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The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, Arthroplasty, Replacement, Hip Unilateral hip disease that is indicated for primary total hip arthroplasty A previous THA on the contralateral hip Any condition contraindicated for primary total hip arthroplasty Refuse to be randomized in the study arms | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Inadequate Initial Weight Loss Persistent Clinically Severe Obesity laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern failed RYGB with a WR pattern patients with prior major bariatric conversion or esophago-gastric surgeries RYGB patients revised by an open surgical approach RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program missing records and/or unreachable patients with scan information for analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Clinically Severe Obesity Obesity Recidivism Inadequate Initial Weight Loss Poor Weight Loss Persistent Obesity Refractory Obesity Intractable Obesity Patients who met NIH for recommendation of a bariatric procedure with the combination of the following characteristics Failed primary proximal gastric bypass with subsequent revision to a malabsortive distal gastric bypass Failed primary distal malabsorptive gastric bypass with subsequent revision to increase the restrictive component (revisional: gastroplasty, Fobi, or adjustable gastric band) Patients with prior major conversions or revisions Missing records and/or unreachable patients with scant information for analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Clinically Severe Obesity Metabolic Complications After Jejunoileal Bypass Nutritional Complications After Jejunoileal Bypass Obesity Recidivism Inadequate Initial Weight Loss Intestinal Malabsorptive Syndrome Protein Malnutrition Met NIH for weight loss surgery with poor weight loss after JIB Intractable, severe and/or recurrent JIB-related late complications after optimized medical management Laparoscopic approach for primary revisional bariatric surgery Any other type of revisional bariatric procedure Open approach for revision surgery missing records and/or unreachable patients with scant information for analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity Nonsmoking men and postmenopausal women, ages 18 Premenopausal women who would not be expected to have significant fluctuations in estrogen and progesterone levels during the study (e.g. those on continuous monophasic hormonal contraception) may be included in the study at the discretion of the PI or designated study staff. 2. Body mass index (BMI) of at least 27 kg/m2 3. Body weight < 200 kg (the weight limit of the Bod Pod® scale) 4. Evidence of insulin resistance, as suggested by any one of the following Fasting glucose of 100 mg/dL or higher Impaired glucose tolerance, with a glucose concentration of 140 mg/dL or higher, 2 hours after a 75-gram oral glucose challenge A fasting insulin concentration of 9 mIU/L or higher 5. Willingness to consume only study food and drink for the duration of the study 6. Willingness to be randomized to any one of the three study diets 7. If applicable, willingness to maintain consistent intake of coffee and/or tea during the inpatient periods (due to the potential effects of these drinks on inflammatory markers) 8. Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study. At the PI's discretion, other nutritional supplements, such as iron, may also be continued during the study if they are deemed medically necessary and are unlikely to influence study results. 9. If applicable, willingness to continue current antihypertensive medications (especially angiotensin converting enzyme inhibitors and angiotensin receptor blockers, which may affect levels of inflammatory markers) at the same dose and schedule throughout the study,unless a change is advised by the subject's primary care provider or the study investigators 10. Willingness to avoid the use of non-steroidal anti-inflammatory drugs (NSAIDS), including low-dose daily aspirin, throughout the inpatient admission, (due to the potential effects of these agents on inflammatory markers). 11. at least two of the following waist circumference greater than 35" in women or 40" in men blood pressure greater than 120/80 mmHg but less than 150/90 mmHg (on 2 blood pressure medications or less) triglyceride level greater than 150 but less than 500 mg/dL HDL ("good") cholesterol less than 40 mg/dL in men or 50 mg/dL in women Current tobacco smoking 2. History of a bleeding disorder 3. Known or suspected cardiovascular disease, including angina, myocardial infarction, medical or surgical treatment for atherosclerotic disease, arrhythmia, or congestive heart failure 4. Blood pressure higher than 145/90 after 10 minutes of rest, confirmed on two or more visits, or treatment with three or more antihypertensive agents at any blood pressure. Subjects taking up to two antihypertensive agents may be included in the study if 1) BP is at least 115/75 mmHg but < 145/90 mmHg on these agents and 2) they agree to remain on the same medications (and same dosages) during the study, unless otherwise advised by a primary care provider or study investigators (e.g. the dosage may be reduced or the medication may be stopped if signs or symptoms of hypotension develop during the study) 5. Fasting glucose > 165 mg/dL, glycosylated hemoglobin > 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents (e.g. metformin or thiazolidinediones), insulin, incretin mimetics (e.g. exenatide), amylin analogues (e.g. pramlintide), or endocannabinoid receptor antagonists (e.g. rimonabant). Volunteers with type 2 diabetes and a glycosylated hemoglobin level of 7.5% or higher will be encouraged to discuss treatment options (e.g. pharmacotherapy versus study participation) with their primary care providers before enrolling in the study 6. History of chronic glucocorticoid use, oral glucocorticoid use for more than 5 days in the previous year, or anticipated treatment with oral or intravenous glucocorticoids during the study period. Daily, low-dose, inhaled or nasal glucocorticoids may be acceptable in some cases, at the discretion of the Principal Investigator. 7. Current treatment with over-the-counter or prescription weight loss medications, such as orlistat or sibutramine 8. History of bariatric surgery 9. Current treatment with any cholesterol-lowering medications, such as statins, niacin,fibrates, or ezetimibe 10. Hyperthyroidism or untreated hypothyroidism. Subjects with chronic, treated, stable hypothyroidism may be included in the study at the discretion of the Principal Investigator 11. Obstructive sleep apnea, or significant symptoms suggestive of this condition 12. Active gallstone disease 13. Known history of chronic hepatitis, or liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal 14. Known infection with HIV or confirmed positive test for HIV antibody 15. Inflammatory bowel disease, active cancer, or any other medical condition that may cause significant acute weight loss or gain 16. Sustained weight loss > 5% of body weight in the previous two months, or sustained weight loss > 10% of body weight in the previous six months 17. History of kidney stones 18. Chronic or acute renal disease 19. Serum calcium, potassium, or magnesium above the normal limit, confirmed on two screening tests 20. Seizure disorder 21. History of any inpatient psychiatric admission within the past two years 22. History of schizophrenia, psychosis, or bipolar disorder 23. History of anorexia nervosa or bulimia nervosa, as defined in the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), or a history of medical or psychological treatment for an eating disorder 24. Severe binge eating disorder, as defined as a Binge Eating Scale score of 27 or more. Individuals with scores of 18-26, which may be indicative of moderate eating disturbances, will be evaluated further to determine whether moderate to severe eating pathology actually exists. This evaluation process will be based on the DSMIVresearch for binge eating disorder. Individuals with scores of 18-26 who meet the DSM-IV research for binge eating disorder will be excluded, whereas those without significant eating pathology may be included in the study. 25. Untreated moderate to severe depression, as evidenced by a Beck Depression Inventory score of 20 or higher at screening. Subjects with a remote history of depression or stable, treated depression may be included in the study at the discretion of the Principal Investigator 26. History of alcohol or drug abuse within the previous two years 27. History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study. 28. Any social or behavioral condition that, in the opinion of the investigator, would interfere with adherence to study requirements | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Marginal Ulcer Chronic Ulcer Disease Persistent Ulcer Disease Recurrent Ulcer Disease Late Morbidity After Gastric Bypass Chronic/Intractable, either recurrent or persistent, marginal ulcers after Roux-en-Y gastric bypass surgery for clinically severe obesity Chronic or Intractable marginal ulcer after other bariatric procedures Revision or re-operation by open approach missing records and/or unreachable patients with scant information for analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Clinically Severe Obesity Gastroesophageal Reflux Disease Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements Met NIH for bariatric surgery With functional or failed antireflux surgery (Nissen fundoplication) Laparoscopic approach for revisional surgery Any other type of revisional bariatric procedure Nonstandard revisional RYGB surgery Open approach for revision surgery Missing records and/or unreachable patients with scant information for analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-999.0, Obesity Morbid Obesity Obese and morbidly obese women (BMI 30 years and older undergoing laparoscopic gastric bypass surgery Present with at least either metabolic syndrome or diabetes Have smoked in the past 4 weeks Pregnant Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA) There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-38.0, Polycystic Ovary Syndrome Women attending with ovulatory PCO due to undergo IVF/ICSI treatment First or second cycle of IVF/ICSI If previously on metformin, a minimum one month washout period was required Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml) Written informed consent Clinical manifestations of PCOS, including any of the following: 1. Oligo or amenorrhoea with cycles ≥42 days apart. 