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NCT ID: NCT02200302 Terminated - Clinical trials for Adolescent Idiopathic Scoliosis (AIS)

Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)

MID-C
Start date: October 2014
Phase: N/A
Study type: Observational [Patient Registry]

Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the vertebrae and discs gradually develop a curvature that is first detected in patients between 11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from radiographs by the Cobb angle . The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each vertebra and disc between the superior and inferior end vertebrae . Although a small curve is well tolerated and does not require treatment, a large curve can progress to the point that it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the initiation of the curve and its subsequent progression. The factors responsible for the initiation of the curve are unknown, but the subsequent progression of the curve is clearly associated with the adolescent growth spurt . The primary risk factors for progression include age at onset and the magnitude of the curve; young patients with large curves are at the highest risk . Although numerous treatment methods have been recommended for patients with AIS, the only accepted treatment includes bracing for skeletally immature patients with curves between 25 and 40 degrees and operative correction with spinal fusion for patients with curves greater than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing has caused compliance problems with wearing the brace and many patients only wear the brace at home . While operative intervention completely corrects the scoliosis or rib hump, it eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion potentially leading to disc degeneration and back pain. Despite satisfactory short-term results of operative instrumentation and fusion, a less invasive technique preserving more motion with a smaller scar represents a major improvement. Realizing this goal is contingent on treating curves early, before they progress to an irreversible deformity, and when there is still enough residual growth and remodeling potential. ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues time to accommodate any incremental correction. The MID-C System inherent benefits are: - Only two screws are used - Incision size is much smaller - Simpler operation with shorter operative time - Less complications (attributed to the three points above). - Minimal spinal mobility loss. All the device components are made of materials well accepted in the orthopedic field and are fully biocompatible (see Investigator Brochure). The unique concept of the system and the materials used may provide favorable results as follows: Smaller scare, quicker healing period and better spine mobility over the years. This study is designed to demonstrate that the MID-C System is safe and effective.

NCT ID: NCT02195817 Terminated - Alcohol Dependence Clinical Trials

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

Start date: August 2014
Phase: Phase 4
Study type: Interventional

To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care

NCT ID: NCT02193074 Terminated - Clinical trials for Spinal Muscular Atrophy

A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy

ENDEAR
Start date: August 19, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.

NCT ID: NCT02190604 Terminated - Cystic Fibrosis Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients

Start date: July 31, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses. This first-in-human and proof of concept study will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic fibrosis patients.

NCT ID: NCT02189460 Terminated - Cognition Clinical Trials

Effect of Normal Aging on Language Processing

SEMVIE
Start date: July 2014
Phase:
Study type: Observational

The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.

NCT ID: NCT02185170 Terminated - Prostate Cancer Clinical Trials

DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections

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

The aim of this study is divided in 4 different steps: - the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging), - the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue, - the third step is to validate the use of: 1. the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue, 2. the Light-CT scanner use for tissue structural observation. - the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.

NCT ID: NCT02184793 Terminated - Clinical trials for Mechanically-ventilated Patients

Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit

Inclinometre2
Start date: June 2014
Phase: N/A
Study type: Interventional

Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care. The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

NCT ID: NCT02178397 Terminated - Clinical trials for NSCLC Patients With EGFR Activating Mutation

A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

FLARE
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs. However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance. It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.

NCT ID: NCT02176486 Terminated - Lupus Nephritis Clinical Trials

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)

Start date: June 9, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.

NCT ID: NCT02174107 Terminated - Spine Metastases Clinical Trials

Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

Radiointer
Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty. Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly, This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center : - Arm A: Percutaneous vertebroplasty - Arm B: External radiotherapy This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).