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      • 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
      • reference_no(null)
      • 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
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      • 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
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      • email_addressjkiprotich@intellisoftkenya.com
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      • 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
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      • trial_therapeutic_exploratory1
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      • 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
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      • investigator1_given_nameLacota Jennings
      • investigator1_middle_nameRebecca Lancaster
      • investigator1_family_nameAlexa Le
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      • 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
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      • 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
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      • 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
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      • 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
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      • abstract_of_study<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • study_title<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • laymans_summary<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
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      • study_objectives<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • principal_inclusion_criteria<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • principal_exclusion_criteria<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • primary_end_points<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
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      • staff_numbers<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_explanation<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_notapproved<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_approved<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_rejected<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • other_details_regulatory_halted<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • estimated_duration3
      • design_controlled_randomisedNo
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyEum labore saepe rem quia sint dolore porro magni nihil facilis doloribus sint ipsa et officia distinctio Aut
      • design_controlled_comparatorBlanditiis quaerat est ex
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listHarum hic tempora ne
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNon ex beatae a dele
      • total_participants_worldwideExcepteur maxime nisi voluptatem minim ad quisquam harum dolore doloribus quia sunt consequatur Perspiciatis doloribus sed
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyExercitation perspic
      • investigator1_given_nameRachel Hewitt
      • investigator1_middle_nameKylynn Townsend
      • investigator1_family_nameOctavia Acosta
      • investigator1_qualificationDolores quae ut corrupti voluptatem in aliquip animi esse aliqua Dicta sapiente ipsam debitis impedit nobis
      • investigator1_professional_addressVel aut quis in consectetur incidunt placeat sint consectetur sint dolores commodi
      • investigator1_telephone+1 (618) 138-4296
      • investigator1_emailbezic@mailinator.com
      • organisations_transferred_Yes
      • number_participantsSuscipit adipisicing
      • notification<p>\n Clinical trials are research studies conducted with human participants to evaluate the safety, effectiveness, and potential side effects of medical interventions, such as new drugs, devices, or therapies. These trials are essential for advancing medical knowledge and ensuring treatments meet rigorous standards. By following a structured approach, clinical trials provide a systematic way to assess new interventions before they are widely adopted in healthcare.</p>\n<p>\n The process of clinical trials typically progresses through multiple phases. Early phases focus on determining safety and optimal dosing in smaller groups, while later phases assess the efficacy and broader application of the intervention in larger populations. This phased approach ensures that each stage addresses specific scientific and medical questions, gradually building a comprehensive understanding of the intervention's impact.</p>\n<p>\n Ethical guidelines and scientific rigor are crucial in clinical trials to protect participants and maintain public trust. Researchers adhere to principles like informed consent and beneficence while ensuring trials are inclusive and unbiased. By bridging the gap between laboratory research and real-world medical practice, clinical trials play a critical role in improving healthcare outcomes globally.</p>\n
      • approval_date29-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted20-11-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonTest
      • approved_date(null)
      • final_report<p>\n test sample</p>\n
      • implication_results<p>\n sample</p>\n
      • quantity_imported2
      • quantity_dispensed3
      • quantity_destroyed4
      • quantity_exported1
      • balance_site2
      • final_date2025-08-05
      • ecitizen_invoice324265
      • modified2025-08-05 08:08:23
      • created2024-10-18 08:02:13
    • InvestigatorContact(array)
      • 0(array)
        • id79
        • application_id121
        • given_nameLinus Sexton
        • middle_nameOri Hill
        • family_nameJacob Mckay
        • qualificationIllum doloribus soluta numquam omnis elit quibusdam non
        • professional_addressAliquam fugiat qui officia veniam excepturi et nisi neque enim aliquip tempora
        • telephone+1 (188) 739-1402
        • emailmipaj@mailinator.com
        • created2024-11-20 09:47:01
        • modified2024-11-20 10:15:06
    • SiteDetail(array)
      • 0(array)
        • id94
        • application_id121
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-16 14:25:04
