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The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Intestinal Perforation Age 18 years old with the diagnosis of morbid obesity, who qualifies for laparoscopic gastric bypass surgical therapy, and has elected to undergo laparoscopic gastric bypass surgery. 2. Receiving care in the Stanford Hospital General Surgery Bariatric Surgery Clinic under the care of Dr. Dan Azagury 3. The patient is scheduled for laparoscopic roux en y gastric bypass surgery, with Dr. Azagury. 4. Willing and cognitively able to sign informed consent Lack of or inability to provide informed consent. 2. Less than 18 years of age or greater than 60 years of age 3. Planned deviation from the standard laparoscopic gastric bypass operation 4. Conversion intra-operatively from a laparoscopic gastric bypass to an alternative laparoscopic surgical operation or to an open gastric bypass operation. 5. Enrollment in another device or drug study that may confound results | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m². 2 Pregnant woman coming to the centre before 18 weeks of gestation. 3 Age ≥ 18 and ≤ 40 years 4 Single Pregnancy 5 No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor... 6 Informed written consent Pregnant woman coming to the center after 18 weeks of gestation, BMI <18.5 kg / m² or between 25 and 29.99 Kg / m². 2 Age <18 or> 40 years 3 Multiple pregnancy 4 Presence of a constitutional disease or progressive disease other than obesity. 5 Patients who underwent obesity surgery type "bypass" or gastroplasty 6 Obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy 7 not stabilized endocrine pathology. 8 pregestational diabetes 9 No affiliation to a social security scheme | 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): 19.0-45.0, Rhinitis, Allergic, Perennial Healthy male volunteer in the age of 19-45 2. Body weight≥50kg and BMI 18~29 kg/m2 3. Subject who sign on an informed consent form willingly Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2. Subject with acute disease within 28 days prior to study medication dosing 3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug 4. Subject with clinically significant chronic disease 5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL 6. Use of any prescription medication within 14 days prior to study medication dosing 7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing 8. Subject with clinically significant allergic disease 9. Subject with known for hypersensitivity reaction to bepotastine 10. Subject with any of the following conditions in laboratory test AST/ALT > UNL (upper normal limit) x 2 Total bilirubin > UNL x 2 Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)] SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg QTc>440msec on ECG Serum potassium < 3.5 mEq/L or > 5.5 mEq/L 11. Immunological incompetence, immune deficiency or taking immunosuppressants 12. Subject who cannot take standard meal 13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing 14. Subject with blood transfusion within 30days prior to study medication dosing 15. Participation in any clinical investigation within 90days prior to study medication dosing 16. Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day) 17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator 18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing 19. Subject who are not using adequate means of contraception 20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption 21. Subject with history of drug abuse or drug addiction | 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): 19.0-45.0, Rhinitis, Allergic, Perennial Healthy male in the age of 19-45 2. Body weight ≥ 50kg, BMI 18~29 kg/m2 3. Subject who sign on an informed consent form willingly Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2. Subject with acute disease within 28 days prior to study medication dosing 3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug 4. Subject with clinically significant chronic disease 5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL 6. Use of any prescription medication within 14 days prior to study medication dosing 7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing 8. Subject with clinically significant allergic disease 9. Subject with known for hypersensitivity reaction to bepotastine 10. Subject with any of the following conditions in laboratory test AST/ALT > UNL (upper normal limit) x 2 Total bilirubin > UNL x 2 Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)] SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg QTc>440msec on ECG Serum potassium < 3.5 mEq/L or > 5.5 mEq/L 11. Immunological incompetence, immune deficiency or taking immunosuppressants 12. Subject who cannot take standard meal 13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing 14. Subject with blood transfusion within 30days prior to study medication dosing 15. Participation in any clinical investigation within 90days prior to study medication dosing 16. Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day) 17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator 18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing 19. Subject who are not using adequate means of contraception 20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption 21. Subject with history of drug abuse or drug addiction | 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, Healthy A Healthy Male Volunteer between 18 and 40 years of age inclusive; 2. A Body Mass Index (BMI) within the range of 19 to 25 kg/m2 and a total body weight >50kg; 3. Medically normal subjects with no significant abnormal findings at the screening vital signs, physical examination, electrocardiogram (ECG), and laboratory parameters as evaluated by the investigator; 4. Fertile male subjects and their partners are willing to undergo contraception as follows: condom, contraceptive sponge, contraceptive gel, contraceptive diaphragm, intrauterine devices, hormonal contraceptives (oral or injectable), subepidermal contraceptive implant and other contraception methods during the study and until 1 year after taking the dose of investigational product, 5. Subject must voluntarily consent to participate in this study, provide their written informed consent prior to start of any study specific procedures and be willing to comply with all study procedures Subjects who have a family history of coronary heart disease; 2. Subjects who have a known history of bleeding such as gingival hemorrhage, epistaxis and hemorrhoid bleeding etc.; 3. Subjects have hypertension (Systolic Pressure ≥140 mmHg or Diastolic Pressure ≥90 mmHg); 4. Subjects who are taking, or have taken any drugs that affect metabolism or prescription medication during the screening or within 30 days prior to the screening; Subjects who are taking, or have taken any OTC, herbal remedies or Vitamin during the screening or within 14 days prior to the screening; Subjects who are taking, or have taken any plant extracts like Hypericum Perforatum L. which are not therapeutic but have health function and can affect the absorption and metabolism during the screening or within 3 days prior to the screening; Subjects who have participated in another clinical trial within 2 months prior to the screening; 5. Subjects who are taking, or have taken any drugs which have toxicity to major organs during the screening or within 3 months prior to the screening; 6. Subjects who test positive for nicotine screening or can't quit smoking completely in the study; 7. Subjects who have history or presence of any clinically significant diseases within 3 months prior to the screening; 8. Subjects who have history or presence of gastrointestinal, hepatic, renal diseases or any other known condition that can affect the absorption, distribution, metabolism or excretion of the investigational product; 9. Subjects who have chronic constipation, diarrhea, irritable bowel syndrome or inflammatory bowel disease; 10. Subjects who have hemorrhoids or perianal complications with regular hematochezia; 11. Subjects who have a known history of severe allergic reaction such as drug allergy or had an acute allergic rhinitis or food allergy within 14 days prior to the study medication; 12. Subjects who have donated blood or plasma more than 500ml within 2 months prior to the study medication or more than 50ml within 14 days prior to the study medication; 13. Subjects who have had a positive test for hepatitis B (HBsAg) or hepatitis C (excluded immunization); 14. Subjects who have had a positive test for human immunodeficiency virus (HIV); 15. Subjects who have taken vaccination during the screening or within 6 months prior to the screening; 16. Subjects who have any prior history of substance abuse or treatment (including alcohol) ; 17. Subjects who can't understand the purpose, extent and possible outcomes of the study because of mental disease; 18. Adult subjects who are imprisoned or whose freedom are restricted because of administrative problem or legal issues; 19. Subjects who can't comply with the protocol such as discontinue the follow-up and finish the study according to the protocol; 20. Subjects who are involved in the study design and proceeding such as investigator, pharmacist, clinical research coordinator or other related personnel; 21. Subjects who have any other unsuitable or adverse condition to be determined by the investigator; 22. Subjects who have participated in a radiolabeled clinical trial prior to study medication; 23. Subjects who have been exposed to significant radiation (e.g., x-ray investigation, CT investigation, more than one time radiation exposure in barium meal examination) or whose occupation requires exposure to radiation in the last 12 months | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Depression Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for the past 12 weeks. 2. Medically cleared for MVPA, documented by a note from their primary care provider. 3. No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also individuals who are planning a surgery in the next 9 months and those with dementia. 4. Elevated depression symptoms. To meet for elevated symptoms, participants must have a QIDS score of 10 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. - 5. No current bulimia or anorexia (past 3 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition (assessed using the SCID). 6. No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet for a substance use disorder in the past 6 months. 7. Depression is not very severe, i.e., QIDS score is < 20. 8. No suicidality requiring immediate treatment. 9. Not pregnant or planning on becoming pregnant in the next year. 10. Understands English sufficiently well to consent and complete study assessments. 11. Aged 18-65. 12. Able to make one of the 2 available exercise class times. 