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NCT ID: NCT02450617 Completed - Clinical trials for Posttraumatic Stress Disorder

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

STAB
Start date: June 2014
Phase: N/A
Study type: Interventional

The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The investigators also aim to study psychophysiological markers associated with complex trauma and treatment, mechanisms of change involved in treatment, and which patient characteristics that predict positive outcome.

NCT ID: NCT02449850 Active, not recruiting - Obesity Clinical Trials

Preventing Atopic Dermatitis and ALLergies in Children

PreventADALL
Start date: December 14, 2014
Phase: N/A
Study type: Interventional

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

NCT ID: NCT02447081 Completed - Stroke Clinical Trials

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amulet™PMS
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

NCT ID: NCT02445248 Completed - Clinical trials for Diffuse Large B-cell Lymphoma (DLBCL)

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

JULIET
Start date: July 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

NCT ID: NCT02445222 Recruiting - Clinical trials for Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

CAR-T Long Term Follow Up (LTFU) Study

PAVO
Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

NCT ID: NCT02444091 Completed - Clinical trials for Chronic Fatigue Syndrome (CFS)

Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS)

CycloME
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Significant clinical improvements of ME/CFS symptoms were observed in two patients with long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for Hodgkin lymphoma. Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response. The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.

NCT ID: NCT02443662 Completed - Clinical trials for Heart Defects, Congenital

Colloid Osmotic Pressure in Patients With Fontan Circulation

Start date: September 2015
Phase:
Study type: Observational

Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid osmotic pressure in patients 10 year after completion of a three step Fontan surgery. This project will evaluate whether increased micro vascular leakage and change in interstitial colloid osmotic pressure are present in patients after ten years with a Fontan circulation.

NCT ID: NCT02443571 Completed - Prostatic Neoplasms Clinical Trials

Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)

Start date: January 2015
Phase:
Study type: Observational

This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.

NCT ID: NCT02443155 Completed - Diabetes Clinical Trials

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Start date: November 10, 2015
Phase: Phase 2
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

NCT ID: NCT02442219 Active, not recruiting - Coeliac Disease Clinical Trials

A Blood Based Diagnostic Test for Coeliac Disease

Start date: February 2015
Phase:
Study type: Observational

Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.