chemNLP/clinical-trials-v2 · Datasets at Hugging Face

NCT0531xxxx/NCT05313893.xml

<clinical_study>  <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/NCT05313893</url> </required_header> <id_info> <org_study_id>SJLGYM-2021-Ⅳ-01</org_study_id> <nct_id>NCT05313893</nct_id> </id_info> <brief_title>A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years</brief_title> <official_title>A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years</official_title> <sponsors> <lead_sponsor> <agency>Jiangsu Province Centers for Disease Control and Prevention</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Jiangsu Province Centers for Disease Control and Prevention</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination. </textblock> </brief_summary> <detailed_description> <textblock> Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">September 11, 2021</start_date> <completion_date type="Actual">May 30, 2022</completion_date> <primary_completion_date type="Actual">December 25, 2021</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%</measure> <time_frame>day 28 after dose 2</time_frame> <description>The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.</description> </primary_outcome> <primary_outcome> <measure>Number of participants with Adverse Reactions (ARs)</measure> <time_frame>28 days after each vaccination</time_frame> <description>Frequency and severity of ARs for 28 days after each vaccination</description> </primary_outcome> <secondary_outcome> <measure>the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%</measure> <time_frame>day 28 after dose 2</time_frame> <description>A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.</description> </secondary_outcome> <secondary_outcome> <measure>Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5</measure> <time_frame>day 28 after dose 2</time_frame> <description>Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI)against each virus strain</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with Adverse Events (AEs)</measure> <time_frame>28 days after each vaccination</time_frame> <description>Frequency and severity of AEs for 28 days after each vaccination</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with Serious Adverse Events (SAE)</measure> <time_frame>6 months after the last vaccination</time_frame> <description>Frequency of SAEs for 6 months after the last vaccination</description> </secondary_outcome> <other_outcome> <measure>Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2</measure> <time_frame>day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2</time_frame> <description>The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.</description> </other_outcome> <other_outcome> <measure>Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2</measure> <time_frame>day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2</time_frame> </other_outcome> <other_outcome> <measure>Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2</measure> <time_frame>day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2</time_frame> <description>A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.</description> </other_outcome> <other_outcome> <measure>Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1and dose 2</measure> <time_frame>day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2</time_frame> </other_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">252</enrollment> <condition>Influenza</condition> <arm_group> <arm_group_label>Quadrivalent influenza vaccine</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Quadrivalent influenza vaccine</intervention_name> <description>Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.</description> <arm_group_label>Quadrivalent influenza vaccine</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Aged 3-8 years old  - Healthy subjects judged from medical history and clinical examination  - Subjects themselves or their guardians able to understand and sign theinformed consent  - Subjects themselves or their guardians can and will comply with therequirements of the protocol  - Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment  - Subjects with temperature <=37.0°C on axillary setting  Exclusion Criteria:  - Any prior administration of other research medicine/vaccine in last 30 days  - Any prior administration of influenza vaccine in last 6 month  - Any prior administration of immunodepressant or corticosteroids in last 3 months  - Any prior administration of blood products in last 3 months  - Any prior administration of any attenuated live vaccine in last 14 days  - Any prior administration of subunit or inactivated vaccines in last 7 days  - Subject who developed guillain-Barre syndrome post influenza vaccination  - Subject who is allergic to any ingredient of the vaccine  - Subject with acute febrile illness or infectious disease  - Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection  - Subject with damaged or low immune function which has already beenknown  - Subject with congenital heart disease or other birth defects unsuitable for vaccination.  - Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.  - Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol </textblock> </criteria> <gender>All</gender> <minimum_age>3 Years</minimum_age> <maximum_age>8 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Donghai County Center for Disease Control and Prevention</name> <address> <city>Lianyungang</city> <state>Jiangsu</state> <zip>222300</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 13, 2022</last_update_submitted> <last_update_submitted_qc>August 13, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 17, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Safety</keyword> <keyword>Immunogenicity</keyword> <keyword>Quadrivalent influenza vaccine</keyword> <condition_browse>  <mesh_term>Influenza, Human</mesh_term> </condition_browse>  </clinical_study>

Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination. Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint Inclusion Criteria: - Aged 3-8 years old - Healthy subjects judged from medical history and clinical examination - Subjects themselves or their guardians able to understand and sign theinformed consent - Subjects themselves or their guardians can and will comply with therequirements of the protocol - Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment - Subjects with temperature <=37.0°C on axillary setting Exclusion Criteria: - Any prior administration of other research medicine/vaccine in last 30 days - Any prior administration of influenza vaccine in last 6 month - Any prior administration of immunodepressant or corticosteroids in last 3 months - Any prior administration of blood products in last 3 months - Any prior administration of any attenuated live vaccine in last 14 days - Any prior administration of subunit or inactivated vaccines in last 7 days - Subject who developed guillain-Barre syndrome post influenza vaccination - Subject who is allergic to any ingredient of the vaccine - Subject with acute febrile illness or infectious disease - Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection - Subject with damaged or low immune function which has already beenknown - Subject with congenital heart disease or other birth defects unsuitable for vaccination. - Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections. - Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol

NCT0531xxxx/NCT05313906.xml

<clinical_study>  <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/NCT05313906</url> </required_header> <id_info> <org_study_id>HenanCH immunotherapy007</org_study_id> <nct_id>NCT05313906</nct_id> </id_info> <brief_title>RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer</brief_title> <official_title>Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer</official_title> <sponsors> <lead_sponsor> <agency>Henan Cancer Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Rongchang Biopharmaceutical</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Zhengda Tianqing Pharmaceutical Group Co., Ltd.</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Henan Cancer Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer. </textblock> </brief_summary> <detailed_description> <textblock> Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 7, 2022</start_date> <completion_date type="Anticipated">April 30, 2024</completion_date> <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>RC48 plus AK105 and cisplatin</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>ORR</measure> <time_frame>three months</time_frame> <description>the proportion of patients who got CR and PR</description> </primary_outcome> <secondary_outcome> <measure>PFS</measure> <time_frame>six months and twelve months</time_frame> <description>the duration of diseases stable or better</description> </secondary_outcome> <secondary_outcome> <measure>DCR</measure> <time_frame>three months</time_frame> <description>the proportion of patients who got CR, PR and SD</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Advanced Gastric Carcinoma</condition> <condition>HER2-positive Gastric Cancer</condition> <arm_group> <arm_group_label>exprimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>RC48 plus AK105 and cisplatin</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>RC48+AK105+cisplatin</intervention_name> <description>RC48 plus AK105 and cisplatin</description> <arm_group_label>exprimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age ≥18 years old, ≤75 years old, regardless gender  - Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+  - ECOG PS scores 0-1  - Stage IV according to AJCC 8.0 and no systemic therapy previously  - Expected lifespan ≥ 3 months  - Adequate organ function  - At least one measurable lesion according to RECIST 1.1  - Asymptomatic intracranial metastasis  - No history of other malignancies  - Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial  - Agreed to participate in this clinical study and signed the Informed Consent  Exclusion Criteria:  - Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose  - Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor  - Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration  - Active autoimmune diseases or immunodeficiency diseases  - Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug  - Severe mental disorder  - Receiving systemic corticosteroids within 7 days prior to the first dose of the study  - Clinically apparent cardiovascular and cerebrovascular disease  - Others investigators evaluated not meet the inclusion criteria </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Quanli Gao, Dr</last_name> <role>Principal Investigator</role> <affiliation>Henan Provincial People's Hospital</affiliation> </overall_official> <overall_contact> <last_name>Quanli Gao, Dr</last_name> <phone>+8637165587795</phone> <email>zlyygql0855@zzu.edu.cn</email> </overall_contact> <location> <facility> <name>Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university</name> <address> <city>ZhengZhou</city> <state>Henan</state> <zip>450008</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Henan Cancer Hospital</investigator_affiliation> <investigator_full_name>Quanli Gao</investigator_full_name> <investigator_title>Dr</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stomach Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cisplatin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>all IPD that underlie results in a publication</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_time_frame>starting 6 months after publication</ipd_time_frame> <ipd_access_criteria>The IPD will be shared with researhers who plan to do meta-analysis or other reasonable requests.</ipd_access_criteria> </patient_data>  </clinical_study>

To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer. Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer. Inclusion Criteria: - Age ≥18 years old, ≤75 years old, regardless gender - Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+ - ECOG PS scores 0-1 - Stage IV according to AJCC 8.0 and no systemic therapy previously - Expected lifespan ≥ 3 months - Adequate organ function - At least one measurable lesion according to RECIST 1.1 - Asymptomatic intracranial metastasis - No history of other malignancies - Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial - Agreed to participate in this clinical study and signed the Informed Consent Exclusion Criteria: - Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose - Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor - Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration - Active autoimmune diseases or immunodeficiency diseases - Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug - Severe mental disorder - Receiving systemic corticosteroids within 7 days prior to the first dose of the study - Clinically apparent cardiovascular and cerebrovascular disease - Others investigators evaluated not meet the inclusion criteria

NCT0531xxxx/NCT05313919.xml

<clinical_study>  <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/NCT05313919</url> </required_header> <id_info> <org_study_id>304/KBL/OIL2019</org_study_id> <secondary_id>PL-2020-01</secondary_id> <nct_id>NCT05313919</nct_id> </id_info> <brief_title>Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis</brief_title> <acronym>MOSAIC-COR</acronym> <official_title>Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis. MOSAIC-COR Study.</official_title> <sponsors> <lead_sponsor> <agency>Bartlomiej Guzik</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Abbott</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>John Paul II Hospital, Krakow</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 24, 2020</start_date> <completion_date type="Anticipated">June 30, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 2022</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Cytokines (serum levels)</measure> <time_frame>baseline</time_frame> </primary_outcome> <primary_outcome> <measure>Diastolic Disfunction parameters in ECHO</measure> <time_frame>baseline, 12- and 24-month follow-up</time_frame> </primary_outcome> <secondary_outcome> <measure>MACCE occurrence</measure> <time_frame>baseline, 12- and 24-month observation</time_frame> </secondary_outcome> <secondary_outcome> <measure>Hospitalization any</measure> <time_frame>baseline, 12- and 24-month observation</time_frame> </secondary_outcome> <secondary_outcome> <measure>symptoms intensity and quality of life (questionnaires)</measure> <time_frame>baseline, 12- and 24-month observation</time_frame> </secondary_outcome> <secondary_outcome> <measure>FMD</measure> <time_frame>baseline, 12- and 24-month observation</time_frame> </secondary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">160</enrollment> <condition>Coronary Artery Disease</condition> <condition>Ischemia and No Obstructive Coronary Arteries</condition> <condition>Ischemic Heart Disease</condition> <condition>Microvascular Angina</condition> <condition>Vasospastic Angina</condition> <arm_group> <arm_group_label>1. Coronary microcirculatory disease</arm_group_label> </arm_group> <arm_group> <arm_group_label>2. Epicardial vasospastic angina</arm_group_label> </arm_group> <arm_group> <arm_group_label>3. Microvessel vasospastic angina</arm_group_label> </arm_group> <arm_group> <arm_group_label>4. Non-cardiac disorder</arm_group_label> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Comprehensive functional diagnostics of coronary circulation</intervention_name> <description>Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including: echocardiography with assessment of diastolic function flow-mediated dilation of brachial artery coronary angiography functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau) provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm) laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level) serum level of inflammatory cytokines and chemokines</description> <arm_group_label>1. Coronary microcirculatory disease</arm_group_label> <arm_group_label>2. Epicardial vasospastic angina</arm_group_label> <arm_group_label>3. Microvessel vasospastic angina</arm_group_label> <arm_group_label>4. Non-cardiac disorder</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Diagnosed chronic coronary syndrome CCS ≥ 2.  2. Evidence of myocardial ischemia (positive result of non-invasive stress test).  3. Informed consent.  4. Age at least 18 years.  Exclusion Criteria: </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>90 Years</maximum_age> </eligibility> <overall_official> <last_name>Bartłomiej Guzik, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>John Paul II Hospital, Krakow, Poland</affiliation> </overall_official> <overall_official> <last_name>Jacek Legutko, MD, PhD, Professor</last_name> <role>Study Director</role> <affiliation>John Paul II Hospital, Krakow, Poland</affiliation> </overall_official> <overall_contact> <last_name>Bartłomiej Guzik, MD, PhD</last_name> <phone>+48 614 35 01</phone> <email>b.guzik@uj.edu.pl</email> </overall_contact> <overall_contact_backup> <last_name>Piotr Szolc, MD</last_name> <phone>+48 614 35 01</phone> <email>piotr.szolc4@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Department of Interventional Cardiology, John Paul II Hospital, Krakow, Poland, Institute Of Cardiology, Jagiellonian University Medical College</name> <address> <city>Krakow</city> <state>Lesser Poland</state> <zip>31-202</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Krzysztof Pazdan</last_name> <phone>+48 12 614 25 85</phone> <email>k.pazdan@szpitaljp2.krakow.pl</email> </contact> <investigator> <last_name>Paweł Kleczyński, MD, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Piotr Szolc, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Łukasz Niewiara, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Maciej Stąpór, MD, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Anna Bernacik, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Poland</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>John Paul II Hospital, Krakow</investigator_affiliation> <investigator_full_name>Bartlomiej Guzik</investigator_full_name> <investigator_title>MD, PhD</investigator_title> </responsible_party> <keyword>coronary artery disease</keyword> <keyword>ischemia and no obstructive coronary arteries</keyword> <keyword>ischemic heart disease</keyword> <keyword>microvascular angina</keyword> <keyword>vasospastic angina</keyword> <keyword>coronary microvascular dysfunction</keyword> <keyword>coronary microcirculation</keyword> <keyword>endothelial dysfunction</keyword> <condition_browse>  <mesh_term>Coronary Artery Disease</mesh_term> <mesh_term>Myocardial Ischemia</mesh_term> <mesh_term>Coronary Disease</mesh_term> <mesh_term>Heart Diseases</mesh_term> <mesh_term>Angina Pectoris</mesh_term> <mesh_term>Coronary Stenosis</mesh_term> <mesh_term>Microvascular Angina</mesh_term> <mesh_term>Angina Pectoris, Variant</mesh_term> <mesh_term>Ischemia</mesh_term> <mesh_term>Inflammation</mesh_term> </condition_browse>  </clinical_study>

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels. Patients with symptomatic chronic coronary syndrome and no significant lesions in epicardial coronary arteries in angiography. Inclusion Criteria: 1. Diagnosed chronic coronary syndrome CCS ≥ 2. 2. Evidence of myocardial ischemia (positive result of non-invasive stress test). 3. Informed consent. 4. Age at least 18 years. Exclusion Criteria:

NCT0531xxxx/NCT05313932.xml

<clinical_study>  <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/NCT05313932</url> </required_header> <id_info> <org_study_id>StMarysUC4</org_study_id> <nct_id>NCT05313932</nct_id> </id_info> <brief_title>The Effects of Sleep Deprivation on Physiological and Perceptual Responses During Exercise</brief_title> <official_title>The Effects of Partial Sleep Restriction on Physiological and Perceptual Responses During Submaximal and Maximal Exercise in Trained Runners</official_title> <sponsors> <lead_sponsor> <agency>St Mary's University College</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>StMarysUC</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 20, 2022</start_date> <completion_date type="Anticipated">September 26, 2022</completion_date> <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Oxygen uptake</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in oxygen uptake measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Respiratory exchange ratio</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in respiratory exchange ratio measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Breathing frequency</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in breathing frequency measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Minute ventilation</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in minute ventilation measured breath-by-breath using an online gas analyzer during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Blood lactate concentration</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in blood lactate concentration measured using capillary puncture during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Rating of perceived exertion</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in ratings of perceived exertion measured using a 15-point (6-20) scale during submaximal and maximal incremental exercise</description> </primary_outcome> <primary_outcome> <measure>Heart rate</measure> <time_frame>From baseline to completion, up to 31 days</time_frame> <description>Change from baseline in heart rate measured using a heart rate monitor during submaximal and maximal incremental exercise</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">12</enrollment> <condition>Sleep Deprivation</condition> <arm_group> <arm_group_label>Sleep deprivation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Two hours of sleep deprivation (Six hours of sleep)</description> </arm_group> <arm_group> <arm_group_label>No intervention</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No sleep deprivation (Eight hours of sleep)</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Sleep deprivation</intervention_name> <description>Participants wake after six hours so that they are deprived of 2 hours of sleep</description> <arm_group_label>Sleep deprivation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Injury-free, trained, male runners  Exclusion Criteria:  - Female, untrained, injured </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Sleep Deprivation</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Sleep deprivation has been found to impact exercise performance. The effects of both partial (several hours) and full (24+ hours) sleep deprivation on exercise performance has shown effects on rating of perceived exertion, rate of oxygen consumption, respiratory exchange ratio, and heart rate. A common practice with athletes is to perform regular physiological testing (submaximal and maximal) in order to assess their fitness and to determine training intensities. However, the effects of sleep deprivation on those same physiological test results has not been investigated Therefore, the purpose of this study is to investigate the effects of partial sleep deprivation on physiological test results. Inclusion Criteria: - Injury-free, trained, male runners Exclusion Criteria: - Female, untrained, injured

NCT0531xxxx/NCT05313945.xml

<clinical_study>  <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/NCT05313945</url> </required_header> <id_info> <org_study_id>69HCL21_0171</org_study_id> <nct_id>NCT05313945</nct_id> </id_info> <brief_title>Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal</brief_title> <acronym>IDESONDE</acronym> <official_title>Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse</official_title> <sponsors> <lead_sponsor> <agency>Hospices Civils de Lyon</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Hospices Civils de Lyon</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction.  It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 21, 2022</start_date> <completion_date type="Anticipated">August 5, 2024</completion_date> <primary_completion_date type="Anticipated">August 5, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Health Services Research</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Patient satisfaction score</measure> <time_frame>Within one hour after indwelling urinary catheter removal at day 0</time_frame> <description>Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)</description> </primary_outcome> <secondary_outcome> <measure>The pain experienced by patients</measure> <time_frame>Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)</time_frame> <description>The pain experienced by patients will be measured using a numerical scale (EN) ranging from the minimum value 0 (The better score) to the maximum value 10 (The worse Score)</description> </secondary_outcome> <secondary_outcome> <measure>The anxiety experienced by patients</measure> <time_frame>Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)</time_frame> <description>The anxiety experienced by patients will be measured using a numerical scale (EN) ranging from the minimum value 0 (The better score) to the maximum value 10 (The worse Score)</description> </secondary_outcome> <secondary_outcome> <measure>Patient satisfaction</measure> <time_frame>at Day 0, at Day 2, at Day 15</time_frame> <description>Patient satisfaction will be evaluated using a satisfaction questionnaire without score</description> </secondary_outcome> <secondary_outcome> <measure>Patient satisfaction</measure> <time_frame>at Day 2, at Day 15</time_frame> <description>Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">160</enrollment> <condition>Urologic Diseases</condition> <arm_group> <arm_group_label>Passive indwelling urinary catheter removal</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The passive indwelling urinary catheter removal takes place due to gravity.</description> </arm_group> <arm_group> <arm_group_label>Manual indwelling urinary catheter removal</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The manual indwelling urinary catheter removal takes place by manual traction by a nurse.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Passive indwelling urinary catheter removal</intervention_name> <description>After washing the patient's perineal area with water and mild soap, the nurse deflates the indwelling urinary catheter balloon and instructs the patient to take a shower (standing). During this time, the catheter will fall under gravity.</description> <arm_group_label>Passive indwelling urinary catheter removal</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Active indwelling catheter removal by a nurse</intervention_name> <description>After washing the patient's perineal area with water and mild soap, the nurse deflates the balloon and removes the catheter from the urethra by manual traction.</description> <arm_group_label>Manual indwelling urinary catheter removal</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male ≥ 18 years old  2. With an indwelling urinary catheter placed after any of the following procedures:  A uro-endoscopic surgery from the list below:  - Endoscopic prostate resection (or transurethral prostate resection).  - Laser prostate enucleation  - Prostate thermotherapy by radiofrequency  - A high-intensity focused ultrasound treatment for prostate cancer  - Cervico-prostatic incision or internal urethrotomy  - Endoscopic/Transurethral Resection of Bladder Tumor (TURBT)  - Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation)  3. Patient who has given written consent to participate  Exclusion Criteria:  1. Patient who is unable to perform intimate hygiene alone in a standing position  2. Patient with a painful genital lesion  3. Patient with an extended pelvic pathology  4. Need to remove the indwelling urinary catheter at the patient's home instead of hospital  5. Patient under guardianship or curator  6. Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Camille BENETON, Nurse</last_name> <role>Principal Investigator</role> <affiliation>Hospices Civils de Lyon</affiliation> </overall_official> <overall_contact> <last_name>Camille BENETON, Nurse</last_name> <phone>0472119111</phone> <phone_ext>+33</phone_ext> <email>camille.beneton@chu-lyon.fr</email> </overall_contact> <overall_contact_backup> <last_name>Vasiliki VELOUDOU, Nurse</last_name> <phone>0472119622</phone> <phone_ext>+33</phone_ext> <email>vasiliki.veloudou@chu-lyon.fr</email> </overall_contact_backup> <location> <facility> <name>CHU Grenoble</name> <address> <city>Grenoble</city> <zip>38000</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>LONG ALEXANDRE, MD</last_name> </contact> </location> <location> <facility> <name>Hôpita Edouard Herriot</name> <address> <city>Lyon</city> <zip>69003</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Beneton Camille, Nurse</last_name> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 9, 2023</last_update_submitted> <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>bladder catheter</keyword> <condition_browse>  <mesh_term>Urologic Diseases</mesh_term> </condition_browse>  </clinical_study>

In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction. It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial. Inclusion Criteria: 1. Male ≥ 18 years old 2. With an indwelling urinary catheter placed after any of the following procedures: A uro-endoscopic surgery from the list below: - Endoscopic prostate resection (or transurethral prostate resection). - Laser prostate enucleation - Prostate thermotherapy by radiofrequency - A high-intensity focused ultrasound treatment for prostate cancer - Cervico-prostatic incision or internal urethrotomy - Endoscopic/Transurethral Resection of Bladder Tumor (TURBT) - Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation) 3. Patient who has given written consent to participate Exclusion Criteria: 1. Patient who is unable to perform intimate hygiene alone in a standing position 2. Patient with a painful genital lesion 3. Patient with an extended pelvic pathology 4. Need to remove the indwelling urinary catheter at the patient's home instead of hospital 5. Patient under guardianship or curator 6. Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions

NCT0531xxxx/NCT05313958.xml

<clinical_study>  <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/NCT05313958</url> </required_header> <id_info> <org_study_id>2021-KY-052</org_study_id> <secondary_id>2021A1515011809</secondary_id> <nct_id>NCT05313958</nct_id> </id_info> <brief_title>Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children</brief_title> <acronym>SCCLG-M5</acronym> <official_title>Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China</official_title> <sponsors> <lead_sponsor> <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Maternal and Child Health Hospital of Foshan</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The First Affiliated Hospital of Guangzhou Medical University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Second Xiangya Hospital of Central South University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Jiangxi Province Children's Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Southern Medical University, China</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The First Affiliated Hospital of Nanchang University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Guangzhou First People's Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>First Affiliated Hospital of Shantou University Medical College</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3. </textblock> </brief_summary> <detailed_description> <textblock> PRIMARY OBJECTIVES  1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children.  SECONDARY OBJECTIVES  1. To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy.  2. To evaluate the 3-year progression-free survival in response to CLAG in children.  3. To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD).  4. To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib.  OUTLINE:  1. The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M).  2. The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed.  INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (< 5% blasts) or MRD< 1% receive a second course treatment as above.  INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy.  3. For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years.  4. After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation.  5. After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation.  Patients must meet one of the following risk criteria:  Standard-risk (SR) group meeting all of the following criteria:  Initial WBC < 10,000/μL  M1 (<5%) blasts or MRD<1% in bone marrow after the first course of induction therapy  M1 (<5%) blasts or MRD<0.1% in bone marrow after two courses of induction therapy  Cytogenetic abnormalities with good prognosis  Intermediate-risk (IR) group meeting the following criteria:  Lack of low-risk and high-risk conditions  High-risk (HR) group meeting ≥ 1 of the following criteria:  M2/M3(≥5%) blasts or MRD>5% in bone marrow after the first course of induction therapy  MRD≥0.1% in bone marrow after two course of induction therapy  Cytogenetic abnormalities with poor prognosis </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 1, 2021</start_date> <completion_date type="Anticipated">March 30, 2026</completion_date> <primary_completion_date type="Anticipated">March 30, 2026</primary_completion_date> <phase>Phase 2/Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Overall survival (OS)</measure> <time_frame>3 years</time_frame> <description>TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.</description> </primary_outcome> <secondary_outcome> <measure>Induced remission rate (CR)</measure> <time_frame>3 years</time_frame> <description>According to the time point specified in the treatment plan (22 days after the end of induction I, 29-43 days after the end of induction II and before each consolidation scheme) bone marrow puncture and lumbar puncture were performed. The follow-up contents included the detection of the count of primitive / immature lymphocytes and flow MRD. If there was a positive gene at the onset, the quantitative monitoring of the gene should be performed as MRD data at the same time. If the gene cannot be analyzed quantitatively, PCR qualitative analysis should still be performed as the monitoring basis</description> </secondary_outcome> <secondary_outcome> <measure>Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)</measure> <time_frame>3 years</time_frame> <description>During treatment, closely monitor relevant laboratory tests, register adverse reaction records, and report the records according to the requirements of CRF form.</description> </secondary_outcome> <secondary_outcome> <measure>Event-free survival (EFS)</measure> <time_frame>3 years</time_frame> <description>EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">43</enrollment> <condition>Leukemia, Monocytic, Acute</condition> <condition>Pediatric AML</condition> <arm_group> <arm_group_label>treatment arm</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol. The targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cladribine</intervention_name> <description>5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine</description> <arm_group_label>treatment arm</arm_group_label> <other_name>cladribine injection</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>G-CSF</intervention_name> <description>5ug/kg/day d0-5,if Peripheral blood leukocytes<20,000/ul</description> <arm_group_label>treatment arm</arm_group_label> <other_name>granulocyte</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cytarabine</intervention_name> <description>2g/㎡/day d1-5 in 4 hours, after the use of Cladribine</description> <arm_group_label>treatment arm</arm_group_label> <other_name>Ara-C</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Idarubicin</intervention_name> <description>Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II</description> <arm_group_label>treatment arm</arm_group_label> <other_name>Idamycin</other_name> <other_name>IDA</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Mitoxantrone</intervention_name> <description>Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II</description> <arm_group_label>treatment arm</arm_group_label> <other_name>MIT</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Sorafenib</intervention_name> <description>200mg/m2/day was taken orally until molecular biology remission for 2 years</description> <arm_group_label>treatment arm</arm_group_label> <other_name>sorafinib</other_name> <other_name>Nexavar</other_name> <other_name>sorafenib tosylate</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  0-14 years old  Cytologically proven acute monocytic leukemia (M5) with other treatment  Exclusion Criteria:  Secondary to immunodeficiency or MDS  Second tumor  Dowm's syndrome  Evolution of chronic myelogenous leukemia to blast crisis  Death or quit treatment in seven days at the begining of induction therapy  Treatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia  Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.)  Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule </textblock> </criteria> <gender>All</gender> <minimum_age>1 Month</minimum_age> <maximum_age>14 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>dunha zhou, M.D</last_name> <role>Study Chair</role> <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation> </overall_official> <overall_contact> <last_name>dunhua zhou, M.D</last_name> <phone>13560099258</phone> <email>zdunhua@163.com</email> </overall_contact> <location> <facility> <name>Maternal and Child Health Hospital of Foshan</name> <address> <city>Foshan</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>riling chen, M.D</last_name> <phone>19820318067</phone> <email>chenrl319@163.com</email> </contact> </location> <location> <facility> <name>Guangzhou First People's Hospital</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>lina wang, M.D</last_name> <phone>18922234317</phone> <email>wanglina_11@yeah.net</email> </contact> </location> <location> <facility> <name>The First Affiliated Hospital of Guangzhou Medical University</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>yawei zhou, M.D</last_name> <phone>136423337577</phone> <email>zywyhscg@qq.com</email> </contact> </location> <location> <facility> <name>Third Affiliated Hospital, Sun Yat-Sen University</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>huiqin chen, M.D</last_name> <phone>13724819908</phone> <email>chenhuiqinchq@126.com</email> </contact> </location> <location> <facility> <name>Zhujiang Hospital of Southern Medical University</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>lihua yang, M.D</last_name> <phone>13580532469</phone> <email>yanglihua@163.com</email> </contact> </location> <location> <facility> <name>Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College</name> <address> <city>Shantou</city> <state>Guangdong</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>beiyan wu, M.D</last_name> <phone>13802336066</phone> <email>1261305798@qq.com</email> </contact> </location> <location> <facility> <name>Second Xiangya Hospital of Central South University</name> <address> <city>Changsha</city> <state>Hunan</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>wuqing wan</last_name> <phone>13507316963</phone> <email>wanwuqing65@163.com</email> </contact> </location> <location> <facility> <name>Jiangxi Province Children's Hospital Southern Medical University, China</name> <address> <city>Nanchang</city> <state>Jiangxi</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>changda liang, M.D</last_name> <phone>13879175309</phone> <email>liangchangda@163.com</email> </contact> </location> <location> <facility> <name>The First Affiliated Hospital of Nanchang University</name> <address> <city>Nanchang</city> <state>Jiangxi</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>qiwen chen, M.D</last_name> <phone>13970807656</phone> <email>13970807656@163.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <reference> <citation>Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.</citation> <PMID>32216042</PMID> </reference> <results_reference> <citation>Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.</citation> <PMID>31279288</PMID> </results_reference> <results_reference> <citation>Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.</citation> <PMID>19242495</PMID> </results_reference> <verification_date>July 2023</verification_date> <study_first_submitted>December 26, 2021</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 25, 2023</last_update_submitted> <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Acute monocytic leukemia</keyword> <keyword>pediatric</keyword> <keyword>Cladribine</keyword> <keyword>sorafenib</keyword> <condition_browse>  <mesh_term>Leukemia</mesh_term> <mesh_term>Leukemia, Monocytic, Acute</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cytarabine</mesh_term> <mesh_term>Sorafenib</mesh_term> <mesh_term>Mitoxantrone</mesh_term> <mesh_term>Idarubicin</mesh_term> <mesh_term>Cladribine</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3. PRIMARY OBJECTIVES 1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children. SECONDARY OBJECTIVES 1. To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy. 2. To evaluate the 3-year progression-free survival in response to CLAG in children. 3. To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD). 4. To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib. OUTLINE: 1. The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M). 2. The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed. INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (< 5% blasts) or MRD< 1% receive a second course treatment as above. INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy. 3. For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years. 4. After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation. 5. After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation. Patients must meet one of the following risk criteria: Standard-risk (SR) group meeting all of the following criteria: Initial WBC < 10,000/μL M1 (<5%) blasts or MRD<1% in bone marrow after the first course of induction therapy M1 (<5%) blasts or MRD<0.1% in bone marrow after two courses of induction therapy Cytogenetic abnormalities with good prognosis Intermediate-risk (IR) group meeting the following criteria: Lack of low-risk and high-risk conditions High-risk (HR) group meeting ≥ 1 of the following criteria: M2/M3(≥5%) blasts or MRD>5% in bone marrow after the first course of induction therapy MRD≥0.1% in bone marrow after two course of induction therapy Cytogenetic abnormalities with poor prognosis Inclusion Criteria: 0-14 years old Cytologically proven acute monocytic leukemia (M5) with other treatment Exclusion Criteria: Secondary to immunodeficiency or MDS Second tumor Dowm's syndrome Evolution of chronic myelogenous leukemia to blast crisis Death or quit treatment in seven days at the begining of induction therapy Treatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

NCT0531xxxx/NCT05313971.xml

<clinical_study>  <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/NCT05313971</url> </required_header> <id_info> <org_study_id>096/2019</org_study_id> <nct_id>NCT05313971</nct_id> </id_info> <brief_title>Impact of Self-awareness in Medical Students</brief_title> <official_title>Impact of Self-awareness in Stress, Burnout, Self-compassion and Compassion in Medical Students - Controlled Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Coimbra</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Coimbra</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Objectives: The goal of this study is to understand whether self-knowledge, using the Enneagram, has a long-term impact as a modifying factor of the quality of life, self-compassion and compassion of medical students.  Methods: An initial sample of 48 medical students answered, before, immediately after and 9 months after an intervention, an online questionnaire with 6 scales. The intervention group took a self-knowledge and communication course based on the Enneagram. The control group was recruited by matching the sociodemographic variables with the intervention group. The data obtained was subject to descriptive and inferential statistical analysis and qualitative content analysis. </textblock> </brief_summary> <detailed_description> <textblock> Study design Longitudinal study of intervention, controlled, with a reassessment 9 months after the intervention.  Selection of participants The process of recruiting participants involved an online dissemination of the study made by students from the Portuguese Faculties of Medicine of the Universities of Coimbra, Minho, Porto and Lisbon. Interested parties signed up on a Google Form, where the conditions of participation were detailed. The only defined inclusion criterion was to be a medical student enrolled in one of the several Portuguese medical schools.  In order to understand the necessary sample size, the significant results obtained on the Burnout scale of a previous pilot study were used as a basis. The average and the standard deviation obtained before the course and the average achieved after the course of the 3 dimensions of the Burnout scale were inserted into a necessary sample calculation formula, for an alpha of 0.05 and power (1-ß) of 80% (Sample Size Calculator: https://clincalc.com/stats/samplesize.aspx.). We therefore set a target of at least 24 participants needed to form the intervention group.  Data collection Data collection was carried out by filling out a questionnaire on Google Forms lasting about 20 minutes. This collection took place in three stages: both intervention and control groups completed the questionnaire for the first time immediately before the beginning of the first session of the course (phase 1), having repeated it after the conclusion of the third module (phase 2) and again 9 months later (phase 3).  The questionnaire was divided into two distinct parts: the first had the coding of each volunteer for later comparison of data, ensuring their confidentiality, which was followed by the collection of sociodemographic variables: gender, age, academic year and educational institution. The second part was intended to collect the variables of the measured dimensions (perceived quality of life, perceived stress, burnout, self-compassion, compassion and self-reflection and insight), through the application of 6 scales:  1. Visual Analogue Scale for Perceived Quality of Life  2. Perceived Stress Scale  3. Maslach Burnout Scale for Portuguese students  4. Self-Compassion Scale  5. Compassion Scale  6. Self-Reflection and Insight Scale- New Adapted and Validated Self-Awareness Measure for Brazilian Adults In the questionnaires of phases 2 and 3, a last open-response question was added so that the intervention group could share the benefits, in personal terms, in the management of stress and in the relationship and communication with others, which they thought they had acquired with the course. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 1, 2020</start_date> <completion_date type="Actual">December 31, 2020</completion_date> <primary_completion_date type="Actual">December 31, 2020</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>After the recruitment period, of the 27 initially enrolled, 24 attended more than 70% of a 28-hour online course, forming the intervention group. The control group was recruited in order to match the age, gender, academic year and teaching faculty variables with the intervention group and people with these characteristics were invited to participate.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>stress symptoms change</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Perceived Stress Scale (PSS-10: Perceived Stress Scale; Cohen, Kamarck & Mermelstein, 1983 (Cohen et al., 1983); Portuguese version by Trigo et al, 2010) (Trigo et al., 2010). Composed of 10 items, it allows to understand how the unpredictability, uncontrollability or excessiveness of life events are perceived as generators of stress by the individual. Each item is assigned a rating between 0 ("never") and 4 ("very often"). To calculate the final score, it is necessary to reverse the rating of items referring to positive situations (items 4, 5, 7 and 8). Thus, a result between 0 and 40 points is obtained, with values between 0 and 13 being defined as low levels of stress, 14 to 26 medium levels and 27 to 40 high levels. In the Portuguese population, the PSS-10 version has good internal consistency (α=0.87)</description> </primary_outcome> <primary_outcome> <measure>burnout risk change</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Maslach Burnout Scale for Portuguese students: Its original version is, to date, the most used burnout rating scale. The version adapted for students (MBI - Student Survey), focusing on feelings and emotions in a school context, comprises 3 subscales, which assess the dimensions Emotional Exhaustion, Disbelief and Professional Effectiveness with 5, 4 and 6 items, respectively. Respondents must rate each of the 15 items between 0 ("never/never") to 6 ("always/everyday"). The final scores are interpreted in the 3 subscales, after the sum of their items, allowing the diagnosis of burnout syndrome when the respondent is simultaneously above the 66th percentile of the Emotional Exhaustion and Disbelief scores and below the 33rd percentile of the Professional Efficacy score, relative to the studied group.</description> </primary_outcome> <primary_outcome> <measure>Quality of life change percieved in visual analogue scale</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Visual Analogue Scale for Perceived Quality of Life (EQ-VAS: European Quality of Life - Visual Analogue Scale; EuroQol Group, 1990; Portuguese version by Ferreira, Ferreira & Pereira, 2014) (Ferreira et al., 2013). It is an integral part of the EuroQoL-5Dimension scale (EQ-5D), which comprises two components: a descriptive system, subdivided into 5 dimensions, and a numerical system, achieved through a visual analogue scale - the EQ-VAS thermometer. This offers the possibility for the respondent to quantify their health status on a scale from 0 ("worst imaginable health status") to 100 ("best imaginable health status"), at that moment. In the Portuguese version, the EQ-VAS showed good internal consistency (α=0.862)</description> </primary_outcome> <secondary_outcome> <measure>compassion change</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Compassion Scale (CS: Compassion Scale; Pommier, 2011 (Pommier, 2011); Portuguese version by Vieira, Castilho & Duarte) (Vieira CS, 2013). Bringing together the six factors of compassion (Kindness vs. Indifference, Common Humanity vs. Disconnectedness, Mindfulness vs. Non-involvement), this scale aims to measure how each individual behaves towards others. Each subject must identify their level of agreement regarding the 24 items of the long version, on a scale from 0 ("almost never") to 5 ("almost always"). Items 1, 2, 3, 5, 7, 10 , 12, 14, 18, 19, 22 and 23, corresponding to subscales with negative connotations (Indifference, Disconnected and Non-Involvement) must be recoded to access the total compassion score. Higher scores translate to a higher level of compassion.</description> </secondary_outcome> <secondary_outcome> <measure>self-compassion change</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Self-Compassion Scale (SELFCS: Self-Compassion Scale; Neff, 2003 (Neff, 2003); Portuguese version of Gouveia & Castilho, 2006) (Castilho & Gouveia, 2011). Considered the most used tool in the assessment of self-compassion, it seeks to measure how the individual behaves in difficult times, through emotional response (Warmness/Understanding vs. Self-criticism), cognitive understanding (Common Humanity vs. Isolation) and attention to one's own suffering. (Mindfulness vs. Overidentification). Each of the 26 items is assigned a rating from 0 ("almost never") to 5 ("almost always"), and it is then possible to calculate the subtotal for each of the six subscales and the total score. For this, all items are summed after recoding items 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24 and 25, with higher values reflecting higher levels of self-compassion.</description> </secondary_outcome> <secondary_outcome> <measure>self-reflection and insight change</measure> <time_frame>Change from Baseline at 2 months and 11 months</time_frame> <description>Self-Reflection and Insight Scale- New Adapted and Validated Self-Awareness Measure for Brazilian Adults (SRIS: Self-Reflection and Insight Scale; Grant et al., 2002 (Grant et al., 2002); Brazilian version by DaSilveira and DeCastro, 2012) (DaSilveira et al., 2012) ). Self-response instrument with 20 items that seek to assess and measure individual differences in self-awareness, as well as intentional readiness to change behaviour. It contemplates the two-dimensionality of self-awareness through its Insight and Self-reflection subscales, which is subdivided into Need for Self-Reflection and Involvement in Self-Reflection, that is, interest vs. actual execution of the action.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">46</enrollment> <condition>Burnout, Student</condition> <condition>Stress, Psychological</condition> <condition>Compassion</condition> <condition>Self-Perception</condition> <arm_group> <arm_group_label>Intervention</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>3-week recruitment period of portuguese medical students wanting to attend the 28-hour online course</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The control group was recruited in order to match the age, gender, academic year and teaching faculty variables with the intervention group and people with these characteristics were invited to participate.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Self knowledge course</intervention_name> <description>The online self-knowledge and communication course, created for the purpose of this clinical trial and taught by professionals with certified training in the area by the Shalom Enneagram Institute (https://iesh.pt/), consisted of providing volunteers with mechanisms for self-knowledge using the enneagram. Three modules were carried out between October and December 2020, spaced in time to allow participants to consolidate knowledge: there was 1 month between the first and second module, and between the second and third, 3 weeks.</description> <arm_group_label>Intervention</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - to be a medical student enrolled in one of the several Portuguese medical schools.  Exclusion criteria:  - not participating in 70% of the course (intervention group) </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ines Rosendo, MD PhD</last_name> <role>Principal Investigator</role> <affiliation>Assistant professor FMUC</affiliation> </overall_official> <location> <facility> <name>Faculdade de Medicina da Universidade de Coimbra</name> <address> <city>Coimbra</city> <country>Portugal</country> </address> </facility> </location> <location_countries> <country>Portugal</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Coimbra</investigator_affiliation> <investigator_full_name>Ines Rosendo</investigator_full_name> <investigator_title>Clinical professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Burnout, Psychological</mesh_term> <mesh_term>Stress, Psychological</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Will not be shared because is not necessary</ipd_description> </patient_data> <provided_document_section> <provided_document> <document_type>Study Protocol</document_type> <document_has_protocol>Yes</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>No</document_has_sap> <document_date>June 1, 2020</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT05313971/Prot_000.pdf</document_url> </provided_document> <provided_document> <document_type>Informed Consent Form</document_type> <document_has_protocol>No</document_has_protocol> <document_has_icf>Yes</document_has_icf> <document_has_sap>No</document_has_sap> <document_date>June 1, 2020</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT05313971/ICF_001.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

Objectives: The goal of this study is to understand whether self-knowledge, using the Enneagram, has a long-term impact as a modifying factor of the quality of life, self-compassion and compassion of medical students. Methods: An initial sample of 48 medical students answered, before, immediately after and 9 months after an intervention, an online questionnaire with 6 scales. The intervention group took a self-knowledge and communication course based on the Enneagram. The control group was recruited by matching the sociodemographic variables with the intervention group. The data obtained was subject to descriptive and inferential statistical analysis and qualitative content analysis. Study design Longitudinal study of intervention, controlled, with a reassessment 9 months after the intervention. Selection of participants The process of recruiting participants involved an online dissemination of the study made by students from the Portuguese Faculties of Medicine of the Universities of Coimbra, Minho, Porto and Lisbon. Interested parties signed up on a Google Form, where the conditions of participation were detailed. The only defined inclusion criterion was to be a medical student enrolled in one of the several Portuguese medical schools. In order to understand the necessary sample size, the significant results obtained on the Burnout scale of a previous pilot study were used as a basis. The average and the standard deviation obtained before the course and the average achieved after the course of the 3 dimensions of the Burnout scale were inserted into a necessary sample calculation formula, for an alpha of 0.05 and power (1-ß) of 80% (Sample Size Calculator: https://clincalc.com/stats/samplesize.aspx.). We therefore set a target of at least 24 participants needed to form the intervention group. Data collection Data collection was carried out by filling out a questionnaire on Google Forms lasting about 20 minutes. This collection took place in three stages: both intervention and control groups completed the questionnaire for the first time immediately before the beginning of the first session of the course (phase 1), having repeated it after the conclusion of the third module (phase 2) and again 9 months later (phase 3). The questionnaire was divided into two distinct parts: the first had the coding of each volunteer for later comparison of data, ensuring their confidentiality, which was followed by the collection of sociodemographic variables: gender, age, academic year and educational institution. The second part was intended to collect the variables of the measured dimensions (perceived quality of life, perceived stress, burnout, self-compassion, compassion and self-reflection and insight), through the application of 6 scales: 1. Visual Analogue Scale for Perceived Quality of Life 2. Perceived Stress Scale 3. Maslach Burnout Scale for Portuguese students 4. Self-Compassion Scale 5. Compassion Scale 6. Self-Reflection and Insight Scale- New Adapted and Validated Self-Awareness Measure for Brazilian Adults In the questionnaires of phases 2 and 3, a last open-response question was added so that the intervention group could share the benefits, in personal terms, in the management of stress and in the relationship and communication with others, which they thought they had acquired with the course. Inclusion Criteria: - to be a medical student enrolled in one of the several Portuguese medical schools. Exclusion criteria: - not participating in 70% of the course (intervention group)