13. Able to walk 1 mile | 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, Body Weight Polycystic Ovary Syndrome Women with PCOS are diagnosed according to Rotterdam (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries Fertile women had regular menstruation, with at least one previous spontaneous pregnancy Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease If they have used induction of ovulation drugs for the last three months If they have used hormonal contraception in the last three 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): 18.0-90.0, Sleep Apnea Patients with coronary artery disease scheduled to undergo non-urgent coronary artery bypass surgery Known sleep apnea on CPAP therapy Cardiogenic shock on mechanical hemodynamic support Intubated on mechanical ventilation Heart failure on oxygen therapy Long -term alpha blocker therapy Severe chronic pulmonary disease Recurrent malignant arrhythmia Inability to provide informed consent | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, PCOS Premenopausal women between 18-45 years of age and BMI less than 42 Diagnosed with PCOS by Rottadom Adequate hepatic, renal, Cardiac and hematological functions Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study Stable weight for last two months (Change of weight<3kg) Male Post menopausal women Women with hysterectomy Hyperprolactinemia Patients with congenital adrenal hyperplasia Patients suffering from Cushing's syndrome Acute or chronic Medical illness including Hepatic, Cardiac or renal insufficiency, COPD,Gastrointestinal Disorders Uncontrolled Hypertensive or known Diabetics on drugs Use of oral contraceptives or HRT for last three months Smoking or drug addicts or with psychiatric illness | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Hypertriglyceridemia Familial Hypercholesterolemia for All Cohorts Must have given written informed consent and be able to comply with all study requirements Males or females 18 to 65 years, inclusive, at the time of informed consent Body Mass Index (BMI) ≤ 35.0 kg/m2 Females must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal Males must be surgically sterile, abstinent or using an acceptable contraceptive method for Cohorts, A, D, and AA to DD only Fasting triglycerides (TG) ≥ 150 mg/dL at Screening Fasting low density lipoprotein cholesterol (LDL-C) > 70 mg/dL at Screening for Cohorts B and C only Fasting TG 90 mg/dL at Screening for All Cohorts Known history or positive test for Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), or Hepatitis B (HBV) Treatment with another Study Drug, biological agent, or device within one-month or 5-half-lives of screening Regular use of alcohol within 6 months of screening Use of concomitant drugs unless authorized by the Sponsor Medical Monitor Known contraindication and/or allergy to heparin Smoking > 10 cigarettes a day Considered unsuitable for by the Principal Investigator for Cohorts EE and FF Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to screening, or cerebrovascular accident within 24 weeks prior to screening. Participants with adequately treated stable angina, per Investigator assessment, may be included | 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): 0.0-999.0, Morbid Obesity Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass All other operations | 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, Parenting Mother-child Relations Mothers with infants 6 weeks months old English or Spanish speaking Access to a telephone Currently or at some point during pregnancy received treatment for a mental health condition (counseling and/or medications) at a participating community health center in the Seattle, Washington area Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment) | 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): 5.0-12.0, Pediatric Sleep Apnea Obesity Morphine Metabolism Child presenting for surgery that will require opioids Age between 5 -12 years of age OSAS group Pre-operative polysomnography study conducted prior to day of surgery Obese Body weight >95th percentile for age Emergency procedures involving AT, including tonsillar bleeding Patients allergic to morphine Patients with comorbidities altering opioid metabolism (i.e. liver disease) Patients with chronic inflammatory, rheumatologic, or other confounding co-morbid diseases (i.e. Crohns disease, ulcerative colitis, sickle cell, Sjogren's, etc.) | 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, Broken Ankle Men and women ages of 18 and up Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures Orthopaedic Trauma Association (OTA) classification of 44A and 44B English speaking Able and willing to consent Open fractures OTA classification of 43 and 44C Patients with diabetes mellitus No other lower extremity injuries that would affect functional outcomes Previous use of walking aides Patients with paralysis or hemiplegia Ankle fractures requiring syndesmotic repair Ankle fractures requiring fixation of the posterior malleolar Associated neurovascular injury Problems maintaining follow up (homeless or not willing to return for follow up) | 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): 0.0-79.0, Obesity Bariatrics Body Weight Diabetes Mellitus Weight Loss Roux-en-Y Gastric Bypass Gastric Bypass Adults and children age ≤79 years at time of surgery Had a primary (not revision) bariatric procedure from years 2005-2015 of one of three types: 1. Roux-en-y gastric bypass (RYGB) 2. Adjustable gastric banding (AGB) 3. Sleeve gastrectomy (SG) We will use ICD-9-CM, CPT-4, and HCPCS codes to identify bariatric cases Have a Body Mass Index (BMI) measurement in the year prior to surgery that is ≥35 kg/m2 for adults and adolescents First bariatric procedure during the study period is a revision procedure, a vertical banded gastroplasty procedure (not used regularly since early 2000s) and the rarely used Biliopancreatic Diversion Procedure Have multiple bariatric procedures coded on the same day Have a ICD-9 diagnosis related to GI cancer occurring on day of surgery or during index hospitalization Emergency department visit on the same day as hospitalization for bariatric 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): 16.0-40.0, Polycystic Ovary Syndrome PCOS Women diagnosed by Rotterdam Age > 16 or menarche of at least 2 yr upto age 40 Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI>23 Women not attempting pregnancy at present PCOS Women with BMI ≤ 23 Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic Known diabetic or 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): 18.0-85.0, Morbid Obesity Subject has provided informed consent Subject is between the ages of 18 and 80 years of age Subject is scheduled for and undergoes primary sleeve gastrectomy Revisional Bariatric Surgery | 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): 20.0-65.0, Metabolic Syndrome patients diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 2. aged 20-65 years 3. had taken clozapine for at least 3 months 4. had at least one of the following metabolic abnormalities: BMI ≥ 24; WC > 90 cm (men) or 80 cm (women); fasting serum TG level ≥ 150 mg/dL; fasting serum HDL-C level ≤ 40 mg/dL (men) or 50 mg/dL (women); systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg; current use of antihypertensive agents; and FPG level = 100-126 mg/dL history of diabetes mellitus 2. current use of hypoglycemic or hypolipidemic agents 3. pregnancy 4. allergy to metformin 5. a creatinine level > 1.4 ng/dL 6. an abnormal liver function test result 7. chronic cardiopulmonary insufficiency | 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, Major Depressive Disorder Persistent Depressive Disorder a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring clinical attention (judgement of intake clinician) a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17) a cumulative duration of depression of at least two months (this will short-lasting first depressive episodes that do not require treatment of this intensity), age 18 or more (no upper limit) capacity to provide informed consent lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or current alcohol or drug use disorder pregnancy recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months) recently introduced antidepressant medication (new antidepressant in past 12 weeks or dose increase in the past 6 weeks) previous non-response to two or more of study medications acute suicide risk (MADRS suicide item≥4) current psychotic symptoms | 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, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support | 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): 30.0-55.0, Metabolic Syndrome Men and premenopausal women 2. 30-55 years of age 3. Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day 4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study) 5. Overweight/obese subjects with BMI 27.0 0 kg/m2 and any one of the following characteristics of the metabolic syndrome: A. Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of >102 cm (40 in) and in women of >88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L) Abnormal thyroid function or known liver disease 2. Diabetes or fasting glucose ≥ 125 mg/dL 3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules) 4. Occasional or regular tobacco use 5. History of gout 6. Uncontrolled hypertension 7. Pregnant or peri-menopausal 8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy) 9. Alcohol intake: females > 70 g/wk, males >140 g/wk 10. Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both | 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): 21.0-999.0, Obesity 25 ≤ BMI ≤ 39 kg/m2 2. Systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg 3. Not currently taking medications for blood pressure Not free of diagnosed heart disease, diabetes, and cancer 2. Medical contraindications to regular, unsupervised physical activity 3. Not stable on all medications over the past 3 months 4. Not free of binge eating disorder or bulimic compensatory symptoms 5. No regular access to a mobile phone and Internet 6. Not able to speak and understand English 7. Currently pregnant or planning to be within the next year 8. Planning to move in the next year 9. Not willing to be randomized | 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, Sleep Apnea Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine Under 18 or over 80 years old Pregnancy Unable to provide informed consent | 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, Obstructive Sleep Apnea All patients aged ≥18 years-old and who are arranged to receive polysomnography for suspected OSA, as per STOP BANG questionnaire, will be eligible for the study Refusal to participate Inability to perform the maneuvers Presence of congestive heart failure Presence of chronic pulmonary disease demonstrated on pulmonary function testing Active neurologic event Active infection or surgery four weeks prior to screening Active inflammation in head and neck region Burns, trauma, radiotherapy involving head and neck region Other diagnosis of sleep disorders Ascites, benign or malignant abdominal mass and | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Poly Cystic Ovary Syndrome Premenopausal women between 18-45 years of age and BMI less than 42 Diagnosed with PCOS Adequate hepatic, renal and hematological functions Patients willing to give informed consent in writing Males Post menopausal women Women with hysterectomy Patients with congenital adrenal hyperplasia Patients suffering from Cushing's syndrome Patients diagnosed with androgen secreting tumors Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age) Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction) Pregnancy or desire for pregnancy or lactating mothers | 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, Pregnancy Gestational Diabetes Hypertension Obesity Impossibility to participate in the research Restrictive pulmonary disease Cardiac pathology with hemodynamic repercussion Familiar hyperlipidemia Multiple pregnancies. • Pregnant women healthy and with risk that want participate in a voluntary way in the research and sign the informed consent | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-55.0, Obesity Obese volunteers (BMI > 30kg/m2) Aged 18 max. 55 years Otherwise healthy Known cardiovascular disease Diabetes mellitus Smoking and drug abuse Arterial hypertension with antihypertensive treatment Dyslipidaemia with statin therapy Known chronic hepatic disease (NASH, hepatitis) Known renal disease: kidney failure Pregnancy Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract Substance abuse, alcohol abuse | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 35.0-65.0, Hyperlipidemia, Periodontal Disease Subjects having no periodontal treatment within previous 6 months number of natural teeth ≥ 10 no history of cancer and systemic disease that affects lipid levels or periodontium no history of medical treatment for hyperlipidemia, BMI< 30 kg/m2 no pregnancy no history of systemic antibiotic treatment within previous 3 months no smoking patients with history of systemic disease that affects lipid metabolism or periodontal disease history of medical treatment for hyperlipidemia pregnancy, lactation or hormone replacement therapy at the time of study use of any other drug known to affect lipid metabolism or periodontal disease systemic infection or any history of systemic antibiotic treatment in previous 3 months smokers as well as ex-smokers | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Prophylaxis of Venous Thromboembolism Patient with past elective bariatric surgery (Roux-en-Y gastric bypass surgery or sleeve gastrectomy 6-8 months ago) Patient aged 18 years and older BMI ≥ 35 kg/m2 Women of child-bearing age: Willingness of using a double barrier contraception method during the study Written, informed consent Intake of oral anticoagulants (phenprocoumon, acenocoumarol, dabigatran, etexilate, apixaban etc.) 4 weeks prior to in the study Application of parenteral anticoagulants (unfractionated heparin, low molecular weight heparins, heparin derivates (fondaparinux etc.) 4 weeks prior to in the study Pharmacologic platelet inhibition 4 weeks prior to in the study Known coagulation disorders (e.g. Willebrand's disease, haemophilia) Evidence for deep vein thrombosis