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  • page3
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• 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  • 9Application withdrawn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
  • 12Ongoing Closeout Phase
• applications(array)
  • 0(array)
    • Application(array)
      • id98
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • total_sites2
      • abstract_of_study<p>\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.</p>\n<p>\n  </p>\n
      • study_title<p>\n Efficacy and Safety of Novel Immunotherapy in Treating Advanced Melanoma: A Randomized Controlled Tria</p>\n
      • laymans_summary<p>\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.</p>\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 <p>\n <strong>Primary Objective:</strong></p>\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 <p>\n <strong>Secondary Objective:</strong></p>\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 <p>\n <strong>Histologically confirmed diagnosis of advanced melanoma:</strong></p>\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 <p>\n <strong>Prior treatment history:</strong></p>\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 <p>\n <strong>Autoimmune disease:</strong></p>\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 <p>\n <strong>Active brain metastases:</strong></p>\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 <p>\n <strong>Primary Endpoint 1: Overall Survival (OS)</strong></p>\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 <p>\n <strong>Primary Endpoint 2: Progression-Free Survival (PFS)</strong></p>\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<p>\n <strong>Capacity of Site:</strong></p>\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<p>\n <strong>Number of Staff and Facilities:</strong></p>\n<ul>\n <li>\n <p>\n <strong>Study Coordinators:</strong></p>\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 <p>\n <strong>Other Staff:</strong></p>\n <ul>\n <li>\n Oncologists, nurses, research assistants with experience in oncology.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Site Facilities:</strong></p>\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 <p>\n <strong>Emergency Facilities:</strong></p>\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<p>\n <strong>Reasons for Conducting the Trial in Kenya:</strong></p>\n<ol>\n <li>\n <p>\n <strong>Access to Diverse Patient Population:</strong></p>\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 <p>\n <strong>Clinical Trial Infrastructure:</strong></p>\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<p>\n <strong>Name of Regulatory Authorities:</strong></p>\n<ul>\n <li>\n FDA (Food and Drug Administration), USA</li>\n <li>\n EMA (European Medicines Agency), EU</li>\n</ul>\n<p>\n <strong>Date(s) of Application:</strong></p>\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 <p>\n <strong>FDA (Food and Drug Administration), USA</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> May 15, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n USA: 25 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>EMA (European Medicines Agency), EU</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> June 1, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\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<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\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<p>\n NA</p>\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
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id53
        • application_id98
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMsc
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • investigator_roleprincipal
        • created2024-06-20 10:32:00
        • modified2024-06-25 08:51:45
    • SiteDetail(array)
      • 0(array)
        • id1701
        • application_id98
        • county_id(null)
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        • 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
  • 1(array)
    • Application(array)
      • id99
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • total_sites1
      • abstract_of_study<p>\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.</p>\n
      • study_title<p>\n Evaluating the Impact of Telemedicine on Postoperative Recovery in Cardiac Surgery Patients: A Multi-Center Prospective Study</p>\n
      • laymans_summary<p>\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.</p>\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 <p>\n <strong>Primary Objective:</strong></p>\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 <p>\n <strong>Secondary Objective:</strong></p>\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 <p>\n <strong>Type 2 Diabetes Mellitus diagnosis:</strong></p>\n <ul>\n <li>\n Patients must have a documented diagnosis of type 2 diabetes mellitus.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Inadequate glycemic control:</strong></p>\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 <p>\n <strong>Renal impairment:</strong></p>\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 <p>\n <strong>Cardiovascular events:</strong></p>\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 <p>\n <strong>Primary Endpoint 1: Change in HbA1c Levels</strong></p>\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 <p>\n <strong>Primary Endpoint 2: Incidence of Adverse Cardiovascular Events</strong></p>\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<p>\n <strong>Capacity of Site:</strong></p>\n<ul>\n <li>\n Leading academic medical center with extensive research capabilities.