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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): 18.0-80.0, Surgical Wound Infection Patients with a BMI > 35 kg/m2 undergoing open or laparoscopic gastric bypass Surgeon does not anticipate primary wound closure History of fever or infection within 24 hours of surgery History of susceptibility to malignant hyperthermia Current heart or lung 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): 18.0-999.0, Sleep Apnea Syndrome Obese patient scheduled to undergo bariatric surgery Age less than 18 Active smoking Psychotropic medication Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication Pregnancy Anesthesia or endotracheal intubation during the previous month Allergic rhinitis Upper airway or bronchopulmonary infection during the previous month Chronic cough Chronic respiratory 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): 18.0-999.0, Glucose Intolerance Obesity The subjects that fulfill the following will be eligible to participate in the study Men and women older than 18 years of age Waist perimeter > 90 cm in males or > 80 cm in females Have plasma glucose levels in fasting between 100 and 125 mg/dL and/or on glucose tolerance test at 2 hours > 140 mg/dL and < 200 mg/dL Having a treatment compliance of over 80% at the end of the run-in phase All women with childbearing potential must have a secure contraceptive method. A secure method will be considered as sterilization by surgical methods, postmenopausal condition with an age greater than 45 years and a menopausal period equal to or greater than two years. In premenopausal women, the use of two barrier contraceptive methods including 1 month after the conclusion of the active phase of study treatment Individuals with any of the following characteristics will be excluded Prior diagnosis of type 1 or 2 diabetes mellitus, chronic or acute renal insufficiency, coronary disease clinically evident (acute myocardial infarction, chest angina, myocardial revascularization) or cardiac insufficiency, or history of prior cardiovascular events (AMI, CVD, or CABG) Significant chronic disease (terminal stage cirrhosis or hepatic disease or cancer) that affects the survival of patients at 12 months Chronic inflammatory diseases of obesity (lupus erythematosus, rheumatoid arthritis, etc.) Infectious acute or chronic processes of any etiology with an occurrence within the 4 weeks prior to the beginning of the study Use of steroid hormones or NSAIDs 1 month prior to the beginning of the study The patient is participating in a program or under treatment to lose weight during the 8 weeks prior to the study entry The patient requires (for any circumstance) treatment with immunosuppressive agents Has participated in a clinical trial in the 8 weeks prior to the study entry At the study entry, the patient is considering the possibility of a surgical procedure during the next 12 months | 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, Hypercholesterolemia Coronary Arteriosclerosis Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9 mmol/L (190 mg/dL) using the Freidewald calculation Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) Participants must have two or more coronary heart disease risk factors listed below Current cigarette smoking Hypertension (BP >= 140/90 mmHg or on antihypertensive medication) Low HDL cholesterol (< 40 mg/dL) Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years) Age (Men >= 45 years; women >= 55 years) Participant must be currently taking atorvastatin 10 mg daily and by history has taken 80% of daily doses for the 6 weeks prior to participating Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of normal, with no active liver disease, and CK < 50% above the upper limit of normal Participants who meet any of the following will be excluded Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2 Consume > 14 alcoholic drinks per week Women who are pregnant or nursing Congestive heart failure defined by NYHA as Class III or IV Uncontrolled cardiac arrhythmia Coronary heart disease (CHD) Unstable or severe peripheral artery disease within 3 months of participating Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg Type I or Type II diabetes mellitus | 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): 30.0-65.0, Hypertension Metabolic Syndrome X Men or women, 30-65 years of age having essential hypertension with metabolic syndrome 2. At Screening and Visit 1, blood pressure should be: sitting systolic blood pressure (SiSBP) >=140 mmHg or sitting diastolic blood pressure (SiDBP)>= 90 mmHg and two or more of the following should apply Abdominal obesity: waist circumference >= 90 cm in men and >= 80 cm in women Hypertriglyceridemia:. >=150 mg/dl (1.695 mmol/l) Low HDL cholesterol: < 40 mg/dl (1.036 mmol/l) in men and < 50 mg/dl (1.295 mmol/l) in women High fasting glucose: >= 110 mg/dl (6.1 mmol/l) Secondary hypertension 2. Malignant 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): 15.0-45.0, Obesity Approved to be scheduled for laparoscopic gastric bypass surgery for VSO at Cincinnati Children's or University Hospital Age at time of gastric bypass surgery date >15 and <21 years, or >30 and <45 years BMI >40 Weight at age 18 consistent with severe adolescent obesity (if height < 5'5" weight > 200 pounds or if height >5'5", weight > 250) Diagnosis of cirrhosis, total bilirubin >1 mg/dL, prothrombin time > 13.3 sec Prior myocardial infarction Serum creatinine >1.7mg/dL Systemic (PO, IV, IM) glucocorticoid therapy within the previous six weeks prior to blood sampling Peri-menopausal (irregularity of menstrual periods over the past 3 months (67) or demonstrated abnormally high follicle stimulating hormone levels (68) Severe T2DM (on insulin for control of hyperglycemia, or HbA1c > 8.5) | 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): 30.0-75.0, Metabolic Syndrome X Dyslipidemias Metabolic Syndrome: individuals must have at least three of the following five 1. Abdominal obesity greater than 90 cm in Asian men, greater than 102 cm in all other men, greater than 80 cm in Asian women, and greater than 88 cm in all other women 2. Triglycerides greater than or equal to 150 mg/dL at two screening visits (Required for the purposes of this study, which focuses on the dyslipidemic phenotype) 3. HDL cholesterol levels less than 40 mg/dL in men and less than 50 mg/dL in women 4. Blood pressure levels greater than 130/85 mmHg or taking an allowed blood pressure medication at Visit 1 (see definition in exclusions below) 5. Fasting glucose greater than or equal to 100mg/dL at Visit 1 LDL greater than or equal to 190 mg/dL Triglycerides greater than 500mg/dL at Visit 1 Blood pressure over a mean of 150/95 at the two first visits Body mass index greater than 40 kg/m² Currently taking any lipid lowering medication other than statins Currently taking high doses of thiazide diuretics (greater than 50mg/day), or any other blood pressure medication in the past 4 weeks Use of plant sterols from sources such as Benecol or Take Control margarines in the past 4 weeks Use of any fish oil supplements in the week prior to screening Blood glucose greater than 140 mg/dL or use of diabetes medications Hospitalization for coronary disease in the last 6 months | 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, Obesity Men and women, ages ≥18 to ≤70 years old with a Body Mass Index (BMI) ≥30 to ≤45 kg/m² OR BMI >27 to <30 kg/m² with hypertension and/or dyslipidemia defined as Hypertension defined as treatment with an antihypertensive agent or mean systolic blood pressure ≥140 and ≤160 mmHg and/or diastolic blood pressure ≥ 90 and ≤ 105 mmHg Dyslipidemia defined as stable dose treatment with a statin, fibrate or ezetimibe for ≥ 6 weeks and/or triglycerides ≥ 150 and ≤ 600 mg/dL, LDL ≥ 130 and ≤ 300 mg/dL, or HDL < 40 mg/dL Type 1 or 2 diabetes mellitus history of MI in the prior 6 months history of heart failure history of symptomatic arrhythmia active hepatic disease any documented muscle disease history of neurological symptoms or disease (including but not limited to tremor, ataxia, dizziness, neuropathy, or episodes of confusion, history of seizures, stroke or TIA) known history of major psychiatric conditions (e.g. schizophrenia anxiety disorder, dementia or bipolar disorder as defined by DSM IV criteria) history of depression or suicide attempt or ideation previous history of surgical procedures for weight loss (e.g., stomach stapling, bypass) | 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): 18.0-40.0, Polycystic Ovary Syndrome PCO ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) normal prolactin, TSH, 17-OH progesterone no evidence of androgen producing malignancy, Cushing's syndrome or acromegaly age 18-40 reliable use of birth control pill for at least 3 months and no plans of pregnancy elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and 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): 18.0-65.0, Overweight Obesity Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions) Has been obese or overweight for at least one year prior to study start Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin Is currently enrolled in or is planning to enroll in a formal weight-loss program Is unwilling or unable to participate in a lifestyle intervention program as part of the study Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start Has previously used pramlintide either by prescription or as part of a clinical study Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start Has donated blood within 2 months before study start, or is planning to donate blood during the study | 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, Schizophrenia Schizoaffective Disorder Diagnosed with schizophrenia or schizoaffective disorder Currently treated with olanzapine, quetiapine or risperidone BMI greater than or equal to 27 Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 mg/dL, then LDL cholesterol must be greater than 100 mg/dL) Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin Non-HDL cholesterol greater than 300 mg/dL Serum triglycerides greater than 500 mg/dL Patients in the first episode of schizophrenia or schizoaffective disorder Known hypersensitivity to aripiprazole On weight loss medications | 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): 17.0-19.0, Obesity All female college freshmen at the University of Oregon will be invited to participate in the study Any participant that meets for an eating disorder at any assessment point will be excluded from the study Any participant with BMI below 5% for their age group will be excluded to avoid health risks Any participant