№ files_lp_4_process_3_072609
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Randomized controlled trial supplemental materials detailing the design, inclusion and exclusion criteria, prohibited medications, visit schedule, and assessment tools for a COPD study.
Year:
2026
Region / City:
Multicenter, unspecified locations
Topic:
Chronic Obstructive Pulmonary Disease
Document Type:
Clinical Study Supplement
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Clinical researchers and healthcare professionals
Study Phase:
Not specified
Inclusion Criteria:
Adults aged 40–80 with COPD, stable maintenance therapy, capable of performing spirometry and following study procedures
Exclusion Criteria:
Recent severe infections or surgeries, significant comorbidities, prohibited medication use, pregnancy or breastfeeding, recent participation in other trials
Prohibited Medications:
Systemic or inhaled corticosteroids, certain antibiotics, leukotriene inhibitors, theophylline, PDE4 inhibitors, terbutaline, nebulized COPD medications, oral β2-agonists
Study Visits:
Screening (visit 1), baseline and dosing (visit 2), mid-study assessment (visit 3), end-of-treatment assessment (visit 4), follow-up call post-treatment
Assessment Tools:
CAT, mMRC Dyspnea Scale, spirometry, vital signs, physical examination
Treatment Duration:
12 weeks
Compliance Monitoring:
Dispensed medication retrieval and assessment at visits 3 and 4
Price: 8 / 10 USD
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Year:
2024
Region / City:
Global
Topic:
Chronic Obstructive Pulmonary Disease (COPD) Management
Document Type:
Research Study
Organization / Institution:
Various international medical organizations
Authors:
Schrijver J, Lenferink A, Brusse-Keizer M, et al.
Target Audience:
Healthcare professionals, researchers, policymakers
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / city:
Australia
Type of document:
Pharmaceutical submission / Public Summary Document
Regulatory authority:
Therapeutic Goods Administration (TGA)
Submitted by:
Generic Health Pty Ltd
Product:
Tiotropium Lupin 18 microgram powder for inhalation, LupinHaler device
Indication:
Chronic obstructive pulmonary disease (COPD)
Previous PBS listing:
Spiriva 18 microgram powder for inhalation, HandiHaler device
Submission type:
Category 4 (cost-minimisation comparison)
PBS item code:
8626BMP,NP
Maximum quantity:
1 pack, 30 units
Prescriber type:
Nurse Practitioners, Medical Practitioners
Restriction type:
Restricted benefit
Administrative advice:
Not to be used in combination with LAMA/LABA or SAMA; adherence to current inhaler technique to be reviewed at each clinical visit; diagnosis requires spirometry confirmation
Year:
2023
Region / City:
England
Topic:
Healthcare, Quality Standards
Document Type:
Policy document
Organization / Institution:
NHS England
Author:
General Practice Specification and Extraction Service (GPSES), NHS England
Target Audience:
Healthcare providers, Medical professionals
Period of Validity:
2023-2024
Approval Date:
01/04/2023
Date of Amendments:
01/08/2023
Contextual Description:
Policy document outlining business rules for COPD management under the Quality and Outcomes Framework for NHS England.
Year:
2019
Region / City:
United Kingdom
Topic:
Chronic Obstructive Pulmonary Disease (COPD), Oxygen Saturation
Document Type:
Guidance
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
NICE
Target Audience:
General practitioners, healthcare professionals
Period of Validity:
Not specified
Approval Date:
August 2019
Date of Last Update:
N/A
Year:
Not specified
Region / City:
Not specified
Topic:
COPD, Medical Research Council score, Fibrinogen levels, Six-minute walking test, Medication costs, Probabilistic analysis
Document Type:
Scientific Analysis
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Healthcare professionals, Clinicians
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Country:
China
Ethics Approval Number:
2023KYLL014
Scientific Field:
Genetic epidemiology
Research Topic:
Causal relationship between chronic obstructive pulmonary disease and lung adenocarcinoma
Study Design:
Two-sample Mendelian randomization study
Document Type:
Reporting checklist
Exposure:
Chronic obstructive pulmonary disease (COPD)
Outcome:
Lung adenocarcinoma (LUAD)
Data Sources:
GWAS dataset ebi-a-GCST90018807; GWAS dataset ebi-a-GCST004744; TCGA; GEO datasets GSE116959 and GSE76925
Sample Size:
57 LUAD patients, 11 healthy controls, 111 COPD cases, 40 smoking controls
Key Biomarkers:
FCRLA, GREM1, MMP9
Statistical Methods:
Inverse variance weighting (IVW), MR Egger, MR-PRESSO, LASSO regression, false discovery rate correction
Software:
R version 4.2.1; TwoSampleMR package; ggplot2
Diagnostic Criteria:
COPD defined by spirometry (FEV1/FVC < 0.7); LUAD confirmed by histopathology
Genetic Variant Selection Criteria:
Genome-wide significance threshold p < 5 × 10⁻⁸; LD pruning r² < 0.01
Core Mendelian Randomization Assumptions:
Relevance, independence, exclusion restriction
Document type:
Clinical correspondence letter
Medical topic:
COPD and bronchiectasis management
Medication:
Azithromycin
Purpose:
Recommendation to initiate azithromycin therapy to reduce exacerbations
Sender role:
Respiratory specialist
Recipient role:
General Practitioner
Patient category:
Patients with COPD or bronchiectasis experiencing exacerbations
Clinical objective:
Reduction in number of exacerbations within a 12-month period
Review schedule:
6 months after treatment initiation and additional follow-up months as specified
Prescribing status:
Amber Recommended
Prescribing guidance source:
Pan-Mersey Area Prescribing Committee
Response requirement:
GP confirmation or refusal within 14 days
Sections included:
Treatment dose and frequency, indication, review plan, GP decision section
Year:
2010
Organization:
Key Medical Resources, Inc.