2. Anovulation with mid-luteal progesterone <16 nmol/L. 3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100). 4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly Age >38 years BMI >35 kg/m2 Basal FSH >12 IU/L Liver disease or ALT >80 IU/L Renal disease, or creatinine >130 nmol/L Alcoholism or drug abuse Diabetes mellitus (evaluated by fasting glucose >6.7mmol/L) Per oral steroid treatment in last month | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Hypertriglyceridemia Men and women, ages >18 Fasting triglyceride ≥200 mg/dL and <500 mg/dL LDL-C (low density lipoprotein cholesterol) ≥40 mg/dL and <100mg/dL High risk for Coronary heart disease On stable dose of statin (atorvastatin, rosuvastatin or simvastatin) Provide written informed consent and authorization for protected health information disclosure Women who are pregnant or lactating, or planning to become pregnant Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects History of bariatric surgery or currently on weight loss drugs Uncontrolled hypertension (BP > 160/100) HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin Consumption of more than 2 alcoholic beverages per day History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer) Participation in another clinical trial involving an investigational agent in the last 30 days Other parameters will be assessed at the study center to ensure for this study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Hypertriglyceridemia Men and women, ages >18 Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL Provide written informed consent and authorization for protected health information disclosure Women who are pregnant or lactating, or planning to become pregnant Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects History of pancreatitis History of bariatric surgery or currently on weight loss drugs Uncontrolled hypertension (BP > 160/100) HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin Consumption of more than 2 alcoholic beverages per day History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer) Participation in another clinical trial involving an investigational agent in the last 30 days Other parameters will be assessed at the study center to ensure for this study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-999.0, Sleep Apnea, Obstructive Consenting adults over the age of 18 Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour & ≥ 90% of disordered breathing events classified as obstructive) Total sleep time from previous sleep study < 4 hours (240 minutes) Severe bilateral nasal obstruction (apparent mouth breathing at rest) Documented history of lung diseases, as defined below Daytime hypercapnia (PaCO2 > 45 mmHg) Baseline SaO2 ≤ 92% Chronic lung disease except mild intermittent or mild persistent asthma Cor pulmonale Documented clinical cardiovascular disease, as defined below Myocardial infarction in past 3 months Revascularization procedure in past 3 months | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Pain Obesity Surgery Age: 18-65 years BMI >35 Kg/m2 Surgery: laparoscopic gastric bypass surgery ASA status: I, II and III Fluent in English History of allergy to local anesthetics Chronic opioid use Pregnant patients Patients who remained intubated after surgery Drop-out Patient or surgeon request Complications related to the procedure or conversion to open route Patient requiring mechanical ventilation after surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Morbid Obesity Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program Weight ≥ than 450 lbs Postmenopausal women Significant heart, kidney, liver, or malignant disease Current disorders known to affect bone Use of medications known to affect bone for more than 7 days in the past 12 months | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-37.0, Body Dissatisfaction Eating Disorder Symptoms If they have a score on the Body Shape Questionnaire of 113 or more AND a score in the EDE-Q of 4 or more in any subscale attention bias score of <-10 | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Contraception Clients adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage bring their infants between the ages 6-12 months to immunization services at study sites Providers all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Human Papillomavirus Prevention Mother is greater than or equal to 18 years of age Mother has a daughter who is between the ages of 11-15 years Daughter has not received any doses of the HPV vaccine When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated." Cannot read/speak English | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-999.0, Obesity For in the study, patients must fulfill all of the following Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the not including the screening visit Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations. After the Informed Consent process, these additional will be applied to potential subjects Age 30 years and older at screening BMI of 27 to 40 kg/m2 inclusive Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS) Use of any other investigational drug(s) within 8 weeks prior to screening Subjects should not have received antibiotics within the prior 4 weeks of screening Abnormal laboratory parameters Serum creatinine greater than 1.6 mg/dL Liver function tests, alanine transaminase (ALT), alanine transaminase (AST), Bilirubin results greater than 2.0 times the upper limit of normal Triglycerides greater than 500 mg/dL Total cholesterol greater than 350 mg/dL | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-80.0, Obstructive Sleep Apnea Subject is between the ages of 18 and 80. 2. Diagnosis of OSA, based on ODI 10-60 (as assessed per home screening night). 3. Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form. 4. BMI < 40. 5. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). 6. Subject has proper mouthpiece fit, as assessed by home screening night (See section 8.3) OSA treatment within two weeks prior to Medical/Dental screening visit. 2. Poor nasal patency as evidenced by Peak Nasal Inspiratory Flow (PNIF) less than 75 l/min (assessed at baseline medical visit). In addition, any ongoing process or condition that limits nasal breathing or indications thereof, including: obligate mouth-breathing, persistent blockage of one or both nostrils resulting in the inability to sleep with the mouth closed, chronic nasal congestion, chronic allergic rhinitis, and intermittent allergic rhinitis that does not respond to non-sedating/non-stimulating medical therapy. 3. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System. 4. Prior use of the Attune Sleep Apnea System. 5. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc. 6. Current use or use within the previous 2 weeks of medications or other agents that may affect sleep or PSG, including: 1. Hypnotics, anxiolytics, anticonvulsants, sedating antihistamines, stimulants, sedating antidepressants or other medications likely to affect neurocognitive function and/or alertness. Patients on stable selective serotonin reuptake inhibitor (SSRI) therapy for > 3 months and who are expected to remain on therapy for the Study duration, may continue SSRI treatment. 2. Consumption of > 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee). 3. Any known illicit drug use or abuse within the past year, or failure to pass drug urine screen test, or alcohol breathalyzer test with result over 0.05% BAL. 4. Smokers who smoke during the night (interference with PSG). 7. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea. 8. Currently working nights, rotating night shifts, planned travel across four or more time zones required during Study period, or within two weeks prior to Study enrollment, or sleep schedule not compatible with sleep lab practices. 9. Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including NYHA class III or IV heart failure, CAD with angina or MI/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the Study. 10. Female subjects who are pregnant or intend to become pregnant during the study period | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Pain Obesity ASA I, II,III BMI > 35 kg/m2 Age between 18-70 Fluent in English Patients undergoing laparoscopic gastric bypass EKG within 3 months History of allergy to local anesthetics History of chronic opioid use Pregnant patients History of EKG abnormalities. Dropout: Conversion to open, patient or surgeon request | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-35.0, Polycystic Ovarian Syndrome Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus Female subjects suitable for IVF/ICSI, undergoing first or second attempt 35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0) Normal FSH value (less than 10 international unit per liter [IU/L]) on Day 3 of spontaneous cycle within 12 months prior to the trial Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter [ng/mL]) of a spontaneous cycle within 12 months prior to the trial or at least at V0 No history of active genito-urinary infection Normal thyroid function (or adequate substitution for at least 3 months) Negative cervical papanicolaou test within the last 12 months prior to study entry No gonadotropins, for at least one month prior to the trial No metformin therapy for at least one month prior to Visit 1 (V1) Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term Drilling 3 months prior to V0 Uterine malformation, diethylstilbestrol syndrome, synechia Female subjects with World Health Organization (WHO) Type I or III anovulation Female subjects with hyperprolactinemia Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons) Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner Abnormal gynecological bleeding of undetermined origin History of major thromboembolic disease Endometriosis (Grade III or IV) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-45.0, Obesity Prevention Non-obese women aged 25-45 years Physician-diagnosed thyroid disease or diabetes or who were menopausal or any other disease that could be influenced by intervention | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-75.0, Obstructive Sleep Apnea Syndrome BMI ≥ 30 kg/M2 Apne hypopnea index (AHI) > 10 No significant comorbidities Abel to exercise Inability to exercise due to musculoskeletal conditions Known ischemic cardiovascular disease Drug abuse Mental illnesses | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Patients 18 years and older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence Receiving anticoagulation therapy prior to surgery (i.e. warfarin) Did not receive enoxaparin after surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-50.0, Obesity Morbid obesity 50 years of age Having a relative or close friend who is willing to participate Pregnancy Serious mental illness Severe overeating behaviour Significant reduced physical functioning Having undergone bariatric surgery earlier Serious heart disease | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 31.0-60.0, Diabetes Obesity Informed consent obtained before any trial-related activities 2. Age at study entry is between 31-60 years of age 3. Body Mass index (BMI) between 30-49 kg/m2 using measured height and weight 4. Body weight <350lbs (MRI table limit) 5. Stable body weight during the previous 3 months with a less than 5 pounds self -reported weight change 6. Type 2 diabetes, insulin naïve (except for use during gestational diabetes) on either metformin, sitagliptin, or dipeptidyl-4 inhibitor (sitagliptin or saxagliptin), or a thiazolidines (rosiglitazone or pioglitazone) 7. HbA1c level between ~6-8% 8. Lives in a community dwelling and has a telephone 9. Agrees to avoid alcohol and exercise within 48 hours of CRC visits, and to comply with the dietary/stimulant restrictions for 48 hours before PET and fMRI studies. 