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)
1.	ECCT/24/04/01	Test Protocol Test	Principal Investigator(s) 1. Javan Test Site(s) in Kenya Mrcuty Test Site	View
2.	ECCT/24/12/01	Et eius sit aut et fugiat adi sample	Principal Investigator(s) 1. Lawrence Jennings Aladdin Powers Elton Delgado Site(s) in Kenya 1. Chastity Horne (Samburu county)	View
3.	ECCT/24/01/01	Short Title Sample Title	Principal Investigator(s) 1. some name principal some name principal some name principal Site(s) in Kenya 1.	View
4.	ECCT/25/01/01	Laborum Doloribus illo impedi Laborum Doloribus illo impedi	Principal Investigator(s) 1. Aidan Madden Yeo Christensen Nola Nielsen Site(s) in Kenya 1. Isadora Long (Vihiga county)	View
5.	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

History
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Request History
4 previous requests available
====
Session
+
Session
- Config(array)
  userAgent9c3d2c89526db53b7b69e8c9faa06145
  time1756505524
  countdown10
====
Request
+
Request

Cake Params
- plugin(null)
- controllerapplications
- actionindex
- named(array)
  sortstudy_title
  directiondesc
  trial_therapeutic_exploratory1
- pass(empty)
- isAjax(false)
- paging(array)
  Application(array)
  page1
  current5
  count9
  prevPage(false)
  nextPage(true)
  pageCount2
  order(array)
  Application.study_titledesc
  limit5
  options(array)
  order(array)
  Application.study_titledesc
  sortstudy_title
  directiondesc
  paramTypenamed
Post data
- Application(array)
  trial_therapeutic_exploratory1
Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

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

Sql Logs

default

Total Time: 2 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`.`trial_therapeutic_exploratory` = '1' AND `Application`.`submitted` = '1' AND `Application`.`approved` = 2 AND `Application`.`deactivated` = '0' AND `Application`.`deleted` = '0' ORDER BY `Application`.`study_title` desc LIMIT 5	5	5	1	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 (14, 125, 2, 127, 86)	5	5	0
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 (14, 125, 2, 127, 86)	8	8	1	maybe slow
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 38	1	1	0
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` = 25	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 (14, 125, 2, 127, 86)	5	5	0
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`trial_therapeutic_exploratory` = '1' AND `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 10.82 MB

Message	Memory use
Component initialization	2.39 MB
Controller action start	3.55 MB
Controller render start	4.50 MB
View render complete	5.22 MB

Timers

Total Request Time: 133 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	48.97
Event: Controller.initialize	1.43
Event: Controller.startup	0.57
Controller action	31.18
Event: Controller.beforeRender	18.85
» Processing toolbar data	18.77
Rendering View	9.76
» Event: View.beforeRender	0.03
» Rendering APP/View/Applications/index.ctp	0.20
» » Rendering APP/View/Elements/google-recommend.ctp	0.05
» Rendering APP/View/Elements/application/public_index.ctp	6.95
» Event: View.afterRender	0.02
» Event: View.beforeLayout	0.02
» Rendering APP/View/Layouts/default.ctp	2.15
» » Rendering APP/View/Elements/google-analytics.ctp	0.06
Event: View.afterLayout	0.00

