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Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Follow-up

- 06.06.20 - 1 Formular, 14 Itemgruppen, 167 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

- 29.05.20 - 1 Formular, 5 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Pregnancy Information, Study Conclusion, Investigator's Statement, General Comments
Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 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

ICHOM Type 1 and Type 2 Diabetes in Adults - Annually collected Characteristics, Clinical/Provider Form

- 30.04.20 - 1 Formular, 8 Itemgruppen, 86 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Diagnosis Profile, Treatment variables, Clinician Reported Outcomes: Intermediate Outcomes, Clinician Reported Outcomes: Acute Events, Clinician-reported Outcomes: Chronic Complications, Clinician Reported Outcomes: Healthcare Utilization, Clinician Reported Outcomes: Survival
Type 1 and Type 2 Diabetes in Adults DATA COLLECTION Version 1.0.0 Revised February 28th, 2019 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. Conditions: Type 1 Diabetes | Type 2 Diabetes Excluded Conditions: Diabetes mellitus types other than 1 and 2 | Secondary Diabetes | Gestational Diabetes Population: Adults Aged 18 years and Above Excluded Populations: Children and Young persons below 18 years Treatment Approaches: Non-Pharmacological Therapy | Non-Insulin-based Pharmacological Therapy | Insulin-based Pharmacological Therapy This form is for documentation of characteristics to be reported annually by Clinicians or Healthcare Providers. Please additionally fill in the 6-monthly form. Use of the following Scores for this standard set: WHO (Five) Well-Being Index (WHO-5): The WHO-5 is free for all health care organizations, and a license is not needed. There are translations available. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. More information (including the WHO-5 Scoring Guide) may be found at www.who-5.org. Problem Areas in Diabetes Questionnaire (PAID): The PAID, authored by Joslin Diabetes Center (http://www.joslin.org), is the copyright of Joslin Diabetes Center (Copyright ©2000, Joslin Diabetes Center). The PAID, provided under license from Joslin Diabetes Center may not be copied, distributed or used in any way without the prior written consent of Joslin Diabetes Center. Contact Susan D. Sjostrom at Joslin Diabetes Center at: susan.sjostrom@joslin.harvard.edu for licensing details and scoring guide. Patient Health Questionnaire (PHQ-9): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site", please visit http://www.phqscreeners.com/ for more information. For this standard set ICHOM was supported by Imperial College London Diabetes Centre and JDRF. Publication: Nano J, Carinci F, Okunade O, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabetic Medicine [Internet]. [cited 2020 Mar 4];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14286 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Type 1 and Type 2 Diabetes in Adults - 6-monthly Characteristics, Clinical/Provider Form

- 30.04.20 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Clinician Reported Outcomes: Glycemic Control, Clinician Reported Outcomes: Acute Events
Type 1 and Type 2 Diabetes in Adults DATA COLLECTION Version 1.0.0 Revised February 28th, 2019 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. Conditions: Type 1 Diabetes | Type 2 Diabetes Excluded Conditions: Diabetes mellitus types other than 1 and 2 | Secondary Diabetes | Gestational Diabetes Population: Adults Aged 18 years and Above Excluded Populations: Children and Young persons below 18 years Treatment Approaches: Non-Pharmacological Therapy | Non-Insulin-based Pharmacological Therapy | Insulin-based Pharmacological Therapy This form is for documentation of characteristics to be reported every 6 months after baseline by Clinicians or Healthcare Providers. Use of the following Scores for this standard set: WHO (Five) Well-Being Index (WHO-5): The WHO-5 is free for all health care organizations, and a license is not needed. There are translations available. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. More information (including the WHO-5 Scoring Guide) may be found at www.who-5.org. Problem Areas in Diabetes Questionnaire (PAID): The PAID, authored by Joslin Diabetes Center (http://www.joslin.org), is the copyright of Joslin Diabetes Center (Copyright ©2000, Joslin Diabetes Center). The PAID, provided under license from Joslin Diabetes Center may not be copied, distributed or used in any way without the prior written consent of Joslin Diabetes Center. Contact Susan D. Sjostrom at Joslin Diabetes Center at: susan.sjostrom@joslin.harvard.edu for licensing details and scoring guide. Patient Health Questionnaire (PHQ-9): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site", please visit http://www.phqscreeners.com/ for more information. For this standard set ICHOM was supported by Imperial College London Diabetes Centre and JDRF. Publication: Nano J, Carinci F, Okunade O, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabetic Medicine [Internet]. [cited 2020 Mar 4];n/a(n/a). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14286 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Chronic Kidney Disease - Treatment-specific (Clinical / administrative)