10. Able and willing to follow prescribed menus plans Known or suspected hypersensitivity to study drug (insulin detemir) 2. Significant co-morbidities including cardiovascular disease, atherosclerotic disease, pulmonary disease, metabolic disease, liver or renal insufficiency 3. Significant pathologic finding on MRI (research MRI scans are not clinical scans and are not standardly read by a neuroradiologist, but if an overt anomaly is noted by study personnel, an advisory read will be obtained and the patient will be provided with the information for follow-up with his/her physician). 4. Clinically significant abnormalities on screening EKG 5. History of Substance Abuse, including but not exclusive to alcohol, cocaine, marijuana, heroin, nicotine 6. Any tobacco use in last 3 months 7. History of psychiatric disorder deemed too severe to permit participation (PI discretion) including subjects with a lifetime history of lifetime Psychotic Disorder (Schizophrenia, Schizoaffective, Psychosis NOS) or Bipolar Disorder, suicide attempt or history of any suicidal behavior or history within the past 6 months of Post Traumatic Stress Disorder, Generalized Anxiety Disorder 8. Long term use of steroids or medications that may cause weight gain within 3 months of study or in foreseeable need (e.g. uncontrolled asthma or rheumatologic disorder). 9. Inability to abstain from alcohol, physical exercise or > 1 cup of coffee or equivalent daily for 2 days prior to imaging studies 10. Any contraindication which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body 11. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (abstinence or the following methods: diaphragm with spermicide, condom with spermicide by male partner, intrauterine device, sponge, spermicide, Norplant, Depo-Provera or oral contraceptives) 12. History of uncontrolled thyroid disease evidenced by TSH outside normal range 13. Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome, Polycystic ovarian syndrome) 14. Previous surgery for weight loss 15. High level aerobic activity such as running for longer than 60 minutes more than 2 times a week regularly in last 3months 16. Significant eating disorder or dietary restraints as determined by three factor eating questionnaire (TFEQ) 17. Appetite reducing diet supplement or herbal supplement use in last 6 months 18. . Food allergy or diet restrictions that would interfere with balanced intake and caloric goals. 19. Dietary supplements of such as EPA, DHA or omega-3 fatty acids. 20. Daily intakes of coffee, black tea and other caffeinated beverages will be assessed and subjects who consume the equivalent of >4 cups coffee or black tea/day at baseline will be excluded 21. Any condition felt by PI or co-investigators to interfere with ability to complete the study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-50.0, Obesity Pre-menopausal BMI (25 Weight < 300 lbs Negative urine glucose test Inability to provide informed consent Age < 21 or menopausal as determined by self-report DSM-IV diagnosis of an eating disorder Any substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention Factors that confound relations between stress and eating, including, drug abuse and use of medications containing corticosteroids Diabetes Polycystic Ovary Syndrome CHD Breastfeeding (due to interference with stress hormone measurement) Non English speaker | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Ischemic Stroke Transient Ischemic Attack Atherosclerotic Stenosis • Recent (less than 3 months) ischemic stroke As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment) These ischemic strokes TIA with ischemic lesion documented by CT or MRI • Or recent TIA (less than 15 days) without documentation of ischemic lesion on CT/MR imaging Must be limb weakness or aphasia lasting more than 10 min • And documented atherosclerotic stenosis In carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray angiography) Or in the aortic arch (investigator judgment) (based on TEE or CTA) Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA) Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography) • And • Ischemic stroke/TIA du to arterial dissection (investigator judgment) Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils • Symptomatic hemorrhagic stroke Presence of microbleeds on gradient echo imaging (T2*) is not an Hemorrhagic transformation of an ischemic stroke is not an Uncontrolled hypertension (investigator judgment) LDL-C <100 mg/dL or patients for whom treatment intensification is impossible F/U impossible or bad observance anticipated Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint Participation to another clinical trial | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-30.0, Healthy Male Subjects Age 18-30 year BMI 18.5-25 kg/m2 Healthy as judged by the participant Females Weight loss or weight gain of more than 5 kg during the last 2 months Using an energy restricted diet during the last 2 months Lack of appetite for any reason Restrained eater: >2.89, measured by DEBQ (35) Smoking Heavy alcohol use: >5 drinks/day (36) Reported stomach or bowel disease Reported diabetes Reported thyroid disease or any other endocrine disorder | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Bariatric Surgery Candidate if they consent aged 18 or over have attended the bariatric clinic at Chichester been accepted for surgery have funding in place for surgery (i.e. their primary care trust has agreed to pay for their surgery) those who do not wish to take part in the randomisation those who do not wish to take part in the intervention those who will not be having bariatric surgery because they are not a suitable patient those who will not be having bariatric surgery because they can not secure funding from their primary care trust for the surgery those who cannot effectively read or speak English, as this would pose a difficulty in implementing the intervention and for data collection | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Renal Function and Chronic Allograft Vasculopathy De novo heart transplant recipients who had received induction therapy with antithomocyte globulin (ATG) were eligible for inclusion. Recipients of multi-organ transplants or a previous transplant were excluded, as were those with a donor aged > 70 years, cold ischemia time >6 hours, patients with severe systemic infection, recipients of ABO incompatible transplants, patients with severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>750 mg/dL), patients with past (<5 years). In order to continue in the study after week 7-11 (period 1), patients had to complete first 7-11 weeks on randomized immunosuppression and none of the following should be present: Ongoing rejection treatment or experience of one grade 3R rejection or two or more grade 2R rejections during first 7-11 weeks | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-65.0, Diabetes Mellitus, Type 2 Obesity currently enrolled at Group Health currently enrolled in a GH insurance product that provides coverage for laparoscopic gastric bypass (e.g., Medicare, PEBB, or has GH bariatric coverage rider) age on January 1, 2011 will be between 25 and 65 years Diabetes: must meet one or more of the following during the past two years (10/1/08 30/10): 1. 1+ fills for a diabetes-specific medication (oral or insulin) 2. Hemoglobin A1c ≥7.0% on one or more occasions 3. Fasting Blood glucose ≥126 mg/dL on two or more occasions [separate days] 4. Random glucose ≥200 mg/dl on two or more occasions [separate days] 5. One fasting blood glucose ≥126 mg/dL plus one random glucose ≥200 mg/dl [must occur on separate days] 6. One or more inpatient (primary or secondary hospital discharge) code related to diabetes. See list below. 