topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 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, Difficult or Failed Intubation Voice Laryngoscopy American Society of Anesthesiologists classification I-III Adults over 18 years Scheduled for intervention or surgical procedure in need of orotracheal or nasotracheal intubation by direct laryngoscopy Patients who have given their informed consent American Society of Anesthesiologists classification > III Minors Emergency procedures Patients who refuse to participate in 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): 18.0-70.0, Obesity Diabetes Mellitus, Type 2 NAFLD Be an eligible candidate for bariatric surgery based on standard in place, have been enrolled in bariatric surgery program at Cleveland Clinic Main Campus, and have been cleared and approved for bariatric surgery by the BMI bariatric program and his/her health insurance Have a Body Mass Index (BMI) more than 35 kg/m2 Have type 2 diabetes (T2D) (but not type 1 diabetes, see ) as defined by 1. If untreated (as per ADA standards of care) FPG > or = 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h OR 2-h PG > or = 200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR A1C > or = 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > or = 200 mg/dL (11.1 mmol/L). 2. the use of any antidiabetic drug or glucose lowering agent, including biguanides (metformin), thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides, DPP4-inhibitors, GLP1-agonists, SGLT2i, any type of insulin Have the ability and willingness to participate in the study and agree to the study terms As a standard of care, have a negative urine pregnancy test prior to surgery for women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives Any contra-indication for bariatric surgery (standard of care) Lack of insurance coverage for bariatric surgery Diabetes mellitus other than T2D including Type 1 diabetes or Latent Autoimmune Diabetes of the Adult (LADA) as defined by personal history of diabetic ketoacidosis or by positive auto-antibodies to glutamic Acid Decarboxylase (GAD-65), Islet Cell Antibodies (ICA), Insulin Autoantibodies (IAA), or to protein tyrosine phosphatase (IA-2A) Monogenetic or neonatal diabetes Prior bariatric surgery of any kind Known history of chronic liver disease except for NAFLD/NASH: hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency Known Gastrointestinal disorders including a known history of celiac disease and/or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis) Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Cholesterol, Elevated Overweight or Obesity BMI ≥ 23 kg/m2 elevated to borderline-high LDL-cholesterol (116-159 mg/dL) known allergy to wheat or gluten currently taking medication for chronic disease including anti-inflammatory, anti-hypertensive, lipid lowering, glucose controlling, or steroidal medications taking any supplements that may affect metabolism having anemia or a history of anemia current smoker or a user in the past three months currently pregnant or lactating/planning to become pregnant during the intervention having elevated blood pressure (≥130mmHg/≥80mmHg) presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions that may affect metabolic processes total cholesterol ≥ 240mg/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): 1.5-999.0, Quality of Life Endometrial Cancer Surgery--Complications Gynecologic Cancer Woman over 18 years of age scheduled for primary surgery for histologically verified endometrial cancer (regardless of histological type or degree) tumor clinically restricted to the uterus (presumptive FIGO stage I or II) speaks and reads Swedish capable of completing the questionnaire independently Clinical or radiological cancer outside the uterus preoperative radio / chemotherapy | 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, Brachymetatarsia Patients operated on for a one-time lengthening for isolated brachymetatarsia Major patients Patient refusing to participate in research | 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): 35.0-64.0, Obesity Body Weight Body Mass Index (BMI) 27-39.9 kg/m2 or 32-50% body fat percentage Willingness to have blood drawn The listed above and at least one of the following: Fasting glucose ≥100 mg/dL but <126 mg/dL or Fasting triglyceride ≥125 mg/dL or HDL-cholesterol ≤50 mg/dL or Blood Pressure (BP): Systolic BP ≥130 mmHg or Diastolic BP ≥85 mmHg or Hemoglobin A1C ≥ 5.7 and <6.5% Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg LDL cholesterol ≥190 mg/dL Triglycerides ≥500 mg/dL Current use of smoking or chewing tobacco, e-cigarettes, cigars, vaping, cannabis or other use of nicotine containing products (within the past 6 months) Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities) Unwillingness to consume intervention foods and beverages Engage in more than moderate drinking (> 1 drink serving per day) or binge drinking (4 drinks within two hours) Unwillingness to cease alcohol intake as required for specific duration of the study Excessive intake of caffeine containing products (excessive defined as ≥ 400 mg/day) | 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 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): 18.0-37.0, PCOS IVM Embryo Transfer Women with high AFC (≥24 Antral Follicles in Both Ovaries), including PCOS plus PCO or high AFC Having indications for ART Having ≤ 2 IVM/IVF attempts Permanent resident in Vietnam Agree to have fresh embryos transfer or freeze-only on day 3 Agree to have ≤ 2 embryos transferred Not participating in another IVF study at the same time Oocyte donation cycles Pre-implantation genetic diagnosis (PGD) cycles | 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 Disordered Breathing Chronic Pain Sleep The are Adult patients (≥18 years old) with cognitive capability Diagnosed with chronic non-cancer pain for > 3 months Reports sleep disturbances such as difficulty falling asleep, staying asleep, or problems waking up too early (responds "Mild", "Moderate", "Severe", or "Very Severe" to items 1, 2, or 3 on the Insomnia Severity Index) Patients with chronic pain secondary to a neoplasm or metastasis Conditions potentially interfering with comprehension and delivery of informed consent, such as certain neurological or psychiatric disorders Patients with severe insomnia (Insomnia Severity Index ≥ 22) Restless legs syndrome Periodic limb movement disorder Sleep apnea Narcolepsy Seizure disorder Patients who are pregnant Currently undergoing a psychological treatment for insomnia | 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, Ovulation Induction Polycystic Ovary Syndrome Clomiphene Inositol Rotterdam for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe >8 MHz) in both ovaries A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2 Use of own or donor sperm Tubal factors Uterine factors Endometriosis AFS score 3 or 4 Moderate to severe male factor (as defined by each local center) BMI > 35 | 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): 20.0-45.0, Autoimmune Hepatitis The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg. 2. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception 3. The subject provided written informed consent Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator. 2. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests. 3. Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration. 4. Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration. 5. Current smoker or history of smoking within 3 months before the Screening Visit. 6. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit. 7. Any use of drugs-of-abuse within 3 months before the Screening Visit. 8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration. 9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus. 10. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration. 11. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical 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): 0.0-999.0, Atrial Fibrillation • Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion The patient would also need to have had an echocardiogram within six months pre-cardioversion (performed for any reason) with a well visualized atrial roof in order to perform the measurements accurately using the software • Patients with a mitral regurgitation greater than moderate (effective regurgitant orifice >= .2 mm2) Patients with post-surgical valve repair or replacement, if the procedure was done with a thoracotomy Any patient how has had any cardiac surgery requiring a thoracotomy | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 3.0-999.0, Proteus Syndrome All participants in all Cohorts must meet the below Signed informed consent, and when applicable, signed assent Have a molecular diagnosis of Proteus syndrome with documented somatic AKT1 mutation from a CLIA-certified laboratory Have progressive and measurable disease (e.g., a measurable manifestation of Proteus syndrome with evidence or report of worsening of manifestation(s)/ in the last 12 months) Adequate organ function as indicated by the following laboratory values: Hematological Hemoglobin (Hgb) depending on age 5 years male and female: greater than or equal to 10.0 g/Dl 9 years male and female: greater than or equal to 11.5 g/dL 17 years female: greater than or equal to 11.0 g/dL 17 years male: greater than or equal to 11.5 g/dL An individual who meets any of the following will be excluded from participation in this study History of Type 1 or Type 2 uncontrolled diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose greater than or equal to 160 mg/dL ( if >12 years old) and greater than or equal to 180 mg/dL (if less than or equal to 12 years old) at the baseline/screening visit History of significant cardiac disorders Myocardial infarction (MI) or congestive heart failure defined as Class II-IV per the New York Heart Association (NYHA) classification within six months of the first dose of miransertib (MI occurring >6 months of the first dose of miransertib will be permitted) Grade 2 (per National Cancer Institute [NCI] Common Terminology for Adverse Events [CTCAE] current version) or worse conduction defect (e.g., right or left bundle branch block) Major surgery, radiotherapy, or immunotherapy within four weeks of the first dose of miransertib Any experimental systemic therapy for the purpose of treating Proteus syndrome (e.g., sirolimus, everolimus, high dose steroids, alpelisib) within two weeks of the first dose of miransertib, except for participants who were previously or are currently treated with miransertib under a Compassionate Use/Expanded Access program or existing protocol --Participants who were previously treated with or currently are receiving miransertib will be enrolled and treated according to the Schedule of Assessments/Study Visits defined in this protocol Intolerance of, or severe toxicity attributed to, AKT inhibitors (e.g., miransertib, uprosertib, afuresertib, ipatasertib) Concurrent severe uncontrolled illness not related to Proteus syndrome Ongoing or active infection | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Diabetes Mellitus, Type 2 Persons who were diagnosed with DM, 2. Aged between 18 and 65 years, 3. Patients who completed the three-month exercise program Had chronic drug (antidiabetic and antilipidemic) adjustments for 3 months at the beginning and during the exercise program, 2. Participated in an exercise program before, 3. Had a health condition other than DM associated with glucose metabolism | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Transtibial Amputee Loading Conventional 3D Being unilateral transtibial amputation To have enough perception level to understand and apply commands To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait The presence of pain that will affect the posture or walking pattern Wound / tenderness on the stump Visual impairment that will affect the posture or gait pattern Use of any assistive device (walking stick, canary, etc.) during walking | 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, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Obesity, Morbid Weight Loss Bariatric Surgery Candidate Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis). 2. Age between 18 and 60 years old Pregnancy or desire to be pregnant during the study. 2. Abnormal findings on upper GI endoscopy. 3. Presence of chronic diarrhea (≥ 3 liquid or loose stools per day, over a period of more than 4 weeks). 4. Obesity due to organic disease e.g, cushing disease and hypothyroidism. 5. Previous bariatric surgery. 6. Coexisting severe hepatic, pulmonary, renal, cardiovascular, neurological and psychiatric diseases | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Overweight Male and female adult subjects; 2. BMI ≥ 27 kg/m2 and ≤ 50 kg/m2 if treatment is for temporary use for weight loss in subjects who failed to achieve and maintain weight loss with a supervised weight-control program; 3. BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities, if treatment is for pre-surgical temporary use for weight loss in order to reduce surgical risk 4. Be willing to commit to a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance; 5. Be able to follow the requirements outlined in the protocol, including complying with the visit schedule; 6. Be able to provide written informed consent Presence of more than one System Balloon at the same time; 2. Prior surgery of the esophagus, stomach, or duodenum; 3. Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease; 4. Has any upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the GI tract such as atresias or stenosis; 5. Has a large hiatal hernia or hernia > 5 cm; 6. Has a structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope; 7. Has any other medical condition which would not permit elective endoscopy, such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease; 8. Has serious or uncontrolled psychiatric illness or disorder that could compromise subject understanding of or compliance with follow-up visits and removal of the device; 9. Alcoholism or drug addiction; 10. Unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up; 11. Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants routinely and not under medical supervision; 12. Females who are pregnant, nursing, or planning a pregnancy within the next year; 13. Known to have, or suspected, allergy to materials contained in 14. Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigational drug or device, or any use of an intragastric balloon prior to this study; 15. Genetically caused obesity; 16. Prior intragastric balloon therapy, bariatric surgery or considering bariatric surgery during the study; 17. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study. 18. Known gastrointestinal motility disorders, especially known delayed gastric emptying 19. Chronic use of anticholinergic medications and psychotropic medications known to delay gastric emptying | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-75.0, Hypercholesterolemia Obesity Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher) Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex) Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week Hormone replacement therapy <5 years Women who are pregnant or planning to become pregnant Regular exercise of >3 hours/week Weight gain or loss of >5% of body weight during last 3 months Plans to begin a weight loss/exercise regiment History of medical or surgical events that could affect digestion or swallowing Gastrointestinal surgeries, conditions or disorders Chronic or metabolic diseases | 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): 15.0-99.0, Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, or no history of any disordered eating behavior Age 15-99 years History of subthreshold disordered eating behaviors | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-75.0, Hypercholesterolemia 75 year old body mass index (BMI) between 18.5-39.9 kg/m2 higher cholesterol levels indicated by "At Risk/Borderline High" in two or more of the variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher), and having triglyceride levels less than 350mg/dL participants with familial hypercholesterolemia LDL levels greater than the 95th percentile based on age and sex HDL levels lower than the 20th percentile based on age and sex women on hormone replacement therapy for less than 2 years individuals who regularly exercise more than 3 h/w weight gain or loss more than 5% of their body weight in the past 3 months plans to begin a weight loss/exercise regiment during the trial history of medical or surgical events that could affect digestion or swallowing gastrointestinal surgeries conditions or disorders | 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 Men and women aged 18-65 years who have undergone RYGB, mini-RYGB or sleeve gastrectomy 2 or more years previously and either 1. Have a percent total weight loss from time of surgery of <20% OR 2. Have a regain of at least 5% or more of nadir weight (lowest weight at 12-18 months after surgery) AND 3. Meet current clinical for use of Mysimba (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with obesity-related comorbidity (diabetes type 2, controlled hypertension, dyslipidemia) Serious illness or complications due to bariatric surgery according to the judgement of the investigators and clinical records Use of any weight loss medications following bariatric surgery Pregnancy or breastfeeding Participation in other weight loss studies Contraindication for use of Mysimba. These but are not limited to epilepsy or history of seizure, uncontrolled hypertension (blood pressure ≥150/95 mmHg with or without medication), previous or current eating disorder, substance abuse, bipolar depression, serious liver or kidney disease, use of certain 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): 18.0-999.0, High Grade Neuroendocrine Neoplasms -Histologically or cytologically confirmed high-grade neuroendocrine tumor that has progressed on first line therapy, excluding small cell lung cancer (SCLC). High grade includes any neuroendocrine neoplasm with a Ki-67 of >=20% or with mitotic count of more than 20 mitoses per high power field or any poorly differentiated neoplasm or any neoplasm lacking these that is deemed high grade by pathology consensus, based on other markers (necrosis or IHC demonstrating p53 or RB mutation). This includes High grade well differentiated neuroendocrine neoplasms Transformed NENs from a lower to a higher grade (patient may have some low grade and some high grade NENs) High grade neoplasms with significant expression of neuroendocrine markers such as synaptophysin, chromogranin or INSM-1 or unknown origin neoplasms with gene expression signatures consistent with neuroendocrine lineage (as per validated tissue of origin testing, such as CancerType ID, after pathology consensus) Mixed neuroendocrine and non-neuroendocrine neoplasms (MiNEN), including MiNEN per WHO and mixed neoplasms not fulfilling of MiNEN. The neuroendocrine component would need to be a high-grade neuroendocrine tumor as documented by pathology review. Note: Up to two prostate NEC patients (primary diagnosis, not transformed adenocarcinoma) will be enrolled in the first phase. Note: For ambiguous cases, will consult with a designated expert pathologist Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam Concurrent or prior somatostatin analogue therapy is allowed (for well differentiated high grade neoplasms). Prior use of investigational agents is allowed At least 18 years of age ECOG performance status ≤ 1 (Karnofsky ≥ 80%) Normal bone marrow and organ function as defined below A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. Allowed are superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy at any point in the prior year Currently receiving any other investigational agents. Prior use of investigational agents is allowed Prior treatment with cabozantinib Receipt of any small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before the first dose of study treatment Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment Inability to swallow tablets A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib or other agents used in the study Concomitant anticoagulation with coumarin agents (e.g. warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel). Allowed anticoagulants are the following | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Contraception Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical [MEC]) Because the CDC MEC are continuously revised, the most updated will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm) Women who are currently participating in a clinical trial or have participated within the past 30 days Less than 2 weeks from the end of a 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): 18.0-40.0, Obesity Polycystic Ovary Syndrome Hyperandrogenism age between 18 and 40 years diagnostic for PCOS overweight with a BMI ≥ 27 kg / m² associated with at least one comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia) or obesity with a BMI between 30 and 45 kg / m² with or without comorbidities severe systemic arterial hypertension (≥180 / 100 mmHg) pregnant or lactating women diabetics using sulfonylurea or insulin any known allergy or intolerance to topiramate medication | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 30.0-65.0, Obesity Dyslipidemias Hypertension Type 2 Diabetes Endothelial Dysfunction Initial for both study groups were as follows: age: 30 to 65 years and stable body weight in the month prior to the trial (permissible deviation ± 1 kg). For Women with Obesity Group: BMI ≥ 30 kg/m2; waist circumference > 80 cm. For Normal-weight Womeng Group: BMI ≤ 24.9 and ≥ 18.5 kg/m2 for both study groups were as follows secondary form of obesity and/or secondary form of hypertension diabetes mellitus history of coronary artery disease stroke congestive heart failure clinically significant arrhythmias or conduction disorders malignancy poorly controlled hypertension (SBP > 140 mmHg and/or DBP > 90 mmHg), and/or modifications to antihypertensive treatment lipid disorders requiring the implementation of drug treatment | 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, Single Embryo Pregnancy Gestational Weeks 24-42 Pain/Sensitivity >5 on Numeric Rating Scale (NRS) Women > 18 years Single embryo pregnancy in week 24-42 was diagnosed with symphysiolisis according to written above Pain/sensitivity >5 on NRS scale in symphysis pubis area for more than two weeks Lack of proficiency in Hebrew or English Pain from a different source pelvic bone disease or history of severe pelvic bone injury Thrombocytopenia (plt<50.000) Acupuncture treatment is contraindicated High risk pregnancy | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Dry Eye Able to Sign and date the informed consent form approved by the Institutional Review Board (IRB) 2. ≥ 18 years of age 3. Patient reported dry eye-related ocular symptoms for at least 3 months before the Screening Visit and use or desire to use artificial tears, ointments or dry eye treatments in the 2 weeks preceding the screening visit 4. Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. This may oral contraceptive pills, birth control implants, barrier methods or abstinence. If a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. If the test is positive, she will be discontinued from the study immediately. 5. Be willing/able to return for all study visits and to follow instructions from the study investigator and his staff Inability to provide informed consent. 2. Vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. 3. Contact lens wear within two weeks of baseline visit | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Sickle Cell Disease For enrollment onto the active phase of the study (IQ supplement vs placebo), subjects must meet all of the following during the screening period (visit #1) which can last from 0-28 days prior to start of study intervention Unequivocal diagnosis of sickle cell anemia (Hemoglobin SS or Hemoglobin SC or Beta Thalassemia Major or Beta Thalassemia Minor) confirmed by hemoglobin electrophoresis performed on patients at least 90 days after a blood transfusion if previously transfused, or DNA genotyping Age 18-70 years old Steady state SCD (no acute vaso-occlusive crisis within 60 days of D0 of the study) and if on HU therapy, on a stable dose for at least 90 days Steady state SCD patient with a previous history of VTE, and/or those receiving anticoagulant/antiplatelet therapy are eligible, so long as the VTE occurred >90 days prior to D0 of the study Be willing to comply with all study procedures for the duration of the study Have provided signed written informed consent prior to performing any study procedure, including screening procedures Subjects who meet any of the following during screening will not receive the study intervention and will be counted toward study accrual. Screen failures will not be included in the analysis for statistical purposes Severe SCD defined as frequent (>6/year) or severe (requiring hospitalization >14 days) vaso-occlusive crisis SCD with a recent VOC (<60 days from D0 of study) SCD with history of recent blood transfusion (<60 days from D0 of study) or exchange transfusion (<90 days from D0 of study) SCD with a recent VTE (within 90 days of diagnosis of either DVT, PE or both) Any patient receiving crizanlizumab therapy for SCD or that has received crizanlizumab within the past 30 days of D0 of study Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions but are not limited to the following: 1. History of recent (within 3 months prior to signing informed consent) congestive heart failure; myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke. 2. Active infection requiring the use of parenteral antimicrobial agents or Grade greater than or equal to 3 in severity (per National Cancer Institute Common Terminology for Adverse Events v5.0) within 2 months prior to the first dose of study drug. 3. Active viral infection as evidenced by testing positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection. If the subject is positive for HCV Ab, a reverse transcriptase-polymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment. 4. Testing positive for human immunodeficiency virus (HIV) 1 or 2 Ab with evidence for ongoing active infection (i.e., CD4 count <400/microL and viral load >100,000 copies/mL) on antiretroviral therapy. 5. Active acute inflammatory disorders rheumatoid arthritis or systemic lupus erythematosus on disease modifying therapy. 6. Diabetes mellitus judged to be under poor control by the Investigator evidenced by a single fasting sugar value >250 gm/dl or requiring >3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary. 7. History of any primary malignancy, with the exception of curatively treated nonmelanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years. 8. Any injury or medical condition that, in the judgement of the Investigator would prevent the subject from participating in the study Have a prior bone marrow or stem cell transplant. OF Vulnerable subjects will not be included in this study | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-64.0, Overweight and Obesity Men and women aged 18-64 years with body mass index (BMI) 25-40 kg/m2 Waist circumference >90/80 cm (men/women for South and Southeast Asian ethnic background) and >1 additional metabolic syndrome component: circulating level of TG >1.7 mmol/l, HDL cholesterol <1.0/1.3 (men/women), blood pressure >130/85 mm of Hg or use of antihypertensive drugs or fasting glucose >5.6 mmol/l, and weight stability within +3 kg during the last three months Those who give consent to participate in our intervention study Those who are pregnant women, lactating women, or planning to become pregnant during the course of study Those who are severely ill or more than two comorbidities such as major psychiatric disorders, previous gastric surgery, haematological disorders, insomnia, Acute excerabation of cronic obstructive pulmonary disease, Asthma, respiratorty tract infections, and Diabetes patients if treated with insulin or incertin analogues Those who have any plan to migrate from the study area for at least 6 months Use of anti-obesity drugs or other drugs affecting body weight Eating disorder, alcohol or drug abuse that could contribute to difficulties with study procedures Donated blood within three months before the commencement 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): 18.0-75.0, Type 2 Diabetes Gender: men and women 2. Ethnicity: all ethnic groups 3. Language: English 4. Age: ≥ 18 to 75 years 5. Type II diabetes Currently treated with MDI (basal/bolus regimen) for at least 6 months MDI must consist of three or more injections of insulin per day, with at least 2 injections being prandial/rapid-acting insulin Prandial insulin restricted to insulin aspart, glulisine, and lispro Basal insulin restricted to long acting once-daily analogues (insulin glargine U- 100, insulin degludec (U-100 or U-200), or insulin glargine U-300) A1C within 30 days of randomization must be ≤ 7.5% on the present therapy Less than or equal to 80 units of total insulin therapy per day 6. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject GAD-65 antibody positive 2. Glomerular Filtration Rate <30 mL/min per 1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI) 3. Current glucocorticoid therapy 4. Known or suspected allergy to trial medication(s), excipients, or related products, i.e., GLP-1RA therapy or insulin aspart or insulin degludec. 5. The receipt of any investigational drug within 90 days prior to this trial. 6. Previous participation in this trial (Randomized) 7. Mental incapacity or language barrier (non-English speaking) 8. Use of incretin-based therapies <3 months before in the study DPP-4 inhibitors sitagliptin, saxagliptin, linagliptin, alogliptin GLP-1RA (exenatide, liraglutide, exenatide LAR, dulaglutide, albiglutide, lixisenatide, semaglutide) GLP-1RA/Basal Insulin combination (IGlarLixi, IDegLira) 9. Present use of oral anti-diabetic agents other than metformin. The dose of metformin must be unchanged and stable for the immediate 3 months prior to baseline. 10. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures 11. Personal or family history of medullary thyroid carcinoma 12. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 13. History of acute or chronic pancreatitis, severe liver disease or LFT's > 2.5X ULN, or severe disease of digestive tract 14. History of bariatric surgery/procedure (gastric banding, gastric sleeve, or Roux-en-Y) 15. Known elevation of serum calcitonin > 50 ng/L | 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): 20.0-34.0, Diet, Healthy Protein; Disease All participants will be required to be omnivores willing to consume both red meat and plant-base alternatives for the purposes of the trial Those with chronic health conditions, hyperlipidaemia, obesity (BMI ≥ 30), use of medications (except occasional use of NSAIDs and antihistamines), history of anosmia and ageusia (issues with taste and smell), current dieting or disordered eating pattern and smoking tobacco or recreational drugs will be excluded from participating Participants will be asked to complete an on-line screening which will the Three-factor Eating Questionnaire-R18 (TFEQ) and a health survey. Participants with a TFEQ score greater than 75% will be excluded from participating on the basis their perception of food is potentially influenced by underlying psychological issues | 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, Obesity age ranged from 16~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. - secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of 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): 20.0-55.0, Nutritional Disorder micronutrient deficiency in morbid obese subjects Adults BMI above 40 presence of comorbidities as hypertenion, DM, dislipidemia all causes which might cause micronutrient deficiency as presence of gastroesophageal reflux all causes which may cause increase obesity "BMI" as hormonal disturbance ; hypothyroidism or cushing, females receiving contraceptive pills | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-55.0, PCOS PCOS defined by the National Institute of Child Health and Human Development (NICHD) obesity with body mass index ≥ 30 kg/m2 normal glucose homeostasis at metformin treatment known type 1 or type 2 diabetes mellitus heart failure renal insufficiency with serum creatinine more than 125 umol/L arterial hypertension pregnancy BMI below 25 kg/m2 | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obesity Blood Pressure Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone 2. Bariatric surgery 3. Diabetes type 2 4. Active malignancy 5. Medication that affects weight (eg corticosteroids, phenothiazines) | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-60.0, Metabolic Syndrome Male or female ≥21 and ≤60 years old Body mass index >25 and ≤35 kg/m2 and is weight stable (<5 kg weight change in the past 6 months). BMI is limited to ≤35 kg/m2 for easier vascular access and cardiac imaging Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome Increased waist circumference (≥102 cm in men; ≥88 cm in women) Elevated triglycerides (≥150 mg/dl) Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women) High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic) Elevated fasting glucose (≥100 mg/dl) Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months Ace inhibitor A diagnosis of any type of diabetes or history of diabetes medication use Recently active (>20 min of moderate/high intensity exercise, 2 times/week) Subjects who are smokers or who have quit smoking <5 years Subjects with hypertriglyceridemia (>400 mg/dl) or hypercholesterolemia (>260 mg/dl) Subjects with BP>160/90 Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy Pregnant (as evidenced by positive pregnancy test) or nursing women Subjects with contraindications to participation in an exercise training program Allergic to perflutren A prior use of Liraglutide | 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 Metabolic Syndrome Type2 Diabetes Insulin Resistance Be between 18 and 65 years of age 2. Have a body mass index of equal to or above 35 kgs per m2 3. Have identifiable obesity-related comorbidity; medical, physical or psycho-social 4. A history of attempts at weight reduction within the past five-year period 5. Ability to understand the non-surgical and surgical options for weight loss 6. Understand the behavioral changes needed to maximize surgical weight loss success 7. Agree to comply with recommended follow-up clinical assessments 8. Agree to comply with lifelong nutritional supplementation Lack of ability to understand weight loss options and requirements for long-term success with surgery 2. Inability to understand and accept the risks and potential benefits 3. Inability to understand and agree to the compliance requirements of the study 4. Prior gastric surgery including all forms of bariatric surgical or endoscopic procedures 5. A history of previous abdominal surgery which precludes gastric bypass 6. Medical contra-indications to bariatric surgery 7. Dementia, active psychosis, unstable psychiatric disease 8. Concurrent experimental drug use 9. Pregnancy or intending to conceive within 12 months or current breast-feeding 10. Recreational drug use or excessive alcohol intake 11. Use of drugs known to affect body composition 12. Use of cytotoxic drugs | 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, Type2 Diabetes Bariatric Surgery Candidate Laparoscopic Gastric Bypass Obesity Any sex >18 years-old <60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass Other bariatric surgery Revisional surgery Incomplete charts | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea of Adult Ages 18 or older Able to speak and read English Legal United States Resident with a Government Issued ID Participating in the Project Baseline Community Study Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form Own a smartphone with a data plan and be the primary user of the smartphone; smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+ Own a computer with a web camera Consistent access to electricity and wifi for the duration of the study Have a high risk of OSA as determined by screening questionnaire Good candidate for PAP therapy, in the opinion of the managing clinician Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea, Central Sleep Apnea, Complex Sleep Apnea, chronic insomnia) Participant is a shift worker (indicated by having a night shift schedule on a regular basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis) Sponsor employees and individuals working on Project Baseline Self reported to be pregnant or planning to become pregnant during the study period Current use of home oxygenation devices, such as supplemental oxygen | 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, Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy Patients voluntarily participate in this study after full informed consent and sign a written informed consent form; 2. Age ≥18 years and ≤75 years at the time of signing informed consent; 3. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma; 4. Disease progression after at least two lines of previous treatment for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma: 1. First-line treatment must be combination regimen of two or more chemotherapy drugs and disease progression occurs; or distant metastasis or local recurrence within 6 months after completion of radical neoadjuvant chemotherapy or adjuvant chemotherapy (or chemoradiotherapy) based on platinum-based combination chemotherapy, which can be considered as progression after first-line treatment; 2. Second-line treatment includes but is not limited to chemotherapy, anti-angiogenic therapy and disease progression occurs; 3. Patients known to be HER2-positive require treatment with approved anti-HER2 targeted agents. 4. The interval between the end of systemic treatment and the first study drug administration is at least 4 weeks (the washout period of oral fluorouracil drugs is 2 weeks); 5. Previous tumor samples or fresh tumor tissue biopsy samples can be provided, and any of the following biomarkers are confirmed positive by the central laboratory: 1)PD-L1 positive: defined as PD-L1 staining positive at any intensity in ≥5% tumor cells (TC) or ≥10% immune cells (IC); 2)Epstein-Barr virus (EBV) positive: defined as positive for EBV-encoded small RNA in situ hybridization (EBER-ISH); 3)Tumor mutation burden-high (TMB-H): tumor tissues will be detected by whole exome sequencing (WES), with tumor mutation burden ≥12 Muts/Mb; 4)Microsatellite instability-high (MSI-H): Tumor tissue is tested by whole exome sequencing (WES) to confirm MSI-H positivity; 6. at least one measurable lesion according to 1.1 assessment criteria; 7. expected survival ≥3 months; 8. According to the Eastern Cooperative Oncology Group (ECOG) (Section 11.2 Appendix 2), the performance status score is 0 or 1; 9. Good organ function: 1. Hematology (no blood transfusion or colony-stimulating factor and thrombopoietin 14 days before the first study drug administration) Neutrophil count≥1.5×109/L; Thrombocyte count≥100×109/L; Hemoglobin≥90 g/L; 2. Kidney function Serum creatinine≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance by referring to the Cockcroft-Gault formula (Section 11.6 Appendix 6) or site practice≥50 mL/min; 3. Hepatic function Bilirubin total≤1.5 x ULN or ≤3 x ULN (patients with known Gilbert's disease) ; ALT/AST≤3 x ULN (without liver metastasis) or ≤5 x ULN (in case of liver metastases) ; Alkaline phosphatase≤3 x ULN (without liver and bone metastasis) or ≤5 x ULN (in case of liver or bone metastasis) ; Albumin≥30 g/L; 4. Coagulation function:International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN. 10. Adverse events and/or complications caused by any previous treatment, including surgery or radiotherapy, have been fully relieved and must have been relieved to grade 0 or 1 [according to the National Cancer Institute Common Terminology for Adverse Events (NCI-CTCAE 5.0)]; except for alopecia/pigmentation of any grade and long-term toxicity caused by other treatments, which cannot be recovered and does not affect the study drug administration/compliance and patient safety in the judgment of the investigator; 11. Within 7 days before the first dose, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 60 days after last dose. A female of childbearing potential in this protocol is defined as a sexually mature female who: 1. No hysterectomy or bilateral oophorectomy, 2. Spontaneous menopause does not last for 24 consecutive months (amenorrhea after cancer treatment and not rule out fertility) (i.e., menstruation at any time within the previous 24 consecutive months). Male patients with partners of childbearing potential must agree to use effective contraception during the use of the study drug and within 60 days after last dose With pathologically diagnosed squamous cell carcinoma or sarcoma or undifferentiated carcinoma of the stomach or gastroesophageal junction; 2. Patients with necrotic lesions, judged by the investigator to have a risk of massive hemorrhage; 3. Symptomatic spinal cord compression, or untreated patients expected to have symptoms of spinal cord compression; or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease is clinically stable for ≥4 weeks before the first study drug administration; 1)Patients with asymptomatic spinal cord compression indicated by imaging, which is assessed as stable by specialists, unless treatment for spinal cord compression is not required temporarily; 4. Poorly controlled pleural effusion, pericardial effusion or ascites requiring regular drainage; 5. Accompanied by severe peritoneal metastasis, mainly manifested as: clinically significant intestinal obstruction; moderate to large amount of ascites; barium enema revealed small intestinal stenosis; 6. Poorly controlled tumor-related pain; 1)For patients requiring analgesics, treatment must be on a stable dose prior to study participation; 2)Symptomatic lesions suitable for palliative radiotherapy (e.g., bone metastasis or metastasis resulting in nerve injury) should be treated before enrollment; 3)Prior to enrollment, local treatment of asymptomatic metastatic lesions that may cause functional deficit or intractable pain due to further growth (e.g., current epidural metastases not associated with spinal cord compression) should be considered if appropriate; 7. Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) assessment during screening and previous imaging assessment; 1)Patients who have previously received treatment for CNS metastases, shown to be stable for ≥4 weeks by imaging examination during the screening period, and stopped systemic hormone therapy (prednisone or other hormones with equal efficacy at a dose > 10 mg/day) for ≥4 weeks before the first study drug administration can participate in the study; 8. Patients with a history of carcinomatous meningitis; 9. Patients with a weight loss of more than 10% within 2 months before signing the informed consent form for concurrent other diseases or concomitant conditions: 10. Patients with other malignant tumors except for gastric cancer (except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer with radical treatment, ductal carcinoma in situ with radical treatment) within 5 years before the first study drug administration; 11. Within 28 days prior to the first study drug administration, there are other major surgeries except for the diagnosis of gastric cancer, or major surgeries are expected to be performed during the study, unless assessed by researchers and specialists that they have fully recovered from the complications of major surgery; 12. Clinically significant underlying medical conditions (e.g., dyspnea, pneumonia, pancreatitis, poorly controlled diabetes, active or poorly controlled infection, drug or alcohol abuse, or psychiatric disorders) that, in the opinion of the investigator, can affect study drug administration and protocol compliance; 13. Presence of severe neurological or psychiatric disorders, including dementia and epileptic seizures; 14. Have NCI-CTCAE ≥grade 2 peripheral neuropathy; 15. Pregnant or lactating female patients; 16. Patients with major cardiovascular diseases, such as heart disease of New York Heart Association (NYHA) functional class II or above (see Section 11.5 Appendix 5), myocardial infarction within 3 months before the first study drug administration, poorly controlled arrhythmia or unstable angina; 1)Patients with known coronary artery disease, congestive heart failure not meeting the above or left ventricular ejection fraction < 50% must be treated with an optimized stable medical regimen at the discretion of the treating physician, with consultation with a cardiologist, as appropriate for medication: 17. Previous history of hypersensitivity to other monoclonal antibodies or any component of Toripalimab Injection (JS001); 18. Previous treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor; 19. Participated in or planned to participate in other intervention studies within 4 weeks before the first study drug administration. 20. Treatment with systemic immunostimulatory drugs (including but not limited to interferon or IL-2) within 2 weeks or 5 half-lives of the drug (whichever is longer) before the first study drug administration; 21. Received systemic corticosteroids (> 10 mg/day prednisone equivalent drug) or other systemic immunosuppressive agents (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor drugs [anti-TNF]) within 2 weeks before the first study drug administration ; 1. Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted; 2. Patients receiving acute low-dose systemic immunosuppressive agents (e.g., a single dose of dexamethasone for nausea) can be enrolled after discussion with and approval by the medical monitor; 3. Patients who need baseline and follow-up MRI/CT tumor assessment can use steroids prophylaxis if they have previous allergic reactions to intravenous contrast media. 4. Inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance treatment of adrenocortical insufficiency are permitted for special immune status: 22. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Section 11.7, Appendix 7 for a more comprehensive list of autoimmune diseases); 1. Patients with autoimmune-related hypothyroidism on stable doses of thyroid hormone replacement are eligible for this study; 2. Patients with type 1 diabetes controlled on a stable insulin regimen are eligible for this study; 23. Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation; 24. Any live vaccine (e.g., vaccines against infectious diseases, such as influenza vaccine, varicella vaccine, etc.) within 4 weeks (28 days) before the first study drug administration; 25. Active infection, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests according to local medical routine), hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive); 1)Patients who are positive for hepatitis B surface antigen (HBsAg+) and/or hepatitis B core antibody (HBcAb+) are required to undergo hepatitis B virus deoxyribonucleic acid (HBV DNA) test. If HBV DNA copy number is ˂1000 cps/mL, or less than the lower limit of detectable value at the study site, the patients can participate in this study; 2)Patients who are positive for hepatitis C antibody (HCV Ab+) are required to have an HCV RNA test and are eligible for this study only if they are negative for HCV RNA (defined as below the lower limit of detectable value at the study site); 26. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening | 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 Paroxysmal Atrial Fibrillation, Persistent Apnea Syndrome Hypopnea Syndrome Patients with paroxysmal or persistent atrial fibrillation Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic No previous diagnosis of apnea-hypopnea syndrome Patients <18 years Pregnant women Doubts about the patient's ability to perform a home respiratory polygraphy Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required) Unavailability for follow-up at our center for at least 1 year | 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, Metabolic Syndrome weight stable > 3 months (changing < 5%) 2. three or more of the following five are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (TG) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (HDL) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmHg 3. can consume food that provided in project 4. healthy consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, SGLT1 inhibitors drugs, SGLT2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs 2. people who exercise vigorously (> 150 minutes per week) 3. people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months 4. people who drink alcohol more than once a week 5. people who had a LDL level within 6 months > 190 mg/dl 6. fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin 7. people with heart disease, type 1 diabetes, renal impairment > level 3A 8. history of cancer, lung disease, gastrointestinal disease 9. people who smoke, people with eating disorder, people who have received psychiatric drugs 10. become a volunteer in a research project that is conducting a study related to food consumption 11. people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months 12. pregnancy or breastfeeding 13. egg allergy | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Overweight and Obesity Participants meeting ALL of the following will be recruited for the trial Male and female participants aged ≥30 and ≤60 years Participants with a BMI in the range of ≥25 to 34.9 kg/m2 Normal levels of SGOT and SGPT i.e. up to 2.5 times of upper limit of reference range Normal level of Creatinine i.e. up to 1.5 times of upper limit of reference range Alkaline Phosphatase i.e. up to 1.5 times of upper limit of reference range Participants having At least 3 of the following five metabolic risk factors: i. Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches) ii. Triglycerides levels >150 mg/dL iii. Blood pressure ≥130 mm Hg (systolic, SBP) and/or ≥85 mm Hg (diastolic, DBP); iv. Fasting blood glucose ≥ 100 mg/ dL v. Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL Participants willing to complete all the study procedures including study-related questionnaires and comply with the study requirements Participants willing to abstain from the restricted supplements and medications prior to and throughout the study period Participants ready to give voluntary, written, informed consent to participate in 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): 18.0-55.0, OBESITY Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vitals and ECGs. Participants with obesity that are otherwise healthy may be enrolled in this study Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures A total body weight >50 kg (110 lb) and BMI of 25.0 to 40.0 kg/m2 at the screening visit Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) Any condition possibly affecting drug absorption (eg, gastrectomy) History of HIV infection, hepatitis B, or hepatitis C; positive testing for HBsAg, HBsAb, HBcAb, HCVAb or HIV. Hepatitis B vaccination is allowed Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 halflives (whichever is longer) prior to the first dose of study intervention Use of hormone replacement therapy or oral/injectable contraceptives Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer) Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06882961 A positive urine drug test | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Mandibular Prognathism dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy no previous orthognathic surgery Patients with craniofacial syndromes Medically compromised patients and patients with bone anomalies | 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): 20.0-80.0, Hemodialysis Patients Hemodialysis patients, ≥ 20 years of age ≥ 80 years of age, liver cirrhosis, cancer, pregnancy, vegetarian | 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): 18.0-85.0, Endothelial Dysfunction We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital History of Coronary artery disease History of Peripheral Arterial Disease History of Heart failure History of Stroke hepatic failure renal failure active neoplasia poorly controlled DM, defined as Hba1C>7% | 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, Sphenopalatine Ganglion Block Adrenaline Post-Dural Puncture Headache Orthopedic Randomized Controlled Study Admitted to the orthopedic department Complaining of of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries American Society of Anesthesiologists (ASA) physical status I and II Patient refusal or uncooperative Patients with uncontrollable hypertension Patient with known coagulopathy Patient with nasal septal deviation, polyp, history of nasal bleeding Patient with allergy to local anesthetics American Society of Anesthesiologists physical status>2 | 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, Thoracic Cancer Abdominal Cancer Patients must be willing and capable to provide informed consent to participate in the protocol. 2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds later to be confirmed. 3. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 Patients must be compliant to all required pretreatment evaluations Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 2. Patients are not compliant to all required pretreatment evaluations | 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, Polycystic Ovary Syndrome Fmale aged 18 2. Meet Rotterdam criteria(2003); 3. body mass index (BMI)≥30 kg/m2 Gender is male; 2. Younger than 18 years old or older than 45 years old ; 3. secondary obesity due to endocrine disorders; 4. history of malignant tumors; 5）sever hepatic and renal disease; 6) concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing | 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, Postsurgical Pain Management Able and willing to provide a written informed consent 2. Subjects requiring elective Orthopaedic surgery 3. Male or female 4. Meet the weight standard 5. Conform to the ASA Physical Status Classification Postoperative randomization Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery History of major surgery 2. History of active or high-risk bleeding disorders 3. History of myocardial infarction or coronary artery bypass 4. History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study 5. Abnormal values in the laboratory 6. Have a known allergy to meloxicam or any excipient of HR021618, , aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri or postoperative medications used in this study 7. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives 8. Planned/actual admission to the intensive care unit 9. Pregnant or nursing women 10. No birth control during the specified period of time 11. Participated in clinical trials of other drugs (received experimental drugs) 12. The inestigators determined that other conditions were inappropriate for participation in 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): 40.0-75.0, Endocrine System Diseases Nutritional and Metabolic Diseases Diabetes Mellitus, Type 2 Dyslipidemias Screening (Visit 1) 1. Korean men and women aged 40 to 75 2. Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis 3. Those who have no history of statin administration or who are receiving low and moderate-intensity statin, and who have the following laboratory values on an empty stomach Low density lipoprotein-cholesterol (LDL-C) ≥ 100 mg/dL (direct measurement result) mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL 4. Those with less than 9% HbA1C 5. Those who voluntarily agreed to participate in this clinical trial and signed a written ICF Randomization (Visit 2) 1. Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment 2. LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2) 3. Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2) Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP 2. Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial 3. Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2 4. Persons with the following medical history or surgical/interventional history Atherosclerotic disease occurring within 24 weeks at screening Myopathy including rhabdomyolysis Patients who have had a history of drug or alcohol abuse, or who have met drug or alcohol abuse within 1 year at screening Major mental illness (depression, bipolar disorder, etc.) Malignant tumor within 5 years at screening 5. Persons with the following comorbidities and laboratory abnormalities CK ≥ 2 X ULN Patients with severe hepatopathy (AST or ALT > 5 X ULN) Patients with unexplained persistent ALT elevation opinion or active liver disease TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator's judgment | 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): 18.0-41.0, Habitual Abortion Recurrent Pregnancy Loss Fertility Disorders Miscarriage Women with ≥ 2 consecutive pregnancy losses (miscarriages or biochemical pregnancies) ≤ completed gestational week 10 after ART with the present partner or with an egg/semen donor BMI ≥35 2. Age ≥41 3. Significant uterine malformation(s) 4. Known parental balanced chromosomal translocations 5. ≥2 previous pregnancies with fetuses with known abnormal karyotype 6. Patients with IgA deficiency, IgA-autoantibodies or hyperprolinaemia 7. Treatment with medication interacting with prednisolone CYP3A4-inhibitors (fx erythromycin, itraconazole, ritonavir, lopinavir), CYP3A4-inductors (fx phenobarbital, phenytoin og rifampicin), loop diuretics, thiazides, amphotericin B, beta2-agonists, antidiabetics, interleukin-2, somatotropins, anticholinergics and regular treatment with NSAIDs. 