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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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177 Search results.

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Baseline Day -1

- 12/1/19 - 1 form, 10 itemgroups, 39 items, 1 language
Itemgroups: Administrative documentation, Physical Examination, Vital signs, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Urine drug screening; Ethanol measurement, Serum pregnancy test (B-HCG), Randomization, Numbers, Therapeutic regimen
Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

ICHOM Congenital Upper Limb Anomalies - On referral - Clinical Form

- 10/29/19 - 1 form, 5 itemgroups, 89 items, 1 language
Itemgroups: Administrative Data, Patient Demographic Factors, Family Demographic Factors, Clinical status, OMT Classification
ICHOM Congenital Upper Limb Anomalies data collection Version 1.0.0 August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ For Congenital Upper Limb Anomalies, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Congenital Hand Anomaly | Congenital Upper Limb Anomaly | Apert | Cleft Hand | Constriction Ring | Polydactyly | Radial Ray Deficiency | Symbrachydactyly | Thumb Hypoplasia | Ulnar Dysplasia | Ulnar Ray Deficiency Treatment approaches: Surgery | Rehabilitation | Other This document contains the On referral - Clinical Form. It has to be filled in at Patient's entry into the set. Collecting Patient-Reported Outcome Measures: Joint Mobility Questions. There are no licensing requirements to use these questions. PROMIS Upper Extremity, Global Health, Peer relationships, Anxiety, Depression. As there is an official distribution site, these questionnaires will not be included in this version of the standard set. For more information see: http://www.healthmeasures.net/exploremeasurement-systems/promis/obtain-administer-measures Goniometry, Dynamometry for Clinician. Follow the clinical assessment recommendations of the American Dynamometry - Clinician Society of Hand Therapists. Manual Muscle Strength Testing – Clinician. Use the Medical Research Council MMST grading. Oberg-Manske-Tonkin Classification. For more information see: Oberg KC, Feenstra JM, Manske PR, et al. Developmental biology and classification of congenital anomalies of the hand and upper extremity. J Hand Surg Am. 2010;35:2066. The Standard set of ICHOM was supported by the Great Ormond Stres Hospital, the Boston Children’s Hospital, the Erasmus MC, the Royal North Shore Hospital, the Texas Scottish Rite Hospital and the Loma Linda University.

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Subject at Home Diary - Baseline

- 10/24/19 - 1 form, 6 itemgroups, 27 items, 1 language
Itemgroups: Administrative documentation, Blood Pressure, Exercise, Information, Pharmaceutical Preparations, Subject Diary, Alcohol consumption, Subject Diary, Caffeine Use, Subject Diary, Tobacco Use, Subject Diary
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Baseline Diaries

- 10/24/19 - 1 form, 5 itemgroups, 21 items, 1 language
Itemgroups: Administrative documentation, Date of visit; Assessment Date, Concomitant Agent, Concomitant Agent, Clinic, Concomitant Agent, Home environment
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Baseline

- 10/24/19 - 1 form, 17 itemgroups, 102 items, 1 language
Itemgroups: Administrative documentation, Date of visit; Assessment Date, Study Subject Participation Status, Eligibility Determination, Trial Screen Failure, Pharmacogenetic Test, Informed Consent, Withdraw, Investigator Signature, Vital signs, Headache, Classification, Migraine Disorders, Medical History, Disease, Heart Diseases, Endocrine System Diseases, Other diseases or conditions , cardiovascular risk factor, Migraine Disorders, Prior Therapy, Randomization, Numbers
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

