Hypotheses : - Frailty is common among the elderly patient population who have a TIA. Compared to control groups of literature. - Patients with high fragility score ABCD2 also have a high score. - Patients with a high score of fragility also have a significant number of vascular risk factors (including atrial fibrillation) - Patients with a high score of fragility also have an average length of stay (ALOS) higher than the others. So underlying the question is: can we learn to better identify patients who are going to need a bigger structure their output at home. objectives: - Assess the feasibility of placing a fragile test in acute phase of AIT in USINV. - To evaluate the frequency of frailty among the population of elderly patients who have a TIA. - Compare in AIT over 70 years those with fragile high score to those with low scores, especially for ABCD2 score, vascular risk factors and the DMS. - Statements parameters: o The fragility score: - Choice of fragility score: among the fragility of scores, the most used in international literature is the score of Linda Fried. Moreover, the stress of the study is related to the environment of the USINV (shortly, short DMS, often tired patients). It is therefore important to use this study for a test only, but quick handover. The score Fried also has the advantage (J Gerontol A Biol Sci Med Sci 2001, 56 (3): M146-56) The first 4 items are simple clinical evaluation. The 5th (grip test) will be performed with a device (single gauge measuring the fingers bending strength) loan from the geriatric ward. Fragility, geriatric concept recent identification is defined by simple physical indicators. The literature suggests that it is related to the risk of hospitalization, falls, institutionalization and death. Some studies have shown a link with heart disease, including heart failure. The link with the TIA (transient ischemic attack) has however never been studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is unknown. Several questions need to be asked: Among older patients hospitalized for TIA, what proportion of those completing the criteria of frailty? In this same population, is there a correlation between fragility and scores ABCD2 score itself predictive of the risk of subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher risk of ischemic stroke (which could cause a strengthening of prevention measures)?
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In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer. Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink. The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.
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To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS. Hypothesis: BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo. Study design: Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection. Study population: Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS. Intervention: Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures: The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire. Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.
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This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months. The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.
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The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma. This is an exploratory study to investigate the following: 1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma. 2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma. To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.
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The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation for all parents and children will be investigated in order to establish an optimized lumbar puncture management process. The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP),less postoperative complications and comfortable LP will be anticipated.
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ROSCO-CF is a phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and effects of (R)-roscovitine in subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in 36 adult cystic fibrosis subjects. These 36 patients will be allocated to 3 groups of 12 subjects who will be randomized in a 2:1 ratio (active drug to matching placebo). In each group, 8 patients will receive roscovitine (200 mg, 400 mg, 2 X 400 mg in group 1, 2 and 3, respectively) and 4 will receive a matching placebo. Treatment will be provided by oral administration of capsules. Each patient will receive the same treatment throughout the 28 day study. This phase II trial will give some preliminary information about safety and hints of effects of a new experimental treatment. If the data suggest that a short term treatment with roscovitine provides a safe, effective and convenient approach for CF patients chronically infected with Pseudomonas aeruginosa, patients participating in this proof of concept trial will be offered to participate in further longer term studies. This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.
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OBJECTIVES: - To determine the correlation between supplemental sulforaphane (broccoli sprout extract) dose and concentrations of sulforaphane and its metabolites in blood and urine samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia. - To determine the effect of this supplement on biomarkers of prognosis in these patients. - To determine the effect of this supplement on HDAC inhibition in peripheral blood cell and normal and cancerous breast tissue samples from these patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. - Sulforaphane Supplement: Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. - Placebo: Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity. Blood and urine samples are collected at baseline and after completion of study treatment for laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or lumpectomy) also undergo breast tissue sample collection at baseline and at the time of surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and apoptosis (TUNEL assay). Patients complete questionnaires at baseline and periodically during study about their dietary history, family history, cruciferous vegetable intake, adverse events, and dietary and medication changes. After completion of study therapy, patients are followed at/around 30 days. RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia. PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.