NCT0531xxxx/NCT05313984.xml

<clinical_study>  <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/NCT05313984</url> </required_header> <id_info> <org_study_id>EC2018/0244</org_study_id> <nct_id>NCT05313984</nct_id> </id_info> <brief_title>OptiLUTS Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation.</brief_title> <acronym>OptiLUTS</acronym> <official_title>Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation: A Prospective Single Centre Study.</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Ghent</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Medtronic</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>University Hospital, Ghent</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.  A holistic assessment tool will be developed and SNM-care pathway will be set-up. </textblock> </brief_summary> <detailed_description> <textblock> A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.  Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.  Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.  Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 1, 2018</start_date> <completion_date type="Actual">December 31, 2021</completion_date> <primary_completion_date type="Actual">December 1, 2021</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Implantation ratio</measure> <time_frame>Through study completion, an average of 3 years</time_frame> <description>Proportion of number of patients who received a definitive implant.</description> </primary_outcome> <primary_outcome> <measure>True success ratio</measure> <time_frame>Through study completion, an average of 3 years</time_frame> <description>Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM.</description> </primary_outcome> <primary_outcome> <measure>False positive ratio</measure> <time_frame>One month after definitive implant.</time_frame> <description>Proportion of patients with discontinued SS although having true success during test phase.</description> </primary_outcome> <secondary_outcome> <measure>Explantation ratio</measure> <time_frame>Within 12 months after definitive implant.</time_frame> <description>Proportion of patients explanted.</description> </secondary_outcome> <secondary_outcome> <measure>Revision ratio</measure> <time_frame>Within 12 months after definitive implant.</time_frame> <description>Proportion of patients that received a revision.</description> </secondary_outcome> <secondary_outcome> <measure>Absolute change in diary variables.</measure> <time_frame>Up to 4 weeks, depending on the duration of the test phase.</time_frame> <description>Test phase compared to baseline. (Different for each indication).</description> </secondary_outcome> <secondary_outcome> <measure>Evolution of PROM scores over time.</measure> <time_frame>At 12 months follow-up.</time_frame> <description>Total PROM scores, based on questionnaires, baseline compared to scores at during the test phase vs. at 1 month, at 6 months and at 12 months follow-up.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">93</enrollment> <condition>Overactive Bladder Syndrome</condition> <condition>Urinary Retention</condition> <condition>Dysfunctional Voiding</condition> <condition>Fecal Incontinence</condition> <condition>Fowler Syndrome</condition> <arm_group> <arm_group_label>Patients planned for the 2-staged tined-lead procedure.</arm_group_label> <description>Patients with the following indications: Overactive bladder without urgency urinary incontinence. Overactive bladder with urgency urinary incontinence. Non-obstructive urinary retention. Dysfunctional voiding or Fowler Syndrome. Fecal incontinence.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Sacral neuromodulation</intervention_name> <description>Sacral neuromodulation: the 2-staged tined lead procedure. (Interstim II therapy, Medtronic). Stage I: Placement of a tined-lead electrode. 2 - 4 weeks test phase. Stage II: Placement of an implantable pulse generator.</description> <arm_group_label>Patients planned for the 2-staged tined-lead procedure.</arm_group_label> <other_name>SNM</other_name> </intervention> <eligibility> <study_pop> <textblock> Patients referred for pelvic organ dysfunctions to the Urology department (UD) and Colorectal Surgery department (CRD) of the Ghent University Hospital and scheduled for a staged SNM procedure using InterstimTM II therapy (Medtronic, Minneapolis, MN) were enrolled. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence  - Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.  Exclusion Criteria:  - Neurogenic bladder.  - Anal sphincter damage more than 120  - Abnormal sacral anatomy  - Mentally or physically disabled patients not capable to handle a patient programmer device.  - Pregnant patients </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Karel Everaert, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>University Hospital, Ghent</affiliation> </overall_official> <location> <facility> <name>Department of Urology, Ghent University Hospital</name> <address> <city>Ghent</city> <zip>9000</zip> <country>Belgium</country> </address> </facility> </location> <location_countries> <country>Belgium</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 3, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Sacral neuromodulation</keyword> <condition_browse>  <mesh_term>Fecal Incontinence</mesh_term> <mesh_term>Urinary Bladder, Overactive</mesh_term> <mesh_term>Urinary Retention</mesh_term> <mesh_term>Syndrome</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account. A holistic assessment tool will be developed and SNM-care pathway will be set-up. A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled. Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant. Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured. Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway. Patients referred for pelvic organ dysfunctions to the Urology department (UD) and Colorectal Surgery department (CRD) of the Ghent University Hospital and scheduled for a staged SNM procedure using InterstimTM II therapy (Medtronic, Minneapolis, MN) were enrolled. Inclusion Criteria: - Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence - Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment. Exclusion Criteria: - Neurogenic bladder. - Anal sphincter damage more than 120 - Abnormal sacral anatomy - Mentally or physically disabled patients not capable to handle a patient programmer device. - Pregnant patients

NCT0531xxxx/NCT05313997.xml

<clinical_study>  <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/NCT05313997</url> </required_header> <id_info> <org_study_id>2022-20</org_study_id> <nct_id>NCT05313997</nct_id> </id_info> <brief_title>The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain</brief_title> <official_title>The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain, A Follow-Up Study</official_title> <sponsors> <lead_sponsor> <agency>Kocaeli University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Kocaeli University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study.  Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program.  Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS).  The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">May 24, 2022</start_date> <completion_date type="Actual">July 15, 2022</completion_date> <primary_completion_date type="Actual">July 15, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Visual Analog Scale (VAS)</measure> <time_frame>10 seconds</time_frame> <description>The Visual Analog Scale (VAS) is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. FM patients mark the point on the line that best corresponds to their symptom severity. To this end, they are instructed to put a cross on the straight line at the point that most accurately expresses their degree of agreement. When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100- value scale using a millimeter tape measure.</description> </primary_outcome> <enrollment type="Actual">194</enrollment> <condition>Thoracic Disc Herniation</condition> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Diclofenac Sodium</intervention_name> <description>at first diclofenac sodium was prescribed to patients with chronic upper back pain. If the patient's pain persisted, she/he was included in the physical therapy (hotpack 20 minutes, ultrason 5 minutes, Transcutaneous electrical nerve stimulation 20 minutes) program.</description> <other_name>physical therapy</other_name> </intervention> <eligibility> <study_pop> <textblock> - 18-65 years old  - admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.  - Diagnosed with TDH as a result of thoracic vertebral MRI </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - 18-65 years old  - admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.  - Diagnosed with TDH as a result of thoracic vertebral MRI  Exclusion Criteria:Patients with  - vertebral fracture,  - developmental spinal deformity,  - spinal infection or tumor,  - chronic widespread pain syndrome such as fibromyalgia,  - diabetes mellitus,  - polyneuropathy  - rheumatological disease  - under 18 years old  - over 65 years old  - who have had previous back and neck surgery </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> </eligibility> <overall_official> <last_name>emine dundar ahi, ass professor</last_name> <role>Principal Investigator</role> <affiliation>Kocaeli University</affiliation> </overall_official> <location> <facility> <name>Private Medar Hospital</name> <address> <city>Kocaeli</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 4, 2022</last_update_submitted> <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 5, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Kocaeli University</investigator_affiliation> <investigator_full_name>Emine Dundar Ahi, MD</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>chronic upper back pain</keyword> <keyword>thoracic disc herniation</keyword> <condition_browse>  <mesh_term>Intervertebral Disc Displacement</mesh_term> <mesh_term>Back Pain</mesh_term> <mesh_term>Hernia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Diclofenac</mesh_term> </intervention_browse>  </clinical_study>

Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study. Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program. Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS). The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically. - 18-65 years old - admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain. - Diagnosed with TDH as a result of thoracic vertebral MRI Inclusion Criteria: - 18-65 years old - admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain. - Diagnosed with TDH as a result of thoracic vertebral MRI Exclusion Criteria:Patients with - vertebral fracture, - developmental spinal deformity, - spinal infection or tumor, - chronic widespread pain syndrome such as fibromyalgia, - diabetes mellitus, - polyneuropathy - rheumatological disease - under 18 years old - over 65 years old - who have had previous back and neck surgery

NCT0531xxxx/NCT05314010.xml

<clinical_study>  <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/NCT05314010</url> </required_header> <id_info> <org_study_id>MIL62-CT303</org_study_id> <nct_id>NCT05314010</nct_id> </id_info> <brief_title>A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)</brief_title> <official_title>A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)</official_title> <sponsors> <lead_sponsor> <agency>Beijing Mabworks Biotech Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Beijing Mabworks Biotech Co., Ltd.</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 18, 2022</start_date> <completion_date type="Anticipated">March 2027</completion_date> <primary_completion_date type="Anticipated">March 2025</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Phase 1b: CD19+ B and CD20+ B lymphocyte ratio</measure> <time_frame>Up to 52 weeks</time_frame> <description>Pharmacodynamics endpoint</description> </primary_outcome> <primary_outcome> <measure>Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP</measure> <time_frame>Up to 52 weeks</time_frame> <description>The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">140</enrollment> <condition>Neuromyelitis Optica Spectrum Disorder</condition> <arm_group> <arm_group_label>MIL62</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>MIL62</intervention_name> <description>Phase 1b:participants will receive IV MIL62 500 mg or 1000 mg on Day 1 and Day 15. Phase 3:Participants will receive IV MIL62 on Day 1, Day 15 and Day 183 of the RCP at the dose confirmed in the phase Ib. The participants who enter the OLP will receive IV MIL62 on Day 1 and matching placebo on Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.</description> <arm_group_label>MIL62</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Phase 3:Participants will receive IV placebo matched to MIL62 on Day 1, Day 15 and Day 183 of the RCP. The participants who enter the OLP will receive IV MIL62 on both Day 1 and Day 15, followed by a single IV dose of MIL62 every 6 months until maximum of 6 months after the last participant enters the OLP.</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.  2. Male or female aged 18～60 years.  3. Expanded Disability Status Scale(EDSS) score ≤6.5.  4. A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening.  5. Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration.  Exclusion Criteria:  1. CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count <300 cells/μL(CD4：CD8≤1.4).  2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.  3. Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .  4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.  5. Any live or attenuated vaccine within 28 days prior to the first administration. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Dehui Huang, doctor</last_name> <phone>8610-55499036</phone> <email>huangdehui@gmail.com</email> </overall_contact> <location> <facility> <name>Ethics Committee of Chinese PLA General Hosptial</name> <address> <city>Beijing</city> <state>Beijing</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dehui Huang, doctor</last_name> <phone>8610-55499036</phone> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 9, 2023</last_update_submitted> <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neuromyelitis Optica</mesh_term> </condition_browse>  </clinical_study>

This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder. Inclusion Criteria: 1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status. 2. Male or female aged 18～60 years. 3. Expanded Disability Status Scale(EDSS) score ≤6.5. 4. A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening. 5. Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration. Exclusion Criteria: 1. CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count <300 cells/μL(CD4：CD8≤1.4). 2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration. 3. Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group . 4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration. 5. Any live or attenuated vaccine within 28 days prior to the first administration.

NCT0531xxxx/NCT05314023.xml

<clinical_study>  <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/NCT05314023</url> </required_header> <id_info> <org_study_id>V503-053</org_study_id> <secondary_id>V503-053</secondary_id> <nct_id>NCT05314023</nct_id> </id_info> <brief_title>Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)</brief_title> <official_title>A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old</official_title> <sponsors> <lead_sponsor> <agency>Merck Sharp & Dohme LLC</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Merck Sharp & Dohme LLC</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">May 7, 2022</start_date> <completion_date type="Anticipated">February 19, 2029</completion_date> <primary_completion_date type="Anticipated">February 19, 2029</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose</measure> <time_frame>Up to Month 13</time_frame> <description>cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.</description> </primary_outcome> <primary_outcome> <measure>cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose</measure> <time_frame>Up to 72 months</time_frame> <description>cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.</description> </primary_outcome> <primary_outcome> <measure>cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine</measure> <time_frame>Up to 72 months</time_frame> <description>cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.</description> </primary_outcome> <secondary_outcome> <measure>cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine</measure> <time_frame>Up to Month 13</time_frame> <description>cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.</description> </secondary_outcome> <secondary_outcome> <measure>Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose</measure> <time_frame>Up to Month 13</time_frame> <description>IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.</description> </secondary_outcome> <secondary_outcome> <measure>IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine</measure> <time_frame>Up to Month 13</time_frame> <description>IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.</description> </secondary_outcome> <secondary_outcome> <measure>Percentage of participants experiencing solicited injection-site adverse events (AEs),</measure> <time_frame>Day 1 through Day 8 following any study vaccination</time_frame> <description>An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.</description> </secondary_outcome> <secondary_outcome> <measure>Percentage of participants experiencing solicited systemic AEs</measure> <time_frame>Day 1 through Day 8 following any study vaccination</time_frame> <description>An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs.</description> </secondary_outcome> <secondary_outcome> <measure>Percentage of participants experiencing serious AEs (SAEs)</measure> <time_frame>Up to 72 months</time_frame> <description>A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.</description> </secondary_outcome> <secondary_outcome> <measure>IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose</measure> <time_frame>Up to 72 months</time_frame> <description>IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.</description> </secondary_outcome> <secondary_outcome> <measure>IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine</measure> <time_frame>Up to 72 months</time_frame> <description>IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">1590</enrollment> <condition>Genital Warts</condition> <arm_group> <arm_group_label>9 to 19 Years Old: Day 1, Months 2 and 6</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Chinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6</description> </arm_group> <arm_group> <arm_group_label>9 to 14 Years Old: Day 1, and Month 6</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6</description> </arm_group> <arm_group> <arm_group_label>9 to 14 Years Old: Day 1 and Month 12</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 12</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>9vHPV vaccine</intervention_name> <description>A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.</description> <arm_group_label>9 to 14 Years Old: Day 1 and Month 12</arm_group_label> <arm_group_label>9 to 14 Years Old: Day 1, and Month 6</arm_group_label> <arm_group_label>9 to 19 Years Old: Day 1, Months 2 and 6</arm_group_label> <other_name>V503</other_name> <other_name>GARDASIL™9</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Is a healthy Chinese male.  - Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose).  Exclusion Criteria:  - Has a history of known prior vaccination with an HPV vaccine.  - Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.  - Has a history of severe allergic reaction that required medical intervention.  - Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.  - Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.  - Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.  - Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections. </textblock> </criteria> <gender>Male</gender> <gender_based>Yes</gender_based> <gender_description>Chinese males only</gender_description> <minimum_age>9 Years</minimum_age> <maximum_age>19 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Medical Director</last_name> <role>Study Director</role> <affiliation>Merck Sharp & Dohme LLC</affiliation> </overall_official> <location> <facility> <name>Liucheng County Centers for Disease Control and Prevention ( Site 0005)</name> <address> <city>Liuzhou</city> <state>Guangxi</state> <zip>545200</zip> <country>China</country> </address> </facility> </location> <location> <facility> <name>Center for Disease Control and Prevention of Rong An ( Site 0006)</name> <address> <city>Liuzhou</city> <state>Guangxi</state> <zip>545400</zip> <country>China</country> </address> </facility> </location> <location> <facility> <name>Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0</name> <address> <city>Louxing District</city> <state>Hunan</state> <zip>417000</zip> <country>China</country> </address> </facility> </location> <location> <facility> <name>Yuechi Disease Prevention and Control Center ( Site 0002)</name> <address> <city>Guang'an</city> <state>Sichuan</state> <zip>638399</zip> <country>China</country> </address> </facility> </location> <location> <facility> <name>Santai County Center for Disease Control and Prevention ( Site 0001)</name> <address> <city>Mianyang</city> <state>Sichuan</state> <zip>621100</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 18, 2023</last_update_submitted> <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 19, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Condylomata Acuminata</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description> <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url> </patient_data>  </clinical_study>

This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type. Inclusion Criteria: - Is a healthy Chinese male. - Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose). Exclusion Criteria: - Has a history of known prior vaccination with an HPV vaccine. - Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer. - Has a history of severe allergic reaction that required medical intervention. - Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose. - Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. - Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids. - Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.

NCT0531xxxx/NCT05314036.xml

<clinical_study>  <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/NCT05314036</url> </required_header> <id_info> <org_study_id>WTN-001</org_study_id> <nct_id>NCT05314036</nct_id> </id_info> <brief_title>The Wellness Transformation Network Pilot Study</brief_title> <official_title>Establishment of a Standard Operating Procedure for Screening of the Pathologies Associated With Prediabetes and Diabetes -The Wellness Transformation Network Pilot Study.</official_title> <sponsors> <lead_sponsor> <agency>SciMar Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Source Nutraceutical, Inc.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>SciMar Ltd.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes. </textblock> </brief_summary> <detailed_description> <textblock> The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims:  1. To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics.  2. To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability).  The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 17, 2022</start_date> <completion_date type="Actual">April 5, 2022</completion_date> <primary_completion_date type="Actual">April 5, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Establishment of proposed Wellness Transformation Network clinical trial procedures.</measure> <time_frame>2 Weeks</time_frame> <description>Practical feasibility of the proposed Wellness Transformation Network clinical trial procedures (Yes/No)</description> </primary_outcome> <secondary_outcome> <measure>Time course and curve analysis of serum glucose response after the test meal administration.</measure> <time_frame>Test: Baseline, every 30 minutes up to 2 hours after test meal administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time course and curve analysis of serum insulin response after the test meal administration.</measure> <time_frame>Test: Baseline, every 30 minutes up to 2 hours after test meal administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time course and curve analysis of serum triglycerides response after the test meal administration.</measure> <time_frame>Test: Baseline, every 30 minutes up to 2 hours after test meal administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time course and curve analysis of plasma hepatalin response after the test meal administration.</measure> <time_frame>Test: Baseline, every 30 minutes up to 2 hours after test meal administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time course and curve analysis of Meal Induced Glycemia (MIG) scores response after the test meal administration.</measure> <time_frame>Test: Baseline, every 30 minutes up to 2 hours after test meal administration</time_frame> <description>MIG is calculated using the formula: MIG = (post meal insulin mIU/L X post meal glucose mmol/L) minus (fasted insulin mIU/L X fasted glucose mmol/L). Higher score equates to a worse (unhealthy) outcome.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">15</enrollment> <condition>Non-Diabetic</condition> <condition>Females Who Are Not Pregnant or Breast Feeding</condition> <arm_group> <arm_group_label>Acute Postprandial Blood Sampling</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Two-hour postprandial blood sampling following administration of a standardized test meal</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Standardized test meal</intervention_name> <description>During this study visit, a standardized test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 2 hours after test meal.</description> <arm_group_label>Acute Postprandial Blood Sampling</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adults (males and females)18 years of age or older.  - Able to understand and communicate in English.  - Willing to answer a questionnaire on lifestyle and health status.  - Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing.  - Willing to fast for 12 hours prior to two in-person study visits.  - Willing to consume a standardized test meal containing food ingredients.  - Willing to provide a urine sample.  - Willing to take a pregnancy test (female participants of childbearing potential).  - Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs).  - Willing to complete an online eDiary, including a 3-day food record.  - Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter)  Exclusion Criteria:  - Individuals diagnosed with diabetes.  - Women with confirmed pregnancy or who are breastfeeding.  - Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein).  - Individuals with a fasting blood glucose of 7.0 mmol/L or higher.  - Individuals with abnormal glucose in their urine.  - Individuals who are related to or working for the clinic site, research staff, and study sponsor. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Vanu Ramprasath, PhD</last_name> <role>Principal Investigator</role> <affiliation>Source Nutraceutical, Inc.</affiliation> </overall_official> <location> <facility> <name>SNI Clinical Research</name> <address> <city>Winnipeg</city> <state>Manitoba</state> <zip>R2K 3Z5</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>February 10, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 21, 2022</last_update_submitted> <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 22, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Glucose</keyword> <keyword>Insulin</keyword> <keyword>Prediabetes</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes. The proposed study will enable screening of pathologies associated with cardiometabolic diseases (i.e., hypertension, prediabetes, insulin resistance, diabetes, and obesity). The Meal-Induced Insulinemia and Glycemia (MIG) score will correlate with those dysfunctions that are components of the Absence of Meal-Induced Insulinemia (AMIS) syndrome. Overall the study aims: 1. To establish an SOP for screening pathologies associated with cardiometabolic diseases using a combination of biometrics and metabolomics. 2. To compare a participant's MIG score and hepatalin levels following consumption of a standardized test meal containing macronutrients, and the measurement of several indices of organ health associated with diabetes (i.e., body composition, handgrip strength, spirometry, blood pressure, and heart rate variability). The study will involve 2 study visits: Visit 1 - Screening and Visit 2 - Intervention (Test meal administration and postprandial blood collection). Inclusion Criteria: - Adults (males and females)18 years of age or older. - Able to understand and communicate in English. - Willing to answer a questionnaire on lifestyle and health status. - Willing to undergo measurements of height, weight, waist circumference, hip circumference, blood pressure, heart rate and heart rate variability, body mass index, handgrip strength (handgrip dynamometry) testing, and pulmonary function (spirometry) testing. - Willing to fast for 12 hours prior to two in-person study visits. - Willing to consume a standardized test meal containing food ingredients. - Willing to provide a urine sample. - Willing to take a pregnancy test (female participants of childbearing potential). - Willing to provide the research team with a listing of all current medications and Natural Health Products(NHPs). - Willing to complete an online eDiary, including a 3-day food record. - Willing to give blood samples (finger prick and blood sampling at defined intervals using an intravenous catheter) Exclusion Criteria: - Individuals diagnosed with diabetes. - Women with confirmed pregnancy or who are breastfeeding. - Individuals with allergy or sensitivity to any component of the standardized test meal (i.e., dextrose, lecithin, soy protein). - Individuals with a fasting blood glucose of 7.0 mmol/L or higher. - Individuals with abnormal glucose in their urine. - Individuals who are related to or working for the clinic site, research staff, and study sponsor.

