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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  • 9Application withdrawn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
• applications(array)
  • 0(array)
    • Application(array)
      • id191
      • user_id26
      • application_id99
      • is_child1
      • 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 - 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
      • 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
      • 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
      • unsubmitted1
      • initial_date_submitted20-06-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice305957
      • modified2025-04-11 08:01:54
      • created2025-02-18 09:40:19
    • InvestigatorContact(array)
      • 0(array)
        • id110
        • application_id191
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMsc Drive
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • created2024-06-20 10:44:12
        • modified2025-02-18 09:59:26
    • SiteDetail(array)
      • 0(array)
        • id1748
        • application_id191
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-06-20 10:55:03
        • modified2025-02-18 09:59:26
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id46
        • application_id191
        • 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
  • 1(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
    • InvestigatorContact(array)
      • 0(array)
        • id53
        • application_id98
        • given_nameJavan
        • middle_name
        • family_nameAyoma
        • qualificationMasters
        • professional_addressMsc
        • telephone+254702674563
        • emailjayoma@intellisoftkenya.com
        • created2024-06-20 10:32:00
        • modified2024-06-25 08:51:45
    • SiteDetail(array)
      • 0(array)
        • id1701
        • application_id98
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-06-20 10:55:30
        • modified2024-06-25 08:51:45
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id23
        • application_id98
        • sponsorBioPharma Innovations Ltd.
        • sponsor_typeIndustry
        • contact_person
        • addressBioPharma Innovations Ltd. 123 Main Street San Francisco, CA 94105 United States
        • telephone_number+1 415-555-6789
        • fax_number
        • cell_number+1 415-555-6778
        • email_addressinfo@biopharmainnovations.com
        • created2024-06-20 10:55:30
        • modified2024-06-25 08:51:45
  • 2(array)
    • Application(array)
      • id120
      • user_id82
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • total_sites1
      • abstract_of_study<p>\n studyabstract</p>\n
      • study_title<p>\n abstract 123</p>\n
      • laymans_summary<p>\n layman</p>\n
      • short_titleuser
      • protocol_noECCT/24/10/02
      • reference_no(null)
      • version_no2
      • date_of_protocol09-10-2024
      • study_drugstudydrug
      • disease_conditionmalaria
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresslchepkwony@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDeleniti et autem ea omnis
      • declaration_date104-05-2023
      • declaration_principal_investigatorQuaerat aspernatur consequatur non voluptas inventore ad officiis do consequatur voluptates enim asperiores minim illum
      • declaration_date218-01-2014
      • placebo_presentYes
      • study_objectives<p>\n objective</p>\n
      • principal_inclusion_criteria<p>\n inclusion</p>\n
      • principal_exclusion_criteria<p>\n exclusion</p>\n
      • primary_end_points<p>\n end point</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifySit ut lorem ut vel
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1234</p>\n
      • other_details_explanation<p>\n explained</p>\n
      • other_details_regulatory_notapproved<p>\n reg</p>\n
      • other_details_regulatory_approved<p>\n reg</p>\n
      • other_details_regulatory_rejected<p>\n reg</p>\n
      • other_details_regulatory_halted
      • estimated_durationEsse ducimus possimus aut architecto esse in dolor illum tempor cillum
      • design_controlled_randomisedNo
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyNeque deserunt nostrud minima aut sed enim veniam odit assumenda officia
      • design_controlled_comparatorRepellendus Sed temporib
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states772
      • number_of_sites961
      • multi_country_listDelectus suscipit e
      • data_monitoring_committeeNo
      • total_enrolment_per_siteDolor sint animi er
      • total_participants_worldwideCorrupti laudantium similique cupiditate nostrum rerum est vero laborum adipisicing
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyVoluptatum perspicia
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBrent Mcknight
      • investigator1_middle_nameNicole Gross
      • investigator1_family_nameCharles Crane
      • investigator1_qualificationId adipisci commodo repellendus Dolor enim iste et quam deserunt id ut ullamco
      • investigator1_professional_addressQuia eius aut adipisicing rerum aut ad tempora necessitatibus cumque nisi at
      • investigator1_telephone+1 (795) 542-5315
      • investigator1_emaildudahabewy@mailinator.com
      • organisations_transferred_No
      • number_participantsVoluptatem ut nisi e
      • notification
      • approval_date19-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-10-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApproved Here successfully
      • approved_date(null)
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • ecitizen_invoice324112
      • modified2024-11-19 16:25:21
      • created2024-10-17 12:04:18
    • InvestigatorContact(array)
      • 0(array)
        • id72
        • application_id120
