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A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 15.0-40.0, Ectopic Pregnancy Criteria:The criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG The criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal) | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 29.0-38.0, Endometriosis Infertility Infertility Mild endometriosis (until stage II) ovarian endometrioma > 2 cm FSH > 12 mIU/ml Mail factor infertility | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-40.0, Cesarean Section; Complications Placenta Previa Placenta Accreta Singleton pregnancy Term (> 37 weeks) pregnancy Cervical dilatation < 4 cm Kerr incision Age > 18 years old Being in active phase of labor Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) Having a history of uterine surgery (myomectomy, hysterotomy) other than CS Extension of Kerr incision Multiple pregnancy Maternal diabetes mellitus Maternal connective tissue disease Uterine malformation Uterine fibroids on Kerr incision line Chorioamnionitis | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 12.0-55.0, Ectopic Pregnancy pregnant females in 1st trimester present to emergency department complaint of abdominal/pelvic pain or vaginal bleeding previous ultrasound diagnostic of location of pregnancy | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 20.0-36.0, Endometriosis Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure No other infertility factors Normal serum basal hormone levels as well as documented ovulation Moderate or severe endometriosis Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery Age more than 36 years, BMI more than 30 kg/m2 women with a previous pregnancy | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 39.0-65.0, Obesity Insulin Resistance Diabetes Mellitus Type 2 No major organ disease Fasting blood glucose < 126 mg/dL BMI 25-35 kg/m2 Nonpregnant/nonlactating pregnancy/lactation major organ disease drugs that influence insulin resistance unstable body weight or active weight loss program outside BMI range or age range diabetic by fasting glucose 126 mg/dL or higher | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 20.0-40.0, Polycystic Ovary Syndrome Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days History of at least one year of infertility Age between 20 and 40 years old Normal semen analysis based on World Health Organization (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy History of significant system diseases such as heart, lung, or kidney diseases History of other endocrine disorders Use of hormonal therapy, including metformin, in the past 3 months Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-65.0, Obesity Subject is willing to give consent and comply with evaluation and treatment schedule 18 to 65 years of age (inclusive) Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may but are not be limited to - Hyperlipidemia Type 2 diabetes Mild obstructive sleep apnea Hypertension Osteoarthritis of the hip or knee Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial HbA1C < 11% Previous malabsorptive or restrictive procedures performed for the treatment of obesity Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery Any condition which precludes compliance with the study History or presence of pre-existing autoimmune connective tissue disease Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion) | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 20.0-65.0, Obesity Weight Loss Diet Age (years): 20-65 Body Mass Index (kg/m2): 28-35 Non-smokers Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1) marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female) planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator blood donation within the past 2 months prior to the study weight change of >3 kg within 2 months prior to the study psychiatric disease (based on medical history only) pregnant or lactating women, or women planning to become pregnant within the next 12 months surgically treated obesity participation in other clinical studies within the last 3 months drug abuse (based on clinical judgment) | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 19.0-39.0, Polycystic Ovarian Syndrome Age > 18 years but < 40 years old Was diagnosed PCOS Normal husband's seminal fluid analysis (SFA) Not having medical problems eg renal disease, tyhroid disorder, hyperprolactinemia, liver disease Other causes of anovulatory infertility | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-50.0, Ectopic Pregnancies Patients with pregnancy of unknown location (PUL) diagnosed 22 days after oocyte retrieval, at first ultrasound routine control (A "pregnancy of unknown location" (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.) Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity | 2 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-46.0, Complication Following Ectopic Pregnancy Patients who suspected ectopic pregnancy hemodynamically unstable patient healthy pregnancy (a healthy increase in ß HCG) missed abortion incomplete abortion The patient who need immediate surgical treatment | 2 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-50.0, Ectopic Pregnancy patients with ectopic pregnancy healthy hemodynamic stable first ectopic hemodynamic non-stable abnormal liver or kidney function allergy reaction to MTX | 2 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-65.0, Type 2 Diabetes patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass age:18-65yr HbAlc>8% diabetes (applies for control patients) chronic inflammatory disease malignant disease pregnancy prior gastric, duodenal, proximal jejunal surgery or pancreas resection current use of thiazolidinediones treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months HbAlc<8% any condition felt by the investigator to interfere with ability to complete the study | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-999.0, Persistent Pregnancy of Unknown Location Ectopic Pregnancy Female with a persisting pregnancy of unknown location A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization Persistence of hCG is defined as at least 2 serial hCG values (over 4-14 days), showing < 50% rise, or < 50% fall between the first and last value Patient is hemodynamically stable, hemoglobin >10 mg/dL Greater than or 18 years of age Hemodynamically unstable in need of acute treatment Most recent hCG > 5000 mIU/mL Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion) Diagnosis of gestational trophoblastic disease Subject unwilling or unable to comply with study procedures Presence of clinical contraindications for treatment with MTX Prior medical or surgical management of this gestation | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 