ID: NCT02571426 Completed - Anesthesia Clinical Trials

Renal Function During Pediatric Anesthesia

Start date: October 2015
Phase: Phase 1
Study type: Interventional

It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. In this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.

NCT ID: NCT02571309 Completed - Asthma Clinical Trials

Asthmatuner a Self-management App for Asthma: A Randomized Controlled Multicentre Trial

Asthmatuner
Start date: August 2016
Phase: N/A
Study type: Interventional

Primary aim: Evaluating the effect of Asthmatuner on patients´ self-reported asthma control test (ACT/C-ACT)compared with conventional asthma management. Secondary aim: Evaluating patients´ health-related quality of life (HR-QoL) medical adherence by using Asthmatuner compared with conventional management. Total sample size: Stratified study population consisting of 43 females and males with diagnosed asthma at the age of at least 6 years pediatric specialist care and 43 females/males in primary care. Study design: This is a multi-centre, blinded, randomized controlled, cross-over trial over to at least 16 weeks. Subjects: Two stratified groups of participants with uncontrolled asthma will be recruited; (1) children and adolescents from Astrid Lindgren's Children's Hospital, Karolinska University Hospital, and (2) adolescents and adults from the primary health care sector in Stockholm, Sweden. The asthma control test (ACT/C-ACT) will be applied for evaluation of asthma control, a score less than 20 will be required for inclusion. Intervention: Asthmatuner is an app supporting self-management evaluating symptoms and lung function with external spirometry. The app gathers the information to define patients´ asthma control. Subsequently, Asthmatuner provides the patient with a treatment recommendation based on the individual treatment plan. Procedures: Participants are randomized (1:1) into the one of two-arms of asthma self-management with Asthmatuner - conventional or conventional - Asthmatuner. Questionnaires will collect information about asthma control, HR-QoL, Medicine adherence report scale (MARS) and history of medical health concerning health care utilization and personal costs and income. Analysis: The study hypothesis will be tested by examining difference in patients´ change in asthma control (ACT/C-ACT) and HR-QoL (PAQLQ/Mini-AQLQ). Results will be summarized at each management period as mean scores and analysed by paired t-tests.

NCT ID: NCT02568995 Completed - Clinical trials for Rescue Pain Requirements

Pain Management Following Total Hip Arthroplasty

FEMORALIA
Start date: May 2014
Phase: Phase 3
Study type: Interventional

Total hip arthroplasty (THA) is a common and standardized procedure. Postoperative mortality after hip joint replacement is low but some complications remain, including chronic post-surgical pain (1), hip dislocation (2), infection (3), and deep vein thrombosis (4). Strategies that have been identified to reduce morbidity and mortality include: posterior surgical approach, mechanical and pharmacological prophylaxis of deep vein thrombosis, and the use of spinal anesthesia (5). One of the important factors for patient satisfaction with lower limb arthroplasty is good postoperative pain management (6). Poorly managed postoperative pain can lead to chronic post-surgical pain and therefore aggressive postoperative pain management is important (7). Several different methods have been used to treat postoperative pain following THA. Recently, local infiltration analgesia (LIA) using a combination of large volume local anesthetics (LA) and non-steroidal anti-inflammatory agents (NSAID) injected systematically peri-articularly has been used for pain management with variable success (8). We found that better analgesia could be achieved when using LIA compared to intrathecal morphine during the first few days postoperatively (9,10). Ultrasound techniques are commonly used for peripheral nerve blocks and have been shown to reduce pain intensity and may be considered by many to be a standard of care. Specifically, the 3-in-1 block has been commonly used because of its ease of application and good pain management following total hip arthroplasty. The present study aims to compare postoperative pain intensity following local infiltration analgesia with a standardised 3-in-1 block for total hip arthroplasty.

NCT ID: NCT02567890 Completed - Eating Disorders Clinical Trials

Swedish Body Project for Prevention of Eating Disorders

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

Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The investigators aim is to investigate the extent to which an interactive prevention program, delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the emergence of eating disorders among young females. The sBody Project is based on a "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations and changes in the format of delivery accomplished in this study might help to disseminate the program on a broad basis, and consequently affect the health of young females on a much larger scale the ever before.