№ files_lp_4_process_3_121308
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Administrative application form used by the European Cystic Fibrosis Society Patient Registry to collect study proposals and data requests from marketing authorisation holders conducting PASS, PAES, or drug utilisation studies in Europe.
Year: Not specified
Region / Area: Europe
Subject: Post-authorisation safety and efficacy studies in cystic fibrosis registries
Document Type: Application form
Organization: European Cystic Fibrosis Society Patient Registry (ECFSPR)
Related Organization: European Medicines Agency (EMA)
Applicant Type: Marketing Authorisation Holder
Purpose: Submission of requests for registry data for PASS / PAES studies
Required Attachments: Study protocol; Statistical analysis plan
Submission Method: Email submission to [email protected]
Key Sections: Applicant details; Study information; Cohort definition; Statistical methods; Data requirements
Population Scope: Patients included in the European Cystic Fibrosis Society Patient Registry
Historical Data Availability: 2008–2023
Fee Structure: €5,000 handling; €25,000 review and feasibility assessment; €5,000 application modification
Governance Note: Individual country applications outside ECFSPR governance may apply separate fees
Price: 8 / 10 USD
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PAES assessment report sub-template for type II variations
Document type: Regulatory assessment report sub-template
Subject: Post-Authorisation Efficacy Study (PAES) results
Regulatory procedure: Type II variation
Purpose: Description and assessment of PAES results within a variation assessment report
Related procedure: Request for Supplementary Information (RSI)
Content elements: Scientific discussion update and reference to detailed RSI assessment section
Language: English
Genetic relatedness and host specificity of Pseudomonas aeruginosa isolates from cystic fibrosis and non-cystic fibrosis patients
Year: 2014
Region / city: Qatar
Topic: Medical Research
Document Type: Research Article
Author(s): Atqah AbdulWahab, Saad J Taj-Aldeen, Emad Ibrahim, Shaikha H Abdulla, Ramees Muhammed, Irshad Ahmed, Yasmine Abdeen, Omnia Sadek, Marawan Abu-Madi
Target Audience: Medical professionals, researchers in infectious diseases
Date of approval: 2014
Note: Contextual description
Giant exophytic cystic adenomyosis with a levonorgestrel containing intrauterine device out of the uterine cavity after uterine myomectomy: A case report
Year: 2020
Region / City: Zhejiang Province, China
Field: Gynecology
Document Type: Case Report
Organization / Institution: Zhejiang University School of Medicine, Women’s Hospital
Authors: Zhou Y, Zheng-Yun Chen, Xin-Mei Zhang
Target Audience: Medical professionals, researchers in gynecology
Period of validity: N/A
Date of approval: N/A
Date of changes: N/A
Date received: September 2, 2019
Date revised: November 28, 2019
Date accepted: December 13, 2019
Date published online: January 6, 2020
Keywords: Cystic adenomyosis, Dysmenorrhea, Levonorgestrel containing intrauterine device, Myomectomy, Case report
URL: https://www.wjgnet.com/2307-8960/full/v8/i1/188.htm
DOI: https://dx.doi.org/10.12998/wjcc.v8.i1.188
Context: This is a medical case report detailing a rare instance of giant exophytic cystic adenomyosis with a levonorgestrel-containing intrauterine device out of the uterine cavity following uterine myomectomy.
