Request History

No previous requests logged.

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1756453515
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(empty)
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page1
    • current5
    • count22
    • prevPage(false)
    • nextPage(true)
    • pageCount5
    • order(array)
      • Application.createddesc
    • limit5
    • options(empty)
    • paramTypenamed

Post data

No post data.

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
• options(empty)
• defaults(array)
  • actionindex
  • plugin(null)
• template/:controller

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
  • 10Paused or preparation for extension of study
  • 11Revoked
• applications(array)
  • 0(array)
    • Application(array)
      • 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)
      • id187
      • user_id86
      • application_id77
      • is_child1
      • trial_status_id(null)
      • total_sites2
      • abstract_of_study<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • study_title<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • laymans_summary<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • short_titleUt qui nulla ut recusandae Om
      • protocol_noECCT/24/06/01 - WERTY
      • reference_no
      • version_noMinus nisi ut fugit dolore doloribus anim rerum in dol
      • date_of_protocol10-06-2024
      • study_drugExplicabo Quis consequatur esse ut enim ut
      • disease_conditionArchitecto enim minus voluptatem odit obcaecati sapiente sapiente eum cupiditate vero
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameAdria Kane
      • product_type_medical_device_nameNero Rowland
      • comparatorYes
      • comparator_nameNomlanga Rice
      • comparator_registeredEst quas dolore sed dolorem
      • comparator_countriesAliquid sunt fuga Q
      • 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_applicantTest Conta ct
      • declaration_date111-06-2024
      • declaration_principal_investigatorTest National Investigator
      • declaration_date211-06-2024
      • placebo_presentYes
      • study_objectives<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • principal_inclusion_criteria<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • principal_exclusion_criteria<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • primary_end_points<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence1
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic1
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • other_details_explanation<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • other_details_regulatory_notapproved<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • other_details_regulatory_approved<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • other_details_regulatory_rejected<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • other_details_regulatory_halted<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • estimated_duration23
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyIste officia veritatis et omnis illum et cupiditate ut et quisquam sit
      • design_controlled_comparatorIpsum dolorem aliquip es
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyVel dolores consectetur expedita quos dolorem earum nihil eveniet
      • 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_states232
      • number_of_sites622
      • multi_country_listAspernatur sint pers
      • data_monitoring_committeeYes
      • total_enrolment_per_siteOptio irure ut ea a
      • total_participants_worldwideAutem aut et et id
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenUnclear
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyVel repudiandae sunt
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLacota Jennings
      • investigator1_middle_nameRebecca Lancaster
      • investigator1_family_nameAlexa Le
      • investigator1_qualificationOptio laboris deserunt eum libero natus repudiandae
      • investigator1_professional_addressTotam voluptas voluptatem mollit ea facilis odio distinctio Aut fugiat culpa id saepe aut
      • investigator1_telephone0700123123
      • investigator1_emailquqyfu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsRepellendus Officii
      • notification<p>\n Clinical trials are systematic investigations conducted in human participants to evaluate the safety, efficacy, and overall therapeutic value of medical interventions, including drugs, medical devices, and treatment regimens. These trials are a critical phase in the drug development process, providing essential data that informs regulatory approvals, clinical practice, and patient care.</p>\n<p>\n Clinical trials are typically conducted in several phases, each designed to answer specific research questions and build upon the knowledge gained from previous phases:</p>\n<ol>\n <li>\n <p>\n <strong>Phase I</strong> focuses on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. This phase aims to determine the appropriate dosage range and identify any potential side effects.</p>\n </li>\n <li>\n <p>\n <strong>Phase II</strong> involves a larger group of patients and aims to provide preliminary data on the intervention's efficacy while continuing to monitor its safety. This phase helps to refine dosing and further assess the intervention's therapeutic potential.