</li>\n</ul>\n<p>\n <strong>Number of Staff and Facilities:</strong></p>\n<ul>\n <li>\n <p>\n <strong>Study Coordinators:</strong></p>\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 <p>\n <strong>Other Staff:</strong></p>\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 <p>\n <strong>Site Facilities:</strong></p>\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 <p>\n <strong>Emergency Facilities:</strong></p>\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 <p>\n <strong>Ethnic Diversity and Genetic Variability:</strong></p>\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<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n <strong>Name of Regulatory Authorities:</strong></p>\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<p>\n <strong>Date(s) of Application:</strong></p>\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 <p>\n <strong>MHRA (Medicines and Healthcare products Regulatory Agency), UK</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> April 20, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n UK: 12 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>TGA (Therapeutic Goods Administration), Australia</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> May 5, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n Australia: 8 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_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
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      • population_childrenYes
      • population_adolescentYes
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      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyNo
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      • subjects_women_child_bearingYes
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      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
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      • 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<p>\n N/A</p>\n
      • approval_date20-06-2024
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        • emailjayoma@intellisoftkenya.com
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        • telephone_number+1 415-555-6789
        • fax_number
        • cell_number+1 415-555-6778
        • email_addressinfo@biopharmainnovations.com
        • created2024-06-20 10:55:03
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      • abstract_of_study<p>\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.</p>\n
      • study_title<p>\n Evaluating the Impact of Telemedicine on Postoperative Recovery in Cardiac Surgery Patients: A Multi-Center Prospective Study</p>\n
      • laymans_summary<p>\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.</p>\n
      • short_titlestudy 4
      • protocol_noECCT/24/06/04 - A
      • reference_no
      • 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
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      • declaration_applicantJames McCurrly
      • declaration_date120-06-2024
      • declaration_principal_investigatorPI Inv
      • declaration_date220-06-2024
      • placebo_presentNo
      • study_objectives<ul>\n <li>\n <p>\n <strong>Primary Objective:</strong></p>\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 <p>\n <strong>Secondary Objective:</strong></p>\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 <p>\n <strong>Type 2 Diabetes Mellitus diagnosis:</strong></p>\n <ul>\n <li>\n Patients must have a documented diagnosis of type 2 diabetes mellitus.</li>\n </ul>\n </li>\n <li>\n <p>\n <strong>Inadequate glycemic control:</strong></p>\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 <p>\n <strong>Renal impairment:</strong></p>\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 <p>\n <strong>Cardiovascular events:</strong></p>\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 <p>\n <strong>Primary Endpoint 1: Change in HbA1c Levels</strong></p>\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 <p>\n <strong>Primary Endpoint 2: Incidence of Adverse Cardiovascular Events</strong></p>\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<p>\n <strong>Capacity of Site:</strong></p>\n<ul>\n <li>\n Leading academic medical center with extensive research capabilities.</li>\n</ul>\n<p>\n <strong>Number of Staff and Facilities:</strong></p>\n<ul>\n <li>\n <p>\n <strong>Study Coordinators:</strong></p>\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 <p>\n <strong>Other Staff:</strong></p>\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 <p>\n <strong>Site Facilities:</strong></p>\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 <p>\n <strong>Emergency Facilities:</strong></p>\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 <p>\n <strong>Ethnic Diversity and Genetic Variability:</strong></p>\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<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n <strong>Name of Regulatory Authorities:</strong></p>\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<p>\n <strong>Date(s) of Application:</strong></p>\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 <p>\n <strong>MHRA (Medicines and Healthcare products Regulatory Agency), UK</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> April 20, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n UK: 12 sites</li>\n </ul>\n </li>\n </ul>\n </li>\n <li>\n <p>\n <strong>TGA (Therapeutic Goods Administration), Australia</strong></p>\n <ul>\n <li>\n <strong>Date of Approval:</strong> May 5, 2024</li>\n <li>\n <strong>Number of Sites per Country:</strong>\n <ul>\n <li>\n Australia: 8 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_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<p>\n N/A</p>\n
      • approval_date11-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-02-2025
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      • initial_date_submitted20-06-2024
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        • emailjayoma@intellisoftkenya.com
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        • 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
        • modified2025-02-18 09:59:26
  • 3(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
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      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • 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
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id41
        • application_id86
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMs Drive
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • investigator_roleprincipal