Correlation between patient-derived intestinal organoids and clinical responses to CFTR modulators in people with cystic fibrosis homozygous for F508del
Authors: Noelia Rodriguez Mier; Senne Cuyx; Kris De Boeck; Marijke Proesmans; Mieke Boon; Lieven Dupont; Kaline Arnauts; Elke De Wachter; Stephanie Van Biervliet; Monique Lequesne; Vicky Nowé; Hedwige Boboli; Anabela Santo Ramalho; François Vermeulen; on behalf of the Belgian Organoid Project
Affiliations: KU Leuven; University Hospital Leuven; University Hospital Brussels; Ghent University Hospital; Antwerp University Hospital; GZA Hospital; CHR Citadelle
Country: Belgium
Research field: Cystic fibrosis; CFTR modulators; organoid research; personalized medicine
Study population: 60 people with cystic fibrosis homozygous for F508del
Genetic focus: F508del CFTR mutation (homozygous)
Interventions studied: Elexacaftor/tezacaftor/ivacaftor; Tezacaftor/ivacaftor
Methods: Patient-derived intestinal organoids from rectal biopsies; forskolin-induced swelling assay; comparison with clinical outcomes
Clinical outcomes assessed: Lung function; sweat chloride levels; body weight; pulmonary exacerbations
Type of document: Scientific research article
Source: PubMed
DOI / Identifier: 40883119
Rotational Team Lead Physiotherapist Respiratory Medicine, Acute Medicine & Cystic Fibrosis
Year: 2023
Region / City: Royal Devon & Exeter Hospital, Wonford, UK
Topic: Healthcare, Physiotherapy
Document Type: Job Description
Organization / Institution: Royal Devon University Healthcare NHS Foundation Trust
Author: N/A
Target Audience: Healthcare professionals, physiotherapists
Period of Validity: N/A
Approval Date: N/A
Amendment Date: N/A
The genetics of cystic fibrosis and prenatal options: information for patients, parents and carers
Year: 2025
Organization: Alder Hey Children’s NHS Foundation Trust
Department: Department of Respiratory Medicine
Document type: Patient information leaflet
Target audience: Patients, parents and carers of children with cystic fibrosis
Topic: Genetics of cystic fibrosis, carrier testing, reproductive options
Review date: March 2025
Contact: Tel: 0151 228 4811, www.alderhey.nhs.uk
Location: Liverpool, United Kingdom
Cystic Fibrosis: Causes, Treatments, and Management Strategies
Year: 2016
Author: Tamia Jackson
Date: March 11, 2016
Period/Class: 5th period
Topic: Cystic Fibrosis
Document Type: Educational overview
Intended Audience: Students
Key Subjects: Genetic causes, airway clearance, inhaled medications, nutrition, fitness, CFTR modulators, lung transplantation
Related Conditions: Fibrocystic Disease of the pancreas, Mucoviscidosis
Medical Note: There is no cure for Cystic Fibrosis
Evaluating the correspondence between the EQ-5D-5L and disease severity and quality of life in adults and adolescences with cystic fibrosis
Year: 2023
Region / City: United Kingdom
Theme: Health-related quality of life, Cystic fibrosis
Document Type: Research Article
Author: Rana Altabee, Siobhan B. Carr, Jaince Abbott, Rory Cameron, Daniel Office, Nicholas J. Simmonds, Jennifer A. Whitty, David Turner, Garry Barton
Target Audience: Researchers, healthcare professionals, policy makers
Period of Study: July 2020 – March 2021
Approval Date: 2023
Date of Changes: None
Cystic Fibrosis Center Hospitalization Guidelines and Procedures
Year: 2026
Location: University of Cincinnati Hospital, 8 East Unit
Subject: Cystic Fibrosis inpatient care and hospital protocols
Document Type: Patient guidance / hospital procedure
Institution: UC Hospital Pulmonary Consult Service
Author: CF Nurse Practitioner Angela Oder
Target Audience: CF patients and their families
Admission Requirements: Direct or scheduled CF admissions
Infection Control: Droplet & Contact isolation, personal protective equipment required
Dietary Guidelines: High calorie diet (3000 cal/day), extended menu for CF patients
Medical Monitoring: Vital signs every 8 hours, weight 2–4 times per week, glucose monitoring as needed
Therapy and Exercise: 4 respiratory therapy sessions/day, encouraged physical activity, home IV setup guidance upon discharge
Follow-up: Appointment within 2 weeks post-discharge
Topics: ECFSPR PAES cystic