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TwitterHealth Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. [from website]
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TwitterOpen Government Licence - Canada 2.0https://open.canada.ca/en/open-government-licence-canada
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Health Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Additional information on Health Canada’s CTD is available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database/frequently-asked-questions.html
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Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and Current Controlled Trials International Standard Randomized Controlled Trials Number Register.
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TwitterObjectives: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorization for products given a conditional approval between January 1, 1998 and June 30, 2017.
Design: Cohort study.
Data sources: Journal articles listing drugs that fulfilled their conditions and received full marketing authorization, Notice of Compliance database, Notice of Compliance with conditions web site, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analyzed, journal articles resulting from confirmatory studies.
Interventions: None
Primary and secondary outcome measures: Characteristics of studies - study design (randomized controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women.
Results: Eleven companies confirmed 36 publications for 19 products (21 indications). T...
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TwitterOpen Government Licence - Canada 2.0https://open.canada.ca/en/open-government-licence-canada
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Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and Current Controlled Trials International Standard Randomized Controlled Trials Number Register.
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Study design We conducted a cross-sectional study to quantify the number and describe the characteristics of prescription drugs on the Canadian market as of August 23, 2022 with a patient support program defined as services (including but not limited to financial assistance) offered to patients prescribed a specific drug and initiated and funded by the manufacturer. We then conducted a structured content analysis of web-based sources to understand the types and range of supports provided to patients through these programs. We chose to rely exclusively on publicly available data sources to both identify and describe manufacturer-sponsored patient support programs as these are sources currently available to patients when making program enrolment decisions and policymakers seeking to understand the extent and impact of this model of care. Sampling frame Because the European Medicines Association defines a patient support program as services for a specific drug offered by the company holding the marketing authorization, we first sought to identify all drug companies with currently marketed, prescription products in Canada. Between June 27, 2022 and August 23, 2022, two investigators independently extracted the names of all member companies listed on the websites of the three main trade associations for the Canadian pharmaceutical industry (Innovative Medicines Canada, representing the research-based pharmaceutical industry; BIOTECanada, representing the biotechnology industry; and the Canadian Generic Pharmaceutical Association, representing generic drug manufacturers). Because trade association membership is voluntary, we supplemented this list with non-member drug manufacturers identified in previous research. Using the Health Canada Drug Product Database,two investigators independently screened the list of companies and included those with marketed, prescription products and excluded companies that were not drug manufacturers (e.g., law firms) or without currently marketed prescription drugs (e.g., products under development). Discrepancies were resolved through discussion or adjudication by a third author. Sample and variables Using the Health Canada Drug Product Database, one investigator searched each identified drug manufacturer and extracted the product and active ingredient name(s) for all marketed, prescription drugs. We counted a single “drug” as all dosages, formulations, or routes of administration with the same active ingredients and manufacturer since industry patient support programs are brand-specific and do not typically differentiate among these factors. We selected variables that reflect known characteristics of drugs that may be associated with having a patient support program, and for which data were publicly available. One investigator also extracted Schedule D (biologic) status, route(s) of administration, and Level 1 Anatomical Therapeutic Chemical (ATC) code from the Drug Product Database and Product Monograph and identified whether the drug had Orphan Drug Status using the searchable United States database. On the basis of type of Health Canada regulatory review (i.e. innovator or subsequent entry), clinical expertise, and knowledge about the manufacturer, two investigators independently identified the brand status of each drug as brand (i.e. “innovator” products first to market); branded generic (i.e. “subsequent entry” products which are bioequivalent or biosimilar to an existing product on the market, but given a proprietary name); or generic (i.e. “subsequent entry” products which are bioequivalent to an existing product on the market). We classified biosimilars as branded generics. We resolved discrepancies through discussion, and/or adjudication by a third author. Identifying patient support programs and their characteristics Our primary outcome was whether a sampled drug had an associated manufacturer-sponsored patient support program. We defined a patient support program as any combination of services or resources related to medication access, administration, adherence, education, storage, or disposal for patients prescribed a specific product and initiated, sponsored and/or operated by the company holding the product’s marketing authorization. We distinguished patient support programs from “patient assistance programs,” excluding programs that exclusively provided financial assistance (e.g., coupons, co-pay coverage, etc.); expanded or compassionate access programs; risk management programs outlined in the Product Monograph (initiated by the regulator rather than the manufacturer); and programs delivered solely for a clinical study. Two investigators independently performed structured searches on Google (“[company name] AND patient support program AND Canada” and “[drug brand name] AND patient support program AND Canada”) to identify industry sponsored patient support programs in Canada and resolving discrepancies through discussion. Using Zotero, a reference management...