NCT0531xxxx/NCT05314049.xml

<clinical_study>  <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/NCT05314049</url> </required_header> <id_info> <org_study_id>FUI/CTR/2022/4</org_study_id> <nct_id>NCT05314049</nct_id> </id_info> <brief_title>Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain</brief_title> <official_title>Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain</official_title> <sponsors> <lead_sponsor> <agency>Foundation University Islamabad</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Foundation University Islamabad</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">October 30, 2022</completion_date> <primary_completion_date type="Anticipated">October 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Back Pain</measure> <time_frame>2 weeks</time_frame> <description>Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.</description> </primary_outcome> <primary_outcome> <measure>Lumbar Range of Motion</measure> <time_frame>2 weeks</time_frame> <description>Disability will be measured via inclinometer. A higher score signifies good outcome.</description> </primary_outcome> <primary_outcome> <measure>Postural Stability</measure> <time_frame>2 weeks</time_frame> <description>Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.</description> </primary_outcome> <primary_outcome> <measure>Lumbar Disability</measure> <time_frame>2 weeks</time_frame> <description>Disability will be measured via Oswestry Disability Index.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">44</enrollment> <condition>Low Back Pain</condition> <condition>Disk Prolapse</condition> <condition>Disk Herniated Lumbar</condition> <condition>Sciatic Radiculopathy</condition> <arm_group> <arm_group_label>Experimental Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Active Comparator Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Mckenzie Extension Protocol</intervention_name> <description>Mckenzie Extension Exercise Protocol will be performed by participants in prone position</description> <arm_group_label>Active Comparator Group</arm_group_label> <arm_group_label>Experimental Group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Lumbar SNAGs</intervention_name> <description>Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position</description> <arm_group_label>Experimental Group</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>inferential therapy</intervention_name> <description>4 pole inferential therapy in combination with superficial heating for 20 minutes</description> <arm_group_label>Active Comparator Group</arm_group_label> <arm_group_label>Experimental Group</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Heat Therapy</intervention_name> <description>superficial heating for 20 minutes</description> <arm_group_label>Active Comparator Group</arm_group_label> <arm_group_label>Experimental Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Both male and female participants  - aged 18-50 years old  - low back pain intensity less than 80/100mm on visual analogue scale  - positive centralization phenomenon  - low signal intensity of IV disc on T2 - weighted MRI  - high intensity zone towards the posterior aspect of the disc on MRI  Exclusion Criteria:  Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.  - </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Muhammad Osama, PhD*</last_name> <phone>+923325540436</phone> <email>osama@fui.edu.pk</email> </overall_contact> <overall_contact_backup> <last_name>Muhammad Osama, PhD*</last_name> <email>osama@fui.edu.pk</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Intervertebral Disc Displacement</mesh_term> <mesh_term>Radiculopathy</mesh_term> <mesh_term>Back Pain</mesh_term> <mesh_term>Low Back Pain</mesh_term> <mesh_term>Prolapse</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain. Inclusion Criteria: - Both male and female participants - aged 18-50 years old - low back pain intensity less than 80/100mm on visual analogue scale - positive centralization phenomenon - low signal intensity of IV disc on T2 - weighted MRI - high intensity zone towards the posterior aspect of the disc on MRI Exclusion Criteria: Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study. -

NCT0531xxxx/NCT05314062.xml

<clinical_study>  <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/NCT05314062</url> </required_header> <id_info> <org_study_id>00002850</org_study_id> <nct_id>NCT05314062</nct_id> </id_info> <brief_title>Effect of Iron Source on the Growth of Enteric Pathogens</brief_title> <official_title>Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens</official_title> <sponsors> <lead_sponsor> <agency>Florida State University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Florida State University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 18, 2022</start_date> <completion_date type="Actual">June 20, 2022</completion_date> <primary_completion_date type="Actual">June 20, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>This is a double-blind study</masking_description> </study_design_info> <primary_outcome> <measure>Concentration of iron taken up by enteric pathogens</measure> <time_frame>0-24 hours</time_frame> <description>Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.</description> </primary_outcome> <primary_outcome> <measure>Growth of enteric pathogens measured by optical density</measure> <time_frame>0-24 hours</time_frame> <description>Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.</description> </primary_outcome> <secondary_outcome> <measure>Gut microbiome composition and diversity</measure> <time_frame>0-24 hours</time_frame> <description>Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.</description> </secondary_outcome> <secondary_outcome> <measure>Individual fecal short chain fatty acid (SCFA) concentration</measure> <time_frame>0-24 hours</time_frame> <description>Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">10</enrollment> <condition>Iron-deficiency</condition> <condition>Iron Deficiency Anemia</condition> <condition>Iron Deficiency Anemia Treatment</condition> <arm_group> <arm_group_label>Ferrous sulfate (FeSO4)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>FeSO4 supplements containing 54 mg elemental iron</description> </arm_group> <arm_group> <arm_group_label>Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Ao iron supplements containing 54 mg elemental iron</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>FeSO4</intervention_name> <description>2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)</description> <arm_group_label>Ferrous sulfate (FeSO4)</arm_group_label> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Ao iron</intervention_name> <description>2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)</description> <arm_group_label>Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy children 5-12 y  - Willing to donate stool sample  Exclusion Criteria:  - Currently taking antibiotics  - Currently taking a vitamin and mineral supplement containing iron  - Wards of the state, including children in foster care </textblock> </criteria> <gender>All</gender> <minimum_age>5 Years</minimum_age> <maximum_age>12 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Florida State University</name> <address> <city>Tallahassee</city> <state>Florida</state> <zip>32306</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2022</verification_date> <study_first_submitted>March 19, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 21, 2022</last_update_submitted> <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 22, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Florida State University</investigator_affiliation> <investigator_full_name>Stephen R. Hennigar, Ph.D.</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Anemia</mesh_term> <mesh_term>Anemia, Iron-Deficiency</mesh_term> <mesh_term>Iron Deficiencies</mesh_term> <mesh_term>Deficiency Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>IPD will not be shared with other researchers.</ipd_description> </patient_data>  </clinical_study>

The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation. Inclusion Criteria: - Healthy children 5-12 y - Willing to donate stool sample Exclusion Criteria: - Currently taking antibiotics - Currently taking a vitamin and mineral supplement containing iron - Wards of the state, including children in foster care

NCT0531xxxx/NCT05314075.xml

<clinical_study>  <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/NCT05314075</url> </required_header> <id_info> <org_study_id>HM20024184</org_study_id> <nct_id>NCT05314075</nct_id> </id_info> <brief_title>Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)</brief_title> <official_title>Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)</official_title> <sponsors> <lead_sponsor> <agency>Virginia Commonwealth University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Virginia Commonwealth University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 27, 2022</start_date> <completion_date type="Anticipated">December 2023</completion_date> <primary_completion_date type="Anticipated">December 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Core body temperature</measure> <time_frame>1 hour post surgery</time_frame> <description>Maternal core temperatures will be measured using a temperature sensing Foley catheter</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">130</enrollment> <condition>Cesarean Section</condition> <arm_group> <arm_group_label>Upper Body</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <arm_group> <arm_group_label>Under body</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Upper Body Forced Air Warming device</intervention_name> <description>Patients will have the Bair Hugger placed over the body</description> <arm_group_label>Upper Body</arm_group_label> <other_name>Bair Hugger</other_name> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Under Body Forced Air Warming device</intervention_name> <description>Patients will have the Bair Hugger placed under the body</description> <arm_group_label>Under body</arm_group_label> <other_name>Bair Hugger</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age =/> 18 years  - Elective non-emergent C-section  Exclusion Criteria:  - BMI<18/>40  - Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis  - Perioperative hemorrhage >1500ml  - Non-Singleton Pregnancies  - Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia)  - Conversion to Emergency C-section  - Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes  - Inmates </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Pregnant females</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Fatoumata Kromah, MD</last_name> <role>Principal Investigator</role> <affiliation>Virginia Commonwealth University</affiliation> </overall_official> <overall_contact> <last_name>Fatoumata Kromah, MD</last_name> <phone>804-828-5021</phone> <email>fatoumata.kromah@vcuhealth.org</email> </overall_contact> <overall_contact_backup> <last_name>Donna Ells</last_name> <email>donna.ells@vcuhealth.org</email> </overall_contact_backup> <location> <facility> <name>Virginia Commonwealth University</name> <address> <city>Richmond</city> <state>Virginia</state> <zip>23298</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 13, 2023</last_update_submitted> <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Thermoregulation</keyword> <keyword>Forced air warming</keyword> <keyword>upper or lower body forced air cover</keyword> <keyword>core body temperature</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device. Inclusion Criteria: - Age =/> 18 years - Elective non-emergent C-section Exclusion Criteria: - BMI<18/>40 - Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis - Perioperative hemorrhage >1500ml - Non-Singleton Pregnancies - Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia) - Conversion to Emergency C-section - Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes - Inmates

NCT0531xxxx/NCT05314088.xml

<clinical_study>  <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/NCT05314088</url> </required_header> <id_info> <org_study_id>1R21AG076377-01A1</org_study_id> <nct_id>NCT05314088</nct_id> </id_info> <brief_title>Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV</brief_title> <acronym>RISE+</acronym> <official_title>Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV</official_title> <sponsors> <lead_sponsor> <agency>University of Alabama at Birmingham</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Institute on Aging (NIA)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>University of Alabama at Birmingham</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV. </textblock> </brief_summary> <detailed_description> <textblock> A two-group RCT will enroll 100 older (aged 50+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 14-day experience sampling method (ESM) protocol, and then be randomized to either the intervention group (n=50) or an attention-matched control group (n=50). We will block randomize groups based on race, sex, and self-reported resilience (Connor Davidson Resilience Scale). If differences are found between groups on influential variables (e.g., SES), such factors will be controlled in analyses and exploratory aim analyses will examine treatment moderators (e.g., sex, race). Both groups will return for four weekly two-hour group visits, followed by a one-month post intervention assessment (including qualitative and quantitative feedback) and a second ESM protocol. A three-month follow-up (comparable to baseline) will assess health outcomes. A blinded research assistant will conduct follow-ups. Our Primary Aims will use ESM via text messaging, and focus on intervention effects on the use of resilience resources following times when stressors are reported and whether such increases drive improved affective stress reactivity and recovery (Aim 1). Our secondary aim will examine effects on health outcomes at three months. Our exploratory aim will examine moderators of treatment response. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">February 3, 2023</start_date> <completion_date type="Anticipated">May 2024</completion_date> <primary_completion_date type="Anticipated">May 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>A two group RCT, one group receives the behavioral intervention and one receives an attention matched placebo control intervention.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>resilience resources</measure> <time_frame>immediately following the 4 week intervention</time_frame> <description>we will use daily text messaging after the intervention to assess use of resilience resources following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a 5 pt Likert scale on their levels of 7 resilience resources: hardiness, optimism, self-efficacy, locus of control, positive reframing, proactive coping, and social support. Scores will be a total average score and individual average scores for each resource.</description> </primary_outcome> <primary_outcome> <measure>stress reactivity</measure> <time_frame>immediately following the 4 week intervention</time_frame> <description>we will use daily text messaging after the intervention to assess use of stress reactivity following stressors. Participants will be texted daily to ask if they experienced a stressor (YES/NO) and then they respond on a Visual Analog Scale of their positive and negative affect. Their are 10 items for positive affect and 10 for negative affect. Total average positive and negative affect scores will be used.</description> </primary_outcome> <secondary_outcome> <measure>health related quality of life</measure> <time_frame>3 months after intervention</time_frame> <description>Medical Outcomes Study HIV Health Survey</description> </secondary_outcome> <secondary_outcome> <measure>depressive symptoms</measure> <time_frame>3 months after intervention</time_frame> <description>Centers for Epidemiological Studies Depression Scale</description> </secondary_outcome> <secondary_outcome> <measure>HIV medication adherence</measure> <time_frame>3 months after intervention</time_frame> <description>Visual Analogue Scale ART adherence</description> </secondary_outcome> <secondary_outcome> <measure>HIV Treatment Management Abilities</measure> <time_frame>3 months after intervention</time_frame> <description>HIV Treatment Adherence Self-Efficacy Scale</description> </secondary_outcome> <secondary_outcome> <measure>HIV Viral Load</measure> <time_frame>3 months after intervention</time_frame> <description>HIV plasma viral load (copies per mL of plasma) extracted from medical records</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Resilience</condition> <condition>HIV-1-infection</condition> <condition>Stress, Psychological</condition> <arm_group> <arm_group_label>RISE+ Resilience Intervention</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants in the intervention group will come to the lab for four two-hour weekly sessions in small groups of 3-4. The intervention includes psychoeducational videos and individual written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience. The intervention will be facilitated by a trained research assistant but as in the pilot study, he/she will be minimally involved (i.e., only administering the videos and explaining the activities) to keep the private reflective nature of the program that participants liked. Upon completion of the program, participants will be given handouts with summaries of the program material. We will gather qualitative and quantitative feedback on the intervention at the one-month posttest.</description> </arm_group> <arm_group> <arm_group_label>Stress Reduction Control</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Control participants will complete an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games. As with the intervention group, participants in the control group will come to the lab for four two-hour weekly sessions in small groups of 3-4. Facilitator involvement will be the same as the intervention group (e.g., the research assistant will explain computer activities and games but will otherwise not interact with the participant).</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>RISE+</intervention_name> <description>The intervention includes psychoeducational videos and written activities on topics such as coping strategies, cognitive appraisals, the responsibility model, and social connections, all integrated into the overarching process of resilience.</description> <arm_group_label>RISE+ Resilience Intervention</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Stress Reduction Control</intervention_name> <description>Placebo Comparator: Stress Reduction Control Control participants will complete an attention-matched internet stress reduction paradigm, which includes an internet navigation protocol and placebo computer games.</description> <arm_group_label>Stress Reduction Control</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - current UAB HIV Clinic patient  - age 50+  - have a recent history (within the past 12 months) of suboptimal HIV management, defined as having either ≥one record of detectable viral load or ≥one missed clinic visit without prior cancellation/reschedule  Exclusion Criteria:  - neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Holley Mears Building</name> <address> <city>Birmingham</city> <state>Alabama</state> <zip>35294</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 8, 2023</last_update_submitted> <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation> <investigator_full_name>Pariya L. Fazeli, PhD</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stress, Psychological</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV. A two-group RCT will enroll 100 older (aged 50+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 14-day experience sampling method (ESM) protocol, and then be randomized to either the intervention group (n=50) or an attention-matched control group (n=50). We will block randomize groups based on race, sex, and self-reported resilience (Connor Davidson Resilience Scale). If differences are found between groups on influential variables (e.g., SES), such factors will be controlled in analyses and exploratory aim analyses will examine treatment moderators (e.g., sex, race). Both groups will return for four weekly two-hour group visits, followed by a one-month post intervention assessment (including qualitative and quantitative feedback) and a second ESM protocol. A three-month follow-up (comparable to baseline) will assess health outcomes. A blinded research assistant will conduct follow-ups. Our Primary Aims will use ESM via text messaging, and focus on intervention effects on the use of resilience resources following times when stressors are reported and whether such increases drive improved affective stress reactivity and recovery (Aim 1). Our secondary aim will examine effects on health outcomes at three months. Our exploratory aim will examine moderators of treatment response. Inclusion Criteria: - current UAB HIV Clinic patient - age 50+ - have a recent history (within the past 12 months) of suboptimal HIV management, defined as having either ≥one record of detectable viral load or ≥one missed clinic visit without prior cancellation/reschedule Exclusion Criteria: - neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders

NCT0531xxxx/NCT05314101.xml

<clinical_study>  <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/NCT05314101</url> </required_header> <id_info> <org_study_id>TBT001</org_study_id> <nct_id>NCT05314101</nct_id> </id_info> <brief_title>TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer</brief_title> <official_title>TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Fujian Cancer Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fujian Cancer Hospital</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">February 28, 2024</completion_date> <primary_completion_date type="Anticipated">February 28, 2023</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>progression free survival</measure> <time_frame>up to 24 months</time_frame> <description>Time from enrollment to the onset of disease progression or death.</description> </primary_outcome> <secondary_outcome> <measure>Objective Response Rate (ORR)</measure> <time_frame>every 8 weeks (up to 24 months)</time_frame> <description>Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor</description> </secondary_outcome> <other_outcome> <measure>Overall survival (OS)</measure> <time_frame>every 3 months (up to 24 months) ]</time_frame> <description>Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up.</description> </other_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">25</enrollment> <condition>Immunotherapy</condition> <condition>Colorectal Cancer</condition> <arm_group> <arm_group_label>TAS-102 combined with bevacizumab and tislelizumab</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tislelizumab</intervention_name> <description>Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks</description> <arm_group_label>TAS-102 combined with bevacizumab and tislelizumab</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>bevacizumab</intervention_name> <description>Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks</description> <arm_group_label>TAS-102 combined with bevacizumab and tislelizumab</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>TAS-102</intervention_name> <description>Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks</description> <arm_group_label>TAS-102 combined with bevacizumab and tislelizumab</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients who provided informed consent and voluntarily enrolled  - Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;  - 18-75 years old;  - Measurable target lesions according to RECIST V1.1 assessment criteria;  - Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);  - 0 ~ 2 points according to ECOG quality of life score;  - Drugs can be taken orally  - Estimated survival ≥3 months;  - Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;  - Ascites with no obvious symptoms and no clinical intervention;  - Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;  - Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.  Exclusion Criteria:  - Previous application of TAS-102;  - Pregnant or lactating women;  - No contraception during the reproductive period;  - patients known to have a history of allergy to any study drug, similar drug or excipient;  - Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;  - Patients with a history of thromboembolism, except those caused by PICC;  - Patients with active infection;  - Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);  - Patients with brain metastases with clinical symptoms or imaging evidence;  - Contraindications for treatment of other chronic diseases;  - Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;  - According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;  - Other conditions that the investigator determines are not suitable for inclusion in the study.  - Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Yang jian wei, bachelor</last_name> <phone>13805097959</phone> <phone_ext>86</phone_ext> <email>swzcq62@163.com</email> </overall_contact> <location> <facility> <name>FujianCH</name> <address> <city>Fuzhou</city> <state>Fujian</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yang jian wei</last_name> <phone>13805097959</phone> <email>swzcq62@163.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 19, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 19, 2022</last_update_submitted> <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Colorectal Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Bevacizumab</mesh_term> <mesh_term>Tislelizumab</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis. Inclusion Criteria: - Patients who provided informed consent and voluntarily enrolled - Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology; - 18-75 years old; - Measurable target lesions according to RECIST V1.1 assessment criteria; - Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil); - 0 ~ 2 points according to ECOG quality of life score; - Drugs can be taken orally - Estimated survival ≥3 months; - Women of childbearing age should comply with contraceptive measures if pregnancy test is negative; - Ascites with no obvious symptoms and no clinical intervention; - Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy; - Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability. Exclusion Criteria: - Previous application of TAS-102; - Pregnant or lactating women; - No contraception during the reproductive period; - patients known to have a history of allergy to any study drug, similar drug or excipient; - Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; - Patients with a history of thromboembolism, except those caused by PICC; - Patients with active infection; - Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg); - Patients with brain metastases with clinical symptoms or imaging evidence; - Contraindications for treatment of other chronic diseases; - Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2; - According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions; - Other conditions that the investigator determines are not suitable for inclusion in the study. - Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.

NCT0531xxxx/NCT05314114.xml

<clinical_study>  <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/NCT05314114</url> </required_header> <id_info> <org_study_id>BC-P29</org_study_id> <nct_id>NCT05314114</nct_id> </id_info> <brief_title>Selective Omission of Axillary Surgery in Triple-negative and HER2-positive Breast Cancer After NACT</brief_title> <official_title>Selective Omission of Axillary Surgery in Distinct Responders With Triple-negative and HER2-positive Breast Cancer After NACT</official_title> <sponsors> <lead_sponsor> <agency>Peking University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Peking University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated by NACT and converted to ypN0 indicating the efficacy of systemic treatment in local disease control.  According to current guidelines, all initial cN0 patients will undergo sentinel lymph node biopsy (SLNB) after NACT and further axillary dissection (ALND) if tumor residual is discovered after SLNB. Data suggest patients who underwent SLNB have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of SLNB might translate into a considerable reduction of physical and emotional distress. Recent studies revealed the association between breast pCR and ypN0 status after NACT. Initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including SLNB.  The investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after NACT will not deteriorate survival. In the planned trial, axillary surgery will be completely eliminated for initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT determined by lumpectomy.  The trial is designed as a prospective, single-center, single-arm study with a limited number of patients (N=136). Patients will be recruited in China over a period of 36 months. Our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 3, 2020</start_date> <completion_date type="Anticipated">September 2028</completion_date> <primary_completion_date type="Anticipated">July 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>ipsilateral axillary recurrence-free survival</measure> <time_frame>5-year</time_frame> <description>time between randomization and confirmed ipsilateral axillary recurrence</description> </primary_outcome> <secondary_outcome> <measure>locoregional lymph node recurrence-free survival</measure> <time_frame>5-year</time_frame> <description>time between randomization and confirmed locoregional lymph node recurrence</description> </secondary_outcome> <secondary_outcome> <measure>distant metastasis-free survival</measure> <time_frame>5-year</time_frame> <description>time between randomization and confirmed distant metastasis</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">136</enrollment> <condition>Breast Cancer Female</condition> <arm_group> <arm_group_label>No Axillary Surgery</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>No axillary surgery including SLNB</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>No axillary surgery</intervention_name> <description>No axillary surgery</description> <arm_group_label>No Axillary Surgery</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Written informed consent  - Core biopsy confirmed unicentric primary invasive triple-negative or HER2-positive breast cancer. Multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible.  - At least 18 years of age  - Initial tumor stage cT1c-T3N0M0 prior to NACT. cN0 stage established by clinical examination and ultrasonography  - In cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required  - Standard NACT with evident radiologic response  - Planned breast-conserving surgery with postoperative external whole-breast irradiation  Exclusion Criteria:  - History of previous malignancy  - Histologically proven N1 patients, patients with distant metastasis (M1)  - Pregnant or lactating patients  - Inflammatory breast cancer  - Radiologically non-responsive after NACT  - Mastectomy planned after NACT  - planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques  - Written informed consent not obtained </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Peking University Cancer Hospital</name> <address> <city>Beijing</city> <state>Beijing</state> <zip>100142</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>TAO OUYANG, M.D</last_name> <phone>0086-10-88196696</phone> <email>ouyanghongtao@263.net</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 14, 2022</last_update_submitted> <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Peking University</investigator_affiliation> <investigator_full_name>Tao OUYANG</investigator_full_name> <investigator_title>Professor, Director of the Breast Cancer Department</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Breast Neoplasms</mesh_term> </condition_browse>  </clinical_study>

Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated by NACT and converted to ypN0 indicating the efficacy of systemic treatment in local disease control. According to current guidelines, all initial cN0 patients will undergo sentinel lymph node biopsy (SLNB) after NACT and further axillary dissection (ALND) if tumor residual is discovered after SLNB. Data suggest patients who underwent SLNB have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of SLNB might translate into a considerable reduction of physical and emotional distress. Recent studies revealed the association between breast pCR and ypN0 status after NACT. Initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including SLNB. The investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after NACT will not deteriorate survival. In the planned trial, axillary surgery will be completely eliminated for initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT determined by lumpectomy. The trial is designed as a prospective, single-center, single-arm study with a limited number of patients (N=136). Patients will be recruited in China over a period of 36 months. Our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison. Inclusion Criteria: - Written informed consent - Core biopsy confirmed unicentric primary invasive triple-negative or HER2-positive breast cancer. Multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible. - At least 18 years of age - Initial tumor stage cT1c-T3N0M0 prior to NACT. cN0 stage established by clinical examination and ultrasonography - In cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required - Standard NACT with evident radiologic response - Planned breast-conserving surgery with postoperative external whole-breast irradiation Exclusion Criteria: - History of previous malignancy - Histologically proven N1 patients, patients with distant metastasis (M1) - Pregnant or lactating patients - Inflammatory breast cancer - Radiologically non-responsive after NACT - Mastectomy planned after NACT - planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques - Written informed consent not obtained

