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  • Research data . Clinical Trial . 2010
    Open Access
    Authors: 
    Nash, Mark S;
    Publisher: nct

    Background: Manual wheelchair propulsion is a primary source of mobility for many individuals with spinal cord injury (SCI). Propelling a manual wheelchair over an extended period often leads to arm pain and, subsequently, to secondary disability. Over 50% of manual wheelchair users with SCI experience arm pain that limits their activities of daily living. The prevalence of shoulder pain and carpal tunnel syndrome among manual wheelchair users is between 31% and 73%, and 49% and 73% respectively. A circuit training protocol has been developed to strengthen and protect the muscles of people with SCI, and has been shown to improve muscle strength and endurance, and reduce HDLcholesterol levels. Purpose: The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with SCI and able-bodied controls. Hypotheses: All subjects will show an increase in nerve cross-sectional area after participation in the circuit training protocol. Nerves and tendons will become less echogenic after participation in the circuit training protocol. These changes will be more pronounced in persons with SCI. Methods: Data collected will include history of pain, a physical exam, and ultrasound images of the nondominant upper extremity before and after a bout of circuit training, which includes exercises lifting weights and using an arm cycle. Before circuit training, ultrasound images will be collected once. After the circuit training, ultrasound images will be collected every 10 minutes over an hour. These images and will be used to measure the health and properties (such as size) of nerves, muscles, and tendons in the arm. Changes in these properties after a bout of circuit training will be related to history and physical exam information. The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with spinal cord injury and able-bodied controls.

  • Open Access
    Authors: 
    Ikizler, Alp;
    Publisher: nct

    The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atherosclerosis, and the strong association between elevated inflammatory biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the mortality in this population of patients is attributable to cardiovascular disease. Insulin resistance is also a common problem in uremic patients. It has been shown that insulin resistance may contribute to atherosclerotic cardiovascular disease. An intriguing observation in CKD patients with advanced uremia is that the metabolic profile of these patients is characterized by persistent low-grade inflammation, a state of insulin resistance, and significantly increased prevalence of atherosclerosis. It is possible that these metabolic derangements can be the inciting factors for development and progression of uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a ligand-activated nuclear transcription factor found in cells of the immune system and the vasculature, where it exerts an overall protective effect on the development of atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma improve not only the insulin resistance, but also have profound beneficial effects on inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the investigators hypothesize that short-term administration of a PPAR-gamma agonist (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial dysfunction in chronic kidney disease patients with advanced uremia.

  • Open Access
    Authors: 
    Vrochides, Dionisios;
    Publisher: nct

    This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.

  • Open Access
    Authors: 
    Kvedar, Joseph C.;
    Publisher: nct

    We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites. Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback. Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback. The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure. The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.

  • Research data . Clinical Trial . 2005
    Open Access
    Authors: 
    Jenkins, David JA;
    Publisher: nct

    Subjects: Thirty overweight hyperlipidemic subjects who wish to lose weight. Design: - Protocol (Metabolic Study): will be randomized to either the Eco-Atkins diet (15 subjects) or NCEP diet (15 subjects). The diets will be provided for the one month period with the aim of inducing the same weight loss (5 kg) as seen in the first month of the published reports on the Atkins diet. The diets will provide about 60% of estimated energy requirements. Subjects will be provided with their diets at weekly intervals by courier and intakes adapted to ensure that they achieve their target weight loss goal. Fasting weight will be taken at weekly intervals together with blood pressure and blood for lipids, glucose and insulin assessment. - Protocol (Ad Libitum Study): After completing the metabolic phase of the study, the thirty subjects will be asked to continue with the diet to which they were randomized for a further 6-month period. During this ad libitum trial, study foods will not be provided. This longer less tightly controlled study will establish the value of this diet in "real life" situations. This will be required to support our shorter term, well-controlled more detailed metabolic study. Fasting weight will be taken at monthly intervals together with blood pressure and blood for lipids, glucose and insulin assessment. Study Details: Participants will come after a 12h overnight fast to the Risk Factor Modification Centre at St. Michael's Hospital or the Department of Nutritional Sciences, University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the metabolic study and monthly during the ad libitum study. Prior to the start of the study, participants will be instructed on details of the study diet protocol. They will also be asked to maintain a constant level of physical activity throughout the course of the study. At all visits, body weight (in kg) will be obtained in indoor clothing, without shoes, and blood pressure will be taken twice in the dominant arm after participants have been seated for at least 20 minutes. Height (in cm) will be recorded at the first visit. Body composition measurements will be measured using bioelectric impedance at baseline and week 4 of the metabolic phase, and months 3 and 6 of the ad libitum phase. Throughout the study period, participants will maintain the diet prescribed on their initial visit. At each visit, participants will provide a fasting blood sample and seven-day food records will be collected. During the last week of the metabolic and ad libitum study, 24h fecal and urine collections will be completed. Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss.

