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Eligibility Non Small Cell Lung Cancer (NSCLC) NCT01210378

- 22-01-21 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 1 Taal
Itemgroep: Inclusion Criteria
Nitroglycerin in Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01210378

Eligibility Multiple Myeloma NCT01177683

- 22-01-21 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01177683

Eligibility Neutropenia in Breast Cancer NCT01079676

- 11-11-20 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01079676

Eligibility Neuroendocrine Carcinoma of the Lung and Thymus NCT01563354

- 10-11-20 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01563354 according to the information on clinicaltrials.gov "other protocol-defined inclusion/exclusion-criteria may apply"

Eligibility Myelomonocytic Leukemia NCT01776723

- 31-10-20 - 1 Formulier, 2 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib; ODM derived from: https://clinicaltrials.gov/show/NCT01776723

Eligibility Multiple Myeloma NCT02248428

- 26-10-20 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02248428

Measurement Instrument Database for the Social Science (MIDSS) - The Brief Edinburgh Depression Scale (BEDS)

- 30-09-20 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: General Information, BRIEF EDINBURGH DEPRESSION SCALE
Lloyd-Williams, M., Shiels, C., Dowrick, C. (2006). The Brief Edinburgh Depression Scale (BEDS). Measurement Instrument Database for the Social Science. Retrieved 30.09.2020, from www.midss.ie Key references: Lloyd-Williams, M., Shiels, C., Dowrick, C. (2007). The development of the Brief Edinburgh Depression Scale (BEDS) to screen for depression in patients with advanced cancer. Journal of Affective Disorders, 99(1-3), 259-264. Primary use / Purpose: The Brief Edinburgh Depression Scale (BEDS) is a 6-item inventory rated on a 4 point Likert-type scale. Its purpose is to briefly and accurately measure depression in those in the advanced stages of cancer. Background: Depression and reduced quality of life have long been recognized as serious problems in the later stages of cancer. These mood states are commonly infered from physical symptoms such as weight loss, loss of appetite, or/and sleep disturbance. However, subjective measures are often ignored. The Brief Edinburgh Depression Scale (BEDS) aims to address this limitation by instead ignoring somatic symptoms, focusing only on subjective feelings of worth and sadness et alia. In its brief form the BEDS also has the advantage of being quick and easy to use which is an important consideration when dealing with terminally ill patients. Psychometrics: The psychometric properties of the Brief Edinburgh Depression Scale (BEDS) are discussed in Lloyd-Williams, Shiels, & Dowrick (2007). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.328 Scoring: Score of 6/18 is indicative of depression Background: The development of a brief valid tool to screen for depression in patients with advanced cancer is important. This paper reports data on the psychometric properties of the Brief Edinburgh Depression Scale Method: Two hundred and forty six patients who fulfilled the inclusion criteria completed the 10 item EDS and Present State Examination. Results: Factor extraction revealed 6 items from the ten item EDS. The most valid cut-off for defining a case, using the PSE diagnosis as the “gold-standard”, was a score of 6 out of 18 on the Brief Edinburgh Depression Scale which gave a sensitivity of 72% and specificity of 83% with a PPV of 65.1% and NPV of 87.1%. Conclusions: The six item EDS is a brief and sensitive method of screening for depression in advanced cancer patients - this novel use of the Edinburgh depression scale may have a significant impact on the assessment and thus management of this distressing symptom

Measurement Instrument Database for the Social Science (MIDSS) - Attitude Follow-Up Scale (AFS)

