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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-40.0, Removable Aligners, Conventional Brackets Moderate to severe crowding orthodontic patients.( Irregularity index of <5 mm) 2) Good oral hygiene. (Patient with periodontally sound dentition). 3) Patient in permanent dentition between the age range 16 years. 4) .Patients requiring extraction of mandibular and maxillary first premolars; 5) Patients having sound general health Systematic disease. 2) Poor oral hygiene patients. 3 ) Periodontally affected teeth
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-42.0, Ovarian Cysts Endometriosis Fertility An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI) Patient able to provide informed consent to her participation in the study Patient covered by the " Sécurité Social " insurance system Adult patient under protection, tutorship or curatorship Refusal of the patient or poor understanding of the French language Known allergy to iodine Current pregnancy or breastfeeding
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Pituitary Adenoma Patients with non-functioning pituitary adenomas who require surgical intervention, as deemed appropriate by a neurosurgeon, either due to size observed growth in lesion on MRI, and/or for alleviation of the symptoms of mass effect Patients with functional pituitary adenomas, including prolactinomas, growth-hormone secreting adenomas, and ACTH-secreting adenomas, where surgery is recommended for biochemical control. Patients with symptoms of Cushing's Disease and centralization of ACTH on IPSS without imaging-confirmed lesions will be included in the study History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 hours Personal or family history of porphyria Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated with 5-aminolevulinic acid Women who are pregnant or become pregnant will be excluded from the trial as it is unknown if aminolevulinic acid (ALA) is teratogenic or has abortifacient effects Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Pruritus Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening Subject is a nonsmoker for at least 6 months prior to the study start Subject has a body mass index ≥ 18 and ≤ 30 kg/m2 Subject has a clear increase in histamine-induced dermal blood flow Subject is judged to be in good health on the basis of medical history, physical examination and vital signs Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent Subject has excessive hair growth on the volar surface of the forearm Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study Subject has a past or present history of (symptomatic) asthma Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate. Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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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
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 9.0-17.0, Amenorrhea Oligomenorrhea Puberty Female adolescents aged 9 to 17 years Menarche within 11 months of the enrollment visit Current or recent use of medications or supplements known or suspected to interfere with reproductive or metabolic function in the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure medications) Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function Currently pregnant or breast feeding History of ovarian surgery Presence of significant acute or chronic illness which may interfere with study participation
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-999.0, Polycystic Ovary Syndrome A polycystic ovarian patient was diagnosed by a specialist in obstetrics and gynecology according to the diagnostic set by the Rotterdam ESHRE / ASRM-sponsored PCOS workshop group (2004) in 2003 diseases similar to the clinical manifestations of polycystic ovary, such as cushing syndrome, congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia. 2. Diagnose a clear mental disorder (such as schizophrenia, severe depression) or take psychiatric drugs (anti-depression or anxiety drugs). 3. Pregnancy, oral contraceptives, use high-dose exogenous androgens, breastfeeding. 4. Those with a history of stroke, myocardial infarction, major trauma or surgery within the past six months. 5. Have taken Chinese medicine in the past month
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea mild-moderate OSA patients with subjective snoring complaints Severe OSA Undergone previous surgical therapy for SS or OSA High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders Inadequate dental anchor for MAD treatment Temporomandibular joint dysfunction Angle Class III maxillomandibular relation
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Breast Cancer Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 75 years. 3. 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side effects of chemotherapy have subsided. 5. The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry. 6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 7. Expected survival ≥ 12 weeks. 8. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10^6/L; platelet (PLT) ≥ 1×10^8/L. 9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 2.5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 6. Inadequate liver and renal function with serum creatinine > 1.5 mg/dl; serum (total) bilirubin > 2.0 mg/dl; AST & ALT > 3 x ULN. 7. Pregnant or lactating females. 8. Serious active infection during screening. 9. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection. 10. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 60.0-85.0, Normal Pressure Hydrocephalus Age of patients (between 60 and 85 years old) Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait and one other symptom from Hakim-Adams triad (incontinence or dementia) maximal initial pressure of 20 cmH2O during lumbar infusion test Rout during LIT >9mmHg/ml*min at least 15% improvement in Gait scale score after ELD Conclusion of neuropsychological examination suggestive of iNPH (based on MoCA, Test of phonemic and verbal fluency, RAVLT, ROCFT, TMT A and B, Subtest of WAIS III, GDS) Aetiology of hydrocephalus other than idiopathic normal pressure hydrocephalus (secondary normal pressure hydrocephalus history of meningitis or subarachnoid haemorrhage, obstructive type of hydrocephalus eg aqueductal stenosis, Blake's pouch cyst) Intracranial tumor Other neurodegenerative diseases may be present (AD, Parkinson's disease, Lewy body dementia, Progressive supranuclear palsy and cerebrovascular diseases), however have to be mild and evaluated in neurological, neuropsychological examinations and on MRI
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-45.0, Infertility Diminished Ovarian Reserve IVF Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Female aged 20 4. Regular menstrual cycles between 21 and 40 days 5. Presence of both ovaries 6. Meets for DOR by the recent ASRM/ACOG Committee Opinion 1. antimüllerian hormone (AMH) value less than 1 ng/mL 2. antral follicle count less than 5-7 and 3. follicle-stimulating hormone (FSH) greater than 10 IU/L or 4. a history of poor response to in vitro fertilization stimulation (fewer than four oocytes at time of egg retrieval) Oocyte donation cycle 2. Oocyte freezing cycle 3. Current ovarian cyst > 3cm 4. Anovulatory or oligo-ovulatory (<6 ovulation per year) 5. Previous oophorectomy 6. Exposure to cytotoxic or pelvic irradiation 7. Planned aromatase inhibitor usage during current ovarian stimulation 8. Sensitizing or ovarian stimulating therapy in the past one month Additional contraindications to this study re, as follows (because such patients cannot receive an estrogen patch): 9. Undiagnosed abnormal genital bleeding 10. Known, suspected, or history of breast cancer 11. Known or suspected estrogen-dependent neoplasia 12. Active DVT, PE, or a history of these conditions 13. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions 14. Known anaphylactic reaction or angioedema with estradiol patches 15. Known liver impairment or disease 16. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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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
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, PCOS Hyperandrogenism Inflammation (patient should meet all the criteria) 1. Diagnosis of PCOS according to Rotterdam 2. Written consent to participate in a clinical trial 3. Age up to 40 years 4. Irregular periods (> 35 days) or secondary amenorrhea over 3 months 5. Hyperandrogenism (hirsutism and / or acne) and / or total serum testosterone> 0.5 ng / mL A diagnosed chronic disease, including in particular Cancer of the ovary, adrenal gland, endometrium, cervix, mammary gland Congenital adrenal hyperplasia (17-OH progesterone> 2 ng / mL) Clinically diagnosed Cushing's disease, acromegaly, gigantism Type I or II diabetes Gastrointestinal diseases (peptic ulcer, inflammatory bowel disease, liver disease) Active or history of gastric and duodenal ulceration, perforation or bleeding, also following NSAIDs. Gastrointestinal bleeding Severe hepatic impairment, severe renal insufficiency or severe heart failure Hemorrhagic diathesis
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-999.0, Ovary Cancer In order to be eligible for participation in this trial, the patient must: 1. Be willing and able to provide written informed consent for the trial 2. Age 16 years or over on day of signing informed consent 3. Histologically proven Ovarian Cancer (OC) FIGO stage III with residual disease of more than 1cm; or stage IV; or stage III at presentation treated with neoadjuvant chemotherapy; or stage III with contraindication to debulking surgery chemotherapy 4. Planned to receive treatment with bevacizumab or biosimilar bevacizumab 5. Be scheduled to receive at least 2 successive doses of bevacizumab with 6 or more weeks of follow up blood samples after the first dose of bevacizumab if given pre-operatively; or to start bevacizumab post-operatively 6. Be eligible for receiving treatment with first line platinum-based chemotherapy 7. Be willing to provide blood samples and comply with trial-specific procedures The patient must be excluded from participating in the trial if the patient: 1. Is unsuitable for treatment with VEGF inhibitors 2. Is unable or unwilling to comply with study procedures 3. Is participating in a clinical study with an investigational product other than carboplatin, paclitaxel and bevacizumab 4. Is judged by the investigator to be unlikely to comply with study procedures 5. Is pregnant or could become pregnant and is not using adequate contraception 6. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) 7. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected). Testing only required if patient has a history of either of these
