Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 28 Data-elementen, 1 Taal

Itemgroepen: Pharmacogenetic Research, prior medication, baseline signs and symptoms

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Eligibility Perimenopausal Depression NCT00060736

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 20 Data-elementen, 1 Taal

Itemgroepen: Criteria, Exclusion Criteria

The Effects of Estrogen Withdrawal on Mood Symptoms in Women; ODM derived from: https://clinicaltrials.gov/show/NCT00060736

Eligibility Depression NCT00904917

- 17-09-21 - 1 Formulier, 5 Itemgroepen, 17 Data-elementen, 1 Taal

Itemgroepen: Criteria, Inclusion Criteria, Exclusion Criteria, Inclusion Criteria, Exclusion Criteria

Preventing Depression in the Children of Depressed African American Mothers; ODM derived from: https://clinicaltrials.gov/show/NCT00904917

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Screening

- 13-04-21 - 1 Formulier, 16 Itemgroepen, 103 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Demography, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Disease, Physical Examination, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, HIV Seropositivity, hepatitis b serology, hepatitis C serology test, Urine drug screening; Ethanol measurement, Serum pregnancy test (B-HCG), Eligibility Determination, Inclusion, Exclusion Criteria

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

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

Eligibility Unipolar Major Depressive Disorder NCT01875419

- 31-12-19 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Non-invasive Brain Stimulation and Cognitive Processing in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01875419

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Unscheduled

- 08-12-19 - 1 Formulier, 7 Itemgroepen, 45 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Study Conclusion

- 08-12-19 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Clinical Trials, Conclusion

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Investigator's Signature

- 08-12-19 - 1 Formulier, 2 Itemgroepen, 4 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Investigator Signature

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Investigator Comment Log

- 08-12-19 - 1 Formulier, 2 Itemgroepen, 3 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Clinical Investigators, Comment

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Pregnancy Information

- 08-12-19 - 1 Formulier, 2 Itemgroepen, 3 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Pregnancy, Information

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

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Serious Adverse Event (SAE)

- 08-12-19 - 1 Formulier, 13 Itemgroepen, 42 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Details, Serious Adverse Event, Diagnostic Procedure, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature

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

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