8. Patients with moderate/severe hypertension, diabetes mellitus, heart insufficiency, severe mental disorders, Cushing syndrome, myasthenia gravis, ocular herpes simplex, pheochromocytoma, systemic sclerosis, and moderate/severe renal dysfunction. 9. Patients with a clinical or biochemical profile indicating need for heparin or levothyroxine treatment during pregnancy 10. Previous treatment with IVIg 11. Allergy to prednisolone and/or IVIg 12. AMH <4 pmol/L. If transfer of donor egg is planned for her IVF cycle, the AMH value will not be an criterion | 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, Relapsed/Refractory Peripheral T-Cell Lymphoma Adult T Cell Leukemia/Lymphoma Written informed consent Participants ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed Eastern Cooperative Oncology Group performance status of 0, 1, or 2 Cohort 1 relapsed/refractory peripheral T-cell lymphoma (PTCL) Should be pathologically confirmed by the local pathologist/investigators; local histological diagnosis will be used for determination. Participants with the following subtypes of PTCL are eligible according to 2016 WHO classification prior to the initiation of study drug. Any T-cell lymphoid malignancies not listed are excluded. Eligible subtypes Enteropathy-associated T-cell lymphoma Monomorphic epitheliotropic intestinal T-cell lymphoma Hepatosplenic T-cell lymphoma Primary cutaneous T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma Participants meeting any for this study will be excluded from this study. Below is a list of the key Diagnosis of mycosis fungoides, Sézary syndrome and primary cutaneous ALCL, and systemic dissemination of primary cutaneous ALCL Diagnosis of precursor T-cell lymphoblastic leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer Presence of active central nervous system involvement of lymphoma History of autologous HCT within 60 days prior to the first dose of study drug History of allogeneic HCT within 90 days prior to the first dose of study drug Clinically significant graft-versus-host disease (GVHD) or GVHD requiring systemic immunosuppressive prophylaxis or treatment Inadequate washout period from prior lymphoma-directed therapy before enrollment, defined as follows | 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, Multiple Sclerosis Male or female between 18 and 55 years of age (inclusive) at time of signing informed consent BMI is between 18.0 and 32.0 kg/m2 Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to first dose and up to 90 days post last dose Medically healthy with no clinically significant or relevant abnormalities in medical history physical exam, vital signs, electrocardiogram (ECG), or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator Has a current or recurrent diseases that could affect the investigational medicinal product or affect clinical or laboratory assessments Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose Has a history of a significant medical, including hepatic and/or renal disease as outlined in the protocol, or psychiatric disorder that may require treatment or make the participant unlikely to fully complete the study or increase risk to the participant History of alcohol or other substance abuse within the 12 months prior to dosing at the discretion of the Investigator Routine alcohol consumption meeting or exceeding protocol limits History of prior malignancy (except adequately treated non-melanoma skin cancer, carcinoma I-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer Donated or lost more than 400ml of blood within 56 days or plasma within 14 days prior to screening Received an investigational agent with the last 30 days prior to dosing or within 5 half-lives of the investigational agent Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparations with 7 days or 5 half-lives prior to study drug administration, as determined by the Investigator. Hormone replacement therapy and hormonal contraception is permissible throughout 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, Sepsis Septic Shock Obesity years of age or older BMI > 30 suspected infection, and either hypotension (a systolic blood pressure < 90mmHg) or blood lactate concentration > 4mmol/L Pregnant Primary diagnosis of acute cerebral vascular event Acute coronary syndrome Acute pulmonary edema Status asthmaticus Major cardiac arrhythmia Active gastrointestinal hemorrhage Seizures Drug overdose Burns or trauma | 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): 22.0-999.0, Sleep Apnea, Obstructive Clinician suspects of having OSA due to presence of any STOP-BANG ≥ 3 overnight oximetry with ODI ≥ 5 STOP-BANG≥ 2 and one or more of: disrupted sleep, cognitive complaints, paroxysmal or prior atrial-fibrillation (now in NSR), stroke, TIA Has a smartphone capable of running both Withings and Itamar's app Stable sleeping quarters and schedule (i.e., no overnight shifts) for at least 14 days Domicile has capable wireless internet service Uses short-acting nitrates within 3 hours of the study Has a permanent pacemaker Atrial fibrillation or sustained supraventricular arrhythmias Known congestive heart failure Class ≥ 1, or known LVEF< 45% Sustained hypoxemia or hypoventilation (results of RA daytime ABG show SaO2<90% or PaCO2>45 mmHg, or overnight oximetry shows mean SaO2<90%.) Advanced pulmonary disease (COPD GOLD stage ≥ II , pulmonary fibrosis with GAP ≥ 1 or significant dyspnea on exertion | 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, HIV Infections HIV-negative No suspicion of acute HIV infection Substantial risk of HIV infection Creatinine clearance is more than 30 ml/min Willingness to use PrEP as prescribed, including periodic HIV testing Willingness to sign informed consent • Anyone who is not eligible with the | 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, Alcohol Drinking Pregnancy pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care and having returned her self-report and having given her written consent woman under 18 years old or not pregnant or not having returned her self-report or woman who refused to participate in the study (absence of written 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): 18.0-999.0, Hypercholesterolemia Cardiovascular Diseases signed informed consent diagnosed with CVD or a high risk of CVD based on 2019 ESC/EAS guidelines Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2 LDL-C ≥90 mg/dL and TG ≤400 mg/dL while on stable diet & lipid-lowering oral drug therapy (ie, high intensity statin with or without ezetimibe) and no PCSK9 mAb for 4 weeks if previously on Q2W dosing or 8 weeks if on Q4W dosing Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit at screening visit: not on high intensity statin; mipomersen or lomitapide within 6 months; gemfibrozil within 6 weeks; bempedoic acid within 4 weeks; inclisiran within 12 months; apheresis within 8 weeks HoFH defined clinically and/or genetically History of prior or active clinical condition or acute and/or unstable systemic disease compromising patient at the discretion of the Investigator estimated glomerular filtration rate <30 mL/min/1.73m2 at screening Active liver disease or hepatic dysfunction, history of liver transplant, and/or AST or ALT >2.5 × the ULN Uncontrolled Type 1 or Type 2 diabetes mellitus, defined as fasting glucose ≥200 mg/dL or glycated hemoglobin (HbA1c) of ≥9% NY Heart Association class III-IV heart failure; or patients with last documented left ventricular ejection fraction <30%; planned PCI, CABG or cardiac surgery Uncontrolled hypertension defined as evidenced by a reproducible (repeated 5 minutes apart) sitting blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic Enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives since ending another investigational device or drug study(ies), or receiving PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in 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, Vascular Stiffness Liver Fibroses Metabolic Syndrome Trimethylamine N-oxyde Toll-like Receptors Patient's written informed consent The presence of metabolic syndrome: as having three or more of the following traits, including traits you're taking medication to control Large waist A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men High triglyceride level milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood Reduced "good" or HDL cholesterol Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol Increased blood pressure 85 millimeters of mercury (mm Hg) or higher Refusal from further participation in the study Individual intolerance to hypoxia Cirrhosis of the liver with liver failure class C according to the classification of Child-Pugh Alcohol use 140 g / week or more for men, and 70 g / week or more for women Patients with positive serological reactions to hepatitis B and C Chronic kidney disease (GFR less than 30 ml / min / 1.73 m 2) Pregnancy, lactation | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Obesity BMI over 35 and obesity related disease BMI over 40 age between 18-60 years agrees to participate in the study age under 18 years or over 60 years abundant adhesions discovered during the surgery active upper gastrointestinal ulcer disease prior bariatric surgery active symptomatic reflux disease active psychiatric disease (eg psychosis) | 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): 30.0-69.0, Healthy Diet Cardiovascular Risk Factor Male or female Age 30-69 y BMI: 25.0-37 kg/m2 Have hypercholesterolemia (total and LDL cholesterol 200-259 and 130-189 mg/dL, respectively) Systolic/diastolic blood pressure <140/90 mm Hg Triglycerides <399 mg/dL, fasting glucose <109 mg/dL Body weight stable for 3 months prior (±3 kg) Stable physical activity regimen 3 months prior Medication use stable for 6 months prior Non-smoking BMI <25 or >37 Total cholesterol >259 mg/dL, low-density lipoprotein cholesterol >189 mg/dL Triglycerides >400 mg/dL, fasting glucose >110 mg/dL Body weight changes in previous 3 months (±3 kg) Changes in physical activity regimen in the previous 3 months Medication changes in the previous 6 months Smoking Diabetic Acute illness Pregnant or lactating | 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, Platelet Activation Testing Before/After Anti-platelet Therapy Subject is ≥18 years of age 2. Subject is willing to participate and provide informed consent 3. Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator 4. Groups A, B and C: BMI between 18 and 30 kg/m2; Groups D and E: BMI ≥ 35 kg/m2 5. Subjects must be age ≥ 18 years old 6. Serum Creatinine < 1.3 mg/dL 7. Platelet count ≥ 150 K/uL 8. Hematocrit ≥ 38% Pregnant. If female of child-bearing age, negative urinary pregnancy test required at time of enrollment. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant she should inform her treating physician immediately. 2. Established diagnosis of cirrhosis or active cancer 3. History of allergy to aspirin or clopidogrel 4. Any history of taking aspirin, antiplatelet drugs, cyclooxygenase (COX)-2 inhibitors, warfarin, low-molecular weight heparin, thrombolytic agents, or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors) within 2 weeks prior to enrollment. (Refer to appendix) 5. Use of certain antibiotics, cardiovascular drugs, lipid-lowering agents, antidepressants, antihistamines, non-prescription drugs, and supplements within the past 2 weeks. (Refer to appendix) 6. Any major illness requiring hospitalization or surgery in the previous six months. 7. Personal history of gastrointestinal bleed in the last 24 months or diagnosis of peptic ulcer disease in the last 12 months 8. Lifetime personal history of hemorrhagic stroke. 9. Personal or family history of bleeding diatheses, including hemophilias, von Willebrand's disease, Bernard-Soulier syndrome, or Glanzmann thrombasthenia (unless otherwise confirmed not present in study subject) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Hypertension Obesity Control BMI<30, age 18-70 Hypertensive BMI<30, age 18-70, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese BMI>30, age 18-70 Obese-hypertensive BMI>30, age 18-70, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring All groups presence of other significant cardiovascular disease, renal disease, history of smoking, 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): 18.0-80.0, Obesity, Morbid Metabolic Syndrome NASH - Nonalcoholic Steatohepatitis Age greater than 18 2. Body mass index of 40-60 kg/m2 3. Meet insurance as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery 4. Planned laparoscopic Roux-en-Y gastric bypass 5. Willingness to have blood collected before and after surgical procedure at defined points and collect and mail stool sample before operation and at defined post-operative time points Age less than 18 2. Patient fails to fulfill insurance mandated 3. Unwilling to be randomized to variable length to gastric bypass or unwilling to have blood collected or personally collect and mail in stool sample 4. Unwilling to follow-up at required postoperative visits | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-35.0, Polycystic Ovary Syndrome (PCOS) Age of 18 to 35 years Overweight and obese PCOS patients (overweight defined as body mass index (BMI) 25-29.9 kg/m2 and obesity defined as BMI ≥ 30 kg/m2) History of amenorrhea or oligomenorrhea with or without hirsutism. Amenorrhea was defined as absence of menstruation for six or more months. Oligomenorrhea was defined as cycle interval of more than 35 days but less than 6 months PCOS diagnosed according to the 2004 Rotterdam ESHRE/ASRM Consensus workshop, with presence of at least 2 out of 3 oligo and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology identified by ultrasound with more than 12 small antral follicles in an ovary Prediabetes defined by the American Diabetes Association 2014, as fasting plasma glucose (FPG) levels of 100 to 125 mg/, or impaired glucose tolerance (IGT) defined as 2-hour readings of 140 to 199 mg/dL in the oral glucose tolerance test (OGTT). Also, patients who had their Glycosylated Hemoglobin A1C levels between 5.7% and 6.4% were Lean or average weight PCOS with BMI < 25 kg/m2, morbidly obese patients with BMI ≥ 35 kg/m2 Patients suffering from any other metabolic disorders History of receiving any hormonal treatment or any drug affecting carbohydrate metabolism 3 months prior to the beginning of the study Inability to attend the regular follow up visits Already known and recently diagnosed diabetic patients. According to the American Diabetes Association 2014 (16), diabetes mellitus was defined as Glycosylated Hemoglobin A1C levels ≥ 6.5% or FPG ≥ 126 mg/dL or 2-hour plasma glucose readings ≥ 200 mg/dL during 75 g OGTT, or presence of classic symptoms of hyperglycemia with random plasma glucose levels ≥ 200 mg/dL Thyroid diseases Hyperprolactinemia | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 38.0-86.0, Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause Postmenopausal women, up to age 86, with angiographically documented coronary artery disease of at least 15 percent, but no more than 75 percent occlusion | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 45.0-75.0, Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause Postmenopausal women with angiographically-documented coronary disease. Approximately 70 percent minority | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A woman may be eligible for this study if She is HIV-positive She is at least 34 weeks pregnant She has a history of at least 4 weeks of continuous oral ZDV during her current pregnancy and tolerated it well She has given consent for her newborn to participate in this study. (The father must also give consent if he is available after reasonable attempts to contact him. A woman under 18 needs the consent of a parent or legal guardian for her and her infant to participate.) A woman will not be eligible for this study if She is taking part in another study of HIV treatment during pregnancy Her infant has a life-threatening illness indicated in an ultrasound Her infant does not appear to be growing normally in the womb She has a cesarean section She has abnormal blood test results She has severe nausea, vomiting, or other problems of the stomach and intestines at the time of study entry She has an active opportunistic (AIDS-related) infection or other serious infection at the time of study entry The study staff cannot find a usable vein The study doctor feels that she cannot take drugs by mouth | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A patient may be eligible for this study if she Is an HIV-positive woman Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available Had a baby on or after January 1, 1998 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-999.0, Cytomegalovirus Infections HIV Infections Concurrent Medication: Recommended PCP prophylaxis. Allowed Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies IF patient is hematologically stable for at least 30 days prior to study entry Discrete courses of oral or parenteral acyclovir for VZV or HSV infection, not to exceed 21 days per episode (may co-enroll on ACTG 169). For recurrent episodes, open-label acyclovir for a total of 60 days over a 12-month period is allowed. Study drug is interrupted Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin Other medications necessary for the patient's welfare, at the discretion of the investigator. Patients must have HIV infection or AIDS-defining conditions CD4+ count < 100 cells/mm3 IgG antibodies to CMV Co-existing Condition: Patients with the following symptoms and conditions are excluded Nausea or vomiting that precludes oral dosing Ocular media opacities that preclude adequate visualization of fundi Pregnancy Known hypersensitivity to acyclovir Known lactose intolerance. Concurrent Medication: Excluded Systemic interferons and immunomodulators (including CMV hyperimmune serum/globulin and chronic corticosteroids at doses in excess of physiologic replacement) Probenecid Investigational or marketed agents with potential activity against CMV, herpes simplex, and/or Varicella zoster, as specifically allowed. Patients with the following prior condition are excluded Pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis. Prior Medication: Excluded | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 8.0-999.0, Leukopheresis Plasmapheresis Enrolled on another LPD protocol Weight greater than or equal to 25 kg Willingness to participate Age less than 7 years Weight less than 25 kg Cardiovascular instability Hct less than 30 Inadequate venous access PTT or PT greater than 1.5 normal Pregnancy Women who are actively breastfeeding Other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure For Hetastarch procedure | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, HIV Infection Children between the ages of 3 months and 18 years. Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC) Definition. Children and adolescents with vertically, transfusion or sexually acquired HIV-1 infection are eligible. Availability of a parent or guardian to provide Informed Consent. ARM A: Children and adolescents with vertically, transfusion or sexually acquired HIV-1 infection. No or moderate immune suppression at the time of study entry as defined by the CDC Classification System, Immune Categories 1 and 2. No history of or indication for antiretroviral intervention at time of enrollment or not receiving antiretroviral treatment because: (a) the patient has elected to decline treatment or (b) in the opinion of the patient's health care provider, antiretroviral treatment is not currently recommended because of the patient's inability to adhere to therapy, promoting the development of viral resistance. Children younger than 24 months of age must not have had plasma HIV-1 RNA levels greater than 8 X 10(4) copies/ml previously and at the time of initial evaluation, confirmed at least at two different time points 2 to 4 weeks apart, showing no sign of increase (increment less than 0.5 log(10). If the child has had plasma HIV-1 RNA levels greater than 8 X 10(4) copies/ml at some point prior to the initial evaluation, he/she will have to be placed on antiretroviral treatment and must meet all the for Arm B. ARM B: Children and adolescents with vertically, transfusion, or sexually acquired HIV-1 infection, who are on or have received antiretroviral treatment of longer than 7 weeks. No or moderate immune suppression at the time of study entry as defined by CDC Classification System, Immune Categories 1 and 2. Children younger than 24 months or age, who meet all the for army B must have plasma HIV-1 RNA levels less than 5 X 10(4) copies/ml while receiving optimal antiretroviral therapy, confirmed at least two different time points 2 to 4 weeks apart, showing no sign of increase (increment less than 0.5 log(10). If the child has been previously treated with antiretroviral drugs for more than 7 weeks (therefore not eligible for arm A) and is currently off drugs, he/she will have to be placed on optimal antiretroviral agents and will have to maintain viral RNA levels below 5 X 10(4) copies/ml prior to the entry. Each child enrolled in arm B has to be on constant regimen of antiretroviral treatment for at least 6 weeks-prior to the first inoculation. Children in immune categories 1 and 2 at the time of study entry will be allowed to enroll. Not critically ill or clinically unstable or no presence of active infection requiring on-going (or induction) therapy. No evidence of severe immune suppression at the time of study entry as defined by CDC classification system, Immune Category 3. For children younger than 24 months of age, no plasma HIV-1 RNA levels greater than or equal to 5 x 10(4) copies/ml despite appropriate antiretroviral treatment, confirmed at least at two different time points 2 to 4 weeks apart. No use of tube feeding or intravenous hyperalimentation itself will be allowed as long as it is a stable regimen. No administration of chemotherapeutic agents, or use of immunomodulating agents such as corticosteroids, interferons, G-CSF, EPO, growth hormone (GH) or IVIG within one month of enrollment. No abnormalities of laboratory findings within one month of enrollment including the following: SGPT or SGOT greater than 5 times the normal value; Total bilirubin greater than 3 times normal; BUN or creatinine greater than 2 times normal; Total WBC greater than 150/mm(3) or ANC greater than 750/mm(3); Hemoglobin greater than 8.0 g/dl (transfusions are allowed); Platelet count greater than 100,000/mm(3). Not pregnant or not planning to become pregnant. No active substance abuse. Able to comply with the study requirements for scheduled evaluations such as periodic clinic visits or blood sampling | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Paralysis American Society of Anethesiology Class I-III adult patients undergoing elective surgery requiring neuromuscular blockage for endotracheal intubation. No pre-existing renal or hepatic disease, Myasthenia-Gravis, Eaton-Lambert Disease, pregnancy, concurrent anticonvulsant therapy, history of hypersensitivity to rocuronium, neostigmine, or glycopyrrolate | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Acquired Immunodeficiency Syndrome HIV Infection to 60 years of age, HIV-1 negative by HIV-1 ELISA, HIV PCR and Western Blot analysis. Subjects in good health with no evidence of underlying disease based on history, physical exam and laboratory analysis. Must have normal organ function as characterized by the following: Hematopoietic: absolute granulocyte count of at least 1500/mm(3); platelet count of at least 150, 000/mm(3); hematocrit within normal range. Renal: BUN less than 23 mg/dl; creatine less than 1.6 mg/dl. Hepatic: serum total bilirubin less than 1.5 mg%. Metabolic: ALT less than or equal to 1.5 x upper limit of normal range; serum calcium within normal range; serum lactate within normal range; total serum CPK within normal range. Endocrine: serum glucose - within normal range. Immunologic: CD4 count greater than or equal to 500 cells/mm(3); total serum immunoglobulin (IgM, IgG and IgA) levels within normal ranges. No other clinically significant laboratory abnormalities. All subjects must understand the basis of transmission of HIV and other common sexual and blood borne infections and agree to practice abstinence or clinically accepted methods of prevention, including barrier protection during intercourse for the duration of the study. Female subjects of child bearing potential must have a negative pregnancy test. Must be available for active follow-up. Able to give informed consent by signing the Institutional Review Board (IRB)-approved consent form(s). Must not have previous immunization with any experimental vaccine directed against HIV or receipt of any experimental agent within 30 days prior to enrollment. Must not receive any blood product or immunoglobulin within 6 months prior to enrollment. Must not be exposed to potentially infective HIV fluids within the prior 6 months or tested positive for HIV at any time. No history of any prior disease or therapy which would affect immune function including: Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; Radiation therapy or cytotoxic/cancer chemotherapy; immunodeficiency or auto-immune disease; Acute infection or a recent (within 6 months) history of chronic infection. Female subjects must not be nursing a child. Must not be taking any medication which may affect immune function, with the following exceptions: subjects may be taking low doses of nonprescription strength (e.g. ibuprofen or aspirin) or acetaminophen. No known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or of any serious adverse reactions to vaccines. No evidence of active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which would interfere with study participation. Must not be engaging in HIV-related high-risk behavior such as unprotected sex, sex with multiple partners, or intravenous drug use. No evidence of infection with HBV, HIV-1, HCV or HTLV-1 using standard testing procedures. Must not have any positive result for anti-DNA antibodies as measured by standard testing procedures (anti-DNA antibody and anti-nuclear antibody (ANA) assays. This study does permit enrollment of volunteers with a low positive ANA (less than or equal to 1:160) titers, if there is no clinical evidence of underlying disorders that are associated with a positive ANA, if no first degree relative has an autoimmune disease, and if anti-DNA and ENA are negative | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-999.0, Lyme Disease Screening FOR PTLDS: Age greater than or equal to 13 years old, suspect of suffering from Lyme disease Post-Treatment Lyme Disease Syndrome (PTLDS): For the purposes of this study, PTLDS is defined as occurring in male or female patients age 13 and above who have been diagnosed with confirmed or probable Lyme disease per CDC definition (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/). Studyphysician will review history to confirm probable cases. They have received recommended antibiotic therapy and have persistent or relapsing symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms. Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joint, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria. Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic. Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme disease. OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix [R]). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot. Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5. Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with Lyme disease and negative serological testing to B.burgdorferi by the CDC criteria. All study participants must agree to allow their samples to be used for future research General Age less than 18 (less than 13 for patients with PTLDS). Weight less than 70 Lb (35 kg). Pregnancy or lactation. Women with childbearing potential who are sexually active with a male partner and unwilling to use effective contraception during the evaluation and treatment phases of the protocol. Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV. Chronic medication use will be evaluated in a case-by-case basis. Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation FOR PTLDS AND LYME In addition to the general these individuals will be excluded for: 1. Use of immunosuppressive drugs such as systemic (but not topical or inhalant) steroids and cytotoxic agents. 