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NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01949259 Completed - Lung Cancer Clinical Trials

Rapid Learning for Lung Cancer

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

A retrospective, data mining project that re-uses routine patient care data for decision support systems.

NCT ID: NCT01949129 Recruiting - Clinical trials for Acute Lymphoblastic Leukaemia

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

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

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

NCT ID: NCT01948960 Completed - Breast Neoplasms Clinical Trials

Influence of Exceptional Patient Characteristics on Everolimus Exposure

INPRES
Start date: August 2013
Phase: Phase 4
Study type: Interventional

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. Furthermore the investigators will investigate the relation between metabolic response assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit. The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.

NCT ID: NCT01948882 Active, not recruiting - Contraception Clinical Trials

Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Start date: September 30, 2013
Phase: N/A
Study type: Interventional

The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

NCT ID: NCT01947985 Completed - Atrial Fibrillation Clinical Trials

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

Start date: February 1, 2012
Phase:
Study type: Observational

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

NCT ID: NCT01947556 Completed - Diabetes Mellitus Clinical Trials

Insulin by Jet-injection for Hyperglycemia in Diabetes

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

The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

NCT ID: NCT01946932 Completed - Clinical trials for Out-of-hospital Cardiac Arrest

Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Start date: June 2011
Phase: N/A
Study type: Interventional

This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest. The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction. Our secondary aims are: - To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life. - To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden. - To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.

NCT ID: NCT01946776 Completed - Epilepsy Clinical Trials

Cardiac Arrhythmias in Epilepsy: the CARELINK-study

CARELINK
Start date: June 2013
Phase: N/A
Study type: Interventional

Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of time, the frequency of clinically relevant arrhythmias appeared much higher in two small observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients at high risk of cardiac arrhythmias, so that we can timely institute preventive measures (e.g. pacemaker implantation).

NCT ID: NCT01946490 Withdrawn - Clinical trials for Non-Small Cell Lung Cancer

Time Trends in Waiting Times of NSCLC Patients.

Start date: December 2015
Phase: N/A
Study type: Observational

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung. Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival. The hypotheses of the study: 1. The diagnostic delay for NSCLC patients has increased during the last 12 years. 2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years. 3. Prolonged waiting times are associated with worse overall survival outcome.