NCT0531xxxx/NCT05314127.xml

<clinical_study>  <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/NCT05314127</url> </required_header> <id_info> <org_study_id>9326/22-2-2022</org_study_id> <nct_id>NCT05314127</nct_id> </id_info> <brief_title>Efficacy of Tazarotene in Treatment of Verruca Plana</brief_title> <official_title>Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana</official_title> <sponsors> <lead_sponsor> <agency>Zagazig University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Zagazig University</source> <oversight_info> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Verruca plana is a common skin infection with worldwide distribution. Approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. Verruca plana is not merely an infectious disease but also affects the quality of patients' life. Verruca plana causes major cosmetic and social concerns. Lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. Verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. The available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. Frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. In this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil </textblock> </brief_summary> <detailed_description> <textblock> Patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607  - Group (A): Patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night.  - Group (B): Patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night.  - Group (C): Patients will be treated with imiquimod cream 5% applied once daily at night.  - Group (D): Patients will be treated with petroleum jelly once daily at night. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 15, 2022</start_date> <completion_date type="Anticipated">December 2022</completion_date> <primary_completion_date type="Anticipated">October 2022</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>The proportion of patients with complete clearance of flat warts (Physician Wart Assessment scale PWA = 0) at the end in the four arms of the clinical trial.</measure> <time_frame>Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first</time_frame> <description>Complete clearance is defined by complete disappearance of the warts and return to normal skin markings</description> </primary_outcome> <primary_outcome> <measure>The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study</measure> <time_frame>Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first</time_frame> </primary_outcome> <secondary_outcome> <measure>The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial</measure> <time_frame>Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first</time_frame> </secondary_outcome> <secondary_outcome> <measure>The median time for participants to achieve clearance of all warts in the different arms of the clinical trial.</measure> <time_frame>Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first</time_frame> </secondary_outcome> <secondary_outcome> <measure>The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared)</measure> <time_frame>Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first</time_frame> </secondary_outcome> <secondary_outcome> <measure>The quality of life index measured by the difference in the wart specific Dermatology Life Quality Index at the end of the trial compared to the baseline</measure> <time_frame>at the end of 6 months period follow up</time_frame> </secondary_outcome> <secondary_outcome> <measure>The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial</measure> <time_frame>at the end of 12 weeks study period</time_frame> </secondary_outcome> <secondary_outcome> <measure>The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials</measure> <time_frame>at the end of 12 weeks study period</time_frame> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">80</enrollment> <condition>Warts Flat</condition> <arm_group> <arm_group_label>Tazarotene</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night</description> </arm_group> <arm_group> <arm_group_label>Imiquimod</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night</description> </arm_group> <arm_group> <arm_group_label>5- fluorouracil</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night</description> </arm_group> <arm_group> <arm_group_label>Petrolatum</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>20 patients with verruca plana will be treated with petroleum jelly once daily at night.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tazarotene 0.1% Gel,Top</intervention_name> <description>once daily topical application at night with a cotton tipped applicator on every lesion</description> <arm_group_label>Tazarotene</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Imiquimod</intervention_name> <description>Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.</description> <arm_group_label>Imiquimod</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fluorouracil Cream</intervention_name> <description>5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator</description> <arm_group_label>5- fluorouracil</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Petrolatum</intervention_name> <description>applied once daily at night</description> <arm_group_label>Petrolatum</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent  - Age > 4 years.  - Both sexes.  - Patients with clinically and dermoscopically diagnosed plane warts.  - Subject is willing and able to follow all study instructions and to attend all study visits  Exclusion Criteria:  - • History of hypersensitivity to any of the drugs used.  - Pregnancy and lactation.  - Patients with epidermodysplasia verruciformis syndrome.  - Patients with eczematous skin disorders.  - Presence of any active infections e.g. herpes, tuberculosis.  - History of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or HPV vaccine in the last 24 weeks. </textblock> </criteria> <gender>All</gender> <minimum_age>4 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Hagar Nofal, Dr.</last_name> <phone>01006387707</phone> <email>hagarnofal@aucegypt.edu</email> </overall_contact> <location> <facility> <name>Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University</name> <address> <city>Zagazig</city> <state>Select Region</state> <zip>44511</zip> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hagar Nofal, Dr.</last_name> <phone>01006387707</phone> <email>hagarnofal@aucegypt.edu</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <reference> <citation>Hodeib AAE, Al-Sharkawy BG, Hegab DS, Talaat RAZ. A comparative study of intralesional injection of Candida albicans antigen, bleomycin and 5-fluorouracil for treatment of plane warts. J Dermatolog Treat. 2021 Sep;32(6):663-668. doi: 10.1080/09546634.2019.1688236. Epub 2019 Nov 12.</citation> <PMID>31682472</PMID> </reference> <reference> <citation>Gladsjo JA, Alio Saenz AB, Bergman J, Kricorian G, Cunningham BB. 5% 5-Fluorouracil cream for treatment of verruca vulgaris in children. Pediatr Dermatol. 2009 May-Jun;26(3):279-85. doi: 10.1111/j.1525-1470.2008.00800.x.</citation> <PMID>19706088</PMID> </reference> <reference> <citation>Kim MB, Ko HC, Jang HS, Oh CK, Kwon KS. Treatment of flat warts with 5% imiquimod cream. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1349-50. doi: 10.1111/j.1468-3083.2006.01709.x. No abstract available.</citation> <PMID>17062069</PMID> </reference> <reference> <citation>Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29.</citation> <PMID>31369771</PMID> </reference> <verification_date>May 2022</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 12, 2022</last_update_submitted> <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Zagazig University</investigator_affiliation> <investigator_full_name>Hagar Nofal</investigator_full_name> <investigator_title>Lecturer, Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Warts</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Fluorouracil</mesh_term> <mesh_term>Imiquimod</mesh_term> <mesh_term>Tazarotene</mesh_term> <mesh_term>Petrolatum</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> </patient_data>  </clinical_study>

Verruca plana is a common skin infection with worldwide distribution. Approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. Verruca plana is not merely an infectious disease but also affects the quality of patients' life. Verruca plana causes major cosmetic and social concerns. Lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. Verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. The available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. Frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. In this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil Patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607 - Group (A): Patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night. - Group (B): Patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night. - Group (C): Patients will be treated with imiquimod cream 5% applied once daily at night. - Group (D): Patients will be treated with petroleum jelly once daily at night. Inclusion Criteria: - All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent - Age > 4 years. - Both sexes. - Patients with clinically and dermoscopically diagnosed plane warts. - Subject is willing and able to follow all study instructions and to attend all study visits Exclusion Criteria: - • History of hypersensitivity to any of the drugs used. - Pregnancy and lactation. - Patients with epidermodysplasia verruciformis syndrome. - Patients with eczematous skin disorders. - Presence of any active infections e.g. herpes, tuberculosis. - History of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or HPV vaccine in the last 24 weeks.

NCT0531xxxx/NCT05314140.xml

<clinical_study>  <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/NCT05314140</url> </required_header> <id_info> <org_study_id>2021-01</org_study_id> <nct_id>NCT05314140</nct_id> </id_info> <brief_title>Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study</brief_title> <acronym>TOSCANA</acronym> <official_title>Towards Optimal Screening and Management of Coronary Artery Disease in Diabetes: TOSCANA Study</official_title> <sponsors> <lead_sponsor> <agency>French Cardiology Society</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Novo Nordisk A/S</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>CEBIMER</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>French Cardiology Society</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high. </textblock> </brief_summary> <detailed_description> <textblock> The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients.  The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors.  The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">June 1, 2022</start_date> <completion_date type="Anticipated">June 30, 2026</completion_date> <primary_completion_date type="Anticipated">June 30, 2026</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Proportions of diabetic patients with high coronary artery calcium score</measure> <time_frame>day 1</time_frame> <description>Number of patient with diabetes having a coronary artery calcium score higher than 400</description> </primary_outcome> <secondary_outcome> <measure>Proportion of patients having a coronary exploration</measure> <time_frame>6 months</time_frame> <description>Number of patient with high coronary artery calcium (>400) score having a coronary exploration compared with patient with low coronary artery calcium score (<400)</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of patients having a myocardial revascularization</measure> <time_frame>3 months</time_frame> <description>Number of patient with high coronary artery calcium score (>400) having a myocardial revascularization compared with patient with low coronary artery calcium score (<400)</description> </secondary_outcome> <secondary_outcome> <measure>Description of adverse events regarding to the coronary artery calcium score</measure> <time_frame>6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months</time_frame> <description>Calculation of number and type of cardiovascular adverse event within patient with high coronary artery calcium score (>400) or low coronary artery calcium score (<400)</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">2000</enrollment> <condition>Diabetes Mellitus</condition> <condition>Cardiovascular Diseases</condition> <arm_group> <arm_group_label>Coronary artery calcium score evaluation</arm_group_label> <description>Patients with diabetes and having a CT scan for evaluation of their coronary artery calcium score will be consecutively include. The indication of the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in compliance with the recommendations</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Coronary artery calcium score evaluation</intervention_name> <description>The evaluation of the coronary artery calcium score will be performed with chest CT scan</description> <arm_group_label>Coronary artery calcium score evaluation</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> The centers participating in this study undertake to consecutively include all diabetic patients meeting the selection criteria and having a CT scan for evaluation of coronary artery calcium score. The indication for the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in accordance with the recommendations. This is a standard practice study. The patient will be informed of the possibility to participate to the study and his consent will be obtained by the cardiologist/diabetologist when it will be decided to perform a chest CT scan to estimate the coronary artery calcium score. All scanner prescriptions will be carried out according to clinical indications in standard practice. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Coronary asymptomatic patient  - Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes for more than 10 years and aged 18 to 50 or - Patient with type 1 diabetes for more than 20 years and aged > 35  - Coronary artery calcium score evaluation planned  Exclusion Criteria:  - Patients who already have a clinical history of coronary disease  - Patients with other peripheral arterial disease  - Patients with clinical suspicion of coronary artery disease  - Patients with progressive cancer  - Patients with serious chronic conditions with an estimated life expectancy < 3 years.  - Pregnant, lactating, or pre-menopausal women without a recent negative pregnancy test available.  - Patients under guardianship or curator or placed under justice safeguard  - Patients who do not benefit from the social security scheme, or any equivalent scheme  - Patients refusing or being linguistically or psychologically unable to sign the informed consent form  Participation in another biomedical research protocol is permitted </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Victor ABOYANS, MD</last_name> <role>Principal Investigator</role> <affiliation>University Hospital, Limoges</affiliation> </overall_official> <overall_official> <last_name>Tessa BERGOT</last_name> <role>Study Director</role> <affiliation>Société Française de la Cardiologie</affiliation> </overall_official> <overall_contact> <last_name>Victor ABOYANS, MD</last_name> <phone>+33 5 55 05 89 53</phone> <email>vaboyans@live.fr</email> </overall_contact> <overall_contact_backup> <last_name>Tessa BERGOT</last_name> <phone>+33 1 44 90 70 33</phone> <email>tessa.bergot@sfcardio.fr</email> </overall_contact_backup> <location> <facility> <name>CHU de Bordeaux</name> <address> <city>Bordeaux</city> <zip>33000</zip> <country>France</country> </address> </facility> <contact> <last_name>Thierry COUFFINHAL, MD</last_name> <email>thierry.couffinhal@inserm.fr</email> </contact> </location> <location> <facility> <name>CHU de Limoges</name> <address> <city>Limoges</city> <zip>87000</zip> <country>France</country> </address> </facility> <contact> <last_name>Victor ABOYANS, MD</last_name> <email>vaboyans@live.fr</email> </contact> </location> <location> <facility> <name>CHU de Nice</name> <address> <city>Nice</city> <zip>06000</zip> <country>France</country> </address> </facility> <contact> <last_name>Emile FERRARI, MD</last_name> <email>ferrari.e@chu-nice.fr</email> </contact> </location> <location> <facility> <name>Hôpital Lariboisière, APHP</name> <address> <city>Paris</city> <zip>75010</zip> <country>France</country> </address> </facility> <contact> <last_name>Patrick HENRY, MD</last_name> <email>patrick.henry@aphp.fr</email> </contact> </location> <location> <facility> <name>Hopital Saint Antoine</name> <address> <city>Paris</city> <zip>75012</zip> <country>France</country> </address> </facility> <contact> <last_name>Franck BOCCARA, MD</last_name> <email>franck.boccara@aphp.fr</email> </contact> </location> <location> <facility> <name>CHU de Poitiers</name> <address> <city>Poitiers</city> <zip>86000</zip> <country>France</country> </address> </facility> <contact> <last_name>Luc CHRISTIAENS, MD</last_name> <email>l.christiaens@chu-poitiers.fr</email> </contact> </location> <location> <facility> <name>CHU de la Réunion</name> <address> <city>Saint-Denis</city> <zip>97400</zip> <country>France</country> </address> </facility> <contact> <last_name>Jérôme CORRE, MD</last_name> <email>jerome.corre@chu-reunion.fr</email> </contact> </location> <location> <facility> <name>Centre de Cardiologie de Thionville</name> <address> <city>Thionville</city> <zip>57100</zip> <country>France</country> </address> </facility> <contact> <last_name>Serge KOWNATOR, MD</last_name> <email>s.kownator@wanadoo.fr</email> </contact> </location> <location> <facility> <name>CHU de Tours</name> <address> <city>Tours</city> <zip>37000</zip> <country>France</country> </address> </facility> <contact> <last_name>Denis ANGOULVANT, MD</last_name> <email>denis.angoulvant@univ-tours.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Coronary artery calcium score</keyword> <keyword>Heart failure risk factors</keyword> <keyword>Prevention</keyword> <keyword>Guidelines</keyword> <condition_browse>  <mesh_term>Cardiovascular Diseases</mesh_term> <mesh_term>Coronary Artery Disease</mesh_term> <mesh_term>Myocardial Ischemia</mesh_term> <mesh_term>Coronary Disease</mesh_term> <mesh_term>Diabetes Mellitus</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Calcium</mesh_term> </intervention_browse>  </clinical_study>

There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high. The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients. The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors. The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk. The centers participating in this study undertake to consecutively include all diabetic patients meeting the selection criteria and having a CT scan for evaluation of coronary artery calcium score. The indication for the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in accordance with the recommendations. This is a standard practice study. The patient will be informed of the possibility to participate to the study and his consent will be obtained by the cardiologist/diabetologist when it will be decided to perform a chest CT scan to estimate the coronary artery calcium score. All scanner prescriptions will be carried out according to clinical indications in standard practice. Inclusion Criteria: - Coronary asymptomatic patient - Patient with type 2 diabetes and aged 50 to 70 or - Patient with type 2 diabetes for more than 10 years and aged 18 to 50 or - Patient with type 1 diabetes for more than 20 years and aged > 35 - Coronary artery calcium score evaluation planned Exclusion Criteria: - Patients who already have a clinical history of coronary disease - Patients with other peripheral arterial disease - Patients with clinical suspicion of coronary artery disease - Patients with progressive cancer - Patients with serious chronic conditions with an estimated life expectancy < 3 years. - Pregnant, lactating, or pre-menopausal women without a recent negative pregnancy test available. - Patients under guardianship or curator or placed under justice safeguard - Patients who do not benefit from the social security scheme, or any equivalent scheme - Patients refusing or being linguistically or psychologically unable to sign the informed consent form Participation in another biomedical research protocol is permitted

NCT0531xxxx/NCT05314153.xml

<clinical_study>  <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/NCT05314153</url> </required_header> <id_info> <org_study_id>20-0812</org_study_id> <nct_id>NCT05314153</nct_id> </id_info> <brief_title>Effects Zulresso on Postpartum Psychosis</brief_title> <official_title>Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis</official_title> <sponsors> <lead_sponsor> <agency>University of North Carolina, Chapel Hill</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Sage Therapeutics</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>University of North Carolina, Chapel Hill</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression. </textblock> </brief_summary> <detailed_description> <textblock> This is a single site, open label study design to evaluate the efficacy, safety and tolerability of Zulresso in female subjects diagnosed with postpartum psychosis.  Participants will be consented, and if possible, participation will be discussed with available family members. Participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. Participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an EKG to determine eligibility. If eligible, participants will be admitted in-patient to UNC Hospitals and administered a continuous 60-hour infusion of Zulresso using the approved FDA REMS protocol for postpartum depression. A target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. Monitoring will occur for an additional 12 hours after the infusion. The subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 23, 2022</start_date> <completion_date type="Anticipated">June 2024</completion_date> <primary_completion_date type="Anticipated">June 2024</primary_completion_date> <phase>Early Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in Positive and Negative Syndrome Scale (PANSS) score</measure> <time_frame>Baseline to post-treatment day 7</time_frame> <description>The PANSS is a standardized, clinical interview that rates the presence and severity of psychosis. The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.</description> </primary_outcome> <primary_outcome> <measure>Change in Young Mania Rating Scale (YMRS) score</measure> <time_frame>Baseline to post-treatment day 7</time_frame> <description>The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. The items are selected based upon the core symptoms of mania. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe symptoms.</description> </primary_outcome> <secondary_outcome> <measure>Change in Hamilton Rating Scale for Depression (HAM-D)</measure> <time_frame>Baseline to post-treatment day 7</time_frame> <description>The 17-item HAM-D will be used to rate the severity of depression in subjects who are already diagnosed as depressed. The HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. The HAM-D maximum score is 52 for the 17 items with a higher score indicating more severe symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Edinburgh Postnatal Depression Scale (EPDS)</measure> <time_frame>Baseline to post-treatment day 7</time_frame> <description>The EPDS is a 10-item subject-rated depressive symptom severity scale specific to the perinatal period. The EPDS maximum score is 30 with higher scores indicating more severe symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Clinical Global Impression Scale (CGI)</measure> <time_frame>Baseline to post-treatment day 7</time_frame> <description>The CGI is a validated scale to allow clinicians to measure a subject's change in illness severity from baseline. The CGI scale consists of three items. Only the first two items (CGI-S and CGI-I) will be used in this study. The CGI-S uses a seven-point Likert scale to rate the severity of the subject's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. The CGI-I employs a seven-point Likert scale to measure the overall improvement in the subject's condition post-treatment. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (very much improved) through to 7 (very much worse).</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">10</enrollment> <condition>Postpartum Psychosis</condition> <arm_group> <arm_group_label>Open Label - Active Drug</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Brexanolone</intervention_name> <description>Brexanolone injection is an Federal Drug Administration (FDA)-approved drug to treat postpartum depression. It is administered via continuous intravenous infusion over a 60-hour time period.</description> <arm_group_label>Open Label - Active Drug</arm_group_label> <other_name>Zulresso</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - All participating subjects sign an informed consent form;  - Age 18-45 years old;  - Onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning;  - Clinician diagnosis of affective psychosis or mania;  - ≤12 months postpartum at screening  Exclusion Criteria:  - Positive pregnancy test at screening or day 1;  - Recent pregnancy did not result in a live birth;  - Subject is in renal failure;  - Subject is in hepatic failure;  - Subject is anemic (hemoglobin ≤10 g/dL);  - Untreated or inadequately treated hypothyroidism or hyperthyroidism;  - History of schizophrenia, and/or schizoaffective disorder;  - Current/active alcohol or drug abuse </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Mary Kimmel, MD</last_name> <role>Principal Investigator</role> <affiliation>University of North Carolina, Chapel Hill</affiliation> </overall_official> <overall_contact> <last_name>Holly Krohn, MPH</last_name> <phone>9194450218</phone> <email>holly_krohn@med.unc.edu</email> </overall_contact> <location> <facility> <name>UNC Hospitals</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27514</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12.</citation> <PMID>28619476</PMID> </reference> <reference> <citation>Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31. Erratum In: Lancet. 2018 Sep 29;392(10153):1116.</citation> <PMID>30177236</PMID> </reference> <reference> <citation>Kanes SJ, Colquhoun H, Doherty J, Raines S, Hoffmann E, Rubinow DR, Meltzer-Brody S. Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression. Hum Psychopharmacol. 2017 Mar;32(2):e2576. doi: 10.1002/hup.2576.</citation> <PMID>28370307</PMID> </reference> <reference> <citation>Scott LJ. Brexanolone: First Global Approval. Drugs. 2019 May;79(7):779-783. doi: 10.1007/s40265-019-01121-0.</citation> <PMID>31006078</PMID> </reference> <verification_date>April 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 11, 2023</last_update_submitted> <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Psychotic Disorders</mesh_term> <mesh_term>Mental Disorders</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Brexanolone</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>Data will be available by investigator request starting 9 months following publication and continue through 36 months afterwards.</ipd_time_frame> <ipd_access_criteria>Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.</ipd_access_criteria> </patient_data>  </clinical_study>

This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression. This is a single site, open label study design to evaluate the efficacy, safety and tolerability of Zulresso in female subjects diagnosed with postpartum psychosis. Participants will be consented, and if possible, participation will be discussed with available family members. Participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. Participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an EKG to determine eligibility. If eligible, participants will be admitted in-patient to UNC Hospitals and administered a continuous 60-hour infusion of Zulresso using the approved FDA REMS protocol for postpartum depression. A target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. Monitoring will occur for an additional 12 hours after the infusion. The subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90. Inclusion Criteria: - All participating subjects sign an informed consent form; - Age 18-45 years old; - Onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning; - Clinician diagnosis of affective psychosis or mania; - ≤12 months postpartum at screening Exclusion Criteria: - Positive pregnancy test at screening or day 1; - Recent pregnancy did not result in a live birth; - Subject is in renal failure; - Subject is in hepatic failure; - Subject is anemic (hemoglobin ≤10 g/dL); - Untreated or inadequately treated hypothyroidism or hyperthyroidism; - History of schizophrenia, and/or schizoaffective disorder; - Current/active alcohol or drug abuse

NCT0531xxxx/NCT05314166.xml

<clinical_study>  <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/NCT05314166</url> </required_header> <id_info> <org_study_id>2022-RIPH_004_MEDIT-ENPRESENT</org_study_id> <nct_id>NCT05314166</nct_id> </id_info> <brief_title>Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat</brief_title> <acronym>MEDIT-PRESENT</acronym> <official_title>Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat</official_title> <sponsors> <lead_sponsor> <agency>Université de Reims Champagne-Ardenne</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Université de Reims Champagne-Ardenne</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. However, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested.  to understand these mechanisms actions, it is essential to distinguish meditative practices. Three different categories of meditation can be distinguished: "Attention Family", "Constructive Family" and "Deconstructive Family" with specific effects for each. </textblock> </brief_summary> <detailed_description> <textblock> The aim of the study is to compare the effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 15, 2022</start_date> <completion_date type="Anticipated">July 15, 2023</completion_date> <primary_completion_date type="Anticipated">May 15, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>non-attachment to the self</measure> <time_frame>week 6</time_frame> <description>Non-attachment to the self evaluated using Adult Self-transcendence Inventory (ASTI). ASTI is composed of 10 items. Each item is coded from 1 (totally disagree) to 7 (totally agree) by comparing how they see life at the time of the questionnaire compared to the last 5 years. The overall score ranges from 10 to 70 points.</description> </primary_outcome> <secondary_outcome> <measure>Identity threat</measure> <time_frame>week 6</time_frame> <description>Identity threat evaluated using Cognitive Appraisal Scale (ECP). ECP is composed of 10 items. Each item is coded from 1 (totally disagree) to 6 (totally agree). The overall score ranges from 6 to 60 points</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">200</enrollment> <condition>Meditation</condition> <arm_group> <arm_group_label>"focused attention" group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>"focused attention" group: adult subjects practicing face-to-face focused attention meditation.</description> </arm_group> <arm_group> <arm_group_label>"contemplation" group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>"contemplation" group: adult subjects practicing face-to-face contemplation meditation.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>meditation practice</intervention_name> <description>Description: meditation practice</description> <arm_group_label>"contemplation" group</arm_group_label> <arm_group_label>"focused attention" group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - male or female  - aged of 18 and more  - without diagnosed psychiatric pathology  - not practicing meditation  - agreeing to participate in the study  Exclusion Criteria:  - less than 18 years old </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Coralie BARBE, MD</last_name> <phone>0326918822</phone> <phone_ext>+33</phone_ext> <email>currs@univ-reims.fr</email> </overall_contact> <verification_date>April 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 26, 2022</last_update_submitted> <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 27, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>non-attachment to the self</keyword> <keyword>identity threat</keyword> <keyword>face-to-face meditation</keyword> <keyword>focused attention</keyword> <keyword>contemplation</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. However, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested. to understand these mechanisms actions, it is essential to distinguish meditative practices. Three different categories of meditation can be distinguished: "Attention Family", "Constructive Family" and "Deconstructive Family" with specific effects for each. The aim of the study is to compare the effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat Inclusion Criteria: - male or female - aged of 18 and more - without diagnosed psychiatric pathology - not practicing meditation - agreeing to participate in the study Exclusion Criteria: - less than 18 years old

