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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Questionnaire Checklist (Screening)

- 09/07/18 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio

Itemgroups: Administrative Data, Questionnaires at Screening

This ODM file contains a checklist for Completion of Questionnaires for the Screening Visit. 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.

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Questionnaire Checklist (Early Withdrawal, Follow-up, 12 Week Follow-up)

- 27/06/18 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio

Itemgroups: Administrative Data, Questionnaires

This ODM file contains a checklist for Completion of Questionnaires to be filled at Early withdrawal, Follow-up and Part B/12-Week 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.

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Scales/Questionnaires

- 16/05/18 - 1 modulo, 5 itemgroups, 5 elementi, 1 linguaggio

Itemgroups: Columbia Suicide Rating scale, Simpson Angus Scale, The Barnes Akathisia Scale, Abnormal Involuntary Movement Scale, Profile of Mood States

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Logs/Repeats- Scales/Questionnaires

Merkmalskatalog - Fragebögen

- 11/05/18 - 1 modulo, 6 itemgroups, 18 elementi, 2 lingue

Itemgroups: MFI-Sum, SF-12, Caregiver Burden (EUROTOLD), Anxiety (GAD-7), Ambivalence Scale, Resilience (RS-13)

Fragebögen Merkmalskatalog

Merkmalskatalog - PHQ - Patient health questionnaires

- 11/05/18 - 1 modulo, 6 itemgroups, 18 elementi, 2 lingue

Itemgroups: PHQ-9 Depression, PHQ-15 Somatisation, PHQ-15 Somatisation_FUP, PHQ Stress, PHQ Functional, PHQ-PT

PHQ - Patient health questionnaires Merkmalskatalog

MEDITUEV Occupational health check

- 27/11/17 - 1 modulo, 17 itemgroups, 156 elementi, 2 lingue

Itemgroups: Personal data, Work history, Former occupations, Current occupation, Working conditions, Working capacity, medical examinations, Work-related stress factors, Work-related sources of irritation, Personal living conditions, diseases in the family, Medical history, Surgeries, dental/medical treatment, Vaccination, Current medication, Miscellaneous

The occupational health check provides information about possibly unhealthy or hazardous working conditions. In this way it can aid in the improvement of work places, the reduction of risks as well as in the early detection and prevention of work-related health problems. The aim is to ensure employability and occupational health protection. https://www.medituev.de/de/arbeitsmedizin/vorsorge/ TÜV Nord MEDITUEV. Provided by Dr. med. Rudolf Richter.

Questionnaire Day 28 REGATTA NCT03151603 - Questionnaire Day 28 REGATTA NCT03151603

- 07/11/17 - 1 modulo, 9 itemgroups, 89 elementi, 2 lingue

Itemgroups: General Information, Previous Urinary Tract Infection, Pharmacotherapy, Further Urinary Tract Infection, Pharmacotherapy: Further Urinary Tract Infection, Further Symptoms, Pharmacotherapy: Further Symptoms, Study Medication, Adverse Event

Original CRFs from: K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor. Further details on: http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html https://clinicaltrials.gov/ct2/show/NCT03151603 Questionnaire Day 28

Questionnaire Day 0 REGATTA NCT03151603 - Questionnaire Day 0 REGATTA NCT03151603

- 01/11/17 - 1 modulo, 10 itemgroups, 19 elementi, 2 lingue

Itemgroups: Patient Information, Severity of Symptoms, Affected by Symptoms, Duration of Symptoms, Vaginal Discharge, Urine Appearance, Urine Odor, Suspicious Urinary Tract Infection, Previous Urinary Tract Infection, Patient Information

Original CRFs from: K.Afshar, J. Bleidorn, E. Hummers-Pradier, I. Gágyor. Further details on: http://www.allgemeinmedizin.med.uni-goettingen.de/en/content/research/510_520.html https://clinicaltrials.gov/ct2/show/NCT03151603 Questionnaire Day 0

self-answering questionnaire SHIP-Trend-1 Fragebogen HOME - Ablaufdaten

- 30/10/17 - 1 modulo, 1 ItemGroup, 1 elemento, 2 lingue

ItemGroup: Fragebogen HOME - Ablaufdaten

Fragebogen HOME - Ablaufdaten form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name TREND.TREND1.SAQ.SAQ_HOME.HOME_OPD. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 1 Day 1 +2.20 hrs

- 18/10/17 - 1 modulo, 4 itemgroups, 5 elementi, 2 lingue

Itemgroups: Administrative Documentation, Panic Symptom List, Visual Analog Scale for Anxiety, Visual Analog Scale for Anxiety

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 1 +1.58hrs

- 18/10/17 - 1 modulo, 4 itemgroups, 5 elementi, 2 lingue

Itemgroups: Administrative Documentation, Panic Symptom List, Visual Analog Scale for Anxiety, Visual Analog Scale for Anxiety

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Session 1 Day 1 +2.10 hrs

- 18/10/17 - 1 modulo, 3 itemgroups, 4 elementi, 2 lingue

Itemgroups: Administrative Documentation, Visual Analog Scale for Anxiety, Visual Analog Scale for Anxiety

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

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