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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Nocera, Joe R.;

    Purpose: The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. Recent research demonstrated that older adults who participated in aerobic fitness training significantly increased their brain volume. Equally important, the demonstrated enhancement in brain size is related to improvement on specific cognitive tasks. For example, researchers demonstrated that 124 older adults randomly assigned to receive aerobic training experienced substantial improvement in cognitive performance tasks related to speed of processing and working memory. Similarly, neuroimaging studies showed that aerobically trained individuals increased brain activation during various cognitive tasks. A growing body of research also demonstrates the beneficial effects of cognitive training in later life to promote a healthy brain. For example, researchers demonstrated cognitive interventions targeting memory, reasoning and speed of processing were effective to improve brain function. Unfortunately, despite these promising findings, the generalizability of cognitive training is limited. For example, researchers showed cognitive training tasks designed to improve reasoning, memory, planning, spatial skills and attention in over 11,000 participants demonstrated no transfer effects to untrained tasks, even when the tasks were closely related. The purpose of this study is to see if combing aerobic exercise and cognitive training can enhance the cognitive improvement of each. Specially, the investigators wish to determine if aerobic exercise done immediately before cognitive training can potentiate the improvement. The investigators hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability. Background: Currently the United States has over 23 million Veterans. Of this number, 39.1 percent are over the age of 65 a number that will greatly increase as a large percent of the US population ages. Unfortunately, many of these individuals will suffer from some form of age-related cognitive decline and/or mobility disability. Significantly, declining mental health and mobility disability are primary components of the expected 25 percent growth in health care cost related to the aging crisis in America. And, despite the fact that the United States federal government spends $100 billion dollars annually to cure and/or treat cognitive impairments, successful strategies to improve these impairments remain elusive. The proposed research will substantially advance the development of treatments for cognitive and mobility impairment because the goals explore an intervention that may potentially have pervasive effects on US Veterans quality of life and well-being from a physical as well as a cognitive standpoint. Methods and Research Plan: To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of cognitive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence. Baseline testing will consist of a battery of cognitive function that target verbal fluency, response inhibition, and working memory. Additionally, participant will undergo a structural and functional MRI. Participants will also be evaluated on their physical function as assessed by a 400 meter walk, balance tests, and questionnaires about their daily l functioning. And lastly, all participants will be assessed on their aerobic capacity and for visual outcomes and serum BDNF. Following the 12-week intervention all participants will be post tested in the same manner as the baseline testing. The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability. To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.

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    OpenTrials
    Clinical Trial . 2016
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2016
      Data sources: OpenTrials
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    Authors: Muscaritoli, Maurizio;

    This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with NSCLC. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and Quality of Life. SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: PEPIN, Jean Louis;

    The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP). An interim analysis will be performed when 40 patients will be included. Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).

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    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2010
      Data sources: OpenTrials
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    Authors: MORISSENS, Marielle;

    Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages. The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction. Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume. The primary goal of this study is thus - to study the longitudinal strain by 2D echography - to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients. The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: Prochazka, Vaclav;

    This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

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    OpenTrials
    Clinical Trial . 2014
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2014
      Data sources: OpenTrials
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    Authors: Fergo, Charlotte;

    Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon. The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: Bashoura, Lara;

