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  1. 1. Essai clinique
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dbGaP phs001165 eMERGE: Children's Hospital of Philadelphia - WGS - Eligibility

- 04/06/2023 - 5 Formulaires, 1 Groupe Item, 8 Eléments de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: MeSH: Pediatrics https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001165 The Center for Applied Genomics (CAG) is a specialized Center of Emphasis at the Children's Hospital of Philadelphia (CHOP) with the primary goal of translating basic research findings to medical innovations. The mission of CAG is to develop new and better ways to diagnose and treat children affected by rare and complex medical disorders. We aim to discover genetic causes for the most prevalent diseases of childhood including asthma, autism, diabetes, epilepsy, obesity, schizophrenia, pediatric cancer, and a range of rare diseases. Ultimately, our objective is to generate new diagnostic tests and to guide physicians to the most appropriate therapies. The CAG is one of the world's largest genetics research programs in pediatrics, and the only center at a pediatric hospital to have established a large-scale biobank of genotyped samples. The electronic Medical Records and Genomics (eMERGE) Network is a consortium of 9 clinical sites with EMR linked DNA biobanks, including Northwestern University and its NUgene biobank, funded by the NHGRI (National Human Genome Research Institute) to investigate the use of electronic medical record systems for genomic research. The goal of eMERGE is to conduct genome-wide association studies in approximately 100,000 individuals using EMR-derived phenotypes and DNA from linked biorepositories. Using electronic phenotyping methods, the consortium has been and is using DNA samples from all participating sites to explore the genetic determinants of approximately 80 phenotypes, including both diseases and traits, for which the electronic phenotyping algorithms have or are being published on PheKB.org.

pht007985.v1.p1

1 Groupe Item 2 Eléments de données

pht007986.v1.p1

1 Groupe Item 3 Eléments de données

pht007988.v1.p1

1 Groupe Item 5 Eléments de données

pht007987.v1.p1

1 Groupe Item 3 Eléments de données

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

- 20/04/2022 - 1 Formulaire, 24 Groupes Item, 70 Eléments de données, 2 Langues
Groupes Item: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12

- 20/04/2022 - 1 Formulaire, 22 Groupes Item, 64 Eléments de données, 2 Langues
Groupes Item: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , Urine Specimen Collection
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments and Clinical Laboratory Examination - Treatment Phase Study Week 10

- 07/04/2022 - 1 Formulaire, 21 Groupes Item, 60 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG)
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples - Treatment Phase Study Week 14

- 07/04/2022 - 1 Formulaire, 24 Groupes Item, 70 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 07/04/2022 - 1 Formulaire, 28 Groupes Item, 87 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Electrocardiography , Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Urine creatinine measurement, Plasma specimen, Clinical status, Clinical status; Finding
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

UKHD - Transitionsvorbereitungsbogen und Fragebogen zum Wechsel aus der Kinder- und Jugendmedizin in die Erwachsenenmedizin - Fragebogen zum Wechsel

- 18/03/2022 - 2 Formulaires, 8 Groupes Item, 32 Eléments de données, 1 Langue
Groupes Item: Demografie, Allgemeine Fragen, Wissen zur Erkrankung , Therapie und Behandlung, Unterstützung und Informationen, Pläne zur Zukunft und zum Beruf, Klinikkontakte, Anmerkungen Fragen Wünsche
Stand: 24.02.2022 Transitionsvorbereitungsbogen und Fragebogen zum Wechsel aus der Kinder- und Jugendmedizin in die Erwachsenenmedizin Urheber: Frau PD Dr. med. Daniela Choukair, Frau Dr. med. Janna Mittnacht, Frau Dr. med. Susanne Rieger und Frau Dorothea Treiber Klinik für Allgemeine Pädiatrie, Neuropädiatrie, Stoffwechsel, Gastroenterologie, Nephrologie Zentrum für Kinder- und Jugendmedizin Angelika-Lautenschläger-Klinik Universitätsklinikum Heidelberg, Im Neuenheimer Feld 672, 69120 Heidelberg Literatur: Traq 5.0 Wood, Sawicki, Reiss, Livingood & Kramer, 2014 TRAQ GV-15 Culen, Wood, Straub, 2019 Findorff, J, Müther, S, von Moers, A, Nolting, H-D, Burger, W (2016): Das Berliner Transitionsprogramm. Berlin, Boston, De Gruyter Minden, K, Berlin; Schalm, S, München; Arbeitskreis Transition der Deutschen Gesellschaft für Rheumatologie e.V., Fragebogen für die Jugendsprechstunde https://gkjr.de/fuer-mitglieder/informationen-fuer-mitglieder/transitionsunterlagen/ The Royal Children’s Hospital Melbourne: http://www.rch.org.au/transition/factsheets_and_tools/transition_checklists/ Southampton Children’s Hospital, Transition to adult care: Ready Steady Go: http://www.uhs.nhs.uk/OurServices/Childhealth/TransitiontoadultcareReadySteadyGo/Transitiontoadultcare.aspx Grasemann C Ein strukturierter Versorgungspfad von der Pädiatrie in die Erwachsenenmedizin für Jugendliche und junge Erwachsene mit einer seltenen Erkrankung. Monatsschrift Kinderheilkunde 1-2022 S. 61-69