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TwitterThe Drug Product Database (DPD) is the official registry of all pharmaceutical products that are authorized for sale in Canada. Maintained by Health Canada, this dataset provides comprehensive information on drugs that are currently approved, previously approved (but discontinued or withdrawn), or under specific regulatory conditions.
This dataset is a crucial resource for researchers, healthcare professionals, regulators, and data scientists working in public health, pharmacovigilance, healthcare analytics, and regulatory intelligence.
The Drug Product Database (DPD) contains details about:
Each record represents a single drug product as listed in Health Canada’s public DPD.
| Column Name | Description |
|---|---|
| DIN | Unique 8-digit Drug Identification Number assigned by Health Canada to each drug product. |
| Product Categorization | Classification category of the product (e.g., Human, Veterinary, etc.). |
| Class | Regulatory class of the drug product. |
| Drug Identification Number | Official identifier assigned to the product in the database (often repeats DIN for traceability). |
| Brand Name | Commercial or brand name of the drug product. |
| Descriptor | Additional product description (e.g., dosage details, formulation notes). |
| Pediatric Flag | Indicates if the product is intended for pediatric use (Y or N). |
| Accession Number | Internal reference number assigned by Health Canada. |
| Active Ingredient | Name(s) of the active medicinal ingredient(s) in the drug. |
| Date First Market Authorization | Date when the drug product was first authorized for sale in Canada. |
| Drug Product Form | Pharmaceutical form of the product (e.g., tablet, solution, injectable). |
| Route Of Administration | How the drug is administered (e.g., oral, intravenous, topical). |
| Therapeutic Description | Therapeutic description or indication, often in English or French. |
| Packaging Or Presentation | Details on dosage presentation or packaging (e.g., single-use ampoules, multi-dose vials, tube format). |
Here are some ideas for how you can use this dataset:
Drug regulation and market authorization are key aspects of public health. This dataset enables:
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Ce jeu de données contient les stratégies de recherche pour les banques de données suivantes : MEDLINE (OVID), EMBASE (OVID), EBM Reviews (OVID), PsycInfo (OVID), CINAHL Complete (EBSCO), Clinicaltrials.gov, ICTRP, ISRCTN, Health Canada Clinical Trials Database, NIHR and Google Scholar. Les concepts recherchés sont "methamphetamine", "psychosocial intervention" and "randomized clinical trials"
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One in five Canadians experiences chronic pain, at a cost of $40.3 billion in 2019. Despite this significant burden, there are few effective treatments for pain. This gap has been recognized by Health Canada, which has put forth the Action Plan for Pain in Canada. Advancing our understanding of pain mechanisms and clinical trials to identify novel therapeutics are essential to address this treatment gap. However, it remains unknown whether the recommendations of the Action Plan have increased research investments. We investigate research investments in pain by the Canadian Institutes of Health Research (CIHR) based on publicly available data. We performed a systematic database search focused on operating funds from competitions between 2008 and 2023 and tabulated pain funding as a proportion of total CIHR operational funds granted each year. Next, we examined the proportion of pain funding across CIHR institutes aggregated across funding years. We identified 20,126 operational grants, of which 459 were pain focused. The highest level of pain funding was 3.32% in 2019, and the average (SD) was 2.13% (0.70%). Funding was stagnant from 2008 to 2023 (R2 = 0.10, P = 0.23). The Institute of Musculoskeletal Health and Arthritis allocated the largest proportion of funding to pain research (11.40%). Eight of the 13 institutes allocated less than 1% of their operating funds to pain research. In sum, CIHR pain research funding does not match the socioeconomic burden posed by pain. We propose three action items to improve pain research funding and to ultimately relieve the burden of pain in Canada.