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-60.0, Headache Pituitary Tumor Acromegaly Patients with GH tumor who have undergone transnasal pituitary tumor resection or craniotomy for pituitary tumor resection in the past (3 months or more), aged between 18 and 60 years old, regardless of gender Preoperative glucose tolerance test (OGTT) simultaneously determines that the trough value of GH is greater than 1ng/ml, and the level of IGF-1 is greater than the upper limit of the age-sex-matched normal value; ③. Biochemical remission is achieved after surgery, that is, the random GH value is less than 1ng/ml, and the IGF-1 level is within the normal range of age and gender matching; ④. The patient still has headaches after the operation, the duration of each attack is more than 4 hours, and the attack is more than 3 times per month; ⑤. The patient is in a headache attack period; ⑥. A clear consciousness, able to understand and sign an informed consent form Patients who are being treated with somatostatin and bromocriptine Patients with other intracranial organic diseases Pregnant women and children who cannot express Patients with other malignant tumors Participate in other clinical research in the same period; ⑥. Patients with severe medical complications, such as heart, lung, kidney, liver and other diseases, severe hypertension or poor blood pressure control, hyperglycemia, blood diseases Those with mental illness who cannot cooperate well with the experiment Patients with acute infection or open wounds; ⑨. Acetaminophen is contraindicated (hemolytic anemia, severe liver and kidney dysfunction) or allergic to its components; ⑩. Patients with contraindications to transcranial magnetic stimulation: patients or users who have implanted cardiac pacemakers, implantable defibrillators and neurostimulators together; those who have a history of epilepsy; wear electronic products (such as insulin Pumps, Holter, etc.)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Ovary Cancer Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III - IV) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum-based chemotherapy, in PR/CR and treated with at least one dose of olaparib in first line maintenance setting Patients aged ≥18 years old Ability and/or willingness to provide a signed informed consent form (where required) Withdrawal of informed consent (where consent required) Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Ovarian Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Ovarian Epithelial Ovarian Diseases Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Carcinoma Bevacizumab Enzyme Inhibitors Antineoplastic Agents Molecular Mechanisms of Pharmacological Action Angiogenesis BRCA1 Mutation BRCA2 Mutation Homologous Recombination Deficiency Subjects understand the trial process, sign informed consent, agree to participate in the study, and have the ability to follow the protocol; 2. Participant must be female ≥18 years of age; 3. Histologically confirmed FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4. Participants must have high-grade serous or endometrioid histology; 5. Subjects were initially treated with platinum, and the disease recurrence occurred within 6 months after the end of the previous platinum-containing chemotherapy, that is, platinum resistance relapsed; Subjects have disease progression during initial platinum based chemotherapy defined as platinum refractory; 6. Patients may have received a PARP inhibitor as first-line maintenance therapy; 7. Patients may have received bevacizumab though no other prior use of anti-angiogenic therapy； 8. Subjects must have measurable lesions (according to and radiologically confirmed disease progression at the time of previous treatment; or CA125 elevated for two consecutive times and 2.5 times upper the limit of normal value； 9. Subject agrees to take blood samples for gBRCA mutations, can provide formalin-fixed, paraffin-embedded tumor tissue samples for sBRCA and homologous recombination deficiency(HRD) detection; 10. Life expectancy>12 weeks; 11. Subject's ECOG physical status score is 0-2; 12. Good organ function, including:Neutrophil count≥1500/μL;Platelets≥100,000/μL;Hemoglobin≥10g/dL;Serum creatinine≤1.5 times the upper limit of normal value, or creatinine clearance≥60mL/min (calculated according to Cockcroft-Gault formula);Total bilirubin≤1.5 times the upper limit of normal value or direct bilirubin≤ 1.0 times the upper limit of normal value;AST and ALT≤2.5 times the upper limit of normal value. When liver metastases are present, it must be≤5 times the upper limit of normal value; 13. For women with fertility potential, if blood test or urine pregnancy test is negative within one week before enrollment, effective contraceptive measures must be taken, such as physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implantable hormonal contraceptives are not allowed. Or women without reproductive potential, defined as: I. Natural menopause and menopause for more than 1 year; II. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); III. serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopausal of the research center laboratory; 14. Subject is able to adhere to the protocol; 15. The adverse effect of any previous chemotherapy have recovered to ≤ Grade1 (CTCAE v5.0) or baseline levels, except for sensory neuropathy or hair loss with stable symptoms ≤ Grade2 (CTCAE v5.0) Personnel involved in the formulation or implementation of the research plan; 2. Patient participated in other clinical trails using other experimental drugs at the same time as the study; 3. People who are known to be allergic to Niraparib or Bevacizumab (or active or inactive ingredients of drugs with similar chemical structure); 4. People who are inability to swallow oral drugs and any gastrointestinal diseases that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption; 5. Major surgery was performed within 4 weeks before the start of the study or did not recover after the operation; 6. Received palliative radiotherapy of >20% bone marrow 1 week before enrollment; 7. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ; 8. Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 9. Patients with serious and uncontrollable diseases or the general situation of the subjects judged by the researchers to be unsuitable for enrolling the study, including but not limited to: active viral infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular disease, uncontrollable ventricular arrhythmia, myocardial infarction in the last three months; uncontrollable grand mal epilepsy, Unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect patients to sign the informed consent; hypertension beyond drug control; immune deficiency (except splenectomy) or other diseases that researchers consider may expose patients to high-risk toxicity; 10. The previous history of thromboembolism was defined as: uncontrolled pulmonary embolism, deep venous thrombosis, and other related conditions after anticoagulant therapy for more than 3 months before enrollment; 11. Any medical history or existing clinical evidence indicates that there may be confusion of study results, interference with patients' compliance with the trial protocol throughout the study treatment period, or not in the best interests of patients; 12. Receive platelet or red blood cell transfusions within 4 weeks; 13. Patients who are pregnant or lactation, or who plan to become pregnant during study treatment
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-0.058, Maternal Depressive Disorder Complicating Childbirth Preterm Birth Maternal Anxiety Disorder Complicating Childbirth Mother Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby Older than 18 years of age Infant • Gestational age between 26 0/7 and 30 6/7 weeks Mother • Younger than 18 years Infant • Major congenital or chromosomal anomalies
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Hand Injuries Finger Fracture -Fractures of the base phalanx of digit 2-5 in the hand Fracture older than 2 weeks More than 25° of sagittal plane and/or 10° lateral angulation after reposition Intra-articular step >1mm Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger Open fractures Patient age <18 years Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-999.0, Pregnancy-Related Condition, Unspecified Viable singleton pregnancy ≥28 weeks' gestation No fetal anomalies according to Fetal Anomaly Screening Programme definition Ability to give written informed consent Maternal Age >16 years Unable to read English (as the survey instruments are only available in English) Multiple pregnancy Pre-existing maternal cardiovascular or respiratory disease Fetal anomaly Contraindication to lying prone (severe pain etc.) Allergy to self-adhesive electrodes used for standard electrocardiography (ECG) Unable to give written informed consent
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Knee Sprain (Mild) Knee Sprain (Moderate) Subject is aged ≥18 years old Subject has a recent mild (grade I) OR moderate (grade II) knee sprain The current condition of his/her knee allows the subject to resume usual physical activity Subject has been informed and is willing to sign an informed consent form Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks) Subject is affiliated to the French social security regime Non-inclusion Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent Subject has worn a support (knee brace or articulated orthosis) since his/her recent injury Subject has resumed regular physical activity since his/her recent injury Subject has any medical condition that could impact the study at investigator's discretion
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Ankle Sprain 1St Degree Ankle Sprain 2Nd Degree Ankle Sprain 3Rd Degree Subject is aged ≥ 18 years old Subject has a recent mild OR moderate OR serious ankle sprain The current condition of his/her ankle allows the subject to resume usual physical activity Subject has been informed and is willing to sign an informed consent form Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks) Subject is affiliated to the French social security regime Non-inclusion Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury Subject has resumed regular physical activity since his/her recent injury Subject has any medical condition that could impact the study at investigator's discretion