        • 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
  • 4(array)
    • Application(array)
      • id128
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id10
      • total_sites2
      • abstract_of_study<p>\n samlpe</p>\n
      • study_title<p>\n Jan 7th</p>\n
      • laymans_summary<p>\n sample Laymans Summary</p>\n
      • short_titleQuis quaerat anim voluptatem p
      • protocol_noECCT/25/01/02
      • reference_no
      • version_noOdit nulla saepe ut possimus esse maiores
      • date_of_protocol02-01-2025
      • study_drugSed velit rerum vel reprehenderit aut aliquid
      • disease_conditionEst excepteur odio quasi aut accusantium fugiat iste ab non aut impedit minima quidem dolorum id aut aliquip dolore
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid1
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameIlliana Smith
      • product_type_medical_device_nameKennedy Cote
      • comparatorYes
      • comparator_nameMyra Anderson
      • comparator_registeredVoluptas consequat Veniam ar
      • comparator_countriesConsequat Voluptati
      • 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_applicantVoluptate necessitatibus aliqua Labore ea deserunt eu amet excepturi
      • declaration_date102-01-2025
      • declaration_principal_investigatorSint voluptates quasi ipsum asperiores nisi quae eum deserunt quod quaerat saepe
      • declaration_date203-01-2025
      • 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_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyMinima proident aut
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specifyIn temporibus volupt
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • 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_durationVoluptatem accusamus similique quia velit quidem ipsa mollit vitae omnis odio pariatur Voluptas et possimus illum tempora id ut maiores
      • design_controlled_randomisedNo
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyEt excepteur do velit illum blanditiis vel
      • design_controlled_comparatorEst deserunt ipsa harum
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyEst elit ipsa dolorem debitis atque quod mollitia exercitationem elit tempor totam alias
      • 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_states141
      • number_of_sites261
      • multi_country_listSint dolore earum i
      • data_monitoring_committeeNo
      • total_enrolment_per_siteHic et dolor placeat
      • total_participants_worldwideDolor ut rem nobis perspiciatis qui necessitatibus facere modi deleniti ut rerum qui atque cupiditate enim quo tempora totam
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenUnclear
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyRatione optio accus
      • subjects_othersYes
      • subjects_others_specifyIncididunt dolores i
      • investigator1_given_nameCarissa Haley
      • investigator1_middle_nameHashim Ellison
      • investigator1_family_nameRuby Conway
      • investigator1_qualificationCorrupti id et velit aperiam sunt eligendi do minim illum et eos tenetur autem modi non et dolore magna eius
      • investigator1_professional_addressCulpa in qui rerum mollit voluptatem quisquam rerum esse dolore libero non aut inventore dicta quis voluptatem molestiae
      • investigator1_telephone+1 (852) 478-7381
      • investigator1_emailpinewideji@mailinator.com
      • organisations_transferred_Yes
      • number_participantsEx eu est et quos
      • notification<p>\n sample</p>\n
      • approval_date07-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-02-2025
      • unsubmitted1
      • initial_date_submitted17-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonSample
      • approved_date(null)
      • final_report<p>\n Sample Executive</p>\n
      • implication_results<p>\n Sample Implications of the results on current practice</p>\n
      • quantity_imported10
      • quantity_dispensed13
      • quantity_destroyed13
      • quantity_exported12
      • balance_site15
      • final_date2025-07-11
      • ecitizen_invoice344039
      • modified2025-07-11 17:18:26
      • created2025-01-07 09:26:39
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id86
        • application_id128
        • given_nameBaker Spears
        • middle_nameCassandra Castaneda
        • family_nameLane Robbins
        • qualificationBlanditiis consequatur recusandae Natus libero quis
        • professional_addressOfficiis illo laborum cupiditate do dolores omnis in sint quisquam nostrud fuga Perspiciatis nemo
        • telephone+1 (993) 659-9852
        • emailpenoguje@mailinator.com
        • investigator_roleprincipal
        • created2025-01-07 09:33:40
        • modified2025-02-17 10:51:23
    • SiteDetail(array)
      • 0(array)
        • id1706
        • application_id128
        • county_id43
        • site_nameDaquan Lane
        • physical_addressUt qui enim recusandae Unde qui esse beatae autem quia velit
        • contact_detailsPO Box 5703
        • contact_personVeniam optio vel modi repellendus
        • site_capacity(null)
        • misc(null)
        • created2025-01-07 09:33:40
        • modified2025-02-17 10:51:23
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
    • Sponsor(array)
      • 0(array)
        • id35
        • application_id128
        • sponsorAut voluptatum est ab voluptas tempore aut et voluptas dolore architecto ad suscipit saepe omnis quaerat
        • sponsor_typeLocal Kenyan Investigator
        • contact_personQuas ut consectetur ratione est tempor quo odio iure esse occaecat eius suscipit explicabo Quasi sit
        • addressExcepteur distinctio Enim vitae reiciendis aut aliquid incididunt repudiandae nesciunt beatae adipisci
        • telephone_number+1 (731) 766-1698
        • fax_number+1 (493) 753-7389
        • cell_number+1 (179) 791-1499
        • email_addresscovoginoby@mailinator.com
        • created2025-01-07 09:33:40
        • modified2025-02-17 10:51:23
• 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

App Constants

CakePHP Constants

PHP Environment

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