</p>\n </li>\n <li>\n <p>\n <strong>Phase III</strong> trials are expanded to a larger patient population and are designed to confirm the intervention's efficacy, monitor side effects, and compare it to standard or placebo treatments. Successful completion of Phase III is often required for regulatory approval.</p>\n </li>\n <li>\n <p>\n <strong>Phase IV</strong> trials, conducted after a drug has been approved and marketed, gather additional information on the intervention's long-term safety, effectiveness, and optimal use. These post-marketing studies help identify any rare or long-term adverse effects and ensure the intervention's continued benefit to patients.</p>\n </li>\n</ol>\n<p>\n The design and conduct of clinical trials are governed by stringent ethical and scientific standards to ensure the protection of participants and the integrity of the data collected. This includes obtaining informed consent, ensuring randomization and blinding where applicable, and conducting rigorous statistical analysis.</p>\n<p>\n Clinical trials provide the foundation for evidence-based medicine, driving advancements in healthcare and enabling the development of new and improved treatments. The data generated from these trials not only supports regulatory decision-making but also informs clinical guidelines and helps shape future research directions, ultimately contributing to improved patient outcomes and public health.</p>\n
      • approval_date21-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-02-2025
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonhey
      • 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_invoice303349
      • modified2025-02-14 09:54:09
      • created2025-02-13 08:06:14
    • InvestigatorContact(array)
      • 0(array)
        • id106
        • application_id187
        • given_nameSigne Stein
        • middle_nameBasil Goodman
        • family_nameIsaac Hughes
        • qualificationUt reprehenderit voluptate consectetur est qui dolorem impedit id aliquid nulla quidem
        • professional_addressQuam molestiae cillum qui quas perferendis Nam sequi itaque animi assumenda
        • telephone0700987897
        • emailqetykolo@mailinator.com
        • created2024-06-04 07:38:41
        • modified2025-02-13 08:26:26
    • SiteDetail(array)
      • 0(array)
        • id1714
        • application_id187
        • county_id8
        • site_nameLinus Dotson
        • physical_addressOmnis doloremque ut nihil aut dolor ut qui
        • contact_detailsP.O. Box 81593
        • contact_personDolor est voluptas sequi alias
        • site_capacity(null)
        • misc(null)
        • created2013-03-28 11:24:20
        • modified2025-02-13 08:26:26
        • County(array)
          • id8
          • county_nameWajir
          • created2012-06-15 10:22:58
          • modified2012-06-15 10:22:58
      • 1(array)
        • id1715
        • application_id187
        • county_id34
        • site_namessss
        • physical_addressssssswwee
        • contact_detailswqqwqasw
        • contact_personwqwqws
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id34
          • county_nameKajiado
          • created2012-06-15 10:26:09
          • modified2012-06-15 10:26:09
      • 2(array)
        • id1716
        • application_id187
        • county_id40
        • site_nameewewqwsa
        • physical_addresswrwqaws
        • contact_detailseqwawd
        • contact_personrewqweds
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
      • 3(array)
        • id1717
        • application_id187
        • county_id39
        • site_nameqwerfdsa
        • physical_addresswertgfds
        • contact_detailswertgfdsq
        • contact_personqwedsazx
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 4(array)
        • id1718
        • application_id187
        • county_id37
        • site_nameqwqwqwq
        • physical_addressqweedsaqwe
        • contact_detailsqwedsaqweed
        • contact_personasdewqasdewqa
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 5(array)
        • id1719
        • application_id187
        • county_id37
        • site_nameqwedsaqwe
        • physical_addressqwedsaqwed
        • contact_detailsdsewaqwseda
        • contact_personqwedsawedsw
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 6(array)
        • id1720
        • application_id187
        • county_id43
        • site_namewwww
        • physical_addressqqqq
        • contact_detailsewewe
        • contact_personwqwqw
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 7(array)
        • id1721
        • application_id187
        • county_id28
        • site_nameqwerfdsa
        • physical_addressqwedsaas
        • contact_detailsasdewqas
        • contact_personasdewqas
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id28
          • county_nameElgeyo/Marakwet
          • created2012-06-15 10:25:27
          • modified2012-06-15 10:25:27
      • 8(array)
        • id1722
        • application_id187
        • county_id28
        • site_nameqwedsa
        • physical_addressasdewq
        • contact_detailsasdewqa
        • contact_personasdewa
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id28