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This data is from the Smart Triage + QI: A digital triaging platform to improve quality of care for critically ill children study. Data collected for this study occurred from December 2021 to July 2023. Objective(s): This is a pre-post intervention study involving pediatric patients presenting to the study hospitals in seek of medical care for an acute illness. The purpose of this project was to implement Smart Triage + QI to improve the quality of care at four health care facilities in Uganda. The primary objective of the program is to enable healthcare workers to recognize the most urgent children more rapidly and allocate existing resources more efficiently. The second objective is to use the proactive processes of QI to identify and examine opportunities for ongoing improvement to strengthen the health system. The study involved two phases: (I) Baseline Period, and (II) Intervention Period. Phase II also involved a community sub-study at 1 site to identify key messaging for an appropriate methods for disseminating educational materials for VHTs and caregivers on Smart Triage. Data Description: Data was collected at the time of triage by trained study nurses using a custom-built mobile application. All data entered into the mobile application was stored an encrypted database. Data was uploaded directly from the mobile device to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). Outcomes were obtained from facility records or telephone follow-up at 7-10 days and the data was collected electronically. Starting in June 2022, outcomes were also collected via automated follow-up (SMS/WhatsApp) messages at one site. Time-specific outcomes were tracked using an RFID tagging system with study personnel as backup. Limitations: There is missing data and some variables were not collected at all sites. Ethics Declaration: This study was approved by the Makerere University Higher Degrees research and Ethics Committee (SPH-2021-41), the Uganda National Institute of Science and Technology (HS 1745ES). Associated datasets: Smart Triage + QI: A digital triaging platform to improve quality of care for critically ill children NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator at sepsiscolab@bcchr.ca or visit our website.
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What is covered in the report about the “Canada Anesthesia and Respiratory Devices Market”? GlobalData’s “Canada Anesthesia and Respiratory Devices Market Outlook to 2021” report is a comprehensive databook report, covering key market data on the Canada Anesthesia and Respiratory Devices market. The databook report provides value (USD) and volume (units) within market categories – Airway and Anesthesia Devices, Anesthesia Machines, Pain Management Devices, Regional Anesthesia Disposables, Respiratory Devices, Respiratory Disposables, Respiratory Measurement Devices and Sleep Apnea Diagnostic Systems. The Canada Anesthesia and Respiratory Devices Market report provides key information and data on • Annualized market revenues (USD) and volume (units) data for each of the market segments. Data is provided from 2007 to 2014 and forecast to 2021. • 2014 company share and distribution share data for Anesthesia and Respiratory Devices market. • Global corporate-level profiles of key companies operating within the Canada Anesthesia and Respiratory Devices Market. Based on the availability of data for the particular category and country, information related to pipeline products, news and deals is also available in the report. Canada Anesthesia and Respiratory Devices is segmented as follows: • Airway and Anesthesia Devices • Anesthesia Machines • Pain Management Devices • Regional Anesthesia Disposables • Respiratory Devices • Respiratory Disposables • Respiratory Measurement Devices • Sleep Apnea Diagnostic Systems Key Reasons to Purchase The Canada Anesthesia and Respiratory Devices Market report helps you to develop • Business strategies by identifying the key market segments poised for strong growth in the future. • Market-entry and market expansion strategies. • Design competition strategies by identifying who-stands-where in the market. • Develop investment strategies by identifying the key market segments expected to register strong growth in the near future. • Understand the key distribution channels and what’s the most preferred mode of product distribution – Identify, understand and capitalize. Key companies covered in the “Canada Anesthesia and Respiratory Devices Market Outlook to 2021” report • Medtronic plc • Philips Respironics, Inc. • ResMed Inc. • Smiths Medical • GE Healthcare • Teleflex Incorporated • Draegerwerk AG & Co. KGaA The GlobalData Differentiation Extensive interviews are conducted with industry experts to validate the market size, company share and distribution share data and analysis. The data and analysis within this report are driven by GlobalData Medical Equipment (GDME) databases. GlobalData Medical Equipment database gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following: • 15,000+ data tables showing market size across more than 780 medical equipment segments and 15 countries, from 2007 and forecast to 2021 • 6,000+ primary interviews, conducted annually to ensure data and report quality • Approximately 4,000+ medical equipment conference reports, industry-leading analysis reports covering growing sectors, market trends, investment opportunities