        • modified2024-11-20 10:15:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id32
        • application_id121
        • sponsorAnim obcaecati dolorem cillum qui nemo in vitae ea veritatis
        • sponsor_typeIndustry
        • contact_personFugiat corporis inventore non commodo nesciunt ut non doloremque optio voluptates minima recusandae Veritatis reprehenderit velit commodo
        • addressAutem odio eaque quia est blanditiis reiciendis commodi et adipisicing enim voluptate
        • telephone_number+1 (343) 625-7251
        • fax_number+1 (936) 324-2944
        • cell_number+1 (942) 698-1737
        • email_addressvugit@mailinator.com
        • created2024-11-20 09:47:01
        • modified2024-11-20 10:15:06
  • 3(array)
    • Application(array)
      • id43
      • user_id26
      • application_id(null)
      • is_child0
      • trial_status_id(null)
      • total_sites(null)
      • abstract_of_study<div>\n This randomized, double-blind, placebo-controlled study aimed to evaluate the safety, efficacy, and pharmacokinetics of Albenimol in adults diagnosed with depression. A total of [Number of Participants] participants were randomly assigned to receive either Albenimol or a placebo for 3years . The primary endpoints included changes in depressive symptoms as measured by standardized rating scales, as well as the incidence of adverse events. Secondary endpoints included pharmacokinetic parameters to evaluate the drug's absorption, distribution, metabolism, and excretion.</div>\n<div>\n  </div>\n<div>\n The results indicated that Albenimol was well-tolerated, with a safety profile comparable to placebo. The most common adverse events reported were [List of Common Adverse Events]. Efficacy analyses suggested a significant reduction in depressive symptoms in the Albenimol group compared to placebo. Specifically, Albenimol demonstrated a [Percentage] reduction in the [Name of Rating Scale] score compared to [Percentage] reduction with placebo (p < 0.001).</div>\n<div>\n  </div>\n<div>\n Pharmacokinetic data revealed Albenimol's predictable and consistent profile, with [Parameter] being [Value]. The results of this study support the further investigation of Albenimol as a potential treatment for depression. Additional research is warranted to confirm these findings and establish the long-term safety and efficacy of Albenimol in this population.</div>\n
      • study_title<p>\n  </p>\n<div class=\"mt-1 flex gap-3 empty:hidden juice:-ml-3\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; margin-top: 0.25rem; display: flex; gap: 0.75rem; margin-left: -0.75rem;\">\n <div class=\"items-center justify-start rounded-xl p-1 flex\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; align-items: center; justify-content: flex-start; border-radius: 0.75rem; padding: 0.25rem;\">\n <div class=\"flex items-center\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; align-items: center;\">\n <span data-state=\"closed\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ;\"><button class=\"rounded-lg text-token-text-secondary hover:bg-token-main-surface-secondary\" style=\"border-width: 0px; border-style: solid; border-color: rgb(227, 227, 227); --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; 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appearance: button; background-image: none; cursor: pointer; border-radius: 0.5rem;\"><span class=\"flex h-[30px] w-[30px] items-center justify-center\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; height: 30px; width: 30px; align-items: center; justify-content: center;\"><svg class=\"icon-md-heavy\" fill=\"none\" height=\"24\" viewbox=\"0 0 24 24\" width=\"24\" xmlns=\"http://www.w3.org/2000/svg\"><path clip-rule=\"evenodd\" d=\"M7 5a3 3 0 0 1 3-3h9a3 3 0 0 1 3 3v9a3 3 0 0 1-3 3h-2v2a3 3 0 0 1-3 3H5a3 3 0 0 1-3-3v-9a3 3 0 0 1 3-3h2zm2 2h5a3 3 0 0 1 3 3v5h2a1 1 0 0 0 1-1V5a1 1 0 0 0-1-1h-9a1 1 0 0 0-1 1zM5 9a1 1 0 0 0-1 1v9a1 1 0 0 0 1 1h9a1 1 0 0 0 1-1v-9a1 1 0 0 0-1-1z\" fill=\"currentColor\" fill-rule=\"evenodd\"></path></svg></span></button></span><span data-state=\"closed\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ;\"><button class=\"rounded-lg text-token-text-secondary hover:bg-token-main-surface-secondary\" style=\"border-width: 0px; border-style: solid; border-color: rgb(227, 227, 227); --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; font-feature-settings: inherit; font-family: inherit; font-size: 16px; font-variation-settings: inherit; font-weight: inherit; letter-spacing: inherit; line-height: inherit; margin: 0px; padding: 0px; appearance: button; background-image: none; cursor: pointer; border-radius: 0.5rem;\"><span class=\"flex h-[30px] w-[30px] items-center justify-center\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; height: 30px; width: 30px; align-items: center; justify-content: center;\"><svg class=\"icon-md-heavy\" fill=\"none\" height=\"24\" viewbox=\"0 0 24 24\" width=\"24\" xmlns=\"http://www.w3.org/2000/svg\"><path d=\"M3.07 10.876C3.623 6.436 7.41 3 12 3a9.15 9.15 0 0 1 6.012 2.254V4a1 1 0 1 1 2 0v4a1 1 0 0 1-1 1H15a1 1 0 1 1 0-2h1.957A7.15 7.15 0 0 0 12 5a7 7 0 0 0-6.946 6.124 1 1 0 1 1-1.984-.248m16.992 1.132a1 1 0 0 1 .868 1.116C20.377 17.564 16.59 21 12 21a9.15 9.15 0 0 1-6-2.244V20a1 1 0 1 1-2 0v-4a1 1 0 0 1 1-1h4a1 1 0 1 1 0 2H7.043A7.15 7.15 0 0 0 12 19a7 7 0 0 0 6.946-6.124 1 1 0 0 1 1.116-.868\" fill=\"currentColor\"></path></svg></span></button></span>\n <div class=\"flex\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex;\">\n <span data-state=\"closed\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ;\"><button class=\"rounded-lg text-token-text-secondary hover:bg-token-main-surface-secondary\" style=\"border-width: 0px; border-style: solid; border-color: rgb(227, 227, 227); --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; font-feature-settings: inherit; font-family: inherit; font-size: 16px; font-variation-settings: inherit; font-weight: inherit; letter-spacing: inherit; line-height: inherit; margin: 0px; padding: 0px; appearance: button; background-image: none; cursor: pointer; border-radius: 0.5rem;\"><span class=\"flex h-[30px] w-[30px] items-center justify-center\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; height: 30px; width: 30px; align-items: center; justify-content: center;\"><svg