  • Open Access
    Authors: 
    Temple, Jennifer L;
    Publisher: nct

    Our previous studies have demonstrated sex differences in both the reinforcing properties of (Temple JL, Briatico LN, Clark EN, Dewey AM, 2009) and physiological responses to (Temple JL, Dewey AM, Briatico LN, 2010) caffeine. This is consistent with the literature on other types of drugs showing that men and women often differ in both drug self administration (Lynch WJ,2008 ) and drug sensitivity (Temple, JL, et al, 2008). These differences have been attributed, at least in part, to differences in gonadal hormones (Lynch WJ, 2008) ,Dreher JC et al, 2007). Our laboratory conducted a study investigating subjective effects of caffeine in post-pubertal adolescents and found that boys reported greater drug effects and liking of drug effects than did females (Temple JL, Dewey AM, Briatico LN, 2010, Temple JL, Ziegler AM,2011). In addition, the differences in feeling of the drug effects were related to salivary estradiol levels in females, but not in males, suggesting that steroid hormones can mediate the subjective effects of caffeine. When taken together, these data suggest that there are gender differences in acute and chronic effects of caffeine and that these differences may be mediated by differences in circulating steroid hormones. Previous studies have shown that subjective responses to caffeine vary across the menstrual cycle (Terner JM, de Wit H, 2006), with the greatest subjective effects occurring during the follicular phase, when estradiol levels begin to rise and peak just prior to the ovulatory LH surge. To date, no well-controlled studies have been conducted in humans examining the relationship between steroid hormones and caffeine effects on cognition, which the investigators will address in this study. Caffeine use is on the rise in America, and one of the most popular sources is soda. Among youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few studies have examined the role of hormones in caffeine consumption within this age group. The purpose of the current experiment was to determine the effect of caffeine on children 8 and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect of puberty on the consumption of caffeine as well as the effect that the caffeine has on the body (for example: heart rate, blood pressure) and cognitive function.

  • Open Access
    Authors: 
    Williams, Gary;
    Publisher: nct

    The primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data. The objectives are to: - identify risk factors. - evaluate stage and histology at the time of presentation. - document treatment modalities and outcomes. - analyze outcomes for comparison to historical data.

  • Open Access
    Authors: 
    Léger, Damien;
    Publisher: nct

    Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality. The subjects realize 3 conditions : - Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. - Random condition : Auditory stimulations are randomly delivered during N3 sleep stage. - Placebo condition: The device is worn without any auditory stimulations delivered. The subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected. This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.