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Cesarean Section Complications Blood Loss, Surgical Misoprostol Tranexamic Acid Women booked for a primary elective cesarean section, not in active labor Aged between 18-40 years BMI 18.5-29.9 kg/ m2 pre-pregnancy weight Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days) Singleton pregnancies Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes) Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age) Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008) Placenta previa Maternal hypertension and Preeclampsia Diabetes mellitus Severe medical disorder (renal or hepatic) Multiple Fibroid uterus Multiple pregnancies Polyhydramnios Previous uterine surgery as myomectomy Contraindication to spinal anesthesia Blood coagulopathy and bleeding disorder
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Headache Covid19 Sphenopalatine Ganglion Block Persistent Headache Following COVID-19 Age > 18 years Moderate to severe headache (NRS >= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (NRS >= 3) on the day of intervention Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection Headache must have persisted for at least 4 weeks following COVID-19 diagnosis Patients who cannot cooperate to the study Patients who does not understand or speak Danish Allergy to the drugs used in the study Has taken opioids within 12 hours prior to intervention History of migraine or persistent headache before COVID-19 infection Active COVID-19 infection (defined by the Danish Goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive COVID-19 test if no symptoms
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-80.0, Contrast Mammography in Pathological Nipple Discharge in diagnosis of female patients with pathological nipple discharge Patients with renal failure or with raised renal chemistry 2-patients who are allergic to contrast 2. Pregnant women
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 12.0-15.0, Imperforate Hymen postpubertal imperforate hymen - Prepubertal imperforate hymen
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Carpometacarpal; Dislocation Closed carpometacarpal fracture dislocation of the hand Adults from 18 to 80 years old history of fractures or tendon lesions in the same hand Children Open fracture dislocations
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Soft Tissue Injuries Distal Radius Fracture Metacarpal Fracture Carpal Fracture Carpal Tunnel Syndrome Thumb Osteoarthritis Dupuytren's Disease Age over 18 Patients with trauma or soft tissue injuries of the wrist, hand and fingers. Dupuytren, carpal tunnel syndrome, rizarthrosis, distal radius fracture, carpal fracture or metacarpal fracture Neurological pathology that affects the upper limb Non-cooperative Psychiatric illness
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Intracranial Pressure Increase minimum age of 18 years traumatic, tumor, ischemic, or hemorrhagic pathology of the posterior fossa GCS of 8 or less coagulation disorders multi-organ failure multiple pathologies open head trauma to the posterior fossa with leakage of nervous tissue
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-100.0, Head and Neck Neoplasm Radiotherapy years of age Histologic proof of primary diagnosis of head and neck cancer Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months) Ability to understand English in order to understand instructions and complete questionnaires Willing to participate in the supervised exercise intervention In the planning stages of/or actively receiving IMRT Must sign study-specific informed consent Medical clearance by attending physician Evidence of distant metastasis prior to enrollment Simultaneous primaries or unknown primary Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions Pregnant or lactating women
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-65.0, Acute Gastroenteritis Abdominal Pain Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain Peritonitis Hemodynamic instability Pregnancy Inability to give consent Medication given in the emergency room before being included in the study Taking pain medication within 4 hours Diabetes Mellitus and other neuropathic diseases
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Epithelial Ovarian Cancer Diagnosed with epithelial ovarian cancer Received treatment at HeCOG-affiliated institutions Have signed informed consent With adequate tumor tissue for analysis
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 40.0-70.0, Primary Open Angle Glaucoma Primary Angle Closure Glaucoma Known cases of POAG and PACG who are compliance to treatment and follow up 2. Those who have more than 10 degree from fixation (based on Humphrey visual field) 3. Best corrected visual acuity of 6/60 on the better seeing eye 4. Pseudophakic or phakic (without visually significant cataract) History of surgical intervention 3 months prior to recruitment 2. Physical disabilities such as stroke, limbs amputation 3. Severe hearing impairment 4. Those with macular and retinal pathology 5. Those already on low vision aids
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-90.0, Thumb Osteoarthritis Diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage Pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation The ability to read and understand the patient information sheets and exercises Neurological disorder affecting the upper limb Had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb; - Fractures or a significant hand injury or previous surgery to the wrist or hand Tenosynovitis and/or Dupuytren disease
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 13.0-18.0, Polycystic Ovary Syndrome The for the patient's were based on the 2003 Rotterdam with the presence of at least two of the following written consent for (girls and their parents) clinical and/or biochemical hyperandrogenism (hirsutism with moderate to severe acne, and/or elevation of serum total testosterone or free testosterone oligoovulation (based on oligomenorrhea defined as bleeding episodes occurring less than 8 times per year or secondary amenorrhea) polycystic ovarian picture in an ultrasound examination (at least 12 follicles in each ovary each measuring 2-9 mm in diameter and/or ovarian volume >10 mL) any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors medications of continuous use the use of hormonal therapy or antibiotics in the past three months vitamin or supplements use alcohol consumption smoking
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Duct Ectasia Breast Benign Breast Disease females with nipple discharge / recurrent peri-ductal mastitis - suspicion or evidence of malignancy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-90.0, Thumb Osteoarthritis Patients were included if they satisfied the following criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation,and the ability to read and understand the patient information sheets and exercises Patients were excluded from participation if they had a neurological disorder affecting the upper limb, had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Thumb Osteoarthritis Proprioceptive Disorders Pain, Chronic Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Male and female subjects ≥18 years of age 2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 <ULN) via stable dose of protocol defined somatostatin receptor ligand therapy 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent Treatment naïve acromegaly subjects 2. Prior treatment with paltusotine 3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy 4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. Known history of HIV, hepatitis B, or active hepatitis C 7. History of alcohol or substance abuse in the past 12 months 8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities 10. Subjects with symptomatic cholelithiasis 11. Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study 12. Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists, or short acting somatostatin analogs (with 12 weeks prior to Screening)
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-100.0, Cardiovascular Diseases Heart Diseases Hypertension Obesity
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-100.0, Cardiovascular Diseases Heart Diseases Coronary Disease
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 30.0-70.0, Cardiovascular Diseases Atherosclerosis Heart Diseases Diabetes Mellitus, Non-insulin Dependent Hypertension Diabetes Mellitus
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Healthy A participant must meet all of the as follows: 1. Age born no later than 1979 age 60 years old 2. Prior vaccination more than 10 years ago with any vaccinia product and evidence of a scar typical of prior vaccination leading to a primary take. 3. Available for follow-up for the duration of the study (at least 28 weeks). 4. Able and willing to sign the informed consent form 5. Willing to allow blood samples to be stored for future research 6. In good general health, without clinically significant medical history, physical examination findings or laboratory results. 7. Hematocrit greater than or equal to 34% for women; greater than or equal to 38% for men 8. White blood cell count within institutional normal limits 9. Differential either within institutional normal range or accompanied by site physician approval 10. Total lymphocyte count greater than or equal to 1000 cells/mm(3) 11. Absolute CD4 count greater than or equal to 400 cells/mm(3) 12. Platelets within institutional normal limits 13. ALT (SGPT) less than or equal to institutional upper normal limit 14. Serum creatinine less than or equal to 1.3 mg/dL and calculated creatinine clearance (CrCl) greater than or equal 55 mL/min using the formula below: Male CrCl (mL/min) = [140 age (yrs)] x [body wt (kg)] / 72 x [serum Cr (mg/dL)] Female CrCl (mL/min) = [140 age (yrs)] x [body wt (kg) x .85] / 72 x [serum Cr (mg/dL)] 15. Normal urinalysis defined as: negative glucose, negative or trace protein, and negative or trace hemoglobin 16. Negative hepatitis B surface antigen (HBsAg) 17. Negative anti-HCV or negative HCV PCR if the anti-HCV is positive 18. Negative HIV ELISA and HIV PCR (volunteers who have previously participated in an HIV vaccine study are eligible with positive ELISA if Western blot is indeterminate or negative and HIV PCR is negative.) 19. Negative serum beta-HCG test for women presumed to be of reproductive potential. 