class=\"icon-md-heavy\" fill=\"none\" height=\"24\" viewbox=\"0 0 24 24\" width=\"24\" xmlns=\"http://www.w3.org/2000/svg\"><path clip-rule=\"evenodd\" d=\"M11.8727 21.4961C11.6725 21.8466 11.2811 22.0423 10.8805 21.9922L10.4267 21.9355C7.95958 21.6271 6.36855 19.1665 7.09975 16.7901L7.65054 15H6.93226C4.29476 15 2.37923 12.4921 3.0732 9.94753L4.43684 4.94753C4.91145 3.20728 6.49209 2 8.29589 2H18.0045C19.6614 2 21.0045 3.34315 21.0045 5V12C21.0045 13.6569 19.6614 15 18.0045 15H16.0045C15.745 15 15.5054 15.1391 15.3766 15.3644L11.8727 21.4961ZM14.0045 4H8.29589C7.39399 4 6.60367 4.60364 6.36637 5.47376L5.00273 10.4738C4.65574 11.746 5.61351 13 6.93226 13H9.00451C9.32185 13 9.62036 13.1506 9.8089 13.4059C9.99743 13.6612 10.0536 13.9908 9.96028 14.2941L9.01131 17.3782C8.6661 18.5002 9.35608 19.6596 10.4726 19.9153L13.6401 14.3721C13.9523 13.8258 14.4376 13.4141 15.0045 13.1902V5C15.0045 4.44772 14.5568 4 14.0045 4ZM17.0045 13V5C17.0045 4.64937 16.9444 4.31278 16.8338 4H18.0045C18.5568 4 19.0045 4.44772 19.0045 5V12C19.0045 12.5523 18.5568 13 18.0045 13H17.0045Z\" fill=\"currentColor\" fill-rule=\"evenodd\"></path></svg></span></button></span></div>\n <span data-state=\"closed\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ;\"><button aria-expanded=\"false\" aria-haspopup=\"menu\" class=\"cursor-pointer rounded-md px-1 text-token-text-secondary h-[30px] hover:bg-token-main-surface-secondary\" data-state=\"closed\" id=\"radix-:ror:\" style=\"border-width: 0px; border-style: solid; border-color: rgb(227, 227, 227); --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; font-feature-settings: inherit; font-family: inherit; font-size: 16px; font-variation-settings: inherit; font-weight: inherit; letter-spacing: inherit; line-height: inherit; margin: 0px; padding: 0px 0.25rem; appearance: button; background-image: none; cursor: pointer; height: 30px; border-radius: 0.375rem;\" type=\"button\">\n <div class=\"flex items-center pb-0.5 juice:pb-0\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; display: flex; align-items: center; padding-bottom: 0px;\">\n <div class=\"[&_svg]:h-full [&_svg]:w-full icon-md h-4 w-4\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; stroke-width: 1.5; flex-shrink: 0; height: 1rem; width: 1rem; color: rgb(180, 180, 180); font-family: ui-sans-serif, -apple-system, system-ui, "Segoe UI", Roboto, Ubuntu, Cantarell, "Noto Sans", sans-serif, Helvetica, "Apple Color Emoji", Arial, "Segoe UI Emoji", "Segoe UI Symbol"; background-color: rgb(33, 33, 33);\">\n <svg fill=\"none\" height=\"24\" viewbox=\"0 0 24 24\" width=\"24\" xmlns=\"http://www.w3.org/2000/svg\"><path d=\"M13.091 4.246 4.682 14H11a1 1 0 0 1 .973 1.23l-1.064 4.524L19.318 10H13a1 1 0 0 1-.973-1.229l1.064-4.525Zm-.848-2.08c1.195-1.386 3.448-.238 3.029 1.544L14.262 8h5.056c1.711 0 2.632 2.01 1.514 3.306l-9.075 10.528c-1.195 1.386-3.448.238-3.029-1.544L9.738 16H4.681c-1.711 0-2.632-2.01-1.514-3.306l9.075-10.527Z\" fill=\"currentColor\"></path></svg></div>\n </div>\n </button></span></div>\n </div>\n</div>\n<div class=\"flex flex-grow flex-col max-w-full\" style=\"border: 0px solid rgb(227, 227, 227); box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; 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box-sizing: border-box; --tw-border-spacing-x: 0; --tw-border-spacing-y: 0; --tw-translate-x: 0; --tw-translate-y: 0; --tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; 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--tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; --text-primary: var(--gray-100); --text-secondary: var(--gray-300); --text-tertiary: var(--gray-400); --text-quaternary: var(--gray-500); --text-error: var(--red-500); --border-light: hsla(0,0%,100%,.1); --border-medium: hsla(0,0%,100%,.15); --border-heavy: hsla(0,0%,100%,.2); --border-xheavy: hsla(0,0%,100%,.25); --main-surface-primary: var(--gray-800); --main-surface-secondary: var(--gray-750); 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--tw-rotate: 0; --tw-skew-x: 0; --tw-skew-y: 0; --tw-scale-x: 1; --tw-scale-y: 1; --tw-pan-x: ; --tw-pan-y: ; --tw-pinch-zoom: ; --tw-scroll-snap-strictness: proximity; --tw-gradient-from-position: ; --tw-gradient-via-position: ; --tw-gradient-to-position: ; --tw-ordinal: ; --tw-slashed-zero: ; --tw-numeric-figure: ; --tw-numeric-spacing: ; --tw-numeric-fraction: ; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(69,89,164,.5); --tw-ring-offset-shadow: 0 0 transparent; --tw-ring-shadow: 0 0 transparent; --tw-shadow: 0 0 transparent; --tw-shadow-colored: 0 0 transparent; --tw-blur: ; --tw-brightness: ; --tw-contrast: ; --tw-grayscale: ; --tw-hue-rotate: ; --tw-invert: ; --tw-saturate: ; --tw-sepia: ; --tw-drop-shadow: ; --tw-backdrop-blur: ; --tw-backdrop-brightness: ; --tw-backdrop-contrast: ; --tw-backdrop-grayscale: ; --tw-backdrop-hue-rotate: ; --tw-backdrop-invert: ; --tw-backdrop-opacity: ; --tw-backdrop-saturate: ; --tw-backdrop-sepia: ; --tw-contain-size: ; --tw-contain-layout: ; --tw-contain-paint: ; --tw-contain-style: ; margin: 0px;\">\n <span style=\"font-family:bookman old style,serif;\">"Exploring the Therapeutic Potential of Albenimol: A Review of Its Antiparasitic and Anticancer Properties"</span></p>\n <div>\n  </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • laymans_summary<div>\n <span style=\"font-family:bookman old style,serif;\">Albenimol is a drug that has shown promise in various studies for its potential therapeutic benefits. It belongs to a class of medications known as benzimidazoles, which have been used in the treatment of various conditions, including parasitic infections and certain cancers. Albenimol is thought to exert its effects by interfering with the growth and reproduction of cells, particularly those of parasites or cancerous cells.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-family:bookman old style,serif;\">One area of interest in Albenimol research is its potential as an anthelmintic, a type of medication used to treat parasitic worm infections. Parasitic worms, or helminths, can infect various organs in the body, causing a range of symptoms and health problems. Albenimol has been studied for its ability to effectively kill these parasites, thereby helping to alleviate the symptoms of infection and improve overall health.