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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

- 20-04-22 - 1 Formulier, 24 Itemgroepen, 70 Data-elementen, 2 Talen
Itemgroepen: 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

- 20-04-22 - 1 Formulier, 22 Itemgroepen, 64 Data-elementen, 2 Talen
Itemgroepen: 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, Clinical Laboratory Examination and Plasma Samples - Treatment Phase Study Week 14

- 07-04-22 - 1 Formulier, 24 Itemgroepen, 70 Data-elementen, 1 Taal
Itemgroepen: 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 and Clinical Laboratory Examination - Treatment Phase Study Week 10

- 07-04-22 - 1 Formulier, 21 Itemgroepen, 60 Data-elementen, 1 Taal
Itemgroepen: 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, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 07-04-22 - 1 Formulier, 28 Itemgroepen, 87 Data-elementen, 1 Taal
Itemgroepen: 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

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

- 20-09-21 - 16 Formulieren, 16 Itemgroepen, 68 Data-elementen, 1 Taal
Itemgroepen: 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 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 1-3

16 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 4-6

16 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 7-9

16 Itemgroepen 68 Data-elementen

Baseline

13 Itemgroepen 77 Data-elementen

Reference

12 Itemgroepen 111 Data-elementen

Eligibility Acute Heart Failure DRKS00008447 NCT02151383 - Eligibility Acute Heart Failure NCT02151383

- 17-09-21 - 1 Formulier, 2 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02151383

Maintenance therapy R2 AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Maintenance therapy R2 AIEOP-BFM ALL 2009 NCT01117441

- 15-03-21 - 1 Formulier, 3 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Patient Information, Examinations, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

SAE documentation AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - SAE documentation AIEOP-BFM ALL 2009 NCT01117441

- 15-03-21 - 1 Formulier, 4 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Patient Information, Therapy, Severe adverse event, Identification and Signature
Study Description Stamm: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation. Clinical Trial Number: NCT01117441.

Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

- 22-01-21 - 1 Formulier, 2 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Pediatric Arthritis Study of Certolizumab Pegol; ODM derived from: https://clinicaltrials.gov/show/NCT01550003

De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation NCT02056054 - Eligibility

- 10-04-19 - 1 Formulier, 6 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria for Pediatric Transplant Patients, Inclusion criteria for healthy pediatric control subjects, Inclusion Criteria for Adult Control Subjects, Exclusion Criteria Pediatric Transplant Patients, Exclusion Criteria Healthy Pediatric Control Subjects, Exclusion Criteria Adult transplanted patients with d-AIH
The purpose of this study is to provide insights into the cause, development and effects of de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and the need for re-transplantation. ODM derived from: https://clinicaltrials.gov/show/NCT02056054

Effects of Strawberries on Parameters of Cardiovascular Health NCT01705093 - Eligibility

- 16-03-19 - 1 Formulier, 2 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The primary purpose of the study is to evaluate the impact of strawberry intake on select measures of cardiovascular function in overweight and obese adolescent males.; ODM derived from: https://clinicaltrials.gov/show/NCT01705093

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