          • county_nameElgeyo/Marakwet
          • created2012-06-15 10:25:27
          • modified2012-06-15 10:25:27
      • 9(array)
        • id1723
        • application_id187
        • county_id37
        • site_nameerfdsewq
        • physical_addresswedsasxzz
        • contact_detailszxdeswaq
        • contact_personasdewqss
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 10(array)
        • id1724
        • application_id187
        • county_id28
        • site_namerttfjhkjfhashfkj
        • physical_addressdkjdjkdjskjf
        • contact_detailsoieuriouoieu
        • contact_personewiurooijfnsndka
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id28
          • county_nameElgeyo/Marakwet
          • created2012-06-15 10:25:27
          • modified2012-06-15 10:25:27
      • 11(array)
        • id1725
        • application_id187
        • county_id14
        • site_namekfkjfkljflkjflk
        • physical_addressklkfljfkljfklsd
        • contact_detailslkslfljfljsd
        • contact_personfalkflkjfklf
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id14
          • county_nameEmbu
          • created2012-06-15 10:23:42
          • modified2012-06-15 10:23:42
      • 12(array)
        • id1726
        • application_id187
        • county_id43
        • site_nameiourioreuroiruiorerue
        • physical_addresseroiiorereiore
        • contact_detailsioruioreuoierre
        • contact_personoiewuioureiore
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 13(array)
        • id1727
        • application_id187
        • county_id36
        • site_nameioreuioreuioreurerew
        • physical_addressroiiropirqpoirpoirq
        • contact_detailsqepripouttiowr
        • contact_personerwljroierjore
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id36
          • county_nameBomet
          • created2012-06-15 10:26:23
          • modified2012-06-15 10:26:23
      • 14(array)
        • id1728
        • application_id187
        • county_id14
        • site_nameiouioruriouiroori
        • physical_addressrekljlrjlrjre
        • contact_detailserlkrjkrejlkrejre
        • contact_personreiorueioreuioreuer
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id14
          • county_nameEmbu
          • created2012-06-15 10:23:42
          • modified2012-06-15 10:23:42
      • 15(array)
        • id1729
        • application_id187
        • county_id11
        • site_nameioreuioreuiruroir
        • physical_addressreljkreklrjklrejklre
        • contact_detailsrelqkjqkljreljre
        • contact_personroirpoirqopiropqr
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id11
          • county_nameIsiolo
          • created2012-06-15 10:23:21
          • modified2012-06-15 10:23:21
      • 16(array)
        • id1730
        • application_id187
        • county_id14
        • site_namedlkjfklajfkljlka
        • physical_addressal;kflkjklejrkljioer
        • contact_detailskljfkjfdkljfljfljfl
        • contact_persondiruoiuopqpqr
        • site_capacity(null)
        • misc(null)
        • created2024-06-11 06:33:24
        • modified2025-02-13 08:26:26
        • County(array)
          • id14
          • county_nameEmbu
          • created2012-06-15 10:23:42
          • modified2012-06-15 10:23:42
    • Sponsor(array)
      • 0(array)
        • id44
        • application_id187
        • sponsorVoluptas architecto sapiente corporis rem nihil officiis itaque
        • sponsor_typeLocal Kenyan Investigator
        • contact_personQuo ipsam labore quis ad necessitatibus rerum explicabo Rerum fuga Nam ratione et duis nihil error totam doloribus
        • addressProvident irure explicabo Duis nihil enim totam ut
        • telephone_number0700432876
        • fax_number0700321876
        • cell_number0700343232
        • email_addresshegito@mailinator.com
        • created2024-06-11 06:27:44
        • modified2025-02-13 08:26:26
  • 2(array)
    • Application(array)
      • id160
      • user_id89
      • application_id118
      • is_child1
      • trial_status_id(null)
      • total_sites5
      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - DLoop
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyVoluptas veniam ut
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states668
      • number_of_sites9
      • multi_country_listAdipisicing et numqu
      • data_monitoring_committeeYes
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsMinim dolor commodo
      • notification
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-01-2025
      • unsubmitted1
      • initial_date_submitted23-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is approved
      • 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_invoice324073
      • modified2025-04-11 06:23:35
      • created2025-01-23 08:22:01
    • InvestigatorContact(array)
      • 0(array)
        • id93
        • application_id160
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-06 10:49:03
    • SiteDetail(array)
      • 0(array)
        • id1711
        • application_id160
        • county_id38
        • site_nameAhmed Trujillo
        • physical_addressDolorum dolores necessitatibus minus magna quo velit eveniet temporibus accusantium eveniet maxime reprehenderit consectetur ipsum ea aut
