Pharmacy and Poisons Board: Applications

Protocol No.	Study Title	Principal Investigator(s)	Name of Site / County	Pages	Clear
Application Submission Dates-to- clear!

#	Protocol No	Study Title	Investigator(s) & Site(s)
11.	ECCT/24/10/02	user abstract 123	Principal Investigator(s) 1. Irene Peterson Melinda Farrell Marah Bush Site(s) in Kenya 1. Harriet Battle (Kirinyaga county)	View
12.	ECCT/25/01/09- KPCTYn	Virunex-3 Trial for Novacov-24 A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus	Principal Investigator(s) 1. Hiroko Lewis Tatyana Medina Castor Gallagher Site(s) in Kenya 1. Ahmed Trujillo (Vihiga county)	View
13.	ECCT/24/06/04	study 4 Evaluating the Impact of Telemedicine on Postoperative Recovery in Cardiac Surgery Patients: A Multi-Center Prospective Study	Principal Investigator(s) 1. Javan Ayoma Site(s) in Kenya test site2	View
14.	ECCT/24/06/05	Study 3 Efficacy and Safety of Novel Immunotherapy in Treating Advanced Melanoma: A Randomized Controlled Tria	Principal Investigator(s) 1. Javan Ayoma Site(s) in Kenya Site1	View
15.	ECCT/24/06/02	Cancer Genomics Investigating Genetic Markers for Predicting Cancer Treatment Response	Principal Investigator(s) 1. Javan Ayoma Site(s) in Kenya 1. Afya Medical Center (Nairobi City county) 2. Upendo Hospital (Mombasa county) 3. Tumaini Medical Center (Kisumu county) 4. Salama Clinic (Kericho county)	View

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====
Session
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Session
- Config(array)
  userAgent9c3d2c89526db53b7b69e8c9faa06145
  time1756477540
  countdown10
====
Request
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Request

Cake Params
- plugin(null)
- controllerapplications
- actionindex
- named(array)
  page3
- pass(empty)
- isAjax(false)
- paging(array)
  Application(array)
  page3
  current5
  count22
  prevPage(true)
  nextPage(true)
  pageCount5
  order(array)
  Application.createddesc
  limit5
  options(array)
  page3
  paramTypenamed
Post data
- Application(empty)
Query string

No querystring data.

Cookie

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Current Route
- keys(array)
  0controller
  1action
- options(empty)
- defaults(array)
  plugin(null)
- template/:controller/:action/*
====

Sql Logs

default

Total Time: 4 ms
Total Queries: 12 queries

Query	Affected	Num. rows	Took (ms)	Actions
SELECT `Application`.`id`, `Application`.`user_id`, `Application`.`application_id`, `Application`.`is_child`, `Application`.`trial_status_id`, `Application`.`total_sites`, `Application`.`abstract_of_study`, `Application`.`study_title`, `Application`.`laymans_summary`, `Application`.`short_title`, `Application`.`protocol_no`, `Application`.`reference_no`, `Application`.`version_no`, `Application`.`date_of_protocol`, `Application`.`study_drug`, `Application`.`disease_condition`, `Application`.`product_type_biologicals`, `Application`.`product_type_proteins`, `Application`.`product_type_immunologicals`, `Application`.`product_type_vaccines`, `Application`.`product_type_hormones`, `Application`.`product_type_toxoid`, `Application`.`product_type_chemical`, `Application`.`product_type_medical_device`, `Application`.`product_type_chemical_name`, `Application`.`product_type_medical_device_name`, `Application`.`comparator`, `Application`.`comparator_name`, `Application`.`comparator_registered`, `Application`.`comparator_countries`, `Application`.`ecct_not_applicable`, `Application`.`ecct_ref_number`, `Application`.`email_address`, `Application`.`applicant_covering_letter`, `Application`.`applicant_protocol`, `Application`.`applicant_patient_information`, `Application`.`applicant_investigators_brochure`, `Application`.`applicant_investigators_cv`, `Application`.`applicant_signed_declaration`, `Application`.`applicant_financial_declaration`, `Application`.`applicant_gmp_certificate`, `Application`.`applicant_indemnity_cover`, `Application`.`applicant_opinion_letter`, `Application`.`applicant_approval_letter`, `Application`.`applicant_statement`, `Application`.`applicant_participating_countries`, `Application`.`applicant_addendum`, `Application`.`applicant_fees`, `Application`.`applicant_complete_form`, `Application`.`applicant_impd`, `Application`.`applicant_prev_data`, `Application`.`applicant_stability_data`, `Application`.`applicant_analysis_cert`, `Application`.`applicant_pictorial_sample`, `Application`.`applicant_gcp_training`, `Application`.`applicant_dsmb_charter`, `Application`.`applicant_detailed_budget`, `Application`.`applicant_indemnity_pi`, `Application`.`applicant_practice_license`, `Application`.`applicant_registration_ctr`, `Application`.`applicant_pan_african`, `Application`.`applicant_hard_copies`, `Application`.`applicant_signed_checklist`, `Application`.`statistical_analysis_plan`, `Application`.`applicant_contractual_agreement`, `Application`.`declaration_applicant`, `Application`.`declaration_date1`, `Application`.`declaration_principal_investigator`, `Application`.`declaration_date2`, `Application`.`placebo_present`, `Application`.`study_objectives`, `Application`.`principal_inclusion_criteria`, `Application`.`principal_exclusion_criteria`, `Application`.`primary_end_points`, `Application`.`scope_diagnosis`, `Application`.`scope_prophylaxis`, `Application`.`scope_therapy`, `Application`.`scope_safety`, `Application`.`scope_efficacy`, `Application`.`scope_pharmacokinetic`, `Application`.`scope_pharmacodynamic`, `Application`.`scope_bioequivalence`, `Application`.`scope_dose_response`, `Application`.`scope_pharmacogenetic`, `Application`.`scope_pharmacogenomic`, `Application`.`scope_pharmacoecomomic`, `Application`.`scope_others`, `Application`.`scope_others_specify`, `Application`.`trial_human_pharmacology`, `Application`.`trial_administration_humans`, `Application`.`trial_bioequivalence_study`, `Application`.`trial_other`, `Application`.`trial_other_specify`, `Application`.`trial_therapeutic_exploratory`, `Application`.`trial_therapeutic_confirmatory`, `Application`.`trial_therapeutic_use`, `Application`.`design_controlled`, `Application`.`site_capacity`, `Application`.`staff_numbers`, `Application`.`other_details_explanation`, `Application`.`other_details_regulatory_notapproved`, `Application`.`other_details_regulatory_approved`, `Application`.`other_details_regulatory_rejected`, `Application`.`other_details_regulatory_halted`, `Application`.`estimated_duration`, `Application`.`design_controlled_randomised`, `Application`.`design_controlled_open`, `Application`.`design_controlled_single_blind`, `Application`.`design_controlled_double_blind`, `Application`.`design_controlled_parallel_group`, `Application`.`design_controlled_cross_over`, `Application`.`design_controlled_other`, `Application`.`design_controlled_specify`, `Application`.`design_controlled_comparator`, `Application`.`design_controlled_other_medicinal`, `Application`.`design_controlled_placebo`, `Application`.`design_controlled_medicinal_other`, `Application`.`design_controlled_medicinal_specify`, `Application`.`single_site_member_state`, `Application`.`location_of_area`, `Application`.`single_site_physical_address`, `Application`.`single_site_contact_person`, `Application`.`single_site_telephone`, `Application`.`multiple_sites_member_state`, `Application`.`multiple_countries`, `Application`.`multiple_member_states`, `Application`.`number_of_sites`, `Application`.`multi_country_list`, `Application`.`data_monitoring_committee`, `Application`.`total_enrolment_per_site`, `Application`.`total_participants_worldwide`, `Application`.`population_less_than_18_years`, `Application`.`population_utero`, `Application`.`population_preterm_newborn`, `Application`.`population_newborn`, `Application`.`population_infant_and_toddler`, `Application`.`population_children`, `Application`.`population_adolescent`, `Application`.`population_above_18`, `Application`.`population_adult`, `Application`.`population_elderly`, `Application`.`gender_female`, `Application`.`gender_male`, `Application`.`subjects_healthy`, `Application`.`subjects_patients`, `Application`.`subjects_vulnerable_populations`, `Application`.`subjects_women_child_bearing`, `Application`.`subjects_women_using_contraception`, `Application`.`subjects_pregnant_women`, `Application`.`subjects_nursing_women`, `Application`.`subjects_emergency_situation`, `Application`.`subjects_incapable_consent`, `Application`.`subjects_specify`, `Application`.`subjects_others`, `Application`.`subjects_others_specify`, `Application`.`investigator1_given_name`, `Application`.`investigator1_middle_name`, `Application`.`investigator1_family_name`, `Application`.`investigator1_qualification`, `Application`.`investigator1_professional_address`, `Application`.`investigator1_telephone`, `Application`.`investigator1_email`, `Application`.`organisations_transferred_`, `Application`.`number_participants`, `Application`.`notification`, `Application`.`approval_date`, `Application`.`submitted`, `Application`.`deleted`, `Application`.`deleted_date`, `Application`.`deactivated`, `Application`.`date_submitted`, `Application`.`unsubmitted`, `Application`.`initial_date_submitted`, `Application`.`admin_stopped`, `Application`.`admin_stopped_reason`, `Application`.`approved`, `Application`.`approved_reason`, `Application`.`approved_date`, `Application`.`final_report`, `Application`.`implication_results`, `Application`.`quantity_imported`, `Application`.`quantity_dispensed`, `Application`.`quantity_destroyed`, `Application`.`quantity_exported`, `Application`.`balance_site`, `Application`.`final_date`, `Application`.`ecitizen_invoice`, `Application`.`modified`, `Application`.`created` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`submitted` = '1' AND `Application`.`approved` = 2 AND `Application`.`deactivated` = '0' AND `Application`.`deleted` = '0' ORDER BY `Application`.`created` desc LIMIT 10, 5	5	5	2	maybe slow
SELECT `InvestigatorContact`.`id`, `InvestigatorContact`.`application_id`, `InvestigatorContact`.`given_name`, `InvestigatorContact`.`middle_name`, `InvestigatorContact`.`family_name`, `InvestigatorContact`.`qualification`, `InvestigatorContact`.`professional_address`, `InvestigatorContact`.`telephone`, `InvestigatorContact`.`email`, `InvestigatorContact`.`created`, `InvestigatorContact`.`modified` FROM `ctr`.`investigator_contacts` AS `InvestigatorContact` WHERE `InvestigatorContact`.`application_id` IN (120, 118, 99, 98, 86)	5	5	1	maybe slow
SELECT `SiteDetail`.`id`, `SiteDetail`.`application_id`, `SiteDetail`.`county_id`, `SiteDetail`.`site_name`, `SiteDetail`.`physical_address`, `SiteDetail`.`contact_details`, `SiteDetail`.`contact_person`, `SiteDetail`.`site_capacity`, `SiteDetail`.`misc`, `SiteDetail`.`created`, `SiteDetail`.`modified` FROM `ctr`.`site_details` AS `SiteDetail` WHERE `SiteDetail`.`application_id` IN (120, 118, 99, 98, 86)	8	8	1	maybe slow
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 47	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 1	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 42	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 35	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 20	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 38	1	1	0
SELECT `Sponsor`.`id`, `Sponsor`.`application_id`, `Sponsor`.`sponsor`, `Sponsor`.`sponsor_type`, `Sponsor`.`contact_person`, `Sponsor`.`address`, `Sponsor`.`telephone_number`, `Sponsor`.`fax_number`, `Sponsor`.`cell_number`, `Sponsor`.`email_address`, `Sponsor`.`created`, `Sponsor`.`modified` FROM `ctr`.`sponsors` AS `Sponsor` WHERE `Sponsor`.`application_id` IN (120, 118, 99, 98, 86)	5	5	0
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`submitted` = '1' AND `Application`.`approved` = 2 AND `Application`.`deactivated` = '0' AND `Application`.`deleted` = '0'	1	1	0
SELECT `TrialStatus`.`id`, `TrialStatus`.`name` FROM `ctr`.`trial_statuses` AS `TrialStatus` WHERE 1 = 1	11	11	0