====

Log
+

Logs

There were no log entries made this request

====
Variables
+
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)
  id14
  user_id26
  application_id(null)
  is_child0
  trial_status_id(null)
  total_sites(null)
  abstract_of_study<p>\n Test Abstract</p>\n
  study_title<p>\n Test</p>\n
  laymans_summary<p>\n Layman's summary of the Test Protocol</p>\n
  short_titleTest Protocol
  protocol_noECCT/24/04/01
  reference_no(null)
  version_no1.0.0
  date_of_protocol01-04-2024
  study_drugTest Protocol Drug
  disease_conditionTest Disease
  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
  comparatorYes
  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_applicant+2541190291827
  declaration_date109-04-2024
  declaration_principal_investigatorJavan
  declaration_date202-04-2024
  placebo_presentNo
  study_objectives<p>\n Test objective</p>\n
  principal_inclusion_criteria<p>\n Test Inclusion criteria</p>\n
  principal_exclusion_criteria<p>\n Test exclusion criteria</p>\n
  primary_end_points<p>\n Primary endpoints</p>\n
  scope_diagnosis0
  scope_prophylaxis0
  scope_therapy1
  scope_safety0
  scope_efficacy0
  scope_pharmacokinetic0
  scope_pharmacodynamic0
  scope_bioequivalence1
  scope_dose_response0
  scope_pharmacogenetic0
  scope_pharmacogenomic0
  scope_pharmacoecomomic0
  scope_others0
  scope_others_specify
  trial_human_pharmacology1
  trial_administration_humans1
  trial_bioequivalence_study0
  trial_other0
  trial_other_specify
  trial_therapeutic_exploratory1
  trial_therapeutic_confirmatory1
  trial_therapeutic_use0
  design_controlledNo
  site_capacity(null)
  staff_numbers<p>\n Test people</p>\n
  other_details_explanation<p>\n test reason</p>\n
  other_details_regulatory_notapproved<p>\n test regulatory</p>\n
  other_details_regulatory_approved<p>\n test reg</p>\n
  other_details_regulatory_rejected
  other_details_regulatory_halted
  estimated_duration2 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_areaMrcuty Test Site
  single_site_physical_address67
  single_site_contact_personContact Person
  single_site_telephone+25478019287
  multiple_sites_member_stateNo
  multiple_countriesYes
  multiple_member_states40
  number_of_sites
  multi_country_listtest
  data_monitoring_committeeYes
  total_enrolment_per_site200
  total_participants_worldwide20000000
  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_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_consentNo
  subjects_specify
  subjects_othersNo
  subjects_others_specify
  investigator1_given_nameGiven Investigator Name
  investigator1_middle_name
  investigator1_family_nameFamily Name
  investigator1_qualificationBsc. Medicine
  investigator1_professional_addressProfessional Address
  investigator1_telephone+25470192846
  investigator1_emailfamilyname@yahoo.com
  organisations_transferred_No
  number_participants2000
  notification
  approval_date17-10-2024
  submitted1
  deleted0
  deleted_date(null)
  deactivated0
  date_submitted09-04-2024
  unsubmitted0
  initial_date_submitted(null)
  admin_stopped0
  admin_stopped_reason(null)
  approved2
  approved_reasonProceed
  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_invoice301246
  modified2024-10-17 10:41:16
  created2024-04-09 08:38:17
  InvestigatorContact(array)
  0(array)
  id11
  application_id14
  given_nameJavan
  middle_name
  family_nameTest
  qualificationMsc Medicine
  professional_addressTets Professional Address
  telephone+2547910292871
  emailjavan@gmail.com
  created2024-04-09 08:47:06
  modified2024-04-09 09:34:57
  SiteDetail(array)
  0(array)
  id1657
  application_id14
  county_id(null)
  site_name
  physical_address
  contact_details
  contact_person
  site_capacity(null)
  misc(null)
  created2024-04-09 08:47:06
  modified2024-04-09 09:34:57
  County(empty)
  Sponsor(array)
  0(array)
  id10
  application_id14
  sponsorSponsor
  sponsor_typeIndustry
  contact_person
  addressAddress
  telephone_number+254790192873
  fax_number
  cell_number+254718290192
  email_addressemail@ac.ke
  created2024-04-09 08:47:06
  modified2024-04-09 09:34:57
  1(array)
  Application(array)
  id125
  user_id29
  application_id(null)
  is_child0
  trial_status_id10
  total_sites5
  abstract_of_study<p>\n sample</p>\n
  study_title<p>\n sample</p>\n
  laymans_summary<p>\n sample</p>\n
  short_titleEt eius sit aut et fugiat adi
  protocol_noECCT/24/12/01
  reference_no(null)
  version_noDolorem veniam pariatur Consequat Numquam et digniss
  date_of_protocol01-12-2024
  study_drugId debitis rerum natus molestiae reprehenderit doloremque recusandae Ratione perspiciatis velit minim delectus similique suscipit fugiat
  disease_conditionTempor numquam voluptas amet aut tempore repellendus Magni pariatur
  product_type_biologicals0
  product_type_proteins0
  product_type_immunologicals1
  product_type_vaccines0
  product_type_hormones1
  product_type_toxoid0
  product_type_chemical0
  product_type_medical_device1
  product_type_chemical_nameStone Atkins
  product_type_medical_device_nameAnthony Lawrence
  comparatorNo
  comparator_nameSydnee Woods
  comparator_registeredEt sint officia eos asperiore
  comparator_countriesVel anim voluptatem
  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_applicantQuo tenetur ex ut tempora consequatur rerum qui amet officiis sed molestiae fuga Quibusdam velit eu soluta voluptates amet
  declaration_date117-12-2024
  declaration_principal_investigatorSint explicabo Sint quos omnis quia aliquid non ullamco ipsum quia dignissimos qui et consequat Voluptatum cupidatat aut
  declaration_date217-12-2024
  placebo_presentYes
  study_objectives<p>\n sample</p>\n
  principal_inclusion_criteria<p>\n sample</p>\n
  principal_exclusion_criteria<p>\n sample</p>\n
  primary_end_points<p>\n sample</p>\n
  scope_diagnosis1
  scope_prophylaxis0
  scope_therapy0
  scope_safety1
  scope_efficacy0
  scope_pharmacokinetic0