who does not report some form of body dissatisfaction will be excluded from 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): 20.0-999.0, Obesity Body Mass Index (BMI) > 25 kg/m² Visceral Fat Area (VFA) > 100 cm² Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia) At least 1 of the following 2 comorbidities Impaired Glucose Tolerance or Type 2 diabetes Hypertension Patient with a secondary obesity Patients who have received the diet therapy for less than 8 weeks before start of the observation period Patients whose body weight changed by more than the variation of ± 2kg for screening period Low compliance to drug intake (< 80%) and dietary instruction during the observation period Patients with type 1 diabetes Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia) Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4 Patients with a secondary hypertension | 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, Obesity Obesity Associated inflammatory diseases | 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, Substance Dependence Healthy adult male smoker between the ages of 18 and 50 years Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2 No abnormalities on the medical, psychiatric or laboratory evaluation Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study History of psychiatric disorder or sleep disorder Receiving treatment for smoking cessation Use tobacco products other than cigarettes | 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, Obese Patients Type 2 Diabetes Mellitus Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0% Any one of the following will be considered to be sufficient evidence that diabetes is present Current regular use of insulin Current regular use of oral hypoglycemic medication Documented diabetes by current ADA (98). 2. Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference and stable weight for the previous 3 months (99). 3. Age between 18-60 years old. Individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity. 4. Ability and willingness to provide informed consent. 5. No expectation that subject will be moving out of the area of the clinical center during the next 24 months Presence of CVD defined as: CAD, electrocardiographic for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease. 2. Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy). 3. Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery. 4. Pregnancy or planning pregnancy. 5. Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl). 6. Uncontrolled hypertension. 7. Smoking | 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 Irregular menses or anovulaty cycles High free testosterone > 0.035 nmol/l or hirsutism PCO in vaginal US 1 and 2 OR 2 and 3 Age > 18 years Postmenopausal Diagnosis diabetes mellitus Use of medicine known to affect hormones measured in the project Pregnancy or planned pregnancy during study period Non-Caucasian Previous tromboembolic disease Heavy smoker > 35 years and BMI > 35 kg/m2 | 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 Impaired Glucose Tolerance Females aged 25-60 2. BMI 28-35 kg/m2 3. No known diagnosis of diabetes 4. No known diagnosis of coronary heart disease 5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week) 6. Stable weight (variation < 3 kg within 6 months of screening visit) 7. Ability to give informed consent 8. Ability to follow verbal and written instructions 9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) 10. Nonsmoker (tobacco, marijuana) 11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association 2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris) 3. Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive medication) 4. Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication) 5. Tobacco, marijuana or intravenous drug use 6. Shift workers (night shift or alternating day/night shifts) 7. Recent weight loss (> 3 kg within 4 months of the screening visit) 8. Gastroparesis 9. Inflammatory bowel disease 10. Malignancy treated with chemotherapy within the past 3 years 11. History of pancreatitis 12. Depression requiring hospitalization or diagnosis of psychosis 13. Renal insufficiency (creatinine clearance < 50 ml/min) 14. Transaminases > 2x above the normal range 15. Pregnancy within 6 months of the screening visit 16. Breastfeeding 17. Failure to use medically approved contraceptive methods 18. History of an eating disorder (anorexia, bulimia or laxative abuse) 19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) 20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit 21. Previous participation in a clinical study with exenatide 22. Presence or history of allergic reaction to multiple drugs | 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): 18.0-40.0, Obesity Polycystic Ovary Syndrome overweight and obese women with PCOS Nonclassical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing's disease, hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment such as antihypertensive drugs, SSRI or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, LHRH agonist) and insulin sensitizing agents (metformin, pioglitazone, roziglitazone) that may interact with insulin sensitivity and lipid profile | 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, Morbid Obesity Morbidly obese patients not planned for bariatric surgery Participation in other weight loss programs during the last 12 mths Serious psychiatric conditions | 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 Post-gastric Bypass Each person who has been judged to be an acceptable candidate for laparoscopic gastric bypass (LGB) will be asked to participate in this protocol when they are scheduled for the operation Age less than 18 Pregnant females Weight greater than the limit of the DEXA table (Patients over 300 pounds) Known allergy to any component fo the amino acid supplement | 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, Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent High levels of low-density lipoprotein cholesterol (LDL-C) Unstable cardiovascular condition or awaiting a myocardial revascularization Congestive cardiac failure Uncontrolled diabetes Cancer Uncontrolled hypothyroidism Familial hypercholesterolemia Liver/muscle disease Pregnancy Other | 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): 18.0-67.0, Obesity Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model Pregnancy, major and active psychiatric disease, active and serious eating 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): 18.0-39.0, Infertility Polycystic Ovarian Syndrome Age: 18 2. BMI < 36 3. Infertility due to anovulation 4. PCOS: At least two of the following diagnostic of: 1. Oligo/amenorrhoea 2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence 3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml) 5. No recent (within 6 months) treatment for induction of ovulation 6. Normal semen analysis (WHO 1999) 7. Proven patency of at least one Fallopian tube Inability to give informed consent 2. Contraindication to letrozole or clomifene citrate 3. Absence of any | 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): 25.0-60.0, Metabolic Syndrome X Participants must meet 3 of the following BMI ≥30 kg/m2 HDL Cholesterol of <40 Triglycerides >150 mg/dl Fasting blood glucose >100 mg/dl Blood pressure >130/85 mm Hg Total Cholesterol of >200 mg/dl LDL Cholesterol of >160 mg/dl Interleukin 6 (IL-6) >5pg/mL Morbidly obese: BMI >40 kg/m2 Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study Enrolled in another clinical study in the past 6 months Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management | 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, Congenital Hypothyroidism Patients with congenital hypothyroidism due to thyroglobulin defective synthesis Patients with another 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): 18.0-999.0, Obesity Obese men and women with a BMI of 30-34 kg/m2, at least 18 years of age, who have had stable body weight (i.e., no gain or loss of >5% of body weight) for the preceding six months, who have normal oral glucose tolerance, and who are able to commit to a six month study Pregnancy, lactation, active medical or mental illness requiring treatment, recent (within 1 year) use of appetite suppressing compounds, previous use of the ketogenic diet | 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, Overweight Obesity Between the ages of 18-65 years of age Body Mass Index (BMI) between 25-35 Willing to stop taking any nutritional supplements Currently taking weight loss medication or supplements Currently smoke Taking any prescription medications Experienced at least a 10 pound weight loss over the past 2 months History of serious heart problems (i.e. heart attack, angina, bypass surgery) Diagnosed with diabetes (insulin or non-insulin dependent) Known history of gastrointestinal diseases (i.e. Crohn's disease, chronic diarrhea, Inflammatory Bowel Disease) Undergone surgical procedure for weight loss (i.e. gastroplasty, gastric by-pass, gastrectomy, stomach stapling, gastric banding, etc) History of stroke or seizure activity Medical conditions known to affect serum lipids | 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): 12.0-999.0, Anaplastic Glioma of Brain Glioblastoma Multiforme Brain Cancer All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital. 2. Patients with histologically proven supratentorial anaplastic oligodendrogliomas, anaplastic mixed oligoastrocytomas anaplastic astrocytomas or glioblastoma multiforme. 3. Patients must have unequivocal evidence for tumor recurrence or progression by MRI scan performed within 14 days prior to enrollment or documented recurrence by tumor resection. Patients must have received radiation therapy previously. 4. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all the following conditions are met: a) Patients have recovered from the effects of surgery; b) Extent of residual disease (if present) has been documented by MRI performed no later than 72 hours after surgery or, if not possible, at least 4 weeks post-operative. Radiographic evidence of residual disease is not mandated for enrollment. 5. The baseline on-study MRI is performed within 14 days of enrollment and on a steroid dosage that has been stable. If the steroid dose is increased between the date of imaging and the initiation of chemotherapy, a new baseline MRI is required on stable steroids for 7 days. 6. Patients must be equal to or greater than 12 years old. 7. Patients must have a Karnofsky performance status of equal to or greater than 60 (Karnofsky Performance Scale; Appendix D). 8. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair. 9. Patients must have adequate bone marrow function (ANC equal or greater than 1,500/mm3 and platelet count of equal or greater than 100,000/mm3), adequate liver function (SGPT and alkaline phosphatase <2 times normal, bilirubin <1.5 mg%), and adequate renal function (BUN and creatinine <1.5 times institutional normal) prior to starting therapy Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years (1 year for localized prostate carcinoma treated by prostatectomy or irradiation) are ineligible. 2. Patients of childbearing potential must not be pregnant or become pregnant. 3. Patients must not have: a) active infection; b) disease that will obscure toxicity or dangerously alter drug metabolism; c) serious intercurrent medical illness; d) acute or chronic pulmonary disease, pulmonary embolus, hypertension, diabetes, metabolic syndrome, stroke, heart disease,myocardial infarction, angina, coronary angioplasty, congestive heart failure, or coronary bypass surgery; e) allergies to sulfa drugs; f) severe psychiatric illness; g) uncontrolled hypertension (i.e. ->135/>85 mm Hg) on three repeated measurements during the 6 weeks prior to enrollment on the study 4. Patients must not have (continued): h) family history of premature coronary disease (i.e onset < 55 years of age); i) uncontrolled hypercholesteremia [low-density lipoprotein cholesterol (LDL-C >130]. Hypercholesteremia must be controlled for at least 3 months prior to enrollment on study; j) history of systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels; k) any indications for ASA deficiency 5. Patients must not have had prior treatment with Capecitabine, 5-FU or a combination of Temozolomide with CCNU (Lomustine) or BCNU (Carmustine). Patients who received only Temozolomide during radiation therapy and did not receive adjuvant chemotherapy with Temozolomide and/or those who received Gliadel (BCNU) wafers at surgery without adjuvant chemotherapy with BCNU or CCNU are eligible if 6 months has passed since the treatment(s) | 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): 19.0-65.0, Obesity Obese adults Body mass index between 30.0 and 42.0 kg/m2 (inclusive) Medically healthy with no clinically significant results of screening exams History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease History of glaucoma or increased intraocular pressure History of kidney stones Cholelithiasis or cholecystitis within 6 months Cardiovascular event within 6 months Obesity of known genetic or endocrine origin Recent weight instability Use of Very Low Calorie diet or participation in organized weight loss program within 3 months Systolic blood pressure > 150 or diastolic > 95 mm Hg Positive urine drug or alcohol screen | 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 Memory Deficits Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon Previous enrollment in LABS-1 and LABS-2 Informed consent not obtained Prior bariatric surgery Unlikely to comply with follow-up protocol Unable to communicate with local study staff Extensive hearing impairment Medical conditions known to impact cognitive performance, including past or present history of traumatic brain injury or neurological disorder Non-English speaking Inability to withhold caffeine and nicotine 2 hours before each visit, and alcohol 12 hours before each visit | 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, Pancreatic Cancer Histologic or cytologic proof of pancreatic adenocarcinoma Subjects with biopsy-proven adenocarcinoma of the pancreas which is potentially resectable by preoperative imaging. Subjects will be considered potentially resectable using defined by Pisters (Pisters et al., 2001) if imaging detects no evidence of extrapancreatic disease no evidence of tumor extension to the superior mesenteric artery (SMA) or celiac axis (intact fat plane between the tumor and the adjacent visceral artery) patent superior mesenteric-portal vein confluence no encasement of portal or superior mesenteric vein Karnofsky performance status ≥ 80 No active second malignancy except for basal cell carcinoma of the skin Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by Serum creatinine level ≤1.6 mg/dl ( Calculated Creat clearance >50) Disease-Specific Exclusions Subjects who have received chemotherapy within 12 months prior to study entry Prior use of radiotherapy or investigational agents for pancreatic cancer Subjects who have undergone laparotomy for pancreas cancer within 6 weeks Any evidence of metastasis to distant organs (liver, lung, peritoneum) Symptomatic or endoscopic evidence of gastric outlet obstruction • Endoscopic findings suggesting tumor erosion into the gastrointestinal mucosa Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin General Medical Exclusions Inability to adhere to study and/or follow-up procedures History of allergic reactions or hypersensitivity to the study drugs (bevacizumab, gemcitabine, and proton pump inhibitors) | 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, Metabolic Syndrome Schizophrenia Patients taking a same antipsychotics at least more than one year schizophrenia or schizoaffective disorder none | 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, Obesity Be at least 18 and equal to or less than 60 years of age BMI of at least 30 and maximum BMI of 40 with co-morbidities Willingness to comply with dietary restrictions required by the protocol History of obesity for at least 5 years History of at least 6 months of documented failures with traditional non-surgical weight loss methods Willingness to follow protocol requirements If female with childbearing potential, using an appropriate form of contraception Age less than 18, age greater than 60 Pregnancy History of major depressive disorder or psychosis Previous bariatric surgery or previous gastric surgery Presence of achalasia Presence of portal hypertension, cirrhosis, and/or varices Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease Patients with autoimmune connective tissue disorders Patients with acute abdominal infections Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study | 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, Endotracheal Intubation Rapid Airway Management Positioner The 50 subjects will be adult surgical candidates age 18-80, ASA I-III, BMI > 30 kg/m2 presenting for gastric bypass or laparoscopic gastric banding surgery who require general anesthesia Patients will be excluded if it is determined that an awake intubation should be performed. Mallampati IV and ASA IV-V patients will also be excluded, as well as patients with unstable cervical, thoracic and/or lumbar fracture | 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, Hodgkin's Disease Patients with histologic proof of HD who are in relapse and have failed > or = to 2 prior chemotherapy regimens Patients must have a life expectancy of at least 8 weeks All patients must have ECOG performance level rating of < or = to 2 Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of CT Patients must have adequate liver function (bilirubin < or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine < or = to 1.5 mg/dl, creatinine clearance > or = to 60 ml/min/1.73 m2) Patients should have a granulocyte count > or = to 500/gL and a platelet count > or = to 100,000/uL (unless due to disease involvement of the bone marrow) Male and female patients of child-bearing age should use effective methods of contraception, if sexually active Patients with active infections or significant medical conditions other than their malignancy shall be excluded Patients with HD who had prior MTX or 6-TG should be excluded | 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, Langerhans Cell Histiocytosis Patients with histologic proof of LCH who have multifocal or multisystem disease involvement Patients must have a life expectancy of at least 8 weeks All patients must have ECOG performance level rating of-< 2 Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy Patients must have adequate liver function (bilirubin _< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine <_ 1.5 mg/dl, creatinine clearance >_ 60 ml/min/1.73 m2) and normal electrolytes Patients should have a granulocyte count > 500/uL and a platelet count >_ 100,000/uL (unless due to disease involvement of the bone marrow) Male and female patients of child-bearing age should use effective methods of contraception, if sexually active Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded | 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): 20.0-85.0, ESRD Sleep Apnea The study will 20 patients with ESRD, treated with chronic hemodialysis in Assaf Harofeh Medical Center and suffering from sleep disturbances, such as frequent arousals, snoring, daytime sleepiness Patients will be excluded from the study if they are Recently started treated with chronic dialysis: less than 3 months Survived recent major illness, requiring hospitalisation in the last 3 months Patients with acute renal failure Currently treated with antioxidants ( NAC, vitamin E ets.) Current use of sleep pills | 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, Normal PCOS Subjects will be healthy women in two groups: (1) women with regular menstrual cycles and no evidence of hyperandrogenism, and (2) women with PCOS (defined as clinical/biochemical evidence of hyperandrogenism plus oligomenorrhea, but with no evidence for other endocrinopathies) Subjects will be 18-35 years old Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent We will women with a history of any disorders that may potentially be complicated by hormonal treatment, such as DVT and breast, ovarian, or endometrial cancer We will women with any other cancer diagnosis and/or treatment (with the exception of basal cell or squamous skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years Women with anemia (hematocrit < 36% and/or a hemoglobin level <12 g/dl) will be treated with iron for a maximum of 2 sequential months before the 1st admission and/or before the 2nd admission. If they remain anemic after 2 sequential months of ferrous gluconate (325 mg bid), they will then be excluded from further participation in the study Women with a history of any disorders that may potentially be complicated by long-term iron supplementation, such as hemochromatosis and polycythemia vera, will be excluded Women with a significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; known or suspected coronary atherosclerosis; asthma requiring systemic intermittent corticosteroids; etc.) will be excluded Women with liver enzymes, alkaline phosphatase, or bilirubin > 1.5 times upper limit of normal (confirmed on repeat) will be excluded, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome Abnormal sodium or potassium concentrations (confirmed on repeat); bicarbonate concentrations <20 or >30 (confirmed on repeat) Women with abnormal renal function (i.e., serum creatinine > 1.4) will be excluded (confirmed on repeat) Pregnant and breast-feeding women will be excluded A history of allergy to progesterone or estradiol will constitute grounds for exclusion | 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 Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery Lack of consent History of previous gastric surgery Contraindication to upper endoscopy | 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, Overweight Obesity age > or = 18 and < or = 65 years body mass index (BMI) > or = 25 and < or = 35 at study entry speak and understand English (since translated versions of study tools have not been validated) for females only: without childbearing potential or negative HCG hormone blood test and use of an appropriate form of contraception signed informed consent form and HIPAA research authorization current use of fiber supplements or intolerance to fiber supplements untreated/unstable metabolic conditions known to influence weight status (e.g., hypothyroidism, type 2 diabetes mellitus) gastrointestinal disorders that might cause complications or influence motility or satiety (e.g., diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing) Stage II hypertension (> or = 160/100 mg Hg) or dyslipidemia (fasting LDL cholesterol > or = 160 mg/dL; total cholesterol > or = 240 mg/dL; triglycerides > 200 mg/dL; HDL < or = 40 mg/dL) fasting serum glucose > 126 mg/dL acute or unstable cardiovascular, pulmonary, hepatic, renal, or psychiatric disorders conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer) use of medications that might affect weight or food absorption (e.g., diuretics, glucocorticoids, anorexigenic agents, Orlistat, laxatives) use of CAM therapies that might affect weight (e.g., acupuncture, Hoodia) weight change of > 5% body weight within 3 months of entry into the study | 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 Nutritional and Metabolic Diseases Metabolic Diseases Nutrition Disorders Overweight Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients receiving antihypertensive and/or hypolipidemic medications, these should have been at a stable dosage for at least 2 months before the start of the run-in period. Controlled hypertension is defined as a diastolic blood pressure <100 mmHg and a systolic blood pressure <160 mmHg, in the presence of antihypertensive drug treatment. For patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 3.4 mmol/L (130 mg/dL), HDL C <1 mmol/L (40 mg/dL) for men or <1.3 mmol/L (50 mg/dL) for women, or triglycerides greater than or equal to 1.7 mmol/L (150 mg/dL) A stable weight, i.e., increasing or decreasing not more than 5 kg in the 3 months before the start of the run-in period Consumption of breakfast and dinner on a daily basis Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water, as judged by e.g., the patients's history of having no difficulty with swallowing e.g., capsules or intact tablets Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control History of obesity with a known cause (e.g., Cushing's disease) History of anorexia nervosa, bulimia, or binge-eating disorder An established diagnosis of diabetes mellitus or treatment with glucose lowering prescription drugs at screening Prior exposure or known contraindication or hypersensitivity to R256918 History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to screening Treatment with any investigational drug or device within 1 month before the start of the run-in period History or evidence of liver or renal impairment History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology History of clinically significant gastro-intestinal disease History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy | 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 Caucasians without type 2 diabetes mellitus Normal OGTT (75 g of glucose) according to WHO's Patients fulfilling the for laparoscopic gastric banding Normal Hemoglobin Informed consent Liver disease (ALAT > 2 x normal level) Nephropathy (s-creatinin > 130 µM or albuminuria) Relatives (parents/siblings) with T2DM Medical treatment witch cannot be stopped for 12 hours | 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 Body mass Index between 35 with comorbidities and 50 kg/mt2 Body mass index <35kg7mt2 and >50kg/mt2 | 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, To Determine the Bioavailability of Tranylcypromine Subjects will be normal, healthy adult men and women who volunteer to participate Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has 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? A no answer to any of the above questions indicates taht the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to tranylcypromine? Does/ s/he have clinically significant laboratory abnormalities that would interface 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, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface 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 saliva alcohol screen, or a positive HIV-1 , 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 alst blood sample has been taken? Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two? Has s/he used any prescription drug 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 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): 20.0-90.0, Metabolic Syndrome ≥ 3 for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria) Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl Written informed consent for participating in the study Severe renal disease or renal dysfunction Chronic liver disease or liver function impairment Inflammatory muscle dysfunction or findings of muscle problems Severe cardiac failure Other protocol defined | 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, Hip Arthritis Patients booked for primary total hip arthroplasty with non-cemented prosthesis No previous surgery/fractures to acetabulum or femur or hip No gross bony abnormality except for osteoarthritis and avascular necrosis Cancer or tumor suspected, morbid obesity, revision, previous acetabular/femur/hip surgery, gross bony deformity, calibration bar not completely pictured on radiograph, unsuccessful surgery fracture/cancer/cemented prosthesis used | 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): 13.0-17.0, Pediatric Obesity Insulin Resistance Hyperinsulinemia Attending weight management clinic at Yale New Haven Hospital Good general health, taking no other medication on a chronic basis Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml) The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6 Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using Baseline creatinine > 1.0 mg/dl Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal Pregnancy Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone Presence of cardiac, pulmonary or other significant chronic illness Adolescents with psychiatric disorder, claustrophobia or with substance abuse Recent use (within six months) of anorexic agents Presence of anemia (hematocrit < 35) Mixed ethnic background (defined as two parents of different ethnicity) Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants) | 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): 30.0-65.0, Obesity Sleep Apnea, Obstructive Scheduled for Laparoscopic roux-en-Y gastric bypass (RYGB) surgery Presence or absence of OSA confirmed by polysomnography Comprehension of spoken and written English Major psychiatric, neurological, or neuromuscular disorder History of untreated thyroid disease Known diabetes mellitus History of stroke with or without apparent neurological deficits Alcohol consumption which exceeds 2 drinks per day or drug abuse. Undergone a sleep study in the past | 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): 0.0-0.077, Premature Birth Mother and Father, if named on the birth certificate application, are English speaking If mother and Father are married, husband is the man identified as the father on the birth certificate application Documentation of Informed Consent for Mother and newborn. Father named on the birth certificate application must consent for newborn to participate Mother's age (and Father if named on the birth certificate application) is 18 years of age or older Infant is a singleton, inborn newborn Newborn gestational age assessment documented in the health record between 23 weeks 0/7 days and 36 weeks 6/7 days Newborn gestational age assessment documented in the health record > 37 weeks and 0/7 days Mother identifies herself as Black or African American on the birth certificate application Mother (or Father identified on the birth certificate application) refuses to sign informed consent Mother (or Father identified on the birth certificate application) does not speak English Father, identified on the birth certificate application, objects to infant's participation Husband is not the father named on the birth certificate application Mother (or Father, if named on the birth certificate application) is less than 18 years of age Mother fails to identify her ethnic group as Black or African American on the birth certificate application Mother is cognitively impaired as a result of receiving narcotic analgesia within four hours of the time the research is explained, consent explained, or the interview is conducted Mother is documented to be cognitively impaired by her physician in the medical record Father appears to be cognitively impaired at the time the research is explained, consent explained, or the interview is conducted Mother or infant has a history of blood transfusion in the last six 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): 12.0-17.0, Obesity Overweight Binge Eating Volunteers will qualify if they meet the following criteria Female Age 12 17 years BMI between 75th and 97th percentile English speaking Good general health Participants must have normal laboratory testing, including negative urine glucose and normal electrolytes, hepatic, and thyroid function, or they will be referred for treatment Individuals will be excluded (and referred to non-experimental treatment programs as needed) Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities hyperlipidemia (LDL-cholesterol greater than 160 mg/dL), hypertension (defined by age-, sex-, and height specific standards fasting hyperglycemia (fasting glucose greater than 100 mg/dL) and nonalcoholic steatohepatitis (ALT above NIH Clinical Center laboratory norms with consistent radiologic findings and absence