Query Explain:

Click an "Explain" link above, to see the query explanation.

====

Timer

Memory

Peak Memory Use 6.36 MB

Message	Memory use
Component initialization	2.41 MB
Controller action start	3.59 MB
Controller render start	4.57 MB
View render complete	5.05 MB

Timers

Total Request Time: 152 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	86.47
Event: Controller.initialize	0.31
Event: Controller.startup	0.60
Controller action	35.17
Event: Controller.beforeRender	4.60
» Processing toolbar data	4.50
Rendering View	9.80
» Event: View.beforeRender	0.03
» Rendering APP/View/Applications/index.ctp	0.40
» » Rendering APP/View/Elements/google-recommend.ctp	0.11
» Rendering APP/View/Elements/application/public_index.ctp	6.76
» Event: View.afterRender	0.02
» Event: View.beforeLayout	0.02
» Rendering APP/View/Layouts/default.ctp	2.16
» » Rendering APP/View/Elements/google-analytics.ctp	0.05
Event: View.afterLayout	0.00

====

Log
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Logs

There were no log entries made this request

====
Variables
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View Variables
- trial_statuses(array)
 1Recruiting
 2Not yet recruiting
 3Suspended
 4Stopped
 5Completed
 6In follow-up
 7Analysing
 8Writing-up
 9Application withdrawn
 10Paused or preparation for extension of study
 11Revoked
- applications(array)
 0(array)
 Application(array)
 id120
 user_id82
 application_id(null)
 is_child0
 trial_status_id(null)
 total_sites1
 abstract_of_study\n studyabstract\n
 study_title\n abstract 123\n
 laymans_summary\n layman\n
 short_titleuser
 protocol_noECCT/24/10/02
 reference_no(null)
 version_no2
 date_of_protocol09-10-2024
 study_drugstudydrug
 disease_conditionmalaria
 product_type_biologicals1
 product_type_proteins1
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical0
 product_type_medical_device0
 product_type_chemical_name
 product_type_medical_device_name
 comparatorNo
 comparator_name
 comparator_registered
 comparator_countries
 ecct_not_applicable0
 ecct_ref_number
 email_addresslchepkwony@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantDeleniti et autem ea omnis
 declaration_date104-05-2023
 declaration_principal_investigatorQuaerat aspernatur consequatur non voluptas inventore ad officiis do consequatur voluptates enim asperiores minim illum
 declaration_date218-01-2014
 placebo_presentYes
 study_objectives\n objective\n
 principal_inclusion_criteria\n inclusion\n
 principal_exclusion_criteria\n exclusion\n
 primary_end_points\n end point\n
 scope_diagnosis1
 scope_prophylaxis1
 scope_therapy0
 scope_safety1
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence1
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic1
 scope_others1
 scope_others_specifySit ut lorem ut vel
 trial_human_pharmacology1
 trial_administration_humans0
 trial_bioequivalence_study1
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory0
 trial_therapeutic_use1
 design_controlledYes
 site_capacity(null)
 staff_numbers\n 1234\n
 other_details_explanation\n explained\n
 other_details_regulatory_notapproved\n reg\n
 other_details_regulatory_approved\n reg\n
 other_details_regulatory_rejected\n reg\n
 other_details_regulatory_halted
 estimated_durationEsse ducimus possimus aut architecto esse in dolor illum tempor cillum
 design_controlled_randomisedNo
 design_controlled_openNo
 design_controlled_single_blindNo
 design_controlled_double_blindNo
 design_controlled_parallel_groupNo
 design_controlled_cross_overNo
 design_controlled_otherYes
 design_controlled_specifyNeque deserunt nostrud minima aut sed enim veniam odit assumenda officia
 design_controlled_comparatorRepellendus Sed temporib
 design_controlled_other_medicinalYes
 design_controlled_placeboYes
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states772
 number_of_sites961
 multi_country_listDelectus suscipit e
 data_monitoring_committeeNo
 total_enrolment_per_siteDolor sint animi er
 total_participants_worldwideCorrupti laudantium similique cupiditate nostrum rerum est vero laborum adipisicing
 population_less_than_18_yearsYes
 population_uteroNo
 population_preterm_newbornNo
 population_newbornYes
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentYes
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male0
 subjects_healthyNo
 subjects_patientsNo
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenNo
 subjects_nursing_womenYes
 subjects_emergency_situationYes
 subjects_incapable_consentYes
 subjects_specifyVoluptatum perspicia
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameBrent Mcknight
 investigator1_middle_nameNicole Gross
 investigator1_family_nameCharles Crane
 investigator1_qualificationId adipisci commodo repellendus Dolor enim iste et quam deserunt id ut ullamco
 investigator1_professional_addressQuia eius aut adipisicing rerum aut ad tempora necessitatibus cumque nisi at
 investigator1_telephone+1 (795) 542-5315
 investigator1_emaildudahabewy@mailinator.com
 organisations_transferred_No
 number_participantsVoluptatem ut nisi e
 notification
 approval_date19-11-2024
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted23-10-2024
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reasonApproved Here successfully
 approved_date(null)
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 ecitizen_invoice324112
 modified2024-11-19 16:25:21
 created2024-10-17 12:04:18
 InvestigatorContact(array)
 0(array)
 id72
 application_id120
 given_nameIrene Peterson
 middle_nameMelinda Farrell
 family_nameMarah Bush
 qualificationId ipsa qui obcaecati sit iste eu reiciendis pariatur Possimus temporibus consequatur et culpa ad tenetur iusto inventore nihil labore
 professional_addressCorporis ut quo libero ut ullam error
 telephone+1 (524) 915-1935
 emailpypamyhezu@mailinator.com
 created2024-10-17 12:49:37
 modified2024-10-23 15:04:34
 SiteDetail(array)
 0(array)
 id1704
 application_id120
 county_id20
 site_nameHarriet Battle
 physical_addressQuae nulla sunt culpa beatae fugiat dolor quae labore similique in quae dignissimos a tempore ut tempore
 contact_detailsP.O. Box 5325
 contact_personNisi eum dolorem fugiat ullam dolore nemo laudantium aut autem natus similique numquam deserunt omnis quod officia
 site_capacity(null)
 misc(null)
 created2024-10-17 12:49:37
 modified2024-10-23 15:04:34
 County(array)
 id20
 county_nameKirinyaga
 created2012-06-15 10:24:22
 modified2012-06-15 10:24:22
 Sponsor(array)
 0(array)
 id29
 application_id120
 sponsorFuga Aut qui est consequatur consectetur dolorem qui blanditiis saepe natus maiores ea repellendus Velit quia ullamco
 sponsor_typeResearch Institution
 contact_personNon corrupti reiciendis placeat elit aut voluptatibus optio labore excepteur
 addressConsectetur ut ipsum quia quos magni
 telephone_number+1 (367) 517-6326
 fax_number+1 (961) 772-5694
 cell_number+1 (895) 885-1686
 email_addressrimumaxy@mailinator.com
 created2024-10-17 12:49:37
 modified2024-10-23 15:04:34
 1(array)
 Application(array)
 id118
 user_id29
 application_id(null)
 is_child0
 trial_status_id7
 total_sites5
 abstract_of_study\n Background: The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.\n\n Objective: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Virunex-3, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.\n\n Methods: A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either Virunex-3 (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.\n\n Expected Outcomes: The study aims to determine whether Virunex-3 can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.\n\n Conclusion: By assessing both the effectiveness and safety of Virunex-3, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.\n
 study_title\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 laymans_summary\n This study is designed to test a new antiviral medication called Virunex-3 to see if it can help people recover faster from an illness caused by a newly identified virus called Novacov-24. Participants in the study will either receive Virunex-3 or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if Virunex-3 can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.\n
 short_titleVirunex-3 Trial for Novacov-24
 protocol_noECCT/25/01/09- KPCTYn
 reference_no1234redwsqa
 version_nov1
 date_of_protocol01-01-2025
 study_drugVirunex-3
 disease_conditionNovacov-24 Virus Infection
 product_type_biologicals1
 product_type_proteins0
 product_type_immunologicals1
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical0
 product_type_medical_device0
 product_type_chemical_name
 product_type_medical_device_name
 comparatorNo
 comparator_name
 comparator_registered
 comparator_countries
 ecct_not_applicable0
 ecct_ref_number
 email_addressjkiprotich@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
 declaration_date110-01-2025
 declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
 declaration_date209-01-2025
 placebo_presentYes
 study_objectives\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 principal_inclusion_criteria\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 principal_exclusion_criteria\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 primary_end_points\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 scope_diagnosis1
 scope_prophylaxis0
 scope_therapy0
 scope_safety0
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic1
 scope_bioequivalence0
 scope_dose_response1
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic1
 scope_others1
 scope_others_specifyIn odit voluptate fu
 trial_human_pharmacology0
 trial_administration_humans1
 trial_bioequivalence_study0
 trial_other1
 trial_other_specifyVoluptas veniam ut
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use1
 design_controlledYes
 site_capacity(null)
 staff_numbers\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 other_details_explanation\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 other_details_regulatory_notapproved\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 other_details_regulatory_approved\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus\n
 other_details_regulatory_rejected
 other_details_regulatory_halted
 estimated_durationTempore id architecto quaerat ad vel
 design_controlled_randomisedNo
 design_controlled_openYes
 design_controlled_single_blindNo
 design_controlled_double_blindYes
 design_controlled_parallel_groupNo
 design_controlled_cross_overYes
 design_controlled_otherYes
 design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
 design_controlled_comparatorAut qui perspiciatis rei
 design_controlled_other_medicinalNo
 design_controlled_placeboNo
 design_controlled_medicinal_otherYes
 design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states668
 number_of_sites9
 multi_country_listAdipisicing et numqu
 data_monitoring_committeeYes
 total_enrolment_per_siteVitae voluptatem se
 total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
 population_less_than_18_yearsYes
 population_uteroYes
 population_preterm_newbornYes
 population_newbornYes
 population_infant_and_toddlerNo
 population_childrenYes
 population_adolescentNo
 population_above_18Yes
 population_adultNo
 population_elderlyNo
