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NCT ID: NCT01821391 Completed - Actinic Keratoses Clinical Trials

Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

COMET2
Start date: July 2013
Phase: Phase 3
Study type: Interventional

This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study. The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

NCT ID: NCT01820611 Completed - Clinical trials for Rheumatoid Arthritis

Arcos Revision Stem: Evaluation of Clinical Performance

Start date: February 2013
Phase:
Study type: Observational

The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the success of the Arcos Stem.

NCT ID: NCT01820572 Completed - Clinical trials for Kidney Transplantation

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

Start date: March 27, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

NCT ID: NCT01819025 Completed - Depression Clinical Trials

Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

NCT ID: NCT01818492 Completed - Clinical trials for Primary Haemophagocytic Lymphohistiocytosis

Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

Start date: July 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.

NCT ID: NCT01817959 Completed - Clinical trials for Islet Transplantation in Diabetes Mellitus Type 1

Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation

REP0211
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The objective of this clinical trial was: - to assess whether Reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in patients with Type 1 diabetes (T1D). The safety of Reparixin in the specific clinical setting was also evaluated. Background: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantation. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in T1D patients.

NCT ID: NCT01817426 Completed - Crohn Disease Clinical Trials

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission

STOP IT
Start date: January 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether infliximab can favourably and safely be discontinued in patients with Crohn's disease in sustained complete clinical, biochemical, and endoscopic remission on infliximab. Further to examine the clinical utility of measuring levels/activity of infliximab and activity of anti-infliximab Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out of three, to measure this activity.

NCT ID: NCT01815736 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

Start date: March 27, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

NCT ID: NCT01815203 Completed - Obesity Clinical Trials

Caffein Consumption and Response Inhibition

Start date: March 2013
Phase: N/A
Study type: Interventional

With the abundance of energy-dense foods that are designed for ease of consumption in the current environment, it is of importance to better understand the factors that may undermine the control of energy intake at healthy levels. One of the factors that is potentially important in response inhibition is caffeine. The aim is to assess the direct effects of caffeine on response inhibition, using a No Go/Go-task. We will also assess whether the presentation of food cues, i.e. as words or as pictures, modulate response inhibition different in restrained vs. non-restrained eaters.

NCT ID: NCT01815164 Completed - Clinical trials for Irritable Bowel Syndrome

Effect of Hypnotherapy and Educational Intervention in Irritable Bowel Syndrome

Start date: August 2007
Phase: N/A
Study type: Interventional

Aim: Gut directed hypnotherapy can reduce IBS symptoms but the mechanisms underlying this therapeutic effect remain unknown. We determined the effect of hypnotherapy and educational intervention on brain responses to cued rectal distensions in IBS patients. Methods: 44 women with moderate to severe IBS and 20 healthy controls (HCs) were included.. Blood oxygen level dependent (BOLD) signals were measured by functional Magnetic Resonance Imaging (fMRI) during expectation and delivery of high (45 mmHg) and low (15 mmHg) intensity rectal distensions. Twenty-five patients were assigned to hypnotherapy (HYP) and 16 to educational intervention (EDU). 31 patients completed the treatments and the post treatment fMRI. Results: Similar symptom reduction was achieved in both groups. HYP responders demonstrated a pre-post treatment BOLD attenuation in both anterior and posterior insula during high intensity distension, while EDU responders had a BOLD attenuation in prefrontal cortex. Pre-post differences for the low distension and for the two expectation conditions were almost exclusively seen in the HYP group. For all responders there was a significant correlation between treatment induced reduction of GI related anxiety and BOLD decrease in the anterior insula. Following treatment, the brain response to distension was similar to that observed in HCs, suggesting that the treatment had a normalizing effect on the central processing abnormality of visceral signals in IBS. Conclusions: The abnormal processing and enhanced perception of visceral stimuli in IBS can be normalized by psychological interventions. Symptom improvement in the treatment groups may be mediated by different brain mechanisms.