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NCT ID: NCT02876484 Completed - Severe Obesity Clinical Trials

Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Start date: June 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.

NCT ID: NCT02873559 Completed - Muscle Weakness Clinical Trials

Effect of PROGRESSive Training and Teststerone in Older Frail Men

PROGRESS
Start date: November 1, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

In this scientific clinical investigation we will test whether testosterone and progressive resistance training can improve muscle strength and reduce the risk of falls in older men. In addition, we will examine whether this treatment improves quality of life, functional capacity, including sexual function and counteracts depression. Such a project have not been performed earlier.

NCT ID: NCT02872714 Completed - Clinical trials for UC (Urothelial Cancer)

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

Start date: January 12, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

NCT ID: NCT02872610 Completed - Suicidal Thoughts Clinical Trials

The Self-help Online Against Suicidal Thoughts (SOS) Trial

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

The objective of the SOS-trial is to examine if an online self-help intervention is effective in reducing suicidal thoughts among people at risk of suicide. The SOS-trial is a randomized, wait-list controlled trial with 1:1 allocation ratio. A total of 438 people with suicidal thoughts will be allocated to the intervention condition (N=219) or the control condition (N=219). The intervention condition consists of a six-week internet-based self-help therapy intervention. The control condition consists of a waiting list assignment for 32 weeks. The primary hypothesis is that the intervention is superior to the control condition in reducing suicidal thoughts at post-test (6 weeks). The SOS-trial is a partial replication of a previously conducted Dutch trial.

NCT ID: NCT02872051 Completed - Depression Clinical Trials

Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

IBBIS
Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark

NCT ID: NCT02871778 Completed - Clinical trials for Primary Ciliary Dyskinesia

Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia

CLEAN-PCD
Start date: August 2016
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).

NCT ID: NCT02870972 Completed - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

APeX-1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

NCT ID: NCT02870023 Completed - Multiple Sclerosis Clinical Trials

How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?

Start date: June 2016
Phase: N/A
Study type: Interventional

Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor control, and compromised gait function. Reduced walking speed, balance, and fatigue are the cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There is increasing scientific support of strength training for improving walking function. The evidence for balance training remains flawed. It is known that neurological damage in MS leads to increased cognitive processing in the planning of movements, which predisposes fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that motoric/balance training with an emphasis on cognitive load can affect gait and fatigue. Purpose: The aim of the study is to determine whether there is a differentiated effect between strength and balance training measured by motor function, strength, balance, and fatigue.

NCT ID: NCT02869035 Completed - Clinical trials for Major Depressive Disorder

Treatment Outcome in Major Depressive Disorder

Start date: August 2016
Phase: Phase 1
Study type: Interventional

Major Depressive Disorder (MDD) is one of the most severe and frequently occurring brain disorders worldwide. It has been linked to serotonergic dysfunction, sexual dysfunction, vulnerability to stress and neuro-inflammation. However, at the same time the etiological understanding is limited. Most antidepressants act on the serotonin (5- HT) system, yet between 30-50 % of patients with MDD does not respond successfully to 5-HT acting drugs. Recent experimental models from our group suggest that cerebral 5-HT levels in vivo can be indexed through molecular brain imaging of the 5-HT 4 receptor (5-HT4R) with a novel Positron Emission Tomography (PET) ligand (11C-SB207145). Also, our human studies have confirmed that cerebral synaptic 5-HT is inversely related to 5-HT4R binding and this technique thus can be used to investigate the role of 5-HT tone in the brain in MDD with differential responses to standard antidepressant treatment. By using multimodal neuroimaging technology, we aim to determine the status of the 5-HT system prior to and after either successful or failed neuropharmacological intervention in a non-randomized longitudinal open clinical trial. 100 untreated patients with moderate to severe MDD will be included. Data collection from various neurobiological domains (i.e, 5-HT4R PET imaging, Magnetic Resonance Imaging (MRI), functional MRI (fMRI), electroencephalogram (EEG), psychometrics, neuropsychological tests, and peripheral biomarkers) will be conducted before, during and after 12 weeks of antidepressant treatment. The objective is to identify predictors of pharmacological antidepressant treatment response in depressed individuals before and after 8 weeks of antidepressant treatment.

NCT ID: NCT02867137 Completed - Clinical trials for Traumatic Brain Injury

Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients

PreTBI I
Start date: February 15, 2017
Phase:
Study type: Observational

The PreTBI I study will investigate whether prehospital blood samples drawn already in the ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims to improve triage and treatment of patients suffering mild head trauma, who are considered low-risk patients. These patients do not always benefit from hospitalization, but are nevertheless admitted on precaution, as clinical assesment can be difficult. Hypotheses: 1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules out traumatic intracranial lesion with a sensitivity >97%. 2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI patients rules out traumatic intracranial lesion with sensitivity >97% and results in lower false positive rate than S100B. 3. Prehospital measurements of both GFAP and S100B results in lower false positive rates than in-hospital measurements.