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-family:bookman old style,serif;\">In addition to its potential as an anthelmintic, Albenimol has also been investigated for its anticancer properties. Cancer is a complex group of diseases characterized by the uncontrolled growth and spread of abnormal cells. Albenimol is believed to inhibit the growth of cancer cells by interfering with their cell division process, ultimately leading to their death. This makes Albenimol a potentially valuable medication in the treatment of certain types of cancer.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-family:bookman old style,serif;\">One of the key advantages of Albenimol is its relatively low toxicity compared to other medications. This means that it can be used at higher doses without causing significant harm to the patient. However, like all medications, Albenimol does have side effects, which can vary depending on the dose and duration of treatment. Common side effects of Albenimol include nausea, vomiting, diarrhea, and abdominal pain. In rare cases, more serious side effects such as liver toxicity or allergic reactions may occur.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-family:bookman old style,serif;\">The use of Albenimol in clinical practice is still being explored, and more research is needed to fully understand its potential benefits and risks. Clinical trials are underway to evaluate the safety and efficacy of Albenimol in various patient populations, including those with parasitic infections and cancer. These studies will help to determine the optimal dose and treatment duration for Albenimol, as well as its long-term effects on patient outcomes.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-family:bookman old style,serif;\">In conclusion, Albenimol is a promising drug with potential therapeutic benefits in the treatment of parasitic infections and certain cancers. While more research is needed to fully understand its effects, early studies suggest that Albenimol could be a valuable addition to the arsenal of medications used to treat these conditions. As research into Albenimol continues, it is hoped that this drug will become an important tool in the fight against parasitic infections and cancer, ultimately improving the lives of patients worldwide.</span></div>\n
      • short_title\"Exploring Albenimol
      • protocol_noECCT/24/05/03
      • reference_no(null)
      • version_no1.0
      • date_of_protocol24-05-2024
      • study_drugAlbenimol
      • disease_conditionDepression
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameComparatorX
      • comparator_registeredYes
      • comparator_countriesUnited States\nUnited Kingdom\nGermany\nFrance\nJapan\nAustralia\nCanada\nBrazil\nSouth Africa\nIndia
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjayoma@intellisoftkenya.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicant+238394047
      • declaration_date124-05-2024
      • declaration_principal_investigatorJames Kware
      • declaration_date224-05-2024
      • placebo_presentNo
      • study_objectives<div>\n Evaluate the efficacy of the intervention in reducing symptoms and improving overall health outcomes, assess the safety profile of the treatment, including any adverse effects or complications, investigate the impact of the intervention on quality of life, including physical, mental, and social well-being, determine the optimal dosage and administration schedule of the drug to maximize effectiveness and minimize side effects, explore the long-term effects of the treatment to assess its sustainability and durability, compare the intervention with standard care or other existing treatments to determine its relative effectiveness, identify predictors of treatment response to personalize and optimize patient care, assess adherence to the treatment regimen to understand patient compliance and its impact on outcomes, evaluate the cost-effectiveness of the intervention to inform healthcare resource allocation and policy decisions, investigate the mechanism of action of the drug to better understand its effects on the body, assess the feasibility of implementing the intervention in real-world settings, considering logistical and practical challenges, determine the pharmacokinetics of the drug, including its absorption, distribution, metabolism, and excretion in the body, assess the impact of the intervention on biomarkers, such as blood tests or imaging studies, to monitor disease progression or treatment response, investigate the effect of the intervention on disease progression to assess its potential to slow or halt the course of the disease, explore the role of genetic factors in treatment response to personalize therapy and improve outcomes, assess the impact of the intervention on healthcare utilization, including hospitalizations, emergency department visits, and outpatient visits, determine the effect of the intervention on comorbid conditions, such as other medical or mental health conditions that may co-occur with the primary condition, evaluate the impact of the intervention on caregiver burden, including the physical, emotional, and financial strain on caregivers, assess the effect of the intervention on functional outcomes, such as the ability to perform daily activities or participate in social and recreational activities, investigate the impact of the intervention on patient satisfaction and quality of care, evaluate the impact of the intervention on healthcare costs, including direct medical costs and indirect costs such as lost productivity, determine the effect of the intervention on treatment adherence and persistence, including factors that may influence patient compliance, assess the effect of the intervention on mental health outcomes, such as anxiety, depression, or other psychological symptoms, explore the impact of the intervention on social functioning, including relationships, work, and community involvement, evaluate the impact of the intervention on physical health, including symptoms, physical functioning, and overall health status, assess the effect of the intervention on healthcare resource utilization, including hospitalizations, emergency department visits, and outpatient services, investigate the impact of the intervention on healthcare disparities, including differences in access to care and health