7. Two or more outpatient ICD-9 codes related to diabetes (ambulatory visits (AV) only not telephone, email, emergency department, lab, radiology, or other (IS, OE) encounter types) [Two visits must occur on separate days] Obesity: All patients must have a body mass index [BMI] between 30 and <40kg/m2; weight measurement must be within the past two years (10/1/08 30/10) Pregnancy within the past one year (10/1/09 30/10) Excluded if the following conditions are recorded within the past two years (10/1/08 - 9/30/10): 1. malignant tumor 2. ascites 3. peritoneal effusion 4. cirrhosis 5. schizophrenia 6. schizoaffective disorder 7. bipolar disorder 8. dementia 9. HIV 10. inflammatory bowel disease 11. dialysis if occurred between 1/1/95 30/10: 1. Any prior bariatric or major gastrointestinal operation 2. Any prior liver, heart, intestinal, and/or lung transplant | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-65.0, Obesity Metabolic Syndrome Schizophrenia phase 1 fulfilled DSM-IV of schizophrenia or schizoaffective disorder 65 year of age receiving clozapine for at least 6 months. phase 2 are those in phase 1 and met the following overweight and obese (BMI ≧ 24) one or more metabolic dysregulation, such as abdominal obesity (waist circumference > 90 cm, in men and > 80 cm, in women fasting hypertriglyceridemia, (≥ 150 mg/dL) low fasting HDL levels (< 40 mg/dL in men and < 50 mg/dL in women) high blood pressure (≥ 130/ ≥ 85 mm Hg or current treatment with antihypertensive medication). The are the following current use of hypoglycemic or hypolipidemic agents FPG levels ≥ 126 mg/dL women who are pregnant known allergy or contraindicated to metformin (including Creatine>1.4 ng/dl abnormal liver function test; chronic cardiopulmonary insufficiency) phase 2 current use of hypoglycemic or hypolipidemic agents FPG levels ≥ 126 mg/dL women who are pregnant known allergy or contraindicated to metformin (including Creatine>1.4 ng/dl abnormal liver function test | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity Metabolic Syndrome Aged 18 to 40 years Body mass index (BMI) ≥ 27 kg/m2 Body weight ≤ 300 lb Access to a working telephone Clearance in writing from a primary care provider (i.e., physician or nurse practitioner) to rule out pre-existing medical conditions Willing and able to attend group workshops (for dietary intervention) on specified evenings Physician diagnosis of a major medical illness or eating disorder Chronic use of any medication that may affect study outcomes (e.g., insulin-sensitizing agents) Current smoking (i.e., 1 cigarette in the past week) Physical, mental, or cognitive handicaps that prevent participation Another member of the family (i.e., first degree relative) or household participating in the study Planning to relocate from current area of residence during the proposed timeframe for study participation If female, planning to become pregnant during the 18 months of the study | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-75.0, Dietary Fiber Weight BMI between 23 having obtained his/her informed consent willing and able to exclusively consume enteral diets for two 14 day periods willing and able to collect stool samples as instructed any disease use of medication except for contraceptive medication and certain OTC medications not affecting laxation smoking excessive exercise (> 2 hours per week) consumption of more than 20 grams of dietary fiber daily pregnancy or lactation use of laxatives use of antibiotics in past 6 months use of pre or probiotics supplements in the past 2 months use of probiotic foods in the past month | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 3.0-14.0, Sleep Apnea Children Obesity Children of both sex, between 3 and 14 years old Body mass index (BMI) ≥ 95 percentile With informed consent Without informed consent | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-75.0, Obstructive Sleep Apnea-hypopnea Syndrome Moderate to severe obstructive sleep apnoea (AHI > 15) With or without continuous positive airway pressure for a minimum of six months aged 30-75 years Vitamin D2D3 level < 30 ng/ml Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism Patients with mixed sleep apnoea (central and obstructive) Patients with CPAP use < 4 hours per night Patients with maxillofacial or oro-pharyngeal diseases) Patients with chronic respiratory failure, hypercapnic patients Muscle diseases Alcohol intake > 2 glasses per day Body mass index > 40 kg/m2 | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Weight Loss Obesity Age 18 years and older Patient is scheduled and consented for laparoscopic Roux-en-Y gastric bypass as part of their routine medical care Younger than Age 18 years Patient is disabled and unable to participate in an exercise program | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-82.0, Body Fat All population who meet with the requirements described on the user's manual Pregnant women Individuals who have a pacemaker or any other internal medical device Population whose weight is under 15 Kg and less than 135 cm tall | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 16.0-60.0, Obesity Being Obese Having heart disease or renal disease using drugs influencing metabolism and appetite | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-60.0, Obstructive Sleep Apnea Male subjects aged between 30 and 60 years old Normal range of laboratory tests complete blood count (CBC), glucose, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (LDL), triglycerides Body Mass Index (BMI) < 35kg/m2 Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders Smoking status Participants who had current or historical treatment with CPAP or any other treatment for OSA Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP Alcoholism Use of sleep-inducing medications | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Subject is at least 18 years of age at the time of enrollment into the study Have a BMI of at least 30 Subject is willing to give consent and comply with protocol evaluation and treatment schedules Subject agrees to refrain from any type of weight-loss drug (prescription or OCT) or elective procedure that affect body weight for the duration of the trial; and HbA1C<11% History of previous malabsorptive bariatric procedures Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery Any condition which precludes compliance with the study History or presence of pre-existing autoimmune connective tissue disease; and Use of prescription or over the counter weight reduction medications or supplements within 30 days of the screening visit or the duration of study participation. This study is a local study (NY, within 50 miles). This study is not a sponsored trial. Therefore, the procedure is not free | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-39.0, Obesity Polycystic Ovaries Syndrome premenopausal nonpregnant nonlactating overweight and obese women classical 21-hydroxylase deficiency hyperprolactinemia adrenal or ovarian tumor and Cushing's disease | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-40.0, Healthy Volunteers Signed an informed consent document Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic Electrocardiogram (ECG) consistent with normal cardiac conduction and function Non-smoker Agree to use an adequate contraception method History of or current clinically significant medical illness that the investigator considers should the participant or that could interfere with the interpretation of the study results Clinically significant abnormal values for hematology, biochemistry or urinalysis Clinically significant abnormal physical examination, vital signs or ECG Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the study treatment History of drug or alcohol abuse within the past 5 years Drug allergy or drug hypersensitivity Blood donation, depending on the volume of blood collection Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis Dermatological disease at application site Photosensitivity | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Type 2 Diabetes Post GBP, LAGB or VSG Subjects Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City History of Type 2 Diabetes before surgery < BMI < 50 Non-Smoker Total Body Weight < 300 LBS Age<60 HbA1c < 9% Resting Blood Pressure < 160/100 mmHg Beta Blockers discontinued 2 weeks prior Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit. 2. Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would significant psychiatric, renal or neurological, or known active coronary artery disease. 3. Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery. 4. Currently pregnant or nursing. 5. Known cardiovascular disease 6. Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection 7. HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment. 8. Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test. 9. Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Body Fat Disorder Male or female subjects > 18 years of age and < 65 years of age Subject has clearly visible fat on intended treatment area(s), which in the investigator's opinion, may benefit from the treatment(s). Treatment areas abdomen, saddlebag (outer aspect of upper thighs), upper arms and inner thighs Subject has not had weight change exceeding 10 pounds in the preceding month Subject with body mass index (BMI) between 25 and 35. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study Subject has read and signed a written informed consent form Subject has had a surgical procedure(s) in the area of intended treatment Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising Subject is taking or has taken diet pills or supplements within the past month Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion) Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Body Fat Disorder Male or female subjects > 18 years of age and < 65 years of age. 2. Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment. 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. Subject with body mass index (BMI) up to 30. [BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.] 5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study. 6. Subject has read and signed a written informed consent form Subject has had a surgical procedure(s) in the area of intended treatment. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment. 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month. 5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 7. Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. 8. Subject is taking or has taken diet pills or supplements within the past month. 9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 11. Subject is pregnant or intends to become pregnant in the next 8 months. 12. Subject is lactating or has been lactating in the past 6 months. 13. Subject is unable or unwilling to comply with the study requirements. 14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Obesity Elevated waist circumference Men: > 40 inches (102 cm) Women> 35 inches (88 cm) Poor dieters with TG>150mg/dL and high-density-lipoprotein cholesterol [HDL-c] <40 mg/dL for men and <50 mg/dL for women Pregnant or lactating women Serum creatinine LT 2 mg/dl Disturbed liver function (LT 3 fold level of ALT and AST enzymes) Active cancer Individuals who cannot start physical activity in the gym Individuals that are highly physically active (more than 4 hours/week) Active in other nutritional trial | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Sleep Apnea, Obstructive Obesity Hypoventilation Syndrome Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States. 