25.0-55.0, Postoperative Nausea and Vomiting Patients undergoing elective laparoscopic cholecystectomy for gallstone disease Patients with age range of 25 to 55 years H/O chronic illness like DM, IHD, CRF, CLD H/O acute or chronic psychiatric or psychological illness H/O APD (acid peptic disease) or regurgitation H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month H/O alcohol intake in last one month Previous hepatobilliary surgery Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy Patients who are given opioids in postoperative period Patients who need epidural analgesia in postoperative period | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 30.0-50.0, Obesity Overfeeding Muscle Mass Body Composition Ectopic Fat Body mass index 25-32 Type 2 diabetes Type 1 diabetes Kidney disease Liver disease Abnormal clinical chemistry at screening Intense physical exercise > 2 hours per week Use of statins or drugs affecting energy metabolism Use of extreme diets | 1 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-999.0, Cholecystitis Signed informed consent All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy Pregnancy Breastfeeding BMI>35 Serious comorbidities precluding a LESS cholecystectomy Known or suspected neuromuscular disorders impairing neuromuscular function Allergies to muscle relaxants, anesthetics or narcotics utilized for this study A (family) history of malignant hyperthermia A contraindication for neostigmine administration Chronic opioid use Prolonged QT syndrome | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-45.0, Hysteroscopic Adhesiolysis Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis Willing to use additional contraception throughout study Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study Has suffered or currently suffers from a gynaecological malignancy Has undergone a previous hysteroscopic surgery (such as removal of fibroids) | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-40.0, Vaginal Bleeding During Pregnancy Postcoital Bleeding women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding age >40 or <18 women with history of more then 3 abortions women with history of more then 2 pre term labor ectopic pregnancy placental previa women who takes anticoagulation therapy women with known pathology at cervix women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-35.0, Infertility Age: between 18-35 years Period of infertility > 2 years Serum level of FSH <10 U/L in the early follicular phase All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO Infertility due to causes other than CC resistant PCOS or due to combined factors Body mass index (BMI) ≥35 Kg/m² The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function Hypersensitivity or contraindications to Letrozole or clomiphene treatment Previous LOD | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-40.0, Infertility Pregnancy Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre Patients undergoing IUI Fresh and frozen sperm treatment cycles Hormone induced and natural cycle (no hormonal stimulation) Patients speaking English or/and French Patients able to consent Patients younger than 18 years or older than 40 years of age Patients undergoing ovarian stimulation without IUI Patients who have been recruited in our study in a previous IUI cycle Patients who don't speak English or French Patients who are not able or refuse to consent Patient who are recruited in a different IUI research study | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-60.0, Morbid Obesity BMI >40 and < 60 kg/m2 No contraindication to any of the procedures No contraindication to general anesthesia No known addiction Patient able to provide informed consent Contraindication to general anesthesia Known psychiatric pathology Pregnancy Previous major digestive surgery Immunosuppressive treatment including corticoids Coagulopathy (INR>1.5) or platelets < 50 000/µl Anemia (Hb<10g/dl) Severe comorbidity Malabsorptive disease or gastro-intestinal disease Myocardial infarction in previous year, angina, cardiac failure | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 18.0-49.0, Hysterectomy Age: 18 to 49 years at index date Gender: Female Diagnosis: Women who underwent hysteroscopic device sterilization procedure Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy Patients undergoing in-vitro fertilization (IVF) procedures Embryo transfer, intrauterine Follicle puncture for oocyte retrieval, any method | 0 |
A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions. | eligible ages (years): 20.0-35.0, Anovulation Polycystic Ovary Syndrome Age between 20-35 Primary or secondary infertility Patients diagnosed as PCOs according to Rotterdam (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003) Any patients have any causes of infertility other than which mentioned in the as Hyperprolactinemia Male factor of infertility WHO Guidelines 2010 for Normal seminal fluid analysis Volume> 1.5 ml ph 7.2 to 8.0 Liquefaction time 20 to 30 min Sperms concentration >15 million/ml Total motility 40%(Progressive motility + non progressive motility) Progressive motility 32% | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.25-9.0, Anemia Age: 3 months to 9 years Haemoglobin concentration 7g/dl on admission to hospital Residence within 30 km of the study centre and availability for the duration of the study period Informed consent to participate in the study given by the parent or guardian Simultaneous participation in any other trial Allergy to sulpha drugs Residence > 30 km from the recruitment site Lack of consent | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 8.0-18.0, Chest Pain 18 years of age Pediatric patients with referrals for innocent heart murmurs Pediatric patients experiencing chest pain English speaking Non English speaking patients | 2 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 12.0-18.0, Anemia Age between 12 and 18 History of Chronic Renal Failure requiring HD or PD Hgb </= 13 g/dL Ferritin < 800 ng/ml TSAT < 50% Receiving EPO Known Sensitivity to Iron Sucrose Severe Concomitant disease of the liver or cardiovascular system Serious bacterial Infection Pregnancy / Lactation Active Hepatitis Patients with Causes of iron deficiency other that Chronic Renal Failure Blood Transfusion Body Weight < 25 KG Currently being treated for Asthma Received investigational drug within last 30 days | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.5-12.0, Sickle Cell Anemia Malaria Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine Pyrimethamine. Patients on cotrimoxazole prophylaxis | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 9.0-12.0, Anaemia Schistosomiasis Infection Malaria Iron Deficiency school children between 9 to 12 year | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-5.0, Anaemia Age under 5 years Pregnancy Suspected anaemia | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.538-0.654, Patent Ductus Arteriosus Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO) Less than 72 hours of age at the time of randomization If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the criteria Consent form signed by parent Either major congenital malformations and/or chromosomal anomalies Proven, severe congenital bacterial infection Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery Treatment with pharmacological replacement steroid therapy at anytime since birth Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution) Renal failure or oliguria defined as urine flow rate < 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life) Platelet count < 75,000/mm 3 Clinical bleeding tendency (i.e. oozing from puncture sites) Expected survival less than 48 hours in the opinion of the attending neonatologist Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 1.0-6.0, Malaria Anaemia All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The for randomization will be Children aged 12 months to 6 years; and History of fever in the preceding 48 hours or a measured temperature > 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 /l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb) Refusal of parent or guardian to give consent to the child's participation in the study Inability of the subjects to take oral medications Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly Children with known haemoglobinopathy Children with a weight for height Z score below -3SD of WHO/NCHS standard Enrolment in another research project | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 5.0-999.0, Sickle Cell Disease Hemolytic Anemia Established Diagnosis of Hemolysis Sickle Cell Disease (e.g., HbSS, HbS/β-thalassemia, HbSC) Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) Age SCD participants: 5 years of age up to 19th birthday All other participants: 5 years of age and up (no age limit) Previous cardiac surgery Known left ventricle dysfunction (i.e. shortening fraction < 28%) Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 12.0-18.0, Chronic Fatigue Syndrome Adolescents (12 years) with Chronic Fatigue Syndrome Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children Score greater than or equal to 20 on the Children's Depression Inventory No availability of computer and/or internet Risk of suicide Mental retardation | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-65.0, Chronic Hepatitis C Male and female patients aged 18-65 years Elevated liver enzymes levels Compensated liver disease Available liver histology confirming F2 fibrosis Written consent to participation Age <18, >65 Prior ribavirin treatment Intolerance towards ribavirin, PegIFN or erythropoetin Pregnancy or breast feeding Relevant cardiovascular or pulmonary disease Kidney insufficiency (creatinine clearance <50ml/min) Coinfection with HIV or hepatitis B virus Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) Alcohol consumption > 40g/day Psychiatric disorders | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-20.0, Thalassemia Alpha Hemolytic Anemia All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-18.0, Anemia Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 21.0-999.0, Coronary Artery Disease Subjects who are undergoing routine screening coronary CT angiography Willingness to sign informed consent form Inability to provide informed consent form Age less than 21 years Any contraindications to coronary CT angiography Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography Supraventricular or ventricular arrhythmias that would be expected to affect CT-angiography image quality (e.g., atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy, and trigeminy). Patients with isolated premature atrial contractions and premature ventricular contractions may enroll Use of intravenous vasodilators Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (e.g., obstructive pulmonary disease, such as asthma or COPD, with audible wheezing) Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs, or continuous murmurs | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 19.0-999.0, Cardiovascular Risk Factors Age ≥ 65 years Hypertension (HTN) Diabetes Obesity (body mass index [BMI] >35) Renal insufficiency Tobacco usage Hypercholesterolemia Sleep apnea/heavy snoring at night Clinical diagnosis of CHF as defined by Dyspnea on exertion Patients expected to say in the hospital for less than 24 hours Inability of undergo TEE and TTE Clinical evidence or suspicion of elevated intracranial pressure Preoperative shock or systemic sepsis Emergency Operation ASA Class V Inability of give informed consent Participation in another clinical trial Prisoner | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Iron Deficiency Signed informed consent prior to study specific procedures Premenopausal, regularly menstruating women Age ≥18 years Body weight between 50 and 90 kg Haemoglobin ≥115 g/L Iron deficiency at screening defined as follows S-ferritin level <50 ng/mL, AND, TfS <20%, OR S-ferritin level <15 ng/mL Serum C-reactive protein <5 mg/L if not on oral contraception, OR Haemoglobin level <115 g/L Haemoglobinopathy Haemochromatose Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2) Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV) Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease) Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness) Important recent weight loss (>10% within the past month) | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Anemia, Hemolytic, Autoimmune Age 18 years or over Clinical and biochemical signs of haemolytic anaemia Positive Coombs test with anti-IgG on its own or with anti-CD3d Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen deposit) for women of childbearing potential Performance status > 2 Previous treatment with Rituximab Other immune suppressive or anti neoplastic treatment including prednisolone within 3 months Auto immune haemolytic anaemia within 6 months Other serious disease Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for the duration of the study Contraindication for treatment with Rituximab, i.e. patients that develop hypersensitivity/allergy to the contents of the drug or have antibodies against murine proteins Active infection which requires antibiotic treatment | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 10.0-16.0, Human Papillomavirus Infection Criteria:schoolgirls, attending the 6th and 7th grades of the elementary school Pregnant and breastfeeding adolescents and girls who did not attend classes | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Warm Autoimmune Hemolytic Anemia Age > 18 years AIHA defined at time of diagnosis by a Hgb level £ 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern) Disease duration equal or less than 6 weeks at time of --> removed by amendment n°4 and substituted by :First episode of AIHA to "hot" antibody previously untreated or treated corticosteroids for less than 6 weeks Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion Absence of detectable lymph nodes on a total body CT-scan (to be performed before if not performed at diagnosis) Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age Negative serum pregnancy test within 14 days prior to study entry Written informed consent Previous treatment with rituximab AIHA diagnosed and treated more than 6 weeks prior to removed by amendment n°4 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia) Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg) Neutrophils count < 1,000/mm 3 at inclusion | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.5-4.917, Malaria, Falciparum Malnutrition Child Age between 6 and 59 months Weight ≥5kg P. falciparum monoinfection confirmed on a thick blood film Parasitic density between 1,000 and 200,000 asexual forms/uL of blood Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours Severe malnutrition (defined as a weight/height ratio less than -3 z-scores) High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..) Consent of a parent or guardian who is at least 18 years of age Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Severe anaemia (haemoglobin <5 g/dL) Known history of hypersensitivity to any of the study medications Symmetric oedema in the feet Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.) History of a full treatment course with the study drug in the past 28 days | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Autoimmune Hemolytic Disease (Cold Type) (Warm Type) Newly diagnosed "warm" or "cold" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria) Idiopathic "warm" or "cold" AIHA relapsed after first line treatment with oral prednisone Aged >18 years ECOG performance status grade 0, 1 or 2 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Cell or humoral immunologic deficit (congenital or acquired) Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients History of malignancies within 3 years prior to study entry Concomitant immunosuppressive or cytotoxic treatment Positive pregnancy test. Lactation The presence of associated organ-specific autoimmune diseases do not constitute Previous splenectomy does not constitute | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-75.0, Non ST Segment Elevation Myocardial Infarction Unstable Angina ICF signature The research subject must agree about following all instructions and perform the procedures and study visits Men and women over the age of 18 and below the age of 75 History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days Patient Randomization up to 6 hours after the arrival at the emergency sector Evidence of or unstable angina due to one or more of the following Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension derivation-ECG with persistent ST-segment elevation Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine) Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment Recent hemorrhagic cerebrovascular accident (last 12 months) Patient scheduled for cardiac surgery of myocardial revascularization Use of drugs, alcohol abuse Pregnancy or lactation Recent neurosurgery or ophthalmic surgery (last 3 months) History or diagnosis of coagulopathy | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-1.0, Anemia Chronic Kidney Disease Girls and boys between birth and < 1 year of age at the time of enrollment Body weight ≥ 3 kg at screening and enrollment Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment Transferrin saturation ≥ 20% at screening Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period) Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment History of cardiovascular events or thromboembolism History of upper or lower gastrointestinal bleeding History of seizures Active liver disease or history of liver disease Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age Major surgery 12 weeks prior to enrollment Red blood cell transfusions 12 weeks prior to enrollment Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-90.0, Skin Closure of Surgical Incisions by Tissue Glue vs Suture Living kidney donor with informed consent Approved comprehensive work-up/evaluation at local hospital Allergy towards acrylate or similar chemicals Unable to communicate in norwegian language | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 12.0-999.0, Iron Deficiency Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study Pregnant, lactating, severe anemia, low BMI would be excluded | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-72.0, Congenital Heart Disease all consecutive live newborn infants between 6-72hours of age declining the screening early discharge before the screening missing | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 10.0-16.0, Myopia Visual acuity: 20/20 or better in each eye Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on) Unable to cooperate with the ocular examination and questionnaire survey | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 12.0-17.0, Acne Quality of Life Between 12 and 17 years of age diagnosis of acne by a pediatric dermatologist ability to read and understand English age appropriate development • developmental delay | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.5-0.917, Iron Deficiency Anaemia Stunting Aged 6-11 Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration Parent/guardian willingness to give consent for the child's participation in the study Weight-for-height Z score <3 SD Mid-upper arm circumference < 11.5 cm Presence of bilateral oedema Severe anaemia (Hb < 7.0 g/dl) HIV positive | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 16.0-70.0, Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) Diagnosis of HbSS, or HbSβ-thalassemia0, confirmed by hemoglobin analysis Males and females age 16 years to 70 years old Greater than 2 episodes of pain in the last 12 months On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin Judged not likely to be study compliant by his/her hematologist History of adverse reaction to montelukast or any of the components of montelukast Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days Chronic blood transfusion therapy defined as regularly scheduled transfusions Hemoglobin A greater than15% on hemoglobin analysis Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate) Current participation in another therapeutic trial for