  • Open Access
    Authors: 
    Mabuchi, Kiyohiko;
    Publisher: nct

    We propose to study the prevalence of thyroid nodules and cancer in relation to radiation dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near the STS is believed to have received radiation doses from fallout that were much higher than that experienced by any population of comparable size in the US. The study population is a defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed villages; the other half lived in lightly-exposed villages. The population is rural, with a diet that was and is heavily dependent upon fresh milk from household or local cows and therefore likely to have led to ingestion of radioactive iodine from fallout. The study is two parts. The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral lymphocytes obtained from blood samples donated by 40 cohort members with individuals radiation dose estimates, and electron paramagnetic resonance (EPR) assays of about 110 stored tooth samples. The two techniques are complementary. Blood samples will be collected from 25 putative high-dose and 15 low-dose cohort members and processed or cytogenetic assay using fluorescent in situ hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It should be possible to detect gamma radiation doses as low as 150 mGy. The EPR investigation will take advantage of a repository of teeth extracted by local dentists during medical and dental programs in 1966-67 and 1999, stored, and catalogued by our collaborators in Kazakhstan (not in connection with this study). Tooth samples are identified by village of exposure, but not individually within villages. However, the identities of the donors, and therefore their ages and exposure histories, are known to our collaborators in Kazakhstan; therefore it will be possible to compare the EPR results with gamma dose estimates calculated on the basis of exposure history. It is intended that the EPR assays will be carried out at the National Institute of Standards and Technology under a purchase order agreement. The second part will involve thyroid screening by ultrasound in selected villages. The population to be screened will comprise 1000-1500 members of the study cohort exposed as young children to high fallout levels, and equal numbers of comparable ages exposed to little or no fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick blood samples will be obtained to assess thyroid function using RIA methods with coated tube technology for T4 and TSH. The most sensitive statistical comparisons are expected to be dose-response analyses with respect to prevalence of thyroid nodules, which are common and known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable power if risks associated with chronic radiation in this population are similar to those associated with acute exposure to X-ray or gamma radiation in other populations. We propose to study the prevalence of thyroid nodules and cancer in relation to radiation dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near the STS is believed to have received radiation doses from fallout that were much higher than that experienced by any population of comparable size in the US. The study population is a defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed villages; the other half lived in lightly-exposed villages. The population is rural, with a diet that was and is heavily dependent upon fresh milk from household or local cows and therefore likely to have led to ingestion of radioactive iodine from fallout. The study is two parts. The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral lymphocytes obtained from blood samples donated by 40 cohort members with individuals radiation dose estimates. Blood samples will be collected from 25 putative high-dose and 15 low-dose cohort members and processed or cytogenetic assay using fluorescent in situ hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It should be possible to detect gamma radiation doses as low as 150 mGy. The second part will involve thyroid screening by ultrasound in selected villages. The population to be screened will comprise 100-1500 members of the study cohort exposed as young children to high fallout levels, and equal numbers of comparable ages exposed to little or no fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick blood samples will be obtained to assess thyroid function using RIA methods with coated tube technology for T4 and TSH. The most sensitive statistical comparisons are expected to be dose-response analyses with respect to prevalence of thyroid nodules, which are common and known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable power if risks associated with chronic radiation in this population are similar to those associated with acute exposure to X-ray or gamma radiation in other populations.

  • Open Access
    Authors: 
    Hosing, Chitra M.;
    Publisher: nct

    You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications. The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given. Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant. You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment. This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson. The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.

search
Include:
139,699 Research products, page 1 of 13,970
  • Research data . Clinical Trial . 2010
    Open Access
    Authors: 
    Nash, Mark S;
    Publisher: nct

    Background: Manual wheelchair propulsion is a primary source of mobility for many individuals with spinal cord injury (SCI). Propelling a manual wheelchair over an extended period often leads to arm pain and, subsequently, to secondary disability. Over 50% of manual wheelchair users with SCI experience arm pain that limits their activities of daily living. The prevalence of shoulder pain and carpal tunnel syndrome among manual wheelchair users is between 31% and 73%, and 49% and 73% respectively. A circuit training protocol has been developed to strengthen and protect the muscles of people with SCI, and has been shown to improve muscle strength and endurance, and reduce HDLcholesterol levels. Purpose: The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with SCI and able-bodied controls. Hypotheses: All subjects will show an increase in nerve cross-sectional area after participation in the circuit training protocol. Nerves and tendons will become less echogenic after participation in the circuit training protocol. These changes will be more pronounced in persons with SCI. Methods: Data collected will include history of pain, a physical exam, and ultrasound images of the nondominant upper extremity before and after a bout of circuit training, which includes exercises lifting weights and using an arm cycle. Before circuit training, ultrasound images will be collected once. After the circuit training, ultrasound images will be collected every 10 minutes over an hour. These images and will be used to measure the health and properties (such as size) of nerves, muscles, and tendons in the arm. Changes in these properties after a bout of circuit training will be related to history and physical exam information. The purpose of this study is to use ultrasound to analyze the effects of a bout of circuit training on the upper extremity of persons with spinal cord injury and able-bodied controls.