NCT0531xxxx/NCT05314179.xml

<clinical_study>  <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/NCT05314179</url> </required_header> <id_info> <org_study_id>HCC 21-265</org_study_id> <nct_id>NCT05314179</nct_id> </id_info> <brief_title>Dignity, Legacy, Advocacy, and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community</brief_title> <acronym>Doulas-AC</acronym> <official_title>Dignity, Legacy, Advocacy, and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community (Doulas - AC)</official_title> <sponsors> <lead_sponsor> <agency>University of Pittsburgh</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Pittsburgh</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The proposed program, "Doulas - AC" will provide Dignity, Legacy, Advocacy and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community." The goals are to: 1) provide a community-based, trained companion to journey alongside the patient with advanced cancer, 2) to help the individual explore meaning and create legacy, 3); offer support and navigation for practical needs of illness (e.g., financial assistance for food and housing, accessing and affording medications, transportation); and 4) to provide support and connection for the bereaved family/friends, including facilitating community connections for routine health screenings and access to mental health services, as needed. </textblock> </brief_summary> <detailed_description> <textblock> The patient will be contacted and consent will be obtained by telephone. Once consent is obtained, the doula will be contacted with the patient information.  The doula will then contact the patient and determine how the 3 hours/week will be sent.  The doula will be trained by the study PI. The protocols for patient engagement will be taught. At the conclusion of the training, the doula that successfully work with standardized patients will be asked to work through the protocols for each clinic visit.  The options of emotional support, practical assistance, family support, and legacy building projects will be offered. The nature and type of visits will be determined by the patient and doula. A weekly plan will be implemented by the doula which may involve conversations, creating legacy projects, conversations with family and patients, and assistance with practical issues. Following completion of data collection, descriptive statistics will be utilized to evaluate % change in patient outcomes from baseline to 2 months and study completion. Implementation outcomes will be quantified. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 13, 2022</start_date> <completion_date type="Anticipated">June 2024</completion_date> <primary_completion_date type="Anticipated">June 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Pre and post intervention pilot study</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in Interpersonal Support Evaluation List (ISEL)</measure> <time_frame>Baseline, up to 6 months</time_frame> <description>The Interpersonal Support Evaluation List (ISEL) is a 40-item scale comprised of four subscales: 1.) Tangible Support; 2.) Belonging Support; 3.) Self-esteem Support; 4.) Appraisal Support. Items are rated by participants on how true or false they believe the statements are for themselves. Answers are given on a 4-point scale ranging from 0-3: definitely false (0), probably false (1), probably true (2), definitely true (3). The ISEL is scored by summing the items to create an overall score that indicates a participant's perceived level of social support. Total scores (total of all subscales) range from 0-120. Higher ISEL scores indicate greater ability to endure stressful experiences and greater perceived social support.</description> </primary_outcome> <primary_outcome> <measure>Change in Hospital Anxiety and Depression Scale (HADS)</measure> <time_frame>Baseline, up to 6 months</time_frame> <description>The HADS questionnaire is a self-assessment questionnaire detecting states of anxiety and depression that includes 7 items each for depression and anxiety subscales. Scoring for each item ranges from 0 - 3. Scores of 3 for a single item denotes highest anxiety or depression level. Total overall scores (total of all subscales) range from 0 - 21. A total score of 8 or more points out of a possible 21 indicates considerable symptoms of anxiety or depression.</description> </primary_outcome> <primary_outcome> <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) Questionnaire</measure> <time_frame>Baseline, up to 6 months</time_frame> <description>The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a short form assessment that uses a single 0-10 numeric pain rating item and seven health domains using four items each. The seven domains included Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. It also includes plus one pain intensity question. Total raw scores range from 0 - 290. Higher PROMIS scores indicate more severe effect of pain on domain items and on quality of life.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">5</enrollment> <condition>Metastatic Breast Cancer</condition> <arm_group> <arm_group_label>DOULA -AC</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Four hours/week of Doula and Patient engagement.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>DOULA-AC 1</intervention_name> <description>Doula and Patient will decide on details of engagement. The components to be included will be: 1) emotional support, 2)practical assistance, 3) family support, and/or 4)legacy building projects as per study protocols. The nature and type of visits will be determined by the patient and doula.</description> <arm_group_label>DOULA -AC</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients diagnosed with Metastatic Breast Cancer  2. Participants must be of African American race  3. Participants must reside in or around Pittsburgh, Pennsylvania area  Exclusion Criteria:  1. Inability to read or understand English </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Margaret Quinn Rosenzweig, PhD</last_name> <role>Principal Investigator</role> <affiliation>UPMC Hillman Cancer Center</affiliation> </overall_official> <overall_contact> <last_name>Joshua Plassmeyer, MS</last_name> <phone>412-648-6417</phone> <email>plassmeyerjm@upmc.edu</email> </overall_contact> <location> <facility> <name>UPMC Hillman Cancer Center</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15232</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Joshua Plassmeyer, MS</last_name> <phone>412-648-6417</phone> <email>plassmeyerjm@upmc.edu</email> </contact> <investigator> <last_name>Margaret Quinn Rosen, PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 6, 2023</last_update_submitted> <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Pittsburgh</investigator_affiliation> <investigator_full_name>Margaret Quinn Rosenzweig</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>doula</keyword> <condition_browse>  <mesh_term>Death</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The proposed program, "Doulas - AC" will provide Dignity, Legacy, Advocacy and Support for Advanced Cancer: Reimagined End of Life Care in the Black Community." The goals are to: 1) provide a community-based, trained companion to journey alongside the patient with advanced cancer, 2) to help the individual explore meaning and create legacy, 3); offer support and navigation for practical needs of illness (e.g., financial assistance for food and housing, accessing and affording medications, transportation); and 4) to provide support and connection for the bereaved family/friends, including facilitating community connections for routine health screenings and access to mental health services, as needed. The patient will be contacted and consent will be obtained by telephone. Once consent is obtained, the doula will be contacted with the patient information. The doula will then contact the patient and determine how the 3 hours/week will be sent. The doula will be trained by the study PI. The protocols for patient engagement will be taught. At the conclusion of the training, the doula that successfully work with standardized patients will be asked to work through the protocols for each clinic visit. The options of emotional support, practical assistance, family support, and legacy building projects will be offered. The nature and type of visits will be determined by the patient and doula. A weekly plan will be implemented by the doula which may involve conversations, creating legacy projects, conversations with family and patients, and assistance with practical issues. Following completion of data collection, descriptive statistics will be utilized to evaluate % change in patient outcomes from baseline to 2 months and study completion. Implementation outcomes will be quantified. Inclusion Criteria: 1. Patients diagnosed with Metastatic Breast Cancer 2. Participants must be of African American race 3. Participants must reside in or around Pittsburgh, Pennsylvania area Exclusion Criteria: 1. Inability to read or understand English

NCT0531xxxx/NCT05314192.xml

<clinical_study>  <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/NCT05314192</url> </required_header> <id_info> <org_study_id>ABSM/EC/29/2020</org_study_id> <nct_id>NCT05314192</nct_id> </id_info> <brief_title>Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients</brief_title> <official_title>Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients</official_title> <sponsors> <lead_sponsor> <agency>Ajman University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>A B Shetty Memorial Institute of Dental Science</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Ajman University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium, resulting in periodontal pocket formation, gingival recession eventually leading to tooth loss.[1] A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses.[2] These inflammatory responses may also cause an increase in inflammatory activities in atherosclerotic lesions in the coronary arteries resulting in the increased risk of cardiovascular events like myocardial infarction.[3] Myocardial infarction (MI) is a cardiovascular condition that occurs when there is deprivation of oxygen in the heart muscle is due to the sudden interruption of the blood supply resulting from the coronary artery blockage by a plaque causing myocardial ischemia and cell death. Inflammation is pivotal in the initiation and progression of atherosclerosis. Various cytokines and chemokines are released during inflammation.[4] These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases.[5] Macrophages secrete macrophage inflammatory protein-1 alpha (MIP-1 alpha) which recruits inflammatory cells, inhibits stem cells, and activates bone resorption cells.[6] Interleukin-6 (IL-6) is produced in response to tissue injury and infection and contributes to the differentiation of B cells, the proliferation of T cells, and bone resorption.[7] The levels of these inflammatory markers are seen to be increased in inflammatory conditions, which include myocardial infarction and stage 4 periodontitis. Therefore, this study aims to assess the levels of these inflammatory markers in patients with myocardial infarction and periodontitis. </textblock> </brief_summary> <detailed_description> <textblock> This was a cross-sectional study involving the patients of the department of periodontics and department of cardiology.  Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis.  The severity of the periodontitis was assessed by a periodontist. The diagnosis of acute MI was made by the cardiologists. Oral health assessment in acute MI patients was done at the subjects' bedside after stabilization of the patient, so as not to interfere with the ongoing medical treatment. Subjects' identification was kept confidential.  All samples were collected from patients admitted within 48 hours of their cardiac event. Patients were diagnosed as acute ST-elevation myocardial infarction (STEMI) based on the elevation of ST segments on the electrocardiogram(ECG) by 0.1mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and/ or development of new left bundle branch block, along with increased cardiac biomarkers. Non-ST-elevation myocardial infarction (NSTEMI) was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers.[8] Stage four periodontitis was diagnosed using the World Workshop 2017 classification.[9] Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study. Smokers, pregnant women, lactating mothers, and those on medication (anti-microbial, non-steroidal anti-inflammatory drugs) in the past 3 months as well as those with other chronic systemic diseases were excluded from the study. These were all excluded as each would affect the levels of biomarkers. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 1, 2021</start_date> <completion_date type="Actual">April 20, 2021</completion_date> <primary_completion_date type="Actual">April 15, 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>salivary test for MIP-1 alpha</measure> <time_frame>72 hours</time_frame> <description>saliva was assessed for biomarker MIP-1 alpha among the 4 groups</description> </primary_outcome> <primary_outcome> <measure>salivary test for IL-6</measure> <time_frame>72 hours</time_frame> <description>saliva was assessed for biomarker IL-6 among the 4 groups</description> </primary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Actual">80</enrollment> <condition>Myocardial Infarction</condition> <condition>Periodontal Diseases</condition> <arm_group> <arm_group_label>Healthy</arm_group_label> <description>Healthy cohorts with no underlying systemic or periodontal disease</description> </arm_group> <arm_group> <arm_group_label>stage 2 periodontitis</arm_group_label> <description>patients with periodontitis but no underlying systemic periodontal disease</description> </arm_group> <arm_group> <arm_group_label>MI patients with stage 4 periodontitis</arm_group_label> <description>patients who had MI and having stage 4 periodontitis patients</description> </arm_group> <arm_group> <arm_group_label>MI patients without periodontitis</arm_group_label> <description>patients who had MI without periodontitis</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>salivary test</intervention_name> <description>saliva was assessed for MIP-1 alpha</description> <arm_group_label>Healthy</arm_group_label> <arm_group_label>MI patients with stage 4 periodontitis</arm_group_label> <arm_group_label>MI patients without periodontitis</arm_group_label> <arm_group_label>stage 2 periodontitis</arm_group_label> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>salivary test</intervention_name> <description>saliva was assessed for IL-6</description> <arm_group_label>Healthy</arm_group_label> <arm_group_label>MI patients with stage 4 periodontitis</arm_group_label> <arm_group_label>MI patients without periodontitis</arm_group_label> <arm_group_label>stage 2 periodontitis</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - subjects who had MI  - who had stage 4 periodontal disease  Exclusion Criteria:  - subjects who did not have MI  - subjects who had systemic disease other than MI  - subjects who had medication in the past 3 months  - smokers  - pregnant and lactating women </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>AB shetty Institute of dental sciences</name> <address> <city>Mangalore</city> <country>India</country> </address> </facility> </location> <location_countries> <country>India</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ajman University</investigator_affiliation> <investigator_full_name>sudhir rama varma</investigator_full_name> <investigator_title>Clinical Assistant Professor</investigator_title> </responsible_party> <keyword>MIP-1 Alpha</keyword> <keyword>IL-6</keyword> <keyword>Myocardial infarction</keyword> <keyword>Periodontal disease</keyword> <condition_browse>  <mesh_term>Periodontitis</mesh_term> <mesh_term>Periodontal Diseases</mesh_term> <mesh_term>Myocardial Infarction</mesh_term> <mesh_term>Infarction</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>The link will be shared among researchers upon request</ipd_description> </patient_data>  </clinical_study>

Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium, resulting in periodontal pocket formation, gingival recession eventually leading to tooth loss.[1] A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses.[2] These inflammatory responses may also cause an increase in inflammatory activities in atherosclerotic lesions in the coronary arteries resulting in the increased risk of cardiovascular events like myocardial infarction.[3] Myocardial infarction (MI) is a cardiovascular condition that occurs when there is deprivation of oxygen in the heart muscle is due to the sudden interruption of the blood supply resulting from the coronary artery blockage by a plaque causing myocardial ischemia and cell death. Inflammation is pivotal in the initiation and progression of atherosclerosis. Various cytokines and chemokines are released during inflammation.[4] These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases.[5] Macrophages secrete macrophage inflammatory protein-1 alpha (MIP-1 alpha) which recruits inflammatory cells, inhibits stem cells, and activates bone resorption cells.[6] Interleukin-6 (IL-6) is produced in response to tissue injury and infection and contributes to the differentiation of B cells, the proliferation of T cells, and bone resorption.[7] The levels of these inflammatory markers are seen to be increased in inflammatory conditions, which include myocardial infarction and stage 4 periodontitis. Therefore, this study aims to assess the levels of these inflammatory markers in patients with myocardial infarction and periodontitis. This was a cross-sectional study involving the patients of the department of periodontics and department of cardiology. Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis. The severity of the periodontitis was assessed by a periodontist. The diagnosis of acute MI was made by the cardiologists. Oral health assessment in acute MI patients was done at the subjects' bedside after stabilization of the patient, so as not to interfere with the ongoing medical treatment. Subjects' identification was kept confidential. All samples were collected from patients admitted within 48 hours of their cardiac event. Patients were diagnosed as acute ST-elevation myocardial infarction (STEMI) based on the elevation of ST segments on the electrocardiogram(ECG) by 0.1mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and/ or development of new left bundle branch block, along with increased cardiac biomarkers. Non-ST-elevation myocardial infarction (NSTEMI) was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers.[8] Stage four periodontitis was diagnosed using the World Workshop 2017 classification.[9] Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study. Smokers, pregnant women, lactating mothers, and those on medication (anti-microbial, non-steroidal anti-inflammatory drugs) in the past 3 months as well as those with other chronic systemic diseases were excluded from the study. These were all excluded as each would affect the levels of biomarkers. Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis. Inclusion Criteria: - subjects who had MI - who had stage 4 periodontal disease Exclusion Criteria: - subjects who did not have MI - subjects who had systemic disease other than MI - subjects who had medication in the past 3 months - smokers - pregnant and lactating women

NCT0531xxxx/NCT05314205.xml

<clinical_study>  <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/NCT05314205</url> </required_header> <id_info> <org_study_id>AUHS2101201</org_study_id> <nct_id>NCT05314205</nct_id> </id_info> <brief_title>Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula</brief_title> <official_title>Long-term Outcome of Ligation of Inter-sphincteric Fistula Tract (LIFT) for Management of Trans-sphincteric Anal Fistula</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> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2019</start_date> <completion_date type="Actual">November 15, 2020</completion_date> <primary_completion_date type="Actual">November 1, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Post-operative complication</measure> <time_frame>2 years</time_frame> <description>The post-operative follow-up was done in an outpatient setting, with weekly visits for the first month, every two months for six months and then by phone calls to know recurrence and infection occurrence.</description> </primary_outcome> <enrollment type="Actual">24</enrollment> <condition>Anal Fistula</condition> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>ligation of inter-sphincteric fistula tract</intervention_name> <description>The surgical treatment was achieved through identification of the fistula by injecting hydrogen peroxide (H2O2) through the external opening. Probing of the fistulous tract by a metallic probe for proper identification of the fistula in the inter-sphincteric plane. Perpendicular skin incision (about 1 cm) was done at inter-sphinctric zone, perpendicular to the fistulous tract. Dissection between the internal and external sphincters and identification of the fistula. Finally, Ligation and transection of the tract in inter-sphinctric space followed by excision of a segment and transferred for histopathology examination. Trans-fixation suture was applied near to the internal mucosal opening of the divided tract to confirm closure using polyglactin suture 2/0. Insertion of a probe to check the closure of the tract segments. The remaining part of the tract was curetted till external opening and left for spontaneous healing.</description> </intervention> <eligibility> <study_pop> <textblock> Patients from surgery clinic at AlAzhar Hospital </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery  Exclusion Criteria:  - Individuals with recurrent fistulae or had specific pathology, like Crohn's disease. </textblock> </criteria> <gender>All</gender> <minimum_age>14 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Abdulkarim Hasan</name> <address> <city>Cairo</city> <zip>11884</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Al-Azhar University</investigator_affiliation> <investigator_full_name>Abdulkarim Hasan</investigator_full_name> <investigator_title>Laboratory coordinator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Rectal Fistula</mesh_term> <mesh_term>Fistula</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up. Patients from surgery clinic at AlAzhar Hospital Inclusion Criteria: - Men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery Exclusion Criteria: - Individuals with recurrent fistulae or had specific pathology, like Crohn's disease.

NCT0531xxxx/NCT05314218.xml

<clinical_study>  <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/NCT05314218</url> </required_header> <id_info> <org_study_id>2045-CIP_v1_01Feb2022</org_study_id> <nct_id>NCT05314218</nct_id> </id_info> <brief_title>The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting</brief_title> <official_title>EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis</official_title> <sponsors> <lead_sponsor> <agency>Alcis</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Alcis</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting. </textblock> </brief_summary> <detailed_description> <textblock> Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 23, 2022</start_date> <completion_date type="Actual">May 26, 2023</completion_date> <primary_completion_date type="Actual">May 25, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Signal quality</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Good signal amplitude and signal stability throughout the procedure without artefact</description> </primary_outcome> <secondary_outcome> <measure>Micro-stimulation</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Micro-stimulation worked well.</description> </secondary_outcome> <secondary_outcome> <measure>Manoeuvrability</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Ease of positioning and manoeuvrability the catheter (access to the desired area)</description> </secondary_outcome> <secondary_outcome> <measure>Bending</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Link between the wheel and the bending for dynamic Xtrem and bending stability</description> </secondary_outcome> <secondary_outcome> <measure>Imaging</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Visibility via X ray or 3D navigation.</description> </secondary_outcome> <secondary_outcome> <measure>Diagnosis</measure> <time_frame>Through study completion, an average of 4 hours</time_frame> <description>Diagnosis efficiency</description> </secondary_outcome> <enrollment type="Actual">168</enrollment> <condition>Cardiac Arrhythmia</condition> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Electrophysiology catheters and cables</intervention_name> <description>The Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle. Xtrem are inserted via femoral vena cava or via artery and can be used in two occasions: Exploration procedures for diagnosis alone Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device.</description> </intervention> <eligibility> <study_pop> <textblock> Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias). </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  To be included, patients must be:  - 18 to 90 years old  - Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)  - Informed and willing to sign an informed consent for approved by EC  - Affiliation to the social security or foreign regime recognized in France  Exclusion Criteria:  A patient will not be eligible to participate in the study if any of the following conditions are present:  - Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).  - Any medical condition that could impact the study at investigator's discretion (e.g. allergy…).  - Pregnant women  - Adult subject to legal protection measure </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Hôpital Henri-Mondor AP-HP</name> <address> <city>Créteil</city> <state>Ile De France</state> <zip>94000</zip> <country>France</country> </address> </facility> </location> <location> <facility> <name>Clinique Rhône Durance</name> <address> <city>Avignon</city> <zip>84000</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 12, 2023</last_update_submitted> <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Arrhythmias, Cardiac</mesh_term> </condition_browse>  </clinical_study>

The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting. Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety. Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias). Inclusion Criteria: To be included, patients must be: - 18 to 90 years old - Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias) - Informed and willing to sign an informed consent for approved by EC - Affiliation to the social security or foreign regime recognized in France Exclusion Criteria: A patient will not be eligible to participate in the study if any of the following conditions are present: - Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times). - Any medical condition that could impact the study at investigator's discretion (e.g. allergy…). - Pregnant women - Adult subject to legal protection measure

NCT0531xxxx/NCT05314231.xml

<clinical_study>  <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/NCT05314231</url> </required_header> <id_info> <org_study_id>ALXN1720-NEPH-102</org_study_id> <nct_id>NCT05314231</nct_id> </id_info> <brief_title>Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria</brief_title> <official_title>A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria</official_title> <sponsors> <lead_sponsor> <agency>Alexion</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Alexion</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">June 29, 2022</start_date> <completion_date type="Actual">May 31, 2023</completion_date> <primary_completion_date type="Actual">May 31, 2023</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Serum Concentration of ALXN1720</measure> <time_frame>Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57</time_frame> </primary_outcome> <secondary_outcome> <measure>Number of Participants With Treatment-Emergent Adverse Events</measure> <time_frame>Day 1 (Predose) through Follow-up (Day 92)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Serum Concentration of Free and Total Complement Component 5 (C5)</measure> <time_frame>Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57</time_frame> </secondary_outcome> <secondary_outcome> <measure>Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720</measure> <time_frame>Day 1 (predose) through Day 57</time_frame> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">13</enrollment> <condition>Proteinuria</condition> <arm_group> <arm_group_label>ALXN1720</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>ALXN1720</intervention_name> <description>All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).</description> <arm_group_label>ALXN1720</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor  - Proteinuria >=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening  - Body weight ≥ 40 kg at Screening  Exclusion Criteria:  - Kidney transplant  - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 during Screening  - Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.  - Treatment with complement inhibitors at any time.  - Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1.  - Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater. </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Clinical Trial Site 2</name> <address> <city>Anyang-Si</city> <state>Gyeonggi-do</state> <zip>14068</zip> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Clinical Trial Site 1</name> <address> <city>Seoul</city> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 28, 2023</last_update_submitted> <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 29, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Proteinuria</keyword> <keyword>Glomerular Disease</keyword> <keyword>Chronic Kidney Disease</keyword> <keyword>Lupus Nephritis</keyword> <keyword>Immunoglobulin A Nephropathy</keyword> <keyword>Primary Membranous Nephropathy</keyword> <keyword>Focal Segmental Glomerulosclerosis</keyword> <keyword>Diabetic Nephropathy</keyword> <keyword>Hypertensive Nephrosclerosis</keyword> <keyword>Minimal Change Disease</keyword> <keyword>Thin Basement Membrane Nephropathy</keyword> <keyword>Membranoproliferative Glomerulonephritis (all forms)</keyword> <condition_browse>  <mesh_term>Proteinuria</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.</ipd_description> </patient_data>  </clinical_study>