and competitive landscape • 600+ medical equipment trends and issues, and investment and M&A trends • 55,000+ medical equipment company profiles • 4,100+ company profiles of medical equipment manufacturers in China and India • 2,000+ company profiles of medical equipment manufacturers in Japan • 825+ companies’ revenue splits and market shares • 1,750+ quarterly and annual medical equipment company financials • 700+ medical equipment company SWOTs • 18,000+ pipeline product profiles • 24,800+ marketed product profiles • 31,600+ clinical trials • 25,000+ trial investigators • 20,600+ product patents • 3,700+ reports on companies with products in development • 21,500+ reports on deals in the medical equipment industry • 1,300+ surgical and diagnostic procedures by therapy area • 50+ key healthcare indicators by country For more information or to receive a free demonstration of the service, please visit: http://globaldata.com/medical/Home.aspx Custom Requirements Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs. Read More
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TwitterMaterial Safety Data Sheets for chemical products are available to laboratory workers for most chemicals and reagents. However because many laboratory workers, whether in research, public health, teaching, etc., are exposed to not only chemicals but infectious substances as well, there was a large gap in the readily available safety literature for employees. These MSDS are produced for personnel working in the life sciences as quick safety reference material relating to infectious micro-organisms. The MSDS are organized to contain health hazard information such as infectious dose, viability (including decontamination), medical information, laboratory hazard, recommended precautions, handling information and spill procedures. The intent of these documents is to provide a safety resource for laboratory personnel working with these infectious substances. Because these workers are usually working in a scientific setting and are potentially exposed to much higher concentrations of these human pathogens than the general public, the terminology in these MSDS is technical and detailed, containing information that is relevant specifically to the laboratory setting. It is hoped along with good laboratory practices, these MSDS will help provide a safer, healthier environment for everyone working with infectious substances. The MSDS is ran by the Public Health Agency of Canada. The Public Health Agency of Canada (PHAC) is the main Government of Canada agency responsible for public health in Canada. PHACs primary goal is to strengthen Canadas capacity to protect and improve the health of Canadians and to help reduce pressures on the health-care system. To do this, the Agency is working to build an effective public health system that enables Canadians to achieve better health and well-being in their daily lives by promoting good health, helping prevent and control chronic diseases and injury, and protecting Canadians from infectious diseases and other threats to their health. PHAC is also committed to reducing health disparities between the most advantaged and disadvantaged Canadians. Because public health is a shared responsibility, the Public Health Agency of Canada works in close collaboration with all levels of government (provincial, territorial and municipal) to build on each others skills and strengths. The Agency also works closely with non-government organizations, including civil society and business, and other countries and international organizations like the World Health Organization (WHO) to share knowledge, expertise and experiences.
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This data is a subset of the Smart Discharges Uganda Under 5 years parent study and is specific to the Phase I observational cohort of children aged 6-60m. Objective(s): Used as part of the Smart Discharge prediction modelling for adverse outcomes such as post-discharge death and readmission. Data Description: All data were collected at the point of care using encrypted study tablets and these data were then uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses systematically collected data on clinical, social and demographic variables. Following discharge, field officers contacted caregivers at 2 and 4 months by phone, and in-person at 6 months, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for children who had died following discharge. . Data Processing: Created z-scores for anthropometry variables using height and weight according to WHO cutoff. Distance to hospital was calculated using latitude and longitude. Extra symptom and diagnosis categories were created based on text field in these two variables. BCS score was created by summing all individual components. Limitations: There are missing dates and the admission, discharge, and readmission dates are not in order. Ethics Declaration: This study was approved by the Mbarara University of Science and Technology Research Ethics Committee (No. 15/10-16), the Uganda National Institute of Science and Technology (HS 2207), and the University of British Columbia / Children & Women’s Health Centre of British Columbia Research Ethics Board (H16-02679). This manuscript adheres to the guidelines for STrengthening the Reporting of OBservational studies in Epidemiology (STROBE). NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under "collaborate with the pediatric sepsis colab."