2. Subject is >18 years old. 3. Diagnosed OHS and OSAHS: 4. Expected to tolerate the ventilator therapy Patient is currently enrolled in another clinical study which may confound the result of this study. 2. Patient for whom inform consent cannot be obtained. 3. Patients with a history of cerebrovascular accident within the 6 months prior to this study. 4. Patients with acute or chronic renal failure, diabetes and severe lung diseases. 5. Patients with unstable angina. 6. Patient who is of pregnant or during lactation period. 7. Patients with a history of injury or surgery within 6 months prior to the study | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Fibromyalgia In order to qualify the subject: 1. must have been diagnosed with fibromyalgia by a medical doctor 2. must be between the ages of 18 to 65 years of age 3. must have a weekly overall body pain average score ≥ 4 4. must pass a screening questionnaire that calculates a physical impairment of ≥ 10 5. must be on stable doses of his/her current medication for at least past four weeks 6. must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary 7. must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team 8. must be willing to maintain a medication diary provided to him/her during the 10-week study period 9. must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits) 10. must agree to use a proven method of contraception to prevent pregnancy throughout this study The subject will not be allowed to participate if: 1. he/she has a history of seizures 2. he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives) 3. he/she has chronic thrombocytopenia (a low blood platelet count) 4. she is currently pregnant, are planning to become pregnant, or is breastfeeding 5. he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder 6. he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases) 7. he/she plans to undergo an elective surgery within the study timeline 8. he/she is in the process of filing, or plan to file for disability benefits within the study timeline 9. his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count) 10. he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Diabetes Effects of Liraglutide Administration on Brain Activity Weight Loss Hunger Subjects will be men and women between the ages of 18 and 65. The following table list for each group (lean diabetic and obese diabetic). Subjects must meet either HbA1c or fasting plasma glucose (FPG) criteria. Lean diabetic: BMI: 18-25 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other On dietary modification and/or metformin Obese diabetic: BMI: >27 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other On dietary modification and/or metformin Additionally, women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child Uncontrolled diabetes (HbA1c>8.9%, or FPG>250 mg/dL) 2. Women who are breastfeeding, pregnant, or wanting to become pregnant. 3. Women using IUD 4. Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study. 5. Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease 6. Moderate, or severe hepatic impairment 7. Hypersensitivity to the active substance or any of the excipients in liraglutide 8. History of diabetic ketoacidosis 9. Congestive heart failure 10. Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc 11. Gastroparesis 12. Pancreatitis 13. Gallstones as they may cause increased risk of pancreatitis 14. Alcohol consumption the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia. 15. Untreated thyroid disease like hypothyroidism or hyperthyroidism 16. Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc). 17. Subjects on any oral anti-diabetic agent except metformin 18. Personal or family history of MEN II or medullary thyroid cancer 19. Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.) 20. Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos 21. Anxiety and/or claustrophobia 22. Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function) 23. Significant sensory or motor impairment 24. Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation 25. Subjects with neurological problems which may interfere with or complicate testing (e.g. presence of titubation) 26. Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan. 27. Subjects who cannot adhere to the experimental protocol for any reason 28. Anemia with Hgb less than 10 29. Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc) 30. Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc 31. Any cancers or lymphoma 32. Eating disorders like anorexia, bulimia 33. Severe hypertriglyceridemia (triglycerides >500 mg/dl) 34. Weight loss surgery or gastrectomy 35. Any changes in medications that affect brain function, e.g. anti-depressants, anti-psychotics, anti-anxiety, anti-seizure medications, antihypertensives etc (subjects should remain on same medication/ same dose during the time of the entire study). 36. Irregular periods, defined as cycle length less than 22 days or more than 40 days. 37. Any change in smoking status. 38. Vegetarians as food images presented will numerous non-vegetarian items and thus will not be appealing as high calorie food items | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Mucositis Patient has oral mucositis pain that is grade 3 or 4 according to the World Health Organization (WHO) Oral Mucositis Scale Patient has received at least one prior chemotherapy or radiation treatment Patient is at least 18 years old Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Patients who have scheduled gastric bypass Use of at least one chronic drug (including contraception) Patients who have undergone another form of bariatric surgery before RYGB | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-50.0, Scar Ages 50 (Both Male & Female) Non-smoker having quit at least 3 months prior to enrollment Non-diabetic Non-pregnant or non-breastfeeding verbal assent If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study No current use of OTC medications or other form of supplements containing vitamin-E Diabetes or HIV diagnosis Alcohol or drug abuse unable to provide informed consent Therapeutically anti-coagulated Prisoner Currently prescribed immunosuppressant medication | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Body Fat Disorder Subject participated in the ZA10-001 study, and received all study treatments. 2. Subject has read and signed a written informed consent form Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments. 2. Subject is pregnant. 3. Subject is unable or unwilling to comply with the study requirements. 4. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 5. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-65.0, Obesity With Complications Morbid Obesity Reactive Hypoglycemia Bariatric Surgery Patients are eligible if aged between 25 and 65 years, have a body mass index of 35 (in presence of complications as sleep apnea, severe coxarthritis or gonarthritis, severe hypertension) to 50 kg/m2, and are able to understand and comply with the study process History of type 1 diabetes or secondary diabetes Previous bariatric surgery History of medical problems such as mental impairment Major cardiovascular disease Major gastrointestinal disease Major respiratory disease Hormonal disorders Infection History of drug addiction and/or alcohol abuse Internal malignancy | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-64.0, HIV Dementia Men and women 18 years of age or older and less than 65 years of age. Able to read and understand English. HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study. Significant dementia but able to give consent (International HIV Dementia Scale score <10). Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test. Beck Depression Inventory score <16. Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit. Baseline CBC and chemistry panel Grade 1 or normal. For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry. NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia. All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. Ability and willingness of subject to provide informed consent Inability to give informed consent. No proxy consent allowed. Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline). Untreated hypogonadism, hypothyroidism or hyperthyroidism. Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit. Pregnancy or breast feeding. Clinically significant EKG abnormalities at screening. History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia. Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis. History of epilepsy. Untreated depression. Uncontrolled diabetes (glucose <70 or >200 at screening). Use of interferon or ribavirin during study and for 1 month prior to screening. History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related. History of schizophrenia, mania or other serious mental illness. History of methylphenidate allergy. Other serious concurrent medical illness other than HIV. History of radiation therapy to the brain or brain injury. History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study. Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit. Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study. History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit. If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study. Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study. History of tic disorders in the past 3 months or any history of Tourette's syndrome. Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height) Uncontrolled migraine headaches. History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis. Family history of sudden cardiac death in a young relative. History of fainting with exercise. History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale. - | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Body Fat Disorder Male or female subjects > 18 years of age and < 65 years of age Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment Subject has not had weight change exceeding 10 pounds in the preceding month Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches Subject with sharp flank curvature that fits well with the CoolCurve+ applicator Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study Subject has read and signed a written informed consent form Subject has had a surgical procedure(s) in the area of intended treatment Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising Subject is taking or has taken diet pills or supplements within the past month Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion) Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity Healthy females between the ages of 18-40 (inclusive) BMI > 27 kg/m² Regular menstrual cycle (28 ± 4 days with a maximum of 4 days within-subject variation in menstrual cycle duration Weight stable (within ± 3-kg) 2 months prior to study Must use barrier contraception (e.g. male/female condom) for the study's duration Must be willing to follow the prescribed diet/exercise plan for the study's duration On hormonal contraceptives (IUD are allowed) or any other daily use of medications which can make the subject unsuitable for in the study Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.) Restrictions against participating in cardiovascular exercise and strength training Any condition, which in the opinion of the investigator makes the subject unsuitable for in the study Women who are pregnant,lactating, or planning to become pregnant during the study period | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, PCOS Obese infertile polycystic ovarian syndrome (PCOS) women Women 40 years or older Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Body Fat Disorder Male or female subjects > 18 years of age. 2. Subjects must be of Asian descent. 3. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment. 4. Subject has not had weight change exceeding 10 pounds in the preceding month. 5. Subject with body mass index (BMI) up to 25. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 6. Subject with sharp flank curvature that fits well with the CoolCurve+ applicator. 7. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 8. Subject has read and signed a written informed consent form Subject has had a surgical procedure(s) in the area of intended treatment. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment. 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 4. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. 5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. 8. Subject is taking or has taken diet pills or supplements for weight loss within the past month. 9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 11. Subject is pregnant or intending to become pregnant during the study period (in the next 4 months). 12. Subject is lactating or has been lactating in the past 6 months. 13. Subject is unable or unwilling to comply with the study requirements. 14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-60.0, Morbid Obesity BMI 35-50 kg/m2 60 y Severe co-morbidity Unmotivated to long term follow up | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-50.0, Obesity Inflammation Age range 20 yrs to 50 yrs BMI > 30 kg/m2 to < 55 kg/m2 Fasting glucose < 110 mg/dl and 120 minute OGTT < 170 mg/dl glucose | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-65.0, Type 2 Diabetes Ability to give informed consent and comply with all study requirements 2. Overweight and obese, generally healthy men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose tolerance, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. 3. Glucose Parameters: 1. Fasting plasma glucose ≥100 mg/dL and <126 mg/dL 2. 2h post-OGTT glucose of ≥140 and <200 mg/dL 3. HbA1c<6.5% 4. Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study). Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential one of the following Abstinence One (1) of the following methods Tubal ligation Copper-containing intrauterine device (IUD) Condom AND spermicidal foam/gel/film/cream/suppository Male partner who has had a vasectomy for at least 6 months. 5. It is required that all male subjects use an acceptable method of contraception (as outlined below), starting from the first dose of study medication and continuing for at least 28 days after the last dose of study drug: 1. Abstinence 2. A condom AND one of the following Vasectomy for more than 6 months Female partner who meets one of the following conditions Has had a tubal ligation, hysterectomy, or bilateral oophorectomy; or Subjects presenting with any of the following will not be included in the study: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, neoplastic, or allergic or clinical findings at Screening (seasonal allergies OK). 2. Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy). 3. Use of unacceptable medications 4. A positive urine drug screen. 5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening. 6. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication. 7. 12 lead ECG demonstrating QTc >450 msec at Screening for males, 470 msec for females. If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. An ECG with evidence for possible old myocardial infarction will need to have prior ECGs to document stability of finding. 8. Supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement. If elevated, confirm by a single repeat, following at least 10 minutes of rest. 9. Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST) greater than 2X the upper limit of the laboratory reference range. 10. Elevated fasting triglycerides at screening (>500 mg/dL), confirmed by a single repeat if deemed necessary. 11. Pregnant or nursing females; inability to use effective contraception. 12. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. 13. Participation in a clinical biomedical research study within prior two months may be excluded, depending on study type and details. 14. History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by the site for blood draws. 15. Unwilling or unable to comply with directions and procedures described in this protocol. 16. Subject is the Investigator or a sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study. 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-70.0, Obesity Male or female 25-70 years of age 2. Obese (BMI ≥ 30 kg/m2 and <40 kg/m2) 3. At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) Hypertension defined by a history of hypertension, treatment of hypertension or BP values >140/90 mmHg in two consecutive office visits ii) High cholesterol defined by an LDL-C ≥130 mg/dL and/or HDL-C <40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dL in two consecutive office visits 4. Participant must be willing and able to provide written informed consent 5. Participant must be willing and able to comply with study related procedures 6. Participant must have access to Internet and e-mail Stage 1 or 2 on Patient Activation Measures tool 2. Weight change of more than 5 kg during the 3 months preceding the screening visit 3. History of bariatric surgery 4. Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L) 5. Hemoglobin A1c at screening >8.5% 6. Treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months) 7. Uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure >160/100 mmHg 8. Secondary hypertension 9. Changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to Screening Visit 10. Personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke 11. Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult. 12. Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study 13. Presence of history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer 14. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening 15. Use of any investigational agent (drug, biologic, device) within 3 months prior to screening | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Body Fat Female Minimum age of 18 years Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study Body Mass Index (BMI) ≤ 30 Visible fat in the thigh / saddlebag area to be treated Subject must be able to read, understand and sign the Consent Form Subject must adhere to the follow-up schedule and study instructions Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment) Taking weight-loss medications/supplements Simultaneous participation in any other clinical study Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis Arteriosclerosis or weakened blood vessels Heart disease Thromboembolic disease Diagnosed or documented immune system disorders (including Panniculitis) Bleeding disorders Presence of uncontrolled hypertension | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-35.0, Treatment Resistant Disorders Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic age more than 40 years tubal,uterine or male factor infertility | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Glucose Response Insulin Response Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male & half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional will Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit) Systolic blood pressure 100-150 mmHg inclusive Diastolic blood pressure 60-90 mmHg inclusive Resting heart rate 50-90 beats/min inclusive after 3 minute rest Able to refrain from eating legumes and drinking alcohol the day before each test session Fasting triglycerides < 2.0 mmol/L (178 mg/dL) Fasting HDL cholesterol > 0.9 mmol/L (35 mg/dL) for males and > 1.1mmol/L (42 mg/dL) for females Fasting LDL cholesterol < 5.0 mmol/L (193 mg/dL) AST and ALT < 120% of upper limit of normal (ULN) failure to meet any one of the age less than 18 or over 45 years known history or AIDS, hepatitis, diabetes or a heart condition participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines Food allergies of any kind General anaesthesia in the month prior to inclusion Smokers | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Morbid Obesity morbidly obese not able to walk slowly for 20 minutes | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Pregnancy Complications Weight Gain Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous) less than 17 weeks gestation a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity) plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited able to tolerate dairy foods approval of primary care provider able to provide signed informed consent unable to understand some English type 1 or type 2 diabetes known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy severe gastrointestinal diseases or conditions any significant heart, kidney, liver or pancreatic diseases pre-existing diabetes currently smoking a depression score 12 or above on the validated Edinburgh depression questionnaire | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-75.0, Type 2 Diabetes Metabolic Syndrome Men and women 75 years old BMI 25-35 kg/m2 Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III at least three of the following must be present central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches(female) dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl) dyslipidemia: HDL-C < 40 mg/dL (male), < 50 mg/dL (female) blood pressure ≥ 130/85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl) BMI >35 kg/m2 Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg) Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc) Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra) Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the capsules Use of any ginseng products within three days preceding the study and during the study Allergies to Panax species, their constituents or to other members of the Araliaceae family. The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Sleep Apnea, Obstructive Brain Ischemia Patients with ischemic stroke (> 1month, within 12 months) and moderate-to-severe OSA (AHI>15) who could wear the positional devices not interfering with his/her sleep unclear consciousness unstable vital sign or neurologic sign unstable medical conditions | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-59.0, Metabolic Syndrome Obese Sedentary Sedentary metabolic syndrome subjects will be 25-59 y of age overweight to Class I or II obese (BMI 25-39 kg/m2) men and women of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG Women must be taking birth control or be postmenopausal Diagnosed cardiovascular disease or diabetes or disease Symptoms that could alter their ability to perform exercise Fasting blood glucose of greater than 126 mg/dl Smoking Taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity Women who are pregnant or plan to become pregnant during the duration of the study Individuals exercising regularly (more than one 30 min session per week) Individuals with an orthopedic limitations for walking Report any allergies to the medications (statins, lidocaine) | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity Bone Loss Caucasians fulfilling the for laparoscopic gastric bypass BMI>40kg/m2 Pregnancy Chronic obstructive pulmonary disease Diabetes mellitus Chronic inflammatory bowel disease Major psychiatric disorder Drug abuse | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-60.0, Morbid Obesity BMI =/> 35 kg/m2 age 30-60 years both sexes history of major abdominal or bariatric surgery disabling cardiac or pulmonary diseases cancer long-term treatment with oral corticosteroids, and mental illness | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Pain, Postoperative Age ≥18 Weight 75kg -120 kg Undergoing arthroscopic rotator cuff repair by same surgeon at Surgicare of Wichita Patients who sign informed consent Patients who do not meet any of the Age < 18 yrs (will reduce risk of overdosing oral acetaminophen) History of opioid abuse or chronic opioid use greater than 3 months (may skew data with regards to pain control due to the concept of tolerance) Acetaminophen allergy (avoids risk of allergic reaction) Liver disease as determined by anesthesiologist by history (acetaminophen involves the liver for metabolism, therefore, if the liver is not functioning appropriately, doses could accumulate and cause damage.) Daily alcohol consumption (same explanation as for liver disease) Renal failure (patient on dialysis or health history indicates renal dysfunction) (acetaminophen has some renal excretion) Asthma (recent concerns for acetaminophen leading to asthma exacerbations) Any other contraindication to taking acetaminophen Surgeon requested pre-operative Interscalene block (this will cause the patient to cease having pain, therefore the effects of acetaminophen reducing pain scores will not be able to be evaluated) Current warfarin, carbamazepine, or phenytoin use (these medications can accumulate in the presence of excessive acetaminophen use or may harm the liver and affect acetaminophen use or may harm the liver and affect acetaminophen concentrations) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-60.0, Obesity Insulin Resistance Metabolic Syndrome Age 30 year old men Willingness to be randomized to resveratrol or placebo BMI 30-40 Evidence of insulin resistance with one of the following: 2 hr oral glucose tolerance result =/>120mg/dl at 2hrs acanthosis nigricans, or HgA1C 5.7 9%, or FBS >/= 100 mg/dl AND at least 2 of the following: waist circumference > 102 cm triglycerides > 150 but < 500 mg/dL HDL < 40 mg/dL Pre hypertension or hypertension: BP>120/80 mmHg but <150/90 mmHg Willingness to consume only study food and drink during the in-pt phases Willingness to avoid the use of over-the-counter medications, herbs, or supplements within the last 30 days Willingness to avoid (advil, aleve, motrin, etc.) and aspirin for the entire study Tobacco smoker any time within the last 3 months Bleeding disorder by history or by Bleeding Questionnaire results History, physical or EKG findings suggestive of CV disease including angina, MI, hx of med/surg tx of atherosclerotic heart disease, or congestive heart disease BP > 145/90 after 10 minutes of rest on 2 or more screening visits Fasting glucose > 165 mg/dL at screening HbA1C > 8.0 at screening Current use of oral hypoglycemic agents Chronic glucocorticosteroid use or use of oral glucocorticosteroids for 5 days within the last year (inhaled glucocorticosteroid use may be acceptable; this will be determined by the PI) Current use of over the counter or prescription weight loss medication Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-64.0, Obesity Weight Control Were between 21-64 years of age Had a BMI 27-35 Kg/cm Did not have a history of weight reduction over 5% of body weight over the past 6 months Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing Were able to understand and willing to provide written informed consent Experienced any difficulty in swallowing Had unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin Had a history or symptoms of thyroid disease which is not controlled by medication Had severe renal, hepatic, pulmonary disease or cancer Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy) Had any abnormal stenosis or obstruction of the GI tract Had a history of adhesive peritonitis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome (PCOS) PCO Androgen Excess Society hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound Normal prolactin, TSH, 17-OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly Age 18-40 Use of oral contraceptives and/or other steroid hormones 3 months prior to the study | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-999.0, HER 2 Positive Advanced Gastric Cancer Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach and Gastric-esophageal junction. 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as more than or equals to 20 mm with conventional techniques or as more than or equals to 10 mm with spiral CT scan. 3. Patients without prior systemic treatment. Patients who completed postoperative adjuvant chemotherapy (and radiotherapy) more than 180 days before may be enrolled. 4. Age more than or equals to 21 years. 5. Life expectancy of greater than 3 months. 6. ECOG performance status less than or equals to 2 (Karnofsky more than or equals to 60%). 7. Patients must have normal organ and marrow function as defined below Hemoglobin > 8.0 g/dL Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Platelets > 100,000/mcL Total bilirubin less than or equals to 1.5 X ULN AST (SGOT)/ALT (SGPT) less than or equals to 3 x institutional upper limit of normal ALP less than or equals to 3 x upper limit of normal* Creatinine within normal institutional limits OR Creatinine clearance** >60 mL/min for patients with creatinine levels above institutional normal In the presence of liver metastasis, patients with AST, ALT and ALP < or = 5 x the upper limit of normal may be admitted. *In the presence of bone metastasis, patients with AST ,ALT and ALP < or = 10x the upper limit of normal maybe admitted. **: Creatinine clearance can be estimated using Cockcroft-Gault formula man: Ccr (mL/min) = body weight (kg) x (140 - age)/(72 x serum creatinine (mg/dL)), woman: Ccr = male Ccr x 0.85]. The above CrCl Formula is to be applied in all sites. 8. Patients who have HER2-positive cancer confirmed with IHC and/or FISH***. *** Immunohistochemistry (IHC) for HER-2 is routine as part of pathological evaluation of gastric hybridisation (FISH) for Her2 copy number is required. A copy number value above 2.2 is taken as positive. The sponsors for the drugs used in our investigator initiated trial (Taiho) have kindly agreed to pay for the HER2 FISH test. 9. Patients able to take orally. 10. Patients with left ventricular ejection fraction of at least 50% on MUGA or 2D-echocardiography done within 28 days before enrollment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 11. The effects of proposed regimen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antitumor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 12. Ability to understand and the willingness to sign a written informed consent document. 13. Consent for fresh frozen tissue collection, mandatory for patients with primary in-situ tumors and optional for patients without primary in-situ tumors Patients who have had radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier. 2. Patients receiving any other investigational agents. 3. Patients with known brain metastases. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TS-ONE, cisplatin and trastuzumab or other agents used in the study. 5. Presence of any contraindications to TS-ONE or cisplatin or trastuzumab. 6. Baseline LVEF (Left Ventricular Ejection Fraction) < 50%. 7. Patients with serious (e.g.inpatient care is needed) complications (e.g. intestinal paralysis, intestinal occlusion, interstitial pneumonia or pulmonary fibrosis, poorly-controlled diabetes, renal failure or hepatic cirrhosis). 8. Patients with massive ascites (moderate or higher, beyond the pelvic cavity and retention on the anterior surface of the liver on CT) or massive pleural effusion retention. 9. Patients with fresh bleeding from the digestive tract which needs repeated blood transfusion. 10. Patients with diarrhea (4 or more times per day or watery diarrhea). 11. Previous malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix. 12. Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients). 13. Significant disease or conditions which, in the investigator's opinion, would patient from the study. 14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 15. Pregnant or lactating female. 