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Personal Health Record

- 27-09-21 - 1 Formulier, 15 Itemgroepen, 269 Data-elementen, 2 Talen
Itemgroepen: General Information, PATIENT REGISTRATION, SERVICE PROVIDER INFORMATION, MEDICAL HISTORY, PATIENT’S IMMUNIZATION RECORD, CLINICAL MEASUREMENTS, EXAM FINDINGS, LABORATORY/OTHER TESTS, DIAGNOSTICS, SUMMARY FINDINGS, TREATMENT RECOMMENDATION, TRAVEL RECOMMENDATION, POST-ARRIVAL RECOMMENDATION, TREATMENT ADMINISTRATION, VACCINE ADMINISTRATION
Personal Health Record السجل الصحي الشخ ي ص

Symptom Checklist (SCL): PaReSiS UKH

- 20-09-21 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 1 Taal
Itemgroep: 50. Symptoms
Symptom Checklist (SCL): 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

Bogen 1 Bestehende medizinische Symptome DRKS00005243 NCT01657604 CML - Bogen 1 Bestehende medizinische Symptome

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 25 Data-elementen, 2 Talen
Itemgroepen: Allgemeine Angaben, Symptome, SAE, Kommentar
German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - Diary Card for General and Local Symptoms

- 24-08-21 - 1 Formulier, 10 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Administrative, Local Symptoms (at Injection Sites), Local Symptoms (at Injection Site), Other Local Symptoms, Pharmaceutical preparation, General Symptoms, General Symptoms, General Symptoms, Other General Symptoms, Administrative
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum malaria vaccine RTS,S/AS01E (0.5 mL dose) to RTS,S/AS02D (0.5 mL dose) administered IM according to a 0, 1, 2- month vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. Parents/guardians are asked to fill in the Diary Card during the one-week period subsequent to each vaccination (i.e., post visit 2 [dose 1], visit 4 [dose 2], and visit 5 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Diary Card for General and Local Symptoms

- 11-08-21 - 1 Formulier, 10 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Administrative, Local Symptoms (at Injection Site), Local Symptoms (at Injection Site), Other Local Symptoms, Pharmaceutical preparation, General Symptoms, General Symptoms, General Symptoms, Other General Symptoms, Administrative
Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Parents/guardians are asked to fill in the Diary Card during the one-week period subsequent to each vaccination (i.e., post visit 2 [dose 1], visit 3 [dose 2], and visit 4 [dose 3]). Note that informed consent has to be obtained prior to any study procedure.

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)

- 04-05-21 - 1 Formulier, 8 Itemgroepen, 35 Data-elementen, 1 Taal
Itemgroepen: Administrative, Form D, Patient Symptom Assessment, Patient Symptom Assessment , Topotecan Post-Study Minimal Follow-Up Report: Month of Report, Topotecan Post-Study Minimal Follow-Up Report: Outcome, Topotecan Post-Study Minimal Follow-Up Report: Form D - (To be completed if the patient died), Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

- 11-03-21 - 1 Formulier, 4 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Total Nasal Symptom Scores, VAS, Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Constitutional Symptoms and ECOG

- 09-02-21 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Constitutional Symptoms, ECOG Performance Status Scale
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the screening visit, the weekly visits during the cycles of treatment, the cycle observation visits, unscheduled visits, withdrawal visits and visits at the end of study/ treatment.

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome

- 11-11-20 - 1 Formulier, 4 Itemgroepen, 41 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Chest X-ray, Cultures and clinical findings, Treatment and Outcome
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.

Measurement Instrument Database for the Social Science (MIDSS) - The Functional Behavior Profile (FBP)

- 04-09-20 - 1 Formulier, 1 Itemgroep, 27 Data-elementen, 1 Taal
Itemgroep: The Functional Behavior Profile
Baum, C., Edwards, D.F., Morrow-Howell, N. (1993). The Functional Behavior Profile (FBP). Measurement Instrument Database for the Social Science. Retrieved 04.09.2020, from www.midss.ie Key references: Baum, C Edwards, D.F. Morrow-Howell, N. (1993). Identification and measurement of productive behaviours in senile dementia of the Alzheimer type. The Gerontologist, 33, 403-408. Baum, M. C. and Edwards, D. F. (2000). Documenting productive behaviors. Using the functional behavior profile to plan discharge following stroke. J Gerontol Nurs, 26, 34-40; quiz 41-33. Burgener, S., Twigg, P., et al. (2005). "Measuring psychological well-being in cognitively impaired persons." Dementia 4(4): 463. Goverover, Y., Kalmar, J., et al. (2005). "The relation between subjective and objective measures of everyday life activities in persons with multiple sclerosis." Arch Phys Med Rehabil 86(12): 2303-2308. Primary use / Purpose: The Functional Behavior Profile (FBP) is a clinical assessment measure used to inform placement and discharge planning decisions following stroke. The FBP provides caregivers with a method of describing the impaired person’s capabilities in performing tasks, social interactions, and problem-solving. It was developed to guide treatment planning, documenting change, and identifying helpful community resources. Background: The Functional Behavior Profile (FBP) comprises 27 items concerning performance of daily activities by the cognitively impaired individual. The items are sectioned into three areas: Task Performance, Problem Solving, and Social Interaction. Each item is rated from 0 (never) to 4 (always) according to the subject’s behavior over the past 7 days. The checklist may be completed by the therapist by interviewing the primary caregiver or by the caregiver independently. Administration of the test takes, on average, 15 minutes. The FBP yields three scores for the factors of Task Performance, Problem Solving, and Social Interaction. An institutional version of the profile is also available for residents of facilities. Psychometrics: Internal consistency and criterion validity scores are provided in Baum et al. (2000) and Baum et al. (1993), respectively. Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.258 The FBP is designed to obtain from the primary caregiver the overall capacity for their loved one to engage in tasks, social interactions and problem solving. All of the questions relate to how their loved one performs in their daily activities. As a reference, the caregiver should respond based upon the person's behavior during the past week. (It can be administered in interview or self scored format). Scoring: Total those marked according to the following key. You can use the task performance, social interaction, and problem solving scales separately or use a total score. Key: T: score items 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 P: score items 9, 10, 21, 22, 23, 24, 25, 26, 27 S: score items 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Clinical assessment dementia (Klinische Einschätzung Demenz)

- 23-03-20 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Clinical assessment dementia
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 Clinical assessment dementia form. It has to be filled in at follow-up visits of the study.

Parkinson's Nonmotor Symptoms Questionnaire (PD NMS Quest) - PD NMS Questionnaire

- 04-02-20 - 1 Formulier, 2 Itemgroepen, 35 Data-elementen, 2 Talen
Itemgroepen: Administrative, Non-movement problems in Parkinson's
Developed and validated by the International PD Non Motor Group For information contact: susanne.tluk@uhl.nhs.uk or alison.forbes@uhl.nhs.uk Entwickelt und validiert von der International PD Non-Motor-Group, deutsche Version von Jost W, Odin P, Storch A. (C) Chaudhuri KR, Jost W, Odin P, Storch A, 2009. For request: Alexander.Storch@uniklinikum-dresden.de

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