Example of a valid OpenTrials XML

RBR-3nm5bv-ot.xml

<?xml version="1.0" encoding="UTF-8"?>

<!DOCTYPE trials SYSTEM "http://localhost:8000/xml/opentrials.dtd">
<trials version="1">

    <trial language="en"
           status="published"
           date_registration="2011-07-06"
           created="2011-06-16"
           updated="2011-08-30">
        <trial_identification>
            <trial_id>RBR-1133</trial_id>
            <utrn_number>U3331-7766-2906</utrn_number>
            <reg_name>REBEC</reg_name>

            <public_title>Impact of pulmonary rehabilitation</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Impact of pulmonary rehabilitation in the incidence of postoperative respiratory complications in pulmonary resection for lung cancer
</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
        </trial_identification>

        <sponsors_and_support>
            <primary_sponsor country_code="BR" type="ministery_of_health">
                <name>HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE</name>
                <address>WWW.HM.CE.GOV.BR</address>
                <state></state>
                <city></city>
            </primary_sponsor>



            <source_support country_code="BR" type="ministery_of_health">
                <name>HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE</name>
                <address>WWW.HM.CE.GOV.BR</address>
                <state></state>
                <city></city>
            </source_support>

        </sponsors_and_support>

        <health_conditions>

            <hc_code vocabulary="decs" version="" code="C04">
                <text>Neoplasms</text>


                <text_translation lang="es">Neoplasias</text_translation>

                <text_translation lang="pt-br">Neoplasias</text_translation>


            </hc_code>

            <hc_code vocabulary="decs" version="" code="C08">
                <text>Respiratory tract diseases</text>


                <text_translation lang="es">Enfermedades respiratorias</text_translation>

                <text_translation lang="pt-br">Doenças respiratórias</text_translation>


            </hc_code>



            <keyword vocabulary="decs" version="" code="C04.588.894.797.520">
                <text>Lung Neoplasms</text>

                <text_translation lang="es">Neoplasias Pulmonares</text_translation>

                <text_translation lang="pt-br">Neoplasias Pulmonares</text_translation>


            </keyword>


            <freetext>Lung Cancer
Pre/post operative complication</freetext>

        </health_conditions>

        <interventions>

            <i_code value="proceduresurgery"></i_code>



            <keyword vocabulary="decs" version="" code="G11.427.590.237">
                <text>Exercise</text>

                <text_translation lang="es">Ejercicio</text_translation>

                <text_translation lang="pt-br">Exercício</text_translation>


            </keyword>

            <keyword vocabulary="decs" version="" code="D23.101">
                <text>Biological Markers</text>


                <text_translation lang="es">Marcadores Biológicos</text_translation>

                <text_translation lang="pt-br">Marcadores Biológicos</text_translation>


            </keyword>


            <freetext>Pulmonary resection
Pulmonary Rehabilitation
Conventional chest therapy
physical exercise

</freetext>
        </interventions>

        <recruitment status="recruiting">

            <recruitment_country value="BR"></recruitment_country>


            <inclusion_criteria>Staging of lung cancer among IA, IB, IIA, IIB and IIIA.
Medical Research Council (MRC)dyspnea scale at moderate to severe.
Candidate for pulmonary resection through thoracotomy.
Males and females aged greater than or equal to 38 years and less than or equal to 80 years.
</inclusion_criteria>
            <exclusion_criteria>Severe cardiovascular or other diseases that contraindicate exercise;
Diseases with orthopedic impairments that preclude the exercise.</exclusion_criteria>

            <gender value="both"></gender>
            <agemin value="38" unit="null"></agemin>
            <agemax value="80" unit="null"></agemax>


            <date_enrolment_actual start="2010-01-01" end="None"></date_enrolment_actual>


            <target_size value="30"></target_size>
        </recruitment>

        <study expanded_access_program="False"
               number_of_arms="2">
            <study_design>Clinical trial, randomized, phase 2-3, blind. The patients will be divided in 2 groups, GA (pulmonary rehabilitation) and GB (chest physical therapy).
</study_design>

            <phase value="2-3"></phase>
            <purpose value="treatment"></purpose>
            <intervention_assignment value="parallel"></intervention_assignment>
            <masking value="single-blind"></masking>
            <allocation value="randomized-controlled"></allocation>
        </study>

        <outcomes>

            <primary_outcome value="The primary endpoint will be evaluated by the post operative pulmonary complications (mechanical ventilation duration, days of intensive care unit, bronchospasm, atelectasis, bronchopleural fistula, empyema, pneumonia, tracheobronchitis, duration of chest tube, acute respiratory failure.
">

                <outcome_translation value="" lang="es"></outcome_translation>

                <outcome_translation value="O desfecho primário será avaliado pelas complicações pulmonares pós-operatórias (tempo de ventilação mecânica, número de dias em unidade de terapia intensiva, broncoespasmo, atelectasia, fístula broncopleural, empiema pleural, pneumonia, traqueobronquite, tempo de dreno torácico, insuficiência respiratória aguda." lang="pt-br"></outcome_translation>

            </primary_outcome>


            <secondary_outcome value="The secondary endpoint will be evaluated by pressure manovacuometry test (respiratory muscle strength)
, health related quality of life test (SF-36 questionnaire), six minutes walk distance test (physical capacity) and hospital anxiety and depression test (HADS - Hospital anxiety and depression scale).

