Palavras-chave
Agents, Anorectic ×
Índice
  1. 1. Estudo clínico
  2. 2. Documentação de rotina
  3. 3. Estudos de registo/coortes
  4. 4. Garantia da qualidade
  5. 5. Padrão de dados
  6. 6. Questionário do paciente
  7. 7. Especialidade médica
    1. 7.1. Anestesia
    1. 7.2. Dermatologia
    1. 7.3. Otorrinolaringologia
    1. 7.4. Geriatria
    1. 7.5. Ginecologia/obstetrícia
    1. 7.6. Medicina interna
      1. Hematologia
      1. Infecciologia
      1. Cardiologia/angiologia
      1. Pneumologia
      1. Gastroenterologia
      1. Nefrologia
      1. Endocrinologia/metabolismo
      1. Reumatologia
    1. 7.7. Neurologia
    1. 7.8. Oftalmologia
    1. 7.9. Medicina paliativa
    1. 7.10. Patologia/medicina Legal
    1. 7.11. Pediatria
    1. 7.12. Psiquiatria/psicossomática
    1. 7.13. Radiologia
    1. 7.14. Cirurgia
      1. Cirurgia geral/abdominal
      1. Neurocirurgia
      1. Cirurgia plástica
      1. Cirurgia cardíaca/torácica
      1. Cirurgia de trauma/ortopedia
      1. Cirurgia vascular
    1. 7.15. Urologia
    1. 7.16. Odontologia/cirurgia bucomaxilofacial
Modelos de dados selecionados

Deve ter sessão iniciada para selecionar vários modelos de dados e para os transferir ou analisar.

- 08/06/2018 - 1 Formulário, 3 Grupos de itens, 12 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Appetite VAS, Distress VAS
This ODM file contains the Appetite VAS and Distress VAS. Appetite VAS to be done at Screening, Sessions 1 and 2 (Day 1, pre-dose and 2 hrs post-dose), Distress VAS to be done at Sessions 1 and 2 (Day 1, pre-dose, 2, 4 and 10 hrs post-dose). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
- 09/07/2018 - 1 Formulário, 2 Grupos de itens, 13 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Non-Serious Adverse Events
- 09/07/2018 - 1 Formulário, 2 Grupos de itens, 6 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Laboratory Data
This ODM file contains Dates of Laboratory Sample Taking (general, Haematology, Clinical Chemistry and Urinalysis). To be filled at Screening, Session 1 and 2 (Day -1 and Day 1, different extent and timepoints), Early Withdrawal and Follow-Up. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
- 03/07/2018 - 1 Formulário, 6 Grupos de itens, 46 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug exposures, Subject withdrawal, information investigator
This ODM file contains pregnancy notification form for the female partner of a male subject as well as a female subject. This form should be completed according to the protocol reporting requirements. Complete this form for each subject(’s partner) who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. All of the header information must be completed before sending back to GSK. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
- 29/06/2018 - 1 Formulário, 12 Grupos de itens, 57 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Serious Adverse Events - Section 1, Serious Adverse Events - Section 2: Seriousness, Serious Adverse Events - Section 3: Demography Data, Serious Adverse Events - Section 4: Recurrence, Serious Adverse Events - Section 5: Causes Of SAE Other Than Investigational Products, Serious Adverse Events - Section 6: Relevant medical conditions, Serious Adverse Events - Section 7: Other relevant risk factors, Serious Adverse Events - Section 8: Relevant concomitant medication, Serious Adverse Events - Section 9: Details of investigational Products, Serious Adverse Events - Section 10: Details of relevant assessments, Serious Adverse Events - Section 11: Narrative Remarks
- 29/06/2018 - 1 Formulário, 2 Grupos de itens, 14 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Concomitant Medications
- 27/06/2018 - 1 Formulário, 7 Grupos de itens, 19 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Liver Events Assessment, Status of Treatment Blind, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's signature
This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
- 27/06/2018 - 1 Formulário, 5 Grupos de itens, 12 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Consent for Pharmacogenetic Research, Pharmacogenetic sampling, Withdrawal of consent for pharmacogenetic research, Sample Destruction
- 27/06/2018 - 1 Formulário, 3 Grupos de itens, 10 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Pharmacodynamics - Blood, Pharmacokinetics - Blood
- 11/06/2018 - 1 Formulário, 7 Grupos de itens, 98 Elementos de dados, 1 Idioma
Grupos de itens: 12-lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities
- 08/06/2018 - 1 Formulário, 2 Grupos de itens, 11 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, 12-Lead ECG
- 08/06/2018 - 1 Formulário, 1 Grupo de itens, 4 Elementos de dados, 1 Idioma
Grupo de itens: Serology - HIV Screen

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