or pulmonary embolism in the personal history or in the history of first degree relatives Medical condition that is associated with an increased risk for VTE, i.e. active cancer disease, lupus erythematodes chronic inflammatory bowel disease Active, clinically significant bleeding Congenital or acquired bleeding disorder Uncontrolled severe hypertension Active gastrointestinal disease that can potentially lead to bleeding disorder: oesophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel 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, Breast Neoplasms women at least 18 years of age first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis ability to complete the intervention and assessments in English; and willingness to attend in-person PCO workshop male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses) local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and use of a personal website to post cancer-relevant material in the past 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): 18.0-999.0, Hematological Malignancy Hematological cancer Ongoing chemotherapy Ability to eat by mouth Informed consent Lack of the ability to understand the informations given Lack of the ability to understand the conditions of the experiment | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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, Fasting for lean subjects Men and women ages 18-60 BMI 19-25 kg/m2; 19-23 for Asian subjects Stable weight (variation < 3 kg within 6 months of screening visit) Ability to give informed consent Ability to follow verbal and written instructions in English Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) Specific for lean subjects Fasting blood glucose >100; 2 hr OGTT blood glucose >140 Fasting triglycerides >150 for metabolic syndrome subjects: 3 or more of the following (based on joint scientific statement by Alberti et al, 2009 Fasting triglycerides >150 mg/dl (or on treatment for elevated triglycerides) HDL cholesterol <40 mg/dl in men or <50 mg/dl in women Blood pressure > 130/85 (or antihypertensive treatment in a subject with history of hypertension) Fasting BG >100 Elevated waist circumference ** see below for race and ethnic specifications Men Women Asian or Central, South or Native American > 90 cm > 80 cm Non-Asian, Non-Latino United States > 102 cm > 88 cm General | 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 Primary diagnosis: eating disorder according to DSM IV (Diagnostic and statistical manual of mental disorders fourth edition) based on diagnostic interview Illness duration of ED >10 Participated in at least three failed specialized eating disorder treatments Written informed consent Having the mental capacity to make provide informed consent to research participation Somatically stable Somatically unstable | 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, Mental Health Crisis for being referred to the crisis centre's Information Class and thus, for participation in the study are presenting to the walk-in service with a mental health-related crisis (e.g., difficulty coping with acute stressors, suicidality) a willingness by the client to participate in class-based or group interventions the ability to attend and have transportation to services during daytime hours the client is not better served by another service for their presenting problem (e.g., Addictions Foundation of Manitoba when alcohol or substance is primary) the client is literate and will be able to understand and benefit from attending class-based or group psychotherapy interventions, and the client is not being admitted to the Crisis Stabilization Unit or hospital (i.e., is not at imminent risk of harming themselves or others) | 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 Completion of the MOVE! Program between 2006-2015 with attendance in at least 75% of classes for group A cohort Completion of the MOVE! Program from 2012-2015 with participation in >75% of activities for group B cohort The patient understands and has signed the study informed consent form Veteran enrolled in the VA Healthcare System and followed by a VA primary care provider History of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise) Individuals with prescription medication usage, or other medical/psychological conditions that could interfere with the physician's ability to assess the effect of the test results on weight loss History of bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months Are currently participating in a weight loss program and/or taking weight loss medication Lost > 5% of body weight during the past 6 months or history of bariatric surgery Failure to complete screening appointments Health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis | 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, Gastric Adenocarcinoma Esophageal Squamous Cell Carcinoma Nasopharyngeal Carcinoma Head and Neck Squamous Cell Carcinoma "Inclusion Subjects may be entered in the study only if they meet all of the following 1. Fully understand the study and signed the Informed Consent Form (ICF) voluntarily; 2. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet the following conditions (not applicable to cohort 5, 6, 7, and 8): Subjects with gastric adenocarcinoma must have received at least one line of anti-tumor treatment for advanced gastric adenocarcinoma and have documented tumor progression or be intolerable to the current available chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant chemotherapy of radical operation are eligible to this study; Subjects with esophageal squamous cell carcinoma must have received at least one line of treatment for advanced esophageal squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to the current chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant therapy (including but not limited to chemotherapy or radio-chemotherapy) of radical operation are eligible to this study; Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma who have received at least one line of treatment for advanced nasopharyngeal carcinoma or head and neck squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to other current chemotherapy regimens. Subjects with recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant radio-chemotherapy of radical operation are eligible to this study (only applies for Version 4.1 and the previous ones); while for the working protocol version 5.0, subjects with nasopharyngeal carcinoma can be enrolled only if they meet the following subjects having received at least two lines of treatment for advanced nasopharyngeal carcinoma (including but not limited to anticancer drug treatment and radio-chemotherapy), who are confirmed to have tumor progression or be intolerable to other current chemotherapy regimens; adjuvant or neoadjuvant radio-chemotherapy after radical surgery can be considered as one line of treatment if tumor recurrence or metastasis occurred within 6 months after the end of the radio-chemotherapy. 3. At least one measurable lesion (according to 1.1); Note: Any lesion which received radiotherapy treatment previously cannot be regarded as a target lesion, unless that it has definitely progressed after radiotherapy. 4. Agree to provide archived tumor tissue specimens or have biopsy to collect tumor tissues for PD-L1 IHC measurement in the central laboratory; 5. Males or females aged between 18 and 75 years old; 6. ECOG score of 0-1; 7. Life expectancy ≥ 3 months; 8. The results of laboratory tests performed within 7 days prior to enrollment must meet the following 1. Neutrophils ≥ 1.5×109/L (not applicable to cohort 5, 6, 7, and 8); 2. Platelets ≥ 75×109/L (not applicable to cohort 5, 6, 7, and 8); 3. Hemoglobin ≥ 90 g/L (without receiving infusion of concentrated red blood cells within 2 weeks); 4. Serum creatinine ≤ 1.5× upper limit of normal (ULN), or creatinine clearance > 50 mL/min (not applicable to cohort 5, 6, 7, and 8); 5. Serum total bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN are acceptable for subjects with Gilbert syndrome); 6. Both AST and ALT ≤ 2.5×ULN; ALT and AST ≤ 5×ULN are acceptable for subjects with liver metastasis; 9. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 60 days after the end of study treatment. Women of childbearing potential are defined as women with sexual maturity, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) (not applicable to cohort 5, 6, 7, and 8). Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Other special for cohort 5, 6, 7, and 8. 1. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet any of the following conditions: 1. Subjects who have not received any systematic treatment. 2. Subjects who have received any neoadjuvant chemotherapy, adjuvant chemotherapy for the purpose of curing must experience a period for at least 6 months from the end of the last chemotherapy to tumor progression. 3. Subjects with head and neck squamous cell carcinoma must have received radiotherapy for the purpose of curing, and the period from the end of radiotherapy to tumor progression must be at least 1 year. 4. For subjects with gastric carcinoma, Her2 negative is required. HER2 positive is defined as IHC 3+ or IHC 2+ combined with ISH+, and ISH positive is defined as the ratio of the number of HER2 gene copies to the number of CEP17 signals ≥ 2.0. 2. Results of laboratory test conducted within 7 days before enrollment must meet the following 1. Neutrophils ≥ 2×109/L; WBC count ≥ 4×109L and < 15×109/L 2. Platelets ≥ 100×109/L; 3. Hemoglobin ≥ 90 g/L (no infusion of concentrated red blood cells within 2 weeks); 4. Creatinine clearance rate > 60 mL/min, based on the predicted value of Cockcroft-Gault glomerular filtration rate: (140 age) × (weight, kg) × (0.85, if females) 72× (serum creatinine, mg/dL) Or: (140 age) × (weight, kg) × (0.85, if females) 0.818 × (serum creatinine, μmol/L) 5. Serum total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN are acceptable for subjects with Gilbert syndrome); 6. INR and aPTT ≤ 1.5 × ULN, applies only to subjects who have not received anticoagulation; and for subjects who are receiving anticoagulation, the dose for anticoagulation must be stable. 3. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 6 months after the end of chemotherapy or 60 days after the end of study treatment (whichever comes last). Women of childbearing potential are defined as women with sexual maturities, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) . Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Subjects fulfilling any of the following conditions cannot be enrolled in the study: 1. Known hypersensitivity to citric acid monohydrate, dihydrate sodium citrate, mannitol or polysorbate (components of the investigational drug); 2. Anti-tumor treatment with cytotoxic drugs, biological drugs (e.g. monoclonal antibody), immunotherapy (e.g. interleukin 2 or interferon), or other investigational drugs within 4 weeks prior to enrollment; 3. Tyrosine kinase inhibitor treatment within 2 weeks prior to enrollment; 4. Radiotherapy within 4 weeks prior to enrollment, or radioactive drugs within 8 weeks prior to enrollment. However, patients receiving local palliative radiotherapy for bone metastasis lesions can be included; 5. Subjects with any major surgical operation within 4 weeks prior to enrollment or who have not completely recovered from the prior operation (for the definition of major surgical operation, please refer to the Level 3 and Level 4 operations stipulated in the Management of Clinical Application of Medical Technology enforced on May 1, 2009); 6. Toxicity due to any previous anticancer treatment has not recovered to CTCAE Grade 0-1, excluding the following conditions: 1. Alopecia; 2. Pigmentation; 3. Peripheral nerve toxicity recovered to < CTCAE Grade 2 (not applicable to cohort 5, 6, 7, and 8, subjects are not eligible if peripheral neurotoxicity does not restore to normal); 4. Long-term toxicity related to radiotherapy, which will not fully recover as judged by the investigator. 7. Central nervous system metastasis with clinical symptoms (e.g. brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. Subjects with prior treatment for brain or meningeal metastasis can be included if they have remained stable clinically for at least 2 months and systemic hormone treatment (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) has been discontinued for more than 4 weeks; 8. Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma, who are found to have necrotic lesions by examination within 4 weeks prior to enrollment, for which there is a potential risk of massive hemorrhage as judged by the investigator; 9. Previous or other concurrent malignant tumors (expect for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors which were effectively controlled without treatment over the past 5 years); 10. Any active autoimmune disease or history of any autoimmune disease (including but are not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism. Patients with vitiligo or asthma (in childhood) which was completely resolved and without need of any intervention in adulthood can be included. However, subjects with asthma which needs bronchodilator for medical intervention cannot be included); 11. Previous treatments with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody which acts on T-cell co-stimulatory or checkpoint pathway); 12. Subjects diagnosed with active tuberculosis (TB), who are receiving anti-tuberculosis therapy or used to have anti-tuberculosis therapy within 1 year prior to screening; 13. Concomitant diseases requiring long-term treatment with immunosuppressive drugs, or corticosteroids at an effective immunosuppressive dose (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) for systemic or local treatment purpose; 14. Subjects who have received any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 15. Pregnant or lactating women 16. Positive test for HIV; 17. Positive test for HBsAg, with HBV DNA copies detected as positive (quantitative measurements ≥ 1000 cps/mL); 18. Positive test for chronic Hepatitis C in blood screening test (HCV antibody positive); Any other clinical significant disease or condition, which as evaluated by the investigator, may affect the protocol compliance, signing of inform consent form (ICF), or not suitable to participate into this clinical trial | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Morbid Obesity Weight Loss Postoperative Complications for bariatric surgery published in 1991 for the National Institutes of Health of the USA Body mass index (BMI)> 40 and <55 kg/m2 Obesity for more than 5 years of evolution Fail in medical supervised weight loss program patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program patient accepting that surgery objective is not to achieve the ideal weight signed specific informed consent women will agree in avoid gestation during one year after surgery Patients unable to sign the informed consent form because of a mental disorder endocrine diseases causing obesity unstable mental disorder, evaluated for a psychiatry MD high anesthetic risk making surgery too risky Malignant neoplasm Inflammatory bowel disease Severe liver disease Digestive disease that makes unwise the bypass technique (mainly gastric illness that may required upper endoscopy for control) abdominal wall hernias Symptomatic biliary pathology that requires cholechistectomy at the same time of the bariatric surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Bulimia Nervosa Binge Eating Disorder BMI (Body Mass Index) over 19 Diagnosis of Bulimia Nervosa, Binge Eating Disorder, or Other Specified Feeding and Eating Disorder (OSFED) Purging Disorder BMI below 19 | 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): 0.0-24.0, Obesity Students in the intensive intervention group must be registered for a general/survey nutrition or wellness course Students in the diffuse intervention group randomly selected from those who screen in because they are at increased health risk (increased BMI and waist circumference, low intakes of fruits and vegetables, high levels of stress, and low levels of physical activity) There are no exclusionary for students in the intensive intervention group Students who are not at-risk for health issues are excluded from the diffuse intervention group | 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, Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Female Veterans Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months Age 18-65 Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System Ability to understand study procedures in English Not actively in suicidal or homicidal crisis warranting imminent hospitalization | 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): 19.0-79.0, Metabolic Syndrome Aged between 19 and 79 years old at screening visit Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization Subjects who have been diagnosed with metabolic syndrome according to following Definition of patients with metabolic syndrome: Patients satisfy two of the following at least Abdominal obesity: Waist measurement > 90 cm(male), > 80 cm(female) Triglyceride(TG) ≥ 150 mg/dL( High-Density Lipoprotein Cholesterol(HDL-C) < 40 mg/dL(male), < 50 mg/dL (female) Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state) Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough Subjects who taking anti-hypertension drugs more than three agent Subjects who have mean Sitting Systolic Blood Pressure(siSBP) > 160 mmHg (excluded if appliable, one of the arms) Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms) Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III Subjects who have triglyceride (TG) ≥ 400mg/dL Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms Other exclusions applied | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 16.0-65.0, Eating Disorder Bulimia Nervosa Binge Eating Disorder DSM-V diagnosis of bulimia nervosa or binge eating disorder Ages 16-65 years Has an Apple or Android smartphone with a data plan or daily access to Wi-Fi Is able to download smartphone applications from the Apple App Store or Google Play Store to their smartphone Lives in Canada Provides consent to participate Actively engaged in psychological treatment, specifically for bulimia nervosa or binge eating disorder Lacks English fluency High risk for suicide, as determined by the Columbia Suicide Severity Rating Scale (Self-Report Screening Version) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Obesity Pregnancy Excessive weight gain during their previous pregnancy (above the IOM recommendations) Child wish for having a next pregnancy Women aged 18 years or more Sufficient fluent in Dutch language Able to give written informed consent Able to use a smartphone. If the women do not have a smartphone because of socio-economic reasons, a smartphone is at her disposal for the whole duration of the intervention, in order to be able to use Apps connected with a Bluetooth pedometer and balance scale Requirement for (complex) diets History of or a plan for bariatric surgery Underlying or chronic disorders (e.g. diabetes, thyroid disease, renal diseases) Significant psychiatric disorder Previous still birth | 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, Laparoscopic Gastric Bypass Obesity Pain, Postoperative Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine | 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): 19.0-80.0, Dyslipidemias Screening Visit Age: 19-80 High risk for cardiovascular disease according to NCEP APT III TG≥130mg/dL and 160mg/dL>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks g/dL>TG≥200mg/dL and LDL-C<110mg/dL for subjects who were taking statins for 4 weeks Baseline Visit g/dL>TG≥200mg/dL LDL-C<110mg/dL Reduction of LDL-C dompairng screening visit The patient has histories of acute artery disease within 3 months The patient has histories of operation revasculatiation or aneurysm within 6 months The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis The patient has histories of Effectable disease to the procedrue and clinical trial result | 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, Alcohol Use Disorder To be eligible, the subject must Be at least 21 years of age Meet the DSM 5 for alcohol use disorder of a least moderate severity (AUD-MS) Be seeking treatment for AUD and desire a reduction or cessation of drinking Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. levonorgestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, and/or 9. hormonal vaginal contraceptive ring Be able to take oral medication and be willing to adhere to the medication regimen Complete all assessments required at screening and baseline Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months Contact site for additional information | 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 primary obesity surgery and indication for gastric bypass 2. age: 18 years 3. BMI > 40 kg/m² or BMI > 35 kg/m² with obesity related comorbidities 4. informed consent obesity surgery in the anamnesis 2. visceral surgery in the anamnesis (excluding appendectomy and 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): 45.0-65.0, Exercise Addiction Diet Habit Obesity Overweight Weight Loss Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control | 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): 45.0-75.0, Men Life Style Lipid Metabolism Disorders Obesity Overweight Non-smokers Weight-stable (± 2 kg, for more than one year) No history of regular exercise (in at least three months before the study) History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control | 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): 14.0-50.0, Contraception Fluent English or Spanish speaking Delivered during current admission to hospital Postpartum day 1 or post-op day 1 or 2 Females less than 14 years of age Status post sterilization or hysterectomy Received an intrauterine device immediately after delivery (postplacental) Does not have a smartphone capable of browsing the internet | 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): 18.0-69.0, Obesity Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2) to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men) and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have elevated LDL cholesterol ≥ 130 mg/dl and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following (unless subject had both elevated LDL and TG) HDL < 50 mg/dl for women and < 40 mg/dl for men blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7% or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥ 2.0 included Pregnancy Lactation Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids Allergy or intolerance to study products Serious, unstable medical conditions including known infection with HIV, tuberculosis or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse Abnormal laboratory findings Participating in or planning to begin a weight loss diet during the study period | 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): 18.0-69.0, Obesity Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2) to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men) and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have elevated LDL cholesterol ≥ 130 mg/dl and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following (unless subject had both elevated LDL and TG) HDL < 50 mg/dl for women and < 40 mg/dl for men blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7% or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥ 2.0 included Pregnancy Lactation Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids Allergy or intolerance to study products Serious, unstable medical conditions including known infection with HIV, tuberculosis or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse Abnormal laboratory findings Participating in or planning to begin a weight loss diet during the study period | 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): 20.0-65.0, Bariatric Surgery Candidate Obesity, Morbid body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea 2. being suitable for general anesthesia 3. being able to give informed consent and committed to follow-up 4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year prior bariatric surgery of any kind 2. being unable to understand the risks, benefits and compliance requirements of this trial 3. pregnancy or planning on being pregnancy 4. non-Korean speaker 5. American society of anesthesiology (ASA) class IV or higher 6. malignancy within 5 years | 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, Obesity Patients older than 18 years and younger than 65 years of age Patients with indication for gastric bypass without ring Patient attending regular appointments in the Gastroenterology Service Patients younger than 18 and over 65 years of age Patients who have no indication of gastric bypass without a ring Pregnant women (a BHCG test will be required from all women of childbearing age) | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Overweight and Obesity Dyslipoproteinemia BMI: between 27.0 and 34.9 kg/m² One of the following blood lipids: total cholesterol ≥ 200 mg/dL, LDL-cholesterol ≥ 175 mg/dL, HDL-cholesterol ≤ 50 mg/dL, TG 150-400 mg/dL women, 18-60 years Specific lactose or protein intolerance hypo or hyperthyroidism pharmacological treatment of diabetes intake of vitamins or mineral supplements anticoagulants cardiac pacemaker contraindications to exercise | 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): 18.0-45.0, Tobacco Dependence Male and/or female subjects 18 to 45 years of age, inclusive, and being verified "Healthy". ("Healthy" is defined as absence of any diseases or abnormalities on the basis of physical examination, standard clinical laboratory and instrumental examinations performed at the screening visit). 