Discussion of Study Design Sample Clauses

Discussion of Study Design. Including the Choice of Control Groups 5 SELECTION OF STUDY POPULATION 5.1 Inclusion Criteria (1) Signed informed consent from one of the parent(s)/legal representative(s). (2) Subjects, both genders, aged 3 to 60 months. (3) Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days). 5.2 Exclusion Criteria (1) Known allergy to Racecadotril or any of its ingredients. (2) Subjects suffering from renal or hepatic impairment. (3) Subjects with fever > 39 degrees Celsius (4) Subjects with bloody and/or purulent stools. (5) Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea. (6) Subjects with alternating bouts of diarrhea and constipation. (7) Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency. (8) Cystic fibrosis or coeliac disease. (9) Subjects suffering from prolonged or uncontrolled vomiting. (10) Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency. (11) Subjects having received antibiotic treatment within 2 weeks prior to start of the current diarrhea episode. (12) Subjects having received antidiarrheal drugs (except pre- or probiotics see section 7.7.) 48 hours prior to Day 1. (13) Subjects with severe dehydration requiring intravenous fluid or electrolyte replacement or hospitalization treatment. (14) Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) (15) Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator (16) Intake of experimental drug within 30 days prior to study start. (17) Subjects with contraindications to ORS or susceptible to the warnings of ORS.
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Discussion of Study Design. This is an open-label study to provide safety data in patients with advanced stage DMD. The study focuses on safety assessments; however, because a majority of patients with advanced stage DMD are non-ambulatory, CCI The 96-week duration of the study provides sufficient follow-up time to obtain safety data in this population. The safety extension (not to exceed 48 weeks) will allow patients who have been receiving once weekly infusions of eteplirsen in Study 4658-204 to continue treatment until the product is commercially available or they are able to transition to another eteplirsen study.
Discussion of Study Design. A single-dose, parallel design is the standard design to investigate the PK of a drug in subjects with hepatic impairment. A parallel design is required to include subjects with hepatic impairment and matched-control healthy subjects with normal hepatic function. A single dose level of LOXO-305 will be used because it is the dose intended for registration. The study will be open label because the primary endpoints are objective rather than subjective. Matched-control healthy subjects with normal hepatic function will be enrolled in this study to serve as a reference group for interpretation of the results. Patients with a range of hepatic impairment will be included to enhance the ability to detect and characterize the effects of hepatic function on the PK of LOXO-305. Based on nonclinical and clinical data, and the known PK profile of the compound, the duration of the treatment period is considered adequate to achieve the study objectives.1 Oral doses were chosen because this is the intended clinical route of administration. Preclinical and clinical data suggest that LOXO-305 is likely to be well tolerated in healthy human subjects. However, liver disease can cause alterations in drug disposition, reducing the clearance of drugs eliminated by hepatic metabolism or biliary excretion and affect plasma protein binding, which in turn could influence the processes of distribution and elimination. Therefore, in this study, a cautious approach will be adopted, where the first 2 subjects from Group 2 (mild hepatic impairment subjects) and Group 3 (moderate hepatic impairment subjects) and matched-control healthy subjects may be dosed concurrently, followed by an interim review of the safety and PK data (if available) before dosing is resumed for the remaining subjects in any (all) group(s) (see Section 8.2).

Related to Discussion of Study Design

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) (eff. Apr. 1, 2025, Section 544.0106, pursuant to House Bill 4611, Acts 2023, 88th Leg., R.S.) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

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