        • contact_detailsP.O. Box 10
        • contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
        • site_capacity(null)
        • misc(null)
        • created2025-01-13 12:13:08
        • modified2025-02-06 10:49:03
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id41
        • application_id160
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • sponsor_typeLocal Kenyan Investigator
        • contact_personDolorem mollitia id quis provident error voluptatem voluptate
        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
        • telephone_number+1 (666) 325-1183
        • fax_number+1 (314) 248-5575
        • cell_number+1 (134) 102-6236
        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-06 10:49:03
  • 3(array)
    • Application(array)
      • id159
      • user_id86
      • application_id118
      • is_child1
      • trial_status_id(null)
      • total_sites5
      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - B
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyVoluptas veniam ut
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states668
      • number_of_sites9
      • multi_country_listAdipisicing et numqu
      • data_monitoring_committeeYes
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsMinim dolor commodo
      • notification
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-01-2025
      • unsubmitted1
      • initial_date_submitted22-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is approved
      • 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_invoice324073
      • modified2025-02-13 08:07:46
      • created2025-01-22 11:13:13
    • InvestigatorContact(array)
      • 0(array)
        • id92
        • application_id159
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
    • SiteDetail(array)
      • 0(array)
        • id1710
        • application_id159
        • county_id38
        • site_nameAhmed Trujillo
        • physical_addressDolorum dolores necessitatibus minus magna quo velit eveniet temporibus accusantium eveniet maxime reprehenderit consectetur ipsum ea aut
        • contact_detailsP.O. Box 10
        • contact_personExcepturi culpa dolore vero ut blanditiis aliquam error exercitation dolore reiciendis harum molestiae molestiae magnam fugit
        • site_capacity(null)
        • misc(null)
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id40
        • application_id159
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • sponsor_typeLocal Kenyan Investigator
        • contact_personDolorem mollitia id quis provident error voluptatem voluptate
        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
        • telephone_number+1 (666) 325-1183
        • fax_number+1 (314) 248-5575
        • cell_number+1 (134) 102-6236
        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:46
  • 4(array)
    • Application(array)
      • id158
      • user_id86
      • application_id118
      • is_child1
      • trial_status_id7
      • total_sites5
      • abstract_of_study<p>\n <em>Background:</em> The Novacov-24 virus, a newly identified respiratory pathogen, has raised global health concerns due to its rapid spread and potential for severe illness. Effective antiviral treatments are urgently needed to reduce symptom severity, prevent complications, and lower hospitalization rates.</p>\n<p>\n <em>Objective:</em> This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of <em>Virunex-3</em>, a novel antiviral agent, in reducing the severity and duration of symptoms in patients infected with the Novacov-24 virus.</p>\n<p>\n <em>Methods:</em> A total of 500 adult participants with confirmed Novacov-24 infection will be enrolled. Participants will be randomly assigned to receive either <em>Virunex-3</em> (100 mg orally, once daily for 7 days) or a placebo. Primary outcomes will include the reduction of viral load and symptom resolution within 7 days. Secondary outcomes will assess hospitalization rates, need for mechanical ventilation, and mortality. Adverse events and treatment safety will also be monitored.</p>\n<p>\n <em>Expected Outcomes:</em> The study aims to determine whether <em>Virunex-3</em> can effectively reduce symptoms and improve patient recovery while ensuring safety. If successful, this trial could contribute to the development of a new standard of care for Novacov-24 infection.</p>\n<p>\n <em>Conclusion:</em> By assessing both the effectiveness and safety of <em>Virunex-3</em>, this trial will provide valuable insights into managing Novacov-24 and preventing severe health outcomes.</p>\n
      • study_title<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • laymans_summary<p>\n This study is designed to test a new antiviral medication called <em>Virunex-3</em> to see if it can help people recover faster from an illness caused by a newly identified virus called <em>Novacov-24</em>. Participants in the study will either receive <em>Virunex-3</em> or a placebo (a pill with no active ingredients) without knowing which one they are getting. The goal is to find out if <em>Virunex-3</em> can reduce symptoms more quickly, lower the need for hospital care, and prevent serious complications. The results will help doctors understand if this new treatment is safe and effective for fighting the virus.</p>\n
