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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: NCT01986036 Active, not recruiting - Healthy Clinical Trials

The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake

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

High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations. This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.

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: NCT01975493 Active, not recruiting - Clinical trials for Paediatric Antimicrobial Pharmacokinetics

Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

NAPPA
Start date: November 2013
Phase:
Study type: Observational

The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. The study population will involve children and neonates who need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. In addition, NAPPA will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). This allows the sample to be stored and tested later on. NAPPA will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.

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: NCT01965899 Active, not recruiting - Syncope Clinical Trials

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

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

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

NCT ID: NCT01962441 Active, not recruiting - Hepatitis C Clinical Trials

SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

NCT ID: NCT01954693 Active, not recruiting - Tuberous Sclerosis Clinical Trials

A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis

TRON
Start date: June 2012
Phase: Phase 2
Study type: Interventional

This is a single centre, two-arm, individually randomised, Phase II, double- blind, placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed medicine in this patient group but for a different target of effect. The current trial is a proof of principle study for memory and executive function outcomes. Following an eligibility visit, patients will be scheduled for baseline visit and randomization. They will then be followed up for 6 months undergoing both safety and neurocognitive assessments whilst taking either the placebo or study drug. 48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ > 60 and a significant deficit in one or more primary outcome measures will be randomly allocated in a ratio of 2:1 to either RAD001 (Everolimus) or Placebo.

NCT ID: NCT01950052 Active, not recruiting - Obese Clinical Trials

Pre-operative Diet: Effect of Wound Healing After Bariatric Surgery

Start date: November 2012
Phase: N/A
Study type: Interventional

This study is a randomised control trial comparing the effects of a pre-operative very low calorie diet (VLCD) on wound healing in the morbidly obese patients undergoing bariatric surgery. The benefits and disadvantages of a very low calorie pre-operative diet are not clear. Some centres ask their patients to take a VLCD 2-6 weeks before bariatric surgery with the aim of shrinking the liver to make surgery easier. Studies have shown that after this diet the liver does shrink and therefore operating may be easier but this did not necessary translate into significant lesser operative times. The effects of operating during a catabolic phase have not been evaluated. Theoretically a low calorie diet before surgery is similar to starving a patient and can potentially create a state of malnutrition. This is rarely advisable before surgery and can lead to poor wound healing and poor healing of bowel anastomosis. This study will ascertain if there is any difference in wound healing rates in these morbidly obese patients (BMI>40kg/m2)undergoing a Laparoscopic Roux en Y gastric by pass in groups who have taken the preoperative diet compared to those who were not on a special diet. Skin wounds will be evaluated. This will potentially reflect the general state of healing of the patient which includes the healing of bowel anastomosis. Surrogate markers will be employed to evaluate the pre-morbid nutritional state, effectiveness of dieting, subsequent wound healing (collagen production, markers for the different aspects of wound healing) and impact on liver cell death .This study will be able to tell us how safe this calorie deficient diet is in these morbidly obese patients before surgery.