Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Groupes Item: Administrative Data, Date of liver biopsy, Liver biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Hepatocytes, Hepatocyte Inclusions or Vacuoles, Hepatocyte Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Parasites or ova in liver biopsy, Histologic Staining of Liver Biopsy or Additional Studies Obtained

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is to be filled in if a liver biopsy is performed because of an Adverse Liver Event. There are seperate forms for general information on the liver event and for liver imaging (if performed).

Regensburg Insomnia Scale

- 11/02/2021 - 1 Formulaire, 1 Groupe Item, 12 Eléments de données, 2 Langues

Groupe Item: Regensburg Insomnia Scale

Derived from Table 1 from: Crönlein, T., Langguth, B., Popp, R., Lukesch, H., Pieh, C., Hajak, G., Geisler, P. (2013): Regensburg Insomnia Rating Scale (RIS): a new short rating scale for the assessment of psychological symptoms and sleep in insomnia; Study design: development and validation of a new short self-rating scale in a sample of 218 patients suffering from insomnia and 94 healthy controls. Health and Quality of Life Outcomes 2013, 11:65. Published with permission from PD Dr. Tatjana Crönlein. Questionnaire for the assessment of psychological symptoms and sleep parameters of primary insomnia. The questionnaire is particularly suitable for measuring therapeutic changes, for example of cognitive behavioural therapy for insomnia. It asks for cognitive and emotional aspects such as anxiety about sleep and measures the psychophysiological component of insomnia. It is suitable for use in people with insomnia and in people with comorbid or secondary insomnia. Indication: Persons suffering from (primary or secondary) insomnia. May be used for other sleeping disorders as well (see Pieh, C., Bach, M. Popp, R. Jara, C., Crönlein, T., Hajak, G., Geisler, P. (2012): Insomnia symptoms influence CPAP compliance. Sleep and Breathing; 17:99-104.) Purpose: Assessment of the expression of the psychophysiological component of insomnia Implementation and Analysis: Age: Validated on adults Use: The questionnaire contains written instructions. Appropriate answers are to be ticked. Time: 5 minutes The questionnaire contains 10 questions, the patient marks the appropriate numbers on a Likert scale (0 to 4). The Likert scale refers to the frequency of events asked within the previous four weeks. The answers are added up. - inconspicuous: 0 - 12 - conspicuous: 13-24 - marked: 25 – 40 Reliability (Crönlein et al., 2013): high internal consistency (Cronbach alpha 0.890). Validity: Validation of the questionnaire on a sample of 218 patients with a psychophysiological insomnia. Good selectivity to healthy controls. High concurrent validity with the Pittsburgh Sleep Quality Index (PSQI).

Eligibility Insomnia NCT01707706

- 21/04/2020 - 1 Formulaire, 2 Groupes Item, 17 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01707706

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - BDI

- 15/11/2019 - 1 Formulaire, 2 Groupes Item, 6 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Beck Depression Inventory

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record the results of the Beck Depression Index (BDI). To be collected at Visit 1 (Screening) and Visit 4.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - IVR Pre-Sleep and Post-Sleep Questionnaires

- 15/11/2019 - 1 Formulaire, 2 Groupes Item, 6 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Interactive Voice Response Pre- and Post-Sleep Questionnaire

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record the results of the IVR Pre- and Post-Sleep Questionnaires.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Bedtime Diary - Worksheet for Investigators

- 15/11/2019 - 1 Formulaire, 4 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Bedtime Diary, Bedtimes ordered, Median Habitual Bedtime Calculation

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to calculate the subject's median habitual bedtime from their bedtime diary, to decide when the investigational product is to be taken (60 minutes before habitual bedtime). This form is filled in at least 8 days after the Screening Visit (Visit 1), and before Visit 2.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Subject Bedtime Diary

- 14/11/2019 - 1 Formulaire, 2 Groupes Item, 6 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Bedtime Diary

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). In this form, the subjects record their lights-out time for seven days following the Screening Visit (Visit 1). There is a seperate form for the calculations performed on this data by the investigators.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent Withdrawal

- 14/11/2019 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Withdrawal of consent for Pharmacogenetic Research, DNA sample destruction

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record whether consent for PGx Pharmacogenetic Research has been withdrawn, and whether the sample was requested to be destroyed.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent

- 14/11/2019 - 1 Formulaire, 2 Groupes Item, 10 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Pharmacogenetic research consent

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record whether and when Informed Consent has been obtained for PGx Pharmacogenetic Research.

Mots-clés

Table des matières

Modèles de données sélectionnés

Eligibility Insomnia NCT02290496

dbGaP phs001253 Pharmacogenetics of Efavirenz Discontinuation for Reported CNS Symptoms - pht006163.v1.p1

pht006164.v1.p1

Eligibility

pht006165.v1.p1

pht006166.v1.p1

pht006167.v1.p1

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Logs/Repeats Vital Signs

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Liver Biopsy