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dbGaP phs001346 Human Gene Expression Patterns Associated with Experimental P. falciparum Infection - Eligibility

- 11/03/2023 - 5 Formulaires, 1 Groupe Item, 43 Eléments de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Hernan A. Lorenzi, PhD, The J. Craig Venter Insititute, Rockville, MD, USA MeSH: Malaria,Malaria, Falciparum,Malaria Vaccines,Transcriptome,Gene Expression Profiling https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001346 Description: Experimental exposure to malaria parasites can lead to development of protective immunity, providing a foothold for the development of a malaria vaccine. The goal of this study is to investigate immune transcriptional profiles associated with malaria protective immune responses induced by experimental Chemo-Prophylaxis and Sporozoites (CPS) immunization of P. *falciparum*-naive human volunteers. Samples for this study were obtained from a CPS-immunization study conducted in 2011 (ClinicalTrials.gov Identifier: NCT01218893), where healthy volunteers received CPS-immunization with bites from different numbers of P. *falciparum*-infected mosquitoes (three times 15 (n=5), 10 (n=9) or 5 (n=10)). Five control subjects received uninfected mosquito bites under chloroquine prophylaxis. Fifteen weeks after discontinuation of chloroquine prophylaxis, all volunteers were challenged by exposure to infected mosquito bites. Study Design: A maximum of 30 volunteers were divided into four groups. All volunteers received weekly chloroquine prophylaxis for a period of 13 weeks (91 days). During these 13 weeks, on days 8, 36 and 64 they were exposed to the bites of 15 mosquitoes. Group 1 (n=5, positive control) received three CPS immunizations by 15 mosquitoes infected with P. falciparum sporozoites. Group 2 (n=10) received three times 10 bites from infected mosquitoes and 5 bites from uninfected mosquitoes. Group 3 (n=10) received three times 5 bites from infected mosquitoes and 10 bites from uninfected mosquitoes. Group 4 (n=5), the negative control, received three placebo immunizations with 15 bites of uninfected mosquitoes. Fifteen weeks after discontinuation of chloroquine prophylaxis, all 30 volunteers were challenged at day 196 by the bites of 5 infectious mosquitoes and followed for 21 days. All subjects were treated with chloroquine 21 days after challenge or whenever they had a positive thick smear during that period.

pht006254.v1.p1

1 Groupe Item 4 Eléments de données

pht006255.v1.p1

1 Groupe Item 5 Eléments de données

pht006256.v1.p1

1 Groupe Item 2 Eléments de données

pht006257.v1.p1

1 Groupe Item 10 Eléments de données

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

- 25/03/2020 - 1 Formulaire, 6 Groupes Item, 23 Eléments de données, 1 Langue
Groupes Item: ESR, PK Blood Sample - Point in Time Collection, Biomarker Samples , Transcriptomic Research Sample Collection Details , Liver Event Assessment , Investigational Product Discontinuation
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing

- 18/03/2020 - 1 Formulaire, 9 Groupes Item, 44 Eléments de données, 1 Langue
Groupes Item: Biomarker Samples, Pharmacogenetic Research Consent/ Blood Sample Collection, Transcriptomic Research Sample Collection Details, PK Blood Sample - Before Infusion, PK Blood Sample - End of Infusion, PK Type Code, Vital Signs, Investigational Product - IV Dosing, Total Volume of Infusion unit
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Investigator's Signature

- 18/12/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Investigator Signature
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 - Investigator's Signature

- 08/12/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: 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

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - CRB Electronic Signature Affidavit

- 03/11/2019 - 1 Formulaire, 1 Groupe Item, 3 Eléments de données, 1 Langue
Groupe Item: Investigator Signature
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Investigator's Signature

- 15/07/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Investigator Signature
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963 - Investigator's Signature

- 22/04/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Investigator Signature
Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Study Conclusion

- 06/03/2019 - 1 Formulaire, 3 Groupes Item, 8 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Conclusion, Clinical Research, Investigator Signature
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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