outcomes among different populations, evaluate the impact of the intervention on health-related quality of life, including physical, mental, and social aspects of well-being, determine the effect of the intervention on healthcare access, including barriers to care and the availability of services, assess the effect of the intervention on patient-reported outcomes, such as symptoms, quality of life, and treatment satisfaction, investigate the impact of the intervention on healthcare costs, including direct medical costs and indirect costs such as lost productivity, assess the effect of the intervention on caregiver outcomes, including caregiver burden, quality of life, and mental health, evaluate the impact of the intervention on healthcare utilization, including hospitalizations, emergency department visits, and outpatient services, determine the effect of the intervention on treatment satisfaction, including patient preferences and experiences with care, investigate the impact of the intervention on healthcare disparities, including differences in access to care and health outcomes among different populations, assess the effect of the intervention on healthcare access, including barriers to care and the availability of services, evaluate the impact of the intervention on health-related quality of life, including physical, mental, and social aspects of well-being, determine the effect of the intervention on patient-reported outcomes, such as symptoms, quality of life, and treatment satisfaction, investigate the impact of the intervention on healthcare costs, including direct medical costs and indirect costs such as lost productivity, assess the effect of the intervention on caregiver outcomes, including caregiver burden, quality of life, and mental health, evaluate the impact of the intervention on healthcare utilization, including hospitalizations, emergency department visits, and outpatient services, determine the effect of the intervention on treatment satisfaction, including patient preferences and experiences with care, investigate the impact of the intervention on healthcare disparities, including differences in access to care and health outcomes among different populations, assess the effect of the intervention on healthcare access, including barriers to care and the availability of services, evaluate the impact of the intervention on health-related quality of life, including physical, mental, and social aspects of well-being, determine the effect of the intervention on patient-reported outcomes, such as symptoms, quality of life, and treatment satisfaction, investigate the impact of the intervention on healthcare costs, including direct medical costs and indirect costs such as lost productivity, assess the effect of the intervention on caregiver outcomes, including caregiver burden, quality of life, and mental health, evaluate the impact of the intervention on healthcare utilization, including hospitalizations, emergency department visits,</div>\n
      • principal_inclusion_criteria<div>\n Inclusion criteria are essential factors that determine whether a participant is eligible to participate in a clinical trial or study. Here are five principal inclusion criteria for a hypothetical study:</div>\n<div>\n  </div>\n<div>\n 1. Age and Gender: Participants must be between 18 and 65 years old, of any gender, to ensure a diverse sample that represents the general population affected by the condition under study. This criterion is important to establish a baseline understanding of how the intervention impacts different age groups and genders.</div>\n<div>\n  </div>\n<div>\n 2. Diagnosis of the Condition: Participants must have a confirmed diagnosis of the target condition, as determined by specific diagnostic criteria (e.g., clinical symptoms, laboratory tests, imaging studies). This criterion ensures that participants have the condition being studied, allowing researchers to assess the intervention's effectiveness in treating or managing the condition.</div>\n<div>\n  </div>\n<div>\n 3. Treatment History: Participants must have a documented history of inadequate response or intolerance to standard treatments for the condition. This criterion helps identify individuals who may benefit from alternative or experimental interventions and ensures that participants have a genuine need for the new treatment approach.</div>\n<div>\n  </div>\n<div>\n 4.Ability to Provide Informed Consent: Participants must be able to understand the study's purpose, risks, and benefits and provide informed consent to participate. This criterion is essential to protect participants' rights and ensure that they understand the nature of their involvement in the study.</div>\n<div>\n  </div>\n<div>\n 5. Willingness to Comply with Study Requirements: Participants must be willing and able to comply with all study procedures, including attending scheduled visits, taking medications as prescribed, and completing study assessments. This criterion helps ensure the study's integrity and reliability by minimizing dropouts and ensuring data completeness.</div>\n<div>\n  </div>\n<div>\n These inclusion criteria help define the characteristics of the participants who will be included in the study, ensuring that the results are meaningful and applicable to the target population.</div>\n
      • principal_exclusion_criteria<div>\n  </div>\n<div>\n 1. **Pregnancy or Lactation:** Women who are pregnant, breastfeeding, or planning to become pregnant during the study period may be excluded due to potential risks to the fetus or infant from the investigational treatment.</div>\n<div>\n  </div>\n<div>\n 2. **Severe Comorbidities:** Individuals with severe comorbid conditions that could interfere with the study outcomes or pose a risk to their safety may be excluded. Examples include severe cardiovascular disease, uncontrolled diabetes, or active cancer.</div>\n<div>\n  </div>\n<div>\n 3. **Psychiatric Disorders:** Individuals with severe psychiatric disorders, such as schizophrenia or bipolar disorder, may be excluded due to potential challenges in assessing the intervention's effects or ensuring compliance with study procedures.</div>\n<div>\n  </div>\n<div>\n 4. **Substance Abuse:** Individuals with a history of substance abuse or dependence, such as alcohol or drug abuse, may be excluded due to potential interactions between the investigational treatment and substances of abuse.