 gender_female1
 gender_male0
 subjects_healthyNo
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenNo
 subjects_nursing_womenYes
 subjects_emergency_situationNo
 subjects_incapable_consentYes
 subjects_specifyId tempora omnis vol
 subjects_othersYes
 subjects_others_specifyUllam laborum Eos
 investigator1_given_nameIlliana Ferguson
 investigator1_middle_nameAllen Fox
 investigator1_family_nameYolanda Rivera
 investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
 investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
 investigator1_telephone+1 (621) 831-1153
 investigator1_emailqeryrilu@mailinator.com
 organisations_transferred_Yes
 number_participantsMinim dolor commodo
 notification
 approval_date13-01-2025
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted07-01-2025
 unsubmitted1
 initial_date_submitted07-01-2025
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 approved_reasonThis is approved
 approved_date(null)
 final_report(null)
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 quantity_imported(null)
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 InvestigatorContact(array)
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 id87
 application_id118
 given_nameHiroko Lewis
 middle_nameTatyana Medina
 family_nameCastor Gallagher
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 professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
 telephone+1 (322) 766-3057
 emailtipyhuqo@mailinator.com
 created2025-01-13 12:13:08
 modified2025-02-06 10:49:58
 SiteDetail(array)
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 application_id118
 county_id38
 site_nameAhmed Trujillo
 physical_addressDolorum dolores necessitatibus minus magna quo velit eveniet temporibus accusantium eveniet maxime reprehenderit consectetur ipsum ea aut
 contact_detailsP.O. Box 10
 contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
 site_capacity(null)
 misc(null)
 created2025-01-13 12:13:08
 modified2025-02-06 10:49:58
 County(array)
 id38
 county_nameVihiga
 created2012-06-15 10:26:37
 modified2012-06-15 10:26:37
 Sponsor(array)
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 application_id118
 sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
 sponsor_typeLocal Kenyan Investigator
 contact_personDolorem mollitia id quis provident error voluptatem voluptate
 addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
 telephone_number+1 (666) 325-1183
 fax_number+1 (314) 248-5575
 cell_number+1 (134) 102-6236
 email_addresstuhokelyh@mailinator.com
 created2025-01-13 12:13:08
 modified2025-02-06 10:49:58
 2(array)
 Application(array)
 id99
 user_id26
 application_id(null)
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 total_sites1
 abstract_of_study\n This prospective multi-center study aims to evaluate the impact of telemedicine on postoperative recovery in patients who have undergone cardiac surgery. A total of 500 patients from five major hospitals will be enrolled and monitored for six months post-surgery. Participants will be divided into two groups: one receiving traditional in-person follow-up care, and the other receiving regular telemedicine consultations. Primary outcomes include readmission rates, complication rates, and patient satisfaction. Secondary outcomes focus on recovery time and healthcare costs. Initial findings indicate that telemedicine may enhance patient outcomes by providing timely medical advice and reducing the need for hospital visits. This study will contribute to understanding the role of telemedicine in improving postoperative care for cardiac surgery patients.\n
 study_title\n Evaluating the Impact of Telemedicine on Postoperative Recovery in Cardiac Surgery Patients: A Multi-Center Prospective Study\n
 laymans_summary\n This research looks at how using telemedicine (video calls with doctors) affects recovery after heart surgery. By studying patients from multiple hospitals, the researchers aim to see if virtual follow-ups can help patients heal better and faster compared to traditional in-person visits.\n
 short_titlestudy 4
 protocol_noECCT/24/06/04
 reference_no(null)
 version_no1.0
 date_of_protocol20-06-2024
 study_drugCanagliflozin
 disease_conditionType 2 Diabetes Mellitus
 product_type_biologicals1
 product_type_proteins1
 product_type_immunologicals0
 product_type_vaccines1
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameCanagliflozin
 product_type_medical_device_name
 comparatorNo
 comparator_name
 comparator_registered
 comparator_countries
 ecct_not_applicable0
 ecct_ref_number
 email_addressjayoma@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantJames McCurrly
 declaration_date120-06-2024
 declaration_principal_investigatorPI Inv
 declaration_date220-06-2024
 placebo_presentNo
 study_objectives<ul>\n <li>\n \n Primary Objective:\n <ul>\n <li>\n To investigate the effect of canagliflozin on glycemic control, measured by changes in HbA1c levels, in patients with type 2 diabetes mellitus over a 24-week treatment period.</li>\n </ul>\n </li>\n <li>\n \n Secondary Objective:\n <ul>\n <li>\n To assess changes in body weight, blood pressure, and lipid profile in patients treated with canagliflozin.</li>\n <li>\n To evaluate the safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus.</li>\n <li>\n To explore patient-reported outcomes related to quality of life and treatment satisfaction with canagliflozin therapy.</li>\n </ul>\n </li>\n</ul>\n
 principal_inclusion_criteria<ul>\n <li>\n \n Type 2 Diabetes Mellitus diagnosis:\n <ul>\n <li>\n Patients must have a documented diagnosis of type 2 diabetes mellitus.</li>\n </ul>\n </li>\n <li>\n \n Inadequate glycemic control:\n <ul>\n <li>\n Patients must have inadequate glycemic control defined as HbA1c levels between 7.5% and 10.5% despite treatment with stable doses of metformin alone or in combination with other oral antidiabetic agents</li>\n </ul>\n </li>\n</ul>\n
 principal_exclusion_criteria<ul>\n <li>\n \n Renal impairment:\n <ul>\n <li>\n Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis are excluded.</li>\n </ul>\n </li>\n <li>\n \n Cardiovascular events:\n <ul>\n <li>\n Patients with a history of recent cardiovascular events such as myocardial infarction, stroke, or unstable angina within the past 3 months are excluded.</li>\n </ul>\n </li>\n</ul>\n
 primary_end_points<ul>\n <li>\n \n Primary Endpoint 1: Change in HbA1c Levels\n <ul>\n <li>\n The primary endpoint is the change in HbA1c levels from baseline to week 24 in patients treated with canagliflozin compared to placebo or standard treatment. HbA1c reflects average blood glucose levels over the past 2-3 months and is a key measure of glycemic control in diabetes.</li>\n </ul>\n </li>\n <li>\n \n Primary Endpoint 2: Incidence of Adverse Cardiovascular Events\n <ul>\n <li>\n Another primary endpoint is the incidence of adverse cardiovascular events (e.g., myocardial infarction, stroke, cardiovascular death) during the treatment period with canagliflozin compared to placebo or standard treatment. This endpoint assesses the cardiovascular safety profile of canagliflozin in patients with type 2 diabetes mellitus.</li>\n </ul>\n </li>\n</ul>\n
 scope_diagnosis1
 scope_prophylaxis0
 scope_therapy1
 scope_safety0
 scope_efficacy1
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use0
 design_controlledNo
 site_capacity(null)
 staff_numbers\n Capacity of Site:\n<ul>\n <li>\n Leading academic medical center with extensive research capabilities.</li>\n</ul>\n\n Number of Staff and Facilities:\n<ul>\n <li>\n \n Study Coordinators:\n <ul>\n <li>\n Laura Marie Smith, MD, FACP (Coordinating Investigator)</li>\n <li>\n John William Davies, PharmD (Pharmacist)</li>\n </ul>\n </li>\n <li>\n \n Other Staff:\n <ul>\n <li>\n Specialists in endocrinology, diabetes, and metabolism.</li>\n <li>\n Research nurses, clinical trial coordinators.</li>\n </ul>\n </li>\n <li>\n \n Site Facilities:\n <ul>\n <li>\n Advanced laboratories for research.</li>\n <li>\n Comprehensive patient care facilities.</li>\n <li>\n High-tech diagnostic and treatment equipment.</li>\n </ul>\n </li>\n <li>\n \n Emergency Facilities:\n <ul>\n <li>\n Level I trauma center.</li>\n <li>\n Rapid response teams and critical care capabilities.</li>\n </ul>\n </li>\n</ul>\n
 other_details_explanation<ol>\n <li>\n <ul>\n <li>\n Kenya has a significant prevalence of type 2 diabetes mellitus, providing a suitable patient population for studying the efficacy and safety of canagliflozin. This ensures adequate enrollment of eligible participants.</li>\n </ul>\n </li>\n <li>\n \n Ethnic Diversity and Genetic Variability:\n <ul>\n <li>\n The ethnic diversity in Kenya offers an opportunity to study the response to canagliflozin across different genetic backgrounds. Understanding genetic variability can provide insights into personalized treatment approaches.</li>\n </ul>\n </li>\n</ol>\n\n \n
 other_details_regulatory_notapproved\n Name of Regulatory Authorities:\n<ul>\n <li>\n MHRA (Medicines and Healthcare products Regulatory Agency), UK</li>\n <li>\n TGA (Therapeutic Goods Administration), Australia</li>\n</ul>\n\n Date(s) of Application:\n<ul>\n <li>\n MHRA: March 10, 2024</li>\n <li>\n TGA: April 5, 2024</li>\n</ul>\n
 other_details_regulatory_approved<ul>\n <li>\n \n MHRA (Medicines and Healthcare products Regulatory Agency), UK\n <ul>\n <li>\n Date of Approval: April 20, 2024</li>\n <li>\n Number of Sites per Country:\n <ul>\n <li>\n UK: 12 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n TGA (Therapeutic Goods Administration), Australia\n <ul>\n <li>\n Date of Approval: May 5, 2024</li>\n <li>\n Number of Sites per Country:\n <ul>\n <li>\n Australia: 8 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n</ul>\n
 other_details_regulatory_rejected\n N/A\n
 other_details_regulatory_halted\n N/A\n
 estimated_duration24 months
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_stateYes
 location_of_areatest site2
 single_site_physical_addressTEST
 single_site_contact_personJoel Justin
 single_site_telephone+254709283746
 multiple_sites_member_stateNo
 multiple_countriesNo
 multiple_member_states
 number_of_sites
 multi_country_list
 data_monitoring_committeeYes
 total_enrolment_per_site200000
 total_participants_worldwide20000000
 population_less_than_18_yearsYes
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerYes
 population_childrenYes
 population_adolescentYes
 population_above_18Yes
 population_adultYes
 population_elderlyYes
 gender_female1
 gender_male0
 subjects_healthyNo
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingYes
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenYes
 subjects_nursing_womenYes
 subjects_emergency_situationYes
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameMichael
 investigator1_middle_name
 investigator1_family_nameThompson
 investigator1_qualificationMD, MPH
 investigator1_professional_addressDepartment of Medicine University of Texas MD Anderson Cancer Center 1515 Holcombe Blvd Houston, TX 77030 United States
 investigator1_telephone +1 713-792-2121
 investigator1_emailmathompson@mdanderson.org
 organisations_transferred_No
