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  1. 1. Clinical Trial
  2. 2. Routine Documentation
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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

- 4/20/22 - 1 form, 24 itemgroups, 70 items, 2 languages
Itemgroups: 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

- 4/20/22 - 1 form, 22 itemgroups, 64 items, 2 languages
Itemgroups: 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

- 4/7/22 - 1 form, 21 itemgroups, 60 items, 1 language
Itemgroups: 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

- 4/7/22 - 1 form, 24 itemgroups, 70 items, 1 language
Itemgroups: 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

- 4/7/22 - 1 form, 28 itemgroups, 87 items, 1 language
Itemgroups: 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

- 3/18/22 - 2 forms, 8 itemgroups, 32 items, 1 language
Itemgroups: 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 itemgroups 25 items

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

- 2/17/22 - 1 form, 4 itemgroups, 26 items, 1 language
Itemgroups: 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

- 9/27/21 - 1 form, 3 itemgroups, 22 items, 2 languages
Itemgroups: 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

- 9/27/21 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: 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)

- 9/27/21 - 1 form, 8 itemgroups, 74 items, 2 languages
Itemgroups: 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

- 9/20/21 - 16 forms, 16 itemgroups, 68 items, 1 language
Itemgroups: 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 itemgroups 68 items

Therapy and toxicity cycle 1-3

16 itemgroups 68 items

Therapy and toxicity cycle 4-6

16 itemgroups 68 items

Pediatrics UKM Emergency room admission - Emergency room admission

- 9/20/21 - 1 form, 5 itemgroups, 20 items, 2 languages
Itemgroups: Patient demographics,Admission,Health insurance,Legal representative/ policyholder,Footer module
Emergency room admission form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Prof. Dr. Omran.

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