        • given_nameIrene Peterson
        • middle_nameMelinda Farrell
        • family_nameMarah Bush
        • qualificationId ipsa qui obcaecati sit iste eu reiciendis pariatur Possimus temporibus consequatur et culpa ad tenetur iusto inventore nihil labore
        • professional_addressCorporis ut quo libero ut ullam error
        • telephone+1 (524) 915-1935
        • emailpypamyhezu@mailinator.com
        • created2024-10-17 12:49:37
        • modified2024-10-23 15:04:34
    • SiteDetail(array)
      • 0(array)
        • id1704
        • application_id120
        • county_id20
        • site_nameHarriet Battle
        • physical_addressQuae nulla sunt culpa beatae fugiat dolor quae labore similique in quae dignissimos a tempore ut tempore
        • contact_detailsP.O. Box 5325
        • contact_personNisi eum dolorem fugiat ullam dolore nemo laudantium aut autem natus similique numquam deserunt omnis quod officia
        • site_capacity(null)
        • misc(null)
        • created2024-10-17 12:49:37
        • modified2024-10-23 15:04:34
        • County(array)
          • id20
          • county_nameKirinyaga
          • created2012-06-15 10:24:22
          • modified2012-06-15 10:24:22
    • Sponsor(array)
      • 0(array)
        • id29
        • application_id120
        • sponsorFuga Aut qui est consequatur consectetur dolorem qui blanditiis saepe natus maiores ea repellendus Velit quia ullamco
        • sponsor_typeResearch Institution
        • contact_personNon corrupti reiciendis placeat elit aut voluptatibus optio labore excepteur
        • addressConsectetur ut ipsum quia quos magni
        • telephone_number+1 (367) 517-6326
        • fax_number+1 (961) 772-5694
        • cell_number+1 (895) 885-1686
        • email_addressrimumaxy@mailinator.com
        • created2024-10-17 12:49:37
        • modified2024-10-23 15:04:34
  • 3(array)
    • Application(array)
      • id124
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id4
      • total_sites2
      • abstract_of_study<p>\n Testronimal Study Phase 2</p>\n
      • study_title<p>\n Testronimal Study Phase 2</p>\n
      • laymans_summary<p>\n Layman SUmmary</p>\n
      • short_titleTestronimal Study Phase 2
      • protocol_noECCT/24/11/01
      • reference_no
      • version_no1
      • date_of_protocol12-11-2024
      • study_drugTestronimal
      • disease_conditionCancer
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEndo
      • 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_applicanttest
      • declaration_date120-11-2024
      • declaration_principal_investigatortest
      • declaration_date220-11-2024
      • placebo_presentNo
      • study_objectives<p>\n test</p>\n
      • principal_inclusion_criteria<p>\n test</p>\n
      • principal_exclusion_criteria<p>\n test</p>\n
      • primary_end_points<p>\n test</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n test</p>\n
      • other_details_explanation<p>\n test</p>\n
      • other_details_regulatory_notapproved<p>\n test</p>\n
      • other_details_regulatory_approved<p>\n test</p>\n
      • other_details_regulatory_rejected<p>\n test</p>\n
      • other_details_regulatory_halted<p>\n test</p>\n
      • estimated_duration1year
      • 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_stateNo
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites
      • multi_country_listtest
      • data_monitoring_committeeYes
      • total_enrolment_per_site2000
      • total_participants_worldwide2000000
      • 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_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • 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_nameInvestigating
      • investigator1_middle_name
      • investigator1_family_name Pharmacist
      • investigator1_qualificationMasters
      • investigator1_professional_address67
      • investigator1_telephone+254792837631
      • investigator1_emailinvest@gmail.com
      • organisations_transferred_No
      • number_participants100000
      • notification<p>\n test</p>\n
      • approval_date21-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-11-2024
      • unsubmitted1
      • initial_date_submitted20-11-2024
      • admin_stopped1
      • admin_stopped_reasontest
      • 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_invoice330895
      • modified2025-01-14 12:41:33
      • created2024-11-20 09:09:12
    • InvestigatorContact(array)
      • 0(array)
        • id78
        • application_id124
        • given_nameJoel
        • middle_name
        • family_nameInvestigator
        • qualificationMasters
        • professional_addressP.O Box 381-3558,Accra
        • telephone+254790129837
        • emailjayoma@intellisoftkenya.com
        • created2024-11-20 09:12:27
        • modified2025-01-14 12:21:23
    • SiteDetail(array)
      • 0(array)
        • id96
        • application_id124
        • county_id42
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-17 09:41:35
        • modified2025-01-14 12:21:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id31
        • application_id124
        • sponsorSponsor
        • sponsor_typeIndustry
        • contact_person
        • addressAddress
        • telephone_number+254782930397
        • fax_number
        • cell_number+254782930397
        • email_addressslow@gmail.com
        • created2024-11-20 09:12:27
        • modified2025-01-14 12:21:23
  • 4(array)
    • Application(array)
      • id121
      • user_id29
      • application_id(null)
      • is_child0
      • trial_status_id10
      • total_sites4
      • abstract_of_study<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • study_title<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • laymans_summary<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • short_titleIusto obcaecati Nam dicta veli