</div>\n<div>\n  </div>\n<div>\n 5. **Previous Participation in Similar Studies:** Individuals who have participated in a similar study involving the investigational treatment or a closely related intervention may be excluded to avoid confounding effects from previous exposure.</div>\n<div>\n  </div>\n<div>\n 6. **Allergy or Sensitivity:** Individuals with known allergies or sensitivities to the investigational treatment or its components may be excluded due to the risk of allergic reactions.</div>\n<div>\n  </div>\n<div>\n 7. **Inability to Provide Informed Consent:** Individuals who are unable to understand the study requirements, risks, and benefits, or provide informed consent, may be excluded to ensure that participants can fully understand and voluntarily participate in the study.</div>\n<div>\n  </div>\n<div>\n 8. **Use of Certain Medications:** Individuals taking medications that could interact with the investigational treatment or affect the study outcomes may be excluded. Examples include certain antibiotics, anticoagulants, or immunosuppressants.</div>\n<div>\n  </div>\n<div>\n 9. **Unwillingness to Comply with Study Requirements:** Individuals who are unwilling or unable to comply with study procedures, such as attending scheduled visits or completing study assessments, may be excluded to ensure the study's integrity and reliability.</div>\n
      • primary_end_points<div>\n  </div>\n<div>\n 1. **Clinical Response Rate:** The primary endpoint is the proportion of patients who achieve a predefined clinical response, such as a reduction in symptoms or improvement in a specific clinical parameter, after a specified treatment period.</div>\n<div>\n  </div>\n<div>\n 2. **Disease Progression:** Another primary endpoint is the rate of disease progression, as measured by changes in biomarkers, imaging studies, or clinical assessments, over the study period.</div>\n<div>\n  </div>\n<div>\n 3. **Survival Rate:** The study may also assess the survival rate of patients treated with the new drug compared to standard treatment or placebo over a specified follow-up period.</div>\n<div>\n  </div>\n<div>\n 4. **Quality of Life Improvement:** The primary endpoint could include improvements in quality of life, as measured by validated questionnaires or assessments, in patients receiving the new drug compared to those receiving standard treatment or placebo.</div>\n<div>\n  </div>\n<div>\n 5. **Disease-Free Survival:** Another primary endpoint is the duration of time during which patients remain free of disease recurrence or progression after receiving treatment.</div>\n<div>\n  </div>\n<div>\n 6. **Symptom Relief:** The study may assess the degree of symptom relief experienced by patients, as measured by changes in symptom severity scores or patient-reported outcomes, after treatment with the new drug.</div>\n<div>\n  </div>\n<div>\n 7. **Functional Improvement:** The primary endpoint could include improvements in physical or cognitive function, as measured by standardized assessments, in patients receiving the new drug compared to standard treatment or placebo.</div>\n<div>\n  </div>\n<div>\n 8. **Safety and Tolerability:** The study will also evaluate the safety and tolerability of the new drug, with the primary endpoint being the incidence and severity of adverse events reported by patients during the study period.</div>\n<div>\n  </div>\n<div>\n These primary endpoints are critical for evaluating the efficacy, safety, and impact of the new drug on patients with the target medical condition.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • 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<div>\n 1. Mombasa General Hospital:</div>\n<div>\n    - Capacity: 300 beds</div>\n<div>\n    - Number of Staff: 250</div>\n<div>\n      - Dr. Jane Kinyua (Medical Director, MBChB, MPH, 15 years experience)</div>\n<div>\n      - Sarah Wambui (Head Nurse, BScN, 10 years experience)</div>\n<div>\n      - John Kamau (Lab Technician, Diploma in Medical Laboratory Sciences, 8 years experience)</div>\n<div>\n    - Site Facilities: Operating theaters, laboratory, pharmacy, radiology department</div>\n<div>\n    - Emergency Facilities: Emergency department, ambulance services</div>\n<div>\n    - Other Infrastructure: Conference rooms, cafeteria</div>\n<div>\n  </div>\n<div>\n 2. Kisumu Medical Center:</div>\n<div>\n    - Capacity: 250 beds</div>\n<div>\n    - Number of Staff: 200</div>\n<div>\n      - Dr. Peter Otieno (Medical Officer, MBChB, 8 years experience)</div>\n<div>\n      - Mercy Auma (Nurse, Diploma in Nursing, 5 years experience)</div>\n<div>\n      - Joseph Ochieng (Pharmacist, BPharm, 7 years experience)</div>\n<div>\n    - Site Facilities: Outpatient department, maternity ward, pediatric ward</div>\n<div>\n    - Emergency Facilities: Emergency room, ICU</div>\n<div>\n    - Other Infrastructure: Library, staff quarters</div>\n<div>\n  </div>\n<div>\n 3. Nakuru Community Hospital:</div>\n<div>\n    - Capacity: 150 beds</div>\n<div>\n    - Number of Staff: 120</div>\n<div>\n      - Dr. Susan Mwangi (Hospital Administrator, MBA, 12 years experience)</div>\n<div>\n      - James Kariuki (Clinical Officer, Diploma in Clinical Medicine, 9 years experience)</div>\n<div>\n      - Faith Njeri (Lab Technologist, Diploma in Medical Laboratory Sciences, 5 years experience)</div>\n<div>\n    - Site Facilities: Radiology department, physiotherapy unit, dental clinic</div>\n<div>\n    - Emergency Facilities: Casualty department, ambulance services</div>\n<div>\n    - Other Infrastructure: Staff canteen, recreational facilities</div>\n<div>\n  </div>\n<div>\n 4. Eldoret Health Center:</div>\n<div>\n    - Capacity: 200 beds</div>\n<div>\n    - Number of Staff: 180</div>\n<div>\n      - Dr. David Kimani (Medical Superintendent, MBChB, MPH, 17 years experience)</div>\n<div>\n      - Grace Chebet (Nurse, BScN, 10 years experience)</div>\n<div>\n      - Charles Omondi (Pharmacist, BPharm, 12 years experience)</div>\n<div>\n    - Site Facilities: Outpatient clinics, surgical unit, HIV/AIDS clinic</div>\n<div>\n    - Emergency Facilities: Emergency room, ambulance services</div>\n<div>\n    - Other Infrastructure: Auditorium, guest house for visitors</div>\n<div>\n  </div>\n<div>\n 