- 30-09-20 - 1 Formulier, 2 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Instructions, Extent
Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., Kievit, J. (1997). Attitude Follow-Up Scale (AFS). Measurement Instrument Database for the Social Science. Retrieved 30.09.2020, from www.midss.ie Key references: Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., and Kievit, J. (1997). Follow-up of colorectal cancer patients: quality of life and attitudes towards follow-up. Br J Cancer, 75(6), 914–920. Kiebert, G. M., Welvaart, K., Kievit, J. (1993). Psychological effects of routine follow up on cancer patients after surgery. Eur J Surg, 159(11–12), 601–607 Thewes, B., Butow, P., Zachariae, R., Christensen, S., Simard, S & Gotay, C. (2012). Fear of cancer recurrence: a systematic literature review of self-report measures. Psycho-Oncology, 21, 571–587 Primary use / Purpose: The Attitude Follow-Up Scale (AFS) is a 19-item inventory rated on a 4 point Likert-type scale. Its purpose is to measure the attitudes of cancer patients towards follow-up. Patients’ attitudes are measured under four dimensions: communication (with a physician), reassurance, nervous anticipation, and perceived disadvantages of the follow-up process. Background: A substantial amount of research exists on the well-being and quality of life associated with clinical samples, especially those diagnosed with cancer. However, little research has specifically studied the physical and psychological outcomes associated with follow-up procedures between patient and physician. To address this, Stiggelbout, de Haes, & Vree et al. (1997) tweaked an existing scale developed by Kiebert, Welvaart, Kievit (1993) and ended up with the Attitude Follow-Up Scale (AFS). Psychometrics: The psychometric properties of the Attitude Follow-Up Scale (AFS) are discussed in Stiggelbout, de Haes, & Vree et al. (1997). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.324

Eligibility Low Grade B Cell Lymphoma NCT01289210

- 06-07-20 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Criteria, Exclusion Criteria
VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01289210

Measurement Instrument Database for the Social Science (MIDSS) - The Caregiver Quality of Life Index-Cancer (CQOLC) scale

- 30-06-20 - 1 Formulier, 2 Itemgroepen, 37 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, CAREGIVER QUALITY OF LIFE- CANCER
M. A. Weitzner, P. B. Jacobsen, H. Wagner Jr., J. Friedland, C. Cox. (1996). The Caregiver Quality of Life Index-Cancer (CQOLC) scale. Measurement Instrument Database for the Social Science. Retrieved 30.06.2020, from www.midss.ie Key references: McMillan, S. C. (1996). Quality of life of primary caregivers of hospice patients with cancer. Cancer Pract;4:191-8. Weitzner, M. A., Jacobsen, P. B., Wagner, H., Friedland, J., & Cox, C. (1999). The Caregiver Quality of Life Index–Cancer (CQOLC) Scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Quality of Life Research, 8, 55–63. Zarit, S. H., Reever, K. E., Bach-Peterson, J. (1980). Relatives of the impaired elderly: correlates of feeling of burden. Gerontologist;20:649 -55. Primary use / Purpose: The Caregiver Quality of Life Index- Cancer (CQOLC) scale is a 35-item cancer-specific instrument that assesses the carer of a cancer patient's quality of life, that is, some of the physical, social, emotional, and financial aspects of well-being, and functioning. Background: A panoply of instruments measuring caregiver burden have been developed since Zarit, Reever, and Bach-Peterson's (1980) pioneering study investigating carer strain using the Zarit Burden interview. Yet, a dearth of studies exist for parsing the physical, emotional, social and financial well-being of the carer. McMillan (1996) designed a valid and reliable caregiver quality of life index to study such constructs in the partner of the patient. Later, Weitzner and colleagues (1999) modified this scale to serve as a well-being outcome measure specifically for carers of cancer patients. Psychometrics: The CQOLC possesses acceptable validity, test-retest reliability and internal consistency (see Weitzner, Jacobsen, Wagner, Friedland, & Cox, 1999). Other Information: Scoring instructions: items 4, 10, 12, 16, 22, 27, 28 and 34 on questionnaire should be reversed scored. Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.388

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information

- 23-06-20 - 1 Formulier, 16 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Administrative, Serious Adverse Event, Serious Adverse Event (SAE) - Section 1, Serious Adverse Event (SAE) - Section 2 (Seriousness), Serious Adverse Event (SAE) - Section 3 (Demography Data), Serious Adverse Event (SAE) - Section 4 (If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?), Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s)), Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions), Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors) , Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications) , Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s)), Was treatment blind broken at investigational site?, Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments), Serious Adverse Event (SAE) - Section 11 (Narrative Remarks) , Investigator’s signature, Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

- 23-06-20 - 1 Formulier, 5 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative, Study Conclusion, Pregnancy Information, Investigator Comment Log, Investigator's Signature
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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