      • protocol_noECCT/24/11/02
      • reference_no(null)
      • version_noConsectetur qui ipsam omnis eos et voluptas
      • date_of_protocol20-11-2015
      • study_drugEst esse ex reprehenderit aute laborum illo consectetur soluta atque dolor quia numquam odit delectus et aut placeat
      • disease_conditionEt officia qui consequuntur quisquam veritatis obcaecati sunt non sit dolorum quae
      • product_type_biologicals0
      • product_type_proteins1
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid1
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameEagan Alston
      • product_type_medical_device_nameTanisha Rowland
      • comparatorYes
      • comparator_nameBrendan Blair
      • comparator_registeredAut enim quaerat consequatur s
      • comparator_countriesRerum quis ut veniam
      • 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_applicantSunt atque ipsum obcaecati commodo aspernatur fuga Voluptatem sed sequi cupidatat quo enim
      • declaration_date107-11-2024
      • declaration_principal_investigatorSit reprehenderit dicta beatae officia et magni deserunt ipsum in sint voluptates sed necessitatibus neque quis aspernatur esse ut
      • declaration_date214-11-2024
      • placebo_presentYes
      • study_objectives<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • principal_inclusion_criteria<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • principal_exclusion_criteria<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • primary_end_points<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyLorem voluptatem Ab
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study1
      • trial_other1
      • trial_other_specifySimilique tempore c
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_explanation<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_notapproved<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_approved<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_rejected<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_halted<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • estimated_duration3
      • design_controlled_randomisedNo
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyEum labore saepe rem quia sint dolore porro magni nihil facilis doloribus sint ipsa et officia distinctio Aut
      • design_controlled_comparatorBlanditiis quaerat est ex
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listHarum hic tempora ne
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNon ex beatae a dele
      • total_participants_worldwideExcepteur maxime nisi voluptatem minim ad quisquam harum dolore doloribus quia sunt consequatur Perspiciatis doloribus sed
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyExercitation perspic
      • investigator1_given_nameRachel Hewitt
      • investigator1_middle_nameKylynn Townsend
      • investigator1_family_nameOctavia Acosta
      • investigator1_qualificationDolores quae ut corrupti voluptatem in aliquip animi esse aliqua Dicta sapiente ipsam debitis impedit nobis
      • investigator1_professional_addressVel aut quis in consectetur incidunt placeat sint consectetur sint dolores commodi
      • investigator1_telephone+1 (618) 138-4296
      • investigator1_emailbezic@mailinator.com
      • organisations_transferred_Yes
      • number_participantsSuscipit adipisicing
      • notification<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • approval_date29-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-11-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonTest
      • approved_date(null)
      • final_report<p>\n test sample</p>\n
      • implication_results<p>\n sample</p>\n
      • quantity_imported2
      • quantity_dispensed3
      • quantity_destroyed4
      • quantity_exported1
      • balance_site2
      • final_date2025-08-05
      • ecitizen_invoice324265
      • modified2025-08-05 08:08:23
      • created2024-10-18 08:02:13
    • InvestigatorContact(array)
      • 0(array)
        • id79
        • application_id121
        • given_nameLinus Sexton
        • middle_nameOri Hill
        • family_nameJacob Mckay
        • qualificationIllum doloribus soluta numquam omnis elit quibusdam non
        • professional_addressAliquam fugiat qui officia veniam excepturi et nisi neque enim aliquip tempora
        • telephone+1 (188) 739-1402
        • emailmipaj@mailinator.com
        • created2024-11-20 09:47:01
        • modified2024-11-20 10:15:06
    • SiteDetail(array)
      • 0(array)
        • id94
        • application_id121
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-16 14:25:04
        • modified2024-11-20 10:15:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id32
        • application_id121
        • sponsorAnim obcaecati dolorem cillum qui nemo in vitae ea veritatis
        • sponsor_typeIndustry
        • contact_personFugiat corporis inventore non commodo nesciunt ut non doloremque optio voluptates minima recusandae Veritatis reprehenderit velit commodo
        • addressAutem odio eaque quia est blanditiis reiciendis commodi et adipisicing enim voluptate
        • telephone_number+1 (343) 625-7251
        • fax_number+1 (936) 324-2944
        • cell_number+1 (942) 698-1737
        • email_addressvugit@mailinator.com
        • created2024-11-20 09:47:01
        • modified2024-11-20 10:15:06
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
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  • 0Html
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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/

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  • Behavior(array)
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