 number_participants2000000
 notification\n N/A\n
 approval_date20-06-2024
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted20-06-2024
 unsubmitted1
 initial_date_submitted20-06-2024
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reason
 approved_date(null)
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 ecitizen_invoice305957
 modified2025-02-18 09:09:35
 created2024-06-20 10:44:12
 InvestigatorContact(array)
 0(array)
 id54
 application_id99
 given_nameJavan
 middle_name
 family_nameAyoma
 qualificationMasters
 professional_addressMsc Drive
 telephone+254702674563
 emailjayoma@intellisoftkenya.com
 created2024-06-20 10:44:12
 modified2024-11-15 11:23:43
 SiteDetail(array)
 0(array)
 id1700
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 site_name
 physical_address
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 created2024-06-20 10:55:03
 modified2024-11-15 11:23:43
 County(empty)
 Sponsor(array)
 0(array)
 id22
 application_id99
 sponsorBioPharma Innovations Ltd.
 sponsor_typeIndustry
 contact_person
 addressBioPharma Innovations Ltd. 123 Main Street San Francisco, CA 94105 United States
 telephone_number+1 415-555-6789
 fax_number
 cell_number+1 415-555-6778
 email_addressinfo@biopharmainnovations.com
 created2024-06-20 10:55:03
 modified2024-11-15 11:23:43
 3(array)
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 abstract_of_study\n This randomized controlled trial investigates the efficacy and safety of a novel immunotherapy in patients with advanced melanoma. A total of 300 participants will be randomly assigned to receive either the new immunotherapy or a standard treatment. The primary outcome measures include overall survival rate, progression-free survival, and incidence of adverse events over a 24-month period. Secondary outcomes will assess quality of life and biomarker responses. Preliminary data suggests that the new therapy may improve survival rates with manageable side effects. This study aims to provide robust evidence on the potential benefits and risks of this innovative treatment, potentially offering a new standard of care for advanced melanoma patients.\n\n \n
 study_title\n Efficacy and Safety of Novel Immunotherapy in Treating Advanced Melanoma: A Randomized Controlled Tria\n
 laymans_summary\n This study tests a new treatment for advanced skin cancer (melanoma). Researchers are checking if this new therapy is both effective and safe. They are comparing it to other treatments by giving it to some patients and not others, then seeing how well it works and if there are any side effects.\n
 short_titleStudy 3
 protocol_noECCT/24/06/05
 reference_no(null)
 version_no1.2
 date_of_protocol20-06-2024
 study_drugNivolumab
 disease_condition Non-Small Cell Lung Cancer (NSCLC)
 product_type_biologicals1
 product_type_proteins1
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_name Nivolumab
 product_type_medical_device_name
 comparatorNo
 comparator_name
 comparator_registered
 comparator_countries
 ecct_not_applicable0
 ecct_ref_number
 email_addressjayoma@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantJospeh McCathy
 declaration_date120-06-2024
 declaration_principal_investigatorPI Inv
 declaration_date220-06-2024
 placebo_presentYes
 study_objectives<ol>\n <li>\n \n Primary Objective:\n <ul>\n <li>\n To compare the overall survival (OS) of patients with advanced melanoma treated with nivolumab versus standard-of-care chemotherapy.</li>\n </ul>\n </li>\n <li>\n \n Secondary Objective:\n <ul>\n <li>\n To assess the progression-free survival (PFS) in patients receiving nivolumab compared to those receiving standard chemotherapy.</li>\n <li>\n To evaluate the safety profile and incidence of adverse events associated with nivolumab treatment.</li>\n <li>\n To explore biomarkers that may predict response to nivolumab therapy in advanced melanoma patients.</li>\n </ul>\n </li>\n</ol>\n<h3>\n </h3>\n
 principal_inclusion_criteria<ul>\n <li>\n \n Histologically confirmed diagnosis of advanced melanoma:\n <ul>\n <li>\n Patients must have histologically confirmed unresectable stage III or stage IV melanoma.</li>\n </ul>\n </li>\n <li>\n \n Prior treatment history:\n <ul>\n <li>\n Patients must have received prior treatment with a BRAF inhibitor (if BRAF V600 mutation positive) or have progressed on or after anti-PD-1/L1 therapy.</li>\n </ul>\n </li>\n</ul>\n
 principal_exclusion_criteria<ol>\n <li>\n \n Autoimmune disease:\n <ul>\n <li>\n Patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) requiring systemic treatment within the past 2 years are excluded.</li>\n </ul>\n </li>\n <li>\n \n Active brain metastases:\n <ul>\n <li>\n Patients with untreated or symptomatic brain metastases are excluded unless they have completed local therapy and are neurologically stable without corticosteroid treatment for at least 4 weeks.</li>\n </ul>\n </li>\n</ol>\n
 primary_end_points<ul>\n <li>\n \n Primary Endpoint 1: Overall Survival (OS)\n <ul>\n <li>\n The primary endpoint is the comparison of overall survival between patients treated with nivolumab and those receiving standard chemotherapy. OS is defined as the time from randomization until death from any cause.</li>\n </ul>\n </li>\n <li>\n \n Primary Endpoint 2: Progression-Free Survival (PFS)\n <ul>\n <li>\n Another primary endpoint is the comparison of progression-free survival between the nivolumab and standard chemotherapy groups. PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.</li>\n </ul>\n </li>\n</ul>\n
 scope_diagnosis0
 scope_prophylaxis1
 scope_therapy0
 scope_safety0
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence1
 scope_dose_response1
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory0
 trial_therapeutic_use1
 design_controlledYes
 site_capacity(null)
 staff_numbers\n Capacity of Site:\n<ul>\n <li>\n Specializes in oncology research and treatment.</li>\n <li>\n Large capacity for clinical trials with dedicated research units.</li>\n</ul>\n\n Number of Staff and Facilities:\n<ul>\n <li>\n \n Study Coordinators:\n <ul>\n <li>\n Sarah Elizabeth Johnson, MD, PhD (Coordinating Investigator)</li>\n <li>\n Emily Jane Carter, PharmD (Pharmacist)</li>\n </ul>\n </li>\n <li>\n \n Other Staff:\n <ul>\n <li>\n Oncologists, nurses, research assistants with experience in oncology.</li>\n </ul>\n </li>\n <li>\n \n Site Facilities:\n <ul>\n <li>\n State-of-the-art research labs.</li>\n <li>\n Dedicated infusion centers.</li>\n <li>\n Imaging facilities (MRI, CT scans).</li>\n <li>\n Patient monitoring and emergency response systems.</li>\n </ul>\n </li>\n <li>\n \n Emergency Facilities:\n <ul>\n <li>\n Close proximity to emergency departments within the hospital.</li>\n <li>\n Dedicated emergency response teams for clinical trials.</li>\n </ul>\n </li>\n</ul>\n
 other_details_explanation\n Reasons for Conducting the Trial in Kenya:\n<ol>\n <li>\n \n Access to Diverse Patient Population:\n <ul>\n <li>\n Kenya offers access to a diverse population of patients with advanced melanoma who may have different genetic backgrounds and disease characteristics compared to the host country of the sponsor. This diversity enhances the generalizability of study findings.</li>\n </ul>\n </li>\n <li>\n \n Clinical Trial Infrastructure:\n <ul>\n <li>\n Kenya has established clinical trial infrastructure, including research centers and experienced healthcare professionals, capable of conducting oncology trials. This infrastructure supports efficient patient recruitment and trial execution.</li>\n </ul>\n </li>\n</ol>\n<h3>\n </h3>\n
 other_details_regulatory_notapproved\n Name of Regulatory Authorities:\n<ul>\n <li>\n FDA (Food and Drug Administration), USA</li>\n <li>\n EMA (European Medicines Agency), EU</li>\n</ul>\n\n Date(s) of Application:\n<ul>\n <li>\n FDA: January 15, 2024</li>\n <li>\n EMA: February 1, 2024</li>\n</ul>\n<h3>\n </h3>\n
 other_details_regulatory_approved<ul>\n <li>\n \n FDA (Food and Drug Administration), USA\n <ul>\n <li>\n Date of Approval: May 15, 2024</li>\n <li>\n Number of Sites per Country:\n <ul>\n <li>\n USA: 25 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n EMA (European Medicines Agency), EU\n <ul>\n <li>\n Date of Approval: June 1, 2024</li>\n <li>\n Number of Sites per Country:\n <ul>\n <li>\n Germany: 15 sites</li>\n <li>\n France: 10 sites</li>\n <li>\n Spain: 8 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n</ul>\n
 other_details_regulatory_rejected\n N/A\n
 other_details_regulatory_halted\n N/A\n
 estimated_duration36months
 design_controlled_randomisedYes
 design_controlled_openYes
 design_controlled_single_blindNo
 design_controlled_double_blindNo
 design_controlled_parallel_groupYes
 design_controlled_cross_overYes
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorcomparator1
 design_controlled_other_medicinalNo
 design_controlled_placeboYes
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateYes
 location_of_areaSite1
 single_site_physical_addressadmin site
 single_site_contact_personTest
 single_site_telephone+254790192
 multiple_sites_member_stateNo
 multiple_countriesNo
 multiple_member_states
 number_of_sites
 multi_country_list
 data_monitoring_committeeYes
 total_enrolment_per_site200000
 total_participants_worldwide200000000
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyYes
 gender_female0
 gender_male1
 subjects_healthyNo
 subjects_patientsNo
 subjects_vulnerable_populationsNo
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionNo
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameSarah
 investigator1_middle_name
 investigator1_family_nameJohnson
 investigator1_qualificationMD, PhD
 investigator1_professional_addressDepartment of Oncology Memorial Sloan Kettering Cancer Center 1275 York Avenue New York, NY 10065 United States
 investigator1_telephone+1 212-639-2000
 investigator1_emailsjohnson@mskcc.org
 organisations_transferred_Yes
 number_participants200000
 notification\n NA\n
 approval_date20-06-2024
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted20-06-2024
 unsubmitted1
 initial_date_submitted20-06-2024
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reason
 approved_date(null)
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 ecitizen_invoice305955
 modified2024-07-16 10:06:14
 created2024-06-20 10:32:00
 InvestigatorContact(array)
 0(array)
 id53
 application_id98
 given_nameJavan
 middle_name
 family_nameAyoma
 qualificationMasters
 professional_addressMsc
 telephone+254702674563
 emailjayoma@intellisoftkenya.com
 created2024-06-20 10:32:00
 modified2024-06-25 08:51:45
 SiteDetail(array)
 0(array)
 id1701
 application_id98
 county_id(null)
 site_name
 physical_address
 contact_details
 contact_person
 site_capacity(null)
 misc(null)
 created2024-06-20 10:55:30
 modified2024-06-25 08:51:45
 County(empty)
 Sponsor(array)
 0(array)
 id23
 application_id98
 sponsorBioPharma Innovations Ltd.
 sponsor_typeIndustry
 contact_person
 addressBioPharma Innovations Ltd. 123 Main Street San Francisco, CA 94105 United States
 telephone_number+1 415-555-6789
 fax_number
 cell_number+1 415-555-6778
 email_addressinfo@biopharmainnovations.com
 created2024-06-20 10:55:30