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Background: Composite outcomes, which include mortality and readmission rates, are often used in risk prediction models following hospital discharge when event rates for the primary outcome of interest, mortality, are low. However, increased readmission rates may result in decreased mortality making interpretation of the composite outcome difficult. We assess the usefulness of a composite outcome of post-discharge readmission and mortality as a target outcome in this context. Methods: This was a secondary analysis of data collected among mothers and their newborn(s) admitted for delivery at two regional referral hospitals in Uganda. Six-week post-discharge mortality (all-cause) and readmission in newborn infants were analyzed using a competing risk framework. The Sub distribution Hazard Ratios (SHRs) were compared across predictor variables to examine the relationship between the two outcomes. Results: Of the 206 predictors, 81 had a consistent association with both outcomes. These include a higher weight (Mortality SHR: 0.14, Readmission SHR: 0.68) and length of the baby (Mortality SHR: 0.85, Readmission SHR: 0.91). However, 125 variables depicted an association in opposing directions for both outcomes which may be linked to social and financial barriers to care-seeking. These include a travel time to the hospital of greater than 1 hour (Mortality SHR: 1.4, Readmission SHR: 0.28). Conclusion: While mortality is unequivocally a negative outcome, readmission may be a positive outcome, reflecting health seeking, or a negative outcome, reflecting recurrent illness. This directional dichotomy is reflected to varying degrees within different variables. When using a composite outcome for a prediction model, caution should be exercised to ensure that the model identifies individuals at risk of the intended outcomes of interest, rather than merely the proxies used to represent those outcomes. Identifying predictors with a consistent relationship for both outcomes may yield a more optimized and less biased prediction model for use in clinical care. Data Collection Methods: All data were collected at the point of care using encrypted study tablets and these data were then uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). Following delivery of newborns, written consent was obtained to complete a structured questionnaire in-person and a follow-up questionnaire over the phone six weeks later broadly categorized into the following five domains: 1) social and demographic, 2) pregnancy history and antenatal care, 3) delivery, 4) maternal discharge, and 5) neonatal discharge. Data Processing Methods: The initial cleaned data file was created using R version 4.2.1 (R Foundation for Statistical Computing, Vienna, Austria). Further processing to obtain the final dataset used for analysis including filtering for exclusion criteria, removing predictors with low incidence, and imputing missing values using multiple imputations were also performed in R in the R scripts titled “MBCO_Analysis_Code_SD.R”. Data Analysis Methods: All analyses were conducted using R version 4.4.0 (R Foundation for Statistical Computing, Vienna, Austria). Libraries used within the script include: tidyverse, Hmisc, reshape2, mice, survival, cmprsk, riskRegression, survminer, ggplot2, ggfortify and gridExtra. Ethics Declaration: This study was approved by Makerere University School of Public Health (MakSPH) Institutional Review Board (SPH-2021-177), the Uganda National Council of Science and Technology (UNCST) in Uganda (HS2174ES) and the University of British Columbia in Canada (H21-03709). This study has been registered at clinicaltrials.gov (NCT05730387). Abbreviations: ANC: Antenatal Care CI: Confidence interval HIV: Human immunodeficiency virus HR: Heart rate JRRH: Jinja Regional Referral Hospital LMIC: Low-middle income country MRRH: Mbarara Regional Referral Hospital OR: Odds ratio PNC: Postnatal care PPD: Postpartum depression Q1: First quartile Q3: Third quartile RR: Respiratory rate SD: Standard deviation SpO2: Oxygen saturation Funding Source(s): Funding was provided by British Columbia Children's Hospital Research Institute Healthy Starts Catalyst Grant: JMA, ACD. Abhroneel Ghosh also received funding from the Mitacs Globalink Research Internship to conduct research with the team at the Institute for Global Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Study Protocol & Supplementary Materials: Smart Discharges for Mom & Baby 2.0: A cohort study to develop prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain...
