<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465747</url>
  </required_header>
  <id_info>
    <org_study_id>MB-2</org_study_id>
    <nct_id>NCT04465747</nct_id>
  </id_info>
  <brief_title>Egyptian Liver Library: Rebuilding the Pyramid of Liver Disease Evidence in Egypt</brief_title>
  <acronym>ELL</acronym>
  <official_title>Egyptian Liver Library: Rebuilding the Pyramid of Liver Disease Evidence in Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A lot of publications about liver disease are available worldwide. Egypt is one of the&#xD;
      countries having a large number of publications in hepatology. There are defects in reviewing&#xD;
      this evidence and making use of it. Addressing the areas of weakness in liver research in&#xD;
      Egypt is challenging to researchers and clinicians. Creating a library for liver disease&#xD;
      evidence in Egypt can solve this problem and lead future research in hepatology in Egypt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Egypt is considered one of the countries with large liver disease burden in the world being&#xD;
      endemic with bilharziasis and hepatitis C for decades. Limitations in health care resource&#xD;
      further augment the magnitude of the problem allowing the development of disease specific&#xD;
      complications in absence of effective treatments over the past. With discovery of&#xD;
      anti-schistosomal therapy and implementation of the national program for eliminating&#xD;
      bilharziasis; bilharzial liver disease incidence regressed markedly. However; complications&#xD;
      of bilharzial liver disease are still present. The situation has been repeated with hepatitis&#xD;
      C which is still a major health problem in Egypt regardless of the availability of highly&#xD;
      effective interferon free antiviral regimens. This is mainly due to the large number of&#xD;
      infected patients (estimated to be more than 6 million) [1], re-infection and presence of&#xD;
      complications that needs further management. The need for addressing these major health&#xD;
      problems in Egypt provoked a lot of research in the field of hepatology. Egyptian and&#xD;
      non-Egyptian researchers have published a lot of scientific reports about liver diseases in&#xD;
      Egypt. Since the ancient age of the pharaohs there were written evidence about liver disease&#xD;
      in Egypt. It was reported in the Ebres Papyrus (around 2600 BC) that hardness of the liver&#xD;
      occurs secondary to excess alcohol ingestion [2]. This was one of the oldest documented&#xD;
      detailed medical literatures in the history of mankind. In the recent age there were a lot&#xD;
      reports from Egypt about bilharziasis and other parasitic infestations as the one published&#xD;
      by Cobbold in 1982 about injurious parasites in Egypt [3]. Further enormous amount of&#xD;
      publications has been released afterwards. Reviewing this evidence and creating an indexed&#xD;
      data base for it could be of value for the national and international hepatology platforms. I&#xD;
      aim with other colleagues at reviewing all published evidence in the field of hepatology from&#xD;
      Egypt up to January 2016 and classifying it by different key words to build a data base of&#xD;
      liver disease evidence in Egypt. This data base will be continuously updated by published&#xD;
      data after January 1st 2016 and will be the reference for researchers from Egypt and rest of&#xD;
      the world. The data base will invite all authors from Egypt to provide their raw data of&#xD;
      published articles to be available for further analyses by other researchers. Moreover the&#xD;
      data base work team will start a series of systematic reviews and meta analyses for the&#xD;
      available relevant data aiming at addressing the areas of strength and areas of weakness in&#xD;
      liver disease research in Egypt making further recommendations to the research authorities&#xD;
      about what is missing and how it is better to be addressed in their future research calls.&#xD;
      This pilot research work can be reproduced elsewhere by other researchers in their own&#xD;
      countries making use of their published data and advising their local research authorities to&#xD;
      fill up the gaps in liver research in their own countries. Hopefully in the near future we&#xD;
      will have these groups working together in a network driving liver research globally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Review of all published articles about liver disease in Egypt till April 2017</measure>
    <time_frame>1 year</time_frame>
    <description>Indexing articles according to types of liver disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identifying missing diseases in hepatology research in Egypt</measure>
    <time_frame>1 year</time_frame>
    <description>Identifying missing diseases in hepatology research in Egypt</description>
  </secondary_outcome>
  <enrollment type="Actual">5068</enrollment>
  <condition>Liver Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Publications</intervention_name>
    <description>Reviewing published evidence</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Published articles about liver disease up to January 2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Published articles about liver disease up to January 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anything else&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Alboraie, M.D., MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhay University, Cairo, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al-Azhar Uinversity</name>
      <address>
        <city>Cairo</city>
        <zip>11884</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Bruggmann, P., Berg, T., Øvrehus, A. L. H., Moreno, C., Brandão Mello, C. E., Roudot-Thoraval, F., Marinho, R. T., Sherman, M., Ryder, S. D., Sperl, J., Akarca, U., Balık, İ., Bihl, F., Bilodeau, M., Blasco, A. J., Buti, M., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hézode, C., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marotta, P., Mauss, S., Mendes Correa, M. C., Müllhaupt, B., Myers, R. P., Negro, F., Nemecek, V., Örmeci, N., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Rosenberg, W. M., Sarmento-Castro, R., Sarrazin, C., Semela, D., Shiha, G. E., Sievert, W., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Vogel, W., Waked, I., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Van Damme, P., Aleman, S. and Hindman, S. J. (2014), Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of Viral Hepatitis, 21: 5-33. doi: 10.1111/jvh.12247</citation>
  </reference>
  <results_reference>
    <citation>Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011 Dec 15;84(12):1353-9.</citation>
    <PMID>22230269</PMID>
  </results_reference>
  <results_reference>
    <citation>Cobbold TS. Remarks on Injurious Parasites of Egypt in Relation to Water-Drinking. Br Med J. 1882 Sep 16;2(1133):503-4. doi: 10.1136/bmj.2.1133.503. No abstract available.</citation>
    <PMID>20750313</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 30, 2016</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Mohamed Alboraie</investigator_full_name>
    <investigator_title>Postgraduate clinical researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465747
org study id: MB-2
nct id: NCT04465747
lead sponsor: 
has dmc: No
A lot of publications about liver disease are available worldwide. Egypt is one of the
      countries having a large number of publications in hepatology. There are defects in reviewing
      this evidence and making use of it. Addressing the areas of weakness in liver research in
      Egypt is challenging to researchers and clinicians. Creating a library for liver disease
      evidence in Egypt can solve this problem and lead future research in hepatology in Egypt.
