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Questionnaire Oral and maxillofacial surgery - Questionnaire

- 17/09/21 - 1 modulo, 2 itemgroups, 14 elementi, 2 lingue

Itemgroups: Patient demographics, Insurance

Questionnaire converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by surgery Prof. Dr. Edgar Schäfer

NINDS CDE Godin Leisure-Time Exercise Questionnaire Multiple Sclerosis - Godin Leisure-Time Exercise Questionnaire

- 31/07/16 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio

ItemGroup: Questionnaire Time Exercise

NINDS Common Data Elements, Multiple Sclerosis Godin Leisure-Time Exercise Questionnaire Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory – Short Form (GAI‐SF) (Geriatrische Depressionsskala (GDS) und GAI-SF)

- 14/04/20 - 1 modulo, 3 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: Administrative Data, Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory – Short Form (GAI‐SF)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Geriatric Depression Scale (GDS) and the Geriatric Anxiety Inventory – Short Form (GAI‐SF). It has to be filled in for Baseline and for all Follow-ups. For use of the questionnaire GDS no licence is required. For more information to the GDS see Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-83;17(1):37-49. Due to potential copyright on the questionnaire GAI-SF included in the DZNE DELCODE protocol, GAI-SF will only be included as text result item in this version of the DELCODE forms (at least until permission to publish is received from the original authors or becomes clear upon further research). The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information to GAI-SF see: Pachana, N., Byrne, G., Siddle, H., Koloski, N., Harley, E., & Arnold, E. (2007). Development and validation of the Geriatric Anxiety Inventory. International Psychogeriatrics, 19, 103-114. doi: 10.1017/S1041610206003504. Rozzini, L., Chilovi, B., Peli, M., Conti, M., Rozzini, R., Trabucchi, M., Padovani, A. (2009). Anxiety symptoms in mild cognitive impairment. International Journal of Geriatric Psychiatry, 24, 300-305. doi: 10.1002/gps.2106.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - GDS, MOCA

- 04/10/19 - 1 modulo, 3 itemgroups, 5 elementi, 1 linguaggio

Itemgroups: Administrative Data, Geriatric Depression Scale, Montreal Cognitive Assessment

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Geriatric Depression Scale (GDS), Montreal Cognitive Assessment (MOCA) Form. It has to be filled in for Week 1, Week 12 and in case of early withdrawal. It also can be filled in unscheduled.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Questionnaires

- 30/01/21 - 1 modulo, 11 itemgroups, 25 elementi, 1 linguaggio

Itemgroups: Administrative Data, Physical Activity Scale for the Elderly (PASE), Lubben Social Network Scale (LSNS-6), PSQI Pittsburgh Sleep Quality Index, ESS (Eppworth sleepiness scale), RBDSQ - REM Sleep Disorder Questionnaire, LEQ (Proband), Big Five Inventory, ECog (Proband), ECog (External rating), FAQ

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out. For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains different kinds of questionnaires which can not be illustrated completely. This form has to be filled out at baseline and all follow-ups. The Big Five Inventory (BFI-10) has to be filled out only at baseline.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Minimal Mental State Examination (MMSE)

- 18/04/20 - 1 modulo, 2 itemgroups, 12 elementi, 2 lingue

Itemgroups: Administrative Data, Minimal Mental State Examination (MMSE)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the results of the Minimal Mental State Examination (MMSE) form. It has to be filled in for Baseline and all Follow-ups. For more information see: Folstein MF, Folstein SE and McHugh PR. Mini-Mental State: A practical method for grading the state of patients for the clinician, Journal of Psychiatric Research 1975; 12: 189-198

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Neuropsychiatric interview (NPI-Q) (Neuropsychiatrisches Intervies (NPI‐Q))

- 22/04/20 - 1 modulo, 2 itemgroups, 6 elementi, 1 linguaggio

Itemgroups: Administrative Data, Neuropsychiatric Interview (NPI-Q)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Neuropsychiatric interview (NPI-Q). It has to be filled in for baseline and for all follow-ups. Due to potential copyright on this questionnaire included in the DZNE DELCODE protocol, the NPI-Q will only be included as text result items in this version of the DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information see: DOI:10.1017/S1041610210001237 or npitest.net.

S0337 Cover Sheet for Patient-Completed Questionnaires NCT00445601

- 05/07/15 - 1 modulo, 4 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: Header, Patient response to questionnaire, Form completed by, Comments

S0337 Cover Sheet for Patient-Completed Questionnaires NCT00445601 Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FE26037B-446B-4AC6-E034-0003BA3F9857

Measurement Instrument Database for the Social Science (MIDSS) - The Pregnancy Related Beliefs Questionnaire (PRBQ)