2. History of any recognized autoimmune disease such as rheumatoid arthritis, vasculitis, systemic erythematous lupus, etc. 3. Serious pre-existing or concurrent chronic medical or psychiatric illnesses other than Lyme disease. 4. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness that might produce neurologic deficit (such as cerebrovascular disease). 5. Use of systemic antibiotics in the previous month. 6. Use of immunomodulators such as interferons. 7. Chronic medication use will be evaluated in a case-by-case basis. 8. Patients will be excluded from this protocol if they are judged by the principal investigator as having a significant impairment in their capacity for judgment and reasoning that compromise their ability to make decisions in their best interest FOR OSPA AND In addition to the above applicable (general and for PTLDS patients and Lyme arthritis controls), these individuals will be excluded for: 1. Pre-existing or concurrent serious chronic medical or psychiatric illness FOR In addition to the above general these individuals will be excluded for: 1. Pre-existing or concurrent serious psychiatric or chronic medical illness besides Multiple Sclerosis. 2. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness, besides Multiple Sclerosis, that might produce neurologic deficit (such as cerebrovascular disease). 3. Previously received total lymphoid irradiation (TLI) or cladribine. 4. Has used of immunoactive medications (excluding beta-interferon) in the three months preceding the study. 5. In the three months prior to the study initiation, was given such investigational treatments as plasmapheresis, hyperbaric oxygen, gangliosides, Copolymer 1, etc. OF Children: Children 13 years and older are eligible to participate in the PTLDS cohort because the condition under study can affect children. T, and this age was selected as appropriate for the children to provide assent to and comply with the study procedures. Children younger than 13 will be excluded from the PTLDS cohort, and no children will be enrolled in the other study cohorts. Pregnant and lactating women: Pregnant and lactating women are excluded from study participation. An enrolled participant who becomes pregnant during the study will be withdrawn Adults who lack capacity to consent: Adults who lack decision-making capacity to provide informed consent are excluded at screening, and enrolled adult participants who permanently lose the ability to consent during study participation will be withdrawn. NIH staff members: NIH staff may be enrolled if they meet criteria. Neither participation nor refusal to participate as a subject in the research will have an effect, either beneficial or adverse, on the participant s employment or position at NIH. Every effort will be made to protect participant information, but such information may be available in medical records and may be available to authorized users outside of the study team in both an identifiable and unidentifiable manner | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 8.0-99.0, Pulmonary Disease Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician. Consenting to pregnancy testing in minors of childbearing age: We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end Patients without symptoms of pulmonary disease will be excluded from this protocol | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Acquired Immunodeficiency Syndrome Mycobacterium Avium-Intracellulare Infection Documented HIV infection (ELISA and Western blot positive). 18 years or older. Clinically stable enough to travel to NIH and meet protocol schedule requirements. Negative urine or serum pregnancy test within 14 days prior to study entry (for women of childbearing potential). Patients should be receiving a combination of FDA approved antiretroviral drugs or expanded access antiretroviral therapy for at least two weeks prior to study entry. The exception would be that, in the opinion of the primary treating physician, this therapy would not likely provide benefit. Greater than or equal to 1 positive blood culture or 1 positive culture from a normally sterile site (e.g. lymph node, bone marrow, etc.) for MAC within 6 weeks of study. The initial screening blood culture at the NIH must be positive. The following lab values must be present at study entry: Transaminases, alkaline phosphatase, total bilirubin less than or equal to 5x upper limit of normal range. Serum creatinine less than or equal to 2.0 mg/ml. Proteinuria less than or equal to positive 1. Normal PT/PTT. Granulocyte count greater than or equal to 750/cubic millimeter. Hemoglobin greater than or equal to 8 gm/dL and platelet count greater than or equal to 75,000. Fasting Blood glucose 1.25x upper normal limit (126 g/dl). (In persons with no history of diabetes.) No malignancy other than Kaposi sarcoma. Patients with Kaposi sarcoma are eligible, but must not have received systemic therapy for KS. No current life threatening AIDS related opportunistic infection other than disseminated MAC. No evidence of active substance abuse according to the standard 8th floor clinic substance abuse assessment, which allows enrollment at the discretion of the principal investigator. No patients exhibiting psychiatric disturbance or illness, which in the assessment of the protocol team may affect patient safety or compliance. No significant cardiac, gastrointestinal, pulmonary, autoimmune, renal, or CNS disease which could interfere with patient safety. No hypertension requiring anti-hypertensive therapy. No pregnant or lactating patients, or any patient with an inability or unwillingness to use effective contraception. Willingness to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV seropositivity and the risk of transmission of HIV infection | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Cerebellar Disease Dementia Healthy Parkinson's Disease Right handed normal volunteers (18-65 years old). Patients with Parkinson's disease off medication. Patients with cerebellar deficits. Patients with frontal lobe lesions. Patients with frontal lobe dementia Subjects with personal or family history of seizures or other neurological disorders. Pregnant women. Volunteers or patients with severe coronary artery disease. Metal in the cranium except mouth. Intracardiac lines. Increased intracranial pressure as evaluated by clinical means. Cardiac pacemakers. Intake of neuroleptics | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Sjogren's Syndrome Female gender only, ages 18 to 75. Patients should have documented primary Sjogren's syndrome as determined by protocol 84-D-0056. The diagnosis of primary Sjogren's syndrome will be based on the presence of all three of the following: Salivary gland abnormalities; Lacrimal gland abnormalities; Serologic abnormalities. Controls should have no signs or symptoms of Sjogren's syndrome, and negative serologic testing reconfirmed within 2 weeks of the OGTT. Willingness to: a) participate in phase I and II of the protocol; b) follow the guidelines set to prepare for the OGTT; and c) modify current medical therapy if necessary. Must be able to comply with protocol procedures. No patients with "incomplete" Sjogren's syndrome, i.e., with less than three positive findings as described above. No presence of physical or mental conditions that may interfere with the protocol. These the following diseases and conditions: (Present at time of phase I/II): significant disruption of sleep-wake pattern (i.e., less than 4 hours of continuous sleep, on the night before the OGTT only), BMI less than 18 or equal to/greater than 30, anemia with Hgb less than 10 gm/dl, use of tobacco or alcohol; (Within the past 6 weeks): acute weight change (greater than 5%), use of contraceptives -BCP-, Depoprovera or Norplant), irregular menstrual cycle, lactation, blood drawing in excess of 50 ml, use of recreational drugs, modification of estrogen replacement therapy; (Within the past 6 months): chronic pattern of weight change (greater than 10%), eating disorders, uncontrolled hypo/hyperthyroidism, breast cancer, lymphoma or other malignancy, pregnancy, treatment for depression, insulinoma, VIPoma, pheochromocytoma, atrophic gastritis, active tuberculosis or treatment for it; (A history of): HIV+, sarcoidosis, secondary Sjogren's syndrome, bleeding diathesis, organ transplant, severe neuroendocrine, renal, cardiovascular, pulmonary or gastrointestinal disease (e.g., renal insufficiency, unstable angina, heart failure, severe emphysema, Crohn's disease), diabetes mellitus, acromegaly and mental retardation. No contraindications to OGTT. These Hospital inpatient status, acute illness, immobilization, starvation, severe emotional distress within one week of the OGTT; Low carbohydrate diet (less than 150 g/day) for 3 days preceding the OGTT; Pregnancy; Therapy which impairs glucose tolerance: e.g., niacin, thiazide diuretics, phenytoin, excess thyroxine or psychotropic drugs within 1 month of phase I, oral contraceptives within 6 weeks of phase I, glucocorticoid treatment within the past 6 months (or one year if treatment lasted over 2 weeks), Beta blockers/agonists (e.g., terbutaline) within 2 days of phase I; Diabetes mellitus; Glucose intolerance. Subjects may not take medications that can affect somatostatin levels, such as antidepressants, benzodiazepines, neuromodulators (e.g., cholinergic, alpha/beta adrenergic), oral contraceptives (BCP), steroid hormones (with the exception of estrogen replacement therapy -ERT-, for which subjects will be matched), immunomodulators, anticonvulsants (e.g., carbamazepine), cimetidine -Tagamet® (Registered Trademark)-, herbal remedies (because of their variable substance content). Subjects may not take drugs affecting gastrin secretion: antacids (e.g., Maalox® (Registered Trademark), Mylanta® (Registered Trademark), H(2) receptor antagonists (e.g., famotidine -Pepcid® (Registered Trademark)-, ranitidine -Zantac® (Registered Trademark)-), cathecolamines, atropine, haloperidol. To become eligible, subjects should be able to safely discontinue these medications at least one month prior to phase I. Antacids, H(2) antagonists and neuromodulators (e.g., Salagen) may be discontinued 2 days prior to phase I. Patients cannot have take experimental drugs within 1 month of the beginning of the protocol | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Acquired Immunodeficiency Syndrome HIV Infections Adults (greater than 18 years) infected with HIV-1. Plasma viral burden greater than 8,000 and less than 60,000 RNA copies per ml. by bDNA method at screening. CD4 cell count above 200 cells per microliter at screen. No prior treatment with any anti-retroviral agent. Laboratory values at screen: hemoglobin greater than 9 g per dl; granulocyte count greater than 900 cells per microliter; platelet count greater than 80,000 cells per microliter; AST (SGOT) less than 151 U/L; creatinine less than 2 mg/dL. Must not be pregnant or breast-feeding and willing to avoid pregnancy by the use of non-hormonal methods of birth control during study participation. Pregnancy test (blood or urine) must be negative within two weeks prior to dosing with study medications. Willing and able to provide written informed consent. No history suggestive of malabsorption. No chronic diarrhea. Must not have had treatment with systemic corticosteroids at greater than physiologic replacement doses, interleukins, interferons, radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or an anticipated need for radiation or chemotherapy treatment within the next 48 weeks (with the exception of local treatment of Kaposi's sarcoma). Must not have current or anticipated therapy with other agents with documented activity against HIV-1 in vitro. Must not have active, untreated opportunistic infection or other major illness that would, in the opinion of the investigator, increase the risk that adverse events might pose to the patient or might render the patient too ill to return for study visits. Must not have significant substance abuse or psychiatric illness that might interfere with assessment or compliance. Must not have current or anticipated future need for any of the following drugs which are contraindicated with an amprenavir-ritonavir regimen because of drug-drug interactions: Terfenadine (Seldane), Astemizole (Hismanal), Cisapride (Propulsid), Triazolam (Halcion), Bepridil (Vascor), Medazolam (Versed), Rifampin (Rifadin, Rifamate, Rifater), Ergotamine/Dihydroergotamine containing regimens (Ergomar, Wygraine, Ercaf, DHE, Migranal), Amiodarone (Cordarone), Flecanaide (Tambocor), Propafenone (Rythmol), Quinidine (Quinaglute, Cardioquin), and Pimozide (Orap). Must not have current or anticipated future need for the following anticonvulsants: phenobarbital, phenytoin, carbamazepine | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Cytomegalovirus Infection Infection Male or female patients that are 10 years of age or older up to 80 years of age are included. Patients must be enrolled in a protocol at the NIH Clinical Center that will result in the patient receiving an allogeneic stem cell transplant (A-HSCT). Patients who have not yet received a pre-transplant chemotherapy and radiation therapy conditioning regimen are eligible. Patients must not have a negative IgG serologic test for CMV and whose hematopoietic stem cell donor also has a negative IgG serologic test as reported by the Bone Marrow Transplant staff. Patients must not have documentation of prior cytomegalovirus antigenemia or disease prior to starting the conditioning regimen | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Endometrial Cancer Psychosocial Effects of Cancer and Its Treatment Pathological stage III/IV endometrial carcinoma of any histology (including clear cell and serous papillary carcinomas) The following extent of disease eligible: Positive adnexa Tumor invading the serosa Positive pelvic nodes Positive para-aortic nodes Involvement of the bowel mucosa Intra-abdominal metastases Positive pelvic washings Vaginal involvement within the radiotherapy field Hysterectomy and bilateral salpingo-oophorectomy (BSO) required with residual tumor not greater than 2 cm at any site Selective pelvic and para-aortic lymph node sampling optional for patients with stage III/IV disease by other If para-aortic nodes are