 modified2024-06-25 08:51:45
 4(array)
 Application(array)
 id86
 user_id26
 application_id(null)
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 total_sites4
 abstract_of_study\n Background\n<div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"6bad6573-5683-44dc-898f-edbdad90c62b\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n \n Cancer treatment efficacy varies significantly among patients, often due to genetic differences in tumor cells. Identifying genetic markers that predict treatment response can enhance personalized medicine approaches, leading to improved outcomes and reduced adverse effects.\n <h4>\n Objective</h4>\n \n This study aims to investigate genetic markers that can predict the response to cancer treatments. By analyzing the genetic profiles of tumors from a diverse patient cohort, we seek to identify patterns associated with favorable or unfavorable treatment outcomes.\n <h4>\n Methods</h4>\n \n We will conduct a genome-wide association study (GWAS) using tumor samples from patients undergoing various cancer therapies. High-throughput sequencing technologies will be employed to identify genetic variants. Bioinformatics tools will analyze the correlation between these genetic variants and treatment responses, including chemotherapy, targeted therapy, and immunotherapy. Multivariate analysis will control for potential confounders such as age, sex, cancer type, and stage.\n <h4>\n Results</h4>\n \n Preliminary data suggest the presence of specific genetic markers associated with treatment efficacy and resistance. Identifying these markers will allow us to develop predictive models for clinical use.\n <h4>\n Conclusion</h4>\n \n Understanding genetic markers that predict cancer treatment response has the potential to revolutionize cancer care by facilitating personalized treatment plans. This study aims to contribute to the growing field of precision oncology, ultimately improving patient outcomes and quality of life.\n <h4>\n Keywords</h4>\n \n Cancer genomics, genetic markers, treatment response, personalized medicine, genome-wide association study, precision oncology.\n </div>\n </div>\n </div>\n</div>\n\n \n
 study_title\n Investigating Genetic Markers for Predicting Cancer Treatment Response\n
 laymans_summary\n Cancer treatment can be highly effective for some patients but less so for others. This difference in treatment response often depends on unique genetic factors within each person's cancer cells. Our study aims to identify specific genetic markers that can predict how well a patient will respond to different cancer treatments.\n<div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"3a341212-4d02-48e4-a41c-b522ac742f4c\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n \n By examining the DNA of cancer cells from a diverse group of patients, we hope to find patterns that indicate whether a particular treatment is likely to be successful. Understanding these genetic markers will help doctors choose the most effective therapy for each individual, leading to better outcomes and fewer side effects.\n \n Ultimately, our goal is to move towards more personalized cancer care, where treatments are tailored to the genetic makeup of each patient's cancer, improving the chances of successful treatment and recovery.\n </div>\n </div>\n </div>\n</div>\n\n \n
 short_titleCancer Genomics
 protocol_noECCT/24/06/02
 reference_no(null)
 version_no1.0
 date_of_protocol11-06-2024
 study_drugGenomirix
 disease_conditionCancer
 product_type_biologicals1
 product_type_proteins1
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device1
 product_type_chemical_name4-(2-(4-Methylpiperazin-1-yl)ethyl)-N-(4-(trifluoromethyl)phenyl)pyridine-2-carboxamide
 product_type_medical_device_nameGeneMark Analyzer
 comparatorYes
 comparator_nameOncoraGen
 comparator_registeredYes
 comparator_countriesUnited States\nCanada\nUnited Kingdom\nGermany\nFrance\nJapan\nAustralia\nSouth Korea\nBrazil\n
 ecct_not_applicable0
 ecct_ref_number
 email_addressjayoma@intellisoftkenya.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries(null)
 applicant_addendum1
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd1
 applicant_prev_data1
 applicant_stability_data1
 applicant_analysis_cert1
 applicant_pictorial_sample1
 applicant_gcp_training1
 applicant_dsmb_charter1
 applicant_detailed_budget1
 applicant_indemnity_pi1
 applicant_practice_license1
 applicant_registration_ctr(null)
 applicant_pan_african1
 applicant_hard_copies(null)
 applicant_signed_checklist1
 statistical_analysis_plan1
 applicant_contractual_agreement1
 declaration_applicantJavan Ayoma
 declaration_date111-06-2024
 declaration_principal_investigatorECR
 declaration_date211-06-2024
 placebo_presentNo
 study_objectives<ol>\n <li>\n To evaluate the safety and efficacy of a new medication in reducing blood pressure in patients with hypertension.</li>\n <li>\n To compare the effectiveness of two different treatment regimens for managing symptoms of depression in adults.</li>\n <li>\n To assess the long-term outcomes of a surgical procedure for patients with advanced stage cancer.</li>\n <li>\n To investigate the impact of a lifestyle intervention program on weight loss and cardiovascular health in overweight individuals.</li>\n <li>\n To determine the optimal dosage of a novel drug in treating acute pain following surgery.</li>\n <li>\n To examine the effects of a dietary supplement on cognitive function in older adults with mild cognitive impairment.</li>\n <li>\n To explore the feasibility of a telemedicine intervention in improving access to mental health services for rural populations.</li>\n <li>\n To investigate the efficacy of a behavioral therapy in reducing symptoms of anxiety disorders in adolescents.</li>\n <li>\n To assess the safety and tolerability of a new vaccine candidate in preventing infections in children.</li>\n <li>\n To evaluate the impact of a physical activity intervention on quality of life and functional outcomes in patients with chronic pain conditions.</li>\n</ol>\n
 principal_inclusion_criteria<ol>\n <li>\n Age between 18 and 65 years.</li>\n <li>\n Diagnosis of type 2 diabetes mellitus.</li>\n <li>\n Body mass index (BMI) between 25 and 40 kg/m^2.</li>\n <li>\n Histologically confirmed diagnosis of breast cancer.</li>\n <li>\n Presence of moderate to severe symptoms of depression as assessed by a standardized questionnaire.</li>\n <li>\n Documented history of hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.</li>\n <li>\n Diagnosis of Alzheimer's disease according to established clinical criteria.</li>\n <li>\n Previously untreated stage III non-small cell lung cancer.</li>\n <li>\n Willingness to comply with study procedures and follow-up visits.</li>\n <li>\n Written informed consent provided by the participant or legally authorized representative.</li>\n</ol>\n
 principal_exclusion_criteria<ul>\n <li>\n Known allergy or hypersensitivity to the investigational drug or any of its components.</li>\n <li>\n History of significant cardiovascular disease, including myocardial infarction or stroke within the past 6 months.</li>\n <li>\n Presence of a severe psychiatric disorder that could affect the participant's ability to comply with study procedures.</li>\n <li>\n Use of concomitant medications that are contraindicated with the investigational drug.</li>\n <li>\n Pregnancy or breastfeeding.</li>\n <li>\n Active substance abuse or dependence within the past 12 months.</li>\n <li>\n Participation in another clinical trial within the past 30 days.</li>\n <li>\n Known history of human immunodeficiency virus (HIV) infection or hepatitis B or C.</li>\n <li>\n Uncontrolled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.</li>\n <li>\n Significant renal or hepatic impairment as determined by laboratory tests.</li>\n</ul>\n
 primary_end_points<ol>\n <li>\n Change in mean systolic blood pressure from baseline to week 12.</li>\n <li>\n Percentage change in tumor size as assessed by imaging studies after 6 months of treatment.</li>\n <li>\n Time to recurrence of depressive symptoms as measured by a standardized depression rating scale.</li>\n <li>\n Overall survival at 2 years post-randomization.</li>\n <li>\n Proportion of participants achieving glycemic control (HbA1c < 7%) after 6 months of treatment.</li>\n <li>\n Improvement in cognitive function as measured by a validated cognitive assessment tool at week 24.</li>\n <li>\n Rate of adverse events leading to treatment discontinuation within the first 3 months of therapy.</li>\n <li>\n Change in mean pain intensity scores from baseline to week 8 as assessed by a visual analog scale.</li>\n <li>\n Proportion of participants achieving a 50% reduction in seizure frequency compared to baseline after 12 weeks of treatment.</li>\n <li>\n Change in mean forced expiratory volume in 1 second (FEV1) from baseline to week 26 in patients with chronic obstructive pulmonary disease (COPD).</li>\n</ol>\n
 scope_diagnosis1
 scope_prophylaxis0
 scope_therapy0
 scope_safety0
 scope_efficacy1
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic1
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans1
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory1
 trial_therapeutic_confirmatory0
 trial_therapeutic_use0
 design_controlledNo
 site_capacity(null)
 staff_numbers<div class=\"flex-1 overflow-hidden\">\n <div class=\"react-scroll-to-bottom--css-wpwpj-79elbk h-full\">\n <div class=\"react-scroll-to-bottom--css-wpwpj-1n7m0yu\">\n <div class=\"flex flex-col text-sm\">\n <div class=\"w-full text-token-text-primary\" data-scroll-anchor=\"true\" data-testid=\"conversation-turn-35\" dir=\"auto\">\n <div class=\"py-2 juice:py-[18px] px-3 text-base md:px-4 m-auto md:px-5 lg:px-1 xl:px-5\">\n <div class=\"mx-auto flex flex-1 gap-3 text-base juice:gap-4 juice:md:gap-5 juice:lg:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]\">\n <div class=\"group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn\">\n <div class=\"flex-col gap-1 md:gap-3\">\n <div class=\"flex flex-grow flex-col max-w-full\">\n <div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2\" data-message-author-role=\"assistant\" data-message-id=\"99efe10e-e141-4373-acd9-b177540b4a00\" dir=\"auto\">\n <div class=\"flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]\">\n <div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n <h3>\n Site 1: Afya Medical Center</h3>\n <ul>\n <li>\n Capacity of Site:\n <ul>\n <li>\n Outpatient Clinic: 20 patients per hour</li>\n <li>\n Inpatient Beds: 50 beds</li>\n </ul>\n </li>\n <li>\n Number of Staff: 30\n <ul>\n <li>\n Dr. Esther Mwangi - Medical Director - MD, MPH, 10 years of experience</li>\n <li>\n Nurse Jane Wanjiku - Head Nurse - BScN, 7 years of experience</li>\n <li>\n Pharmacist David Kimani - PharmD, 5 years of experience</li>\n <li>\n Lab Technician Mary Achieng - BSc in Medical Laboratory Science, 3 years of experience</li>\n <li>\n Study Coordinator Grace Njeri - BSc in Clinical Research, 2 years of experience</li>\n </ul>\n </li>\n <li>\n Facilities: Fully equipped outpatient clinic, laboratory, pharmacy, inpatient wards, emergency room</li>\n <li>\n Emergency Facilities: Fully equipped emergency room with resuscitation equipment and trained staff</li>\n <li>\n Other Relevant Infrastructure: Dedicated research wing for clinical trials, including separate study rooms and monitoring facilities.