    The Study Drug: Fluticasone propionate is designed to stop the inflammatory action of asthma cells in PTCB. Screening Tests: Before you can start treatment on this study, you will have a pulmonary function test (PFT). For this tests, you will be asked to breathe in several different ways while you have a mouthpiece in your mouth to test your lung function. Study Groups: If you are found eligible to take part in this study, participants will be assigned to receive fluticasone propionate. Study Drug Administration: You will receive fluticasone propionate twice a day by oral inhalation. The study drug will be taken through a metered-dose inhaler. You will be given detailed instructions by the research nurse or clinic nurse at your first study visit. You will use an Albuterol MDI (rescue inhaler) when needed for shortness of breath. This inhaler is commonly used to treat asthma, chronic obstructive pulmonary disease (COPD), and other respiratory problems. Your clinic nurse will tell you how to use it. You will fill out a diary to record how often you use the rescue inhaler. You will also record when you take the study drug each week. The diary will be collected at each visit. The diary will take a few minutes to fill out. Study Visits: On Day 1, the following tests and procedures will be performed: - You will have a 6-minute walk test. To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be checked throughout the test. To measure oxygen saturation, you will wear a small clip on your finger that will send the oxygen saturation data to a small computer. - You will also complete St. George's respiratory questionnaire.The questionnaire will have 17 multiple choice or true/false questions about your lung function and overall health. A research nurse will be available to help you with the questionnaire. It will take about 30 minutes to complete. - You will also complete a NIOX flex test. This measures the amount of nitric oxide in your lungs. While seated, you will exhale and then place the NIOX filter in your mouth. You will then inhale to full lung capacity over 2-3 seconds. Then you will exhale slowly keeping constant flow with the aid of a meter on the computer screen. This is repeated until 3 valid readings are measured and then the test is completed. Between Weeks 4 and 6, you will have a PFT. At 3 months, 6 months, and 1 year, the following tests and procedures will be performed: - You will have a PFT. - You will complete the St. George's respiratory questionnaire. - You will have a 6-minute walk test. - You will have an exhaled nitric oxide (NIOX) Flex test, only at baseline, 3 and 6 months. Length of Study: You will be taken off study if the disease gets worse or if intolerable side effects occur. All patients whose condition stayed the same or improved at the end of 1 year will continue study drug and visit schedule. End-of-Study Visit: Before you are considered off-study, you will have an end-of-study visit. The following tests and procedures will be performed: - You will have a PFT. - You will complete the St. George's respiratory questionnaire. - You will have a 6-minute walk test. Follow-Up: Patients may be contacted by mail or by phone to answer follow-up questions. Follow-up questions and contact frequency will be based on your condition. If you are contacted by phone, the conversation will last about 15 minutes. This is an investigational study. Fluticasone propionate is FDA approved and commercially available for use in asthma and COPD patients. It's use in PTCB is investigational. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson. The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients who continue with standard of care.

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    OpenTrials
    Clinical Trial . 2008
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2008
      Data sources: OpenTrials
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    Authors: Shehadah, Naim;

    This usability study was designed in order to test independent home use and device interface effectiveness of the NiliMedix Adi Insulin Pump, in order to validate safe and effective use by intended users. The study objectives are as following: - Validate the safe and effective use while using the ADI Insulin Pump by intended users. This objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully. - Evaluate user's satisfaction. Study Design Orientation, consent, and pre-test questionnaire Participants will receive a short, scripted verbal orientation explaining the purpose of the usability test. Prior to any study related procedures participant will provide written informed consent. Performance evaluation The performance evaluation will consist of a list of tasks that participants will attempt to complete. The tasks were designed to explore the usability concerns. Participants will be provided with the Adi Insulin Pump and the user manual. All participants will be guided by the investigator how to use the ADI Insulin Pump independently, how to read and interpret the display readings, how to program the device including insulin Basal and Bolus settings as well as how to maintain the device. In addition, participants will be given sufficient time to read carefully the user manual. After ensuring that the participant has perceived the directions for use he will be asked to operate the Adi Insulin Pump by performing list of tasks. All tasks will be conducted by the participants independently. The investigator will not guide the subject during this phase- unless the subject asked him to. Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical consequences. Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is an attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. Insulin pumps require extensive user interaction because it is critical for treatment. Avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.

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    Clinical Trial . 2007
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      Clinical Trial . 2007
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    Authors: Paul, Dorian; Howes, Daniel;

    The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment. The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

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    Clinical Trial . 2006
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      Clinical Trial . 2006
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    Authors: Camphausen, Kevin A;

    Effective image-guided prostate therapies require excellent visualization of the prostate and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and the potential to yield spectral/biological tumor mapping. Despite the potential for MRI-guided prostate therapies, there are currently no techniques that allow for precise trans-rectal intraprostatic needle placement in patients. In this pilot study we seek to validate the accuracy and tolerability of a new system and technique that allows for accurate placement of needles within the prostate based upon MR images. The method is very similar to transrectal ultrasound guided biopsy of the prostate, except that it is applicable within a closed high-field MRI scanner. Four gold fiducial markers will be placed within the prostate under needle guidance in a series of patients with localized prostate cancer before external beam radiotherapy. Fifteen patients will be enrolled onto this study with sample size determined to obtain reasonably precise estimates of mean placement accuracy. The accrual period is expected to be less than a year. While placement of the fiducial markers has no direct therapeutic benefit for the patient, intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in assessing daily setup errors and off-line organ motion during external beam radiation therapy for prostate cancer. Therefore, a secondary objective is to gain experience using these intraprostatic fiducial markers for daily assessment and adjustment of external radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and results in better target delineation for treatment planning. In this way, prostate cancer patients who are receiving external-beam radiation therapy may benefit from participation. To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles. Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.