20. A female participant must meet one of the following a) no reproductive potential due to menopause (one year without menses), hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice contraception at least 30 days prior to enrollment and throughout the duration of the study by means of IUD, hormone-based therapy (e.g., contraceptive pills, Norplant (Registered Trademark), or Depo-Provera (Registered Trademark)) or other FDA-licensed methods). 21. Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process Volunteers are excluded from study participation if one or more of the following is true: 1. Vaccination with any vaccinia product within the last 10 years including vaccination with any vaccinia recombinant product. 2. Diseases or conditions that cause immunodeficiency (examples are HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, or therapy with alkylating agents, antimetabolites, radiation, or oral or parental corticosteroids). 3. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency. 4. History of eczema, even if the condition is mild or not presently active. 5. In close physical contact (household or at work) with an individual who has eczema, even if mild or not presently active. 6. Acute or chronic skin conditions such as atopic dermatitis, burns, impetigo, or varicella zoster (shingles). 7. Household member who is pregnant. 8. Women who are breast-feeding. 9. Household member less than 1 year old or work with children less than 1 year old. 10. Serious, life-threatening allergies to antibiotics polymixin B, streptomycin, tetracycline, neomycin or cidofovir. 11. Allergy to eggs or blood products (including Immunoglobulin products) or hypersensitivity to probenicid or sulfa-containing medications. 12. Receipt of live attenuated viruses within 30 days prior to enrollment. 13. Receipt of subunit or killed vaccines within 14 days prior to enrollment. 14. Use of investigational research agents within 30 days prior to enrollment. 15. Receipt of blood products within 120 days prior to HIV screening. 16. Receipt of immunoglobulin within 60 days prior to HIV screening. 17. History of serious adverse reactions to vaccines, such as anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain. 18. History of type I or type II diabetes mellitus, except gestational diabetes or diabetes controlled with diet alone. 19. Currently taking anti-TB prophylaxis or therapy. 20. History of seizure disorder other than: a) febrile seizures under the age of two, or b) seizures secondary to alcohol withdrawal more than 3 years ago, or c) a singular seizure more than 3 years ago. 21. Bleeding disorder that was diagnosed by a physician, (e.g., factor deficiency, coagulopathy, or platelet disorder that requires special precautions). 22. Splenectomy. 23. Hypertension that is not well controlled by medication or is more than 150/100 at enrollment. 24. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well-controlled on medication within the past two years; disorder requiring lithium; suicidal ideation occurring within five years prior to enrollment. 25. Any medical, psychiatric, social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent. 26. History of cardiomyopathy, myocardial infarction, angina, congestive heart failure, coronary artery disease, stroke, transient ischemic attack, or history of 3 or more risk factors for coronary heart disease from the following list: current cigarette smoking; high blood pressure diagnosed by a doctor; high blood cholesterol diagnosed by a dicotr or a fasting LDL greater than 160 mg/dL at screening; diabetes diagnosed by a doctor; a first-degree relative (father, mother, brother, sister) who had coronary artery disease before the age of 50
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-45.0, Healthy Alcohol Drinking Male and female healthy participants, between 21 and 45 years of age. Weight and Body Mass Index: Males: between 60 kg and 90 kg; Body Mass Index between 18 and 28. Females: between 45 kg and 80 kg; Body Mass Index between 18 and 28. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Normal vital signs after 10 minutes in supine position: systolic blood pressure between 95 mmHg and 140 mmHg, diastolic blood pressure between 50 mmHg and 90 mmHg, heart rate between 45 bpm and 90 bpm. Normal 12-lead EKG, PR less than 210 ms, QRS less than 120 ms, QTcB(1) less than or equal to 430 ms for male and less than or equal to 450 ms for female (incomplete right bundle branch block can be accepted). Laboratory results should be within the normal range. Laboratory results which are found to be marginally outside the normal range (i.e., minor variances in the complete blood count (CBC) or electrolytes) will be clinically evaluated for relevance to this protocol. Liver functions must be less than two times normal. Written informed consent prior to study participation. Female participants of childbearing capability must use a double contraceptive method (such as oral contraceptives, condom with spermicide or intra-uterine device with spermicide) from the start of the study until two months post medication trial. Normal dietary habits and willingness to abstain from grapefruit juice consumption during the study. (Grapefruit juice inhibits hepatic enzymes which could potentially interfere with the metabolism of SR141716.) Must agree to abstain from the use of illicit drugs for the duration of the study Any history or presence of significant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic (including any history of convulsions), systemic, infectious diseases, or psychiatric disorders (i.e., a current diagnosis of major depression, panic disorder, eating disorders, or history of schizophrenia, bipolar disorder, or obsessive compulsive disorder). Individuals who report suicidal ideation or who have a past history of suicide attempts. Frequent headaches and/or migraine, recurrent nausea and/or vomiting. Symptomatic hypotension whenever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position. Blood donation within three months before administration. Presence or history of any allergy or unusual reactions to drugs or anesthetics that would suggest the participant could have a problem tolerating SR141716 or placebo. A participant who, in the judgment of the Investigator, is likely to be non-compliant, is violent when drinking, or is unable to cooperate because of a language problem or poor mental development. Participant who cannot be contacted in case of emergency. Currently taking any prescription medications or over-the-counter medications on a regular basis. Participants will be allowed to take an occasional pain medication or an antibiotic, if they get sick during their participation in the protocol. Excessive consumption of beverages with xanthine bases (greater than 6 cups or glasses/day). Female participants who have a positive Beta-HCG test (urine and/or plasma) or who are lactating. Positive reaction to any of the following tests: HBs antigen, anti-HCVantibody, anti-HIV1 antibodies, anti-HIV2 antibodies. (Hepatitis could interfere with the metabolism of SR141716 in the liver. HIV could alter brain function.) Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates). A DSM-IV diagnosis of illicit drug dependence in the last 6 months. Participants who come to the NIAAA Clinic and evidence withdrawal symptoms that result in a score of 8 or above on the CIWA Instrument
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Fabry Disease Subject is a male hemizygote, age 18 years or older, with confirmed diagnosis of Fabry Disease. Diagnosis of Fabry disease may be confirmed by proof of a mutation of the alpha-Galactosidase A gene compatible with Fabry Disease and/or a deficiency of alpha-Galactosidase A (less than 4.0 nmol/mL/hour in plasma or serum or less than 8% of average mean normal in leukocytes). Subject must have one or more clinical manifestations of Fabry disease including neuropathic pain, angiokeratoma, corneal verticillata, cardiomyopathy, hypo or anhydrosis, abdominal pain and/or diarrhea, serum creatinine greater than 1.0 mg/dl or proteinuria greater than 300 mg/24 hours. Subject must have voluntarily signed an Institutional Review Board (IRB) approved informed consent form after all relevant aspects of the study have been explained and discussed with the subject Subject has been previously treated with Replagal or any other enzyme replacement therapy for Fabry Disease. If the patient has previously been treated with Replagal or another enzyme replacement therapy then they must have been off the therapy for at least 30 days and must have a Day-14 antibody blood sample drawn and that test must be negative for anti-agalsidase alfa IgG and IgE antibodies and not experienced a prior severe infusion reactions with prior enzyme replacement therapy. Subject has been enrolled in another clinical investigative study in the past 30 days. Subject is unable to give informed consent or is deemed unable to comply with all aspects of the clinical trial. Subject has plasma Gb(3) drawn on Day -14 less than 4.0 nmol/mL. Subject is undergoing dialysis or who has received a renal transplant. Subjects who cannot tolerate the study procedures or who are unable or unwilling to travel to the study center as required by this protocol. Subjects with an inter-current medical condition that would render them unsuitable for the study (e.g. HIV, diabetes) by confounding an assessment of the effects of the experimental therapy and its adverse events. Subjects who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-17.0, Vomiting Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated Cycle 1: Participant has Karnofsky score ≥60 Cycle 1: Participant has a predicted life expectancy of ≥3 months Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Graft Versus Host Disease Hodgkin Lymphoma Myelodysplastic/Myeloproliferative Neoplasm Non-Hodgkin Lymphoma Plasma Cell Myeloma Waldenstrom Macroglobulinemia Patients having received a preceding allogeneic transplantation from either a human leukocyte antigen (HLA)-matched related or unrelated donor are eligible for this protocol Related donor: HLA genotypically identical at least at one haplotype and may be phenotypically or genotypically identical at the allele level at HLA A, B, C, DRB1, and DQB1 Unrelated donor who are prospectively Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing Patients with less than 50% donor CD3 peripheral blood chimerism on two separate, consecutive evaluations; the two evaluations must be at least 14 days apart OR patients with absolute decreases of donor CD3 peripheral blood chimerism of >= 20% if the second test shows < 50% donor CD3 cells; the two evaluations must be at least 14 days apart Patients with evidence of disease are only eligible if the disease is stable (or persistent) in comparison to the status prior to transplantation Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day Patients must have persistent donor CD3 cells (>= 5% donor CD3 cells by a deoxyribonucleic acid [DNA]-based assay that compares the profile of amplified fragment length polymorphisms [ampFLP] [or fluorescent in situ hybridization (FISH) studies or variable number of tandem repeats (VNTR)]) DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the following apply for the DLI product Current grade II to IV acute GVHD or extensive chronic GVHD Karnofsky score < 50% Pediatric Lansky play-performance score < 40 Evidence of relapse or progression of disease after transplantation Prior recipient of cord blood DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the of the American Association of Blood Banks (AABB) DONOR: Pregnancy DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection DONOR: Recent immunization may require a delay