of another cause such as infectious hepatitis) Regular use of prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis. In particular, participants currently prescribed SSRIs, neuroleptics, tricyclics, stimulants, or any medication known to affect body weight or eating will be excluded Current involvement in psychotherapy or a structured weight loss program Weight loss during the past 2 months for any reason exceeding 3 per cent of body weight Pregnant or recently pregnant girls (within 1 year of delivery) History of an eating disorder or a current eating disorder (other than binge eating disorder) as determined by medical history or if uncovered during the study s structured clinical interviews. Subjects found to have an eating disorder other than binge eating disorder at baseline will be referred to mental health specialists for further evaluation and treatment | 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, Open Pilon Fractures Patients admitted to the Hershey Medical Center with a primary diagnosis of an open pilon fracture and surgically treated between 1/1/2000 and 12/31/2007 Temporization of the fracture may be performed elsewhere or by other orthopaedists at the Hershey Medical Center. Definitive surgery must be performed by Dr.'s David Goodspeed, J. Spence Reid, or Robert Simpson closed pilon fracture or pathological fracture; definitive fracture fixation performed outside the Hershey Medical center or by a surgeon other than Dr.'s David Goodspeed, J. Spence Reid, and Robert Simpson; patient is diagnosed with active infection at the time of first surgery at the Penn State Hershey Medical Center; patient is less than 18 years of age at the time of definitive surgery patient is mentally compromised and unable to give consent does not cooperate with survey data acquisition; patient is deceased patient presented with significant ipsilateral leg fracture or injury at anytime within the time frame of 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): 18.0-35.0, Pharmacokinetics 35 yo Meet BMI requirements Weight stable English speaking Desire contraception History of regular menses with normal uterus and ovaries Medically eligible for combined hormonal contraception Tolerates phlebotomy/TVS Heavy smokers Users of medications that alter hormone levels | 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): 18.0-40.0, Pregnancy Polycystic Ovary Syndrome Key (Must have ovulatory dysfunction and either hyperandrogenism or PCO) 1. Chronic anovulation or oligomenorrhea: defined as spontaneous intermenstrual periods of ≥45 days or a total of ≤8 menses per year, or for women with suspected anovulatory bleeding, a midluteal serum progesterone level < 3 ng/mL is indicative of chronic anovulation. For women who have been on ovarian suppressive therapy or other confounding medication (i.e. insulin sensitizing agents) within the last year prior to the study, a history of ≤8 menses per year prior to the initiation of this prior therapy will qualify as evidence of oligomenorrhea. For women with more regular bleeding patterns, but who are suspected to be experiencing anovulatory bleeding, a midluteal progesterone level < 3ng/mL will be evidence of ovulatory dysfunction and qualify as anovulation. Undiagnosed persistent vaginal bleeding should be diagnosed and treated prior to enrollment. 2. Hyperandrogenism (either Hirsutism or Hyperandrogenemia) or Polycystic Ovaries on Ultrasound: 1. Hirsutism is determined by a modified Ferriman-Gallwey Score >8 at screening exam (Hatch, Rosenfield et al. 1981 Aug 1). Subjects who have hirsutism do not need local or core labs documenting elevated androgen levels. 2. Hyperandrogenemia can be determined from local labs. Local cutoffs will be pre-determined by each site prior to study initiation. Hyperandrogenemia will be defined as an elevated total testosterone, or free androgen index (FAI)(in our lab at Penn State College of Medicine a total T > 50 ng/dL or a free androgen index >5) will allow entry into the study (Legro, Driscoll et al. 1998). The FAI is calculated from measurable values for total T and SHBG, as previously described (Miller, Rosner et al. 2004), using the following equation: (FAI = Total testosterone in nmol/L / SHBG in nmol/L) X 100. Outside lab values obtained within the last year documenting elevated T or FAI levels are sufficient to meet of hyperandrogenemia. 3. Polycystic Ovaries on Ultrasound: We will use the revised Rotterdam for diagnosing polycystic ovaries (Balen, Laven et al. 2003). PCO will be defined as either an ovary that contains 12 or more follicles measuring 2-9 mm in diameter, or an increased ovarian volume (> 10 cm3) on one ovary for entry into the study. If there is a follicle > 10 mm in diameter, the scan should be repeated at a time of ovarian quiescence in order to calculate volume and area if the subject does not otherwise qualify for the study. The presence of a single polycystic ovary (PCO), either by volume or morphology, is sufficient to provide the diagnosis We will subjects with medical conditions that represent contraindications to CC, aromatase inhibitors and/or pregnancy or who are unable to comply with the study procedures. We will subjects with poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding, and use of other medications known to affect reproductive function or metabolism (e.g., OCP, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers). As in PPCOS we will allow a 2 months washout period for subjects who desire to participate and discontinue exclusionary medications (most commonly OCP, but also possibly metformin), and a period of observation or treatment for correctable conditions. Couple 1. Sperm concentration of 14 million/mL in at least one ejaculate within the last year, with at least some motile sperm. 2. Ability to have regular intercourse during the ovulation induction phase of the study. 3. At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years. An uncomplicated intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course resulting in live birth within the last three years will also serve as sufficient evidence of a patent tube and normal uterine cavity as long as the subject did not have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or tubal disease or other disorder leading to an increased suspicion for intrauterine abnormality or tubal occlusion. 4. No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed. The prior procedure may affect study outcomes. Specific Current pregnancy. 2. Patients on oral contraceptives, depo-progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins. 3. Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart > 30 ng/mL or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry. 4. Patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 21-hydroxylase deficiency will be excluded in all patients by a fasting 17-hydroxyprogesterone (17-OHP) level <2 ng/mL (Azziz, Hincapie et al. 1999 Nov). If relevant, this level should be determined in the follicular phase, because the 17-hydroxyprogesterone level is likely to be elevated beyond this range if the patient is in the luteal phase of an infrequent ovulatory cycle. In the case of elevated fasting 17-OHP levels in the follicular phase, an ACTH stimulation test will be performed. A 1-hour stimulated value > 10 ng/mL will be an (Moran, Knochenhauer et al. 1998). As 21-hydroxylase deficiency is a congenital condition, any normal level in the past of 17-hydroxyprogesterone allows entry into this study. 5. Patients with menopausal levels of FSH (> 15 mIU/mL). A normal level within the last year is adequate for entry. 6. Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry. 7. Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as a glycohemoglobin level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded. 8. Patients with liver disease defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL. 9. Patients with renal disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL. 10. Patients with significant anemia (Hemoglobin < 10 g/dL). 11. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident. 12. Patients with known heart disease that is likely to be exacerbated by pregnancy. 13. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear result within ACOG guidelines for Pap smear frequency will be required for women 21 and over. 14. Patients with a current history of alcohol abuse. Alcohol abuse is defined as > 14 drinks/week or binge drinking. 15. Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled. 16. Patients taking other medications known to affect reproductive function or metabolism. These medications oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, anti-diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be two months and a list is found in the appendix. 17. Patients with a suspected adrenal or ovarian tumor secreting androgens. 18. Patients with suspected Cushing's syndrome. 19. Couples with previous sterilization procedures (vasectomy, tubal ligation) which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that should not adversely affect recruitment. 