5. Thika District Hospital:</div>\n<div>\n    - Capacity: 280 beds</div>\n<div>\n    - Number of Staff: 220</div>\n<div>\n      - Dr. Mercy Wanjiku (Head of Department, Pediatrics, MBChB, 13 years experience)</div>\n<div>\n      - John Mwangi (Registered Nurse, BScN, 8 years experience)</div>\n<div>\n      - Esther Njoki (Lab Technologist, Diploma in Medical Laboratory Sciences, 6 years experience)</div>\n<div>\n    - Site Facilities: Maternity wing, laboratory, pharmacy</div>\n<div>\n    - Emergency Facilities: Emergency department, ambulance services</div>\n<div>\n    - Other Infrastructure: Staff gym, daycare center</div>\n<div>\n  </div>\n<div>\n 6. Kitale Medical Clinic:</div>\n<div>\n    - Capacity: 100 beds</div>\n<div>\n    - Number of Staff: 80</div>\n<div>\n      - Dr. James Mugo (Medical Officer, MBChB, 6 years experience)</div>\n<div>\n      - Mary Njoroge (Nurse, Diploma in Nursing, 4 years experience)</div>\n<div>\n      - Patrick Ochieng (Lab Technologist, Diploma in Medical Laboratory Sciences, 3 years experience)</div>\n<div>\n    - Site Facilities: Outpatient services, laboratory, pharmacy</div>\n<div>\n    - Emergency Facilities: Emergency room</div>\n<div>\n    - Other Infrastructure: Waiting area, administrative offices</div>\n<div>\n  </div>\n<div>\n 7. Machakos General Hospital:</div>\n<div>\n    - Capacity: 220 beds</div>\n<div>\n    - Number of Staff: 180</div>\n<div>\n      - Dr. Alice Mutisya (Hospital Administrator, MBA, 10 years experience)</div>\n<div>\n      - Paul Kimani (Clinical Officer, Diploma in Clinical Medicine, 7 years experience)</div>\n<div>\n      - Grace Wambui (Lab Technologist, Diploma in Medical Laboratory Sciences, 5 years experience)</div>\n<div>\n    - Site Facilities: Surgical unit, maternity wing, radiology department</div>\n<div>\n    - Emergency Facilities: Emergency department, ambulance services</div>\n<div>\n    - Other Infrastructure: Staff cafeteria, pharmacy, library</div>\n
      • other_details_explanation<div>\n 1. **Access to a Diverse Patient Population:** Kenya's population is diverse, with a wide range of genetic, environmental, and lifestyle factors that can influence disease prevalence, progression, and treatment response. Conducting a trial in Kenya may allow researchers to study the effects of the investigational treatment in a population that is different from the sponsor's home country, potentially providing valuable insights into the treatment's efficacy and safety across different populations.</div>\n<div>\n  </div>\n<div>\n 2. **Availability of Expertise:** Kenya has a growing healthcare infrastructure and a skilled workforce of healthcare professionals who are experienced in conducting clinical trials. Collaborating with Kenyan researchers and institutions can provide access to local expertise and resources that may enhance the quality and efficiency of the trial.</div>\n<div>\n  </div>\n<div>\n 3. **Regulatory Environment:** Kenya has a well-established regulatory framework for clinical trials, which is aligned with international standards and guidelines. Conducting a trial in Kenya may streamline the regulatory approval process and facilitate the timely initiation and completion of the study.</div>\n<div>\n  </div>\n<div>\n 4. **Patient Recruitment:** Conducting a trial in Kenya may offer access to a larger pool of eligible participants, which can be particularly beneficial for studies that require a diverse or specific patient population. Kenya's population size and demographic diversity make it an attractive location for patient recruitment.</div>\n<div>\n  </div>\n<div>\n 5. **Cost-Effectiveness:** Conducting a trial in Kenya may be more cost-effective than in other countries, due to lower operational costs, including clinical trial site fees, healthcare costs, and staffing costs. This can be especially advantageous for sponsors looking to conduct large-scale or long-term trials.</div>\n<div>\n  </div>\n<div>\n Overall, conducting a clinical trial in Kenya can offer several advantages, including access to a diverse patient population, local expertise, a supportive regulatory environment, and cost-effectiveness. These factors can contribute to the successful completion of the trial and the generation of valuable data that can benefit patients both in Kenya and globally.</div>\n
      • other_details_regulatory_notapproved<p>\n P<span apple=\"\" color=\"\" font-size:=\"\" noto=\"\" segoe=\"\" style=\"background-color: rgb(33, 33, 33); color: rgb(236, 236, 236); font-family: ui-sans-serif, -apple-system, system-ui, \" ui=\"\" white-space-collapse:=\"\">harmacy and Poisons Board </span></p>\n
      • other_details_regulatory_approved<div>\n 1. **United States (FDA):**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 10</div>\n<div>\n  </div>\n<div>\n 2. **European Medicines Agency (EMA) - European Union:**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 8</div>\n<div>\n  </div>\n<div>\n 3. **Australia (TGA):**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 5</div>\n<div>\n  </div>\n<div>\n 4. **Canada (Health Canada):**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 4</div>\n<div>\n  </div>\n<div>\n 5. **India (CDSCO):**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 6</div>\n<div>\n  </div>\n<div>\n 6. **South Africa (SAHPRA):**</div>\n<div>\n    - Date of Approval: May 24, 2024</div>\n<div>\n    - Number of Sites: 3</div>\n
      • other_details_regulatory_rejected<div>\n  </div>\n<div>\n 1. **Incomplete or Insufficient Data:** If the trial application lacks essential information or the data provided is not comprehensive enough to assess the risks and benefits of the trial, it may be rejected.</div>\n<div>\n  </div>\n<div>\n 2. **Safety Concerns:** If the regulatory authority or ethics committee determines that the investigational drug poses significant safety risks to participants, they may reject the trial to protect participant safety.</div>\n<div>\n  </div>\n<div>\n 3. **Ethical Concerns:** If the trial design or procedures raise ethical issues, such as inadequate informed consent procedures, exploitation of vulnerable populations, or insufficient protection of participant rights, the trial may be rejected.</div>\n<div>\n  </div>\n<div>\n 4. **Methodological Concerns:** If the trial design, including the sample size, randomization, or statistical analysis plan, is deemed inadequate or flawed, the trial may be rejected due to concerns about the validity and reliability of the results.</div>\n<div>\n  </div>\n<div>\n 5. **Conflict of Interest:** If there are perceived conflicts of interest, such as financial relationships between the trial sponsor and investigators that could bias the study results, the trial may be rejected to ensure the integrity of the research.</div>\n<div>\n  </div>\n<div>\n 6. **Regulatory Non-Compliance:** If the trial does not comply with regulatory requirements or guidelines, such as those related to Good Clinical Practice (GCP) or reporting of adverse events, it may be rejected until these issues are addressed.</div>\n