- 30/09/20 - 1 modulo, 2 itemgroups, 54 elementi, 1 linguaggio

Itemgroups: Instructions, Belief

Moorhead, S. R. J., Owens, J., Scott, J. (2003). The Pregnancy Related Beliefs Questionnaire (PRBQ). Measurement Instrument Database for the Social Science. Retrieved 29.09.2020, from www.midss.ie Key references: Moorhead, S. R. J., Owens, J., and Scott, J. (2003). DEVELOPMENT AND PILOTING OF THE PREGNANCY RELATED BELIEFS QUESTIONNAIRE (PRBQ). Behavioural and Cognitive Psychotherapy, 31, 207-213. doi:10.1017/S1352465803002091 Primary use / Purpose: The Pregnancy Related Beliefs Questionnaire (PRBQ) is a 54-item inventory rated on 7 point Likert-type scale. Its purpose is to measure women’s' beliefs about pregnancy and make similar contributions as existing scales towards greater understanding and prediction of postnatal depression Background: Psychological measures have proven disappointing in the prediction of postnatal depression in women. To address this weakness, Moorhead, Owens, and Scott (2003) developed the Pregnancy Related Beliefs Questionnaire (PRBQ). The PRBQ was shown to correlate with several other constructs as measured by the Beck Depression Inventory (BDI), the Dysfunctional Attitude Scale, and the Cognitive Adaption to Stressful Events Questionnaire (CASE), as well as showing early potential in the prediction of postnatal depression. Psychometrics: The psychometric properties of the Pregnancy Related Beliefs Questionnaire (PRBQ) are discussed in Moorhead, Owens, and Scott (2003). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.323

DASS Depressions-Angst-Stress-Skalen – deutschsprachige Kurzfassung - DASS

- 28/12/21 - 1 modulo, 1 ItemGroup, 21 elementi, 1 linguaggio

ItemGroup: Fragen zum Befinden

Die deutschsprachige Kurzfassung der Depressions-Angst-Stress-Skalen (DASS) wird in der Schmerzforschung und -behandlung verwendet und wurde entwickelt, um psychologische Kernaspekte von Depression, Angst und Stress zu erfassen. Sie umfasst drei Skalen mit jeweils sieben Items. Die Erfassung psychischer Belastung hat einen zentralen Stellenwert in der Schmerzforschung und -behandlung. Für Depression als Komorbidität bei Schmerz bestehen dabei besondere methodische und konzeptionelle Schwierigkeiten. Reliabilität: Cronbachs Alpha lag bei Alpha = .91 (Depression), Alpha = .78-.82 (Angst) bzw. Alpha = .81-.89 (Stress). Validität: Konstruktvalidität des DASS wurden mit HADS (Hospital Anxiety and Depression Scale) und ADS (Allgemeine Depressionsskala) verglichen. Spezifität und Sensitivität für Depression wurden anhand eines strukturierten klinischen Interviews für DSM-IV (SKID) ermittelt und ebenfalls mit ADS und HADS verglichen. Nilges, P. & Essau, C. (2021). DASS. Depressions-Angst-Stress-Skalen - deutschsprachige Kurzfassung [Verfahrensdokumentation und Fragebogen mit Auswertung]. In Leibniz-Institut für Psychologie (ZPID) (Hrsg.), Open Test Archive. Trier: ZPID. https://doi.org/10.23668/psycharchives.4579 Disclaimer: After completion of my work with the measure, I will inform the test authors about the use of the measure and the results I have obtained by means of the feedback form.

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

Measurement Instrument Database for the Social Science (MIDSS) - The Psychosocial Pain Assessment Form (PPAF)

- 13/01/21 - 1 modulo, 7 itemgroups, 138 elementi, 1 linguaggio

Itemgroups: Pain, Psychosocial assessment, Pain, Psychosocial assessment, Rating scale, Pain, Psychosocial assessment, Economic, Pain, Psychosocial assessment, Social support, Pain, Psychosocial assessment, Activities of Daily Living, Pain, Psychosocial assessment, Emotional support, Pain, Psychosocial assessment, Coping Behavior

Otis-Green, S., & The City of Hope Pain/Palliative Resource Center. (2012) . The Psychosocial Pain Assessment Form (PPAF). Measurement Instrument Database for the Social Science. Retrieved 12.01.2021, from www.midss.ie. Key references: Otis-Green, S. (2006). Psychosocial Pain Assessment Form. In Dow (Ed.), Nursing Care of Women with Cancer. St. Louis, MO: Elsevier Mosby, 556-561. Otis-Green, S. (2005). Psychosocial Pain Assessment Form. In Kuebler, Davis, Moore (Eds.), Palliative Practices: An Interdisciplinary Approach. St. Louis, MO: Elsevier Mosby, 462-467. Primary use / Purpose: The Psychosocial Pain Assessment Form (PPAF) is a comprehensive assessment form for measuring psychosocial pain. It does so under five domains: economic, social support, activities of daily living, emotional impact, and coping style. Additionally, an assessment of prior history is included to help clinicians focus interventions where sexual abuse or other traumatic memories are present. Background: The psychosocial model of pain is now widely accepted. Pain is no longer treated, or thought of, as a purely physiological condition, but instead, one that is the product of a myriad of both psychological and physiological factors. For this reason, there is a need for instruments which measure the full range of outcomes and causes associated with chronic pain, whether they be psychological, economic, or physiological. The Psychosocial Pain Assessment Form (PPAF) was developed to be used in this capacity. Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.344

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