  • Open Access
    Authors: 
    Ikizler, Alp;
    Publisher: nct

    The substantially increased cardiovascular morbidity and mortality rates in chronic kidney disease (CKD) patients cannot be sufficiently explained by traditional coronary risk factors. It is apparent that inflammation of the vessel wall plays an essential role in the pathophysiology of atherosclerosis, and the strong association between elevated inflammatory biomarkers and cardiovascular death further supports this mechanism. Approximately 50% of the mortality in this population of patients is attributable to cardiovascular disease. Insulin resistance is also a common problem in uremic patients. It has been shown that insulin resistance may contribute to atherosclerotic cardiovascular disease. An intriguing observation in CKD patients with advanced uremia is that the metabolic profile of these patients is characterized by persistent low-grade inflammation, a state of insulin resistance, and significantly increased prevalence of atherosclerosis. It is possible that these metabolic derangements can be the inciting factors for development and progression of uremic atherosclerosis. Peroxisome proliferator-activated receptor gamma (PPAR-gamma) is a ligand-activated nuclear transcription factor found in cells of the immune system and the vasculature, where it exerts an overall protective effect on the development of atherosclerosis, in part through modulation of inflammation. The agonists for PPAR-gamma improve not only the insulin resistance, but also have profound beneficial effects on inflammation, oxidative stress, endothelium, and lipid metabolism. In this proposal, the investigators hypothesize that short-term administration of a PPAR-gamma agonist (pioglitazone) will improve the inflammatory state, insulin resistance, and endothelial dysfunction in chronic kidney disease patients with advanced uremia.

  • Open Access
    Authors: 
    Vrochides, Dionisios;
    Publisher: nct

    This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.

  • Open Access
    Authors: 
    Kvedar, Joseph C.;
    Publisher: nct

    We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites. Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback. Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback. The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure. The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.

  • Research data . Clinical Trial . 2005
    Open Access
    Authors: 
    Jenkins, David JA;
    Publisher: nct

    Subjects: Thirty overweight hyperlipidemic subjects who wish to lose weight. Design: - Protocol (Metabolic Study): will be randomized to either the Eco-Atkins diet (15 subjects) or NCEP diet (15 subjects). The diets will be provided for the one month period with the aim of inducing the same weight loss (5 kg) as seen in the first month of the published reports on the Atkins diet. The diets will provide about 60% of estimated energy requirements. Subjects will be provided with their diets at weekly intervals by courier and intakes adapted to ensure that they achieve their target weight loss goal. Fasting weight will be taken at weekly intervals together with blood pressure and blood for lipids, glucose and insulin assessment. - Protocol (Ad Libitum Study): After completing the metabolic phase of the study, the thirty subjects will be asked to continue with the diet to which they were randomized for a further 6-month period. During this ad libitum trial, study foods will not be provided. This longer less tightly controlled study will establish the value of this diet in "real life" situations. This will be required to support our shorter term, well-controlled more detailed metabolic study. Fasting weight will be taken at monthly intervals together with blood pressure and blood for lipids, glucose and insulin assessment. Study Details: Participants will come after a 12h overnight fast to the Risk Factor Modification Centre at St. Michael's Hospital or the Department of Nutritional Sciences, University of Toronto immediately prior to commencement of each treatment phase and at weekly intervals during the metabolic study and monthly during the ad libitum study. Prior to the start of the study, participants will be instructed on details of the study diet protocol. They will also be asked to maintain a constant level of physical activity throughout the course of the study. At all visits, body weight (in kg) will be obtained in indoor clothing, without shoes, and blood pressure will be taken twice in the dominant arm after participants have been seated for at least 20 minutes. Height (in cm) will be recorded at the first visit. Body composition measurements will be measured using bioelectric impedance at baseline and week 4 of the metabolic phase, and months 3 and 6 of the ad libitum phase. Throughout the study period, participants will maintain the diet prescribed on their initial visit. At each visit, participants will provide a fasting blood sample and seven-day food records will be collected. During the last week of the metabolic and ad libitum study, 24h fecal and urine collections will be completed. Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss.

