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Eligibility Geriatric Patients with Hyponatremia DRKS00005776 NCT02242604 DRKS00005776 - Eligibility Geriatric Patients with Hyponatremia NCT02242604 DRKS00005776

- 2017-06-25 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Responsible Party: Volker Burst, MD, University of Cologne ClinicalTrials.gov Identifier: NCT02242604 History of Changes Other Study ID Numbers: V1.1 DRKS00005776 ( Registry Identifier: DRKS ) Study First Received: September 8, 2014 Last Updated: October 24, 2016 Characterization of Neuropsychologic and Physical Performance in Geriatric Patients With Hyponatremia. ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02242604

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)

- 2020-04-14 - 1 Formulär, 3 Item-grupper, 21 Dataelement, 1 Språk
Item-grupper: 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.

Geriatric Depression Scale: PaReSiS UKH

- 2016-11-27 - 1 Formulär, 1 Item-grupp, 16 Dataelement, 1 Språk
Item-grupp: 49. Being
Geriatric Depression Scale: PaReSiS UKH Rehabilitation Study: "Partizipatives Rehabilitationsprozessmanagement, PaReSiS Schlaganfall in Sachsen-Anhalt" Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Institut für Gesundheits- und Pflegewissenschaft Projekt: Partizipatives Rehabilitationsprozessmanagement „Schlaganfall in Sachsen-Anhalt“ Magdeburger Straße 8 06097 Halle (Saale), Germany E-Mail: paresis@medizin.uni-halle.de

medical examination SHIP-START-3 timed up & go

- 2021-07-03 - 1 Formulär, 1 Item-grupp, 20 Dataelement, 2 Språk
Item-grupp: timed up & go
timed up & go form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MEX.PHYSEXAM.NEU. 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 The English version of this form is under development.

ICHOM Older Person - Baseline and Follow-up - Patient-reported

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 92 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographic factors, Disutility of care, Symptoms, functioning and quality of life, Participation and decision making, Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline and Follow-up - Patient-reported Form. It has to be filled in at Patient's entry into this set. NOTE: One Item (LEVEDC) only is scheduled for Baseline. All other Items are for both Baseline- and Follow-up-form- For Follow-up: fill in at least annually, but may be filled in more often (annually for a 69 year old person not admitted to hospital within 1 year, but 6-monthly for a 84 year old person). Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). RAND owns the copyright. All of the surveys and tools from RAND Health are public documents, available without charge. No further written permission is needed for use of this Health Survey. For more information see http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. The Maryland State Medical Society holds the copyright for the Barthel Index. It may be used freely for non- commercial purposes with the following citation: Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. Permission is required to modify the Barthel Index or to use it for commercial purposes. ASCOT Toolkit. As a license agreement is needed for use of this questionaire, the used question will not be included in this version of the standard set word-for-word. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use, the scale will not be included in this version of the standard set word-for-word. Zarit Burden Interview: A license agreement might be neccessary for use of the long version of this questionnaire, for more information: https://eprovide.mapi-trust.org/instruments/zarit-burden-interview . For the used 4-item version (Questions 2, 3, 9, 19) see: Michel Bédard, D. William Molloy, Larry Squire, Sacha Dubois, Judith A. Lever, Martin O'Donnell, The Zarit Burden Interview: A New Short Version and Screening Version, The Gerontologist, Volume 41, Issue 5, 1 October 2001, Pages 652–657, https://doi.org/10.1093/geront/41.5.652 . As license for use of this questionaire is not certain at the moment, only the total score will be included in this version of the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Older Person - Baseline and Follow-up - Caregiver-reported

- 2020-04-30 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: Administrative Data, Carer burden, Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline and Follow-up Caregiver-reported Form. It has to be filled in at patient's entry into the set (Baseline). For Follow-up: fill in at least annually, but may be filled in more often (annually for a 69 year old person not admitted to hospital within 1 year, but 6-monthly for a 84 year old person). Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). RAND owns the copyright. All of the surveys and tools from RAND Health are public documents, available without charge. No further written permission is needed for use of this Health Survey. For more information see http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. The Maryland State Medical Society holds the copyright for the Barthel Index. It may be used freely for non- commercial purposes with the following citation: Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. Permission is required to modify the Barthel Index or to use it for commercial purposes. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, the used question will not be included in this version of the standard set word-for-word. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use, the scale will not be included in this version of the standard set word-for-word. Zarit Burden Interview. A license agreement might be neccessary for use of the long version of this questionnaire, for more information see https://eprovide.mapi-trust.org/instruments/zarit-burden-interview . For the used 4-item version (Questions 2, 3, 9, 19) see: Michel Bédard, D. William Molloy, Larry Squire, Sacha Dubois, Judith A. Lever, Martin O'Donnell, The Zarit Burden Interview: A New Short Version and Screening Version, The Gerontologist, Volume 41, Issue 5, 1 October 2001, Pages 652–657, https://doi.org/10.1093/geront/41.5.652. As license for use of this questionaire is not certain at the moment, only the total score will be included in this version of the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Older Person - Baseline - Clinician- and Administrative-reported

