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NCT ID: NCT02544568 Completed - Diabetes Mellitus Clinical Trials

Effects of Standardized Meals on the Metabolic, Hormonal and Inflammatory Responses in Human

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

Meal composition is important for blood sugar levels in patients with diabetes. The aim of this study is to investigate if a meal composition of fat, protein and carbohydrate is important for the hormonal and inflammatory responses Patients with type 1 and type 2 diabetes and healthy controls will be included in the study. At four different occasions the participants will receive lunch with the same amount of calories but different composition of fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the meals. The participants will estimate their satiety. In addition participant will fill in questionnaires about their food habits and wellbeing. This study is the first study to compare both hormonal and inflammatory responses, as well as psychological aspect of the meals, after meals with different composition. Results from this study will help to make recommendation about meal composition which is beneficial for patients with diabetes type 1 and type 2.

NCT ID: NCT02544451 Completed - Cystic Fibrosis Clinical Trials

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

Start date: August 2015
Phase: Phase 3
Study type: Interventional

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

NCT ID: NCT02543372 Completed - Gambling Clinical Trials

RCT of Internet-Delivered CBT Treatments for Pathological Gambling: Comparing the Effects of Added Involvement From CSOs

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

Background: Problem gambling is a public health concern with prevalence rates at 2 %. Problem gambling also severely affects concerned significant others (CSOs). Several studies have investigated the effects of individual treatments based on cognitive behavior therapy (CBT), but there is a shortage in studies on the effect of involving CSOs in treatment. This study aims to compare an intervention based on behavioral couples therapy (BCT) involving a CSO with an individual CBT treatment to determine their relative efficacy. BCT has shown promising results in working with substance abuse, but this is the first time it is used as an intervention for problem gambling. Both interventions will be Internet-delivered and participants will receive e-mail and telephone support. Method/Design: A sample of at least 100 couples will be randomized to either the BCT condition or the CBT condition. The participants will work through 10 modules over 12 weeks in a secure online environment, and receive support via email and over telephone. Repeated measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome measure is gambling behavior, defined as time spent and money lost on gambling, as measured by timeline follow-back. Secondary outcomes include gambling related harm, alcohol consumption, relationship satisfaction and mental health for the gambler as well as for the CSO. Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT will be superior to CBT on increasing relationship satisfaction, d) relationship functioning will mediate change in gambling behavior in the BCT group and e) reduction in gambling behavior will mediate change in relationship functioning in the CBT group.

NCT ID: NCT02542267 Completed - Clinical trials for Peripheral Artery Disease

In-Stent Restenosis Post-Approval Study

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

The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.

NCT ID: NCT02541968 Completed - Clinical trials for Obsessive-compulsive Disorder

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

Start date: September 3, 2015
Phase: N/A
Study type: Interventional

Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults. The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general. Research Questions: Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life? Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life? Q3: Is ICBT a cost-effective treatment, compared to f2f CBT? Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients? Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?

NCT ID: NCT02540993 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

FIDELIO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

NCT ID: NCT02538666 Completed - Lung Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

CheckMate 451
Start date: October 13, 2015
Phase: Phase 3
Study type: Interventional

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

NCT ID: NCT02536807 Completed - Clinical trials for Interdental Papilla Augmentation

Minimally Invasive Volume Augmentation of Papillae Around Implant Restorations With Hyaluronic Acid Injection

Start date: August 2014
Phase: N/A
Study type: Interventional

Open gingival embrasures, also called "black triangles", may occur after surgical intervention or tooth replacement by an implant. They are perceived as anaesthetic by most patients and causing functional and phonetic problems. The aim of the present study is to assess the effect of injection of hyaluronic acid for papilla augmentation next to an implant restoration in a clinical controlled double-blinded randomized trial with 6 months follow-up.

NCT ID: NCT02535598 Completed - Behavior Therapy Clinical Trials

Therapy Labs: To Improve Adherence in Internet Based Psychotherapy

Start date: May 2014
Phase: N/A
Study type: Interventional

This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and potentially in the end also better outcome for participants in internet interventions.

NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.