16. HIV-positive patients | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Morbid Obesity Steatosis To be clinically severe obese; To be in preoperative phase of bariatric surgery Pregnancy and minors under 18 and adults over 60 years of age | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Gestational Diabetes Metformin Treatment Oxidative Stress Women Age more than 18 and less than 40 years Unique spontaneous pregnancy.-BMI less than 30kg/m2 before pregnancy to 30 weeks of amenorrhea or 22 to 28 weeks of gestation Gestational diabetes Social Security affiliated subject Patient able to understand and signed informed consent Contraindications to metformin Metformin treatment prior to protocol inclusion Multiple pregnancies Diabetes diagnosed prior to pregnancy High blood pressure prior to pregnancy Pregnancy hepatic complication High blood pressure prior to study inclusion Pre or eclampsia Premature membranes rupture | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Obesity Pregnancy Weight Gain Pregnant, African American, Socioeconomically disadvantaged Established prenatal care at our clinic before 15-6/7 weeks gestation Singleton viable pregnancy Gestational age 9 to 15 weeks Body Mass Index (BMI) of 25-45 kg/m² Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes Current use of certain medications Contraindications to aerobic exercise in pregnancy History of contraindicated medical conditions | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-65.0, Obesity Insulin Resistance Healthy Subjects Men and women in good general health with no significant underlying illnesses who are between the ages of 21 years of age with HbA1C < 5.7 %, fasting blood glucose < 100 mg/dL, blood pressure less than 120/80, and BMI between 20 kg/m2. Subjects should have never smoked tobacco or not smoked within the previous year. Obese Subjects Men and women in good general health with no significant underlying illnesses except obesity who are between the ages of 21 years of age with HbA1C < 5.7 %, fasting blood glucose < 100 mg/dl, blood pressure less than 130/90, and BMI between 30 - 45 kg/m2 Subjects will be excluded from our study if they are pregnant, breastfeeding, or if they plan pregnancy prior to the end of the study. In addition, subjects will be excluded if their age > 65 yrs, BMI ≥ 45 kg/m2, or have liver disease (including liver transaminase levels greater than twice the upper limit of normal), pulmonary disease, renal insufficiency (serum creatinine greater than 2.0 mg/dl), coronary heart disease, heart failure (New York Heart Association heart failure Class III or IV), peripheral vascular disease, coagulopathy, Major depressive disorder, actively smoking or used tobacco within last year, history of cancer, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids, thiazolidinediones (within 3 months), insulin, or anticoagulants, use food supplements that cannot be discontinued, regular intake of 8 or more cups of tea per week within 3 months prior to study entry, regular alcoholic beverage intake of more than two drinks per day (a drink corresponds to approximately 12 ounces of beer, 4 ounces of table wine, and between 1 and 1.5 ounces of 80-proof spirits), poor compliance during run-in period or regular use of medications that affect insulin sensitivity, blood pressure or vascular function and that cannot be discontinued. In addition, history of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment. Subjects will be excluded if they are unable to give informed consent for all procedures | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Morbid Obesity Metabolic Syndrome X Diabetes Mellitus Dyslipidemia Hypertension BMI≥40 kg/m2 BMI≥35 kg/m2 with at least one comorbidity associated with obesity BMI > 60 kg/m2 poorly controlled significant medical or psychiatric disorders active alcohol or substance abuse active duodenal/gastric ulcer disease difficult to treat gastro-esophageal reflux disease with a large hiatal hernia previous major gastrointestinal surgery diagnosed or suspected malignancy | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 25.0-60.0, Obesity Female 60 years Obesity (BMI > 35 kg/m2) Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol) Undergoing gastric bypass surgery Written informed consent Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease) May have arthrosis or depression Any present or previous malignancy History of smoking Alcohol dependency (more than 14 units of alcohol per week) Participation in studies with radioactive isotope within the last six months Hemoglobin under the normal range regarding to sex (under 7.3 mmol/l for women) | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-80.0, OSA symptoms of OSA with home sleep study AHI >= 15/hr unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure) neuromuscular disease affecting or potentially affecting respiratory muscles moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of <92% psychiatric disease that limits the ability to give informed consent or complete the study | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-60.0, Obesity Awaiting laparoscopic gastric bypass Residing near Uppsala Weight above 140 kg Metal implants such as pacemaker or intracerebral clips Failure to understand or comply with study protocol | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-48.0, Polycystic Ovary Syndrome Dietary Habits Physical Activity Between 18 and 48 years BMI ≥ 18 kg/m2 If ≥ 21 years old, must have completed a pelvic exam in the past 2 years In PCOS if: Confirmed PCOS diagnosis from their primary care provider Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function Pregnant or breastfeeding | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, HIV Infection She is at least 18 years of age She reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods She reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and She reports being interested in learning about and developing her own small business assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-80.0, Postoperative Complications Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded. Lost to follow up | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Bariatric Surgery Patients registered for bariatric surgery Not applicable | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-50.0, Obesity Binge Eating Disorder Patients of Eating Disorders Clinic with a diagnosis of Bulimia Nervosa, Eating Disorders Not Otherwise Specified 3 and 6 with Binge Eating Disorder according to research in Diagnostic and Statistical of Mental Disorders, version IV revised, who started taking Topiramate. 2. Probands with diagnosis of obesity (BMI ≥30 kg/m2 kg/m2). 3. Capable to give written informed consent. 4. Age of 18 to 50 years at screening. 5. Maternal and paternal grandparents of Mexican descent. 6. Probands without psychopharmacological treatment (including anticonvulsants) at least 4 weeks before inclusion Subjects with alcohol or substance abuse or dependence. 2. Any psychiatric or medical disorder that requires inpatient treatment. 3. Psychosis or suicidal thoughts. 4. Abnormal blood chemistry. 5. Diabetes uncontrolled. 6. Unstable hypertension or difficult to control (criterion 7 of section). 7. Metabolic acidosis. 8. Narrow-angle glaucoma. 9. Unstable hypothyroidism or hyperthyroidism. 10. Unable or unwilling to give a blood sample. 11. Pace-makers or metal implants that would preclude the functional Magnetic Resonance Image scan. 12. Pregnant or lactating women at screening or positive blood pregnancy test. 13. Presence of any epileptic disorder. 14. Subjects unable or unlikely to follow the protocol procedures | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-60.0, Metabolic Syndrome 60 years old BMI >/=26 and <40 kg/m2 not planning to or currently attempting to gain or lose weight low reported omega-3 fatty acid intake per Omega-3 Checklist Metabolic Syndrome as define 3/5 of the following:Waist circumference: men > 102 cm women > 88 cm, triglycerides > 150 mg/dL, HDL cholesterol: men < 40 mg/dL women < 50 mg/dL,Blood pressure >130/>85 mmHg,Fasting glucose > 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers) smoke or use tobacco or nicotine in any form (including pills and patches) take any medication that makes you unable to exercise have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes have uncontrolled hypertension have alcohol, anabolic steroid, or other substance abuse issues consume more than 3 alcoholic drinks/week have joint or muscle injuries that affects your ability to exercise have cancer (other than skin cancer or carcinoma in situ of the cervix pregnant or lactating currently exercise regularly | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-99.0, Metastatic Clear Cell Renal Cell Carcinoma Biopsy-proven metastatic clear cell RCC. 2. Radiographic evidence of metastatic disease. 2.1 Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist. 3. Patient must have ≥1 lesion of size >1.5cm. 4. Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2 5. Age ≥ 18 years. 6. Performance status ECOG 0, 1. 7. Patient must be eligible for HD IL-2 treatment 8. Patient must be eligible for SABR to one or more extra cranial sites. 9. Adequate organ and marrow function as defined below leukocytes ≥ 3,000/mcL absolute neutrophil count ≥ 1,500/mcL platelets ≥ 50,000/mcl total bilirubin ≤ 2mg/dL AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal 10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 10.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 11. Ability to understand and the willingness to sign a written informed consent 12. Adequate Renal function with Cr ≤ 1.6 mg/dL. 13. Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test 14. Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%) Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study 2. History of HIV, Hepatitis B, Hepatitis C and HTLV serology 3. Subjects may not be receiving any other investigational or standard antineoplastic agents. 4. Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis 5. Subjects with life expectancy < 6 months. 6. History of allergic reactions to recombinant IL-2 7. Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,. 8. Psychiatric illness/social situations that would limit compliance with study requirements. 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 10. Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days 11. Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft | 0 |
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