SCD Known current pregnancy Known history of HIV | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-15.0, Malnutrition Anemia household with infant < 12 mo or adolescent 10-15 y Living in selected communities of Upper Manya Krobo District (Ghana) infant or adolescent has medical condition that limits dietary intakes or growth | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Sickle Cell Disease Sickle Cell Anemia SCD Patients must have one of the following inherited hemoglobin gene disorders Hemoglobin SS Hemoglobin SC Hemoglobin S-Beta-zero-Thalassemia or Hemoglobin S-Beta-plus Thalassemia Disease Morbidity For matched sibling donor grafts (low-risk e.g., matched sibling donor), patients must have evidence for morbid disease that has failed conventional therapy 2 or more painful episode/year (requiring Emergency Department or inpatient care) x 3 years or 2 or more diagnoses of Acute Chest Syndrome within 5 years, or 2-year mortality 5-10% eGFR <50 ml/min ≥2.0 liter-per-minute pm home oxygen requirement An estimated Left Ventricular Ejection Fraction ≤40% (echo or MUGA) Hepatic cirrhosis (Biopsy Proven) HIV positive, ineligible because of the increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Red cell alloimmunization to a degree that precludes extended transfusion Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or breastfeeding women are excluded from this study because the immunomodulatory treatment, preparative regimen, and anti-GVH therapy contain agents with the potential for teratogenic or abortifacient effects. Further, this treatment, if indicated, is for a chronic condition, and can be delayed until the pregnancy has been successfully concluded. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study Subjects must not have evidence for impaired liver function due to iron overload, +/ hepatitis. Patients will be evaluated by hepatology if ferritin >1500, if history of hepatitis, or ALT/ALP are >1.5 X ULN | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-0.014, Heart Murmurs Mitral Valve Prolapse Systolic Murmurs any premature baby or newborn parental approval for study participation | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 16.0-999.0, Autoimmune Hemolytic Anemia Patients diagnosed with primary warm Autoimmune Hemolytic Anemia Secondary Autoimmune Hemolytic Anemia (infections, hemopathy, systemic diseases) Naive to any treatment for hemolytic anemia or in relapse Older than 16 years of age Able to understand written and spoken French who have provided written informed consent • for Persons without an auto-immune disease, or cancer or an active infection Older than 16 years of age Able to understand written and spoken French Cold agglutinin disease Pregnant women Persons not covered by national health insurance Non-Inclusion controls Persons treated with corticoids or immunosuppressants Pregnant women Persons not covered by national health insurance | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.654-0.788, Anemia Iron Deficiency Neonatal Jaundice Late preterm or term pregnancy (gestational age 34 to 41 weeks) Vaginal delivery Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Anemia Critical Illness Hospitalized for 5 Days or More Hospitalized man/woman in reanimation unit for at least 5 days Age ≥ 18 years old Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl) Signed inform consent by the patient or a close person Subject affiliated to a national health insurance Known iron metabolism pathology (such as primitive or secondary hemochromatosis, …) Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months) Current chemotherapy Patient having an organ transplant Expected survival < 28 days post Intensive Care Unit discharge Pregnancy Patient deprived of freedom, by judicial or administrative order Major protected by the law Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated) Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma….) | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Autoimmune Hemolytic Anemia Adults (18 years old) wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3) Absence of infection or other hematologic disease wAHAI not responding to conventional steroids despite a dose over 10 mg No treatment with rituximab for a minimum of 6 months Signed informed consent form Less than 18 years old Cold AHAI IL2 allergy Chemiotherapy or immunosuppressive treatment Treatment with rituximab for less than 6 months Neoplasia or hematologic malignancy Aplastic anemia Neutropenia ≤ 1000 mm3 Infection Hepatitis B or C | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.083-0.25, Biliary Atresia persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%) elevated liver enzymes ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis with radionuclide imaging confirmation of obstructed biliary excretion concomitant cardiovascular or abdominal organ malformations | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 0.0-18.0, Heart Murmurs Mitral Valve Prolapse Systolic Murmurs outpatient parental approval for study participation | 2 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 12.0-17.0, Cancer Teenagers at the ages 12-17 Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting The specific type of chemotherapy may vary across the four/five consecutive courses but shall one of the following moderate and/or highly emetogenic types of chemotherapy Moderate emetogenic chemotherapy Carboplatin Cyclophosphamide <1500 mg/m2 Cytarabine >1 g/m2 Daunorubicin Doxorubicin Epirubicin Previous and/or acute psychiatric diagnosis Cognitive and mental deficits or impaired functioning | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-65.0, Nicotine Dependence Have no known serious medical conditions Are 18-65 years old Smoke an average of at least 10 cigarettes per day Have smoked at least one cumulative year Have an expired air CO reading of at least 10ppm Are able to read and understand English Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study Participation in any other nicotine-related modification strategy outside of this protocol Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco Use of e-cigarettes other than the ones provided during the study Intent to quit smoking with FDA approved pharmaceutical products within the next 90 days Hypertension (systolic >160 mm Hg, diastolic >100 mm Hg. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety Coronary heart disease Lifetime history of heart attack Clinically significant cardiac rhythm disorder (irregular heart rhythm) Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source) Clinically significant cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure) Clinically significant liver or kidney disorder (except kidney stones, gallstones) Clinically significant gastrointestinal problems or disease Active ulcer in the past 30 days | 0 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-999.0, Warm Antibody Autoimmune Hemolytic Anemia Subject must have had a diagnosis of primary or secondary warm antibody AIHA Must have previously received at least 1 prior treatment regimen for AIHA and have evidence of relapse Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria Subject with a platelet count of < 100,000/μL Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg | 1 |