ICHOM Congenital Upper Limb Anomalies - On referral - Parent-reported Form

- 10/23/19 - 1 form, 3 itemgroups, 21 items, 1 language
Itemgroups: Administrative Data, Patient Demographic Factors, Family Demographic Factors
ICHOM Congenital Upper Limb Anomalies data collection Version 1.0.0 August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ For Congenital Upper Limb Anomalies, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Congenital Hand Anomaly | Congenital Upper Limb Anomaly | Apert | Cleft Hand | Constriction Ring | Polydactyly | Radial Ray Deficiency | Symbrachydactyly | Thumb Hypoplasia | Ulnar Dysplasia | Ulnar Ray Deficiency Treatment approaches: Surgery | Rehabilitation | Other This document contains the On referral - Parent-reported Form. It has to be filled in at Patient's entry into the set. Recognising that different countries have established practices and may take time to transition to these time points, ICHOM has agreed age categories for measurement that fit around the recommended specific ages: 6 months: +/- 1 month 1 year: +/- 1 month 2 years: +/- 1 month 8 years: 8-9 years 12 years: 11 - 13 years 15 years: 14 - 15 years End of Paediatric Care: 16 - 18 years (according to the policy of each institution for end of paediatric care) Post-operative period: up to 6 months following the date of the operation Collecting Patient-Reported Outcome Measures: Joint Mobility Questions. There are no licensing requirements to use these questions. PROMIS Upper Extremity, Global Health, Peer relationships, Anxiety, Depression. As there is an official distribution site, these questionnaires will not be included in this version of the standard set. For more information see: http://www.healthmeasures.net/exploremeasurement-systems/promis/obtain-administer-measures Goniometry, Dynamometry for Clinician. Follow the clinical assessment recommendations of the American Dynamometry - Clinician Society of Hand Therapists. Manual Muscle Strength Testing – Clinician. Use the Medical Research Council MMST grading. Oberg-Manske-Tonkin Classification. For more information see: Oberg KC, Feenstra JM, Manske PR, et al. Developmental biology and classification of congenital anomalies of the hand and upper extremity. J Hand Surg Am. 2010;35:2066. The Standard set of ICHOM was supported by the Great Ormond Stres Hospital, the Boston Children’s Hospital, the Erasmus MC, the Royal North Shore Hospital, the Texas Scottish Rite Hospital and the Loma Linda University.

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Current stroke status

- 9/25/19 - 1 form, 3 itemgroups, 21 items, 1 language
Itemgroups: Administrative Data, Current Stroke, Risk Factors
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 current stroke status form. It has to be filled in for Day 1.

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

- 9/25/19 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Demography, Geographic ancestry
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 demography form. It has to be filled in for Day 1.

ICHOM Paediatric Facial Palsy - Baseline - Clinical Form

- 8/28/19 - 1 form, 5 itemgroups, 32 items, 1 language
Itemgroups: Administrative Data, Patient Demographic Factors, Baseline Clinical Status, Other, Degree of Health
ICHOM Paediatric Facial Palsy data collection Version 1.0.0 Revised: August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ For Paediatric Facial Palsy, the following conditions and treatment approaches (or interventions) are covered by ICHOM‘s Standard Set. Conditions: Congenital/Syndromic | Acquired Unilateral (single- and multi-territory) | Bilateral (single- and multi-territory) Treatment approaches: Medical treatment | Surgery | Eye care Physiotherapy/Occupational therapy | Botulinum toxin | Psychological support This document contains the Baseline - Clinical Form. It has to be filled in at Patient's first encounter/visit. Collecting Patient-Reported Outcome Measure: eFACE – Clinician. For more information see: Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic Facial Paralysis Assessment: The eFACE, August 2015. doi: 10.1097/PRS.0000000000001447 FACE-Q Kids. As there is a license for use of this questionnaire, the questions will not be included in this version of the standard set, only subscores. Snellen Chart – Clinician. PROMIS Paediatric Global Health 7 and PROMIS Pediatric Peer Relationships SF 8a. As there is an official distribution site, only the total score of these questionnaires will be included in this version of the standard set. For more information see: http://www. healthmeasures.net/explore-measurement-systems/promis/ obtain-administer-measures Reference: Butler DP, De la Torre A, Borschel GH, et al. An International Collaborative Standardizing Patient-Centered Outcome Measures in Pediatric Facial Palsy. JAMA Facial Plast Surg. Published online May 09, 2019. doi:10.1001/jamafacial.2019.0224 The Standard set of ICHOM was supported by the royal free charity and the Dianne and Michael Bienes Charitable Foundation Inc.

