Inclusion Criteria Clause Samples

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 BA058 Injection 80 µg/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. 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 ▇▇▇▇▇ ▇▇▇▇▇) 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 ▇▇▇▇▇▇▇’▇ 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. Chapter 5 Questionnaire Tuberculin skin testing Blood sampling and laboratory procedures

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. The service will accept referrals from people aged 16 years and over • The service will comply with national protocol for the selection of heart transplant patients ▇▇▇▇://▇▇▇.▇▇/transplantation/guidance-policies including : o Documented severe cardiac dysfunction despite optimum tolerated medical treatment o No evidence of co-morbidities that would compromise transplant benefit

Inclusion Criteria. Participants must meet all of the following criteria at the time of randomisation: 1. Healthy male or female adults aged 18 years and over 2. Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28 days prior to, randomisation 3. A female participant is eligible for this study if she is not pregnant or breast feeding and one of the following: a. Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) b. Of childbearing potential but agrees to practice effective contraception 8 weeks post-vaccination and has a negative urine pregnancy test pre-vaccination. Acceptable methods of contraception include one or more of the following: i. Male partner who is sterile prior to the female participant’s entry into the study and is the sole sexual partner for the female participant ii. Implants of levonorgestrel