2. Smoking at least 10 tobacco cigarettes daily for at least three months preceding and presence of motivation to quit smoking. 3. Subjects with a Body Mass Index (BMI) between 18.5 to 30 kg/m2, inclusive, and a body weight >50 kg. 4. Females of childbearing potential must have a negative urine pregnancy test at the screening visit. 5. Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including male's and female partner's use of a highly effective methods of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of study drug) as outlined in Section 10.7 6. Has a personally signed and dated informed consent document before participating in any study-specific procedures, indicating that the subject has been informed of all pertinent aspects of the study; and 7. Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment), and is willing and able to comply with scheduled visits,treatment plan, laboratory tests, and other study procedures specified in the protocol Deviations from normal ranges as a result of standard clinical laboratory and instrumental examinations including ECG, performed at the screening visit. 2. Use of vitamins, herbal supplements and medicinal plants (e.g. garlic) within 7 days before the first dose of study medication. Use of products containing St. John's wort [Hypericum perforatum] 30 days prior to the study start. 3. Intake of medications having a significant impact on hemodynamics, hepatic function etc. (e.g. [but not limited to] barbiturates, omeprazole cimetidine). 4. Subjects who will not abstain from using nicotine-containing products (besides treatments specified in this protocol) and smoking from 12 hours before planned treatment intake and throughout each visit. 5. Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products that will be used in the study or has severe allergy (e.g. anaphylaxis, angioedema) in the past. 6. Females with a positive pregnancy test and/or are breast-feeding. 7. Females, currently using hormonal contraceptives, (including use less than 2 weeks prior to enrollment) 8. Males with a pregnant spouse or partner or males who are not willing to prevent conception in a spouse or partner. 9. Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV) or syphilis (RW). 10. Has a positive test for psychoactive and narcotic substances, psychoactive drugs at screening and/or at any admission to the clinical center or has drugs abuse in the past. 11. Consumes alcohol regularly in excess of the following: >10 units per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml wine or 50 ml of vodka) or presence of information on alcoholism in medical history. The subject must also abstain from alcohol consumption within 48 hours prior to the screening visit and have a negative respiratory alcohol test at the screening visit and/or at any admission clinical center (breathalyzer). 12. Use of xanthine products within 48 hours prior to the first dose of the investigational product. 13. Ingestion of food or beverages containing grapefruit, Chinese grapefruit (pomelo) or Seville oranges (including marmalade) within 10 days prior to the first dose of the investigational product and inability to stop these products taking during the study. 14. Abuse of caffeine products exceeding 500mg caffeine daily (5 cups of coffee) and the ability to abstain from caffeine products at least 48 hours before the first dose of investigational product intake and prior to prior to collection of the last blood sample in each period of the study. 15. Renal or hepatic impairment. 16. Has a history of gastrointestinal surgery other than appendectomy, ulcers or any other lesions in the mouth. 17. Erosive and ulcerative lesions of oral mucosa, xerostomia, including a history of these diseases, jaw trauma and surgery. 18. Heart rate < 60 or > 80 per minute at rest, or systolic blood pressure <100 or >130 mm Hg, or diastolic blood pressure < 70 or > 90 mm Hg. 19. Acute infections within 4 weeks prior to the study. 20. Treatment with an investigational drug within 3 months preceding the first dose of study treatment. 21. Donation of ≥450mL blood or plasma, or loss of ≥500mL of blood 3 months prior to the first of investigational product intake. 22. Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study. 23. Inability to give written informed consent or comply with the protocol requirements. 24. Probability to refuse to comply with the protocol requirements, instructions and restrictions; for example, unwillingness to cooperate, inability to return to the clinical center for follow-up visits and the probability of incomplete participation in the clinical trial. 25. Participation in clinical trials less than 3 months prior to the study. 26. Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub investigators; study coordinators; other study personnel; employees or contractors of the Sponsor or Johnson & Johnson subsidiaries; and the families of each) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity Lifestyle-related Condition Macrosomia, Fetal All subjects will have had by the time of randomization at 3 months postpartum: 1. Planning another pregnancy within the next 24 months 2. Planning to deliver at Tufts medical center during their next pregnancy 3. A previous full-term singleton pregnancy (gestational age > 37 weeks) 4. 18 to 40 years of age at the time of enrollment into the study 5. Vaginal or cesarean delivery 6. Normal glucose tolerance or gestational diabetes (GDM), but without evidence of postpartum diabetes as defined by a 75 g 2-hr oral glucose tolerance test (OGTT) 7. Normal blood pressure or mild preeclampsia but normal postpartum blood pressure 8. Bottle or breast feeding 9. Normal thyroid function (determined by TSH concentration in blood), normal cell blood count and normal kidney and liver functions. Lipid profile with triglyceride levels not higher than 400 mg/dl (fasting) and LDL levels less than 180 mg/dL 10. No clinical signs or symptoms of cardiovascular disease or any other disease or condition that may contraindicate participation in exercise training (i.e. COPD, severe asthma, orthopedic abnormalities) 11. Using contraception Pre or post-delivery diabetes 2. Post-delivery hypertension requiring medication 3. asthma requiring more than occasional use of a sympathomimetic inhaler, but not chronic inhaled steroids 4. Inflammatory bowel disease 5. Need for assisted reproductive technologies to become pregnant 6. Medical or obstetrical contraindication to the defined exercise program or diet 7. Tobacco, excessive alcohol use (greater than 2 drinks/day) or illicit drug use 8. Eating disorders such as bulimia 9. Gastric surgery to lose weight including banding or bypass procedures 10. Any psychological or psychiatric condition which may impair participation in the lifestyle intervention program 11. Multiple pregnancy 12. HIV, or hepatitis B or C 13. If a LIPP subject becomes pregnant prior to 16 weeks after randomization before the weight loss phase for the lifestyle intervention is completed or a control subject becomes pregnant before the 3 month postpartum randomization, i.e. no baseline measurement | 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 Pregnancy Active labor according to the Swedish definition; two out of three of the following must be present: painful contractions (two to three contractions in every ten minutes), cervix shortened and dilated > one centimeter (cm) and/or rupture of membranes The maximum cervix dilatation was of seven centimeters The participant had to be aged ≥18 years The participant had to be proficient in the Swedish language Not in active labor Cervix dilatation of more than seven centimeters Age <19 Not speaking Swedish | 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, Sepsis Sepsis Severe Sepsis Septic Shock On glucocorticoids On Vitamin A On any active medical research study Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl) | 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): 14.0-45.0, Eating Disorder Age between 14 and 45 years Diagnosis of Eating Disorder that meets DSM 5 diagnostic for Anorexia Nervosa (AN), Bulimia Nervosa (BN) or Other Specified Feeding or Eating Disorder (OSFED) A clinical severity which permits to treat the person at out-patient level Eating Disorder of high clinical severity, not treatable at out-patient level Comorbidity with psychotic symptoms or any other DSM 5 disorder which might hinder eating disorder treatment Medical conditions which might impede data interpretation (chemotherapy, pregnancy status) Substances use and abuse Having previously received an evidence-based CBT treatment for the same eating disorder and/or EMDR | 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, Bipolar Disorder Obesity Men and women, ages of 18-65 years, inclusive. 2. Participants will have a DSM-5 bipolar disorder that is clinically stable. 3. Participants will have received a stable major psychotropic drug regimen (except for minor dosage adjustments) for at least 3 months prior study entry. Major psychotropic drugs are antipsychotics, mood stabilizers, and antidepressants. Subjects may have had changes in adjunctive benzodiazepines and hypnotic agents. 4. Participants will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia. 5 Participants in treatment for a weight-related comorbidity (hypertension, type 2 diabetes, and/or dyslipidemia) must be on a stable and allowed treatment regimen for that condition for at least 3 months prior to study enrollment. 6 Participants will be able to provide informed consent before any trial-related activities Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1.Intrauterine device (IUD); 2. Barrier protection; 3.Contraceptive implantation system (Norplant); 4.Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are > 2 years post-menopausal or surgically-sterile are not considered of childbearing potential. All female participants will have a negative pregnancy test prior to randomization. 2. Participants who have made a suicide attempt in the last 10 years, who are displaying clinically significant psychotic features, suicidality, or homicidality on mental status examination, or who have suicidal ideation or behavior as assessed with the C-SSRS. 3. Participants who are receiving behavioral weight loss treatment (BWLT) (e.g., Weight Watchers) that was begun within the 3 months before study entry. Participants who are receiving BWLT that was started 3 months prior to the beginning of the study will be allowed to continue to receive their BWLT during the trial only if they have had no weight loss in the past 3 months and they agree to not make any changes in the frequency or nature of their BWLT during the course of the drug trial. 4. A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 3 months prior to enrollment. 5. A DSM-5 diagnosis of dementia, a psychotic disorder, or a depressive disorder. 6. History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance. 7. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, neurological, metabolic, endocrine, or other systemic disease. Clinically stable hypertension, type 2 diabetes, or dyslipidemia are not exclusionary. 8. Have a history of a structural cardiac abnormality, valvular cardiac disease, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, congestive heart failure, stroke, or other serious cardiovascular problem. 9. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation. 10. Have clinically relevant abnormal laboratory results. 11. Participants requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes anti-obesity drugs, psychostimulants, modafinil or armodafinil, topiramate or zonisamide, and antipsychotics. Participants receiving metformin at a stable dose for ≥ 3 months can be included. 12. Participants receiving GLP-1 based therapies, sodium-glucose co-transporter 2 inhibitors (SGLT2s), thiazolidinediones, sulfonylureas, or insulin. 13. Participants with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. 