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Neuroinflammatory demyelinating diseases CNS Common Data Elements

- 2021-09-17 - 1 Formulär, 13 Item-grupper, 46 Dataelement, 2 Språk
Item-grupper: Diagnosis Demyelinating disease of central nervous system, MS, NMOSD, Acute disseminated encephalomyelitis (ADEM), CSF, Current relapse, Previous relapses, EDSS, Current therapy, Risk stratification Natalizumab, Previous Therapy, MRI Results, Other medical information
Common Data Elements for Neuroinflammatory Demyelinating Diseases of the central nervous system (NID CDEs). The NID CDEs may be used in clinical routine, clinical trial and registry documentation of Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD) and Acute Disseminated Encephalomyelitis (ADEM). The NID CDEs were developed by the Institute of Medical Informatics of the University Muenster in cooperation with the Department of Neurology of the University Hospital Muenster.

AAFP: Pelvic Inflammatory Disease Admission Order

- 2021-09-17 - 1 Formulär, 12 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Default Itemgroup, Status, Attending, Admitting Diagnosis, Condition, Allergies, Diet, Activity, Nursing, Medications, IV, Lab
AAFP: Pelvic Inflammatory Disease Admission Order, Standardizes Admission Orders, Author: Robert M. Wiprud, MD The primary purpose of these Ordersets is to decrease unnecessary variability and to improve quality through standardized Admission Orders. Developed by the Scott & White Clinic at College Station, Texas. Copyright © 2006 American Academy of Family Physicians. Physicians may photocopy or adapt for use in their own practices; all other rights reserved. Wiprud RM. Providing consistent care with standardized admission orders. Fam Pract Manag. September 2006: 49-52 See http://www.aafp.org/fpm/2006/0900/p49.html This ODM Form includes the twenty-sixth section ("AAFP: Pelvic Inflammatory Disease Admission Order")

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 1: PRESENTATION/ADMISSION CASE REPORT FORM

- 2021-08-03 - 1 Formulär, 10 Item-grupper, 188 Dataelement, 1 Språk
Item-grupper: Participant Identification, Demographics, Onset of current illness and vital signs, Possible signs and symptoms of multisystem inflammatory syndrome, Other signs and symptoms of multisystem inflammatory syndrome, Recent history, Co-morbidities, past history, Pre-admission and chronic medication, Laboratory results, Imaging and pathogen testing
Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. This Module is to be completed when multisystem inflammatory syndrome is suspected, on admission or in-patients.

Befundbogen_NTX_ohneLabor S.0002 Befundbogen_NTX_ohneLabor - Befundbogen_NTX_ohneLabor

- 2021-04-13 - 1 Formulär, 9 Item-grupper, 95 Dataelement, 2 Språk
Item-grupper: Patients identity details, Dialysis Center, Patient Immunology, Conversations, Family anamnesis, Patient anamnesis, Renal anamnesis, Results of obligatory examinations , Results of Optional Examinations
Befundbogen fuer die Aufnahme von Patienten in der Nierentrasplantransplantion, siehe Laborbefund_Nierentransplantationspatient für den entsprechenden Laborbefundbogen. Quelle: Transplantationsnephrologie, Wartelistenbüro, Univeritätsklinikum Münster

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - MODULE 1: PRESENTATION/ADMISSION CASE REPORT FORM

- 2021-01-18 - 1 Formulär, 10 Item-grupper, 112 Dataelement, 1 Språk
Item-grupper: Participant Identification, Clinical Inclusion Criteria, Demographics, Post Partum, Infant, Onset and admission, Signs and symptoms at hospital admission, Admission signs and symptoms, Pre-admission medication, Co-morbidities and risk factors
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death GENERAL GUIDANCE - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory

- 2020-11-29 - 1 Formulär, 10 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Administrative, Informed Consent, Admission Criteria, Admission Criteria , Demographics, Electrocardiogram, Central Laboratory - Haematology, Central Laboratory - Chemistry/ Serum HCG/ SP Chem, Central Laboratory - UA/ UDS/ Urine Chem , Central Laboratory - Serology
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

FHIR v4.0.1 - Resource Encounter (2)

- 2020-03-10 - 1 Formulär, 1 Item-grupp, 17 Dataelement, 1 Språk
Item-grupp: Encounter
The form corresponds to an incomplete version of FHIR Resource Encounter, v4.0.1. It contains all data elements that query a medical issue. The file was created for analysis purposes. https://www.hl7.org/fhir/resourcelist.html 02.01.2020

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Inform Enrollment

- 2019-10-24 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: Enrollment
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Sentinel Common Data Model Enrollment

- 2019-09-02 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: Enrollment
Sentinel: Overview and Description of the Common Data Model v7.0.0: "The primary goal ofSentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org SCDM: Enrollment Table Structure: The SCDM Enrollment Table has a start/stop structure that contains records on continuous enrollment periods. Members with medical coverage, drug coverage, or both should be included. A unique combination of PatID, Enr_Start, Enr_End, MedCov, DrugCov, and Chart identifies a unique record. A break in enrollment (of at least one day) or a change in the medical coverage, drug coverage, or chart abstraction flag variables should generate a new record.

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Inform Enrollment (Enroll)

- 2019-08-22 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: Clinical Trial Subject Unique Identifier
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Patient Log

- 2019-08-21 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Patients, Exclusion
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Patient Enrollment Form

- 2019-03-06 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk
Item-grupp: Enrollment
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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