20. Subjects who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon. 21. Patients with untreated poorly controlled hypertension defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart | 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, Metabolic Syndrome Overweight Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following) Waist Circumference: men: >40 in women: >35 in Blood Pressure: >135/>85 mm Hg Triglycerides: >150 mg/dl HDL-cholesterol: men: <40 mg/dl women: <50 mg/dl Fasting Glucose: >100 mg/dl Ages 18 to 65 Years BMI range of 27 to 42 kg/m^2 Body weight <300 lbs Weight Stable for 3 Months Subjects who habitually consume protein supplements or have eating disorders Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes Triglyceride >500 mg/dl, Cholesterol >260 mg/dl Use of insulin sensitizers, lipid lowering medication or ACE inhibitors Use of anti-obesity medications or supplements for at lease 6 months prior to start of study Known allergy or adverse reaction to protein and dairy products (including lactose) | 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): 30.0-65.0, Sleep Apnea Obese adults 30 years old (inclusive) Women of child-bearing potential must be using adequate contraception BMI between 30 and 40 kg/m2 (inclusive) Diagnosis of OSA syndrome with Apnea/Hypopnea Index (AHI) of 15 or greater Unwilling or unable to comply with CPAP treatment Known allergy or hypersensitivity to phentermine or topiramate Sleep disorder other than OSA syndrome Women who are pregnant, breast feeding, or intend to become pregnant during the study Presence of unstable angina or heart failure corresponding to NYHA functional class III or IV History of myocardial infarction or coronary revascularization within the past year; any history of stroke Presence of any clinically significant abnormality on electrocardiogram Use of any prescription CNS stimulants History of cholecystitis or cholelithiasis unless treated by cholecystectomy History of glaucoma or any past or present use of medications to treat increased intraocular pressure Weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 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): 18.0-999.0, Heart Failure Clinical indication for left and right heart catheterization Willing and able to provide informed consent Male or female 18 years of age or greater Symptomatic heart failure (≥ NYHA Class II) Ejection fraction ≤ 35% Patient is in sinus rhythm Patient is considered to be in suitable health in the opinion of the investigator, as determined by: o A pre-study physical examination with no clinical abnormalities which in the opinion of the investigator would preclude participation in the study other than physical symptoms or signs consistent with stable heart failure For female patients only: Post-menopausal or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant for up to 90 days following the study, and she is using contraceptive drugs or devices Acute myocarditis Hypertrophic, restrictive, or constrictive cardiomyopathy Congenital heart disease Known left ventricular thrombus Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis) Poorly controlled hypertension (SBP > 180 mmHg) Pacemaker dependent ventricular rhythm Detectable troponin or CK-MB > ULN at any timepoint within 14 days of enrollment Acute coronary syndrome or revascularization procedure within 30 days of enrollment ≥ 50% stenosis of the left main coronary artery | 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, Dyslipidemia Subjects with a Body Mass Index (BMI)≤ 35 kg/m2 Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3 (diet stabilization period) HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women) TG ≤ 500 mg/dL LDL-C ≤ 190 mg/dL Subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG Females who are pregnant or breast-feeding AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet stabilization period) Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central laboratory reference range at the screening visit Medical history of diabetes mellitus or two fasting serum glucose measurements > 126 mg/dL at the screening visit Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic at the screening visit History of drug or alcohol abuse within 12 months of the screening visit Use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study | 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): 18.0-88.0, Obesity obesity WHO I-III pregnancy acute vascular event within the last 3 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): 18.0-60.0, Morbid Obesity BMI > 40 or BMI > 35 with a comorbidity associated with obesity Age 18 years Failed prior effective and controlled conservative treatments of morbid obesity BMI > 60 Difficult psychiatric conditions or lack of co-operation Difficult eating disorder (binge eating, bulimia etc.) Alcohol abuse Gastric ulcer | 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): 16.0-50.0, Bacterial Vaginosis Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following must be met for enrolment in the study: 1. ages 16-50 and premenopausal; 2. capable of giving written informed consent; 3. English speaking; 4. negative pregnancy test on enrolment day; 5. agree to follow study protocol; 6. documented BV infection by positive vaginal swab +/ positive whiff test/pH > 4.5; 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable); 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices); 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication); 10. agree to no new medications or antibiotics during treatment; 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas; 12. patient is reliable for follow up The following women would be excluded from study participation: 1. less than 16 or post-menopausal; 2. negative vaginal swab regardless of whiff test/pH > 4.5; 3. menstruating at diagnosis; 4. symptoms so severe as to make allocation to placebo unacceptable to the patient; 5. currently pregnant or at high risk for pregnancy; 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV); 7. current yeast infection as determined by history, physical and swabs; 8. history of PID; 9. allergy to latex or metronidazole; 10. presently lactating; 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam; 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response; 13. using lithium, anti-coagulants or disulfiram drugs; 14. any antifungal or antibiotic use 14 days prior to enrolment 15. PAP smear done within one week of enrollment | 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, Polycystic Ovary Syndrome (PCOS) Obstructive Sleep Apnea Obesity Women aged 18-75 years and men 45-75 years Healthy lean, overweight and obese women (BMI 18-40 kg/m2) and obese men (BMI 30-40 kg/m2) Obese women (BMI 30-40 kg/m2) with OSA or PCOS Pregnant, lactating, peri or postmenopausal women will be excluded from the study because of potential confounding influences of these factors and potential ethical concerns (pregnant women) Women taking medications known to affect substrate metabolism and those with evidence of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus, liver disease, hypo or hyper-thyroidism) other than PCOS and OSA Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl) Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number of obstructive events divided by the total hours of sleep) will be excluded and instructed to seek medical care | 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): 35.0-65.0, Obesity men and women age 35-65 yr body weight <300 lbs (136 kg) body mass index between 28 kg/m2 and 35 kg/m2 fasting glucose <110 mg/dL blood pressure <160/100 mm Hg plasma total cholesterol <260 mg/dL LDL-cholesterol <160 mg/dL triacylglycerol <400 mg/dL not currently or previously following a weight loss diet or other special/non-balanced diet (in the past 6 months) <1 hour/week of habitual aerobic exercise training and no resistance men and women age < 35 yr or >65 yr body weight >300 lbs (136 kg) body mass index between <28 kg/m2 or >35 kg/m2 fasting glucose >110 mg/dL blood pressure >160/100 mm Hg plasma total cholesterol >260 mg/dL LDL-cholesterol >160 mg/dL triacylglycerol >400 mg/dL currently or previously following a weight loss diet or other special/non balanced diet (in the past 6 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): 18.0-999.0, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None | 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, Obesity Hypercholesterolemia Metabolic Syndrome Hypertension Diabetes Age ≥ 21 years BMI 30-50 kg/m2 and weight ≤ 400 lbs At least 2 of 5 for metabolic syndrome Elevated waist circumference (> 102 cm for men, > 88 cm for women) Elevated blood pressure (≥ 130/85 mmHg) Impaired fasting glucose (≥ 100 mg/dl) Elevated triglycerides (≥ 150 mg/dl) Low HDL cholesterol (< 40 for men, < 50 mg/dl for women) Willing to change diet, physical activity and weight Willing to accept randomization to each group Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment within 2 yrs) Prior or planned bariatric surgery Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine) Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight) Intentional weight loss within 6 months of enrollment (≥ 5% of body weight) Pregnant or nursing within past 6 months Plans to relocate from the area within 2 years Another member of household is a study participant or staff in the trial Consumes > 14 alcoholic drinks per week Current use of illicit substances | 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, Fetal Macrosomia Gestational Diabetes Age 18 Pregnant (12-14 weeks gestation) Lean (BMI 20-26 kg/m2) Obese (BMI 30-38 kg/m2) Age < 18 or > 35 yr Pre-existing diabetes Chronic medical conditions: 1. hypertension, 2. hepatitis, 3. Human immunodeficiency Virus (HIV), 4. Thrombophilias, 5. History of: 1. thromboembolism, 2. renal disease, 3. neurologic diseases, 4. rheumatologic disorders, 5. gastrointestinal disease, 6. cardiac dysfunction, or 7. pulmonary disease Obstetric conditions: 1. history of stillbirth, 2. severe growth restriction, 3. severe preeclampsia, or 4. placental abruption Medications known to affect lipid or glucose metabolism: 1. Metformin, 2. glucocorticoids, 3. beta agonists or blockers, or 4. antihypertensives Use of recreational drugs, alcohol or tobacco | 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 Age 18-45 years, male or female Body mass less than 350 lbs. (max. weight dictated by table limit for functional magnetic resonance imaging (fMRI) scanner) when acquisition of large bore fMRI is complete, max. wt. limit will increase to 400 lbs Weight stable (less than plus or minus 5 kg over past 6 months) Body mass index greater than or equal to 30.0 kg/m(2) Premenopausal (women only) Healthy, as determined by medical history and laboratory tests Able to complete daily bouts of walking at a moderate rate Written informed consent Body mass greater than 350 lbs. (max. weight dictated by table limit for fMRI scanner) when acquisition of large bore fMRI is complete, max. wt. limit will increase to 400 lbs BMI less than 30.0 kg/m(2) Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease) Taking any prescription medication (except birth control) or other drug that may influence metabolism (e.g. diet/weight-loss medication) Hematocrit less than 34% (women only) Hematocrit less than 40% (men only) Pregnancy, lactation (women only) Allergy to lidocaine or ethanol Participating in a regular exercise program (greater than 2h/week of vigorous activity) Caffeine consumption greater than 150 mg/day (will be clamped at baseline intake during 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): 0.0-999.0, Stress Healthy first-time mothers with singleton baby delivered at term with no complications Mothers with chronic health problems Pregnancy complications, OR Infants with congenital problems or conditions requiring admission to the intensive care nursery | 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, Obstructive Sleep Apnea years or older Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit Pregnancy | 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, Eating Disorders age 18 or above DSM-IV Anorexia nervosa, Bulimia nervosa or Eating disorders not otherwise