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This data is a subset of the Smart Discharges Uganda Under 5 years parent study and is specific to the Phase I observation cohort of children aged 0-6 months collected during the Covid-19 pandemic in 2020. Objective(s): Used as part of the Smart Discharge prediction modelling for adverse outcomes such as post-discharge death and readmission. Data Description: All data were collected at the point of care using encrypted study tablets and these data were then uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses systematically collected data on clinical, social and demographic variables. Following discharge, field officers contacted caregivers at 2 and 4 months by phone, and in-person at 6 months, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for children who had died following discharge. . Data Processing: Created z-scores for anthropometry variables using height and weight according to WHO cutoff. Distance to hospital was calculated using latitude and longitude. Extra symptom and diagnosis categories were created based on text field in these two variables. BCS score was created by summing all individual components. Limitations: There are missing dates and the admission, discharge, and readmission dates are not in order. Ethics Declaration: This study was approved by the Mbarara University of Science and Technology Research Ethics Committee (No. 15/10-16), the Uganda National Institute of Science and Technology (HS 2207), and the University of British Columbia / Children & Women’s Health Centre of British Columbia Research Ethics Board (H16-02679). This manuscript adheres to the guidelines for STrengthening the Reporting of OBservational studies in Epidemiology (STROBE). NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator at sepsiscolab@bcchr.ca or visit our website.
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This data is a subset of the Smart Discharges Uganda Under 5 years parent study and is specific to the Phase I observational cohort of children aged 0-6 months containing pulse oximetry data. Background: Substantial mortality occurs after hospital discharge in children under 5 years old with suspected sepsis. This study aimed to refine and externally validate a previously developed post-discharge mortality prediction model. Methods: In this prospective observational cohort study, we recruited 0-6-month-old children admitted with suspected sepsis from the community to the paediatric wards of six Ugandan hospitals. The primary outcome was six-month post-discharge mortality among those discharged alive. Data Collection Methods: All data were collected at the point of care using encrypted study tablets and these data were then uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses systematically collected data on clinical, social and demographic variables. Following discharge, field officers contacted caregivers at 2 and 4 months by phone, and in-person at 6 months, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for children who had died following discharge. Ethics Declaration: This study was approved by the Mbarara University of Science and Technology Research Ethics Committee (No. 15/10-16), the Uganda National Institute of Science and Technology (HS 2207), and the University of British Columbia / Children & Women’s Health Centre of British Columbia Research Ethics Board (H16-02679). This manuscript adheres to the guidelines for STrengthening the Reporting of OBservational studies in Epidemiology (STROBE). NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under "collaborate with the pediatric sepsis colab."
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TwitterThis data is the Saving young lives: Triage and treatment using the pediatric rapid sepsis trigger (PRST) tool study. Data collected for this study occurred from April 2020 to April 2022. Objective(s): This is a pre-post intervention study involving pediatric patients presenting to the study hospitals in seek of medical care for an acute illness. The purpose of this study was to develop a prediction model and to perform clinical validation of a digital triage tool to guide triage and treatment of children at health facilities in LMICs with severe infections/suspected sepsis. The study involved three phases: (I) Baseline Period, (II) Interphase Period, (III) Intervention Period. The study hospitals include 2 sites in Kenya (1 control site, 1 experimental site) and 2 in Uganda (1 control site, 1 experimental site). Data Description: Predictor variables were collected at the time of triage by trained study nurses using a custom-built mobile application. All data entered into the mobile application was stored an encrypted database. Data was uploaded directly from the mobile device to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). Outcomes were obtained from facility records or telephone follow-up at 7-10 days and the data was collected electronically. Time-specific outcomes were tracked using an RFID tagging system with study personnel as backup. Limitations: There is missing data and some variables were not collected at all sites. Ethics Declaration: This study was approved by the Makerere University Higher Degrees research and Ethics Committee (No. 743), the Uganda National Institute of Science and Technology (HS 528ES), and the University of British Columbia / Children & Women’s Health Centre of British Columbia Research Ethics Board (H19-02398 & H20-00484). NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator at sepsiscolab@bcchr.ca or visit our website.
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TwitterHealth Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. [from website]