Egypt is considered one of the countries with large liver disease burden in the world being
      endemic with bilharziasis and hepatitis C for decades. Limitations in health care resource
      further augment the magnitude of the problem allowing the development of disease specific
      complications in absence of effective treatments over the past. With discovery of
      anti-schistosomal therapy and implementation of the national program for eliminating
      bilharziasis; bilharzial liver disease incidence regressed markedly. However; complications
      of bilharzial liver disease are still present. The situation has been repeated with hepatitis
      C which is still a major health problem in Egypt regardless of the availability of highly
      effective interferon free antiviral regimens. This is mainly due to the large number of
      infected patients (estimated to be more than 6 million) [1], re-infection and presence of
      complications that needs further management. The need for addressing these major health
      problems in Egypt provoked a lot of research in the field of hepatology. Egyptian and
      non-Egyptian researchers have published a lot of scientific reports about liver diseases in
      Egypt. Since the ancient age of the pharaohs there were written evidence about liver disease
      in Egypt. It was reported in the Ebres Papyrus (around 2600 BC) that hardness of the liver
      occurs secondary to excess alcohol ingestion [2]. This was one of the oldest documented
      detailed medical literatures in the history of mankind. In the recent age there were a lot
      reports from Egypt about bilharziasis and other parasitic infestations as the one published
      by Cobbold in 1982 about injurious parasites in Egypt [3]. Further enormous amount of
      publications has been released afterwards. Reviewing this evidence and creating an indexed
      data base for it could be of value for the national and international hepatology platforms. I
      aim with other colleagues at reviewing all published evidence in the field of hepatology from
      Egypt up to January 2016 and classifying it by different key words to build a data base of
      liver disease evidence in Egypt. This data base will be continuously updated by published
      data after January 1st 2016 and will be the reference for researchers from Egypt and rest of
      the world. The data base will invite all authors from Egypt to provide their raw data of
      published articles to be available for further analyses by other researchers. Moreover the
      data base work team will start a series of systematic reviews and meta analyses for the
      available relevant data aiming at addressing the areas of strength and areas of weakness in
      liver disease research in Egypt making further recommendations to the research authorities
      about what is missing and how it is better to be addressed in their future research calls.
      This pilot research work can be reproduced elsewhere by other researchers in their own
      countries making use of their published data and advising their local research authorities to
      fill up the gaps in liver research in their own countries. Hopefully in the near future we
      will have these groups working together in a network driving liver research globally.
observational model: Cohort
time perspective: Retrospective
measure: Review of all published articles about liver disease in Egypt till April 2017
time frame: 1 year
description: Indexing articles according to types of liver disease
measure: Identifying missing diseases in hepatology research in Egypt
time frame: 1 year
description: Identifying missing diseases in hepatology research in Egypt
intervention type: Other
intervention name: Publications
description: Reviewing published evidence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohamed Alboraie, M.D., MRCP
role: Principal Investigator
affiliation: Al-Azhay University, Cairo, Egypt
facility: 
country: Egypt
citation: Bruggmann, P., Berg, T., Øvrehus, A. L. H., Moreno, C., Brandão Mello, C. E., Roudot-Thoraval, F., Marinho, R. T., Sherman, M., Ryder, S. D., Sperl, J., Akarca, U., Balık, İ., Bihl, F., Bilodeau, M., Blasco, A. J., Buti, M., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hézode, C., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marotta, P., Mauss, S., Mendes Correa, M. C., Müllhaupt, B., Myers, R. P., Negro, F., Nemecek, V., Örmeci, N., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Rosenberg, W. M., Sarmento-Castro, R., Sarrazin, C., Semela, D., Shiha, G. E., Sievert, W., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Vogel, W., Waked, I., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Van Damme, P., Aleman, S. and Hindman, S. J. (2014), Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of Viral Hepatitis, 21: 5-33. doi: 10.1111/jvh.12247
citation: Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011 Dec 15;84(12):1353-9.
PMID: 22230269
citation: Cobbold TS. Remarks on Injurious Parasites of Egypt in Relation to Water-Drinking. Br Med J. 1882 Sep 16;2(1133):503-4. doi: 10.1136/bmj.2.1133.503. No abstract available.
PMID: 20750313
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Mohamed Alboraie
investigator title: Postgraduate clinical researcher
mesh term: Liver Diseases
sharing ipd: No