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  1. 1. Klinische Studie
    1. 1.1. Ein-/Ausschluss
    1. 1.2. Anamnese
    1. 1.3. Körperliche Untersuchung
    1. 1.4. Score
    1. 1.5. Apparative Diagnostik
    1. 1.6. Labor
    1. 1.7. Pathologie/Histologie
    1. 1.8. Aufklärung/Einverständis
    1. 1.9. Therapie
    1. 1.10. Operationsbericht
    1. 1.11. Unerwünschtes Ereignis
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 06.04.22 - 1 Formular, 16 Itemgruppen, 158 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Vital Signs, 12-Lead ECG, Laboratory Results Data (Haematology) - Pre-Dose, Laboratory Results Data (Clinical Chemistry) - Pre-Dose, Urinalysis - Pre-Dose, Randomisation Number, Investigational Product, Treatment Confirmation, PET Scan (2), fMRI Scan - Post-PET Scan, PET Scan (3), Pharmacokinetics - Blood, Laboratory Results Data (Haematology) - 24hrs Post-Dose, Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose, Urinalysis - 24hrs Post-Dose
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Risk perception and optimism during the early stages of the COVID-19 pandemic - Questionnaire risk perception and optimism about COVID-19

- 05.01.22 - 1 Formular, 7 Itemgruppen, 151 Datenelemente, 1 Sprache
Itemgruppen: Risk perception for COVID-19, Control questions for optimism, Adherence to protective measures, Mental health, General control questions, Other, Demographics
In this study, we assessed risk perception and optimism about COVID-19 in a multinational (UK, USA and Germany), longitudinal design during the early stages of the pandemic (16 March 2020; 1 April 2020; 20 May 2020). Our main findings are that (i) people showed a comparative optimism bias about getting infected and infecting others, but not for getting severe symptoms, (ii) this optimism bias did not change over time, (iii) optimism bias seemed to relate to perceived level of control over the action, (iv) risk perception was linked to publicly available information about the disorder, (v) people reported adhering closely to protective measures but these measures did not seem to be related to risk perception, and (vi) risk perception was related to questions about stress and anxiety. Kuper-Smith BJ, Doppelhofer LM, Oganian Y, Rosenblau G, Korn CW. 2021 Risk perception and optimism during the early stages of the COVID-19 pandemic. R. Soc. Open Sci. 8: 210904. https://doi.org/10.1098/rsos.210904

Eligibility Schizophrenia and Disorders With Psychotic Features NCT00791882

- 28.09.21 - 1 Formular, 2 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Social Skills Training in Refractory Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00791882

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 27.09.21 - 1 Formular, 8 Itemgruppen, 98 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.

Eligibility Postpartum Depression NCT00744328

- 20.09.21 - 1 Formular, 2 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Postpartum Depression: Transdermal Estradiol Versus Sertraline; ODM derived from: https://clinicaltrials.gov/show/NCT00744328

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Logs and Repeats and Concomitant Medications

- 20.09.21 - 1 Formular, 3 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Date of visit/ assessment, Adverse event | Concomitant Medication Ongoing | Evaluation, Pharmaceutical Preparations Concomitant Therapy
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 20.09.21 - 1 Formular, 8 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Local Laboratory, Urinalysis | Local, Vital signs, 12 lead ECG, Electrocardiogram abnormal, Drug Kinetics; Blood, 12 lead ECG | Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Vital Signs and ECG - Screening

- 20.09.21 - 1 Formular, 5 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Patient identification, Vital signs, 12 lead ECG, Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Eligibility Major Depressive Disorder NCT00785434

- 20.09.21 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD; ODM derived from: https://clinicaltrials.gov/show/NCT00785434

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Screening - 12-Lead ECG; Subject Identification; Summary Holter; Summary Holter Abnormalities

- 20.09.21 - 1 Formular, 4 Itemgruppen, 22 Datenelemente, 1 Sprache
Itemgruppen: 12-Lead ECG, Subject Identification, Summary Holter, Summary Holter Abnormalities
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Eligibility Cigarette Smoking NCT00879177

- 20.09.21 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Smoking Study With Behavioral Therapy for Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00879177

Eligibility Schizophrenia NCT00654706

- 20.09.21 - 1 Formular, 2 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00654706

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