14. Participants who have received any investigational medication within three months prior to randomization. 15. Participants previously screen-failed or randomised to participate in this trial. 16. Participants who have a known or suspected allergy to liraglutide 3.0 mg sc injection, its constituents, or related products. 17. Participants with a urine drug screen positive for a drug that, in the opinion of the investigator, is being abused. 18. Participants with a past medical history of pancreatitis. 19. Participants who had received any investigational drug within 3 months prior to this trial. 20. Participants who require bariatric surgery or are anticipated to require it during the course of the trial. If such surgery becomes warranted during the study, such patients will be excluded from the primary endpoint analysis | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 15.0-65.0, Eating Disorder Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) Patient aged from 15 to 65 years Patient who performs the day-hospital evaluation Patient affiliated to a French social security system Patient able to understand the nature, the aim and the methodology of the study For minor one of the legal guardians gave his consent Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments) Patient's refusal to participate Patient on protective measures (guardianship or trusteeship) Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of 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): 18.0-65.0, Obese all patients underwent elipse insertion from July 2016 to January 2017with BMI 27-40 Age 18-65 Failed multiple diet attemps Motivated with realistic weight loss expectations, ready and committed to follow a physician-guided weight-loss program Patients with psychologically-driven eating disorders (e.g. binge eating, bulimia, etc.) Patients with a history of abdominal and/or pelvic surgery only ONE of the following surgeries that was performed at least 12 months prior to the Elipse™ Treatment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy Patient has had previous bariatric or gastric surgery Patient has a history of acute pancreatitis Patient has a history of small bowel obstructions Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias >2 centimeter (cm), inflammatory diseases, cancer, and varices Patients with an abnormal swallowing mechanism Patients with a history of cancer, inflammatory disease, bleeding or other disorder of the gastrointestinal (GI) tract Women who are pregnant or breast feeding | 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 Overweight Age 18-65 years BMI 23.5 kg/m2 Diabetes more than two years and less than ten years American Society of Anesthesiologists (ASA) classification < 4 Able to give informed consent Age: below 18 and above 65 Inability to informed consent Patients on GLP-1 agonist and insulin two weeks before admission into the trial Diabetes more than ten years or less than two years C-Peptide level < 2.0 ng/mL American Society of Anesthesiologists (ASA) classification > 3 Logistic issue where patient come from rural area and has difficulty in complying with the post-operation close monitoring and follow-up Patient who has psychiatric disorder (depression, substance abuse, eating disorder, alcoholism, dementia etc.) | 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, Atrial Fibrillation Patients with symptomatic (CCS-SAF ≥2) recurrent paroxysmal or persistent nonvalvular atrial fibrillation despite rate control, desiring catheter ablation AND one of : BMI>27, BP>140/90 or history of hypertension, alcohol use > recommended limit, current smoking, diabetes with HgA1C>7%, physical inactivity (<150 minutes/week). (Definitions: Recurrent paroxysmal at least 4 episodes of symptomatic AF in the prior 6 months, with or without cardioversion; Persistent AF lasting greater than 7 days but less than 3 years; AF must be documented on a Holter, rhythm strip or electrocardiogram within the last 24 months.) Permanent AF (AF lasting > 3 years) Prior catheter ablation for AF Left ventricular ejection fraction <30% Left atrial size > 5.5 cm NYHA IV heart failure Participation in a cardiac rehabilitation program within the last year Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity Unable to exercise Unable to give informed consent Other noncardiovascular medical condition making 1 year survival unlikely | 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, Bariatric Surgery Candidate Pregnancy Complications Pregnancy Related Glucose Metabolism Disorders pregnant women with a history of RYGB Operation normal weight pregnant women obese pregnant women infectious diseases such as Hepatitis B or C, HIV, hematological diseases, acute infections, liver disease, renal disease, cancer | 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): 60.0-80.0, Vitamin D Deficiency Diabetes Mellitus Hypertension Lipid Metabolism Disorders Obesity, Abdominal Food insecure Have fit of metabolic syndrome; (WC>90 cm), obesity (BMI≥30 kg/m2), diabetes (FBS>100 mg/dl), high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (LDL≥ 240 mg/dl, HDL<40 mg/dl, TC≥ 160 mg/dl; TG≥ 200 mg/dl) Vitamin D deficient; serum 25(OH) D level <30 ng/ml No use of vitamin D supplementation before 60 days An inability or unwillingness to participate Those who are already taking any type of vitamin D supplements Individuals with a history of allergy Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc Illness that required corticosteroids or insulin Drugs are known to influence vitamin D level; steroids, anti-acids, oestrogen People with conditions that contradict vitamin D supplementation, for example, a history of hypercalcaemia, hepatic disease or renal stones, sarcoidosis, or malignancy | 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): 19.0-45.0, Healthy Healthy male volunteer 19 years to 45 years Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease Subject with acute disease within 28 days before the first dose of Investigational product Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration 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): 18.0-999.0, Sleep Apnea Syndromes Epilepsies, Partial Male or female age ≥ 18 Patient suffering of pharmacoresistant epilepsy Frequency of epilepsy crisis : minimum 4 per month Antiepileptic drug on a stable dose for at least 2 months SA-SDQ score ≥ 25 Written informed consent obtained Patient affiliated with a social security regimen Pregnant females (female subjects who are lactating are not excluded) Anterior CPAP treatment Central apnea >20% during the initial polysomnography Mental retardation or severe cognitive impairment Presence of pseudo-crisis | 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, Pain, Postoperative Body mass index (BMI) >40 Kg/m2 BMI >35 Kg/m2 and obesity associated comorbidities Patients undergoing laparoscopic Roux en Y gastric bypass Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass Patients undergoing open bariatric surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity BMI greater than or equal to 40 kg/m2, greater than or equal to to 30 kg/m2 with 1 more obesity related co-morbidity, or or greater than or equal to 35 kg/m2 without co-morbidity Co-morbidities 1. Sleep apnea (STOP-BANG questionnaire and polysomnography) 2. BP >130/80 or on hypertension meds. 3. A1c > or = to 5.7, fasting >100 OR >126, 6.5 and above 4. Waist circumference >102, or 40 inches if male or >80 cm 35 inches if female 5. Metabolic syndrome (3 blood pressure, waist circumference, triglycerides > 150 or HDL < 50/40) Failure to respond to non-invasive weight loss management for at least 6 months Valid health insurance to cover the cost of procedure and standard of care pre-and post-procedure management/workup Untreated endocrine diseases (diabetes, thyroid disorder, pituitary disorder, and sex gland disorder) diabetes or A1c >6.5 Heart Disease, for example, arrhythmia, heart failure, myocardial infarction Kidney disease with serum creatinine greater than 2.5 mg/dl Cerebrovascular disease, for example, stroke or otherwise unable to exercise Any pregnant or lactating women or who have had childbirth within 6 months Any patients on retinoid therapy or undergoing retinoid therapy that will not last throughout the length of the trial Patients with significant psychiatric disorder Any other chronic condition deemed unsuitable to undergo either arm of the trial | 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, Complications of Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes mellitus type 2 between 6 months to 10 years of disease Body mass index between 25 and 35 kg/m2 Fasting glucose between 120 and 250 mg / dL Glycated Hb A1c greater than 7,5 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue Male or female (not pregnant), who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria Patients with DM1, DM2 using insulin and other types of diabetes T2DM with chronic complications that already have clinical consequences Creatinine serum greater than 1.4 (female) and 1.5 mg/dl (male) History of heart disease and severe concomitant diseases such as liver, coronary artery, renal, with severe psychiatric or neurological disorders Patients with a history of abuse of alcohol and/or illegal drugs or psychotropic medicines in the past six months Hypersensitivity to any component of the of study drug and placebo formulation | 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, Postoperative Pain Body Mass Index (BMI) >40 Kg/m2 BMI >35 Kg/m2 with obesity-associated comorbidities Patients undergoing other bariatric procedures Patients undergoing bariatric revisional 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): 20.0-40.0, Thinness Health Behavior Genetics control: BMI 20-25 kg/m2, healthy, age 20-40 years old superlean: BMI 15-18 kg/m2, healthy, with no eating disorders and diabetes, age 20-40 years old Pregnant women and women in lactation Subjects are suffering from eating disorders or diabetes | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 16.0-65.0, To Compare the Difference of AHI Variation Between LSG and Combined Surgery Chinese Han population aged 16 to 65 years 2. BMI more than 32.5Kg/㎡ with AHI more than ≥30/hour 3. First diagnosed with PSG without any corresponding treatment; 4. Adenoid tonsil hypertrophy (Friedman stage II-III) Drug abuse, alcohol addiction and mental diseases 2. Dysgnosia 3. Over-high expectation 4. Risk-averse patient; 5. Poor tolerance to surgery 6. Patient suffering from gastroesophageal reflux and hiatal hernia 7. Central or mixed sleep apnea diagnosed by PSG 8. PO2<60mmHg when the patient is awake 9. Suffering from maligent tumor, neural system injury and respiratory insufficiency 10. Hypothyroidism 11. Other special issue decided by specialist | 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, Obesity, Morbid Morbid obese patients Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during and those who had previously undergone obesity surgery (revision surgery) were excluded | 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, Alcoholism Patients with AUD 1. Age 18 years and older. 2. Ability to provide written informed consent as determined by clinical examination and verbal communication. Capacity to consent will be determined by those giving the informed consent. 3. DSM-IV diagnosis of alcohol dependence or alcohol abuse or DSM 5 diagnosis of moderate or severe AUD (established through history and clinical exam). 4. Participants seeking treatment for their AUD (self-report) 5. Minimum 5-year history of heavy drinking (SAMSHA s for heavy drinking: for men 5 or more drinks/day on at least 5 different days per month; and for women 4 or more drinks/day on at least 5 different days per month [self-report]). 6. Alcohol specified as the preferred drug (self-report). 7. NIH employees with an AUD may participate in this study Unwilling or unable to refrain from use, within 24 hours of MRI and NPT procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics [must finish course at least 24 hours prior to a scheduled procedure], antidiarrheal preparations, anti-inflammatory drugs [systemic corticosteroids are exclusionary], antinauseants, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted as long as they have been taken for at least 1 month before procedure visits and dose has been stabilized. 2. Current DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are mild/moderate) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics). Chronic benzodiazepine use prior to alcohol detox will also be excluded. Note that nicotine and/or caffeine use will not participation. 