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 33 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographic factors, Disutility of care, Symptoms, functioning and quality of life, Frailty, Time spent in hospital, Overall survival, Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline - Clinician- and Administrative-reported form. It has to be filled in at patient's entry into the set. Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Older Person - Follow-up - Clinician- and Administrative-reported

- 2021-09-20 - 1 Formulär, 8 Item-grupper, 30 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographic factors, Disutility of care, Symptoms, functioning and quality of life, Frailty, Time spent in hospital, Overall survival, Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Follow-up - Clinician- and Administrative-reported form. For Follow-up: fill in at least annually, but may be filled in more often (annually for a 69 year old person not admitted to hospital within 1 year, but 6-monthly for a 84 year old person. Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Follow Up - DESCRIBE CRF Follow Up

- 2021-09-20 - 1 Formulär, 22 Item-grupper, 223 Dataelement, 1 Språk
Item-grupper: Date of visit, Clinical diagnosis, Cumulative documentation, Living situation, Professional status, Consumption of semiluxury food - nicotine, Consumption of semiluxury food - alcohol, Vital signs, Clinical phenotype, Clinical phenotype - Anamnesis and inspection, Clinical phenotype - Further examination, Umsars I: Questions 9-12, Anamnesis motor skills, Montreal Cognitive Assessment (MoCA), Geriatric depression scale (GDS), Sampling - Blood collection, Sampling according to SOP, Registration of samples, Sampling - Urine sample, Sampling according to SOP (Urine), Results of urine strips, Registration of samples (Urine)
Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Baseline Basis Module - DESCRIBE CRF Baseline Basis Module

- 2021-09-20 - 1 Formulär, 23 Item-grupper, 256 Dataelement, 1 Språk
Item-grupper: Date of visit, Demographics, National origin, Mother tongue, Clinical diagnosis, Living situation, Education and profession, Consumption of semiluxury food - nicotine, Consumption of semiluxury food - alcohol, Vital signs, Clinical phenotype - Anamnesis and inspection, Clinical phenotype - Further examination, Umsars I: Questions 9-12, Anamnesis motor skills, Montreal Cognitive Assessment (MoCA), Geriatric depression scale (GDS), Sampling - Blood collection, Sampling according to SOP, Registration of samples, Sampling - Urine sample, Sampling according to SOP (Urine), Results of urine strips, Registration of samples (Urine)
Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

dbGaP phs001004 Genetic Analysis of Parkinson's Disease - Eligibility

- 2023-09-19 - 6 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Tatiana Foroud, PhD, Indiana University, IN, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001004 A portion of the sample includes multiplex PD families recruited as part of a previously funded study (R01NS037167; PI: Tatiana Foroud). Families were ascertained initially through a living affected sibling pair. Subsequently, ascertainment was loosened to include PD probands having a positive family history of PD in a first degree relative, who was not required to be part of the study. All individuals completed an in-person evaluation at one of the 65 Parkinson Study Group sites participating in this study. Individuals completed a detailed evaluation that included the Unified Parkinson Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS) and a diagnostic checklist that implemented the UK PD Brain Bank inclusion and exclusion criteria. An autopsy program was established in this study and brain tissue for confirmation of diagnosis and further experimental study are available from over 100 participants. Autopsy confirmation of the PD diagnosis was nearly 100% for those who met UK PD Brain Bank criteria. In addition, because this was a cross sectional study and family members were often seen very early in disease course, among those who did not meet UK PD Brain Bank criteria but had a subsequent autopsy, a significant subset (1/3) had autopsy confirmation of PD. The second source of samples is from the NINDS Human Genetics DNA and Cell Line Repository located at the Coriell Institute. Currently DNA from 4,509 PD patients is available from the Coriell Institute. We restricted the selected sample to include only Caucasians and ensured there was no overlap with samples contributed by the PROGENI Study.

pht010439.v1.p1

1 Item-grupp 5 Dataelement

pht010440.v1.p1

1 Item-grupp 5 Dataelement

pht010441.v1.p1

1 Item-grupp 3 Dataelement

pht010442.v1.p1

1 Item-grupp 37 Dataelement

pht010443.v1.p1

1 Item-grupp 3 Dataelement

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

- 2019-10-04 - 1 Formulär, 3 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: 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.

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