Risultati di ricerca - Portale di modelli di dati medici (MDM-Portal)

Itemgroups: Administrative Data, Serology - HIV Screen, Laboratory Result Data (Haematology), Haematology Test Result, Laboratory Result Data (Clinical Chemistry), Clinical Chemistry Test Result, Urinalysis, Urinalysis (Dipstick) Test Result, Urinalysis (Microscopy) Test Result

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921

HICDEP - Basic follow-up/visit related data (tblVIS)

- 29/01/18 - 26 moduli, 4 itemgroups, 19 elementi, 1 linguaggio

Itemgroups: Basic follow-up/visit related data, Additional questions for adolescents and adults, Additional questions for children and infants, Additional questions for infants

HICDEP stands for HIV Cohorts Data Exchange Protocol. The HIV Cohorts Data Exchange Protocol (HICDEP) is a protocol that allows for simple sharing of data from HIV cohorts by providing a standard format for datasets. It is used by several major HIV Cohort Collaborations such as CASCADE, COHERE, EuroSIDA, PENTA, EPPICC ART-CC and D:A:D. Its first version was presented at the 7th International Workshop on HIV Observational Databases in March 29–30, 2003, Fiuggi, Italy, and a summary was published in Antiviral Therapy. The specification currently consists of 27 tables in a relational structure which cover most medical aspects of HIV patient histories used in clinical research, including pediatric aspects. Subform Descriptions: -tblCEP - Clinical Events and Procedures: holds type and date of adverse events including serious non-AIDS conditions -tblART- Antiretroviral treatment: holds type of antiretroviral drug, start and stop dates and reason for stopping -tblBAS - Basic clinical, background and demographic information: holds basic information such as demographics, basic clinical information, date of AIDS diagnosis, death and drop-out information -tblDELIVERY_CHILD - Delivery information related to the child(ren): This table holds information about a delivery specific to a child. Mother-specific data is kept in tblDELIVERY_MUM. -tblDELIVERY_MUM - Delivery information related to the mother: This table contains information about the delivery specific to the mother. Child-specific information is recorded in tblDELIVERY_CHILD instead. -tblDIS - Opportunistic infections: holds type and date of CDC-C diseases. -tblLAB - Laboratory values: holds type, date, value and unit of laboratory tests -tblLAB_BP - Laboratory values - Blood pressure: holds date, diastolic and systolic values and unit of blood pressure measurements. -tblLAB_CD4 - Laboratory values: holds date and value of CD4 measurements. -tblLAB_RNA - Laboratory values: holds date, value, detection limit and type of viral assay. -tblLAB_RES - Resistance testing: holds background information on the resistance test, laboratory, library, kit, software and type of test -tblLAB_RES_LVL_1 - Nucleotide sequences (PRO, RT, GP41, GP120): holds nucleoside sequence for the PRO and RT sequences. No entry is made if the test was a phenotype test. -tblLAB_RES_LVL_2 - Mutations: holds mutations and positions of PRO and RT sequences. -tblLAB_RES_LVL_3 - Resistance test result: holds resistance result in relation to antiretroviral drug. tblLAB_VIRO - Laboratory values - viro-/serology: holds test results for viro-/serological tests (hepatitis etc.) -tblLTFU - Death and drop-out: holds data in death and drop-out -tblMED - Other medication: holds type, start and stop dates for other medication/treatments. -tblNEWBORN - Newborn: holds information related to newborns -tblNEWBORN_ABNORM - Abnormalities: Abnormalities in newborns are recorded here, one abnormality per row. The absence of a record is to be interpreted as "unknown whether the abnormality existed" since most cohorts only record positive events. -tblOVERLAP - Cross-cohort identification: holds information on the patient's participation in other cohorts -tblPREG - Pregnancy: holds general pregnancy-related information -tblPREG_OBS - Obstetrical problems during pregnancy: This table describes problems during a pregnancy. Abnormalities in newborns are recorded in tblNEWBORN_ABNORM instead. -tblPREG_OUT - Pregnancy outcome: This table describes outcomes of pregnancies described in tblPREG. -tblREFILL - Prescription refill data: holds drug, refill date and supply of prescriptions -tblSAMPLES - Blood Samples: This table contains information on the storage of blood, urine and other samples stored in a laboratory. -tblVIS - Basic follow-up/visit related data: holds visit related information such as weight, wasting, smoking, occupational status etc.

Obstetrical problems during pregnancy (tblPREG_OBS)

1 ItemGroup 5 elementi

Abnormalities (tblNEWBORN_ABNORM)

1 ItemGroup 3 elementi

Laboratory values - viro-/serology (tblLAB_VIRO)

1 ItemGroup 9 elementi

Cross-cohort identification (tblOVERLAP)

1 ItemGroup 4 elementi

Prescription refill data (tblREFILL)

1 ItemGroup 4 elementi

Pregnancy outcome (tblPREG_OUT)

1 ItemGroup 8 elementi

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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Repeat Test

- 09/01/19 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio

Itemgroups: Administrative Data, HIV repeat test

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 contains information about the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Confirmation Testing

- 01/11/18 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio

Itemgroups: Administrative Data, HIV Confirmatory Test

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 contains information about the confirmation testing of the subject for HIV. It should be checked at Visit 4 and is part of study amendment 1.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Testing

- 01/11/18 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio

Itemgroups: Administrative Data, HIV Testing

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 contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Study Continuation, Elimination Criteria, ICF Amendment, Weight, Meningitis, Breastfeeding Continuation

- 17/10/19 - 1 modulo, 7 itemgroups, 23 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Study Continuation, Elimination Criteria during Study, Informed Consent Amendment 1 / 2, Weight, Meningitis, Breastfeeding

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Study Continuation Check and (if applicable) information on why the subject was withdrawn from the study, the Elimination Criteria Check, information on whether the ICF Amendment has been signed, the subject's weight, and whether the child experienced a meningitis, and is to be filled in at Visits 2 to 10, for all cohorts. Additionally, this form records whether the infant is still breastfed, which is only applicable to HIV-negative subjects with HIV-positive mothers (=HIV-exposed cohort).

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - SAE

- 17/10/19 - 1 modulo, 14 itemgroups, 68 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Section 1: General SAE information, Section 2: Seriousness, Section 3: Demography Data, Section 4: SAE recurrence, Section 5: Possible Causes of SAE Other Than Investigational Product(s), Section 6: Relevant Medical Conditions, Section 7: Other Relevant Risk Factors, Section 8: Relevant Concomitant Medications, Section 9: Details of investigational product(s), Section 10: Details of Relevant Assessments, Section 11: Narrative Remarks, Section 12: SAE additional / follow-up information, Investigator's signature

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form is to be used in case of a Serious Adverse Event (SAE), which is here defined as: A serious adverse event (SAE) is any untoward medical occurrence that: a. results in death, b. is life-threatening, NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c. requires hospitalization or prolongation of existing hospitalization, NOTE: In general, hospitalization signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d. results in disability/incapacity, or NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e. is a congenital anomaly/birth defect in the offspring of a study subject. f. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately lifethreatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to GSK concurrent medication will be collected and recorded from the time the subject consents to participate in the study. For all other SAEs, the standard time period for collecting and recording SAEs will begin from the administration of the first dose of vaccine / placebo / comparator and will end minimum 30 days (see protocol) following administration of the last dose of vaccine / placebo / comparator for each subject.

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