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-64.0, Dyspepsia Right handed men and non-pregnant women ages 18 to 64 Diabetes History of aspiration or severe respiratory complications linked to gastrointestinal disease Use of any over the counter medications within 7 days of the study Current or previous history of gastric surgery Use of any medications which may alter gastrointestinal motility
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Cardiovascular Diseases Heart Diseases Obesity Physically inactive C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry Does not smoke Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10% Triglyceride levels no higher than 300 mg/dl Fasting glucose level less than 126 Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than 90 mm Hg as measured at study entry If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory medications, must be on a stable dose for 6 months prior to study entry If taking a cholesterol medication, including statins, blood pressure medication (including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months prior to study entry Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers) Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months of study entry History of stroke or TIA History of cancer within at least 5 years of study entry Diabetes or glucose intolerance Planning on participating in any other research trials during the next year
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis All patients (men and women) more than 18 years old who are going to have an ERCP procedure performed at the different centers from September 1, 2004 to about January 31, 2005 will be included Before the study: active acute pancreatitis (defined as: acute upper abdominal pain and S-amylases x 3 upper normal limit OR upper abdominal pain + radiological findings [CAT-/MR-scan] consistent with acute pancreatitis OR pathoanatomical findings consistent with acute pancreatitis by surgery) Known previous sphincterotomy Chronic pancreatitis with known calcifications Hypotension (definition: systolic blood pressure < 100 mmHg) Anemia, men/women (hemoglobin < 6 mmol/l or <9.7 g/dl) Constrictive pericarditis Pericardial tamponade Hypertrophic obstructive cardiomyopathy, aortic stenosis Mitral stenosis sildenafil within 24 hours before the ERCP procedure and 24 hours after the procedure Hypersensibility to nitroglycerine
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis Painful chronic pancreatitis (>1 abdominal pain attack during the preceding 12 months) At least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct (MPD) with upstream duct dilation Written informed consent obtained from the patient History of treatment of the pancreas using ESWL, endoscopy, or surgery Pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan Alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis Age below 18 years Pregnancy or lactation
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Obesity Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)] Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa Subjects on prescription and non-prescription appetite or weight modifying drugs
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Diabetic Gastroparesis Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with gastrointestinal motility
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 15.0-90.0, Helicobacter Infections Gastritis Gastric Ulcer Duodenal Ulcer Patients with H. pylori infection Patients without H. pylori infection
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-75.0, Type 2 Diabetes Age ≥ 40 years History of diabetes mellitus type 2 for at least three months with stable antidiabetic treatment Systolic and/or diastolic blood pressure ≥ 135 or 85 mmHg, respectively. In alternative, antihypertensive therapy regardless of blood pressure values Serum creatinine ≤ 1.5 mg/dL Urinary albumin excretion rate < 200 µg/min Written informed consent for the trial participation Clinical or histological evidence of non-diabetic renal disease, including vascular disease of the kidney, obstructive uropathy, prostatic hypertrophy or incomplete bladder emptying Transplanted kidney Moderate to severe chronic heart failure (III-IV stage according to the NYHA classification) Cerebral hemorrhage, stroke or transient ischemic attack within three months prior to the trial enrolment Myocardial infarction within three months prior to the trial enrolment Unstable angina pectoris Mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy Secondary (e.g., Cushing disease, phaeochromocytoma, etc.) or severe refractory hypertension Poor glycemic control (HbA1c>11%) Connective tissue or autoimmune disease
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Type 2 Diabetes Mellitus Individuals with Type 2 Diabetes HbA1c over 8% Individuals with bleeding disorders including GERD, PUD, any GI bleeding High blood pressure History of Coronary Artery Disease or exertional chest pain
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Prostatitis Diagnosis of male Chronic Pelvic Pain Syndrome Type III Age 18 Pelvic pain duration of at least 3 months Urinary tract infection within the last year Sexually transmitted disease within 3 months Antiviral therapy or antibiotics within the last 3 months Currently taking any medications or recreational drugs containing nitrates 3A4 inhibitors such as erythromycin, ketoconazole, or itraconazole Alpha-blocker therapy for treatment of high blood pressure or prostate problems Suffered a heart attack, stroke or life-threatening arrhythmia within the last months Cardiac failure or coronary artery disease causing unstable angina Resting hypotension (BP<90/50) or hypertension (BP>170/110) Patients with retinitis pigmentosa Kidney, liver or blood problems (including sickle cell anemia or leukemia)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 8.0-17.0, Abdominal Pain Ages 8 years Evaluated in Abdominal Pain Clinic at Children's Mercy Hospital or the Gastroenterology Clinic at Children's Mercy South for abdominal pain of at least 8 weeks duration and fulfilling symptom-based for FD, IBS, or FD/IBS Previous abdominal surgery Chronic disease requiring regular medical care (e.g. gastrointestinal diseases, diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer) Non-English speaking NOTE: Control subjects will meet all patient inclusion/ except for #2. Control subjects will be excluded for history of abdominal pain, nausea, vomiting, diarrhea, constipation, or bloating
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-90.0, Helicobacter Infections Gastritis Gastric Ulcer Duodenal Ulcer Patients with H. pylori infection Patients without H. pylori infection
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Hypertension adults age 18 years and older with essential hypertension who are treated with medication to lower their blood pressure whose mean daytime blood pressure at enrolment is 135/85 mm Hg or greater and who are not currently using HBPM a diagnosis of secondary hypertension pregnancy hypertension management primarily by a consultant a disability that precludes use of a home blood pressure monitor enrolled in another hypertension trial white coat hypertension
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Planned Abdominal Hysterectomy Planned abdominal hysterectomy with or without BSO Age above 18 years Written informed consent American Society of Anesthesiologists (ASA) class I-III Planned vaginal or laparoscopic hysterectomy Hysterectomy as part of other surgery Allergy to part of the treatment regimen Previous reactions to opioids (nausea, cognition) Previous inability to place correct epidural catheter Severe state anxiety according to the OCAP or STAI ASA class IV Dependency on alcohol, opioids or central stimulants Chronic pain condition Hemorrhagic diathesis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Nasal Polyps Gastroesophageal Reflux Subjects will Be adults with nasal polyposis recruited from the PI's private practice Not be currently taking a PPI Be able and willing to undergo a noninvasive 24 hour pH probe study; and Take a PPI Patients who Are pregnant Have a history of surgical treatment for reflux disease History of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period; and Do not meet criteria
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 15.0-80.0, Leukemia, Lymphocytic, Chronic, B-Cell Patients with histologically or cytologically confirmed CLL Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal Patients who have not received cancer chemotherapy or radiotherapy Patients with apparent infections (including viral infections) Patients with serious complications (heart, liver, or kidney disease, etc.) Patients with a serious bleeding tendency (e.g., DIC) Patients with serious CNS symptoms Patients with fever >= 38°C (excluding tumor fever) Patients with interstitial pneumonia or pulmonary fibrosis Patients with active multiple cancers Patients receiving other investigational products within 6 months before registration in this study Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives) Women who are pregnant, of childbearing potential, or lactating
