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Smart Device System Meta Data Definitions - Neurologic Examination

- 2020-09-03 - 7 Formulär, 1 Item-grupp, 6 Dataelement, 2 Språk
Item-grupp: Neurologic examination
Metadata definitions for the Smart Device System for Movement Disorders. Clinical Protocol and Registration Information available on: https://clinicaltrials.gov/ct2/show/NCT03638479 Principal Investigator: Julian Varghese Description for Assessment Steps for Neurologic Examination are available under: Varghese J, Niewöhner S, Soto-Rey I, et al. A Smart Device System to Identify New Phenotypical Characteristics in Movement Disorders. Front Neurol. 2019;10:48. doi:10.3389/fneur.2019.00048

Family History

1 Item-grupp 2 Dataelement

Medication

1 Item-grupp 3 Dataelement

Vital Signs

1 Item-grupp 1 Dataelement

PD NMS

1 Item-grupp 1 Dataelement

Demography

2 Item-grupper 5 Dataelement

Medical History

1 Item-grupp 9 Dataelement

dbGaP phs000918 International Parkinson's Disease Genomics Consortium (IPDGC), NeuroX Dataset - Eligibility

- 2024-04-18 - 5 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Andrew B. Singleton, PhD, National Institute on Aging, National Institutes of Health, Bethesda, MD, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000918 Expanded replication set based on Nalls et al. 2014.

pht004747.v1.p1

1 Item-grupp 3 Dataelement

pht004749.v1.p1

1 Item-grupp 5 Dataelement

pht004750.v1.p1

1 Item-grupp 22 Dataelement

pht004748.v1.p1

1 Item-grupp 3 Dataelement

dbGaP phs000901 University of Washington CSF biomarker study for Parkinson disease - pht004672.v1.p1

- 2024-01-17 - 5 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk
Item-grupp: pht004672
Principal Investigator: Mohammad Faghihi, MD, PhD, University of Miami, Miami, FL, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000901 There is a clear need to develop biomarkers for Parkinson disease (PD) diagnosis and monitoring disease progression. In this study we evaluated cerebrospinal fluid (CSF) proteins, which are known to be critically involved in PD or identified in our preliminary profiling studies, aptamers, and RNAs as potential PD biomarkers. Access to subjects for this study was via the Pacific Northwest Udall Center (PANUC) and the Alzheimer's Disease Research Center (ADRC) at the University of Washington and Oregon Health and Sciences University (OHSU). Using CSF samples from 30 well-characterized patients with PD and 30 age-, sex-matched healthy controls, we prepared RNA seq libraries and performed deep sequencing of all RNA species, including small and long RNA, mRNAs, noncoding RNAs and differentially spliced transcripts. We then tried several methods for RNAseq data analysis to optimize our analysis pipeline. We identified a total of 3381 transcripts corresponding to 182 long intergenic RNAs (LincRNAs), 11 microRNAs (miRNAs), 2861 protein-coding transcripts, 200 pseudogenes and 127 antisense RNAs; some of them were differentially expressed between PD and control groups. Selected differentially expressed RNAs have been validated in the same set of CSF samples using real-time PCR (RT-PCR). Further validations in independent, larger cohorts of samples are still ongoing. Our results obtained so far suggested that CSF proteins and RNAs could be used as good indexes for PD diagnosis and disease severity/progression. This study is a part of the NIDDS-funded Parkinson's Disease Biomarkers Program (PDBP).

pht004673.v1.p1

1 Item-grupp 5 Dataelement

pht004674.v1.p1

1 Item-grupp 3 Dataelement

pht004675.v1.p1

1 Item-grupp 6 Dataelement

Eligibility

1 Item-grupp 2 Dataelement

TRR295 Retune Core Data Set - Basisdaten Baseline

- 2023-10-09 - 37 Formulär, 1 Item-grupp, 92 Dataelement, 2 Språk
Item-grupp: Basisdaten Baseline
DRKS-ID der Studie: DRKS00028750 Allgemeinverständliche Kurzbeschreibung Die zentrale Patientenkohorte des SFB/TR ReTune beinhaltet einen klinischen Kerndatensatz von Patienten mit Parkinson, Tremor oder Dystonie. Sie dient als eine Informationsplattform, um Effekte der Behandlung mit Tiefen Hirnstimulation auf die Patient:innen mit unterschiedlichen Erkrankungen zu untersuchen.