specified serious medical complications psychosis suicidal behavior | 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, Obesity female patients aged 20-60 years BMI 40-45 (inclusive) agreed on giving written informed consent secondary obesity alcohol or drug use severe psychiatric disorder binge-eating of sweets previous stomach or bowel 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): 17.0-66.0, Type 2 Diabetes Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. - Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam. - | 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): 18.0-55.0, Obesity Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body Mass Index (BMI) of 30 to 40 kg/m², inclusive Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55, inclusive Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population Female of childbearing potential Sexually active fertile male not using effective birth control method (for example, condom) if your partners are females of childbearing potential Abnormal blood work results (for example, triglyceride ≥ 400 mg/dL, glucose ≥126 mg/dL and total cholesterol ≥ 300 mg/dL) High blood pressure (≥160/95 mm Hg) Major surgical procedure within 4 weeks prior to randomization Chronic infections (e.g., HIV [human immunodeficiency virus] or Hepatitis C) Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease, or a previous surgery for weight loss History of gastrointestinal disease within the past 3 months History of Type I or Type II diabetes in the past 12 months | 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, Smoking years of age or older Speak English Registered for prenatal care Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant) Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible | 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): 18.0-39.0, Polycystic Ovary Syndrome years, inclusive ≤ BMI History of irregular menstrual cycles Clinical and/or biochemical androgen excess (determined during screening) Medical History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives. Psychiatric and Behavioral Pregnant or breast-feeding women | 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): 0.0-45.0, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy | 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, Polycystic Ovary Syndrome for all participants Subjects will be 18-35 years old; we use a cutoff age of 35 y because early menopause at this age is very rare No significant health problems (other than PCOS and obesity) Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent. for normal controls Controls will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism. for PCOS PCOS will be defined according to NIH consensus criteria As such, subjects with PCOS will have hyperandrogenism, whether it is clinical (e.g., hirsutism) or biochemical (i.e., elevated plasma T) Subjects with PCOS will also have oligo or amenorrhea (i.e., < 7 periods per year) and no evidence for other endocrinopathies (e.g., hyperprolactinemia, Cushing's syndrome, etc.) Being a study of GnRH pulse regulation in women with and without PCOS, men are excluded Obesity associated with a diagnosed (genetic) syndrome, obesity related to medications (e.g., glucocorticoids), etc Pregnancy or lactation Virilization A total testosterone > 150 ng/dl in women with PCOS (which suggests the possibility of a virilizing neoplasm) (confirmed on repeat) Elevated DHEAS (mild elevations may be seen in PCOS, and elevations < 1.5 times the upper limit of normal will be accepted in PCOS)(confirmed on repeat) Follicular 17-hydroxyprogesterone > 300 ng/dl, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase and there is a concern about the possibility of congenital adrenal hyperplasia, the 17-hydroxyprogesterone may be collected during the follicular phase, or >60 if oligomenorrheic). *NOTE: If a 17-hydroxyprogesterone > 300 ng/dl is confirmed on such repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5% Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study will at the least be delayed pending appropriate treatment) (confirmed on repeat) Abnormal prolactin (mild elevations may be seen in PCOS, and elevations < 1.5 times the upper limit of normal will be accepted in this group) (confirmed on repeat) | 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, Obesity Overactive Bladder Incontinence OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit) Obese Chronic kidney failure Abdominal bypass surgery for obesity Moderate or severe memory impairment Uncontrolled narrow angle glaucoma Uncontrolled systemic disease Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia | 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): 25.0-44.0, Obesity African-American Female Ages 25-44 BMI between 25-34.9 kg/m2 Patients with at least 1 visit in the previous 24 months to a participating Community Health Center Not currently pregnant Not given birth within the past 12 months No history of myocardial infarction or stroke in last 2 years | 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 Age 18-65 BMI ≥40, or ≥35 with concomitant obstructive sleep apnea, or hypertension scheduled for RYGB surgery at Hvidovre Hospital, Copenhagen, Denmark Must have lost between 1-4% body weight after 3 months of dietary counselling Deemed ineligible for RYGB surgery by patient's own physician(s) Diabetes Mellitus Non Caucasian Weight >160kg (due to DEXA scanner limitations), or morphologically unable to accommodate in DEXA scanner (>40cm in maximum supine anterior-posterior dimension, or >60cm in maximum supine body width) Hemoglobin <7.0 mmol/L Psychiatric illness under the care of a psychiatrist Eating disorder such as bulimia Patients on special diets (eg vegetarian, Atkins) Any history of thyroid dysfunction, or use of thyroid medication (with the exception of transient thyroiditis) Hypothalamic or genetic etiology of obesity | 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, Anorexia Nervosa Obesity Healthy Participants In addition to satisfying specific DSMIV for anorexia nervosa (B1, B2) or WHO for obesity (C1), or obesity and diabetes mellitus type II (C2), general aged at least 18 and not more than 40 years able to communicate well with the investigators and provide written consent no physical co-morbidity requiring active treatment, in particular diabetes mellitus, impairment of liver or kidney function (subjects with diabetes mellitus type II are eligible for study group C2) no psychiatric (DSM IV) disorders limiting the ability to comply with study requirements no use of medications influencing upper GI motility within one week of the study (i.e. nitrates, prokinetic drugs, macrolide antibiotics). Acid suppression and antihypertensive medication beta-blocker, calcium channel blockers are acceptable no evidence of current drug or alcohol abuse no history of gastrointestinal disease or surgery except appendicectomy or hernia repair females will take a urine pregnancy test before each study, any participant with a positive pregnancy test will be excluded (females will be investigated always in the same menstrual phase) • pregnancy | 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, Adult Polyglucosan Body Disease Glycogen Brancher Enzyme Deficiency Glycogen Storage Disease Type IV Confirmed diagnosis of APBD by the presence of mutations of the GBE1 gene in both alleles or brancher enzyme deficiency Willing and able to travel to Dallas TX Able to tolerate dietary oil Able to provide informed consent Intercurrent medical conditions that would confound the assessment of efficacy, such as HIV or diabetes Patients who are wheelchair bound Patients deemed unsuitable for the study by the investigator | 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, Cholelithiasis Ultrasonography Laparoscopic Gastric Bypass Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass Prior history of gallbladder 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): 20.0-45.0, Overweight Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL. 2. Subject states that he/she does not have type 1 or 2 diabetes. 3. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female. 4. Subject's BMI is ≥ 25 kg/m2. 5. Subject's blood pressure is < 140 mm Hg systolic and < 90 mm Hg diastolic. 6. Subject is between 20 and 45 years of age, inclusive. 7. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 8. If female is of childbearing potential, is practicing birth control 9. If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan. 2. Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 3. Subject states that he/she has an active malignancy. 4. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 5. Subject states that he/she has end-stage organ failure or is status post organ transplant. 6. Subject states that he/she has a history of renal disease. 7. Subject states that he/she has current hepatic disease. 8. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 9. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose. 10. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol. 11. Subject states that he/she has clotting or bleeding disorders | 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, Bone Loss Bone Density Gastric Bypass Bariatric Surgery Morbidly obese female patients undergoing elective laparoscopic Roux-en-Y gastric bypass at a single institution Male patients Patients unable to fulfill the study protocol requirements | 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, Melanoma (Skin) Histologic proof of stage IV malignant melanoma not amenable to surgery; (biopsy can be of locoregional disease in setting of clinically evident stage IV disease, but primary tumor alone will not qualify) At most one prior chemotherapy based regimen for metastatic melanoma (no prior taxane-based regimens allowed); note: prior adjuvant non-taxane based chemotherapy and/or adjuvant immunotherapy are allowed; no limit on the number of prior biologic, immunologic or targeted therapies Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) scan; note: disease that is measurable by physical examination only is not eligible Life expectancy >= 4 months Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Absolute neutrophil count (ANC) >= 1500/mL Platelets (PLT) >= 100,000 x 10^9/L Hemoglobin (Hgb) >= 9 g/dL (patients may be transfused to meet this requirement) Total cholesterol =< 300 mg/dL and; (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment) Triglycerides =< 2.5 X upper limit of normal (ULN); (note: serum levels of cholesterol or triglycerides found to be elevated may be lowered with anti-lipid therapy, but must be documented to be below these