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    Clinical Trial . 2003
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    Authors: Nocera, Joe R.;

    Purpose: The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. Recent research demonstrated that older adults who participated in aerobic fitness training significantly increased their brain volume. Equally important, the demonstrated enhancement in brain size is related to improvement on specific cognitive tasks. For example, researchers demonstrated that 124 older adults randomly assigned to receive aerobic training experienced substantial improvement in cognitive performance tasks related to speed of processing and working memory. Similarly, neuroimaging studies showed that aerobically trained individuals increased brain activation during various cognitive tasks. A growing body of research also demonstrates the beneficial effects of cognitive training in later life to promote a healthy brain. For example, researchers demonstrated cognitive interventions targeting memory, reasoning and speed of processing were effective to improve brain function. Unfortunately, despite these promising findings, the generalizability of cognitive training is limited. For example, researchers showed cognitive training tasks designed to improve reasoning, memory, planning, spatial skills and attention in over 11,000 participants demonstrated no transfer effects to untrained tasks, even when the tasks were closely related. The purpose of this study is to see if combing aerobic exercise and cognitive training can enhance the cognitive improvement of each. Specially, the investigators wish to determine if aerobic exercise done immediately before cognitive training can potentiate the improvement. The investigators hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability. Background: Currently the United States has over 23 million Veterans. Of this number, 39.1 percent are over the age of 65 a number that will greatly increase as a large percent of the US population ages. Unfortunately, many of these individuals will suffer from some form of age-related cognitive decline and/or mobility disability. Significantly, declining mental health and mobility disability are primary components of the expected 25 percent growth in health care cost related to the aging crisis in America. And, despite the fact that the United States federal government spends $100 billion dollars annually to cure and/or treat cognitive impairments, successful strategies to improve these impairments remain elusive. The proposed research will substantially advance the development of treatments for cognitive and mobility impairment because the goals explore an intervention that may potentially have pervasive effects on US Veterans quality of life and well-being from a physical as well as a cognitive standpoint. Methods and Research Plan: To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of cognitive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence. Baseline testing will consist of a battery of cognitive function that target verbal fluency, response inhibition, and working memory. Additionally, participant will undergo a structural and functional MRI. Participants will also be evaluated on their physical function as assessed by a 400 meter walk, balance tests, and questionnaires about their daily l functioning. And lastly, all participants will be assessed on their aerobic capacity and for visual outcomes and serum BDNF. Following the 12-week intervention all participants will be post tested in the same manner as the baseline testing. The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability. To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.

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    Clinical Trial . 2016
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      Clinical Trial . 2016
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    Authors: Muscaritoli, Maurizio;

    This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with NSCLC. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and Quality of Life. SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

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    Clinical Trial . 2015
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      Clinical Trial . 2015
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    Authors: PEPIN, Jean Louis;

    The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP). An interim analysis will be performed when 40 patients will be included. Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).

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    Clinical Trial . 2010
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      Clinical Trial . 2010
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    Authors: MORISSENS, Marielle;

    Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages. The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction. Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume. The primary goal of this study is thus - to study the longitudinal strain by 2D echography - to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients. The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.

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    Clinical Trial . 2015
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      Clinical Trial . 2015
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    Authors: Prochazka, Vaclav;

    This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

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    Clinical Trial . 2014
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      OpenTrials
      Clinical Trial . 2014
      Data sources: OpenTrials
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    Authors: Fergo, Charlotte;

    Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon. The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2015
      Data sources: OpenTrials
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    Authors: Bashoura, Lara;