  scope_pharmacodynamic1
  scope_bioequivalence0
  scope_dose_response0
  scope_pharmacogenetic0
  scope_pharmacogenomic1
  scope_pharmacoecomomic0
  scope_others0
  scope_others_specify
  trial_human_pharmacology0
  trial_administration_humans0
  trial_bioequivalence_study1
  trial_other0
  trial_other_specify
  trial_therapeutic_exploratory1
  trial_therapeutic_confirmatory0
  trial_therapeutic_use0
  design_controlledYes
  site_capacity(null)
  staff_numbers<p>\n sample</p>\n
  other_details_explanation<p>\n sample</p>\n
  other_details_regulatory_notapproved<p>\n sample</p>\n
  other_details_regulatory_approved<p>\n sample</p>\n
  other_details_regulatory_rejected<p>\n sample</p>\n
  other_details_regulatory_halted<p>\n sample</p>\n
  estimated_duration4
  design_controlled_randomisedNo
  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
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  single_site_physical_address
  single_site_contact_person
  single_site_telephone
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  total_participants_worldwideSit ut quae amet at tempor et commodo voluptas quod neque adipisci nemo labore Nam officia ut commodi
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  investigator1_emailpydekizef@mailinator.com
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  given_nameLawrence Jennings
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  emailxycuqez@mailinator.com
  created2024-12-17 08:32:23
  modified2025-01-06 11:48:30
  SiteDetail(array)
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  created2024-12-17 08:32:23
  modified2025-01-06 11:48:30
  County(array)
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  created2012-06-15 10:24:58
  modified2012-06-15 10:24:58
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  email_addresscidesy@mailinator.com
  created2024-12-17 08:32:23
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  created2024-01-09 05:37:44
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  created2024-01-09 05:37:44
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  created2024-05-22 16:52:09
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  3(array)
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  study_title<p>\n Laborum Doloribus illo impedi</p>\n
  laymans_summary<p>\n test</p>\n
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  reference_no
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  date_of_protocol15-01-1977
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  declaration_date207-01-2025
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  estimated_durationEx qui assumenda laudantium eos dolor voluptatem Quaerat vero ut ex voluptatem corporis neque laborum Irure
  design_controlled_randomised
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  investigator1_given_nameRemedios Steele
  investigator1_middle_nameTaShya Moore
  investigator1_family_nameBrady Key
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  investigator1_professional_addressVoluptatibus voluptates nemo sit et lorem
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  investigator1_emailcuvicenuwy@mailinator.com
  organisations_transferred_No
  number_participants20000
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  approval_date07-01-2025
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  modified2025-02-18 08:53:19
  created2025-01-06 15:07:01
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  id84
  application_id127
  given_nameAidan Madden
  middle_nameYeo Christensen
  family_nameNola Nielsen
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  professional_addressConsectetur iure ea blanditiis illo facilis sed magna elit non alias
  telephone+1 (375) 498-2766
  emailtomap@mailinator.com
  created2025-01-06 15:08:18
  modified2025-02-06 14:33:08
  SiteDetail(array)
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  contact_detailsP.O. Box 5
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  site_capacity(null)
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  created2013-06-27 11:37:16
  modified2025-02-06 14:33:08
  County(array)
  id38
  county_nameVihiga
  created2012-06-15 10:26:37
  modified2012-06-15 10:26:37
  Sponsor(array)
  0(array)
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  sponsorFugit nulla amet numquam veniam qui minim ratione ducimus voluptatem Eos molestiae obcaecati est repudiandae aut id Nam enim ut
  sponsor_typeResearch Institution
  contact_personQuasi voluptas voluptate veritatis quis
  addressVoluptatem Sit eum voluptas nobis aliqua Nostrud minus officia voluptatum eveniet vel lorem aperiam cupidatat
  telephone_number+1 (924) 838-9502
  fax_number+1 (461) 834-7154
  cell_number+1 (976) 269-8435
  email_addressgopokilos@mailinator.com
  created2025-01-06 15:08:18
  modified2025-02-06 14:33:08
  4(array)
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  abstract_of_study<p>\n Background</p>\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 <p>\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.</p>\n <h4>\n Objective</h4>\n <p>\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.</p>\n <h4>\n Methods</h4>\n <p>\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.</p>\n <h4>\n Results</h4>\n <p>\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.</p>\n <h4>\n Conclusion</h4>\n <p>\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.</p>\n <h4>\n Keywords</h4>\n <p>\n Cancer genomics, genetic markers, treatment response, personalized medicine, genome-wide association study, precision oncology.</p>\n </div>\n </div>\n </div>\n</div>\n<p>\n </p>\n
  study_title<p>\n Investigating Genetic Markers for Predicting Cancer Treatment Response</p>\n