Endpunkte Baseline

1 Item-grupp 21 Dataelement

Basisdaten Baseline

1 Item-grupp 92 Dataelement

Basisdaten FU 12 Mon

1 Item-grupp 61 Dataelement

Operations Details

1 Item-grupp 8 Dataelement

Endpunkte Follow-up

1 Item-grupp 24 Dataelement

Endpunkte Follow-up

1 Item-grupp 24 Dataelement

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

dbGaP phs000727 miRNA profiles in serum and CSF of Parkinson's and Alzheimer's patients - pht003862.v1.p1

- 2022-12-28 - 5 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: pht003862
Principal Investigator: Kendall Van Keuren-Jensen, PhD, The Translational Genomics Research Institute (TGen), Phoenix, AZ, USA MeSH: Alzheimer Disease,Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000727 We profiled the miRNA contents from cerebrospinal fluid and serum (using next generation sequencing) from postmortem patients diagnosed with Alzheimer's or Parkinson's disease, and neurologically normal controls. All biofluids were cell-free and patient matched, there was one cerebrospinal fluid and one serum sample from each of 70 patients with Alzheimer's disease, 67 patients with Parkinson's disease and 78 age-similar controls. We correlated the miRNA changes with measurements of neuropathology such as plaques, tangles and Lewy bodies.

pht003863.v1.p1

1 Item-grupp 5 Dataelement

pht003864.v1.p1

1 Item-grupp 23 Dataelement

pht003865.v1.p1

1 Item-grupp 3 Dataelement

Eligibility

1 Item-grupp 1 Dataelement

dbGaP phs000394 Autopsy-Confirmed Parkinson Disease GWAS Consortium (APDGC) - pht002651.v1.p1

- 2022-10-12 - 4 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: pht002651
Principal Investigator: Jeffery Vance, MD, PhD, University of Miami, Miami, FL, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000394 The APDGC was formed to conduct a genome-wide association study in individuals with neuropathologically confirmed Parkinson Disease (PD) and neuropathologically normal controls. The rationale for the study is that including only cases and controls with neuropathologically confirmed disease status will reduce diagnostic misclassification and increase power to detect novel genetic associations.

pht002652.v1.p1

1 Item-grupp 5 Dataelement

pht002653.v1.p1

1 Item-grupp 5 Dataelement

pht002654.v1.p1

1 Item-grupp 4 Dataelement

dbGaP phs000376 Whole Exome Sequencing in Familial Parkinson Disease - Eligibility

- 2022-10-12 - 6 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Tatiana Foroud, PhD, Indiana University School of Medicine, Indianapolis, IN, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000376 We have an ongoing study that has recruited families having at least a sibling pair with Parkinson disease (PD). Families have been screened for mutations in known PD causative genes (LRRK2, parkin, etc). Following review of families without a causative mutation, we selected families for whole exome sequencing that had the strongest history of PD and with the most definitive diagnosis. All families have at least 3 affected family members who were evaluated as part of this study. Only affected family members were included for whole exome sequencing.

pht002306.v1.p1

1 Item-grupp 5 Dataelement

pht002307.v1.p1

1 Item-grupp 5 Dataelement

pht002308.v1.p1

1 Item-grupp 3 Dataelement

pht002309.v1.p1

1 Item-grupp 29 Dataelement

pht002310.v1.p1

1 Item-grupp 4 Dataelement

44963_dbGaP phs000048 Mayo-Perlegen LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) Collaboration - Eligibility

