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Part 1: Document Description
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Citation |
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Title: |
Data for: Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children |
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Identification Number: |
doi:10.7910/DVN/J6YSV8 |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2024-01-11 |
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Version: |
2 |
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Bibliographic Citation: |
Berkley, James A.; Bandsma,Robert H.J.; Ngao, Narshion M.; Ngari, Moses M., 2024, "Data for: Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children", https://doi.org/10.7910/DVN/J6YSV8, Harvard Dataverse, V2 |
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Citation |
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Title: |
Data for: Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children |
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Identification Number: |
doi:10.7910/DVN/J6YSV8 |
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Authoring Entity: |
Berkley, James A. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Bandsma,Robert H.J. (Hospital for Sick Children, Toronto, Ontario, Canada) |
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Ngao, Narshion M. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Ngari, Moses M. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Ngari, Moses M. |
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Access Authority: |
Berkley, James A. |
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Access Authority: |
The Data Governance Committee |
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Depositor: |
Berkley, James A. |
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Date of Deposit: |
2024-01-10 |
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Holdings Information: |
https://doi.org/10.7910/DVN/J6YSV8 |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences |
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Abstract: |
<p>This dataset contains clinical information for 429 participants who were enrolled in the PBSAM trial (see protocol for more details). Participants were enrolled after meeting an inclusion criteria into the study of having at least 2 severe characteristics for an acute illness and with a severe acute malnutrition diagnosis. They were then followed up for 6 months post discharge. Data was collected in the following time-points: at admission, daily review (during hospitalization), at discharge, at 21 days after admission and finally 60 days after admission. Both clinical and some social data were collected at these time points. Clinical chemistry and biochemistry tests were conducted on samples collected in all the visits as well as blood culture and stool culture were also collected on some visits. All serious adverse events and toxicity events were recorded as well and were investigated and their data has been included here as well. </p> <p> Also included in the package is the Statistical Analysis Plan (SAP) for the trial, blank copies of the study questionnaires, informed consent form and data dictionary </p> <p>Trial Registration: <a href="https://clinicaltrials.gov/study/NCT04542473">www.clinicaltrials.gov NCT04542473</a></p> |
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Kind of Data: |
Restricted Acess |
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Kind of Data: |
Clinical Trial |
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Notes: |
Data and associated files are embargoed. Please contact the Data Governance Committee <a href="dgc@kemri-wellcome">(Send email)</a> for more information. |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Notes: |
Data and associated files are embargoed. Please contact the Data Governance Committee <a href="dgc@kemri-wellcome">(Send email)</a> for more information |
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Other Study Description Materials |
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Label: |
Analysis Code.zip |
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Text: |
Uses the analysis dataset to generate findings reported to DSMB |
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Notes: |
application/zip |
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analysis_data.zip |
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Notes: |
application/zip |
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Label: |
Codebook_Dictionary.zip |
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Notes: |
application/zip |
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Label: |
ICF.zip |
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Notes: |
application/zip |
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Label: |
PB-SAM_SAP_Final.docx.pdf |
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Notes: |
application/pdf |
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Label: |
Protocol.zip |
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Notes: |
application/zip |
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raw_data.zip |
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Notes: |
application/zip |
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Readme.txt |
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Notes: |
text/plain |
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Label: |
Study Questionnaires_CRFs.zip |
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Notes: |
application/zip |