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NCT ID: NCT01435369 Completed - Melanoma Clinical Trials

Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells. All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug: Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg). Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg). Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.

NCT ID: NCT01434979 Completed - Heat Illness Clinical Trials

Exertional Heat Illness: Biomarkers for Prediction and Return to Duty

Heat3
Start date: July 2011
Phase:
Study type: Observational

The investigators goal is to monitor and quantify the differential physiologic and biomarker responses of controls to standardized exercise under thermoneutral and thermally challenged conditions and responses of exertional heat stroke (EHS) subjects under a thermal-challenged environment to develop unique bio-signature panels to predict those at risk for exertional heat illness (EHI) and guide return to duty following an episode of EHS.

NCT ID: NCT01433354 Terminated - Fragile X Syndrome Clinical Trials

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

NCT ID: NCT01433341 Completed - Healthy Clinical Trials

Evaluation of Postural Control After Exercise in Athletes Using Tetra Axial Posturography (tetrax1)

Start date: March 2012
Phase: N/A
Study type: Observational

Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. These are sensitive to vertical pressure produced by a subject standing straight but in various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields additional parameters not obtained by the traditional monoplate stabilometers, namely, weight-distribution patterns and correlation among six combinations of paired outputs from the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric synchronizations). Most athletic injuries occur at the end of an activity, when the participant is fatigue. It is likely that significant portion of the injuries result from instability of the lower extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue increase postural sway, impaired muscle control, and increase the onset delay of movement. Comparing pre-exercise with post-exercise results for each athlete, should detect significant and clinically meaningful differences with the Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and synchronizations of toe parts. The method is suitable for young subjects, and the equipment is portable and tests can be conveniently carried out in a child's familiar training setting and right before/after exercise. The goal of the present study is to measure the balance of the athletes after different types of exercises, to measure the ability of the athletes to recover different types of exercises, and to measure the influence of increasing physical fitness on balance ability. Fifty basketball and football players between the ages of 12 and 18 years old will be examined following informed consent from the children and their legal guardian. Each participant would be measured three times during the year (pre-season, middle-season, and post-season), three times each (before-training, after aerobic warming-up, and after-training) on the Tetrax. Additionally, physical parameters (as height, and weight), anatomical parameters (as leg length), and joint range of movement, would be record.

NCT ID: NCT01433042 Completed - Small/Large Bowel Clinical Trials

PillCam SB3 Capsule- Feasibility Study

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

Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy. Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease. Preparation for procedure will include 12 hours fasting prior to the capsule ingestion Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion. Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured

NCT ID: NCT01432912 Completed - Smoking Clinical Trials

Study Evaluating the Effect of Physician Education on Smoking Cessation Counselling

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

The purpose of the study is to see if a short seminar educating physicians about smoking cessation counselling will effectively improve their smoking counselling cessation practices.

NCT ID: NCT01431339 Completed - Clinical trials for Surgical Site Infection

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01430845 Completed - Cerebral Palsy Clinical Trials

Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay

Start date: September 1, 2011
Phase:
Study type: Observational

The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).

NCT ID: NCT01430832 Terminated - Clinical trials for Post Traumatic Stress Disorder

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Start date: September 1, 2011
Phase:
Study type: Observational

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.