A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative. | eligible ages (years): 18.0-120.0, Atypical Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura Microparticles Microangiopathic Hemolytic Anemia Patients with MAHA, TTP, and/or aHUS Prisoners | 1 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 0.0-999.0, Lyme Disease Tick-Borne Diseases Ferry passengers traveling to Nantucket Island Foreign (non-U.S.) residence | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-65.0, Lyme Disease You may be eligible for this study if you Are between 18 and 65 years of age Are a resident of Long Island or greater NY metropolitan area Are fluent in English Have a history of Lyme Disease Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study Have severe fatigue Are not pregnant or planning to be pregnant You will not be eligible for this study if you Have or have had major medical, neurologic, or psychiatric disorder Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease Have had Fibromyalgia Syndrome Have a history of sleep apnea, narcolepsy, or other serious sleep disorder Have a learning disability Have had head trauma requiring hospitalization Have symptomatic gallbladder disease Are anemic Abuse alcohol or illicit drugs | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Lyme Disease You may be eligible for this study if you Are at least 18 years of age Are seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment Have documented history of acute Lyme disease Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary) Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen You will not be eligible for this study if you Have previously enrolled in this study Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study Are taking chronic medication that could interfere with evaluation of symptoms Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary) Are hypersensitive to ceftriaxone or doxycycline Have active inflammatory synovitis Have another disease that could account for symptoms of acute Lyme disease Have another serious or active infection Are unable to tolerate an IV | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 13.0-999.0, Lyme Disease Screening Age greater than or equal to 13 years old Suspect of suffering from Lyme disease Post-Treatment Lyme Disease Syndrome (PTLDS): For the purposes of this study, PTLDS is defined as occurring in male or female patients age 13 and above who have been diagnosed with confirmed Lyme disease, have received recommended antibiotic therapy and have persistent or relapsing symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC (IgG immunoblot is considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC), 28 kDa, 30 kDa, 39 kDa, 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa) Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joint, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme disease OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix [R]). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5 Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with acute or chronic Lyme disease and negative western blot to B.burgdorferi in the serum by the CDC criteria General Age less than 18 (less than 13 for patients with chronic Lyme disease) Weight less than 70 Lb (35 kg) Pregnancy or lactation Women with childbearing potential who are sexually active and unwilling to use effective contraception Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV Chronic medication use will be evaluated in a case-by-case basis Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation FOR PTLDS AND LYME In addition to the general | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Erythema Migrans Lesions Erythema Migrans Patients Age greater than or equal to 18 years Diagnosis of EM an expanding annular lesion, at least 5 cm in diameter on a person with a history of exposure to the disease Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme disease is endemic A history of tick bite is not required The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on the face, neck, scalp, and over the tibia Not know to be positive for RPR, HIV, HBsAg or HCV Able to give consent Healthy Volunteers Patients Antibiotic therapy for the current episode of Lyme disease Oral corticosteroids within the past 2 weeks History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year Diagnosis of diabetes, active cancer, or autoimmune diseases Investigational drugs in the past month History of forming large thick scars after skin injuries or surgery History of excessive bleeding after cuts or procedures or on anticoagulation Use of steroid cream/ointment at the rash Healthy Volunteers | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Lyme Neuroborreliosis Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled Intrathecal production of borrelia antibodies White cell count in cerebrospinal fluid (CSF) > 5/mm3 Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval Verified acrodermatitis chronica atrophicans Allergy to the contents in the medication, or earlier type I reaction to penicillin Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days Pregnancy or breastfeeding Age < 18 years | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Encephalitis, Tick-Borne Subjects who participated in Study 223 will be eligible for participation in this study if they understand the nature of the study, agree to its provisions and provide written informed consent they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 blood was drawn after their first booster vaccination in Study 223 Subjects will be excluded from participation in this study if they received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Subjects will not be eligible for booster vaccination if they are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223 | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 7.0-12.0, Lyme Disease Child age 7-12 and their parents living in the selected endemic areas No exclusions | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 15.0-999.0, Nervous System Lyme Borreliosis erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old pregnancy lactation history of adverse reaction to a beta-lactam antibiotic | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 15.0-999.0, Erythema Chronicum Migrans solitary erythema migrans in patients > 15 years a history of Lyme borreliosis in the past pregnancy or lactation immunocompromised status serious adverse event to doxycycline taking antibiotic with antiborrelial activity within 10 days multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 15.0-999.0, Suspected Early Lyme Neuroborreliosis age >15 years erythema migrans in 4 months period before neurologic symptoms normal CSF cell count absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy) pregnancy lactation allergy on doxycycline and ceftriaxone immune deficiency | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis adult patients >/= 18 years of age active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA functional class IV by ACR classification history of inflammatory joint disease other than RA previous treatment with cell-depleting therapies, abatacept or rituximab active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 17.0-65.0, Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 10.0-999.0, Anaplasmosis Tick-borne Disease Ehrlichia patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- patient with fever with at least one of following : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities patient with tick-borne encephalitis, or primary stage Lyme borreliosis children less that 10 years pregnancy patients with an other diagnosis that can explain clinical symptoms or biological abnormalities antibiotherapy with cyclins during the days before | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Tick-Borne Encephalitis Encephalitis, Tick-Borne Tick-Borne Disease Glycoprotein E, Flavivirus NSI Protein, Flavivirus All subjects must meet the following at study entry Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID Be 18 years of age or older at the time of the first immunization Comprehend the study requirements Provide written informed consent to participate in this study Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination Have a stable health status as determined by the Investigator Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments) Express availability for the required study period, and ability to attend scheduled visits The following should be checked at the time of the study entry. If any apply, the subject will not be included in the study The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.) The presence on the day of immunization of an oral temperature of > 101.2 degrees F or acute symptoms other than mild severity Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.) | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Lyme Neuroborreliosis patients with typical clinical manifestations of Lyme neuroborreliosis and intrathecal antibody production against Borrelia burgdorferi patients with typical clinical manifestations of Lyme neuroborreliosis and erythema migrans within three months patients with some clinical manifestations of Lyme neuroborreliosis and presence of antibodies against Borrelia burgdorferi bacteria in blood pregnancy lactation use of any antibiotics two weeks before study treatments begins an allergy to ceftriaxone or doxycycline | 1 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 0.167-3.0, Urinary Infection Children aged 2 months Non-toilet-trained children Indication to bag urine collection with the following fever ≥ 38.5 °C unexplained fever and at least 1 of the following for girls and uncircumcised boys, at least 2 for circumcised boys age ≤ 12 months fever ≥ 48 hours poorly tolerated fever (chills ± cyanosis ± pronounced weakness…) Parents opposed to the participation of their children in the study Diarrhea Current antibiotic treatment or during the 8 preceding days of the urine collection Genitals / perineal anomaly | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 8.0-14.0, Duchenne Muscular Dystrophy Diagnosis of Duchenne muscular dystrophy confirmed by at least one of the following Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical presentation consistent with typical DMD Positive gene deletion test (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as "out-of-frame", and clinical presentation consistent with typical DMD Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) definitively associated with DMD, and clinical presentation consistent with typical DMD Age between 5 yrs old (inclusive) Positive Gower sign (indicating ability to rise from the floor & presence of proximal muscle weakness) Able to walk 10 meters in <12 seconds Able to stand upon WBVT plate (with knees flexed) for entire treatment protocol (i.e. 15-minutes) Stable absolute dose of glucocorticoids (i.e. prednisone or deflazacort) for at least 3 months prior Clinical presentation, genetic testing and/or muscle biopsy consistent with Becker muscular dystrophy History of recent surgery (within past 6-months) History of a recent fracture (long-bone or vertebral) within past 6-months Acute inflammatory processes of lower extremities (e.g. cellulitis, etc) due to risk of pain and/or worsening inflammatory process History of venous thrombosis (theoretically risk of inducing thromboembolic event) History of kidney or bladder stones History of uncontrolled seizures or severe migraines History of cardiac arrhythmia Intracranial pathology or hardware (e.g. ventriculoperitoneal shunt, cochlear implant) Use of any investigational or experimental products within last 6-months and/or concomitant participation in another study | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Acute Injury of Upper Extremity All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) English fluency and literacy Able to take informed consent Pregnant women | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 7.0-9.0, Duchenne Muscular Dystrophy Diagnosis of DMD confirmed by clinical history with features before the age of five physical examination elevated serum creatine kinase level absence of dystrophin expression, as determined by immunostain or Western blot (<2%) and/or DNA confirmation of dystrophin mutation Age 7 to 9 years: a lower age limit of 7 years was selected, since in our experience children younger than 7 years are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 9 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs Currently using corticosteroids (prednisone or deflazacort) as prescribed by a physician Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants) Presence of a condition in control subjects or a secondary condition in boys with DMD that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy) Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Unstable medical condition (e.g. uncontrolled seizure