Inclusion Criteria. Written informed consent must be obtained before any study specific assessment is performed. Upon signing informed consent, the subject is considered enrolled in the study. Subjects eligible for inclusion in this study must fulfill all of the following criteria:
Inclusion Criteria. Subjects must meet all of the following criteria to be eligible to participate in this study:
Inclusion Criteria. Patients must meet all of the following criteria to be eligible to participate in this study.
Inclusion Criteria. The inclusion criteria for this study are: · voluntarily signed the informed consent form prior to the conduct of any study specific procedures · male or female inpatients aged 18 to 75, inclusive · negative pregnancy test for all women of child-bearing potential, or surgically sterilized (i.e. tubal ligation, hysterectomy) prior to Screening, or post-menopausal for at least 1 year · acute MI defined as: · typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: a) ischemic symptoms; b) development of pathologic Qwaves on the ECG; c) ECG changes indicative of ischemia (ST segment elevation or depression) · first anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads]) · regional wall motion score index (at least 4 out of 16 akinetic segments) · one or more of the following: · LVEF >20% and <45% measured and calculated by 2-dimensional measurement · Biomarkers: peak CK > 2000 IU · infarct size > 25% as measured by MRI · successful revascularization with PCI within 7 days of the index MI (only safe and MRI compatible stents) · at time of application of device patient must have patent infarct related artery (XXX) and TIMI flow grade = 3
Inclusion Criteria. 1. Only infants younger than 366 days of age with status post ileostomy or jejunostomy creation (double loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects such as the response to parenteral nutrition and its hepatic toxicity resulting into neonatal cholestasis. The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid-, vitamin- and electrolyte resorption
Inclusion Criteria. Otherwise healthy ambulatory postmenopausal (> 5 years) women from 50 to 85 years of age (inclusive) who meet the study entry criteria and have provided written informed consent are eligible for the study. The women are to have a BMD T-score < -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T-score < -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T-score is <-3.0 and > -5.0. All patients are to be in good general health as determined by medical history, physical examination (including xxxxx xxxxx) and clinical laboratory testing. Serum calcium, PTH(1-84), serum phosphorus and serum alkaline Attachment 2, Attachment E-3 phosphatase values must be within the normal range during the Screening Period. Serum 25-hydroxy Vitamin D must be above 15 ng/mL and within 3 times the upper normal range to be eligible for enrollment. The resting 12-lead ECG obtained during screening should have no clinically significant abnormality and a QTc (Bazett’s correction) of < 470 msec. Patients with more than four mild or moderate fractures, or any severe fractures, will be excluded from the study. In addition, patients with fewer than 2 evaluable lumbar vertebrae or patients with unevaluable hip BMD will be excluded from the study. Patients with unexplained elevation of serum alkaline phosphatase, with a history of Paget’s disease, of any cancer within the past 5 years other than basal cell or squamous cancer of the skin, will be ineligible for enrollment. Also, patients with a history of Xxxxxxx’x disease, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year are also ineligible for enrollment. Patients who have ever received treatment with a PTH or PTHrP drug will be excluded. Treatment with bisphosphonates, fluoride or strontium in the past 5 years, or treatment with androgens, other anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months will also exclude patients from enrollment. Patients who had a short course of bisphosphonate treatment (3 months or less) and w...
Inclusion Criteria. To be eligible for inclusion in the study, each patient must fulfill the criteria below: - Presence of a devoted informed consent signed by the patient and the physician - Female patients, 40-70 years of age at the time of recruitment of diagnosis - Histologically confirmed invasive early or locally advanced operable breast cancer - Tumor stage I, II and III - Patients receiving surgery as part of the local treatment - Patients receiving any type of systemic treatment for breast cancer regardless of treatment type
Inclusion Criteria. Group 1: ICU admission ● Admission to intensive care unit or coronary care unit, other than for standard postoperative recovery Group 2: Uterine rupture ● clinical symptoms (pain, fetal distress, acute loss of contractions, haemorrhage) that led to an emergency caesarean section, at which the presumed diagnosis of uterine rupture was confirmed ● Peripartum hysterectomy or laparotomy for uterine rupture Group 3: Eclampsia / HELLP syndrome ● Eclampsia ● HELLP-syndrome only when accompanied by liver haematoma or rupture Group 4: Major Obstetric Haemorrhage ● Transfusion need of ≥ 4 units of packed cells ● Embolisation or hysterectomy for major obstetric haemorrhage
Inclusion Criteria. Chapter 5 Eligible for inclusion were BCG unvaccinated subjects aged ≥ 17 years who had visited the supermarket at least once monthly within the period of infectiousness of the index case and in whom a TST was indicated. Questionnaire Demographic data and data reflecting the amount of exposure were obtained by ques- tionnaire. The following demographic data were were included in the questionnaire: age, sex, country of origin (TB-endemic country with reported incidence of >50/100,000 new TB cases per year), BCG vaccination status, use of immunosuppressive drugs, work with risk groups for TB, travel to TB endemic regions, previous TST and previous TST results. Exposure at the supermarket was measured as frequency of visits to the supermarket in question (categories: ≤ 1 ×/month, > 1×/month and < 1×/week, 1 ×/week or > 1×/ week), contact period (calculated as the number of months between the first and last supermarket visit within the presumed contagious period of the index case), estimated average duration of a supermarket visit (categories: <5 min, 5-15 min, 15-30 min, 30-60 min, >60 min per visit). From these three parameters, the cumulative shopping time was calculated by multiplication of the contact period, frequency of visits per month and average duration of a visit. For reasons of confidentiality it could not be assessed whether face to face exposure to the index case had actually occurred. Tuberculin skin testing TST was performed according to the Mantoux method using two TU of tuberculin RT-23 (Statens Serum Institute, Copenhagen, Denmark) was used according to standard proto- col. This tuberculin is bioequivalent to the international standard of 5TU PPD-S. 30. TST were administered and read by experienced staff from the Municipal Health Authority (MHA). Indurations were measured at 72 ± 8 h by two independent readers, the average was used as final result. In case of a discrepancy exceeding 2 mm, a third person made the final reading. Blood sampling and laboratory procedures In total, 10 mL of blood was collected in three tubes; one 8 mL cell preparation tube (Vacutainer citrate CPT™, BD, Franklin Lanes, NJ, USA) for the isolation of peripheral blood mononuclear cells (PBMC) for use in T-SPOT.TB, and two heparinized tubes of 1 mL each for QFT-GIT. QFT-GIT In this study, QFT-GIT was used following the manufacturers instructions (www.cellestis. com/IRM/contentAU/gold/InTube_PackageInsert.pdf). This novel format provided two heparinized blood tubes pe...
Inclusion Criteria. 1. Quantitative design and present data on measures assessing involvement of service user, caregiver and community in the Indian mental health system
