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. Patients must meet all of the following criteria to be eligible to participate in this study.
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
2. All patients with meconium ileus are included into the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF and in further analysis subgroups will be established.
3. Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child
Inclusion Criteria. Subjects must meet all of the following criteria to be eligible to participate in this study:
1. The subject was enrolled, randomized to Abaloparatide-SC/Placebo and completed 18-months of blinded treatment within Study BA058-05-003.
2. The subject is no more than 40 days from Visit 9 in Study BA058-05-003.
3. The subject has read, understood, and signed the written informed consent form for the Extension Study.
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: 1 Subject must be at least 18 years of age. 2 Subject must be able to understand and must sign an ICF that has been approved by an IRB.
Inclusion Criteria. Chapter 5 Questionnaire Tuberculin skin testing Blood sampling and laboratory procedures
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 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 were intolerant of the treatme...
Inclusion Criteria. This Protocol applies to a) community based patients b) patients being discharged from an acute to a community setting If they meet all of the following criteria: • Uses a GP and community pharmacy within NHSGGC area And • Is aged 18 years or over AND • Has consented to dietetic treatment and, as part of this, to a course of prescribable ONS Exclusion criteria: 1. Patients who do not consent to dietetic treatment 2. Patients who decline treatment with ONS
Inclusion Criteria. 1. Quantitative design and present data on measures assessing involvement of service user, caregiver and community in the Indian mental health system
2. Qualitative design and report text-based data on experiences relating to service user, caregiver and community involvement in the Indian mental health system
3. Mixed methods research design and include a component that meets the criteria regarding qualitative and/or quantitative research outlined above
4. Narrative studies presenting evidence of involvement of service user, caregiver and community in the Indian mental health system Research protocols, comments, letters and dissertations were excluded from a systematic review.
Inclusion Criteria. 2.4.1 The Service shall be available to all adults aged 25 years and under who require access to EHC (in line with the requirements of the PGD), information, advice and signposting.
2.4.2 The pharmacist will assess the need and suitability of the Service User to receive EHC, in line with the PGD. Where appropriate a supply will be made. If supply is inappropriate, advice and referral to another source of assistance will be provided.
2.4.3 All Service Users will be offered a referral for a Copper IUD as the most effective form of Emergency Contraception. If a CuIUD is accepted the pharmacy will facilitate the referral to CASH or GP. The Provider should still supply EHC where clinically appropriate.
2.4.4 Service Users who have exceeded the time limit for levonorgesterel will be offered Ullipristal Emergency Hormonal Contraception in line with the PGD.
2.4.5 The pharmacist will use their discretion whether the Service User needs a pregnancy test. Inclusion and exclusion criteria, which are detailed in the PGD, will be applied during the provision of the service.
2.4.6 Service Users excluded from the PGD criteria will be referred to another local service that will be able to assist them, as soon as possible, e.g. GP, CASH, or will be invited to purchase the Pharmacy medicine product if the exclusion from supply via the PGD is due to age.
