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NCT ID: NCT01617057 Terminated - Otosclerosis Clinical Trials

Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

OTOPHOS
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis

NCT ID: NCT01616537 Terminated - Solid Organ Sites Clinical Trials

Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter

QASICC-EVA
Start date: November 2011
Phase: N/A
Study type: Interventional

Background Patient satisfaction with or acceptance of care assessment is increasingly taken into account in oncology. Most cancer and other critically-ill patients require a totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir connected to a central venous catheter, which may or may not be valved. It is impossible to estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over 7 million CVCs were placed in the United States in both chronic and acute care. Although many patients fitted with a CVC are able to undertake activities which are hindered with other external vascular access devices, they are often physically or psychologically anxious about their device. To our knowledge, no validated questionnaire measuring patient acceptance of and satisfaction with their CVC has been reported in the literature. Based on these observations, the aim of our study was to develop and to validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC. QASICC is designed as a multi-dimensional, self-administered questionnaire comprising approximately 30 items related to the use, appearance and pros and cons of the device as well as quality of life as perceived by patients using one for treatment. Objective The purpose of the study is to validate a French-language self-administered questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning their totally-implanted central venous catheter: confirmatory validation of questionnaire psychometric properties. Study Design This is a prospective, multicenter, open study. Primary Outcome Measures: Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure: - Items quality - Dimensional structure - Dimensional consistence - Measure accuracy - Measure reliability - Sensitivity to change

NCT ID: NCT01614704 Terminated - Breast Cancer Clinical Trials

Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Start date: October 2011
Phase:
Study type: Observational

Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate. On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility. Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports. Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.

NCT ID: NCT01613482 Terminated - Breast Cancer Clinical Trials

TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention

TSARINE
Start date: October 2007
Phase: Phase 3
Study type: Interventional

Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

NCT ID: NCT01612988 Terminated - Clinical trials for B-cell Chronic Lymphocytic Leukemia (B-CLL)

Treatment With Bendamustine, Ofatumumab and MethylPrednisolone in Relapsed B-CLL

BOMP
Start date: July 2012
Phase: Phase 2
Study type: Interventional

ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL). A study of the GOELAMS / GCFLLC-MW intergroup

NCT ID: NCT01612481 Terminated - Soft Tissue Sarcoma Clinical Trials

Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma

Start date: April 2012
Phase: Phase 2
Study type: Interventional

Cancer surveillance has a significant cost and generate anxiety for the patient. It is important to avoid exams that will not modify health support or whose results wont allow to decide.

NCT ID: NCT01609582 Terminated - Type 2 Diabetes Clinical Trials

Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

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

The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

NCT ID: NCT01608490 Terminated - Emphysema Clinical Trials

Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

RENEW
Start date: October 2012
Phase: N/A
Study type: Interventional

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

NCT ID: NCT01607346 Terminated - Epilepsy Clinical Trials

An Open Label Study to Evaluate the Effects of Ezogabine/Retigabine Added to Existing Anti-epileptic Drug(s) on Urinary Voiding Function in Subjects With Partial Onset Seizures

Start date: March 27, 2013
Phase: Phase 4
Study type: Interventional

This is a multicentre, open label study to examine the effect of ezogabine/retigabine on the voiding function of adult subjects with drug-resistant partial onset seizures (POS). Subjects fulfilling the study entry criteria at Screening and at Baseline including a comprehensive eye examination by an ophthalmologist or retina specialist and a skin assessment by the investigator will receive ezogabine/retigabine. The starting dose of ezogabine/retigabine will be 300 mg/day. Subjects will be up titrated by 150 mg/day weekly up to the maximum ezogabine/retigabine daily dose of 1200 mg (or the highest tolerated dose). During the 49 days of the treatment phase, subjects will undergo three repeat non-invasive assessments of voiding function. In addition, subjects who meet pre-determined criteria for voiding dysfunction will undergo multichannel cystometry in order to characterise bladder hypocontractility, bladder outlet obstruction or a combination of events which clinically is manifest with difficulty emptying the bladder or acute urinary retention. At the end of the Treatment Phase, all subjects will enter the Taper Phase, a 3-week down titration period. Subjects who have new findings of abnormal pigmentation of the retina, unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lip, nail, or mucosa since baseline will be asked to enter the Safety Follow-Up / Continuation Phase. All subjects will undergo 6-monthly comprehensive eye examinations during the Safety Follow-Up / Continuation Phase. Subjects who have not developed abnormal discoloration of the skin, lips, nails or mucosa will continue to undergo skin assessments by the investigator. Any subject who has developed abnormal discoloration of the skin, lips, nails or mucosa since baseline will be referred to a dermatologist for evaluation and 6-monthly follow up assessments. All subjects will continue to be followed until the pigmentation and/or discoloration has resolved or stabilised, as defined by no change over 2 consecutive 6-monthly assessments conducted over at least 12 months after discontinuation of ezogabine/retigabine.

NCT ID: NCT01606618 Terminated - Spina Bifida Aperta Clinical Trials

Self-esteem and Neuro-urological Follow-up in Patients With Spina Bifida or Spinal Cord Injury

ESTIME
Start date: March 12, 2012
Phase:
Study type: Observational

With improved life expectancy over the last fifty years, spina bifida has become a disease of the adult. One of the major stakes for these patients is the preservation of a regular follow-up of uro-nephrologicals risk factors and of a respect for the rules of self management of their neurological bladder. The main objective of this study is to highlight a difference in the level of global self-esteem among a population of adult patients with spina bifida and a population of adult patients with traumatic spinal cord injury gained the same level of neurological.