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Bright light therapy has been shown to improve depression and insomnia in multiple studies. These are common conditions among elders, particularly those residing in long term care environments. Bright light therapy has been inadequately studied in the geriatric population. We will show that a groups of twenty elders can simultaneous be exposed to bright light and that it will result in improvements in multiple realms of behavior and quality of life. Elders will be tested with a number of neuropsychological test batteries prior to exposure to bright light and again at the end of a four week exposure. Some subjects will have daytime and night time activity levels monitored with actigraphy. Cortisol and melatonin levels will be obtained prior to and at the end of the exposure period. The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will: 1. improve sleep quality 2. improve cognitive scores 3. improve depression scores 4. improve quality of life scores.
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Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.
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Hypotheses : - Frailty is common among the elderly patient population who have a TIA. Compared to control groups of literature. - Patients with high fragility score ABCD2 also have a high score. - Patients with a high score of fragility also have a significant number of vascular risk factors (including atrial fibrillation) - Patients with a high score of fragility also have an average length of stay (ALOS) higher than the others. So underlying the question is: can we learn to better identify patients who are going to need a bigger structure their output at home. objectives: - Assess the feasibility of placing a fragile test in acute phase of AIT in USINV. - To evaluate the frequency of frailty among the population of elderly patients who have a TIA. - Compare in AIT over 70 years those with fragile high score to those with low scores, especially for ABCD2 score, vascular risk factors and the DMS. - Statements parameters: o The fragility score: - Choice of fragility score: among the fragility of scores, the most used in international literature is the score of Linda Fried. Moreover, the stress of the study is related to the environment of the USINV (shortly, short DMS, often tired patients). It is therefore important to use this study for a test only, but quick handover. The score Fried also has the advantage (J Gerontol A Biol Sci Med Sci 2001, 56 (3): M146-56) The first 4 items are simple clinical evaluation. The 5th (grip test) will be performed with a device (single gauge measuring the fingers bending strength) loan from the geriatric ward. Fragility, geriatric concept recent identification is defined by simple physical indicators. The literature suggests that it is related to the risk of hospitalization, falls, institutionalization and death. Some studies have shown a link with heart disease, including heart failure. The link with the TIA (transient ischemic attack) has however never been studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is unknown. Several questions need to be asked: Among older patients hospitalized for TIA, what proportion of those completing the criteria of frailty? In this same population, is there a correlation between fragility and scores ABCD2 score itself predictive of the risk of subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher risk of ischemic stroke (which could cause a strengthening of prevention measures)?
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In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer. Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink. The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.
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To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS. Hypothesis: BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo. Study design: Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection. Study population: Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS. Intervention: Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures: The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire. Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.
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This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months. The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.
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The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma. This is an exploratory study to investigate the following: 1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma. 2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma. To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.
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The study is carried out in a prospective randomized controlled way. In the context of informed understanding from parents, compared with traditional process(no anesthesia; lying without the pillow and fasting water and food for four hours after lumbar puncture), randomly select lidocaine surface anesthesia and postoperative management (lying without the pillow for half an hour after lumbar puncture) . All children will be evaluated by the FLACC(The face,legs,activity,cry,consolability behavioral tool) scale to assess the degree of pain during and after lumbar puncture. Lumber puncture time, success rate and any postoperative condition will be recorded and analyzed.A questionaire about the operation for all parents and children will be investigated in order to establish an optimized lumbar puncture management process. The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP),less postoperative complications and comfortable LP will be anticipated.
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ROSCO-CF is a phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and effects of (R)-roscovitine in subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in 36 adult cystic fibrosis subjects. These 36 patients will be allocated to 3 groups of 12 subjects who will be randomized in a 2:1 ratio (active drug to matching placebo). In each group, 8 patients will receive roscovitine (200 mg, 400 mg, 2 X 400 mg in group 1, 2 and 3, respectively) and 4 will receive a matching placebo. Treatment will be provided by oral administration of capsules. Each patient will receive the same treatment throughout the 28 day study. This phase II trial will give some preliminary information about safety and hints of effects of a new experimental treatment. If the data suggest that a short term treatment with roscovitine provides a safe, effective and convenient approach for CF patients chronically infected with Pseudomonas aeruginosa, patients participating in this proof of concept trial will be offered to participate in further longer term studies. This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.
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