</li>\n </ul>\n <h3>\n Site 2: Upendo Hospital</h3>\n <ul>\n <li>\n Capacity of Site:\n <ul>\n <li>\n Outpatient Clinic: 25 patients per hour</li>\n <li>\n Inpatient Beds: 70 beds</li>\n </ul>\n </li>\n <li>\n Number of Staff: 40\n <ul>\n <li>\n Dr. Kevin Maina - Medical Director - MBChB, MPH, 12 years of experience</li>\n <li>\n Nurse Sarah Kinya - Head Nurse - BScN, 8 years of experience</li>\n <li>\n Pharmacist James Ogutu - PharmD, 6 years of experience</li>\n <li>\n Lab Technician Mercy Wangari - BSc in Medical Laboratory Science, 4 years of experience</li>\n <li>\n Study Coordinator Peter Kamau - BSc in Clinical Research, 3 years of experience</li>\n </ul>\n </li>\n <li>\n Facilities: Comprehensive outpatient and inpatient facilities, including surgery theaters, radiology department, pharmacy, laboratory.</li>\n <li>\n Emergency Facilities: Dedicated emergency department with trauma center and intensive care unit.</li>\n <li>\n Other Relevant Infrastructure: On-site research department with dedicated study rooms and conference facilities.</li>\n </ul>\n <h3>\n Site 3: Tumaini Medical Center</h3>\n <ul>\n <li>\n Capacity of Site:\n <ul>\n <li>\n Outpatient Clinic: 30 patients per hour</li>\n <li>\n Inpatient Beds: 60 beds</li>\n </ul>\n </li>\n <li>\n Number of Staff: 35\n <ul>\n <li>\n Dr. Faith Njoroge - Medical Director - MBChB, MPH, 11 years of experience</li>\n <li>\n Nurse Peter Otieno - Head Nurse - BScN, 9 years of experience</li>\n <li>\n Pharmacist Grace Wambui - PharmD, 7 years of experience</li>\n <li>\n Lab Technician John Mwangi - BSc in Medical Laboratory Science, 5 years of experience</li>\n <li>\n Study Coordinator Susan Auma - BSc in Clinical Research, 4 years of experience</li>\n </ul>\n </li>\n <li>\n Facilities: Modern outpatient department, fully equipped laboratory, pharmacy, comfortable inpatient wards.</li>\n <li>\n Emergency Facilities: Well-equipped emergency room with 24/7 availability.</li>\n <li>\n Other Relevant Infrastructure: Dedicated research wing with state-of-the-art equipment for clinical trials and data collection.</li>\n </ul>\n <h3>\n Site 4: Salama Clinic</h3>\n <ul>\n <li>\n Capacity of Site:\n <ul>\n <li>\n Outpatient Clinic: 15 patients per hour</li>\n <li>\n Inpatient Beds: 40 beds</li>\n </ul>\n </li>\n <li>\n Number of Staff: 25\n <ul>\n <li>\n Dr. Grace Nyambura - Medical Director - MBChB, MPH, 9 years of experience</li>\n <li>\n Nurse David Gitau - Head Nurse - BScN, 6 years of experience</li>\n <li>\n Pharmacist Mary Njeri - PharmD, 4 years of experience</li>\n <li>\n Lab Technician Mercy Chepkoech - BSc in Medical Laboratory Science, 3 years of experience</li>\n <li>\n Study Coordinator Paul Ochieng - BSc in Clinical Research, 2 years of experience</li>\n </ul>\n </li>\n <li>\n Facilities: Well-equipped outpatient department, pharmacy, laboratory, and comfortable inpatient wards.</li>\n <li>\n Emergency Facilities: Dedicated emergency room with basic resuscitation equipment and trained staff.</li>\n <li>\n Other Relevant Infrastructure: Limited research facilities, but capable of conducting basic clinical research and data collection.</li>\n </ul>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n\n \n
 other_details_explanation<ul>\n <li>\n \n Population Diversity: Kenya offers a diverse population with varying genetic backgrounds and lifestyles, which may provide valuable insights into the generalizability of study findings across different populations.\n </li>\n <li>\n \n Access to Patients: Kenya may have a higher prevalence of the target disease or condition, providing easier access to eligible participants for the clinical trial.\n </li>\n <li>\n \n Infrastructure and Expertise: Kenya has established research institutions, hospitals, and clinics with experienced healthcare professionals and researchers capable of conducting high-quality clinical trials.\n </li>\n <li>\n \n Regulatory Environment: Kenya's regulatory framework for clinical trials may be favorable or offer expedited approval processes, making it an attractive location for conducting research.\n </li>\n <li>\n \n Ethical Considerations: Kenya may have specific ethical guidelines or cultural considerations that align with the study objectives, ensuring that research is conducted in an ethical and culturally sensitive manner.\n </li>\n <li>\n \n Cost Considerations: Conducting clinical trials in Kenya may be more cost-effective compared to the host country, due to lower operational costs and potentially faster recruitment timelines.\n </li>\n</ul>\n
 other_details_regulatory_notapproved<ol>\n <li>\n \n Kenyan Pharmacy and Poisons Board (PPB)\n <ul>\n <li>\n Date of Application: March 15, 2024</li>\n </ul>\n </li>\n <li>\n \n South African Health Products Regulatory Authority (SAHPRA)\n <ul>\n <li>\n Date of Application: April 10, 2024</li>\n </ul>\n </li>\n <li>\n \n Uganda National Drug Authority (NDA)\n <ul>\n <li>\n Date of Application: May 5, 2024</li>\n </ul>\n </li>\n <li>\n \n Tanzania Medicines and Medical Devices Authority (TMDA)\n <ul>\n <li>\n Date of Application: June 1, 2024</li>\n </ul>\n </li>\n <li>\n \n Nigerian National Agency for Food and Drug Administration and Control (NAFDAC)\n <ul>\n <li>\n Date of Application: July 3, 2024</li>\n </ul>\n </li>\n</ol>\n
 other_details_regulatory_approved<ul>\n <li>\n \n United States Food and Drug Administration (FDA)\n <ul>\n <li>\n Date of Approval: January 20, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n United States: 10 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n European Medicines Agency (EMA)\n <ul>\n <li>\n Date of Approval: February 5, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n United Kingdom: 5 sites</li>\n <li>\n Germany: 3 sites</li>\n <li>\n France: 2 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n Canadian Health Products and Food Branch (HPFB)\n <ul>\n <li>\n Date of Approval: March 1, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Canada: 4 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n Australian Therapeutic Goods Administration (TGA)\n <ul>\n <li>\n Date of Approval: March 15, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Australia: 3 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n \n Brazilian Health Regulatory Agency (ANVISA)\n <ul>\n <li>\n Date of Approval: April 10, 2024</li>\n <li>\n Number of Sites:\n <ul>\n <li>\n Brazil: 2 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n</ul>\n
 other_details_regulatory_rejected\n N/A\n
 other_details_regulatory_halted\n N/A\n
 estimated_duration18 Months
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states4
 number_of_sites4
 multi_country_listChina\nIndia\nBraizil\nRussia \nUSA
 data_monitoring_committeeYes
 total_enrolment_per_site22500
 total_participants_worldwide30000000
 population_less_than_18_yearsYes
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentYes
 population_above_18Yes
 population_adultYes
 population_elderlyYes
 gender_female1
 gender_male1
 subjects_healthyYes
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingYes
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenYes
 subjects_nursing_womenYes
 subjects_emergency_situationYes
 subjects_incapable_consentYes
 subjects_specifychildren aged 13-17years
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameDr. Jane
 investigator1_middle_name
 investigator1_family_nameKamau
 investigator1_qualificationMD, PhD
 investigator1_professional_addressKenya Medical Research Institute (KEMRI) Clinical Research Center 123 Research Avenue Nairobi, Kenya
 investigator1_telephone+254 123 456 789
 investigator1_emailjkamau@kemri.go.ke
 organisations_transferred_No
 number_participants45000
 notification\n N/A\n
 approval_date21-06-2024
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted11-06-2024
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reasontest
 approved_date(null)
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 ecitizen_invoice304493
 modified2024-06-21 06:55:17
 created2024-06-11 03:54:24
 InvestigatorContact(array)
 0(array)
 id41
 application_id86
 given_nameJavan
 middle_name
 family_nameAyoma
 qualificationMasters
 professional_addressMs Drive
 telephone+254702674563
 emailjayoma@intellisoftkenya.com
 created2024-06-11 03:54:24
 modified2024-06-11 09:01:24
 SiteDetail(array)
 0(array)
 id1670
 application_id86
 county_id47
 site_name Afya Medical Center
 physical_address123 Daktari Road, Nairobi, Kenya
 contact_detailsTelephone Number: +254 701 234 567 P.O. Box: 10100-12345, Nairobi, Kenya
 contact_person Dr. Esther Mwangi
 site_capacity(null)
 misc(null)
 created2024-06-11 04:05:15
 modified2024-06-11 09:01:24
 County(array)
 id47
 county_nameNairobi City
 created2012-06-15 10:27:40
 modified2012-06-15 10:27:40
 1(array)
 id1671
 application_id86
 county_id1
 site_nameUpendo Hospital
 physical_address456 Afya Street, Mombasa, Kenya
 contact_detailsTelephone Number: +254 702 345 678 P.O. Box: 80100-45678, Mombasa, Kenya
 contact_personMr. Kevin Maina
 site_capacity(null)
 misc(null)
 created2024-06-11 04:26:59
 modified2024-06-11 09:01:24
 County(array)
 id1
 county_nameMombasa
 created2012-05-31 16:15:11
 modified2012-07-09 13:06:23
 2(array)
 id1672
 application_id86
 county_id42
 site_nameTumaini Medical Center
 physical_address789 Matibabu Drive, Kisumu, Kenya
 contact_detailsTelephone Number: +254 703 456 789 P.O. Box: 40100-78901, Kisumu, Kenya
 contact_personDr. Faith Njoroge
 site_capacity(null)
 misc(null)
 created2024-06-11 04:26:59
 modified2024-06-11 09:01:24
 County(array)
 id42
 county_nameKisumu
 created2012-06-15 10:27:02
 modified2012-06-15 10:27:02
 3(array)
 id1673
 application_id86
 county_id35
 site_nameSalama Clinic
 physical_address101 Jibu Avenue, Nakuru, Kenya
 contact_detailsTelephone Number: +254 704 567 890 P.O. Box: 20100-10101, Nakuru, Kenya
 contact_personMs. Grace Nyambura
 site_capacity(null)
 misc(null)
 created2024-06-11 04:26:59
 modified2024-06-11 09:01:24
 County(array)
 id35
 county_nameKericho
 created2012-06-15 10:26:16
 modified2012-06-15 10:26:16
 Sponsor(array)
 0(array)
 id18
 application_id86
 sponsorGenoPharmaceuticals Inc.
 sponsor_typeIndustry
 contact_personMr. John Smith
 address789 Pharma Avenue, MedTech City, State, ZIP
 telephone_number+1 (800) 555-1234
 fax_number+1 (800) 555-5678
 cell_number+1 (800) 555-9012
 email_addressinfo@genopharmaceuticals.com
 created2024-06-11 04:05:15
 modified2024-06-11 09:01:24
- page_options(array)
 55
 1010
- redir
- $request->data(array)
 Application(empty)
- $this->validationErrors(array)
 Permission(empty)
 Aro(empty)
 Aco(empty)
 Application(empty)
 User(empty)
 TrialStatus(empty)
 InvestigatorContact(empty)
 Sponsor(empty)
 SiteDetail(empty)
 County(empty)
- Loaded Helpers(array)
 0Html
 1Form
 2Session
 3Text
 4Number
 5SimpleGraph
 6Paginator
 7DebugTimer
 8Toolbar
 9HtmlToolbar
====

