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149 Suchergebnisse.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - Study Conclusion

- 01.11.18 - 1 Formular, 4 Itemgruppen, 23 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Study Conclusion, Study Withdrawal, Signature

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form concludes the study and should be filled out at the last visit.

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314 - Study relevant visits

- 20.09.21 - 16 Formulare, 4 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Visit overview, Quality of life assessment, Surrogate Markers, Comment

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

Registration

4 Itemgruppen 39 Datenelemente

Therapy and toxicity cycle 10-13

16 Itemgruppen 68 Datenelemente

Therapy and toxicity cycle > 13

16 Itemgruppen 68 Datenelemente

Therapy and toxicity cycle 1-3

16 Itemgruppen 68 Datenelemente

Therapy and toxicity cycle 4-6

16 Itemgruppen 68 Datenelemente

Therapy and toxicity cycle 7-9

16 Itemgruppen 68 Datenelemente

Neurology follow Pediatric surgery UKM - Neurology follow up

- 12.12.16 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 2 Sprachen

Itemgruppen: Patient identification, Neurological assessment

Neurology follow up form converted to ODM format. Routine documentation of University Hospital of Münster.

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 15 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 19.12.17 - 1 Formular, 14 Itemgruppen, 149 Datenelemente, 2 Sprachen

Itemgruppen: 15 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 15 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 18 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 19.12.17 - 1 Formular, 14 Itemgruppen, 149 Datenelemente, 2 Sprachen

Itemgruppen: 18 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 18 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 12 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 19.12.17 - 1 Formular, 18 Itemgruppen, 210 Datenelemente, 2 Sprachen

Itemgruppen: 12 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Cognitive functions, WPPSI-III scale, WISC-IV scale, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 12 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 6 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 19.12.17 - 1 Formular, 18 Itemgruppen, 206 Datenelemente, 2 Sprachen

Itemgruppen: 6 year follow up, Demography, Community Outreach, Preschool/School, leisure / free time, Medical background data, Additional handicap, Cognitive functions, WPPSI-III scale, WISC-IV scale, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 6 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 9 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 18.12.17 - 1 Formular, 14 Itemgruppen, 147 Datenelemente, 2 Sprachen

Itemgruppen: 9 year follow up, Demography, Community Outreach, School, leisure / free time, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, General self-assessed health, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 9 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry - 3 year follow up Health monitoring of children and adolescents with Cerebral Palsy

- 18.12.17 - 1 Formular, 13 Itemgruppen, 173 Datenelemente, 2 Sprachen

Itemgruppen: 3 year follow up, Demography, Community Outreach, Preschool / School, Medical background data, Additional handicap, Attention to daily life, activities, Pediatric Evaluation of Disability Inventory (PEDI), Functional skills, Help Requirements, Communication - Language - Eating, Background issues regarding socio-emotional and practical support to Parents / Guardians

Child and Adolescent Habilitation (cerebral palsy) Swedish National Quality Registry Source: https://old.liu.se/habq/habq-formular-cp?l=sv Registry owner:Gunilla Rydberg, HabQ, Region Skåne, Child and youth rehabilitation, Skåne University Hospital (SUS), 205 02 Malmö gunilla.rydberg@skane.se Copyright:old.liu.se (habq) 3 year follow up Health monitoring of children and adolescents with Cerebral Palsy

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Seizure record - Baseline, Treatment Phase, Taper and Follow- up and innumerable seizure activity record - Study week 1 through Taper and Follow-up

- 08.10.18 - 1 Formular, 5 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Seizures; Records | Baseline, Seizures; Records | Treatment Epoch, Seizures; Records | follow-up, seizure activity

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

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

- 03.08.21 - 1 Formular, 10 Itemgruppen, 188 Datenelemente, 1 Sprache

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.

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

- 07.04.22 - 1 Formular, 21 Itemgruppen, 60 Datenelemente, 1 Sprache

Itemgruppen: 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

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