">

                <outcome_translation value="" lang="es"></outcome_translation>

                <outcome_translation value="O desfecho secundário será avaliado pelos testes de Manovacuometria (força muscular respiratória), teste de qualidade de vida (Questionário de qualidade de vida SF-36),  teste de ansiedade e depressão (Questionário HADS - Hospital anxiety and depression scale) e teste da caminhada de seis minutos (capacidade física)" lang="pt-br"></outcome_translation>

            </secondary_outcome>

        </outcomes>

        <contacts>

            <person pid="152" country_code="BR">
                <firstname>Maria</firstname>
                <middlename>Tereza Pessoa</middlename>
                <lastname>Morano</lastname>
                <address>Av. Frei Cirilo, 3480</address>
                <city>Fortaleza</city>

                <zip>60864190</zip>
                <telephone>85 - 310140565</telephone>
                <email>ttmorano@hotmail.com</email>

                <affiliation country_code="BR" type="ministery_of_health">
                    <name>HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE</name>
                    <address>WWW.HM.CE.GOV.BR</address>

                </affiliation>

            </person>

            <person pid="153" country_code="BR">
                <firstname>Comitê de Ética em Pesquisa</firstname>
                <middlename>dos Seres Humanos</middlename>
                <lastname>Dr. Carlos Alberto Studat Gomes</lastname>

                <address>Av. Frei Cirilo, 3480</address>
                <city>Fortaleza</city>
                <zip>60864190</zip>
                <telephone>3101-7845</telephone>
                <email>cep.hm@hm.ce.gov.br</email>

                <affiliation country_code="BR" type="ministery_of_health">

                    <name>HOSPITAL DE MESSEJANA DR. CARLOS ALBERTO STUDART GOMES - SESA/CE</name>
                    <address>WWW.HM.CE.GOV.BR</address>
                </affiliation>

            </person>



            <public_contact person="152"></public_contact>


            <scientific_contact person="152"></scientific_contact>



            <site_contact person="153"></site_contact>

        </contacts>

        <secondary_ids>

            <secondary_id>

                <sec_id>540/08</sec_id>
                <issuing_authority>Comitê de Ética em Pesquisa do Hospital Dr. Carlos Alberto Studart Gomes</issuing_authority>
            </secondary_id>

        </secondary_ids>

        <references>
            <link url="http://127.0.0.1:8000/rg/RBR-3nm5bv/v1/"></link>
        </references>



        <translation lang="pt-br">
            <public_title>Efeitos dos exercícios físicos em indivíduos com cancer de pulmão</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Impacto da reabilitação pulmonar na incidência de complicações respiratórias no pós operatório de ressecção pulmonar por neoplasia de pulmão</scientific_title>
            <scientific_acronym></scientific_acronym>

            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext>Câncer de pulmão
Complicações Pré/pós operatório</hc_freetext>
            <i_freetext>Cirurgia de Ressecção Pulmonar
Reabilitação Pulmonar
Fisioterapia respiratória convencional
Exercício físico
</i_freetext>
            <inclusion_criteria>Estadiamento do câncer de pulmão entre IA, IB, IIA, IIB E IIIA.
Dispnéia pelo escala de dispneia do Medical Research Council (MRC) de moderado a grave.
Candidato a cirurgia de ressecção pulmonar por toracotomia.
Sexo masculino e feminino com idade maior ou igual a 38 anos e inferior ou igual a 80 anos.</inclusion_criteria>
            <exclusion_criteria>Doenças cardiovasculares graves ou outras doenças que contra-indiquem o exercício;
Doenças com limitações ortopédicas que impossibilitem o exercício.</exclusion_criteria>
            <study_design>Ensaio clínico, randomizado, de fase 2-3, cego. Os pacientes serão divididos em 2 grupos, GA (reabilitação pulmonar) e GB (Fisioterapia respiratória convencional).</study_design>

        </translation>

        <translation lang="es">
            <public_title></public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title></scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>

            <hc_freetext></hc_freetext>
            <i_freetext></i_freetext>
            <inclusion_criteria></inclusion_criteria>
            <exclusion_criteria></exclusion_criteria>
            <study_design></study_design>
        </translation>


    </trial>

</trials>