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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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GSK Study Unscheduled Visit HEMATOLOGY AND CLINICAL CHEMISTRY LOCAL NCT00079911

- 4/6/22 - 1 form, 3 itemgroups, 30 items, 1 language
Itemgroups: Study administration, HEMATOLOGY, CLINICAL CHEMISTRY
NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count 100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

GSK Study Unscheduled Visit HEMATOLOGY AND CLINICAL CHEMISTRY LOCAL NCT00079911

- 4/6/22 - 1 form, 3 itemgroups, 30 items, 1 language
Itemgroups: Study administration, HEMATOLOGY, CLINICAL CHEMISTRY
NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count 100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

Eligibility Rhizarthrosis NCT01233739

- 9/28/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis.; ODM derived from: https://clinicaltrials.gov/show/NCT01233739

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons SERIOUS ADVERSE EVENTS NCT00079911

- 9/20/21 - 1 form, 13 itemgroups, 54 items, 1 language
Itemgroups: Study administration, SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, Seriousness, Demography Data, INSTRUCTIONS FOR COMPLETING SERIOUS ADVERSE EVENT FORMS, Possible Causes of SAE Other Than lnvestigational Products, RELEVANT Medical Conditions, Other RELEVANT Risk Factors, RELEVANT Concomitant Medications, Details of lnvestigational Products, Details of RELEVANT Assessments, Narrative Remarks
NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

Unscheduled Visit >> Unscheduled Event Form 1/2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

- 9/17/21 - 1 form, 7 itemgroups, 22 items, 1 language
Itemgroups: Physical Examination, Vital Signs, ECG: 12 Lead ECG, Laboratory Tests: Hematology, Abnormal Lab tests: Hematology, Laboratory Tests: Biochemistry, Abnormal Lab tests: Biochemistry
Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Unscheduled Visit >> Unscheduled Event Physical Examination Vital Signs 12 Lead ECG Laboratory Tests: Hematology

Unscheduled Visit >> Unscheduled Event Form 2/2 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

- 9/17/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Pregnancy Test, Unscheduled Event
Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Unscheduled Visit >> Unscheduled Event Form Pregnancy Test Unscheduled Event

Screening Visit Form 2/4 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

- 9/17/21 - 1 form, 6 itemgroups, 19 items, 1 language
Itemgroups: Primary Diagnosis: Old diagnosis fields, Primary Diagnosis: New diagnosis fields, Physical Examination, Vital Signs, Height and Weight, ECG: 12 Lead ECG
Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Screening Visit Form 2/4: Primary Diagnosis Physical Examination Vital Signs Height and Weight ECG: 12 Lead ECG

Eligibility Schizophrenia NCT02210962

- 9/15/21 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02210962

Eligibility Osteo Arthritis of the Knees NCT02178137

- 8/18/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Effect of Interventions on the Progression of Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02178137

Eligibility Sleep Apnea NCT01128816

- 6/22/21 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01128816

Eligibility Subclinical Hypothyroidism NCT01853579

- 11/18/20 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The TRUST Study - Depression Substudy; ODM derived from: https://clinicaltrials.gov/show/NCT01853579

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - 30-Day Followup (+/- 14 Days)

- 10/24/20 - 1 form, 5 itemgroups, 32 items, 1 language
Itemgroups: Administrative Data, Followup visit, Vital Signs, Physical examination, Clinical Endpoints
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form has to be filled in at the Followup Visit. It records Vital Signs, changes from the Post-Treatment Exam and (re)occurence of specified Events.

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