Transitionsvorbereitungsbogen

5 Groupes Item 25 Eléments de données

Measurement Instrument Database for the Social Science (MIDSS) - Conduct Disorder Rating Scale - Parent Version

- 17/02/2022 - 1 Formulaire, 4 Groupes Item, 26 Eléments de données, 1 Langue
Groupes Item: General Information, Instructions, past year child, impact daily life
Waschbusch, D. A., Elgar, F. J. (2007). Conduct Disorder Rating Scale - Parent Version. Measurement Instrument Database for the Social Science. Retrieved 22.09.2020, from www.midss.ie Key references: Waschbusch, D. A., & Elgar, F. J. (2007). Development and validation of the conduct disorder rating scale. Assessment, 14, 65-74. Fabiana. G. A, Pelham, W. E., Waschbusch, D. A., Gnagy, E. M., Lahey, B. B., et al. (2006). A Practical Measure of Impairment: Psychometric Properties of the Impairment Rating Scale in Samples of Children With Attention Deficit Hyperactivity Disorder and Two School-Based Samples. Journal of Clinical Child and Adolescent Psychology, 35(3), 369–385. Primary use / Purpose: The purpose of the Conduct Disorder Rating Scale- For Parents (CDRS-P) is to allow for measurement of conduct disorder (CD). The CDRS-P is a Likert-type scale with scores ranging from 1-4 which measures CD in line with current conceptualizations as described in the DSM-IV. The fifteen symptom used in the scale are taken directly form the DSM-IV definition of CD. Background: It is considered a public health priority to effectively manage the troublesome behaviour of disorderly adolescents and children. Conduct disorder (CD) is estimated to affect up to 5% of children between the ages of four and sixteen and is often linked to drug abuse, violence, and sexual victimization. Therefore it is important to have reliable and consistent measures of CD. However, many existing scales measure CD is ways which are not wholly consistent with the criteria set out in the DSM-IV. To address this shortcoming Waschbusch & Elgar (2007) developed the Conduct Disorder Rating Scale- for parents (CDRS-P). Psychometrics: The psychometric properties of the Conduct Disorder Rating Scale- for parents (CDRS-P) are discussed in Waschbusch & Elgar, (2007). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.301

Pediatric surgery UKM - Head injury admission form

- 27/09/2021 - 1 Formulaire, 3 Groupes Item, 22 Eléments de données, 2 Langues
Groupes Item: Patient identification, Glasgow coma scale, Neurological assessment
Head injury admission form converted to ODM format. Routine documentation of University Hospital of Münster.

Clinical risk index for babies II (CRIB II) score

- 27/09/2021 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: CRIB II
The five-item CRIB II score is an update of the with clinical risk index for babies (CRIB) score, a risk-adjustment instrument widely used in neonatal intensive care. Parry, G., Tucker, J., Tarnow-Mordi, W., & UK Neonatal Staffing Study Collaborative Group. (2003). CRIB II: an update of the clinical risk index for babies score. The Lancet, 361(9371), 1789-1791.

Pediatric oncology (Kinderonkologie) - Medical history (Anamnese)

- 27/09/2021 - 1 Formulaire, 8 Groupes Item, 74 Eléments de données, 2 Langues
Groupes Item: Pregnancy, Childbirth, Postpartum development, Kindergarten / school, Puberty stage, Other information, Physical examination basic information, Physical examination (further information)
This form about medical history originates from the Department of Pediatric Oncology, Hematology and Clinical Immunology of the University Hospital Düsseldorf.

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314 - Therapy and toxicity cycle 10-13

- 20/09/2021 - 16 Formulaires, 16 Groupes Item, 68 Eléments de données, 1 Langue
Groupes Item: Therapy cycle 10-13, Therapy after cycle, Propranolol, Propranolol therapy deviation, Celecoxib, Celecoxib deviation, Cyclophosphamide, Cyclophosphamide deviation, Vinblastine, Vinblastine deviation, Toxicity overview, Toxicity, Hospitalization, Comments, Transfusion, Footer module
NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln

Therapy and toxicity cycle > 13

16 Groupes Item 68 Eléments de données

Therapy and toxicity cycle 1-3

16 Groupes Item 68 Eléments de données

Therapy and toxicity cycle 4-6

16 Groupes Item 68 Eléments de données

Therapy and toxicity cycle 7-9

16 Groupes Item 68 Eléments de données

Baseline

13 Groupes Item 77 Eléments de données

Reference

12 Groupes Item 111 Eléments de données

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