Environment

App Constants

Constant	Value
MEDIA	'/var/www/ctr/app/webroot/media/'
MEDIA_STATIC	'/var/www/ctr/app/webroot/media/static/'
MEDIA_FILTER	'/var/www/ctr/app/webroot/media/filter/'
MEDIA_TRANSFER	'/var/www/ctr/app/webroot/media/transfer/'
MEDIA_URL	'media/'
MEDIA_STATIC_URL	'media/static/'
MEDIA_FILTER_URL	'media/filter/'
MEDIA_TRANSFER_URL	'media/transfer/'
HTTP_HOST	'45.79.161.190:8080'
HTTP_BASE	'http://45.79.161.190:8080'
HTTP_SELF	'/app/webroot/index.php'
HTTP_URI	'/applications/index/page:3'
CHOWN_PUBLIC	(int) 504
LF	''
NL	''
CR	''
TB	''
BR	' '
WINDOWS	false
FORMAT_DB_DATETIME	'Y-m-d H:i:s'
FORMAT_DB_DATE	'Y-m-d'
FORMAT_DB_TIME	'H:i:s'
DEFAULT_DATETIME	'0000-00-00 00:00:00'
DEFAULT_DATE	'0000-00-00'
DEFAULT_TIME	'00:00:00'
FILES	'/var/www/ctr/app/files/'
LOCALE	'/var/www/ctr/app/locale/'
CLASS_USER	'User'
VALID_ALPHA	'/^[a-zA-Z]+$/'
VALID_ALPHA_UNDERSCORES	'/^[a-zA-Z_]+$/'
VALID_ALPHA_MINUS_UNDERSCORES	'/^[a-zA-Z_-]+$/'
VALID_ALPHA_WHITESPACES	'/^[a-zA-Z ]+$/'
VALID_ALPHANUMERIC_UNDERSCORES	'/^[\da-zA-Z_]+$/'
VALID_ALPHANUMERIC_MINUS_UNDERSCORES	'/^[\da-zA-Z_-]+$/'
VALID_ALPHANUMERIC_WHITESPACES	'/^[\da-zA-Z ]+$/'
VALID_ALPHANUMERIC_WHITESPACES_UNDERSCORES	'/^[\da-zA-Z _]+$/'
VALID_NUMERIC_UNDERSCORES	'/^[\d_]+$/'
VALID_NUMERIC_WHITESPACES	'/^[\d ]+$/'
VALID_NUMERIC_WHITESPACES_UNDERSCORES	'/^[\d _]+$/'
VALID_INTEGERS	'/^[\d]+$/'
FORMAT_NICE_YMDHMS	'd.m.Y, H:i:s'
FORMAT_NICE_YMDHM	'd.m.Y, H:i'
FORMAT_NICE_YM	'm.Y'
FORMAT_NICE_YMD	'd.m.Y'
FORMAT_NICE_MD	'd.m.'
FORMAT_NICE_D	'd'
FORMAT_NICE_W_NUM	'w'
FORMAT_NICE_W_ABBR	'D'
FORMAT_NICE_W_FULL	'l'
FORMAT_NICE_M	'm'
FORMAT_NICE_M_ABBR	'M'
FORMAT_NICE_M_FULL	'F'
FORMAT_NICE_Y_ABBR	'y'
FORMAT_NICE_Y	'Y'
FORMAT_NICE_HM	'H:i'
FORMAT_NICE_HMS	'H:i:s'
FORMAT_LOCAL_WA_YMDHMS	'%a, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WF_YMDHMS	'%A, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WA_YMDHM	'%a, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_WF_YMDHM	'%A, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMDHMS	'%d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_YMDHM	'%d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMD	'%d.%m.%Y'
FORMAT_LOCAL_MD	'%d.%m.'
FORMAT_LOCAL_D	'%d'
FORMAT_LOCAL_W_NUM	'%w'
FORMAT_LOCAL_W_ABBR	'%a'
FORMAT_LOCAL_W_FULL	'%A'
FORMAT_LOCAL_M	'%m'
FORMAT_LOCAL_M_ABBR	'%b'
FORMAT_LOCAL_M_FULL	'%B'
FORMAT_LOCAL_Y_ABBR	'%y'
FORMAT_LOCAL_YMS_ABBR	'%d.%m.%y'
FORMAT_LOCAL_Y	'%Y'
FORMAT_LOCAL_H	'%H'
FORMAT_LOCAL_S	'%S'
FORMAT_LOCAL_HM	'%H:%M'
FORMAT_LOCAL_HMS	'%H:%M:%S'
CHAR_LESS	'<'
CHAR_GREATER	'>'
CHAR_QUOTE	'"'
CHAR_APOSTROPHE	'''
CHAR_ARROWS	'»'
CHAR_ARROWS_R	'»'
CHAR_ARROWS_L	'«'
CHAR_AVERAGE	'Ø'
CHAR_INFIN	'∞'
CHAR_MILL	'‰'
CHAR_PLUSMN	'±'
CHAR_HELLIP	'…'
CHAR_CIRCA	'≈'
CHAR_CHECKBOX_EMPTY	'☐]'
CHAR_CHECKBOX_MAKRED	'☑'
CHAR_CHECKMARK	'✓'
CHAR_CHECKMARK_BOLD	'✔'
CHAR_BALLOT	'✗'
CHAR_BALLOT_BOLD	'✘'
CHAR_ABOUT	'≈'
CHAR_RPIME	'′'
CHAR_DOUBLE_RPIME	'″'