- 2022-08-22 - 3 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: IG.elig
Principal Investigator: Demetrius M. Maraganore, Mayo Clinic, Rochester, MN, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000048 We performed a two-tiered, whole-genome association study of Parkinson disease (PD). For tier 1, we individually genotyped 198,345 uniformly spaced and informative single-nucleotide polymorphisms (SNPs) in 443 sibling pairs discordant for PD. For tier 2a, we individually genotyped 1,793 PD-associated SNPs (P.01 in tier 1) and 300 genomic control SNPs in 332 matched case-unrelated control pairs. We identified 11 SNPs that were associated with PD (P.01) in both tier 1 and tier 2 samples and had the same direction of effect. For these SNPs, we combined data from the case-unaffected sibling pair (tier 1) and case-unrelated control pair (tier 2) samples and employed a liberalization of the sibling transmission/disequilibrium test to calculate odds ratios, 95% confidence intervals, and P values. A SNP within the semaphorin 5A gene (SEMA5A) had the lowest combined P value (P=7.62E-6). The protein encoded by this gene plays an important role in neurogenesis and in neuronal apoptosis, which is consistent with existing hypotheses regarding PD pathogenesis. A second SNP tagged the PARK11 late-onset PD susceptibility locus (P=1.70E-5). In tier 2b, we also selected for genotyping additional SNPs that were borderline significant (P.05) in tier 1 but that tested a priori biological and genetic hypotheses regarding susceptibility to PD (n=941 SNPs). In analysis of the combined tier 1 and tier 2b data, the two SNPs with the lowest P values (P=9.07E-6; P=2.96E-5) tagged the PARK10 late-onset PD susceptibility locus. Independent replication across populations will clarify the role of the genomic loci tagged by these SNPs in conferring PD susceptibility. Note: The following instruments were used: 1)clinical assessments form and manual; 2) sibling screening form and manual; 3) unrelated control screening and manual; and 4) risk factors questionnaire and manual. All cases underwent #1, as did sibling controls screening positive (see below). Unrelated controls were not examined. All siblings underwent #2. All unrelated controls underwent #3. All subjects (cases, sibling controls, and unrelated controls) underwent #4. Any publications using the data are to cite the original American Journal of Human Genetics article (Maraganore et al., 2005). Investigators using the data collection instruments are to acknowledge Drs. Maraganore and Rocca, and cite grants ES-10751 and NS-33978.

pht000184.v1.p1

1 Item-grupp 6 Dataelement

pht000071.v1.p1

1 Item-grupp 6 Dataelement

44953_dbGaP phs000089 NINDS Parkinson's Disease - pht000801.v2.p2

- 2022-06-03 - 4 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: pht000801.v2.p2
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000089.v3.p2 Epidemiological studies have estimated a cumulative prevalence of PD of greater than 1 per thousand. When prevalence is limited to senior populations, this proportion increases nearly 10-fold. The estimated genetic risk ratio for PD is approximately 1.7 (70% increased risk for PD if a sibling has PD) for all ages, and increases over 7-fold for those under age 66 years. The role for genes contributing to the risk of PD is therefore significant. This study utilized the well characterized collection of North American Caucasians with Parkinson's disease, and neurologically normal controls from the sample population which are banked in the National Institute of Neurological Disorders and Stroke (NINDS Repository) collection for a first stage whole genome analysis. Genome-wide, single nucleotide polymorphism (SNP) genotyping of these publicly available samples was originally done in 267 Parkinson's disease patients and 270 controls, and this has been extended to include genome wide genotyping in 939 Parkinson's disease cases and 802 controls. The NINDS repository was established in 10-2001 towards the goal of developing standardized, broadly useful diagnostic and other clinical data and a collection of DNA and cell line samples to further advances in gene discovery of neurological disorders. All samples, phenotypic, and genotypic data are available to the research community including to academics and industry scientists. In addition, well characterized neurologically normal control subjects are a part of the collection. This collection formed the basis of this first stage study by Fung et al., and the expanded study by Simon-Sanchez et al. The genotyping data was generated and provided by the laboratory of Dr. Andrew Singleton NIA, and Dr. John Hardy NIA (NIH Intramural, funding from NIA and NINDS). *Important links to apply for individual-level data* - Data Use Certification Requirements (DUC) - Apply here for controlled access to individual level data - Participant Protection Policy FAQ

pht000802.v2.p2

1 Item-grupp 4 Dataelement

pht000177.v3.p2

1 Item-grupp 65 Dataelement

pht000178.v3.p2

1 Item-grupp 43 Dataelement

Eligibility Parkinson's Disease NCT01268891

- 2021-09-28 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea; ODM derived from: https://clinicaltrials.gov/show/NCT01268891

Vital Signs Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Vital Signs Follow- Up (Visit 10)

- 2021-09-27 - 1 Formulär, 1 Item-grupp, 10 Dataelement, 1 Språk
Item-grupp: Vital Signs
Study Part: Vital Signs Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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