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NCT ID: NCT02035384 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

guardian™ 5
Start date: June 5, 2014
Phase:
Study type: Observational

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

NCT ID: NCT02034110 Completed - Cancer Clinical Trials

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Start date: March 12, 2014
Phase: Phase 2
Study type: Interventional

This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT) / non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).

NCT ID: NCT02033902 Completed - Epilepsy Clinical Trials

A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

Start date: June 6, 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

NCT ID: NCT02033031 Completed - Clinical trials for Branch Retinal Vein Occlusion

Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature. Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME) and the development of neovascular glaucoma. The occurence of ME is the main reason for visual loss and frustrates visual recovery among patients with both central or branch RVO. Therapeutic options that have been used and discussed over the years are the treatment with anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution. Furthermore, surgical options like vitrectomy and radial optic neurotomy were used. Panretinal photocoagulation and grid pattern photocoagulation had established as additional tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of these different treatment options could not be verified and remains mostly unknown. Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE). Unfortunately, often high numbers of re-treatments become necessary over the years. In our knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are important, as the mean age < 70 years with an onset of BRVO has been estimated in about 60% of all cases. In addition, most patients with regard to the application of anti-VEGF treatment in real clinical setting, there is only rare experience concerning need of optimum time duration for follow-up at the departments. Hence, the present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.

NCT ID: NCT02032836 Completed - Clinical trials for Pulmonary Arterial Hypertension

Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)

Start date: March 10, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb

NCT ID: NCT02032745 Completed - Breast Neoplasms Clinical Trials

Genomic Signatures to Predict Treatment Response

AGO-Austria
Start date: August 2011
Phase:
Study type: Observational

A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.

NCT ID: NCT02031809 Completed - Lung Neoplasms Clinical Trials

Multicentric Study VATS Major Introperative Complications

Start date: January 2014
Phase:
Study type: Observational

This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

NCT ID: NCT02031432 Completed - Pain Clinical Trials

CORAL XT - Open-label Extension Trial of the CORAL Trial

CORAL XT
Start date: December 18, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.

NCT ID: NCT02031198 Completed - Alzheimer's Disease Clinical Trials

18-months Safety Follow-up Study of AADvac1, an Active Tau Vaccine for Alzheimer's Disease

FUNDAMANT
Start date: January 2014
Phase: Phase 1
Study type: Interventional

This follow-up study continues to observe patients who have completed the phase 1 trial of AADvac1, for another 18 months. Long-term safety and behavior of the immune response to AADvac1 over time are the main points of interest. AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is the main constituent of neurofibrillary tangles (NFTs), and is intended to be a disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress. As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner.

NCT ID: NCT02028507 Completed - Clinical trials for Metastatic Breast Cancer

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

PEARL
Start date: March 13, 2014
Phase: Phase 3
Study type: Interventional

This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125 mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3 weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous nonsteroidal aromatase inhibitors (NSAI) (letrozole or anastrozole) in cohort 1 or previous aromatase inhibitors (AI) (letrozole, anastrozole or exemestane) in cohort 2 defined as: recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or progression while on or within 1 month after the end of treatment with NSAI/AI for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone lesions, lytic or mixed, in the absence of measurable disease.