    The Study Drug: Fluticasone propionate is designed to stop the inflammatory action of asthma cells in PTCB. Screening Tests: Before you can start treatment on this study, you will have a pulmonary function test (PFT). For this tests, you will be asked to breathe in several different ways while you have a mouthpiece in your mouth to test your lung function. Study Groups: If you are found eligible to take part in this study, participants will be assigned to receive fluticasone propionate. Study Drug Administration: You will receive fluticasone propionate twice a day by oral inhalation. The study drug will be taken through a metered-dose inhaler. You will be given detailed instructions by the research nurse or clinic nurse at your first study visit. You will use an Albuterol MDI (rescue inhaler) when needed for shortness of breath. This inhaler is commonly used to treat asthma, chronic obstructive pulmonary disease (COPD), and other respiratory problems. Your clinic nurse will tell you how to use it. You will fill out a diary to record how often you use the rescue inhaler. You will also record when you take the study drug each week. The diary will be collected at each visit. The diary will take a few minutes to fill out. Study Visits: On Day 1, the following tests and procedures will be performed: - You will have a 6-minute walk test. To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be checked throughout the test. To measure oxygen saturation, you will wear a small clip on your finger that will send the oxygen saturation data to a small computer. - You will also complete St. George's respiratory questionnaire.The questionnaire will have 17 multiple choice or true/false questions about your lung function and overall health. A research nurse will be available to help you with the questionnaire. It will take about 30 minutes to complete. - You will also complete a NIOX flex test. This measures the amount of nitric oxide in your lungs. While seated, you will exhale and then place the NIOX filter in your mouth. You will then inhale to full lung capacity over 2-3 seconds. Then you will exhale slowly keeping constant flow with the aid of a meter on the computer screen. This is repeated until 3 valid readings are measured and then the test is completed. Between Weeks 4 and 6, you will have a PFT. At 3 months, 6 months, and 1 year, the following tests and procedures will be performed: - You will have a PFT. - You will complete the St. George's respiratory questionnaire. - You will have a 6-minute walk test. - You will have an exhaled nitric oxide (NIOX) Flex test, only at baseline, 3 and 6 months. Length of Study: You will be taken off study if the disease gets worse or if intolerable side effects occur. All patients whose condition stayed the same or improved at the end of 1 year will continue study drug and visit schedule. End-of-Study Visit: Before you are considered off-study, you will have an end-of-study visit. The following tests and procedures will be performed: - You will have a PFT. - You will complete the St. George's respiratory questionnaire. - You will have a 6-minute walk test. Follow-Up: Patients may be contacted by mail or by phone to answer follow-up questions. Follow-up questions and contact frequency will be based on your condition. If you are contacted by phone, the conversation will last about 15 minutes. This is an investigational study. Fluticasone propionate is FDA approved and commercially available for use in asthma and COPD patients. It's use in PTCB is investigational. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson. The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients who continue with standard of care.

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    OpenTrials
    Clinical Trial . 2008
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2008
      Data sources: OpenTrials
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    Authors: Shehadah, Naim;

    This usability study was designed in order to test independent home use and device interface effectiveness of the NiliMedix Adi Insulin Pump, in order to validate safe and effective use by intended users. The study objectives are as following: - Validate the safe and effective use while using the ADI Insulin Pump by intended users. This objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully. - Evaluate user's satisfaction. Study Design Orientation, consent, and pre-test questionnaire Participants will receive a short, scripted verbal orientation explaining the purpose of the usability test. Prior to any study related procedures participant will provide written informed consent. Performance evaluation The performance evaluation will consist of a list of tasks that participants will attempt to complete. The tasks were designed to explore the usability concerns. Participants will be provided with the Adi Insulin Pump and the user manual. All participants will be guided by the investigator how to use the ADI Insulin Pump independently, how to read and interpret the display readings, how to program the device including insulin Basal and Bolus settings as well as how to maintain the device. In addition, participants will be given sufficient time to read carefully the user manual. After ensuring that the participant has perceived the directions for use he will be asked to operate the Adi Insulin Pump by performing list of tasks. All tasks will be conducted by the participants independently. The investigator will not guide the subject during this phase- unless the subject asked him to. Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical consequences. Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is an attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. Insulin pumps require extensive user interaction because it is critical for treatment. Avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.

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    OpenTrials
    Clinical Trial . 2007
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2007
      Data sources: OpenTrials
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    Authors: Paul, Dorian; Howes, Daniel;

    The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment. The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

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    OpenTrials
    Clinical Trial . 2006
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2006
      Data sources: OpenTrials
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    Authors: Camphausen, Kevin A;

    Effective image-guided prostate therapies require excellent visualization of the prostate and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and the potential to yield spectral/biological tumor mapping. Despite the potential for MRI-guided prostate therapies, there are currently no techniques that allow for precise trans-rectal intraprostatic needle placement in patients. In this pilot study we seek to validate the accuracy and tolerability of a new system and technique that allows for accurate placement of needles within the prostate based upon MR images. The method is very similar to transrectal ultrasound guided biopsy of the prostate, except that it is applicable within a closed high-field MRI scanner. Four gold fiducial markers will be placed within the prostate under needle guidance in a series of patients with localized prostate cancer before external beam radiotherapy. Fifteen patients will be enrolled onto this study with sample size determined to obtain reasonably precise estimates of mean placement accuracy. The accrual period is expected to be less than a year. While placement of the fiducial markers has no direct therapeutic benefit for the patient, intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in assessing daily setup errors and off-line organ motion during external beam radiation therapy for prostate cancer. Therefore, a secondary objective is to gain experience using these intraprostatic fiducial markers for daily assessment and adjustment of external radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and results in better target delineation for treatment planning. In this way, prostate cancer patients who are receiving external-beam radiation therapy may benefit from participation. To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles. Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.

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    OpenTrials
    Clinical Trial . 2003
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2003
      Data sources: OpenTrials