positive, scalene nodes must be negative on biopsy and chest CT must be negative for intrathoracic disease The following disease conditions Parenchymal liver metastasis Lung metastasis Positive inguinal nodes Positive scalene nodes Recurrent disease Protocol therapy must begin within 8 weeks after surgery Age: Not specified Performance status: GOG 0-3 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction normal Other: No past or concomitant malignancy other than nonmelanomatous skin cancer PRIOR Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior progestational agents allowed No other prior endocrine therapy Radiotherapy: No prior pelvic or abdominal radiotherapy Surgery: Hysterectomy and BSO required Pelvic and para-aortic lymph node sampling optional (see Disease Characteristics) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 10.0-70.0, Melanoma Skin Cancer Histologically diagnosed malignant melanoma with regional lymph node metastases Undergone complete lymph node dissection and free of any residual tumor No greater than 90 days from diagnosis of regional lymph nodes metastases No distant or resected in-transit metastases Age to 66 to 70 if in excellent physical condition Performance status 2 Life expectancy At least 12 months Hematopoietic Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm^3 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Cervical Cancer Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer PRIOR Not specified | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-99.0, Head and Neck Cancer Histologically confirmed cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists Metastatic disease OR incurable with surgery or radiation Measurable disease by CT scan or MRI Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas Age and over Performance status Karnofsky 60-100% Life expectancy At least 2 months Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic No hepatic insufficiency | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Healthy Neuromuscular Disease Postpoliomyelitis Syndrome Adult patients with weakness or motor dysfunction: 8/year. Normal volunteers, adults: 2/year Anticoagulation or uncorrected bleeding disorder. Children are not optimal subjects for fellows undergoing training in these techniques and will be excluded | 2 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-999.0, Myasthenia Gravis ENTRY --Disease Characteristics- Mild or moderate generalized myasthenia gravis Grade 2 or 3 myasthenia gravis according to a modified Osserman groups system Ocular myasthenia gravis alone or myasthenia gravis in crisis not eligible Must have elevated acetylcholine receptor antibody titer No evidence of thymoma on chest CT or MRI No immunoglobulin-A deficiency less than 5 mg/dL Group 1: Patients who have not received other immunosuppressive therapy in the past, including intravenous immunoglobulin Group 2: Patients considered steroid-dependent Considered steroid-dependent if demonstrated improvement following initiation of corticosteroid therapy but continue to have generalized weakness on examination despite receiving 20 mg of prednisone (or equivalent) every other day and experience unacceptable symptoms on lower doses Prednisone and other immunosuppressive drug doses must not have changed within last 4 weeks May have had other immunosuppressive medication (azathioprine, cyclosporine, cyclophosphamide) or have received plasma exchange if these treatments were not initiated in the 2 months prior to study enrollment Must be receiving immunosuppressive medication for at least 3 months prior to study --Prior/Concurrent Therapy- Endocrine therapy: Corticosteroid must be maintained at a constant dose during study Surgery: No thymectomy in the last 3 months Other: No plasmapheresis in the last 2 months --Patient Characteristics- Age: 15 and over Weight: No greater than 80% above ideal body weight Hepatic: SGOT, SGPT, and alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN) Renal: BUN no greater than ULN Creatinine no great than ULN Neurology: No history of relevant chronic degenerative, psychiatric, or neurologic disorder, other than myasthenia gravis, that can produce weakness or fatigue No altered consciousness, dementia, or abnormal mental status Pulmonary: Forced vital capacity at least 50% of predicted Not at high risk for aspiration Other: No active thyroid gland dysfunction as manifested by abnormal thyroid function tests or the need for current thyroid replacement Normal thyroid function tests required No other major relevant chronic or debilitating illnesses within 6 months of study Not pregnant or nursing Adequate contraception required of all fertile patients | 2 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Vulvar Cancer Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both At least 1 positive inguinal and/or femoral lymph node No inoperable (fixed or ulcerating) groin nodes Must not require resection of urethra or anal sphincter to achieve negative margins Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization No metastatic disease Age Any age Performance status GOG 0-2 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Focal Segmental Glomerulosclerosis Patients with idiopathic focal segmental glomerulosclerosis on renal biopsy, including the following categories: A) Untreated FSGS B) Steroid-dependent FSGS C) Steroid resistant FSGS D) Recurrent FSGS, with functioning allograft E) FSGS in ESRD, receiving hemodialysis 2. Adults greater than or equal to18 will be eligible for all studies. 3. Children greater than 20 kilograms, will be eligible for all branches of the study except for treatment of steroid resistant FSGS with pirfenidone, as pirfenidone has not previously been administered to pediatric patients in any setting. Children less than 20 kilograms will be excluded from the study for the following reason: plasma exchange in patients less than 20 kilograms requires a red blood cell transfusion, which significantly increases the risk of the procedure by exposing the patient to the risk of transfusion associated infections, and the safety of an aggressive course of plasma exchange has not been established in this population Secondary FSGS: HIV-associated FSGS or hyperfiltration FSGS, including FSGS associated with congenital renal abnormalities, renal mass reduction, reflux nephropathy, interstitial nephritis, and sickle cell anemia are excluded. 2. Patients with disease associated with immunosuppression, other than chronic renal failure. 3. The presence of malignancy or the history of other serious, complicating illness such as myocardial infarction or cerebrovascular accident in the past six months, at the discretion of the investigators. 4. For plasma exchange: A Department of Transfusion Medicine consultant will evaluate all potential plasma exchange patients. Those with prolonged PT, PTT, platelet count less than 100,000 or receiving anticoagulant therapy will undergo plasma exchange only if the consultant considers this to be safe. 5. For prednisone: uncontrolled diabetes mellitus (requiring greater than 100 units of insulin/day with the concurrence of the Endocrinology consultant), active infection including hepatitis B or C (if that is the advice of the Hepatology consultant), infection with HIV (as these patients are at increased risk of avascular necrosis), other active infection (if that is the advice of the Infectious Disease consultant), history of avascular necrosis or bone densitometry indicating bone mass less than 2SD below normal, active ulcer disease, history of steroid-induced psychosis, morbid obesity, positive PPD or history of past positive PPD without adequate treatment are excluded. 6. For Cyclophosphamide: A) Allergy or hypersensitivity to cyclophosphamide B) Leukocyte less than 3000 cells/microliter or ANC less than 1500 cells/microliter or evidence of bone marrow compromise C) Prior irradiation to the heart or therapy with doxorubicin or other cardiotoxic medication (may increase the risk for cardiotoxicity) D) Peritoneal dialysis, as there is no published evidence that cyclophosphamide metabolites can be safely removed. E) Certain drugs will be used with caution or avoided. Barbiturates and phenytoin induce the hepatic enzymes that metabolize cyclophosphamide and therefore if these medications are required, cyclophosphamide doses may need to be increased to achieve a comparable immunosuppressive effect. Drugs that inhibit cyclophosphamide metabolism allopurinol, imipramine, and phenothiazines, chloramphenicol and chlorpromazine; these drugs will be avoided. NSAID increase the risk of hyponatremia; these drugs will be avoided | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Esophageal Cancer Gastric Cancer Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor No more than 8 weeks since primary tumor resection No metastatic disease Age Not specified Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic WBC (white blood cell count) at least 4,000/mm^3 Platelet count at least 150,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal Renal | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, HIV Infections HIV positive to 24 weeks pregnant Willing to take the planned antibiotic treatment Planning to deliver at 1 of the study sites Willing to come back for follow-up visits for 1 year after the baby is born Have taken antibiotics, except for syphilis or gonorrhea, within the last 2 weeks Are allergic to penicillin, ampicillin, erythromycin, or metronidazole Have major illnesses, such as diabetes, severe kidney or heart disease, or active tuberculosis, which might affect the pregnancy Are having major problems with the pregnancy, such as placenta previa, ruptured membranes, or multiple pregnancy Have a central nervous system disease, such as seizures Are taking anticoagulant drugs | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-999.0, HIV Infections Late Presenter Group Unknown HIV serostatus >= 34 weeks gestation Peripartum Group Unknown HIV serostatus >= 24 weeks gestation In active labor or delivery expected within 24 hours Infants Maternal Step I enrollment Positive maternal OraQuick and/or EIA/Western blot result Late Presenter Group Previous or current antiretroviral therapy for treatment of HIV infection In active labor Evidence of ruptured membranes Peripartum Group Previous or current antiretroviral therapy for treatment of HIV infection | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-999.0, Breast Neoplasms Metastases, Neoplasm Patients will be eligible for this trial if Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception Sixteen years of age or older Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer Suitable candidate for paclitaxel therapy Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis Expected survival of at least 12 weeks | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 3.0-999.0, Mitochondrial Diseases Mitochondrial Disease | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 12.0-999.0, Cystic Fibrosis Eligible subjects will be randomized to two aerosolized doses of either tgAAVCF or placebo 30 days apart. Subjects will undergo pulmonary function testing every two weeks during the active portion of the study (three months) and will be followed for safety for a total of seven months | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-999.0, HIV Infections Note: The pharmacokinetics testing portion of this study has been discontinued in Version 2.0 of this protocol. for Mothers HIV infected Between the 12th and 30th week of pregnancy Intend to continue pregnancy Viral load less than 55,000 copies/ml within 30 days of study entry CD4 count greater than 350 cells/ml within 30 days of study entry Have not previously taken anti-HIV medications (women who have taken 8 weeks or fewer of zidovudine are still eligible) OR have taken anti-HIV medication but have been off treatment for more than 180 days Intend to stop taking anti-HIV medications after pregnancy Willing to have her infant tested for HIV Parent or guardian willing to provide informed consent, if applicable for Mothers Chemotherapy for active cancer Active opportunistic infection or severe medical condition within 14 days of study entry Chronic diarrhea within 1 month of study entry or unresolved acute diarrhea within 7 days of study entry Certain abnormal laboratory values Diabetes mellitus when not pregnant. Participants who have gestational diabetes are not excluded Current alcohol or other substance abuse that, in the opinion of the investigator, may interfere with the study Acute hepatitis within 90 days of study entry Major birth defects in infant Severe skin disorder (e.g., eczema or psoriasis) requiring systemic treatment | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer Patients must have histologically or cytologically confirmed renal cell carcinoma which is either metastatic (M1) or unresectable (M0); patients must have a component of conventional clear cell renal carcinoma; patients with true papillary renal cell carcinoma, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible Patients must have measurable disease; soft tissue disease, which has been radiated in the 2 months prior to registration, is not assessable as measurable disease; X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measureable disease must have been completed within 42 days prior to registration; all disease must be assessed Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery Patients must not have received any prior systemic therapy for renal cell carcinoma, including chemotherapy, interferon, interleukin-2, other biologic response modifiers, anti-angiogenic therapy, hormonal therapy, or any other experimental systemic therapy; prior treatment with thyroid medications is allowed Patients may have received prior radiation therapy to less than 25% of the bone marrow; at least 28 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration Total bilirubin =< institutional upper limit of normal SGOT or SGPT =< 2.5 x institutional upper limit of normal Serum creatinine =< institutional upper limit of normal or calculated creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal Patients who have had a prior nephrectomy must have a serum creatinine =< 2 x institutional upper limit of normal Patients must be offered the opportunity to consent for specimen submission | 0 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.