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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed, and HIV-negative infants - NCT00829010 - Vaccine Administration, Contraindications, Precautions

- 26-08-19 - 1 formulario, 5 itemgroups, 33 items, 1 idioma
Itemgroups: Administrative documentation, Contraindications to vaccination, Tritanrix-HepB/Hib Warnings and Precautions, Rotarix vaccine warnings and precautions, VACCINE ADMINISTRATION
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 information on the actual vaccine administration as well as warnings and contraindiciations to the vaccination which should be checked beforehand, and is to be filled in repeatedly during the study at the vaccination visits, which are Visits 1, 2, 3 (all cohorts), 5 (all cohorts except the 3+0 ("EPI") schedule without the booster) and 8 (all cohorts).

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Quality of Life

- 15-03-19 - 1 formulario, 9 itemgroups, 62 items, 1 idioma
Itemgroups: Administrative data, Physical well-being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Additional Concerns, Brief Pain Inventory, BRIEF PAIN INVENTORY, Pain Interference
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - GOG Toxicity Case Summary

- 15-03-19 - 1 formulario, 12 itemgroups, 55 items, 2 idiomas
Itemgroups: Administrative data, Demographics, Description, Protocol Treatment, Drugs and Doses for this Course, Cumulative Totals to Date, Serious Adverse Event, Pretreatment Counts for this Course, Nadir Counts, GOG #, Quality of Life Cover Sheet (Investigator's details), Time of Today's Assessment
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Treatment Completion Form

- 14-03-19 - 1 formulario, 10 itemgroups, 39 items, 1 idioma
Itemgroups: Administrative data, Treatment Completion, Tumor Measurements, Best Tumor Response, Follow-Up Form, Disease Follow-Up Status, Notice of New Primary, Long Term Adverse Events, Adverse Events details, Additional Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Common Toxicity Report

- 14-03-19 - 1 formulario, 2 itemgroups, 15 items, 1 idioma
Itemgroups: Administrative data, Common Toxicity Report
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369 - Drug Dose Form

- 14-03-19 - 1 formulario, 6 itemgroups, 38 items, 1 idioma
Itemgroups: Administrative data, Investigational Product, Drug Dose, Tumor Measurements, Best Tumor Response, Pre-treatment Hematologies and Chemistries
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Pre-Treatment Summary Sheet

- 14-03-19 - 1 formulario, 5 itemgroups, 41 items, 1 idioma
Itemgroups: Administrative data, Physical Examination, Laboratory Findings, Measurable Mass, Performance Grade
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Initial On Study Form

- 14-03-19 - 1 formulario, 5 itemgroups, 47 items, 1 idioma
Itemgroups: Administrative data, Tracking Informaion, Demographic Information, Disease Information, Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369 - Initial On Study Form

- 14-03-19 - 1 formulario, 5 itemgroups, 47 items, 1 idioma
Itemgroups: Administrative data, Tracking Informaion, Demographic Information, Disease Information, Cancer Therapy
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Diary Cards

- 11-03-19 - 1 formulario, 19 itemgroups, 85 items, 1 idioma
Itemgroups: Administrative data, LOCAL SYMPTOMS (at injection site), Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, OTHER LOCAL SYMPTOMS (from Day 0 to Day 20), MEDICATION, GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, OTHER GENERAL SYMPTOMS, Reminder
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Concomitant Medication, Non-Serious Adverse Events, Study Conclusion

- 11-03-19 - 1 formulario, 14 itemgroups, 53 items, 1 idioma
Itemgroups: Administrative data, CONCOMITANT VACCINATION, Vaccination details, CONCOMITANT MEDICATION, Medication details, NON-SERIOUS ADVERSE EVENTS, Adverse Events, STUDY CONCLUSION, PREGNANCY INFORMATION, ELIMINATION CRITERIA, SUBJECT WITHDRAWAL, INVESTIGATOR'S SIGNATURE, USE OF HUMAN SAMPLES BY GSK, INVESTIGATOR'S SIGNATURE
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 21"

- 11-03-19 - 1 formulario, 19 itemgroups, 112 items, 1 idioma
Itemgroups: Administrative data, ELIMINATION CRITERIA, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

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