  • Open Access
    Authors: 
    Temple, Jennifer L;
    Publisher: nct

    Our previous studies have demonstrated sex differences in both the reinforcing properties of (Temple JL, Briatico LN, Clark EN, Dewey AM, 2009) and physiological responses to (Temple JL, Dewey AM, Briatico LN, 2010) caffeine. This is consistent with the literature on other types of drugs showing that men and women often differ in both drug self administration (Lynch WJ,2008 ) and drug sensitivity (Temple, JL, et al, 2008). These differences have been attributed, at least in part, to differences in gonadal hormones (Lynch WJ, 2008) ,Dreher JC et al, 2007). Our laboratory conducted a study investigating subjective effects of caffeine in post-pubertal adolescents and found that boys reported greater drug effects and liking of drug effects than did females (Temple JL, Dewey AM, Briatico LN, 2010, Temple JL, Ziegler AM,2011). In addition, the differences in feeling of the drug effects were related to salivary estradiol levels in females, but not in males, suggesting that steroid hormones can mediate the subjective effects of caffeine. When taken together, these data suggest that there are gender differences in acute and chronic effects of caffeine and that these differences may be mediated by differences in circulating steroid hormones. Previous studies have shown that subjective responses to caffeine vary across the menstrual cycle (Terner JM, de Wit H, 2006), with the greatest subjective effects occurring during the follicular phase, when estradiol levels begin to rise and peak just prior to the ovulatory LH surge. To date, no well-controlled studies have been conducted in humans examining the relationship between steroid hormones and caffeine effects on cognition, which the investigators will address in this study. Caffeine use is on the rise in America, and one of the most popular sources is soda. Among youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few studies have examined the role of hormones in caffeine consumption within this age group. The purpose of the current experiment was to determine the effect of caffeine on children 8 and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect of puberty on the consumption of caffeine as well as the effect that the caffeine has on the body (for example: heart rate, blood pressure) and cognitive function.

  • Open Access
    Authors: 
    Williams, Gary;
    Publisher: nct

    The primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data. The objectives are to: - identify risk factors. - evaluate stage and histology at the time of presentation. - document treatment modalities and outcomes. - analyze outcomes for comparison to historical data.

  • Open Access
    Authors: 
    Léger, Damien;
    Publisher: nct

    Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality. The subjects realize 3 conditions : - Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage. - Random condition : Auditory stimulations are randomly delivered during N3 sleep stage. - Placebo condition: The device is worn without any auditory stimulations delivered. The subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected. This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.