CakePHP Constants

Constant	Value
APP	'/var/www/ctr/app/'
APP_DIR	'app'
APPLIBS	'/var/www/ctr/app/Lib/'
CACHE	'/var/www/ctr/app/tmp/cache/'
CAKE	'/var/www/ctr/lib/Cake/'
CAKE_CORE_INCLUDE_PATH	'/var/www/ctr/lib'
CORE_PATH	'/var/www/ctr/lib/'
CAKE_VERSION	'2.2.2'
CSS	'/var/www/ctr/app/webroot/css/'
CSS_URL	'css/'
DS	'/'
FULL_BASE_URL	'http://45.79.161.190:8080'
IMAGES	'/var/www/ctr/app/webroot/img/'
IMAGES_URL	'img/'
JS	'/var/www/ctr/app/webroot/js/'
JS_URL	'js/'
LOGS	'/var/www/ctr/app/tmp/logs/'
ROOT	'/var/www/ctr'
TESTS	'/var/www/ctr/app/Test/'
TMP	'/var/www/ctr/app/tmp/'
VENDORS	'/var/www/ctr/vendors/'
WEBROOT_DIR	'webroot'
WWW_ROOT	'/var/www/ctr/app/webroot/'

PHP Environment

Environment Variable	Value
Php Version	'5.6.40-63+ubuntu18.04.1+deb.sury.org+2'
Redirect Redirect Status	'200'
Redirect Status	'200'
Http Accept	'/'
Http User Agent	'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)'
Http Cookie	'CAKEPHP=9g8c4ucdjca036qruq180sqop3'
Http Accept Encoding	'gzip, br, zstd, deflate'
Http Host	'45.79.161.190:8080'
Http Via	'1.1 squid-proxy-5b5d847c96-qq957 (squid/6.10)'
Http X Forwarded For	'10.3.82.253'
Http Cache Control	'max-age=259200'
Http Connection	'keep-alive'
Path	'/usr/local/sbin:/usr/local/bin:/usr/sbin:/usr/bin:/sbin:/bin:/snap/bin'
Server Signature	' Apache/2.4.29 (Ubuntu) Server at 45.79.161.190 Port 8080 '
Server Software	'Apache/2.4.29 (Ubuntu)'
Server Name	'45.79.161.190'
Server Addr	'45.79.161.190'
Server Port	'8080'
Remote Addr	'216.73.216.36'
Document Root	'/var/www/ctr'
Request Scheme	'http'
Context Prefix	''
Context Document Root	'/var/www/ctr'
Server Admin	'webmaster@localhost'
Script Filename	'/var/www/ctr/app/webroot/index.php'
Remote Port	'3486'
Redirect Url	'/app/webroot/applications/index/page:3'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/index/page:3'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1756448740.262
Request Time	(int) 1756448740

====

Include
+
Included Files

Include Paths
- 0/var/www/ctr/app/Plugin/Media/Lib/mm/src
- 1/var/www/ctr/lib
- 3/usr/share/php
- 4-> /var/www/ctr/lib/Cake/
Included Files
- core(array)
  Behavior(array)
  0CORE/Model/Behavior/TreeBehavior.php
  1CORE/Model/Behavior/ContainableBehavior.php
  2CORE/Model/Behavior/AclBehavior.php
  Cache(array)
  0CORE/Cache/Cache.php
  1CORE/Cache/Engine/FileEngine.php
  2CORE/Cache/CacheEngine.php
  Component(array)
  0CORE/Controller/Component/AclComponent.php
  1CORE/Controller/Component/Acl/DbAcl.php
  2CORE/Controller/Component/Acl/AclInterface.php
  3CORE/Controller/Component/AuthComponent.php
  4CORE/Controller/Component/RequestHandlerComponent.php
  5CORE/Controller/Component/SessionComponent.php
  6CORE/Controller/Component/PaginatorComponent.php
  Config(array)
  0CORE/Config/routes.php
  1CORE/Config/config.php
  Controller(array)
  0CORE/Controller/Controller.php
  1CORE/Controller/ComponentCollection.php
  2CORE/Controller/Component.php
  Datasource(array)
  0CORE/Model/Datasource/CakeSession.php
  1CORE/Model/Datasource/Database/Mysql.php
  2CORE/Model/Datasource/DboSource.php
  3CORE/Model/Datasource/DataSource.php
  Error(array)
  0CORE/Error/exceptions.php
  1CORE/Error/ErrorHandler.php
  I18n(array)
  0CORE/I18n/I18n.php
  1CORE/I18n/L10n.php
  Log(array)
  0CORE/Log/CakeLog.php
  1CORE/Log/LogEngineCollection.php
  2CORE/Log/Engine/FileLog.php
  3CORE/Log/Engine/BaseLog.php
  4CORE/Log/CakeLogInterface.php
  Model(array)
  0CORE/Model/ConnectionManager.php
  1CORE/Model/Permission.php
  2CORE/Model/Model.php
  3CORE/Model/BehaviorCollection.php
  4CORE/Model/Aro.php
  5CORE/Model/AclNode.php
  6CORE/Model/Aco.php
  7CORE/Model/ModelBehavior.php
  Network(array)
  0CORE/Network/CakeRequest.php
  1CORE/Network/CakeResponse.php
  Other(array)
  0CORE/bootstrap.php
  1CORE/basics.php
  2CORE/Core/App.php
  3CORE/Core/Configure.php
  4CORE/Core/CakePlugin.php
  5CORE/Event/CakeEventListener.php
  6CORE/Event/CakeEvent.php
  7CORE/Event/CakeEventManager.php
  8CORE/Core/Object.php
  Routing(array)
  0CORE/Routing/Dispatcher.php
  1CORE/Routing/Filter/AssetDispatcher.php
  2CORE/Routing/DispatcherFilter.php
  3CORE/Routing/Filter/CacheDispatcher.php
  4CORE/Routing/Router.php
  5CORE/Routing/Route/CakeRoute.php
  6CORE/Routing/Route/PluginShortRoute.php
  Utility(array)
  0CORE/Utility/Hash.php
  1CORE/Utility/Inflector.php
  2CORE/Utility/ObjectCollection.php
  3CORE/Utility/Debugger.php
  4CORE/Utility/String.php
  5CORE/Utility/ClassRegistry.php
  6CORE/Utility/Set.php
  7CORE/Utility/Sanitize.php
  View(array)
  0CORE/View/HelperCollection.php
- app(array)
  Behavior(array)
  0APP/Model/Behavior/SoftDeleteBehavior.php
  Config(array)
  0APP/Config/core.php
  1APP/Config/bootstrap.php
  2APP/Config/routes.php
  3APP/Config/database.php
  Controller(array)
  0APP/Controller/ApplicationsController.php
  1APP/Controller/AppController.php
  Model(array)
  0APP/Model/AppModel.php
  1APP/Model/Application.php
  2APP/Model/User.php
  3APP/Model/TrialStatus.php
  4APP/Model/InvestigatorContact.php
  5APP/Model/Sponsor.php
  6APP/Model/SiteDetail.php
  7APP/Model/County.php
  Other(array)
  0APP/webroot/index.php
- plugins(array)
  CakePdf(array)
  Config(array)
  0CakePdf/Config/bootstrap.php
  1CakePdf/Config/routes.php
  CakeResque(array)
  Config(array)
  0CakeResque/Config/bootstrap.php
  Plugin(array)
  0CakeResque/Lib/CakeResque.php
  1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
  2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
  3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  DebugKit(array)
  Component(array)
  0DebugKit/Controller/Component/ToolbarComponent.php
  Plugin(array)
  0DebugKit/Lib/DebugMemory.php
  1DebugKit/Lib/Panel/HistoryPanel.php
  2DebugKit/Lib/DebugPanel.php
  3DebugKit/Lib/Panel/SessionPanel.php
  4DebugKit/Lib/Panel/RequestPanel.php
  5DebugKit/Lib/Panel/SqlLogPanel.php
  6DebugKit/Lib/Panel/TimerPanel.php
  7DebugKit/Lib/Panel/LogPanel.php
  8DebugKit/Lib/Log/Engine/DebugKitLog.php
  9DebugKit/Lib/Panel/VariablesPanel.php
  10DebugKit/Lib/Panel/EnvironmentPanel.php
  11DebugKit/Lib/Panel/IncludePanel.php
  12DebugKit/Lib/DebugTimer.php
  Media(array)
  Config(array)
  0Media/Config/bootstrap.php
  Plugin(array)
  0Media/Lib/mm/src/Mime/Type.php
  1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
  2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
  3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
  4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
  5Media/Lib/mm/src/Media/Process.php
  6Media/Lib/mm/src/Media/Info.php
  Search(array)
  Component(array)
  0Search/Controller/Component/PrgComponent.php
  Behavior(array)
  0Search/Model/Behavior/SearchableBehavior.php
  Shim(array)
  Config(array)
  0Shim/Config/bootstrap.php
  Tools(array)
  Config(array)
  0Tools/Config/bootstrap.php
====

Clinical Trial Applications: Filter, Search, and view applications {lang: 'en-GB'}

Request History

Session

Request

Cake Params

Post data

Query string

Cookie

Current Route

Sql Logs

default

Total Time: 4 ms Total Queries: 12 queries

Query Explain:

Memory

Timers

Logs

View Variables

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

Included Files

Clinical Trial Applications: Filter, Search, and view applications

Total Time: 4 ms
Total Queries: 12 queries