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KLINICHESKOE ISSLEDOVANIE, IV FAZA ×
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Medical History GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons

- 12/05/2017 - 1 Formulário, 3 Grupos de itens, 14 Elementos de dados, 1 Idioma
Grupos de itens: Study administration, History of Herpes Infections, Genital Examination
The GlaxoSmithKline group of companies Condensed Clinical Study Report for Study HS2100181 (Phase IV) 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 Initiation Date: 19 May 2004 Early Termination Date: 14 Sep 2004 Date of Report: July 2005

Demography GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons - GlaxoSmithKline Study of Valaciclovir for the Suppression and Episodic

- 12/05/2017 - 1 Formulário, 4 Grupos de itens, 8 Elementos de dados, 1 Idioma
Grupos de itens: Study administration, Demography, Vital Signs, Randomisation Number
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

Cumulative Form 3/3 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

- 21/08/2016 - 1 Formulário, 1 Grupo de itens, 7 Elementos de dados, 1 Idioma
Grupo de itens: Non-medication Therapy
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 Cumulative Form 2/2 Non-medication Therapy

End of Study Form 1/ 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

- 11/08/2016 - 1 Formulário, 6 Grupos de itens, 16 Elementos de dados, 1 Idioma
Grupos de itens: Vital Signs: 75 mins prior to patch application, Identification of Painful Area: Change, NPRS 'average pain' score, NPRS 'pain now' score: Post patch application and post patch removal, Tolerability score: Post patch removal, Additional Information
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 End of Study Form 1/: Vital Signs Identification of Painful Area: Change NPRS 'average pain' score NPRS 'pain now' score Adverse Event 1 Concomitant Medication 1 Any Non-medication Therapy

Treatment Visit Form 2/5 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

- 11/08/2016 - 1 Formulário, 4 Grupos de itens, 24 Elementos de dados, 1 Idioma
Grupos de itens: Randomization, Vital Signs: 75 mins prior to patch application, Vital Signs: 15 mins prior to patch application, Vital Signs: Post patch application and post patch rGeemnoevraatl
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 Treatment Visit Form 2/5: Randomization Vital Signs: 75 mins prior to patch application Vital Signs: 15 mins prior to patch application Post patch application and post patch removal

Treatment Visit Form 4/5 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

- 11/08/2016 - 1 Formulário, 5 Grupos de itens, 21 Elementos de dados, 1 Idioma
Grupos de itens: Application of Lidocaine, Administration of Tramadol, NPRS 'average pain' score prior to patch application, Application of Qutenza, Application of Qutenza: Treatment Area
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 Treatment Visit Form 4/5: Application of Lidocaine Administration of Tramadol NPRS 'average pain' score prior to patch application Application of Qutenza

Treatment Visit Form 3/5 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

- 11/08/2016 - 1 Formulário, 4 Grupos de itens, 19 Elementos de dados, 1 Idioma
Grupos de itens: Pregnancy Test, Identification of Painful Area: Change, Identification of Painful Area, Dermal Assessment
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 Treatment Visit Form 3/5: Pregnancy Test Identification of Painful Area: Change Identification of Painful Area Dermal Assessment

Treatment Visit Form 1/5 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

- 11/08/2016 - 1 Formulário, 3 Grupos de itens, 7 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Inclusion Criteria, Exclusion Criteria
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 Treatment Visit Form 1/5: Date of Visit Inclusion Criteria Exclusion Criteria

Screening Visit Form 1/4 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

- 23/07/2016 - 1 Formulário, 5 Grupos de itens, 15 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Screening Status, Informed Consent 1, Demographics, Medical and Surgical History
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 1/4: Date of Visit Screening Status Informed Consent 1 Demographics Medical and Surgical History

Screening Visit Form 4/4 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

- 23/07/2016 - 1 Formulário, 4 Grupos de itens, 18 Elementos de dados, 1 Idioma
Grupos de itens: Pregnancy Test, Identification of Painful Area, NPRS 'average pain' score, NPRS 'pain now' score
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: Pregnancy Test Identification of Painful Area NPRS 'average pain' score NPRS 'pain now' score

Screening Visit Form 3/4: Laboratory tests 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

- 23/07/2016 - 1 Formulário, 4 Grupos de itens, 10 Elementos de dados, 1 Idioma
Grupos de itens: Laboratory Tests: Hematology, Laboratory Tests: Hematology, specification, Laboratory Tests: Biochemistry, Tests: Biochemistry, specification
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 3/4: Laboratory Tests: Hematology Laboratory Tests: Biochemistry

Patient information and informed consent SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746 - Patient information and informed consent NCT01539746

- 29/01/2016 - 1 Formulário, 2 Grupos de itens, 3 Elementos de dados, 1 Idioma
Grupos de itens: Patient information, Informed consent
Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

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