  • Open Access
    Authors: 
    Mabuchi, Kiyohiko;
    Publisher: nct

    We propose to study the prevalence of thyroid nodules and cancer in relation to radiation dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near the STS is believed to have received radiation doses from fallout that were much higher than that experienced by any population of comparable size in the US. The study population is a defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed villages; the other half lived in lightly-exposed villages. The population is rural, with a diet that was and is heavily dependent upon fresh milk from household or local cows and therefore likely to have led to ingestion of radioactive iodine from fallout. The study is two parts. The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral lymphocytes obtained from blood samples donated by 40 cohort members with individuals radiation dose estimates, and electron paramagnetic resonance (EPR) assays of about 110 stored tooth samples. The two techniques are complementary. Blood samples will be collected from 25 putative high-dose and 15 low-dose cohort members and processed or cytogenetic assay using fluorescent in situ hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It should be possible to detect gamma radiation doses as low as 150 mGy. The EPR investigation will take advantage of a repository of teeth extracted by local dentists during medical and dental programs in 1966-67 and 1999, stored, and catalogued by our collaborators in Kazakhstan (not in connection with this study). Tooth samples are identified by village of exposure, but not individually within villages. However, the identities of the donors, and therefore their ages and exposure histories, are known to our collaborators in Kazakhstan; therefore it will be possible to compare the EPR results with gamma dose estimates calculated on the basis of exposure history. It is intended that the EPR assays will be carried out at the National Institute of Standards and Technology under a purchase order agreement. The second part will involve thyroid screening by ultrasound in selected villages. The population to be screened will comprise 1000-1500 members of the study cohort exposed as young children to high fallout levels, and equal numbers of comparable ages exposed to little or no fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick blood samples will be obtained to assess thyroid function using RIA methods with coated tube technology for T4 and TSH. The most sensitive statistical comparisons are expected to be dose-response analyses with respect to prevalence of thyroid nodules, which are common and known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable power if risks associated with chronic radiation in this population are similar to those associated with acute exposure to X-ray or gamma radiation in other populations. We propose to study the prevalence of thyroid nodules and cancer in relation to radiation dose, in a defined cohort of Kazakhstan residents exposed as children to radioactive fallout from atomic bomb tests at the neighboring Semipalatinsk Test Site (STS). The population near the STS is believed to have received radiation doses from fallout that were much higher than that experienced by any population of comparable size in the US. The study population is a defined cohort of 20,000 residents, half of whom, in 1960, resided in heavily-exposed villages; the other half lived in lightly-exposed villages. The population is rural, with a diet that was and is heavily dependent upon fresh milk from household or local cows and therefore likely to have led to ingestion of radioactive iodine from fallout. The study is two parts. The first part involves a cytogenetic assay for radiation biodosimetry purposes of peripheral lymphocytes obtained from blood samples donated by 40 cohort members with individuals radiation dose estimates. Blood samples will be collected from 25 putative high-dose and 15 low-dose cohort members and processed or cytogenetic assay using fluorescent in situ hybridization (FISH) for stable chromosome aberrations in peripheral lymphocytes. This biodosimetric validation assay, will be carried out by Nailya Chaizhunusova, chief of cytogenetics at the Scientific research Institute for Radiation Medicine and Ecology, in collaboration with Dr. Tracy Yang at the NASA Johnson Space Center in Houston, Texas. It should be possible to detect gamma radiation doses as low as 150 mGy. The second part will involve thyroid screening by ultrasound in selected villages. The population to be screened will comprise 100-1500 members of the study cohort exposed as young children to high fallout levels, and equal numbers of comparable ages exposed to little or no fallout. Fine needle aspiration biopsy will be performed, under separate informed consent, if the palpation and ultrasound results suggest presence of a tumor. Presence and malignancy of tumor will be determined by cytopathology. Subjects with evidence of thyroid disease will be referred to thyroid specialists at the Semipalatinsk State Medical Academy. Finger stick blood samples will be obtained to assess thyroid function using RIA methods with coated tube technology for T4 and TSH. The most sensitive statistical comparisons are expected to be dose-response analyses with respect to prevalence of thyroid nodules, which are common and known to be associated with radiation dose. Comparisons in terms of thyroid cancer, and benign and malignant neoplasms combined, are likely to be less sensitive but of acceptable power if risks associated with chronic radiation in this population are similar to those associated with acute exposure to X-ray or gamma radiation in other populations.

  • Open Access
    Authors: 
    Hosing, Chitra M.;
    Publisher: nct

    You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications. The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given. Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant. You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment. This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson. The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.

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