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NINDS CDE Demographics Multiple Sclerosis - Demographics

- 15/03/21 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics 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.

Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 15/10/17 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: Demography
Study Part: Demography Screening. 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

Eligibility Dementia NCT00294307

- 01/03/17 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers; ODM derived from: https://clinicaltrials.gov/show/NCT00294307

Eligibility Parkinson's Disease NCT01268891

- 28/09/21 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: 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

Anxiety And Depression Scale (HADS) Ropinirole Restless Legs Syndrom NCT00355641 - Anxiety And Depression Scale

- 27/09/21 - 1 modulo, 1 ItemGroup, 1 elemento, 1 linguaggio
ItemGroup: Hospital anxiety and depression scale
Study part: Anxiety And Depression Scale. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/206. Clinical Study ID: 101468/206.

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

- 27/09/21 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: 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

Urinalysis Test Results Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Urinalysis Test Results Follow- Up (Visit 10)

- 27/09/21 - 1 modulo, 2 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: URINALYSIS TEST RESULTS, Dip stick
Study Part: Urinalysis Test Results 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

Laboratory Collections Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Laboratory Collections Follow- Up (Visit 10)

- 27/09/21 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio
ItemGroup: clinical chemistry; haematology
Study Part: Laboratory Collections 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

Visite 8 (Woche 24) TMP001 Multiple Sclerosis NCT02686788 - Visite 8 (Woche 24)

- 27/09/21 - 1 modulo, 11 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vital signs; Body Temperature, study drug, Comorbidity, Adverse Events; Exacerbation of multiple sclerosis, Physical examination, Urinalysis, Laboratory, Blood sampling, Kurtzke Expanded Disability Status Scale Questionnaire, study drug
Study part: Visite 8 (Woche 24). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

Visite 7 (Woche 20) TMP001 Multiple Sclerosis NCT02686788 - Visite 7 (Woche 20)

- 27/09/21 - 1 modulo, 11 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vital signs; Body Temperature, study drug, Comorbidity, Adverse Events; Exacerbation of multiple sclerosis, Physical examination, Urinalysis, Laboratory, Blood sampling, Kurtzke Expanded Disability Status Scale Questionnaire, study drug
Study part: Visite 7 (Woche 20). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

Baseline Visite (Visite 2/ Woche 0) TMP001 Multiple Sclerosis NCT02686788 - Baseline Visite (Visite 2/ Woche 0)

- 27/09/21 - 1 modulo, 10 itemgroups, 53 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vital signs; Body Temperature, Comorbidity; Exacerbation of multiple sclerosis, Physical examination, Urinalysis, Inclusion criteria; exclusion criteria, Laboratory, Blood sampling, Kurtzke Expanded Disability Status Scale Questionnaire, study drug
Study part: Baseline Visite (Visite 2/ Woche 0). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

Visite 5 (Woche 12) TMP001 Multiple Sclerosis NCT02686788 - Visite 5 (Woche 12)

- 27/09/21 - 1 modulo, 11 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Vital signs; Body Temperature, study drug, Comorbidity, Adverse Events; Exacerbation of multiple sclerosis, Physical examination, Urinalysis, Laboratory, Blood sampling, Kurtzke Expanded Disability Status Scale Questionnaire, study drug
Study part: Visite 5 (Woche 12). TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial.

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