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- 2020-04-30 - 1 Formulär, 4 Item-grupper, 25 Dataelement, 1 Språk
Item-grupper: Administrative Data, Patient Demographic Factors, Clinical Status, Degree of Health
ICHOM Paediatric Facial Palsy data collection Version 1.0.0 Revised: August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Paediatric Facial Palsy, the following conditions and treatment approaches (or interventions) are covered by ICHOM‘s Standard Set. Conditions: Congenital/Syndromic | Acquired Unilateral (single- and multi-territory) | Bilateral (single- and multi-territory) Treatment approaches: Medical treatment | Surgery | Eye care Physiotherapy/Occupational therapy | Botulinum toxin | Psychological support This document contains the End of pediatric or planned care - Clinical Form. It should be completed at the end of paediatric care (16y to 18y) or when no further treatments are planned, and allow for >1 year follow-up. Collecting Patient-Reported Outcome Measure: eFACE – Clinician. For more information see: Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic Facial Paralysis Assessment: The eFACE, August 2015. doi: 10.1097/PRS.0000000000001447 FACE-Q Kids. As there is a license for use of this questionnaire, the questions will not be included in this version of the standard set, only subscores. Snellen Chart – Clinician. PROMIS Paediatric Global Health 7 and PROMIS Pediatric Peer Relationships SF 8a. As there is an official distribution site, only the total score of these questionnaires will be included in this version of the standard set. For more information see: http://www. healthmeasures.net/explore-measurement-systems/promis/ obtain-administer-measures Reference: Butler DP, De la Torre A, Borschel GH, et al. An International Collaborative Standardizing Patient-Centered Outcome Measures in Pediatric Facial Palsy. JAMA Facial Plast Surg. Published online May 09, 2019. doi:10.1001/jamafacial.2019.0224 The Standard set of ICHOM was supported by the royal free charity and the Dianne and Michael Bienes Charitable Foundation Inc. For this version of the standard set, semantic annotation with UMLS CUIs has been added.
- 2020-03-23 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative Data, End of study participation, Mortality
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the end of study form. It has to be filled in at the end of study or if early withdrawal.
- 2020-02-24 - 1 Formulär, 5 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Administrative data, Status of treatment Blind, Study conclusion, Pregnancy information (female), Pregnancy information (male)
- 2019-12-05 - 1 Formulär, 3 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: Administrative Data, Early withdrawal or unscheduled assessments, Investigational product discontinuation
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 End of treatment/Early withdrawal and unscheduled visit assessments forms as well as information on discontinuation of the investigational product.
- 2019-11-26 - 1 Formulär, 5 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: Administrative Data, Study conclusion, Pregnancy information (female), Pregnancy information (male), Case book signature
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 study conclusion and pregnancy information form. It has to be filled in for the end of study.