The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria. Inclusion Criteria: - Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor - Proteinuria >=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening - Body weight ≥ 40 kg at Screening Exclusion Criteria: - Kidney transplant - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 during Screening - Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study. - Treatment with complement inhibitors at any time. - Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1. - Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

NCT0531xxxx/NCT05314244.xml

<clinical_study>  <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/NCT05314244</url> </required_header> <id_info> <org_study_id>DGE_2022</org_study_id> <nct_id>NCT05314244</nct_id> </id_info> <brief_title>Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Delayed Gastric Emptying and Nutrition</brief_title> <official_title>A Prospective Randomized Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Postoperative Delayed Gastric Emptying and Nutritional Status</official_title> <sponsors> <lead_sponsor> <agency>Asan Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Asan Medical Center</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying.  However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy.  The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status. </textblock> </brief_summary> <detailed_description> <textblock> Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results.  Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups.  - This study aimed to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status in 5 tertiary referral centers in Korea..  - A case of pancreaticoduodenectomy with periampullary benign and malignant tumors will be included. The expected number of patients is 394. The pylorus resecting group was performed in the experimental group and the pylorus preserving group was performed in control group.  This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows.  - Nursing Hypothesis: There is no difference in incidence of delayed gastric emptying between patients who underwent pylorus resecting pancreaticoduodenectomy and patients who underwent pylorus preserving surgery.  - Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average incidence of delayed gastric emptying for pylorus preserving pancreaticoduodenectomy is estimated to be 20%, and the average incidence of delayed gastric emptying for pylorus resecting pancreaticoduodenectomy is estimated to be 10%.  The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.  - Plan for recruitment of research subjects : All patients scheduled for open pancreaticoduodenectomy for pancreatic or periampullary lesions will be explained about this study and will be selected after informed consent.  - Operative method : Both patients underwent conventional open pancreaticoduodenectomy with or without pylorus resection. In the experimental group, stomach resection was performed 1.0cm proximal to pylorus. In the control group, duodenal resection was performed 2.0cm distal to pylorus. Both groups are performed through the same surgical procedure except pylorus preservation or resection and the procedure is as follows. Kocher maneuver is performed to mobilize the duodenum. Omentectomy is performed and the gastrocolic truck is identified and ligated. The stomach or duodenum is cut off using an automatic stapler. A cholecystectomy is performed. The bile duct is cut and the frozen section is checked to confirm whether the tumor is invaded. The hepatic and hepatic arteries are dissected and the surrounding lymph nodes are dissected. The gastroduodenal artery is detached and ligated. The pancreas is cut from the pancreas neck, and the tumor is examined by freezing biopsy. The proximal plant is dissected and cut, and the pancreas uncinate process is released from the superior mesenteric artery and vein. Pancreaticojejunal anastomosis, hepaticojejunal anastomosis, gastrojejunal or duodenojejunal anastomosis are performed. In this case, anastomosis is performed by the method used by each institution.  Patient management after surgery  - preoperative : NRI(weight, albumin), BMI, Blood chemistry, Abdomen&Pelvic Computed Tomography(APCT) (body composition calculation)  - 1day after surgery : blood chemistry, removal of nasogastric tube, water intake, early gate  - 2days after surgery : start diet (liquid or solid)  - 3days after surgery : blood chemistry, intravenous patient controlled analgesia removal, after 3 days, considering drain amylase and drain volume it can be removed.  - 5days after surgery : APCT  - 7days after surgery : NRI(weight, albumin), blood chemistry, tumor marker(if pathology is malignant)  - 14days after surgery : NRI(weight, albumin), blood chemistry  - 21days after surgery : NRI(weight, albumin), blood chemistry  - 3months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)  - 6months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)  - 12months after surgery : NRI(weight, albumin), blood chemistry, APCT(body composition check)  ** Daily check amount of food intake from operation to discharge(Grade 1~3)  - Grade I: 30% or less of the provided amount can be consumed  - Grade II: 30~50% of the provided amount can be consumed  - Grade III: 50% or more of the provided amount can be consumed  - Nutritional risk index (NRI) was calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">April 28, 2025</completion_date> <primary_completion_date type="Anticipated">April 28, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Incidence of delayed gastric emptying</measure> <time_frame>up to 1 months</time_frame> <description>Delayed gastric emptying(DGE) is defined by International Study Group of Pancreas Surgery(ISGPS) definition. Grade A DGE should be considered if the Nasogastric tube(NGT) is required between the Postoperative Day(POD) 4 and 7, or if reinsertion of the NGT was necessary owing to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but resumes a solid diet before Postoperative Day(POD)14 ** Grade B DGE is present if the NGT is required from POD 8-14, if reinsertion of the NGT was necessary after POD 7, or if the patient cannot tolerate unlimited oral intake by Postoperative Day(POD)14, but is able to resume a solid oral diet before POD 21 *** Grade C DGE is present when nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21</description> </primary_outcome> <secondary_outcome> <measure>Nutritional risk index(NRI)</measure> <time_frame>up to 12 months</time_frame> <description>Nutritional risk index (NRI) is calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period</description> </secondary_outcome> <secondary_outcome> <measure>Sarcopenia</measure> <time_frame>up to 12 months</time_frame> <description>Body composition, including Skeletal muscle area(SMA), Subcutaneous fat area(SFA), Visceral fat area(VFA) is calculated by axial CT slice at the L3 vertebral inferior endplate level</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">394</enrollment> <condition>Pancreaticoduodenectomy</condition> <condition>Delayed Gastric Emptying</condition> <condition>Nutrition</condition> <arm_group> <arm_group_label>pylorus resecting group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The patients who underwent pylorus resecting pancreaticoduodenectomy for periampullary tumors</description> </arm_group> <arm_group> <arm_group_label>pylorus preserving group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The patients who underwent pylorus preserving pancreaticoduodenectomy for periampullary tumors</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Pylorus resecting pancreaticoduodenectomy</intervention_name> <description>The patients in pylorus resection group will underwent pylorus resecting procedure during pancreaticoduodenectomy</description> <arm_group_label>pylorus resecting group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age: 18 to 79 years  - Performance: Eastern Cooperative Oncology Group (ECOG) 0-2  - The preoperative examination showed that the lesion could invade to major artery.  - No distant metastasis  - Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3  - Liver function : aspartate transaminase (AST)/alanine transaminase(ALT) less than 3 times upper limit of normal  - Kidney function: Creatinine no greater than 1.5 times upper limit of normal.  - Patients who consented to and signed the consent  Exclusion Criteria:  - Patients diagnosed with duodenal cancer  - Those with active or uncontrolled infections  - Those with severe psychiatric / neurological disorders  - Alcohol or other drug addicts  - Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy)  - Patients included in other clinical studies that may affect this study  - Patients who cannot follow the directions of the researcher  - Those with uncontrolled heart disease  - Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (ex. cirrhosis, chronic kidney failure, heart failure, etc.)  - Pelvic tumor, benign tumor, malignant tumor in other organs  - Patients who received prior chemotherapy  - In addition to the planned pancreaticoduodenectomy, patients who require resection of other major abdominal organs, such as gastrectomy, colectomy </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>79 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Song-Cheol Kim, MD-PhD</last_name> <role>Principal Investigator</role> <affiliation>Asan Medical Center</affiliation> </overall_official> <overall_contact> <last_name>Bong Jun Kwak, MD</last_name> <phone>+82-10-4519-0280</phone> <email>iio1000@nate.com</email> </overall_contact> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Asan Medical Center</investigator_affiliation> <investigator_full_name>Song Cheol Kim</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Gastroparesis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying. However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy. The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status. Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results. Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups. - This study aimed to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status in 5 tertiary referral centers in Korea.. - A case of pancreaticoduodenectomy with periampullary benign and malignant tumors will be included. The expected number of patients is 394. The pylorus resecting group was performed in the experimental group and the pylorus preserving group was performed in control group. This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows. - Nursing Hypothesis: There is no difference in incidence of delayed gastric emptying between patients who underwent pylorus resecting pancreaticoduodenectomy and patients who underwent pylorus preserving surgery. - Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average incidence of delayed gastric emptying for pylorus preserving pancreaticoduodenectomy is estimated to be 20%, and the average incidence of delayed gastric emptying for pylorus resecting pancreaticoduodenectomy is estimated to be 10%. The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set. - Plan for recruitment of research subjects : All patients scheduled for open pancreaticoduodenectomy for pancreatic or periampullary lesions will be explained about this study and will be selected after informed consent. - Operative method : Both patients underwent conventional open pancreaticoduodenectomy with or without pylorus resection. In the experimental group, stomach resection was performed 1.0cm proximal to pylorus. In the control group, duodenal resection was performed 2.0cm distal to pylorus. Both groups are performed through the same surgical procedure except pylorus preservation or resection and the procedure is as follows. Kocher maneuver is performed to mobilize the duodenum. Omentectomy is performed and the gastrocolic truck is identified and ligated. The stomach or duodenum is cut off using an automatic stapler. A cholecystectomy is performed. The bile duct is cut and the frozen section is checked to confirm whether the tumor is invaded. The hepatic and hepatic arteries are dissected and the surrounding lymph nodes are dissected. The gastroduodenal artery is detached and ligated. The pancreas is cut from the pancreas neck, and the tumor is examined by freezing biopsy. The proximal plant is dissected and cut, and the pancreas uncinate process is released from the superior mesenteric artery and vein. Pancreaticojejunal anastomosis, hepaticojejunal anastomosis, gastrojejunal or duodenojejunal anastomosis are performed. In this case, anastomosis is performed by the method used by each institution. Patient management after surgery - preoperative : NRI(weight, albumin), BMI, Blood chemistry, Abdomen&Pelvic Computed Tomography(APCT) (body composition calculation) - 1day after surgery : blood chemistry, removal of nasogastric tube, water intake, early gate - 2days after surgery : start diet (liquid or solid) - 3days after surgery : blood chemistry, intravenous patient controlled analgesia removal, after 3 days, considering drain amylase and drain volume it can be removed. - 5days after surgery : APCT - 7days after surgery : NRI(weight, albumin), blood chemistry, tumor marker(if pathology is malignant) - 14days after surgery : NRI(weight, albumin), blood chemistry - 21days after surgery : NRI(weight, albumin), blood chemistry - 3months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check) - 6months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check) - 12months after surgery : NRI(weight, albumin), blood chemistry, APCT(body composition check) ** Daily check amount of food intake from operation to discharge(Grade 1~3) - Grade I: 30% or less of the provided amount can be consumed - Grade II: 30~50% of the provided amount can be consumed - Grade III: 50% or more of the provided amount can be consumed - Nutritional risk index (NRI) was calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period Inclusion Criteria: - Age: 18 to 79 years - Performance: Eastern Cooperative Oncology Group (ECOG) 0-2 - The preoperative examination showed that the lesion could invade to major artery. - No distant metastasis - Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3 - Liver function : aspartate transaminase (AST)/alanine transaminase(ALT) less than 3 times upper limit of normal - Kidney function: Creatinine no greater than 1.5 times upper limit of normal. - Patients who consented to and signed the consent Exclusion Criteria: - Patients diagnosed with duodenal cancer - Those with active or uncontrolled infections - Those with severe psychiatric / neurological disorders - Alcohol or other drug addicts - Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy) - Patients included in other clinical studies that may affect this study - Patients who cannot follow the directions of the researcher - Those with uncontrolled heart disease - Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (ex. cirrhosis, chronic kidney failure, heart failure, etc.) - Pelvic tumor, benign tumor, malignant tumor in other organs - Patients who received prior chemotherapy - In addition to the planned pancreaticoduodenectomy, patients who require resection of other major abdominal organs, such as gastrectomy, colectomy

NCT0531xxxx/NCT05314257.xml

<clinical_study>  <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/NCT05314257</url> </required_header> <id_info> <org_study_id>Granisetron</org_study_id> <nct_id>NCT05314257</nct_id> </id_info> <brief_title>Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section</brief_title> <official_title>Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section: A Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy. </textblock> </brief_summary> <detailed_description> <textblock> The subarachnoid block is the most used anesthesia technique for conducting a cesarean section. The incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. Similarly, bradycardia is also commonly associated with post-SAB, and the reported incidence is around 13%. Spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. Hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. However, if vagus nerve-mediated Bezold-Jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension.  Levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. Compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. It has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. Plain levobupivacaine is isobaric to CSF. One of its advantages is that it has a more expectable spread. Several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. It has been suggested to use 12.5-13.5mg levobupivacaine for effective spinal anesthesia for cesarean delivery. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">April 2022</start_date> <completion_date type="Anticipated">December 2022</completion_date> <primary_completion_date type="Anticipated">November 2022</primary_completion_date> <phase>Phase 2/Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>post-spinal hypotension, and bradycardia</measure> <time_frame>24 hours postoperative</time_frame> <description>post-spinal hypotension, and bradycardia in rheumatic patients undergoing elective cesarean section</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">102</enrollment> <condition>Granisetron</condition> <arm_group> <arm_group_label>Group G</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>IV granisetron 1mg</description> </arm_group> <arm_group> <arm_group_label>Group C</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>IV 5ml of 0.9% normal saline</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Granisetron Hydrochloride</intervention_name> <description>IV granisetron 1mg</description> <arm_group_label>Group G</arm_group_label> <other_name>granisetron</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>0.9% normal saline</intervention_name> <description>IV 5ml of 0.9% normal saline</description> <arm_group_label>Group C</arm_group_label> <other_name>normal saline</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Rheumatic female patients in the childbearing period scheduled for elective cesarean sections  Exclusion Criteria:  - Patients with eclampsia and pre-eclampsia history,  - uncontrolled diabetes mellitus, morbid obesity,  - coagulation abnormalities,  - vertebral deformities, also patients who refused regional anesthesia,  - having contraindications to spinal anesthesia </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Assiut governorate</name> <address> <city>Assiut</city> <zip>715715</zip> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ghada M Aboelfadl, MD</last_name> <phone>01005802086</phone> <email>ghadafadl77@gmail.com</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <reference> <citation>Chatterjee A, Gudiwada B, Mahanty PR, Kumar H, Nag DS, Ganguly PK, Shukla R. Effectiveness of Granisetron in Prevention of Hypotension Following Spinal Anaesthesia in Patients Undergoing Elective Caesarean Section. Cureus. 2020 Dec 16;12(12):e12113. doi: 10.7759/cureus.12113.</citation> <PMID>33489528</PMID> </reference> <reference> <citation>Fakherpour A, Ghaem H, Fattahi Z, Zaree S. Maternal and anaesthesia-related risk factors and incidence of spinal anaesthesia-induced hypotension in elective caesarean section: A multinomial logistic regression. Indian J Anaesth. 2018 Jan;62(1):36-46. doi: 10.4103/ija.IJA_416_17.</citation> <PMID>29416149</PMID> </reference> <reference> <citation>Sharma B, Koirala E, Regmi S, Dhungana J, Neupane BK, Bhattarai S. Rheumatic Heart Disease among Pregnant Women with Cardiac Diseases in a Tertiary Care Center of Nepal: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2021 May 25;59(237):468-472. doi: 10.31729/jnma.6177.</citation> <PMID>34508429</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Ghada Mohammed AboelFadl</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Hypotension</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Granisetron</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. Although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. Cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. Among cardiac diseases, Rheumatic Heart Disease is the commonest cardiac disease complicating pregnancy. The subarachnoid block is the most used anesthesia technique for conducting a cesarean section. The incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. Similarly, bradycardia is also commonly associated with post-SAB, and the reported incidence is around 13%. Spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. Hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. However, if vagus nerve-mediated Bezold-Jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension. Levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. Compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. It has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. Plain levobupivacaine is isobaric to CSF. One of its advantages is that it has a more expectable spread. Several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. It has been suggested to use 12.5-13.5mg levobupivacaine for effective spinal anesthesia for cesarean delivery. Inclusion Criteria: - Rheumatic female patients in the childbearing period scheduled for elective cesarean sections Exclusion Criteria: - Patients with eclampsia and pre-eclampsia history, - uncontrolled diabetes mellitus, morbid obesity, - coagulation abnormalities, - vertebral deformities, also patients who refused regional anesthesia, - having contraindications to spinal anesthesia

NCT0531xxxx/NCT05314270.xml

<clinical_study>  <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/NCT05314270</url> </required_header> <id_info> <org_study_id>Non-B Non-C Liver cirrhosis</org_study_id> <nct_id>NCT05314270</nct_id> </id_info> <brief_title>Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study</brief_title> <official_title>Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC).  To describe the different patient's outcomes. </textblock> </brief_summary> <detailed_description> <textblock> Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014)  Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019)  Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012)  The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">October 1, 2022</start_date> <completion_date type="Anticipated">November 1, 2023</completion_date> <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Detection of different etiologies of liver cirrhosis that not related to HBV or HCV in our community</measure> <time_frame>Base line</time_frame> </primary_outcome> <secondary_outcome> <measure>Detection of the most common etiologies of Non B Non C liver cirrhosis in our community</measure> <time_frame>Baseline</time_frame> </secondary_outcome> <enrollment type="Anticipated">100</enrollment> <condition>Non-B Non-C Liver Cirrhosis</condition> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Diagnostic tests</intervention_name> <description>Diaagnostic tests for all pt diagnosed as Non-B Non-C Liver Cirrhosis</description> <other_name>24h copper in urine.. Iron profile.. Liver biopsy</other_name> </intervention> <eligibility> <study_pop> <textblock> All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023 </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023  Exclusion Criteria:  - We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_contact> <last_name>Abdelrahman Mohammed Abdelrahman Morsi</last_name> <phone>01140530170</phone> <email>bdalrhmnmrsy702@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Magda Shehata Hassan</last_name> <phone>01066900939</phone> <email>Magda_sh@yahoo.com</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Abdelrahman mohammed abdelrahman morsi</investigator_full_name> <investigator_title>Doctor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Liver Cirrhosis</mesh_term> <mesh_term>Fibrosis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Copper</mesh_term> </intervention_browse>  </clinical_study>

To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC). To describe the different patient's outcomes. Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014) Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019) Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012) The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated. All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023 Inclusion Criteria: - All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023 Exclusion Criteria: - We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis

NCT0531xxxx/NCT05314283.xml

<clinical_study>  <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/NCT05314283</url> </required_header> <id_info> <org_study_id>DV3395-4711</org_study_id> <secondary_id>U1111-1253-1898</secondary_id> <nct_id>NCT05314283</nct_id> </id_info> <brief_title>A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.</brief_title> <official_title>A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.</official_title> <sponsors> <lead_sponsor> <agency>Novo Nordisk A/S</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Novo Nordisk A/S</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut. It will be checked if the device activates itself in the stomach as planned. Participants will be admitted to the clinic research center on day -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to 5 hours ending with administration of a small amount of contrast agent for better visualisation. The participants will stay at the clinic research center for up to 6 days until the device has been excreted. A follow-up phone call will take place 1 week after the device has been excreted. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 28, 2022</start_date> <completion_date type="Actual">November 8, 2022</completion_date> <primary_completion_date type="Actual">November 8, 2022</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Including a pilot cohort and a main cohort</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Number of adverse events</measure> <time_frame>From exposure (defined as when the participant takes DV3395-C1 into his/her hand with the intention of swallowing it) to DV3395 C1 on day 1 (visit 2) to 7 days after excretion of DV3395 C1 (phone visit 3, expected between day 9 and day 12)</time_frame> <description>Number of events</description> </primary_outcome> <secondary_outcome> <measure>Confirmed DV3395 C1 integrity upon excretion (yes/no)</measure> <time_frame>On day of excretion of DV3395 C1 (visit 2, expected between day 2 and day 5)</time_frame> <description>Count of participant</description> </secondary_outcome> <secondary_outcome> <measure>Confirmed gastric activation of DV3395 C1 (yes/no)</measure> <time_frame>From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)</time_frame> <description>Count of participant</description> </secondary_outcome> <secondary_outcome> <measure>Time to activation of DV3395 C1</measure> <time_frame>From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)</time_frame> <description>Minutes</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">65</enrollment> <condition>Healthy Volunteers, Medical Device</condition> <arm_group> <arm_group_label>DV3395 C1</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>DV3395 C1</intervention_name> <description>Participants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days .</description> <arm_group_label>DV3395 C1</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.  - Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive).  Exclusion criteria:  - Presence of any known or suspected clinically significant gastrointestinal disease or gastrointestinal disorder (including functional and structural disorders) as judged by the investigator.  - History of clinically significant gastrointestinal or abdominal surgery (including gynaecological/obstetrical and urological procedures) as judged by the investigator.  - History of radiotherapy of the neck, thorax or abdomen.  - Exposure to ionizing radiation from diagnostic or interventional procedures of greater than 0.1 mSv within 1 year prior to V2 pre-administration, a radiation burden of greater than 1.1 mSv within 2 years prior to V2 pre-administration, a radiation burden of greater than 2.1 mSv within 3 years prior to V2 pre administration, etc. (add 1 year per 1 mSv).  - Known or suspected hypersensitivity to any component of DV3395 C1 or to any iodine based contrast agent.  - Female for whom any of the below applies:  - pregnant as determined by a positive laboratory pregnancy test at screening or at V2 pre administration  - breast-feeding  - of child-bearing potential and not using an adequate contraceptive method for 28 days or more prior to screening or between screening and V2 pre-administration, and not willing to maintain use of adequate contraception during the study period (adequate contraceptive measures as required by local regulation or practice)  - wish to become pregnant within 6 months after the study </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Clinical Transparency (dept. 2834)</last_name> <role>Study Director</role> <affiliation>Novo Nordisk A/S</affiliation> </overall_official> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Groningen</city> <zip>9728 NZ</zip> <country>Netherlands</country> </address> </facility> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>November 16, 2022</last_update_submitted> <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 17, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"</ipd_description> <ipd_url>http://novonordisk-trials.com</ipd_url> </patient_data>  </clinical_study>

This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut. It will be checked if the device activates itself in the stomach as planned. Participants will be admitted to the clinic research center on day -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to 5 hours ending with administration of a small amount of contrast agent for better visualisation. The participants will stay at the clinic research center for up to 6 days until the device has been excreted. A follow-up phone call will take place 1 week after the device has been excreted. Inclusion criteria: - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. - Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive). Exclusion criteria: - Presence of any known or suspected clinically significant gastrointestinal disease or gastrointestinal disorder (including functional and structural disorders) as judged by the investigator. - History of clinically significant gastrointestinal or abdominal surgery (including gynaecological/obstetrical and urological procedures) as judged by the investigator. - History of radiotherapy of the neck, thorax or abdomen. - Exposure to ionizing radiation from diagnostic or interventional procedures of greater than 0.1 mSv within 1 year prior to V2 pre-administration, a radiation burden of greater than 1.1 mSv within 2 years prior to V2 pre-administration, a radiation burden of greater than 2.1 mSv within 3 years prior to V2 pre administration, etc. (add 1 year per 1 mSv). - Known or suspected hypersensitivity to any component of DV3395 C1 or to any iodine based contrast agent. - Female for whom any of the below applies: - pregnant as determined by a positive laboratory pregnancy test at screening or at V2 pre administration - breast-feeding - of child-bearing potential and not using an adequate contraceptive method for 28 days or more prior to screening or between screening and V2 pre-administration, and not willing to maintain use of adequate contraception during the study period (adequate contraceptive measures as required by local regulation or practice) - wish to become pregnant within 6 months after the study

