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NCT ID: NCT02134028 Completed - Asthma Clinical Trials

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Start date: August 5, 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: - Systemic exposure - Anti-drug antibodies - Biomarkers

NCT ID: NCT02133118 Completed - Clinical trials for Type 2 Diabetes Mellitus

Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

ZODIAC-39
Start date: January 1998
Phase: N/A
Study type: Observational [Patient Registry]

Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs). With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.

NCT ID: NCT02132702 Completed - Spinal Cord Injury Clinical Trials

Performance Attributes and User Progression While Using Ekso

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

This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.

NCT ID: NCT02132013 Completed - Clinical trials for Chronic Kidney Disease

SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology

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

The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.

NCT ID: NCT02130726 Completed - Gastric Cancer Clinical Trials

Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

STOMACH
Start date: December 2014
Phase: N/A
Study type: Interventional

Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield. Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy. Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.

NCT ID: NCT02130557 Completed - Clinical trials for Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Start date: July 15, 2014
Phase: Phase 3
Study type: Interventional

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

NCT ID: NCT02130362 Active, not recruiting - Crohn's Disease Clinical Trials

A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

CAPE
Start date: August 28, 2014
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

NCT ID: NCT02130349 Recruiting - Ulcerative Colitis Clinical Trials

IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD.

IBDSL
Start date: February 2011
Phase: N/A
Study type: Observational [Patient Registry]

The IBD South Limburg (IBDSL) project was initially designed as a prospective population based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and prospectively followed. As from 2011, the cohort is being scaled up into a population based biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response. Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, which represents 93% of the IBD population in South Limburg. The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra intestinal manifestations, medication, surgery, comorbidity and demographics. Data has prospectively been updated through chart review (clinical data), questionnaires (i.e. quality of life) and linkage to the authority database (vital state, residence). The biobank includes serum, plasma, DNA, faeces, biopsies and exhaled air. We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.

NCT ID: NCT02130154 Completed - Obesity Clinical Trials

Brown Adipose Tissue Activity and Age

Start date: May 2013
Phase: N/A
Study type: Observational

In this study the investigators aim to investigate whether the sympathetic stimulation of BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between young and elderly subjects, as an explanation for the diminished metabolic brown adipose tissue activity in the elderly. The investigators hypothesis is that sympathetic nervous system activity in the elderly is diminished as compared to their younger counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.

NCT ID: NCT02130011 Completed - Adenocarcinoma Clinical Trials

Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

DGRT
Start date: March 2014
Phase: N/A
Study type: Interventional

This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.