- 30.04.20 - 1 Formular, 2 Itemgruppen, 35 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Treatment-Specific
CHRONIC KIDNEY DISEASE DATA COLLECTION REFERENCE GUIDE Version 1.0.0 Revised October 25th, 2017 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. Conditions: Chronic Kidney Disease Stage G3a/A3 | Chronic Kidney Disease StageG 3b/A2/A3 | Chronic Kidney Disease Stage G4 | Chronic Kidney Disease Stage G5 (KDIGO 2012 Stages) Treatment Approaches: Pre-RRT = Pre-Renal Replacement Therapy | HD = Haemodialysis | PD = Peritoneal Dialysis | Tx = Renal Transplantation | CC = Conservative Care This ODM-file contains Treatment-specific variables, clinical or administrative. To be collected 6-monthly or annually. Surveys used: The OptumTM SF-36v2® Health Survey: The SF-36v2 Health Survey requires a license agreement prior to the use or reprodution of the tool. Information on how to obtain a license can be found here: bit.ly/SF36LIC . The scoring guide for the SF36v2 is only available upon a license agreement being made. Due to the requirement of a license the Score cannot be found in this version of the standard set. PROMIS-Global Health and PROMIS-29: Free for use in clinical practice and a license is not required. Information http://www.nihpromis.org/measures/translations . The scoring guides for the two PROMIS Scores can be found at bit.ly/PROMISGLOBALSCORE and bit.ly/PROMIS29SCORE . RAND-36: Free for use in clinical practice and a license is not required. The RAND-36 is available in English and Arabic. https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html . The Scoring guide can be found at bit.ly/RAND36Score . Publication: Verberne WR, Das-Gupta Z, Allegretti AS, et al. Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. American Journal of Kidney Diseases. Volume 73, Issue 3, 2019, Pages 372-384, ISSN 0272-6386, https://doi.org/10.1053/j.ajkd.2018.10.007 ICHOM was supported for the Chronic Kidney Disease Standard Set by NSW Agency for Clinical Innovation, Providence Health and Services, ERCPA, santeon and Dutch Kidney Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Hepatitis B vaccine in newborn of HBeAg and HBsAg positive mothers - 103860-115 - Long Term Follow-Up

- 27.12.19 - 1 Formular, 10 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Long Term Follow-Up (Year 14), BLOOD SAMPLING, DEMOGRAPHICS, LABORATORY TESTS, INVESTIGATOR SIGNATURE, Long Term Follow-Up (Year 15), BLOOD SAMPLING, DEMOGRAPHICS, LABORATORY TESTS, INVESTIGATOR SIGNATURE
Study ID: 103860-115 Clinical Study ID: 103860-115 Study Title: Immunogenicity and protective efficacy of GlaxoSmithKline (previously SmithKlineBeecham) Biologicals’ hepatitis B vaccine (10mcg) in newborn of HBeAg and HBsAg positive mothers compared with a historical control group. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: N/A Study Indication: Hepatitis B 

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Follow-up

- 27.12.19 - 1 Formular, 8 Itemgruppen, 33 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Vital signs, Semi-erect, Vital signs, Erect, Pulmonary function tests, Blinded Clinical Study, Status, Clinical Research, Conclusion, Pregnancy, Information, Laboratory Procedures
Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Follow-up

- 17.12.19 - 1 Formular, 11 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Vital signs, Pulmonary function tests, 12 lead ECG, Physical Examination, Vital signs, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Laboratory Procedures, Renal function, Blood, Laboratory Procedures, Renal function, Urine
Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects 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: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Follow-Up

- 08.12.19 - 1 Formular, 9 Itemgruppen, 50 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Physical Examination, Serum pregnancy test (B-HCG), Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis
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

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Follow-Up

- 20.11.19 - 1 Formular, 9 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Follow-up, Month, Clinical Trials, Result, X-Ray Computed Tomography, Tumor Markers, follow-up visit date, Response to treatment, Evaluation, Therapeutic procedure, Other, Investigator Signature
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Follow-Up - Dateof Visit; Status of Treatment Blind; Study Conclusion; Pregnancy Information

- 28.10.19 - 1 Formular, 5 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Date of Visit, Status of Treatment Blind, Study Conclusion, Pregnancy Information (Preg F), Pregnancy Information (Preg M)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277) - Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up

- 17.10.19 - 1 Formular, 16 Itemgruppen, 83 Datenelemente, 1 Sprache
Itemgruppen: Administration, Follow-up studies, Study conclusion, Investigator signature, Tracking Document Safety Follow-Up, Tracking Document Safety Follow-Up , Serious adverse event safety follow-up - Administrative, Serious adverse event safety follow-up, Serious adverse event safety follow-up - Study vaccine information, Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE, Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE , Serious adverse event safety follow-up - Drug(s) used to treat this SAE , Serious adverse event safety follow-up - Surgical treatment for this SAE , Serious adverse event safety follow-up - Description , Serious adverse event safety follow-up - Comments , Serious adverse event safety follow-up - Investigator signature
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

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