      • other_details_regulatory_halted<p>\n /a</p>\n
      • estimated_duration36
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorComparatorX
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites12
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site3000
      • total_participants_worldwide3600000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSamuel
      • investigator1_middle_name
      • investigator1_family_nameMwangi
      • investigator1_qualificationMBChB, MPH
      • investigator1_professional_addressKenyatta National Hospital, P.O. Box 12345, Nairobi, Kenya
      • investigator1_telephone+254-722-123-456
      • investigator1_emailsamuel.mwangi@kenyahospitals.org
      • organisations_transferred_No
      • number_participants360000
      • notification<p>\n N/A</p>\n
      • approval_date21-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-05-2024
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApproved
      • 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_invoice301885
      • modified2024-06-21 07:00:59
      • created2024-05-24 11:44:21
    • InvestigatorContact(array)
      • 0(array)
        • id17
        • application_id43
        • given_nameGrace
        • middle_name
        • family_nameOmondi
        • qualificationPhD
        • professional_addressUniversity of Nairobi, P.O. Box 54321, Nairobi, Kenya
        • telephone+254-733-987-654
        • emailgrace.omondi@uonbi.ac.ke
        • created2024-05-24 11:52:46
        • modified2024-05-24 12:58:04
    • SiteDetail(array)
      • 0(array)
        • id37
        • application_id43
        • county_id1
        • site_nameMombasa General Hospital
        • physical_addressMoi Avenue, Mombasa
        • contact_details+254-41-222-2222, P.O. Box: 12345-00100
        • contact_personDr. Jane Kinyua
        • site_capacity(null)
        • misc(null)
        • created2013-02-21 08:45:41
        • modified2024-05-24 12:58:04
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
      • 1(array)
        • id1663
        • application_id43
        • county_id42
        • site_nameKisumu Medical Center
        • physical_addressOginga Odinga Road, Kisumu
        • contact_detailsTel: +254-57-333-3333, P.O. Box: 54321-40100
        • contact_personDr. Peter Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1664
        • application_id43
        • county_id32
        • site_nameNakuru Community Hospital
        • physical_addressKenyatta Avenue, Nakuru
        • contact_details+254-51-444-4444, P.O. Box: 67890-20100
        • contact_personDr. Susan Mwangi
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id32
          • county_nameNakuru
          • created2012-06-15 10:25:52
          • modified2012-06-15 10:25:52
      • 3(array)
        • id1665
        • application_id43
        • county_id27
        • site_name Eldoret Health Center
        • physical_addressUganda Road, Eldoret
        • contact_detailsTel: +254-53-555-5555, P.O. Box: 98765-30100
        • contact_personDr. David Kimani
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 4(array)
        • id1666
        • application_id43
        • county_id22
        • site_nameThika District Hospital
        • physical_address Uhuru Street, Thika
        • contact_detailsTel: +254-67-666-6666, P.O. Box: 23456-50100
        • contact_personDr. Mercy Wanjiku
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 5(array)
        • id1667
        • application_id43
        • county_id26
        • site_name Kitale Medical Clinic
        • physical_addressHospital Road, Kitale
        • contact_detailsTel: +254-54-777-7777, P.O. Box: 34567-30200
        • contact_personDr. James Mugo
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id26
          • county_nameTrans Nzoia
          • created2012-06-15 10:25:05
          • modified2012-06-15 10:25:05
      • 6(array)
        • id1668
        • application_id43
        • county_id16
        • site_nameMachakos General Hospital
        • physical_addressMwatu Wa Ngoma Road, Machakos
        • contact_detailsTel: +254-44-888-8888, P.O. Box: 45678-90100
        • contact_personDr. Alice Mutisya
        • site_capacity(null)
        • misc(null)
        • created2024-05-24 12:28:23
        • modified2024-05-24 12:58:04
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
    • Sponsor(array)
      • 0(array)
        • id17
        • application_id43
        • sponsorABC Pharmaceuticals Ltd.
        • sponsor_typeIndustry
        • contact_personJohn Smith
        • address 789 Oak Avenue, Nairobi, Kenya
        • telephone_number+254-20-987-6543
        • fax_number+254-20-987-6544
        • cell_number+254-712-345-678
        • email_addressjohn.smith@abcpharma.co.ke
        • created2024-05-24 11:52:46
        • modified2024-05-24 12:58:04
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_exploratory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
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  • 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)
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    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
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    • 2CORE/Cache/CacheEngine.php
  • Component(array)
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    • 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)
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    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
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    • 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