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Post-ERCP Acute Pancreatitis patients undergoing endoscopic retrograde cholangiopancreatography children, pregnant or breastfeeding women patients with coagulation disorders inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic Leukemia, Lymphoblastic, Acute Lymphocytic Leukemia, Chronic Myelodysplastic Syndromes Multiple Myeloma Lymphoma, Non-Hodgkin Hodgkin Disease Donor Donor is 18 to 70 years of age inclusive If female and of child-bearing age, must be non-pregnant not breast feeding and using adequate contraception Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for transplant Donor must be willing to provide written informed consent Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Idiopathic Chronic Pancreatitis Pain Patients will be eligible if: They are age 18 years or older They have daily abdominal pain for at least three months attributed to their chronic pancreatitis Average pain scores (VAS) in the baseline period higher than 4. The diagnosis of chronic pancreatitis will be based on the existence of chronic abdominal pain and at least one of the four following Calcifications throughout the pancreas on plain abdominal radiograph. Endoscopically derived pancreatogram showing ductal changes consistent with chronic pancreatitis. Abnormal secretin pancreatic function test with a peak bicarbonate level of less than 70 mEq/L (normal being >80 mEq/L). Tissue diagnosis of chronic pancreatitis from a surgical specimen Other causes of chronic pancreatitis will be excluded as follows: Hereditary pancreatitis based on genetic mutations or a family history of pancreatitis; Alcohol abuse (the for "at risk" [heavy] drinking established by the National Institute on Alcohol Abuse and Alcoholism [NIAAA], which suggest that the person is at risk for adverse consequences, are greater than 14 drinks per week or 4 drinks per occasion for men, and greater than 7 drinks per week or 3 drinks per occasion for women); Medications associated with the development of pancreatitis (e.g. valproic acid, metronidazole, tetracycline, sulfonamides, nitrofurantoin, azathioprine, pentamidine), trauma, metabolic causes including hyperlipidemia and hypercalcemia, and autoimmune pancreatitis. Participants will be excluded if there are known complications of chronic pancreatitis requiring interventions including pseudocysts or pancreatic duct obstruction or if there is the presence of cancer. In addition, in order to minimize the risk of TMS, the following will be followed: Patients with a clinical diagnosis of severe depression including suicidal ideation; Prior neurosurgical procedure; Past history of epilepsy or family history of epilepsy; Previous head injury; Metal located in the head, i.e. shrapnel, surgical clips, or fragments from welding; Signs of increased intracranial pressure; Stroke; Chronic treatment with epileptogenic medications; Abnormal neurological examination other than as signs of the condition studied in the present protocol; Implanted pacemaker; Medication pump; Vagal stimulator; Deep brain stimulator; Transcutaneous electrical stimulation (TENS) unit and ventriculo-peritoneal shunt; Pregnancy; Other chronic medical conditions and history of substance abuse; History of medical and surgical therapies for pain within 3 months
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Vomiting Male or female patients from 18 to 65 years of age, inclusive. 2. History of functional vomiting for at least 12 weeks (which need not be consecutive) in the preceding 12 months, or history of cyclic vomiting with at least 3 episodes in the previous 12 months. 3. Female patients must have negative serum and urine pregnancy tests and be post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For female patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). 4. Able to provide voluntary, written informed consent with full comprehension of all aspects of the protocol Serious underlying diseases (cardiovascular, genitourinary, urinary, thyroid or hematological diseases, psychiatric disorders, central nervous system disorders, or coagulation disorders). 2. Clinically significant abnormal examination findings or laboratory tests. 3. Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which would interfere with study assessments. 4. Use of drugs or ethanol which may interfere with compliance of study procedures or influence study outcome. 5. Presence of a medical condition which could interfere with the interpretation of study data. 6. Significant use of nicotine or caffeine
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Common Variable Immunodeficiency A subject is eligible for the study if all of the following are met: Has given written informed consent prior to screening. Is male or female aged 18 through 75 years. Has CVID diagnosed definitively prior to screening (based on the IUIS criteria). Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.) If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period. Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort) A subject is excluded from the study if any of the following are met: General Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial. Is a woman who has a positive serum pregnancy test or who is breast-feeding. Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period. Has hypersensitivity to any of the components of STA 5326 mesylate drug product. Has any of the following clinical chemistry values: AST greater than 2.5 x upper limit of normal (ULN). ALT greater than 2.5 x ULN. Serum bilirubin greater than 1.5 x ULN. Serum creatinine greater than 1.5 x ULN. Alkaline phosphatase greater than 2.5 x ULN. Has a hemoglobin level less than 9 g/dL or hematocrit less than 30%. Has a Prothromin Time INR greater than 1.3 or a Partial Thromboplastin Time greater than 3 sec compared to control value. Has the following cell counts (cells/microliter): Platelet count less than 90,000 or greater than 800,000. White blood cell count less than 1,500. Neutrophil count less than 900. Has a current infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia). Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ. Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years. Has a history of active tuberculosis (or a CXR with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Gastrointestinal Has a stool sample positive for gastrointestinal infection during screening. Has a positive hydrogen breath test Prior Medication Received parenteral corticosteroids within 1 month prior to receiving study drug. The use of short-term or single-dose corticosteroids as a pretreatment regimen for IVIG is acceptable. Received any investigational drug within 3 months prior to receiving study drug. Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to receiving study drug. Received any biological product (e.g., infliximab, adalimumab, natalizumab, etc.) within 3 months prior to receiving study drug. Ever received treatment with STA-5326 mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 4.0-17.0, Vomiting All pediatric patients attending the graduate student pediatric dental clinic of the Department of Pediatric Dentistry at Hadassah Clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. All participants must be in good health (ASA I)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-21.0, Congenital Disorders Congenital long QT Syndrome single case report Single case report
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 4.0-12.0, Vomiting Meet the2004 ICHD for Cyclical Vomiting vomiting attack lasting > 24 hours duration for 3 consecutive months 12 years of age If female, subjects must: 1. be premenarchal or otherwise incapable of pregnancy, or 2. have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility, or 3. be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence Able to take oral medication in tablet form or sprinkle form Subjects or their guardians must be willing and able to: a) read and comprehend written instructions, b) complete the assessment forms, c) return for regular visits, and d) adhere to medication regimens Subjects (or their legally acceptable representative) must have signed an informed consent document Have taken topiramate within 14 days prior to the start of the prospective baseline period Have taken certain medications for cyclical vomiting prophylaxis Have progressive neurological disorder or a structural disorder of the brain from birth, trauma or past infection Subjects who have taken any medications for migraine prophylaxis, within 2 weeks of the start of the prospective baseline period Subjects starting non-pharmacologic prophylactic approaches (e.g., acupuncture, biofeedback, chiropractic methods) within 1 month prior to Visit 1 Require continuing treatment with anticonvulsant therapy for a non-migraine condition Significant major psychiatric disorder (e.g., major depression) or subjects receiving anti-psychotic medication History of attempted suicide or suicidal tendencies History of substance abuse Pregnant or lactating females
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Smoking Cessation Interested in quitting gradually At least 18 years old Daily cigarette smoker Smoke at least 15 cigarettes per day (CPD) No change greater than 20% in CPD in the last month Interested in quitting in next 30 days Must agree to not use non-cigarette tobacco during study No use of smoking cessation medication in last month Have phone with voice mail Willing to use nicotine lozenge Women who are pregnant or breastfeeding Currently using medication for depression or asthma Heart disease requiring medication Heart attack in last month Irregular heartbeat High blood pressure not controlled by medication Stomach ulcers Diabetes
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Chronic Prostatitis Pelvic Pain Male subjects aged 18 and older. 2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies 3. Subjects with a minimum score of 15 on the CPSI. 4. Male subjects must give written informed consent. 5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to He understands and can reliably carry out all instructions He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy He agrees NOT to be a sperm or blood donor while being treated with thalidomide - Subjects who are female. 2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months 3. Subjects with duration of symptoms less than three months 4. Subjects with active genital infections 5. Subjects with prior urologic surgeries 6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate 7. Subjects having received prior radiation to the abdominal or pelvic area 8. Subjects with known bladder or ureteral calculi 9. Subjects unable to complete a voiding diary 10. Subjects diagnosed with neuropathy 11. Subjects with neutropenia 12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state 13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program 14. Subjects with orthostatic hypotension 15. Subjects with known malignancies in the last 2 years