Author:
Terry Rudd, RN, MSN
Type of Document:
Educational self-study module
Target Audience:
Nurses and healthcare professionals
Location:
Rancho Cucamonga, California, USA
Continuing Education Hours:
15.0
Certification:
California Board of Registered Nursing CEP#15122
Format:
Self-study with exam and evaluation form
Content Focus:
Asthma, COPD, respiratory assessment, lung function, pharmacology
Year:
2021
Study:
Global Burden of Disease Study 2021 (GBD 2021)
Topic:
Epidemiological modeling and data sources for COPD incidence and mortality
Document type:
Technical nomenclature and methodological description
Field:
Epidemiology and public health
Model:
Age–Period–Cohort (APC) model
Data source system:
Global Health Data Exchange (GHDx)
Database:
Causes of Death (CoD) database
Modeling tools:
DisMod-MR; MR-BRT (Bayesian regularized model with temporal smoothing)
Geographic coverage:
204 countries and territories
Health condition:
Chronic Obstructive Pulmonary Disease (COPD)
Data source types:
surveys, censuses, vital registration, surveillance systems, cancer registries, police records, sibling history, survey/census data, minimally invasive tissue sample diagnoses
Reference parameters:
reference age group (a0), reference period (p0), reference cohort (c0)
Statistical measures:
Net Drift, Age Deviations, Period Deviations, Cohort Deviations, Longitudinal Age Curve, Period Rate Ratios, Cohort Rate Ratios, Local Drifts
Data access platform:
Global Health Data Exchange citation tool
File format available:
CSV metadata export
Outlier criteria:
exclusion of implausible values, conflicts with age or temporal patterns, and inconsistencies with comparable data sources
Year:
2010–2011
Region:
United Kingdom, England
Subject:
Telehealth, Chronic Obstructive Pulmonary Disease (COPD), Health Economics
Document type:
Research Study / Pilot Programme Report
Organization:
National Health Service Direct (NHSD)
Authors:
Not specified
Target population:
Patients with chronic obstructive pulmonary disease (COPD)
Study sites:
Two Primary Care Trusts (PCT1, PCT2)
Participants:
321 enrolled, 227 included in final analysis
Intervention:
Remote patient monitoring / telehealth
Outcome measures:
Cost-effectiveness, resource utilization, hospital admissions, length of stay
Data collection period:
12 months before, immediately before, and during monitoring
Keywords:
telehealth, telemedicine, cost-effectiveness, remote patient monitoring
Year:
2018
Region / city:
Regional Victoria
Topic:
Pathophysiology, Pharmacology, COPD, Pneumonia
Document type:
Case report
Organization / institution:
CRICOS Provider No. 00103D
Author:
Not specified
Target audience:
Healthcare professionals, Medical students
Action period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2026
Region:
West Yorkshire, UK
Subject:
Health communication / Patient engagement
Document type:
Template messages
Organization:
West Yorkshire Health Service
Target audience:
Patients with Asthma or COPD, parents/carers of children with Asthma
Platforms referenced:
Google Play, Apple App Store
Conditions addressed:
Asthma, COPD
Message length:
Short (≤160 characters), Long (≤300 characters)
Date:
August 3, 2011
Author:
Lisa Hull
Document type:
Personal letter
Subject:
Support for Anna Stubblefield
Institutions mentioned:
Rutgers University; Essex County Superior Court
Individuals mentioned:
Anna Stubblefield; DMan; Judge Siobhan Teare
Location:
Newark, New Jersey
Related event:
Criminal trial beginning September 9, 2011
Purpose:
Request for awareness, attendance, and support
Funding information:
Defense fund contribution details
Communication medium:
Written correspondence
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Topic:
Clinical Trials
Document Type:
Plan
Target Audience:
Study team, sponsors, and regulatory authorities
Year:
2014
Region / City:
Geneva
Topic:
Revision of TGP/8, DUS Trial Design and Data Analysis
Document Type:
Draft Document
Organization / Institution:
International Union for the Protection of New Varieties of Plants (UPOV)
Author:
UPOV Office
Target Audience:
Technical Committees, Working Parties for Vegetables, Agricultural Crops, Fruit Crops, Ornamental Plants, and others involved in plant variety protection
Period of Validity:
Ongoing (as of 2014)
Approval Date:
May 27, 2014
Date of Changes:
N/A
Note:
Year
Year:
2025
Region / City:
Eastern Region, Central Region, Western Region
Subject:
Field Trial Planning and Management
Document Type:
Meeting Minutes
Organization:
English Cocker Spaniel Club of America
Author:
Jack Glinsky, Jonathon Sims, Jeff Lusk, Barb Defalco, Paul McGagh, Mark Mercie, David Williams
Target Audience:
Members of the Field Trial Committee, Judges, Participants
Period of Effect:
2025
Approval Date:
July 15, 2025
Date of Changes:
Not specified
Year:
2025
Region / City:
Shanghai
Topic:
Arbitration, Early Determination
Document Type:
Guideline
Organization:
Shanghai International Economic and Trade Arbitration Commission (Shanghai International Arbitration Center)
Target Audience:
Parties involved in arbitration cases under SHIAC rules
Period of Validity:
Starting June 1, 2025
Approval Date:
June 1, 2025