disorder) Behavioral problems causing an inability to cooperate during testing | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Tick-borne Encephalitis years or older clinical picture compatible with tick-borne encephalitis clear cerebrospinal fluid cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus positive serum IgG antibodies against Lyme borreliae isolation of B.burgdorferi sensu lato from cerebrospinal fluid positive intrathecal borrelial antibody production index seroconversion of borrelial IgG antibodies presence of erythema migrans and/or borrelial lymphocytoma in the last month Bannwarth syndrome | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-130.0, Lung Cancer Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures Adults (according to each country regulations for age of majority) Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation Prior therapy with an EGFR-TKI. Patients may have also received additional lines of treatment World Health Organization (WHO) performance status 0-2 Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline (please refer to IB for guidance) ECG recording at baseline showing absence of any cardiac abnormality as per criterion #6 Female patients of childbearing potential must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to start of dosing. Otherwise, they must have evidence of nonchildbearing potential Male patients must be willing to use barrier contraception, i.e., condoms Previous (within 6 months) or current treatment with AZD9291 Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, active infection including hepatitis B, hepatitis C, and human immunodeficiency virus, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the investigator's opinion would significantly alter the risk/benefit balance Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to start AZD9291 administration Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD Any of the following cardiac Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 0.0-0.019, Microbiota Eczema Atopy Term-born babies (≥ 36 weeks gestational age) (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment Signed informed consent by the parents Congenital illness or malformations Severe perinatal infections for which transfer to the neonatal intensive care unit is needed Maternal probiotic use ≤ six weeks before delivery Insufficient knowledge of the Dutch language | 0 |
A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated. | eligible ages (years): 18.0-999.0, Tick Bites Tick-borne Diseases over 18 years of age spending an average of 10 or more hours of outdoor work per week during peak tick season, and completion of written informed consent pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved) non-English speakers, or having a known allergy or sensitivity to insecticides | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 1.0-17.0, Cardiovascular Diseases Coronary Aneurysm Heart Diseases Mucocutaneous Lymph Node Syndrome Boys and girls who met the CDC for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness | 2 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 4.0-12.0, Obsessive-Compulsive Disorder OCD Participants (N = 72) Aged 4-12 years and living within a four-hour commute from NIH Currently meet DSM-IV for OCD Recent onset of symptoms (less than 6 months.) Healthy Controls (N = 60-72) Age and sex matched to ODC participants Must be free of current or past psychopathology OCD Participants Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever Significant or unstable medical illness Full scale IQ less than 80 Healthy Controls Full scale IQ less than 80 Significant or unstable medical illness | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 12.0-999.0, Pharyngitis Tonsillitis Give informed consent, assent and patient authorization Age 12 and over A clinical diagnosis of acute pharyngitis or tonsillitis A positive rapid Strep test Can swallow the oral study dosage forms Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active Chronic or recurrent odynophagia Need for hospitalization or IV antimicrobial therapy Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials Known carrier of S. pyogenes Allergies to penicillin or other beta-lactam antibiotics Any serious illness or concomitant condition that the investigator judges will preclude to the study Seizure disorder Pregnant or nursing Expectation of additional systemic antibacterials would be required for another condition Current drug or alcohol abuse | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 0.5-12.0, Pharyngitis Give informed consent, assent, and documentation of patient authorization for disclosure of study results Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian Age > = 6 months -12 years A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following Tonsillar or pharyngeal exudate Tender cervical lymph nodes Fever or history of fever treated with antipyretics Odynophagia Uvular edema Pharyngeal Erythema of moderate or greater intensity Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology The need for hospitalization or I.V. antimicrobial therapy Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials Patients who are known carriers of S. pyogenes Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 3.0-15.0, Streptococcus Group A All children 3 to 15-years old with pharyngitis who are seen at a participating site will be invited to participate Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 12.0-999.0, Sore Throat Pharyngitis Tonsillitis Informed consent/assent Age 12 and older A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following Odynophagia Tonsillar or pharyngeal exudates Tender cervical lymph nodes Fever or history of fever treated with antipyretics Chills Uvular edema Elevated white blood cell count Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials Subjects who are known carriers of S. pyogenes Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other immunocompromised state | 0 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 18.0-999.0, Streptococcal Infections Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005) | 1 |
A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge. | eligible ages (years): 0.5-13.0, Tonsillitis Pharyngitis Age 6 months to less than 13 years of age (<13) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Tonsil and/or pharyngeal erythema and/or exudate Cervical adenopathy Uvular edema Fever Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Females of childbearing potential (ie, have reached menarche) Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm) Myasthenia gravis Known impaired renal function, as shown by creatinine clearance ≤25 mL/min The subject | 0 |
Subsets and Splits