      • short_titleVirunex-3 Trial for Novacov-24
      • protocol_noECCT/25/01/09 - A
      • reference_no1234redwsqa
      • version_nov1
      • date_of_protocol01-01-2025
      • study_drugVirunex-3
      • disease_conditionNovacov-24 Virus Infection
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantOfficia quasi sunt ab ducimus eaque consectetur aut hic modi omnis
      • declaration_date110-01-2025
      • declaration_principal_investigatorCupidatat consectetur consequuntur fugiat labore necessitatibus dolore est saepe dolorem cumque aliquid aliqua In id quibusdam accusamus
      • declaration_date209-01-2025
      • placebo_presentYes
      • study_objectives<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_inclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • principal_exclusion_criteria<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • primary_end_points<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic1
      • scope_others1
      • scope_others_specifyIn odit voluptate fu
      • trial_human_pharmacology0
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyVoluptas veniam ut
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_explanation<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_notapproved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_approved<p>\n A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Virunex-3 in the Treatment of Patients Infected with the Novacov-24 Virus</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_durationTempore id architecto quaerat ad vel
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherYes
      • design_controlled_specifyQuo magna rerum dolor et atque adipisci esse nostrum
      • design_controlled_comparatorAut qui perspiciatis rei
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifySed iste tempore quia tempore tempor repudiandae molestias explicabo Omnis cum et asperiores vel est
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites6
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteVitae voluptatem se
      • total_participants_worldwideAutem ut aut commodo quas eaque velit dolore proident adipisicing eaque lorem sunt doloribus dolor quo pariatur
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyId tempora omnis vol
      • subjects_othersYes
      • subjects_others_specifyUllam laborum Eos
      • investigator1_given_nameIlliana Ferguson
      • investigator1_middle_nameAllen Fox
      • investigator1_family_nameYolanda Rivera
      • investigator1_qualificationAut labore non sed sed aut iusto et asperiores eu ut ut do qui ullam aut obcaecati earum modi in
      • investigator1_professional_addressEst doloremque dolores adipisicing quidem laboris voluptates vitae ex
      • investigator1_telephone+1 (621) 831-1153
      • investigator1_emailqeryrilu@mailinator.com
      • organisations_transferred_Yes
      • number_participantsMinim dolor commodo
      • notification
      • approval_date13-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-01-2025
      • unsubmitted1
      • initial_date_submitted22-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThis is approved
      • 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_invoice324073
      • modified2025-02-13 08:07:31
      • created2025-01-22 10:39:23
    • InvestigatorContact(array)
      • 0(array)
        • id91
        • application_id158
        • given_nameHiroko Lewis
        • middle_nameTatyana Medina
        • family_nameCastor Gallagher
        • qualificationQuis molestiae voluptate aut aliquam velit est consequat Asperiores possimus et neque molestias aliqua Omnis voluptas non dolor nulla laudantium
        • professional_addressNisi qui dolor optio tempore quisquam laborum Suscipit
        • telephone+1 (322) 766-3057
        • emailtipyhuqo@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:31
    • SiteDetail(array)
      • 0(array)
        • id128
        • application_id158
        • county_id42
        • site_nameMiranda Alvarez
        • physical_addressAut ad quasi commodi non sint libero enim eos consequatur corrupti harum non
        • contact_detailsP.O. Box 86856
        • contact_personVoluptatibus molestias eligendi non repudiandae quis ipsa minim quia nostrum ut nisi possimus veniam
        • site_capacity(null)
        • misc(null)
        • created2013-06-27 10:49:32
        • modified2025-02-13 08:07:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id39
        • application_id158
        • sponsorEnim sint voluptatem eos nobis reiciendis dolore et qui corrupti quod minim pariatur Possimus
        • sponsor_typeLocal Kenyan Investigator
        • contact_personDolorem mollitia id quis provident error voluptatem voluptate
        • addressDolore laborum delectus dolor corrupti rerum aut magnam impedit quia cillum et cupiditate aliquid sapiente
        • telephone_number+1 (666) 325-1183
        • fax_number+1 (314) 248-5575
        • cell_number+1 (134) 102-6236
        • email_addresstuhokelyh@mailinator.com
        • created2025-01-13 12:13:08
        • modified2025-02-13 08:07:31
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(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