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NCT ID: NCT01992289 Active, not recruiting - Clinical trials for X-linked Hypohidrotic Ectodermal Dysplasia

Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002

ECP-002e
Start date: March 2014
Phase: N/A
Study type: Observational

The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The efficacy evaluations will incorporate growth and development parameters, frequency of infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ function. The safety evaluations will include physical examinations, adverse events and concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD

NCT ID: NCT01990963 Active, not recruiting - Severe Brain Trauma Clinical Trials

Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

Start date: January 2010
Phase: N/A
Study type: Observational

Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of brain tissue after patients with severe brain trauma

NCT ID: NCT01980797 Active, not recruiting - Clinical trials for Bicuspid Aortic Valve Disease

International Bicuspid Aortic Valve Consortium (BAVCon)

BAVCon
Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability. The Specific Aims of this study are: 1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease. 2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease. To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

NCT ID: NCT01979393 Active, not recruiting - Uterine Sarcoma Clinical Trials

IRCI Gynae Sarcomas, High Grade Uterine Sarcoma

Start date: February 2015
Phase: Phase 2
Study type: Interventional

This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread. Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy. All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

NCT ID: NCT01972022 Active, not recruiting - Clinical trials for Coronary Artery Lesions

TRANSFORM OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography

TRANSFORM
Start date: November 2013
Phase: Phase 4
Study type: Interventional

First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.

NCT ID: NCT01969578 Active, not recruiting - Clinical trials for Salivary Gland Cancer

Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

Start date: September 24, 2015
Phase: Phase 2
Study type: Interventional

Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

NCT ID: NCT01968200 Active, not recruiting - Cancer Clinical Trials

Prevention of Anthracycline-induced Cardiotoxicity

ICOS-ONE
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF). ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients.

NCT ID: NCT01968109 Active, not recruiting - Neoplasms by Site Clinical Trials

An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Start date: November 5, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

NCT ID: NCT01963273 Active, not recruiting - Pilonidal Sinus Clinical Trials

Video Assisted Ablation of Pilonidal Sinus

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

The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.

NCT ID: NCT01957436 Active, not recruiting - Clinical trials for Metastatic Prostate Cancer

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

PEACE1
Start date: November 13, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.