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Enterocolitis Pseudomembranous Colitis Antibiotic-associated Colitis Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-50.0, Cutaneous Leishmaniasis Men and women between 18 and 50 years old Cutaneous ulcers of more than two weeks of evolution Positive parasitological diagnosis for CL Patients that voluntarily agree to participate in the study and sign the informed consent Disposition to attend all the visits punctually (initial, treatment and follow-up) Acceptation of not using any other treatment for CL while in the study Pregnant women Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of CL Diffuse CL or more than five active lesions Mucocutaneous leishmaniasis (no lesion must be located less than 2 cm from the nasal, uro-genital, and/or anal mucous membranes or from the edge of the lips) Visceral leishmaniasis Complete or incomplete treatment with antimony compounds in the last three months Patients with history of hepatic, renal or cardiovascular disease Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-70.0, Chronic Pancreatitis CP with significant pain i.e., at least one episode of pain in a month requiring oral analgesic or one episode of severe pain in last three months requiring hospitalization Painless disease Current pain more likely due to non-pancreatic origin If the patient already has an intervention in the form decompressive therapy i.e., surgery or endoscopic sphincterotomy/ stenting or ESWL Systemic conditions like CRF, malignancy, hypertension, and pregnancy Complications like pseudocyst, pancreatic abscess Patients who would have received antioxidants in the preceding 4 weeks Narcotic addicts Uncontrolled diabetes Comorbid conditions like liver diseases
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-59.0, Leukemia, Lymphocytic 59 years ALL newly diagnosed (blast < 20%) Central Nervous System (CNS) positive or negative Signed written informed consent For trial only: t(9;22) or BCR ABL positive Lymphoblastic lymphoma ALL 3 Chronic myeloid leukemia Severe organ condition
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Vomiting Healthy or have mild or moderate renal impairment Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner) Be negative for Hepatitis B and C Have negative results on drug, alcohol and HIV tests Have stable renal function Have a peptic ulcer Abuse drugs or alcohol Are pregnant or lactating Have heart failure Have uncontrolled emesis Have an infection Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start Active peptic ulcer disease Digoxin use Laboratory results that show low iron or pepsinogen levels, AST and CK level >1,5 ULN, or that show stool is positive for occult blood
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Vomiting Healthy or have mild or moderate hepatic impairment Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner) Negative for Hepatitis B and C(healthy subjects) Negative drug, alcohol and HIV tests Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function Encephalopathy Active peptic ulcer disease Drug or alcohol abuse Pregnant or lactating Esophageal bleeding Heart failure Infection
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Heart Failure, Congestive Patients must have symptomatic congestive heart failure, NYHA Class II to IV symptoms and an ejection fraction < 40% by nuclear ventriculography within the previous 6 months. Patients must be stable with no change in dosage on conventional therapy (including digoxin, diuretics, ACE inhibitors, hydralazine, nitrates, angiotensin II receptor blockers and/or beta blocker) for at least 4 weeks active alcohol or illicit drug use myocardial infarction or unstable angina within the previous 3 months obstructive valvular disease exercise induced sustained arrhythmias or symptomatic myocardial ischemia pregnancy psychiatric disorder non-compliance with medical regimen
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, B-cell Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Diagnosis of 1 of the following Biopsy proven small lymphocytic lymphoma (SLL) Chronic lymphocytic leukemia (CLL) meeting all of the following Peripheral blood lymphocyte count > 5,000/mm^3 Lymphocytes must consist of small to moderate size lymphocytes, with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Immunophenotyping consistent with CLL, defined by the following Predominant population of lymphocytes share both B-cell antigens (i.e., CD19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (e.g., CD3 or CD2) Dim surface immunoglobulin expression Exclusively kappa and lambda light chains Splenomegaly, hepatomegaly, or lymphadenopathy are not required
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pain, Postoperative Orthopedic Procedures Analgesia Patients undergoing primary, unilateral total knee replacement surgery where use of opioid analgesics for short-term postoperative pain is required At baseline must be able to tolerate oral liquids, swallow a tablet, and have the presence of bowel sounds upon examination Patients must demonstrate stable vital signs immediately before dosing with OROS hydromorphone HCI At baseline pain intensity upon movement must be scored by the patient as 2 or 3 (moderate or severe) on the Pain Intensity Rating Scale At baseline patients receiving regional anesthetics/analgesics must demonstrate recovery from the motor and sensory effects of the nerve blockade Patients must be administered OROS hydromorphone HCI between 6 and 48 hours following completion of surgery Patients should expect to remain hospitalized for 36 hours after study drug administration Patients either intolerant of hydromorphone or who have experienced an anaphylactic IgE-mediated immune response (e.g. hives, wheezing, angioedema or bronchospasms) to any opioid agonist Patients having previously undergone the following major surgery for high tibial osteotomy, knee arthroplasty to the affected knee Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs Patients who are pregnant or breast-feeding. A negative pregnancy test is required prior to administration of the study medication in females of childbearing potential Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition Patients with clinically significant impaired renal, hepatic, or hematological function adrenocortical insufficiency uncontrolled hypothyroidism or hyperthyroidism, or clinically significant urinary obstruction
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 25.0-80.0, Healthy Type 2 Diabetes Endotoxemia Healthy Type 2 diabetes Heart failure Lung disease Anti-coagulation treatment
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 25.0-80.0, Type 2 Diabetes Healthy Endotoxemia Healthy Type 2 diabetes Heart failure Lung disease Infections in the last two weeks before endotoxin injections Treatment with antibiotics
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 25.0-80.0, Healthy Type 2 Diabetes Endotoxemia Healthy Type 2 diabetes Renal failure Heart failure Lung disease
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Hypertension Female or male patient with age ≧ 18 years old Patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure (sDBP) ≦ 180/110 mmHg at screening visit For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient, sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure (sDBP) ≧ 80 mmHg at baseline visit Patient or his/her legally acceptable representative has signed and dated the informed consent form Known or suspected secondary hypertension sSBP > 180 mmHg or sDBP > 110 mmHg at baseline visit Patients taking more than two anti-hypertensive medications at the screening visit. (Fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.) Known NYHA functional class Chronic Heart Failure (CHF) III and IV With a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters SGPT (ALT) or SGOT (AST) > two times upper the limit of normal range Serum creatinine > 2.3 mg/dl or creatinine clearance < 30 ml/min Other protocol-defined inclusion/
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, HIV Diabetes Hyperglycemia Documented + HIV ELISA. Diabetes mellitus (DM) will be defined as: Documented diagnosis of type 2 diabetes mellitus or FPG greater than or equal to 126 mg/dl on two occasions or casual blood glucose greater than or equal to 200 mg/dL and symptoms of diabetes. Impaired Fasting Glucose (IFG) defined as: FPG greater than or equal to 100 mg/dl and less than 126 mg/dl on one or more occasions within past year. Age 18+, male or female Type 1 Diabetes. Known current pregnancy or pregnancy within 6 mo. Documented hemoglobinopathy. Changes in antiretroviral therapy within 3 months. History of anemia (Hb less than 9g/dL in past 6 months). Active opportunistic Infection or opportunistic Infection within 3 mo. Creatine greater than 1.8 mg/dL or known end stage renal disease (ESRD). Changes in diabetes therapies within 3 mo (excluding dose adjustments). Subject is deemed unable to comply with requirements of study participation. Use of oral corticosteroid within the past 3 mo (stable dose inhaled steroids will be allowed). Blood transfusion within 3 months
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-999.0, Low Back Pain Age > 21 Chronic axial low back pain without radicular pain for > six months, not responding to at least three months of non-surgical management under the direction of a physician One or two discs at L5/S1, L4/L5 or L3/L4 with abnormal findings by MRI, including any of the following: loss of disc hydration, loss of disc height, high intensity zone (HIZ), Modic changes at adjacent vertebral endplates, or herniation without nerve root compression Subject states that he/she is willing to undergo lumbar spinal fusion, disc replacement, or other definitive treatment if eventual diagnosis supports such treatment Physician believes that discography is clinically indicated for the purpose of surgical decision-making for the subject Pre-treatment low back pain by numerical rating scale (NRS) score > 4 (measured as average in last 24 hours on a 0-10 scale) Pre-treatment Oswestry Disability Index (ODI) > 40 (0 scale) Subject states availability for all study visits Subject is able to understand the risks and benefits of participating in the study and provides written informed consent Known osteoporosis or osteopenia, metabolic bone disorder, or history of chronic steroid use (the equivalent of 7.5 milligrams of daily prednisone use for > 6 months) Suspected painful disc degeneration (based on clinical examination and MRI findings) outside of L5/S1, L4/L5 or L3/L4 levels MRI shows disc abnormalities (listed in #3) at all 3 lower lumbar discs (L3/L4, L4/L5 and L5/S1) Abnormal neurologic exam attributable to lumbar disc disease, herniation, or lumbar stenosis Back, buttock or pelvic pain suspected to be due to spinal stenosis, spinal fractures, infection, cancer, facet arthropathy or other hip or pelvis pathology Schmorl's node or endplate disruption evident on MRI at L5/S1, L4/L5, or L3/L4 Medical history, physical examination or radiographic evidence (e.g., disc height too narrow) to suggest that either PD or F.A.D. may not be technically feasible Any previous lumbar spine fusion or disc replacement More than grade 1 spondylolisthesis as assessed by x-ray or MRI Significant clinical comorbidity that may potentially interfere with data collection or follow-up (e.g., dementia, severe comorbid illness)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Vomiting Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function, respectively defined by: platelets >100000/mm3 and absolute neutrophil count >1500/mm3; bilirubin, AST and ALT <2 times x upper limit of normality; and creatinine <1.5 mg/dl ECOG performance status <2 and body mass index from 20-28 kg/m2 Pregnancy Serious concomitant diseases, in the invesgator´s