levels prior to enrollment) Prior treatment with agents disrupting vascular endothelial growth factor (VEGF) activity (i.e., bevacizumab, VEGF-trap, anti-VEGF receptor [R] monoclonal antibody [Mab]) or targeting VEGFR (e.g. sunitinib, sorafenib) Prior treatment with an mTOR inhibitor for melanoma (sirolimus, temsirolimus, everolimus) Brain metastases per MRI or CT at any time prior to registration; note: patients that have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or stereotactic radiation therapy [SRT] even if stable) are not eligible Other investigational agents =< 4 weeks prior to registration/randomization Chemotherapy treatment =< 3 weeks prior to registration/randomization Any biologic, immunologic or targeted therapy =< 2 weeks prior to registration/randomization Major surgical procedure, open biopsy, or significant traumatic injury =< 4 weeks prior to registration/randomization Fine needle aspirations or core biopsies =< 7 days prior to registration/randomization Planned/or anticipated major surgical procedure during the course of the study Other medical conditions including but not limited to | 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): 45.0-70.0, Cardiovascular Disease Patients with an appointment in the Geisinger clinic who are between the ages of 45-70 (male) or 50-70 (female), and have one of the following risk factors: 1. Smoke 2. Direct LDL > 160 mg/dl 3. HDL < 45 mg/dl (males) HDL < 35 mg/dl (females) 4. Diabetes diagnosis 5. Hypertension diagnosis 6. CAD diagnosis > 70 years Stomach Ulcer History Aspirin Allergy Anti-coagulation Therapy History Clotting Disorder Diagnosis Hypersensitivity to non-steroidal anti-inflammatory agents such as Ibuprofen, Aleve, or Motrin Hemorrhagic Stroke History Current Aspirin use t Outpatient Visit | 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, Healthy Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl BMI 18.5 to 35, and body weight ≤150 kg, inclusive Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results Secondary hyperlipidemia Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing | 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, Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair Undergoing elective thoracoabdominal aneurysm repair Over 18 years of age Able to give written informed consent Previous aortic surgery (re-do surgery) Emergency surgery Pregnancy Females of child-bearing age (less than 45 years) not using medically approved method of contraception Congenital or acquired coagulopathy Known allergy to study drug | 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 Hypertension (cases) Caucasians fulfilling the for laparoscopic gastric bypass participants with hypertension, defined as blood pressure > 140/90 and/or use of antihypertensive medication and 12 participants without hypertension Body mass index 40-50 kg/m2 (controls) Caucasian No hypertension or use of antihypertensive medication Body mass index < 30 kg/m2 (all) Pregnancy Chronic obstructive pulmonary disease Diabetes mellitus Medical treatment with sibutramine | 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, Diabetes Mellitus, Type 2 Adult males and females who meet the following will be offered the opportunity to participate in the study: 1. Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following 1. normal or high C-peptide level (> 0.9 ng/ml) to type 1 Diabetes Mellitus 2. positive glucagon test to confirm T2DM 3. fasting plasma glucose of 126 mg/dl or more on at least two occasions 2. Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2 3. History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years correlates with failure to achieve diabetes resolution after gastric bypass 4. No contraindication for surgery or general anesthesia as determined by a multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist, dietitian, psychologist) 5. Between 18 and 65 year of age 6. Able to provide informed consent 7. If a female with reproductive potential, she has to agree to use a reliable method of birth control for at least one year from the date of surgery Subjects who meet any of the following will not be eligible to participate in the study: 1. Enrollment in another clinical study, which involves an investigational drug 2. Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus 3. Significant renal failure of chronic liver disease (except NAFLD) 4. Major psychological disorders 5. Pregnancy all female subjects will have serum beta-hCG prior to operation, and must use birth control of their choice to avoid pregnancy during the first year after surgery 6. Previous gastric or esophageal surgery 7. Immunosuppressive drugs including corticosteroids 8. Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/µl 9. Anemia defined as a Hb <10.0 g/dl 10. Inflammatory bowel diseases or other medical condition that would serve as a contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency) 11. A severe concurrent illness that is likely to limit life or require extensive systemic treatment (e.g. cancer) 12. A pre-existing major complication of diabetes: 1. unstable, proliferative retinopathy 2. severe autonomic cardiac neuropathy or intestinal neuropathy 3. Myocardial infarction within the previous year, current unstable angina, or poorly-controlled congestive heart failure (Stage III) | 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): 20.0-75.0, Metabolic Syndrome Overweight Obesity Hypercholesterolemia BMI ≥25 and <45 LDL >100 mg/dl TG ≥150 and <400 mg/dl meet 2 or more of the following 4 HDL <50 mg/dl blood pressure ≥130/85 mmHg (or diagnosed hypertension on medication) fasting glucose ≥100 mg/dl and <150 mg/dl waist circumference >35 inches Medical History and Concurrent Diseases 1. Over the preceding 4 weeks, initiation or cessation of regular exercise 2. Over the preceding 4 weeks, involvement in a significant diet or weight loss program such as Atkin's diet program, a very low calorie liquid program (such as Optifast, Medifast, and HMR), or any diet that has led to a weight loss of 10% of body weight over a period of 6 weeks 3. Use of blood sugar lowering medications including thiazolidinedione class of oral medications including Avandia (rosiglitazone), Avandamet (metformin/rosiglitazone), Actos (pioglitazone), metformin (Glucophage, Fortamet, Riomet) or insulin over the preceding 12 weeks 4. Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week 5. Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week 6. Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.) 7. Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone 8. Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin 9. Use of electronic implants such as pacemakers, defibrillators, nerve stimulators 10. Allergy to one or more of the ingredients in the investigational products 11. Poorly controlled hypertension (blood pressure above 155/95) 12. History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.) 13. History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure) 14. History of deep vein thrombosis or pulmonary embolus (blood clot to lungs) 15. History of autoimmune diseases such as inflammatory bowel disease (Crohn's disease, and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma and thyroiditis 16. History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years 17. History of alcoholism or drug addiction in the preceding 5 years 18. History of serious mental illness 19. History of attempted suicide in past 10 years 20. Untreated endocrine, neurological, or infectious disorder 21. Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS) 22. Current cancer or a history of cancer (except skin cancer) 23. Pregnancy or lactation 24. If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies) 25. Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) Physical and Laboratory Test Findings 1. TG ≥ 400 mg/dl 2. abnormal blood count (Hct < 30 or > 47%, WBC < 3,000 or > 12,000, platelets <140 or > 500) 3. abnormal kidney function test(s) (BUN > 30 mg/dL or creatinine > 1.5 mg/dL) or liver function test(s) (bilirubin total > 2.0 mg/dL, ALT > 75 IU/L, AST > 75 IU/L; Alk Phos > 130 IU) 4. fasting glucose >150 mg/dL, serum calcium (>10.5 mg/dL), positive pregnancy test (ß-hCG in blood) | 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, Dietary Supplements adult male and non-pregnant female outpatients, with hypertension (blood pressure ≥ 140/90 or current treatment for hypertension), or dyslipidemia (total cholesterol > 220 mg/dL + LDL cholesterol > 130 mg/dL, or current use of lipid-lowering medications), or controlled type 2 diabetes mellitus (glycated hemoglobin < 8.0 % with or without medication) history of congestive heart failure (any classification) unstable angina or acute coronary syndrome within the last 30 days uncontrolled hypertension (blood pressure ≥ 170/100 mm/Hg) type 1 diabetes mellitus uncontrolled type 2 diabetes mellitus (HbA1C ≥ 8.0%) history of gastrointestinal disease or surgery affecting absorption peripheral arterial disease diagnosis of active cancer (excluding squamous cell or basal cell skin cancer) current use of long-acting nitrate compounds such as isosorbide dinitrate or nitroglycerin recent change in any medications (last 30 days) | 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, Obstructive Sleep Apnea Willingness to provide written informed consent Patients who are using a ResMed mask system Patients who are at least 18 years of age Patients who use a ResMed CPAP device Patients currently using Bilevel PAP Patients who are pregnant Patients who the researcher believes are unsuitable for because either they do not comprehend English they are unable to provide written informed consent they are physically unable to comply with the protocol | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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 morbid obese patients aged from 18-65 BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc psychiatric illness substance abuse previous gastrointestinal surgery, and any patient who transfers from laparoscopic to convention procedure | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 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): 19.0-50.0, Polycystic Ovary Syndrome Diagnosed with PCOS Body mass index 18.5-35 kg/m2 Cushing's syndrome Type 1 or 2 diabetes Self-reported claustrophobia Androgenic tumors or adrenal hyperplasia Hyperprolactinemia Implanted metal items Use of metformin or other diabetes drug Women using oral contraceptives will not be excluded, but will be required to discontinue use of these agents 3 months prior to testing | 1 |
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