ICHOM Paediatric Facial Palsy - Baseline - Parent-reported Form

- 8/27/19 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, Patient Demographic Factors, Degree of Health
ICHOM Paediatric Facial Palsy data collection Version 1.0.0 Revised: August 31st, 2018 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ For Paediatric Facial Palsy, the following conditions and treatment approaches (or interventions) are covered by ICHOM‘s Standard Set. Conditions: Congenital/Syndromic | Acquired Unilateral (single- and multi-territory) | Bilateral (single- and multi-territory) Treatment approaches: Medical treatment | Surgery | Eye care Physiotherapy/Occupational therapy | Botulinum toxin | Psychological support This document contains the Baseline - Parent-reported Form. It has to be filled in at Patient's first encounter/visit. Most of the items only has to be filled in for patient <8 years. If the patient is >8 years the document "Pre-Intervention/Several documents - Patient Form" can be used additionally. Collecting Patient-Reported Outcome Measure: eFACE – Clinician. For more information see: Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic Facial Paralysis Assessment: The eFACE, August 2015. doi: 10.1097/PRS.0000000000001447 FACE-Q Kids. As there is a license for use of this questionnaire, the questions will not be included in this version of the standard set, only subscores. Snellen Chart – Clinician. PROMIS Paediatric Global Health 7 and PROMIS Pediatric Peer Relationships SF 8a. As there is an official distribution site, only the total score of these questionnaires will be included in this version of the standard set. For more information see: http://www. healthmeasures.net/explore-measurement-systems/promis/ obtain-administer-measures Reference: Butler DP, De la Torre A, Borschel GH, et al. An International Collaborative Standardizing Patient-Centered Outcome Measures in Pediatric Facial Palsy. JAMA Facial Plast Surg. Published online May 09, 2019. doi:10.1001/jamafacial.2019.0224 The Standard set of ICHOM was supported by the royal free charity and the Dianne and Michael Bienes Charitable Foundation Inc.

ICHOM Atrial Fibrillation - Baseline - Patient-reported

- 8/26/19 - 1 form, 5 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data, Demographic Factors, Lifestyle interventions measured at baseline, Complications of treatment, Patient-Reported Outcomes
ICHOM Atrial Fibrillation data collection Version 1.0.0 Published: 3rd April 2019 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ The following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Atrial Fibrillation Population: An adult (≥ 18 years) diagnosed with atrial fibrillation (including symptomatic patients) Treatment approaches: Management of cardiovascular risk factors and institution of preventive therapy | Pharmacological management| Non-Pharmacological management Excluded populations: Children and Young persons below 18 years Excluded conditions: Patients diagnosed with cardiotoxic acute atrial fibrillation This document contains the Baseline - Patient-reported Form. It has to be filled in at index event. Collecting Patient-Reported Outcome Measure: PROMIS Global Health. As there is an official distribution site, the questions of this questionnaire will not be included in this version of the standard set. For more information see: https://bit.ly/29aOZu9 Montreal Cognitive Assessment Test. For more information see: https://www.mocatest.org/ The Standard set of ICHOM was supported by the BigData@Heart organization.

ICHOM Atrial Fibrillation - Baseline - Clinical Form

- 8/26/19 - 1 form, 6 itemgroups, 62 items, 1 language
Itemgroups: Administrative Data, Lifestyle interventions measured, Baseline health status, Health status measured at baseline, Long-term consequences of disease, Complications of treatment
ICHOM Atrial Fibrillation data collection Version 1.0.0 Published: 3rd April 2019 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ The following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Atrial Fibrillation Population: An adult (≥ 18 years) diagnosed with atrial fibrillation (including symptomatic patients) Treatment approaches: Management of cardiovascular risk factors and institution of preventive therapy | Pharmacological management| Non-Pharmacological management Excluded populations: Children and Young persons below 18 years Excluded conditions: Patients diagnosed with cardiotoxic acute atrial fibrillation This document contains the Baseline – Clinical Form. It has to be filled in at index event. Collecting Patient-Reported Outcome Measure: PROMIS Global Health. As there is an official distribution site, the questions of this questionnaire will not be included in this version of the standard set. For more information see: https://bit.ly/29aOZu9 Montreal Cognitive Assessment Test. For more information see: https://www.mocatest.org/ The Standard set of ICHOM was supported by the BigData@Heart organization.