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Diabetes Mellitus, Type 2 Male subjects aged 18 to 65 years. 2. Eligible subjects must be free from clinically significant illness or disease (other than type 2 diabetes)with the exception of chronic stable-treated hypertension (BP<160/90, and >90/50), thyroid disease (TSH in the normal reference range) and/or dyslipidaemia. 3. BMI must be > or = 25kg/m2 to < or = 40kg/m2, 4. HbA1c between 7and 10%, fasting blood glucose above 7mmol/L (fasting means greater or = 8 hours prior to screening). 5. On diet alone or diet plus metformin (GSK data indicate that the latter group more faithfully reflect the behaviour of 'naive' patients than those who have been washed off prior medications)for at least 1 month. 6. On stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required Prior treatment with thiazolidinedione, insulin or GLP-1 analogue (Byetta) 2. History of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT>2 times upper limit of normal range (ULN), bilirubin>1.5 time ULN. History of renal disease or serum creatinine greater than 1.5 X ULN. 3. Contraindications to rosiglitazone treatment. 4. Serum creatinine greater than 1.5 X upper limit of normal range. 5. Any other clinically significant laboratory abnormality. 6. Claustrophobic or other contraindication to MRI scan 7. Females of child-bearing age who are unwilling to use appropriate methods of contraception. 8. Unable to give informed consent. 9. Unable to comply with study protocol. 10. Clinically significant co-morbidity. -
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Pancreatitis Multiple Organ Failure Severe acute alcoholic pancreatitis with early multiple organ failure (Sofa score >2) If patient or his/her family member refuses, pregnancy
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 10.0-65.0, Crohn's Disease Patients ages 10-65 years, inclusive Patient suffers from either diarrhea for more than 6 weeks and less than 3 years and/or abdominal pain for more than 6 weeks and less than 3 years and/or extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis Patient suffers from at least one of the symptoms / lab abnormalities listed below Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment Unexplained anemia (less than normal limits) within 3 months prior to enrollment Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment Positive ASCA within 3 months of enrollment Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the are not otherwise met Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting Definite long stricture seen on radiological exam Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract Known history of small bowel Crohn's Disease Current treatment for active IBD Positive Anti-tTG or anti-endomysial antibody Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment Patient is pregnant
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Pancreatitis, Acute Helicobacter Infections Acute alcohol pancreatitis (first) Death during hospitalization
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Infection Hospitalized men or women >/=18 years of age Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days Ability to provide documented and signed written informed consent Confirmed or suspected intra abdominal infection defined as follows For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following Gross peritoneal inflammation with purulent exudates (i.e. peritonitis) Intra abdominal abscess Macroscopic intestinal perforation with localized or diffuse peritonitis Subjects enrolled on the basis of a suspected intra abdominal infection must have Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients Women who are pregnant or lactating or in whom pregnancy cannot be excluded History of tendon disease/disorder related to quinolone treatment Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil) Known severe end stage liver disease Creatinine clearance </= 30 mL/min/1.73 m2 Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment Need for systemic antibacterial therapy with agents other than those described in the study protocol Indwelling peritoneal catheter
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 55.0-999.0, Moderate Risk of CVD Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment Current smoking: defined as any cigarette smoking in the past 12 months Low HDL cholesterol (HDL<40 mg/dL; as measured at screening) Elevated blood pressure (SBP>140 mmHg; as measured at screening) Currently on any medication to treat high blood pressure Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years) Females aged 60 and above with 3 or more risk factors. Female Risk Factors Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment Current smoking: defined as any cigarette smoking in the past 12 months History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders Active diagnosed and documented reflux esophagitis Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study Lactating women or women of childbearing potential Severe liver disease or damage based on the clinical judgment of the investigator Severe renal disease or damage based on the clinical judgement of the investigator A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Renal Insufficiency A female is eligible to enter and participate in this study if she is of Non-child-bearing potential with a negative pregnancy test at screening or of Childbearing potential, has a negative serum pregnancy test at screening, is not lactating, and agrees to adequate contraception Satisfactory medical evaluation based upon medical history, medication history, physical examination, and clinical laboratory data obtained at the Screening visit Body weight > 50 kg. BMI within the range of 19 to 40 kg/m2 Signed and dated written informed consent prior to participation in any protocol-specific procedures, including screening procedures The subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions Additional for Subjects with Renal Insufficiency: Subjects with renal insufficiency must be considered by the investigator to be clinically stable. Subjects must continue to meet this criterion of stable renal function upon check-in into the clinic History of regular alcohol consumption averaging >7 drinks per week for women or >14 drinks per week for men within 6 months of Screening. One drink is equivalent to 12 g alcohol = 5 ounces (oz; 150 ml) of wine or 12 oz (360 ml) of beer or 1.5 oz (45 ml) of 80 proof distilled spirits A positive drug or alcohol test at Screening or Check-in Smokers will be allowed to enrol in the study; however, smoking that interferes with the collection/recording of ongoing study procedures will not be allowed. Smoking status will be recorded in the CRF The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication for the current study The subject has donated more than 450mL blood within the 56 day period prior to the first scheduled administration of GSK189075 Known or suspected gastroparesis, gastric surgery within the 6 months prior to screening, or any other gastrointestinal condition that would likely interfere with absorption of GSK189075 Subjects with clinical laboratory values outside rages as specified in the protocols Any subject with either documented cirrhosis or a history consistent with a diagnosis of cirrhosis Urinary tract or bladder infection within 4 weeks of the first scheduled administration of study drug Positive hepatitis B surface antigen, or HIV at Screening. If negative test results have been documented within the last 2 months, it will not be necessary to repeat these tests. Subjects with positive results for hepatitis C antibodies may be eligible if they have normal liver enzymes and no history of hepatitis and are approved by the GSK medical monitor
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Leukemia A histologically confirmed diagnosis of AML (patients only) 2. Aged 18 or older 3. Resident of Texas 4. Willing and able to provide written informed consent and authorization 5. Willing to donate 10mL of blood and complete a personal interview Under 18 years of age 2. History of invasive cancer, excluding non-melanoma skin cancer (controls only)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-80.0, Diabetes Males and females >40 years old High-risk subjects with type 2 diabetes (WHO criteria) History of diabetes not exceeding 25 years High blood pressure (systolic and/or diastolic blood pressure >135/85 mmHg or concomitant treatment with blood pressure lowering medications) Serum creatinine concentration <1.5 mg/dl Overnight urinary albumin excretion (in at least 2 of 3 consecutive overnight urine collections) ≥ 7 and <20 µg/min Legal capacity Written informed consent Uncontrolled diabetes (glycated hemoglobin >11%) Specific contraindications or history of hypersensitivity to the study drugs Serum potassium ≥ 5.5 mEq/L despite diuretic therapy, and optimized metabolic and acid/base control Bilateral renal artery stenosis Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer Drug or alcohol abuse Any chronic clinical conditions that may affect completion of the trial or confound data interpretation Pregnancy or lactating Women of childbearing potential without following a scientifically accepted form of contraception Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial
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0
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