Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Itemgruppen: 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.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Study Completion

- 14.09.20 - 1 Formular, 5 Itemgruppen, 25 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Completion of study by subject, Study completed by subject, Study not completed by subject, Investigator's Signature

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form is to be completed on Study Conclusion and is used to verify that no important steps were omitted. Also includes Investigator's Signature.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Dosing Information - Circuit Prime and Bolus

- 03.09.20 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Dosing Information - Circuit Prime, Dosing Information - Bolus

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in during the Treatment period after Circuit Prime is administered and whenever a Bolus of Argatroban is administered. Continuous infusions are recorded in a separate form.

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Slit lamp examination and biomicroscopy, indirect ophthalmoscopy, reflexes motility pressure

- 26.11.19 - 1 Formular, 5 Itemgruppen, 29 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Slit lamp examination, Slit lamp biomicroscopy of posterior pole features for each eye, Indirect ophthalmoscopy, Reflexes, Motility, Pressure

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Slit lamp examination and biomicroscopy, indirect ophthalmoscopy and reflexes motility pressure form. All has to be filled in for screening, Day 1, all part visits, in case of early withdrawal and at follow-up (Months 3 and 6). Additionnaly it can be filled in as unscheduled form.

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 2: OUTCOME CASE REPORT FORM

- 11.08.21 - 1 Formular, 7 Itemgruppen, 195 Datenelemente, 1 Sprache

Itemgruppen: Participant Identification, Summary of clinical features of current illness, Laboratory results, Imaging and pathogen testing, Treatment, Supportive care, Outcome

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. 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). This Module is to be completed at time of discharge or death.

Recurring cancer children (ADVL0212 NCT00053963) - Reporting Period Worksheet cancer (NCT00053963)

- 22.03.15 - 1 Formular, 5 Itemgruppen, 58 Datenelemente, 1 Sprache

Itemgruppen: Header, Patient characteristics, Concomitant Medication, Patient status, Adverse event

ADVL0212: Reporting Period Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

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