  laymans_summary<p>\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.</p>\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 <p>\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.</p>\n <p>\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.</p>\n </div>\n </div>\n </div>\n</div>\n<p>\n </p>\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 <strong>Capacity of Site:</strong>\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 <strong>Number of Staff:</strong> 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 <strong>Facilities:</strong> Fully equipped outpatient clinic, laboratory, pharmacy, inpatient wards, emergency room</li>\n <li>\n <strong>Emergency Facilities:</strong> Fully equipped emergency room with resuscitation equipment and trained staff</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> 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 <strong>Capacity of Site:</strong>\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 <strong>Number of Staff:</strong> 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 <strong>Facilities:</strong> Comprehensive outpatient and inpatient facilities, including surgery theaters, radiology department, pharmacy, laboratory.</li>\n <li>\n <strong>Emergency Facilities:</strong> Dedicated emergency department with trauma center and intensive care unit.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> 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 <strong>Capacity of Site:</strong>\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 <strong>Number of Staff:</strong> 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 <strong>Facilities:</strong> Modern outpatient department, fully equipped laboratory, pharmacy, comfortable inpatient wards.</li>\n <li>\n <strong>Emergency Facilities:</strong> Well-equipped emergency room with 24/7 availability.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> 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 <strong>Capacity of Site:</strong>\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 <strong>Number of Staff:</strong> 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 <strong>Facilities:</strong> Well-equipped outpatient department, pharmacy, laboratory, and comfortable inpatient wards.</li>\n <li>\n <strong>Emergency Facilities:</strong> Dedicated emergency room with basic resuscitation equipment and trained staff.</li>\n <li>\n <strong>Other Relevant Infrastructure:</strong> 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<p>\n </p>\n
  other_details_explanation<ul>\n <li>\n <p>\n <strong>Population Diversity:</strong> 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.</p>\n </li>\n <li>\n <p>\n <strong>Access to Patients:</strong> Kenya may have a higher prevalence of the target disease or condition, providing easier access to eligible participants for the clinical trial.</p>\n </li>\n <li>\n <p>\n <strong>Infrastructure and Expertise:</strong> Kenya has established research institutions, hospitals, and clinics with experienced healthcare professionals and researchers capable of conducting high-quality clinical trials.</p>\n </li>\n <li>\n <p>\n <strong>Regulatory Environment:</strong> Kenya's regulatory framework for clinical trials may be favorable or offer expedited approval processes, making it an attractive location for conducting research.</p>\n </li>\n <li>\n <p>\n <strong>Ethical Considerations:</strong> 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.</p>\n </li>\n <li>\n <p>\n <strong>Cost Considerations:</strong> 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.</p>\n </li>\n</ul>\n
  other_details_regulatory_notapproved<ol>\n <li>\n <p>\n <strong>Kenyan Pharmacy and Poisons Board (PPB)</strong></p>\n <ul>\n <li>\n Date of Application: March 15, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>South African Health Products Regulatory Authority (SAHPRA)</strong></p>\n <ul>\n <li>\n Date of Application: April 10, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Uganda National Drug Authority (NDA)</strong></p>\n <ul>\n <li>\n Date of Application: May 5, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Tanzania Medicines and Medical Devices Authority (TMDA)</strong></p>\n <ul>\n <li>\n Date of Application: June 1, 2024</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Nigerian National Agency for Food and Drug Administration and Control (NAFDAC)</strong></p>\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 <p>\n <strong>United States Food and Drug Administration (FDA)</strong></p>\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 <p>\n <strong>European Medicines Agency (EMA)</strong></p>\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 <p>\n <strong>Canadian Health Products and Food Branch (HPFB)</strong></p>\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 <p>\n <strong>Australian Therapeutic Goods Administration (TGA)</strong></p>\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 <p>\n <strong>Brazilian Health Regulatory Agency (ANVISA)</strong></p>\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<p>\n N/A</p>\n
  other_details_regulatory_halted<p>\n N/A</p>\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<p>\n N/A</p>\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(array)
  trial_therapeutic_exploratory1
- $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/sort:study_title/direction:desc/trial_therapeutic_exploratory:1'
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 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	'1341'
Redirect Url	'/app/webroot/applications/index/sort:study_title/direction:desc/trial_therapeutic_exploratory:1'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/index/sort:study_title/direction:desc/trial_therapeutic_exploratory:1'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1756476724.858
Request Time	(int) 1756476724

====

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: 2 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: 2 ms
Total Queries: 12 queries