3. Chronic use of the following medications: analgesics containing narcotics; anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticoagulants; anticonvulsants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives (except angiotensin converting enzyme (ACE) inhibitors such as Lisinopril, or Angiotensin receptor blockers (ARB) such as Losartan); anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); cough/cold preparations (dextromethorphan preparations, pseudoephedrine); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; and muscle relaxants. 4. Major medical problems that can impact brain function or the use of a ketogenic diet (e.g., epilepsy, diabetes, liver disease, kidney disease, kidney stones (current and/or in the past), chronic metabolic acidosis or a cardiomyopathy) as determined by EKG, history and clinical exam. 5. Clinically significant laboratory findings that could affect brain function (e.g. HIV+). 6. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history). 7. Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 60 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study. (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding. 8. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist). 9. Cannot lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 10. Body weight > 550 lbs. The MR scanner bed is tested to a weight limit of 0 lbs. 11. Milk or soy allergy (self-report). Note that subjects will not be excluded on initial screening from enrollment onto this study if their breath alcohol test is positive; or if their urine test is positive for drugs. The following guideline will be followed for positive alcohol/drug screens on study procedure days: -If an AUD subject s breath alcohol and/or urine drug screen test is/are positive on study days (i.e., within 24 hours before study procedures except for benzodiazepines during detox, including oxazepam [Serax], the procedures will be postponed and rescheduled to another day. If the urine drug screen is positive for a saliva drug screen will be performed and subject may proceed with MRI/NPT procedures if saliva results for THC are negative. We will not place a limit on rescheduling study 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): 18.0-50.0, Weight Loss Diet Modification Obesity Adult woman (≥18 and <50 years old) Enrolled in WIC or with an infant enrolled in WIC 12 months postpartum A pre-pregnancy BMI of 25 kg/m2 (based on self-reported height and weight prior to pregnancy) Postpartum body mass index between 25 and 50 kg/m2 English and/or Spanish-speaking Owns a mobile phone with texting functionality in order to receive texts during the trial Health conditions impacting weight or ability to participate in a weight loss trial Pregnancy or planned pregnancy in next 5 months Any health problems or undergoing any treatments that might interfere with what participant eats or her ability to exercise Medical provider recommendation to avoid exercise Plans to be in a different geographic area within the next 5 months Plans to stop coming to Aurora WIC in the next 5 months Unable to give informed consent Not able to read and understand English or Spanish at an 8th grade level Not willing to create a Facebook account if they do not already have one Asked to follow-up in < 3 months at most recent WIC 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): 18.0-999.0, Obesity Obstructive Sleep Apnea Syndrome Patients over 18 years of age male or female obesity defined by a body mass index (BMI = weight in kg / height in m²) ≥ 30 free from acute or chronic painful pathology free from any chronic analgesic treatment free from any psychotropic treatment by benzodiazepine and / or tricyclic antidepressant presence of obstructive sleep apnea syndrome (with apnea-hypopnea index (IAH) 10 per hour of sleep) among 60 patients absence of obstructive sleep apnea syndrome (IAH <10 per hour of sleep) among 60 patients person who signed the information and consent form patients who have been screened for sleep apnea syndrome by Somnochek® negative (AHI <10 / h) in the last 6 months, provided that their weight is the same or lower at the time of difficulties in understanding and speaking French an alcohol abuse or dependence (DSM-IV) an abuse or dependence on illicit drugs (DSM-IV) an acute or chronic inflammatory pathology a neuro-muscular pathology clinical signs of right heart failure an analgesic treatment treatment with benzodiazepines and / or tricyclic antidepressants, a β-blocking treatment Central sleep apnea person who is absent from another study or who has received more than 4500 euros in the year following his participation in clinical studies | 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): 30.0-64.0, Metabolic Syndrome Obesity Central Obesity 3,720 baseline participants (mean±SD age(y) of 48.3±9.4, 45.3% men, and 59.1% African-American), 2. Genetic data were available on 1,024 African-American participants. 3. Incomplete covariate data reduced the sample to n=769, while additional exclusions lead to a sample size ranging between 574 and 598 participants, with 539 having complete data on all baseline and follow-up outcome measures (cross-sectional part of the analysis). 4. In the longitudinal analysis, metabolic disturbance-free at baseline participants were selected for each outcome. Sample sizes ranged from n=246 (central obesity-free) to n=466 (hyperglycemia-free). 5. There were n=294 MetS-free individuals at baseline Whites in since they did not have any genetic data collected. 2. All African-Americans in without genetic data collected. 3. All African-Americans in with genetic data collected, who had incomplete data on key outcome variables and/or basic covariates of interest | 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, Pelvic Gynecological Cancer ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary) at any stage of the disease patient coming for anesthesia consultation before hysterectomy informed signed consent patient affiliated to or beneficiary of social security patient <18yrs patient with a pelvic gynecological cancer that does not require hysterectomy patient with psychiatric history or a depressive syndrome deaf patient (deafness makes the hypnosis session impossible) patient under legal protection | 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, Coronary Heart Disease years or older Have no CHD at enrollment At high risk of CHD with at least two of the following risk factors current smoking: current smokers are defined as individuals who smoked regularly during the last 12 months central obesity: for Chinese, central obesity is defined as waist circumstance above 90cm for male and 80cm for female, or with BMI above 30kg/m² raised BP (systolic BP [SBP] ≥ 130 mmHg or diastolic BP [DBP] ≥85 mmHg or under antihypertensive treatment) raised fasting BG (FBG) (100mg/dL [5.6mmol/L]) or under treatment with insulin or oral hypoglycemic agents elevated TG (150mg/dL [1.7mmol/L]) elevated TC (≥ 240 mg/dL [5.18 mmol/L]) raised LDL-C (≥ 160 mg/dL [4.15 mmol/L]) Impaired bilateral hearing Impaired mental status (according to their medical record) | 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): 60.0-90.0, Metabolic Syndrome Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c. Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood Sugar (FBS) Participant must be married or co habituating Both partners are over sixty Either partner is non English speaking Either partner practices mind body therapies more than once a week/ Either partner taking psychiatric medicine | 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, Obese Antibiotic Prophylaxis Bariatric Surgery Candidate Age ≥ 18 years-old Severely obese patient with a BMI ≥ 35 kg.m-2 Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy Affiliated to social security The patient is able to consent to clinical research and has received all information on the study design/protocol Signed/written informed consent Refuse to consent to the study or the patient is unable to consent Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected Pregnancy Persons deprived of their liberty by judicial or administrative decision Urgent or emergent surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-45.0, Menstrual Cycle Abnormal PCOS Overweight Obesity Aged 18-45 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>35 days); or Previous diagnosis of PCOS from a primary care provider Weight >300lbs Currently pregnant or breast feeding History of ovarian surgery Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months Evidence of reproductive aging as assessed by the principal of STRAW+10 stages | 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): 30.0-59.0, Type2 Diabetes Obesity Aims 1-3. 1. Age 30-59 2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30 type 2 diabetic, BMI between 30 3. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 4. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period. 5. Subjects must range in age as described in each specific protocol. 6. Subjects must have the following laboratory values: 1. Hematocrit ≥ 35 vol% 2. Serum creatinine ≤ 1.6 mg/dl 3. AST (SGOT) < 2 times upper limit of normal 4. ALT (SGPT) < 2 times upper limit of normal 5. Alkaline phosphatase < 2 times upper limit of normal 6. Triglycerides < 150 mg/dl for nondiabetics (except for Aim 4). 7. Triglycerides <300 for diabetics (except for Aim 4) 8. INR ≤ 1.3 Aim 4 1. Age 30-59 2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30 3. Patients may have normal or impaired glucose tolerance. 4. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 5. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period. 6. Subjects must have the following laboratory values: 1. Hematocrit ≥ 35 vol% 2. Serum creatinine ≤ 1.6 mg/dl 3. AST (SGOT) < 2 times upper limit of normal 4. ALT (SGPT) < 2 times upper limit of normal 5. Alkaline phosphatase < 2 times upper limit of normal 6. Triglycerides > 300 mg/dl for nondiabetics, > 250 mg/dl for impaired glucose tolerance. 7. INR ≤ 1.3 7. Patients must be prescribed gemfibrozil from their doctor Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded. Patients with type 2 diabetes will be excluded if they are taking thiazolidinediones, but may be taking sulfonylureas or other medications known to work through effects on insulin sectretion. 2. Subjects receiving Gemfibrozil must not also be receiving a statin. 3. Subjects with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied. 4. Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP>180, diastolic BP>105, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities | 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, Gout CKD Stage 1-4 SUA Level (>8 mg/dL; 480 µmol/L) outpatient adults withgout and hyperurecemia (SUA level above 8 mg/dL (480 µmol/L) outpatient adults with CKD 1-4 stages and hyperurecemia (SUA level above 8 mg/dL (480 µmol/L) CKD 5 stage heart failure III-IV NYHA stroke peripheral arterial disease obesity with BMI above 30 kg/m2 hypertension 3 grade insulin-dependent DM any kind of cancer inpatient intensive unit patients | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Pancreatic Cancer Stereotactic Body Radiation Therapy Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail 2. Disease that is appropriate for SBRT by virtue of being: a. Locally advanced and technicallyunresectable, as determined by a pancreaticobiliary surgeon as part of a multidisciplinary review at the investigative site, including multi-phasic CT demonstrating: i.Greater than 180 degree tumor involvement of the superior mesenteric artery ii. Greater than 180 degree tumor involvement of the celiac axis, including major branches of the celiac axis that render it unresectable (e.g. common hepatic artery). iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein or hepatic artery that is not surgically reconstructible b. Potentially resectable, but patient is judged not a candidate for surgery, after multidisciplinary review at the investigative site; c. Potentially resectable, but the patients refuses surgery and is considered an acceptable candidate for SBRT after multidisciplinary review at the investigative site; d. "Borderline" resectable, as determined by multidisciplinary review, including absence of distant lymphadenopathy and the primary tumor characterized by one of more of the following: i. A tumor-vessel interface (TVI) with the mesenteric vein (SMV) or portal vein (PV) measuring ≥180° of the circumference of either vein's wall or short-segment occlusion of either vein with a normal vein above or below the obstruction amenable to reconstruction; ii. Any TVI with the common hepatic artery (CHA) with normal artery proximal and distal to the TVI amenable to reconstruction; iii. A TVI with the superior mesenteric artery (SMA) measuring <180° of the circumference of the vessel wall 3. Pancreatic tumor size and limited bowel involvement by tumor must be judged acceptable for SBRT at the discretion of the treating investigator 4. No evidence of distant metastasis either prior to or after induction chemotherapy. 5. Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either gemcitabine or nab-paclitaxel or another standard combination of induction chemotherapy agents 6. Patient must have metal stent in place if duodenal stent is required. If patient has plastic stent, this must be replaced prior to radiation. 7. Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to <= 5mm. 8. Age 18 years or older 9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (0, 1 or 2) 10. Adequate hematologic function as indicated by i. Absolute neutrophil counts (ANC) ≥ 1,500/mm3 ii. Hemoglobin (Hgb) ≥ 8.0 g/dL iii. Platelet count ≥ 75,000/mm3 11. Adequate renal and liver function as indicated by: i. Creatinine ≤ 1.5 x upper-normal limit (ULN) ii. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) iii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN iv. Alkaline phosphatase ≤ 2.5 x ULN 12. Properly obtained written informed consent Prior radiation therapy to the abdomen that would overlap with treatment field 2. Prior surgical resection of pancreatic tumor 3. Receiving any approved or investigational anti-cancer agent other than those provided for in this study 4. Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment 5. Visible invasion of tumor into the lumen of the bowel or stomach on endoscopy (Note: Radiological infiltration into bowel is allowed, unless deemed clinically unsafe.) 6. Residual or ongoing ≥ Grade 3 non-hematologic toxicity from chemotherapy 7. Contraindication to IV contrast 8. Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study entry Note: Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation. 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment 10. Second primary malignancy within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator 11. Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible) 12. Female patients who are pregnant or breastfeeding 13. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for 30 days after the last dose of GC4419. This includes any woman who has experienced menarche but has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative urine or serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. 14. Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 90 days after the last dose of GC4419 are excluded. 15. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure. 16. Medical history that includes any condition, or requires the use of concomitant medications which, in the investigator's judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes | 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, Bariatric Surgery Candidate Patients undergoing Roux-en-Y gastric bypass surgery Patients who able to tolerate general anesthetic and pneumoperitoneum Patients who able to provide informed consent for the surgery Patients over the age of 18 years Patient undergoing planned sleeve gastrectomy (intra-op conversion to sleeve gastrectomy after delivery of Ropivacaine/placebo will be included and analyzed using intention-to-treat approach) Patients with an allergy to local anesthetics Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease) Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/min) Patients with hepatic dysfunction Child-Pugh Class B or C Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections Patients weighing less than or equal to 100 kilograms as measured in the pre-admission unit Patients enrolled in any other study involving involve tissue biopsy Patients with Chronic Pain and Chronic Opioid use Oral Morphine Equivalent of >100mg/day | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-75.0, Acute Coronary Syndrome After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram planned to undergo PCI recently planned to DAPT for 1 year after PCI taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks Platelet count <100g/L A history of bleeding tendency Aspirin, ticagrelor or clopidogrel allergies Severe liver injury | 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 BMI of 25.0-39.9 Has a smartphone English or Spanish as primary language assessed at "medium health risk" according a risk stratification algorithm based on clinical diagnostic scoring, and health care utilization Does not meet | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity Infertility Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy Simultaneous practice of another strategy to lose weight Physical conditions limiting exercise training Patients unable to understand spanish language or to give informed consent | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-75.0, Osteoarthritis, Knee Knee pain for at least 6 months Clinically diagnosed knee osteoarthritis Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV) Confirmation of exposed subchondral bone by high-resolution knee ultrasonography Anticoagulation therapy Inflammatory or post-infectious knee arthritis Systemic inflammatory conditions Knee flexion of less than 100 degrees Knee extension of less than 165 degrees Any Valgus Varus more than 15 degrees Any knee injection in the past 3 months BMI more than 40 Gross synovial folds on ultrasound | 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, Cancer Colonic Male or female age ≥18 years and ≤80 years. 2. Planned resection due to benign or malign disease in the left colon (descending colon and sigmoid) or the upper rectum (15 cm above the anal rim). 3. Cognitive ability to take part in the study and understand the information he/she receives about participating in the study. 4. The patient has signed a written informed consent Urgent medical condition requiring immediate care. 2. Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or severe dissemination (metastases) of cancer. 3. Stenosis or other obstructions in the anal passage. 4. Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis. 5. Health condition classified as ASA III VI . 6. Albumin level less than 35 g/l. 7. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease). 8. Disease that requires more than one anastomosis during the surgical procedure. 9. Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery. 10. Contraindications to general anaesthesia. 11. Perioperative detection of extreme variants of intestinal diameters or wall thickness. 12. Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study. 13. BMI > 35. 14. Myocardial infarct ≤ 6 months or sever heart disease. 15. Severe embolic disease. 16. Other conditions which surgeons think the patient 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): 20.0-60.0, Body Fat BMI 23~30 kg/m2 Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable) Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg) Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more Those who are treated with hypothyroidism or hyperthyroidism Creatinine levels: more than twice the normal upper limit AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking Participated in the commercial obesity program within the last 3 months If you have participated or are planning to participate in another clinical trial within the past month If yes | 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, Primary Hypercholesterolemia Subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at Visit 1 (screening visit) LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks A qualifying LDL-C value must be obtained at the beginning and end of the placebo run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower; the average of both qualifying values must be in the range of 130 to 189 mg/dL (inclusive) for in the study TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3 Signed written informed consent Liver transaminases > 1.5 x upper limit of normal Homozygous Familial Hypercholesterolemia Subject who was diagnosed as diabetes with aged greater than 40 years old Subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or BMI≥28kg/m2 Women who are pregnant or breast feeding Atherosclerotic cardiovascular disease including Arteriosclerotic heart disease, Acute coronary syndrome，Coronary artery bypass graft,Coronary angioplastyPeripheral arteriosclerosis,Cerebrovascular accident history of Severe Endiocrine disease (for example Thyroid function abnormal) History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C History of advanced cancer Arrhythmias need to be treated by 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): 20.0-999.0, Pain Control Subjects are 20 years of age or older. 2. Subjects whose body mass index (BMI) at screening is within a range of ≧18.5 kg/m2 and <25.0 kg/m2. BMI = Body Weight (kg) / [Height (m)]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively. 3. Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products). 4. Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs), chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests. 5. The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study. 6. The Subject did not take any of the following medications in the specified durations Any medication within 14 days prior to the first dose of the study Any enzyme inducer or inhibitor within 30 days prior to the first dose of the study 7. Subject understood and has signed the written informed consent form Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study. 2. Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the study 3. Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study 4. Subjects who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazole, fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study 5. The subject had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study. 6. The subject had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study. 7. The subject had a history of drug abuse or alcohol abuse. 8. Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first dose of the study and during the entire study period. 9. Subjects who are pregnant or lactating 10. For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 30 days prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above. 11. Subjects who are inappropriate to participate in this study, as judged by the medical investigator or sub-investigator 12. Subjects with any contraindication to the use of test medications 13. Subjects who are carriers of hepatitis B virus, hepatitis C virus, or are syphilis (STS) positive, or human immunodeficiency virus (HIV) positive | 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, Cardiotoxicity HER2/Neu Positive Metastatic Malignant Neoplasm in the Brain Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 STEP 1 Patients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy Trastuzumab Trastuzumab + chemotherapy or hormonal therapy Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab) Ado-trastuzumab (Kadcyla) NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted Patients must be at increased risk for cardiotoxicity defined by at least one of the following Previous anthracycline exposure, OR or more of the following risk factors for heart disease | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-44.0, Plasma Volume Micronutrients Menstrual Cycle Female to 44 years of age General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital) BMI 18.5-24.9 kg/m2 Regular menstrual cycle (26-35 days) Non-smoker Non-pregnant If pregnant before, ≥12 months since last pregnancy Known allergy to shellfish or iodine Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) <90 or ≥130 mmHg and/or diastolic blood pressure (DBP) <60 or ≥80 mmHg) Currently has low or high blood pressure (SBP <90 or ≥130 mmHg and/or DBP <60 or ≥80 mmHg), self-reported Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia) Taking regular medication(s) (physician's prescribed medications for a health condition) Currently trying to conceive Currently breastfeeding Currently using hormonal birth control or used within last 3 months Used depot medroxyprogesterone acetate (DMPA) in the past 12 months Diagnosis of polycystic ovary syndrome | 0 |
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