NCT0531xxxx/NCT05314296.xml

<clinical_study>  <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/NCT05314296</url> </required_header> <id_info> <org_study_id>ESR-17-13290</org_study_id> <nct_id>NCT05314296</nct_id> </id_info> <brief_title>Osimertinib for Russian EGFR T790M Mutation-positive NSCLC Patients Who Progressed on or After EGFR TKI Therapy</brief_title> <acronym>TRUST</acronym> <official_title>Multicenter Non-interventional Study of Osimertinib Administration in Patients With NSCLC Progression Occurred During or After Therapy With EGFR Tyrosine Kinase Inhibitors, With Confirmed Т790М Positive Mutation in EGFR Gene</official_title> <sponsors> <lead_sponsor> <agency>N.N. Blokhin National Medical Research Center of Oncology</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>N.N. Blokhin National Medical Research Center of Oncology</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to assess safety of Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression during or after therapy with a prior EGFR tyrosine kinase inhibitor (TKI), with confirmed Т790М positive mutation in EGFR gene. </textblock> </brief_summary> <detailed_description> <textblock> This study is a multicenter non-interventional retro- and prospective study of safety and efficacy of the Osimertinib administration in frames of Early Access Program (EAP) and real clinical practice in patients with locally advanced or metastatic non-small cell lung cancer that progressed during or after therapy with an EGFR tyrosine kinase inhibitor, with confirmed Т790М positive mutation in EGFR gene with explorative analysis of the set of mutations detected in plasma ctDNA taken after the progression on Osimertinib.  It is planned to include in the study approximately 70 patients in the Russian Federation (RF) who are participating or having completed their participation in EAP, or patients, who were treated with Osimertinib in real clinical practice.  For the patients participating in EAP and patients taking Osimertinib in real clinical practice, prospective data collection is planned after signing the informed consent form(ICF) for participation in the study. Data from those patients who completed participation in EAP or completed therapy with Osimertinib in real clinical practice will be gathered retrospectively, following the procedure of signing the ICF, or without it, if the procedure is not applicable (patient's death prior to the data collection).  Patients who are participating in EAP at the moment of inclusion into the TRUST study will receive therapy by Osimertinib at a dose of 80 mg a day orally, as a single dose. Patients will be treated according to the SmPC and local clinical regulations. Assessment of response to the therapy will be performed in accordance with RECIST 1.1.  From all patients included into the study will be performed retro- or prospective data collection of two-year-course of the disease starting from the time of first dose of Osimertinib.  For patients with progression of the disease on Osimertinib will be performed molecular-genetic testing of their plasma ctDNA at the time when the fact of the progression is registered.  During the study, each patient, for whom data will be collected prospectively, will undergo two data collection points: the first point (for signing of ICF and evaluation of eligibility criteria) and the final point, which will take place 2 years after the first dose of Osimertinib or at the time when therapy by Osimertinib is discontinued. Patients, for whom data will be collected retrospective, should underdo only the first visit for signing the ICF. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2020</start_date> <completion_date type="Anticipated">December 2022</completion_date> <primary_completion_date type="Anticipated">September 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Ecologic or Community</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Proportion of patients with at least one adverse event</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female By line of treatment: First line therapy Second line of therapy By treatment duration: Up to a year More than a year By effectiveness of therapy: Progression Stabilization Negative feedback Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </primary_outcome> <primary_outcome> <measure>Proportion of patients who discontinued therapy with Osimertinib</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female By line of treatment: First line therapy Second line of therapy By treatment duration: Up to a year More than a year By effectiveness of therapy: Progression Stabilization Negative feedback Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </primary_outcome> <secondary_outcome> <measure>Disease Control Rate and Objective Response Rate</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </secondary_outcome> <secondary_outcome> <measure>Progression-free survival</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </secondary_outcome> <secondary_outcome> <measure>Overall Survival</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </secondary_outcome> <secondary_outcome> <measure>Time to Treatment Discontinuation</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>By sex: Male Female Previous targeted therapy: Yes No Variant of mutation: Exon 19 Exon 21</description> </secondary_outcome> <other_outcome> <measure>Exploratory outcome</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Percentage of patients who had been treated with other therapies prior to the start of therapy with Osimertinib. Percentage of patients who previously underwent targeted therapy and other types of therapies.</description> </other_outcome> <enrollment type="Anticipated">70</enrollment> <condition>Non Small Cell Lung Cancer</condition> <condition>T790M</condition> <condition>EGFR Gene Mutation</condition> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Blood samples </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> The study plans to include all the patients enrolled in an Osimertinib Early Access Program in Russia With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to and progression on or after other EGFR TKI Therapy (presumably 45 to 50 subjects) and patients, who were treated with osimertinib in local clinical practice (presumably 20 to 25 subjects). </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Participation in Osimertinib EAP and /or taking / completion therapy with Osimertinib in real clinical practice;  - Confirmed diagnosis of IIIB (locally advanced) or IV (metastatic) stages of NSCLC with T790M EGFRm;  - Progression of the disease that occurred during or after the therapy with first- or second-generation EGFR TKI  Exclusion Criteria:  - Participation in any other clinical study;  - Absence of data essential for obtaining all necessary information in full. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Konstantin Laktionov, MD</last_name> <phone>+79031709795</phone> <email>lkoskos@mail.ru</email> </overall_contact> <location> <facility> <name>Federal State Budgetary Institution National Medical Research Center of Oncology named after N.N. N.N. Blokhin" of the Ministry of Health of Russia</name> <address> <city>Moscow</city> <zip>115478</zip> <country>Russian Federation</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Konstantin Laktionov, M.D.</last_name> <phone>+79031709795</phone> <email>lkoskos@mail.ru</email> </contact> </location> <location_countries> <country>Russian Federation</country> </location_countries> <verification_date>December 2021</verification_date> <study_first_submitted>March 5, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Tyrosine kinase inhibitor</keyword> <keyword>Osimertinib</keyword> <condition_browse>  <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to assess safety of Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression during or after therapy with a prior EGFR tyrosine kinase inhibitor (TKI), with confirmed Т790М positive mutation in EGFR gene. This study is a multicenter non-interventional retro- and prospective study of safety and efficacy of the Osimertinib administration in frames of Early Access Program (EAP) and real clinical practice in patients with locally advanced or metastatic non-small cell lung cancer that progressed during or after therapy with an EGFR tyrosine kinase inhibitor, with confirmed Т790М positive mutation in EGFR gene with explorative analysis of the set of mutations detected in plasma ctDNA taken after the progression on Osimertinib. It is planned to include in the study approximately 70 patients in the Russian Federation (RF) who are participating or having completed their participation in EAP, or patients, who were treated with Osimertinib in real clinical practice. For the patients participating in EAP and patients taking Osimertinib in real clinical practice, prospective data collection is planned after signing the informed consent form(ICF) for participation in the study. Data from those patients who completed participation in EAP or completed therapy with Osimertinib in real clinical practice will be gathered retrospectively, following the procedure of signing the ICF, or without it, if the procedure is not applicable (patient's death prior to the data collection). Patients who are participating in EAP at the moment of inclusion into the TRUST study will receive therapy by Osimertinib at a dose of 80 mg a day orally, as a single dose. Patients will be treated according to the SmPC and local clinical regulations. Assessment of response to the therapy will be performed in accordance with RECIST 1.1. From all patients included into the study will be performed retro- or prospective data collection of two-year-course of the disease starting from the time of first dose of Osimertinib. For patients with progression of the disease on Osimertinib will be performed molecular-genetic testing of their plasma ctDNA at the time when the fact of the progression is registered. During the study, each patient, for whom data will be collected prospectively, will undergo two data collection points: the first point (for signing of ICF and evaluation of eligibility criteria) and the final point, which will take place 2 years after the first dose of Osimertinib or at the time when therapy by Osimertinib is discontinued. Patients, for whom data will be collected retrospective, should underdo only the first visit for signing the ICF. Blood samples The study plans to include all the patients enrolled in an Osimertinib Early Access Program in Russia With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to and progression on or after other EGFR TKI Therapy (presumably 45 to 50 subjects) and patients, who were treated with osimertinib in local clinical practice (presumably 20 to 25 subjects). Inclusion Criteria: - Participation in Osimertinib EAP and /or taking / completion therapy with Osimertinib in real clinical practice; - Confirmed diagnosis of IIIB (locally advanced) or IV (metastatic) stages of NSCLC with T790M EGFRm; - Progression of the disease that occurred during or after the therapy with first- or second-generation EGFR TKI Exclusion Criteria: - Participation in any other clinical study; - Absence of data essential for obtaining all necessary information in full.

NCT0531xxxx/NCT05314309.xml

<clinical_study>  <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/NCT05314309</url> </required_header> <id_info> <org_study_id>M22ANC</org_study_id> <secondary_id>1691110-204907-PG</secondary_id> <nct_id>NCT05314309</nct_id> </id_info> <brief_title>Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening</brief_title> <acronym>mtFIT</acronym> <official_title>Clinical Validation of a Multi-target Faecal Immunochemical Test (mtFIT) Versus a Faecal Immunochemical Test (FIT) for Detecting Advanced Neoplasia in Population Screening for CRC: a Prospective Cohort Study With Paired Design</official_title> <sponsors> <lead_sponsor> <agency>The Netherlands Cancer Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Amsterdam University Medical Centres (AUMC)</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Erasmus Medical Center</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>The Netherlands Cancer Institute</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity. </textblock> </brief_summary> <detailed_description> <textblock> Background:  The primary goal of population-based CRC screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. New tests, with higher sensitivity for advanced precursor lesions than the current FIT, are desired. The investigators have developed a protein-based multitarget faecal immunochemical test (mtFIT) that shows higher sensitivity for advanced adenomas without losing in specificity.  Objective:  To prospectively validate the better performance of the mtFIT in comparison to FIT in the setting of a population-based CRC screening program.  Material and Methods:  In this prospective study, participants of the Dutch National CRC screening program (55-75 years of age) will be invited to participate. Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings.  Expected results:  mtFIT has higher sensitivity for AN, and in particular advanced adenomas, than FIT, at equal positivity rate. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">March 25, 2022</start_date> <completion_date type="Anticipated">May 31, 2023</completion_date> <primary_completion_date type="Anticipated">May 31, 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Detection rate of advanced neoplasia</measure> <time_frame>10 months</time_frame> <description>Relative sensitivity of mtFIT compared to FIT in the detection of advanced neoplasia (AN; CRC, advanced adenomas and advanced serrated polyps) at an equal positivity rate.</description> </primary_outcome> <secondary_outcome> <measure>Diagnostic yield of mtFIT in comparison to FIT</measure> <time_frame>10 months</time_frame> <description>mtFIT detects more CRC, more early-stage CRC and more advanced polyps (advanced adenomas and advanced serrated polyps) compared to FIT.</description> </secondary_outcome> <other_outcome> <measure>Long-term mtFIT efficacy</measure> <time_frame>10 months</time_frame> <description>mtFIT reduces CRC incidence and CRC-related mortality compared to FIT and is cost-effective to be used in a CRC screening program.</description> </other_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">14712</enrollment> <condition>CRC</condition> <condition>Advanced Neoplasia</condition> <arm_group> <arm_group_label>mtFIT</arm_group_label> <description>Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Comparison of two tests (FIT and mtFIT) in the same bowel movement</intervention_name> <description>Invitees for the Dutch National CRC screening program will be randomly selected by the Screening Organization and invited to participate in this study, where next to the current FIT, participants will also perform the mtFIT in one bowel movement. Both tests will be analysed and if one of the two test results is positive, the individual will be referred for colonoscopy.</description> <arm_group_label>mtFIT</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> The intended population of this study consists of subjects participating in the national Dutch National CRC screening program </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Individuals of the Dutch population suitable for CRC screening (age between 55 and 75 years old) will be randomly selected.  - The participants will be invited in phases and are selected out of different age groups.  - The selected participants will participate in the population CRC screening program for either the first, second, third or fourth time.  Exclusion Criteria:  - Collection of stool not complete for both tests (FIT and mtFIT) </textblock> </criteria> <gender>All</gender> <minimum_age>55 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Gerrit A Meijer, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>The Netherlands Cancer Institute</affiliation> </overall_official> <overall_official> <last_name>Evelien Dekker, MD, PhD</last_name> <role>Study Chair</role> <affiliation>Amsterdam University Medical Centres (AUMC)</affiliation> </overall_official> <overall_official> <last_name>Manon CW Spaander, MD, PhD</last_name> <role>Study Chair</role> <affiliation>Erasmus University Medical Centre Rotterdam (Erasmus MC)</affiliation> </overall_official> <location> <facility> <name>Netherlands Cancer Institute</name> <address> <city>Amsterdam</city> <country>Netherlands</country> </address> </facility> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>February 14, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 10, 2023</last_update_submitted> <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity. Background: The primary goal of population-based CRC screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. New tests, with higher sensitivity for advanced precursor lesions than the current FIT, are desired. The investigators have developed a protein-based multitarget faecal immunochemical test (mtFIT) that shows higher sensitivity for advanced adenomas without losing in specificity. Objective: To prospectively validate the better performance of the mtFIT in comparison to FIT in the setting of a population-based CRC screening program. Material and Methods: In this prospective study, participants of the Dutch National CRC screening program (55-75 years of age) will be invited to participate. Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings. Expected results: mtFIT has higher sensitivity for AN, and in particular advanced adenomas, than FIT, at equal positivity rate. The intended population of this study consists of subjects participating in the national Dutch National CRC screening program Inclusion Criteria: - Individuals of the Dutch population suitable for CRC screening (age between 55 and 75 years old) will be randomly selected. - The participants will be invited in phases and are selected out of different age groups. - The selected participants will participate in the population CRC screening program for either the first, second, third or fourth time. Exclusion Criteria: - Collection of stool not complete for both tests (FIT and mtFIT)

NCT0531xxxx/NCT05314322.xml

<clinical_study>  <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/NCT05314322</url> </required_header> <id_info> <org_study_id>2022-02-016A</org_study_id> <nct_id>NCT05314322</nct_id> </id_info> <brief_title>Deep Brain Stimulation on Dual-task Gait Performance in PD</brief_title> <official_title>The Impacts of Deep Brain Stimulation on Dual-task Gait Performance in Parkinson's Disease: Focusing on Long-term Outcome and the Effects of Stimulation Modes</official_title> <sponsors> <lead_sponsor> <agency>National Yang Ming University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>National Yang Ming University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">July 31, 2025</completion_date> <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Dual-task gait performance: Stride length</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the OPTO gait system to evaluate stride length</description> </primary_outcome> <primary_outcome> <measure>Dual-task gait performance: Double limb support time</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the OPTO gait system to evaluate double limb support time</description> </primary_outcome> <primary_outcome> <measure>Executive function - Inhibition control</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the Stroop test to evaluate inhibition control</description> </primary_outcome> <primary_outcome> <measure>Executive function - Shifting attention</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the Trail Making Test to evaluate shifting attention</description> </primary_outcome> <primary_outcome> <measure>Executive function - Working memory</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the Digit span test to evaluate working memory</description> </primary_outcome> <primary_outcome> <measure>Cognitive function</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function</description> </primary_outcome> <primary_outcome> <measure>Non-motor symptoms</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms</description> </primary_outcome> <secondary_outcome> <measure>Usual gait performance: Stride length</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the OPTO gait system to evaluate stride length</description> </secondary_outcome> <secondary_outcome> <measure>Usual gait performance: Double limb support time</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using the OPTO gait system to evaluate double limb support time</description> </secondary_outcome> <secondary_outcome> <measure>Brain activity: Prefrontal Cortex</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR</description> </secondary_outcome> <secondary_outcome> <measure>Brain activity: Supplementary Motor Cortex</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Supplementary Motor Area with the formula: Hb diff=HbO-HbR</description> </secondary_outcome> <secondary_outcome> <measure>Brain activity: Premotor Cortex</measure> <time_frame>Three days after frequency adjustment</time_frame> <description>Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR</description> </secondary_outcome> <secondary_outcome> <measure>Functional activity: Gait and balance performance</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Timed up and go test to evaluate functional activity</description> </secondary_outcome> <secondary_outcome> <measure>Functional activity: Lower limb function</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the 30s Chair Stand Test to evaluate functional activity</description> </secondary_outcome> <secondary_outcome> <measure>Balance performance</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Mini-BEST test to evaluate balance performance</description> </secondary_outcome> <secondary_outcome> <measure>Motor symptoms</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms</description> </secondary_outcome> <secondary_outcome> <measure>Parkinson's Disease patients' Quality of life</measure> <time_frame>Every 6-month up to 2 years</time_frame> <description>Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">24</enrollment> <condition>Parkinson Disease</condition> <arm_group> <arm_group_label>High frequency group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed</description> </arm_group> <arm_group> <arm_group_label>Low frequency group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Deep brain stimulation with high frequency</intervention_name> <description>Deep brain stimulation implanted at the patients' Substantia Nigra</description> <arm_group_label>High frequency group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Deep brain stimulation with low frequency</intervention_name> <description>Deep brain stimulation implanted at the patients' Substantia Nigra</description> <arm_group_label>Low frequency group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Idiopathic PD  - Age: 50~80 yrs old  - Hoehn and Yahr stage ≤ IV after DBS operation  - Implanted DBS system for at least 6 months  - MMSE ≥24  Exclusion Criteria:  - Other neurological disorders  - Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Yea-Ru Yang, PhD</last_name> <phone>+886-2-2876-7279</phone> <email>yryang@nycu.edu.tw</email> </overall_contact> <location> <facility> <name>Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University</name> <address> <city>Taipei</city> <zip>112</zip> <country>Taiwan</country> </address> </facility> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>National Yang Ming University</investigator_affiliation> <investigator_full_name>Yea-Ru Yang</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Deep brain stimulation</keyword> <keyword>Dual-task walking</keyword> <keyword>Executive function</keyword> <condition_browse>  <mesh_term>Parkinson Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD. Inclusion Criteria: - Idiopathic PD - Age: 50~80 yrs old - Hoehn and Yahr stage ≤ IV after DBS operation - Implanted DBS system for at least 6 months - MMSE ≥24 Exclusion Criteria: - Other neurological disorders - Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability

NCT0531xxxx/NCT05314335.xml

<clinical_study>  <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/NCT05314335</url> </required_header> <id_info> <org_study_id>FAKYUZOZDEMİR</org_study_id> <nct_id>NCT05314335</nct_id> </id_info> <brief_title>Reflexology Socks and Opioid-induced Constipation</brief_title> <official_title>The Effect of Reflexology Socks On The Management of Opioid-Induced Constipation</official_title> <sponsors> <lead_sponsor> <agency>Muğla Sıtkı Koçman University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Muğla Sıtkı Koçman University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Opioids are one of the most commonly used treatment approaches in the treatment of severe pain due to cancer and non-cancer causes. The most commonly reported side effect by patients related to opioid use is constipation. Opioid-related constipation, with an overall incidence of between 17% and 88%, requires a reduction in the treatment dose or drug rotation in some patients. It also makes it difficult for patients to comply with treatment. However, if the constipation due to opioid use is not managed properly and continues for a long time, many problems such as hemorrhoids and perforation, rectal pain and burning, intestinal rupture, anal fissure, diarrhea due to partial obstruction, urinary incontinence may develop.  It is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.  The aim of this study is to examine whether reflexology stockings are an effective approach in reducing opioid-related constipation. </textblock> </brief_summary> <detailed_description> <textblock> The basis of the physiopathological mechanism of constipation due to opioid use is the reducing effect on intestinal motility. There are opioid receptors called "mu" in the enteric nervous system. In patients using opioids, opioid agonists bind to these receptors. As a result of the binding of opioid agonists to the "mu" receptors, the release of excitatory and inhibitory neurotransmitters is inhibited and the coordinated rhythmic contractions required for bowel movements are reduced, as a result, peristaltic movements in the ileum and colon slow down and opioid-related intestinal dysfunction develops. With the prolonged stay of feces in the intestinal lumen, fluid absorption from the intestine increases and dry, hard stools are formed. Sphincter tone and non-impulsive contractions increase. As a result of all these effects, constipation develops.  In the management of constipation; In this study, both the effects of reflexology applied to the foot on the neuropeptide system and the effect of regulating electromagnetic transmissions were utilized. In a study conducted with the participation of children with cerebral palsy with constipation, it was reported that reflexology applied to the foot twice a week for 8 weeks had a positive effect on constipation. In a different study evaluating the effect of foot reflexology in patients with Multiple Sclerosis, it was reported that reflexology massage applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30-40 minutes once a week for 6 weeks reduced constipation. In a different study conducted with the participation of elderly patients, it was reported that foot reflexology applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30 minutes 3 times a week for 1 month resulted in a significant increase in bowel movements. In a systematic review and meta-analysis study evaluating the effect of foot reflexology in the management of functional constipation; It has been concluded that foot reflexology has a positive effect on stool frequency, stool consistency, difficult defecation, incomplete emptying of the intestines, abdominal pain and bloating. However, since the randomized controlled studies included in this study were studies with small sample groups, it was stated that larger studies were needed.  In addition to the effects in these studies, it is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply.  RESEARCH PROTOCOL The patients will be divided into 2 groups as experimental and control groups according to the predetermined randomization control list. In the first interview with the patients in the experimental group; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again.  For the patients in the control group; In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 30, 2020</start_date> <completion_date type="Actual">July 7, 2022</completion_date> <primary_completion_date type="Actual">July 7, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>The change in defecation routine ( frequency, amount of stool etc.)</measure> <time_frame>Every day / for 5 weeks</time_frame> <description>The daily defecation routine of the patients was assessed with the Daily Defecation Scale. With this chart, the amount of stool, stool consistency, straining during defecation, feeling of incomplete evacuation after defecation, and number of defecations are monitored weekly. With this form, patients recorded their defecation status for 5 weeks each time they defecated. Scores collected for each symptom of constipation are calculated by dividing the number of defecations in the same week.</description> </primary_outcome> <primary_outcome> <measure>The change in the severity of the symptoms of constipation</measure> <time_frame>Every day / for 5 weeks</time_frame> <description>The changes in constipation-related symptoms were assessed with the Visual Comparison Scale. Visual Comparison Scale: It is a 6-question scale that evaluates the severity of the symptoms of constipation (constipation severity, straining, feeling of incomplete evacuation, rectal fullness, rectal pain and gas) in the patient. The visual comparison scale consists of a horizontal line between 0-10.</description> </primary_outcome> <primary_outcome> <measure>The change in stool consistency and type.</measure> <time_frame>At the time of defecation/ for 5 weeks</time_frame> <description>At the time of defecation, stool consistency and type were assessed with the Bristol Stool Scale.This scale is used to evaluate stool shape and form in order to monitor changes in bowel functions. Stool shape is classified into 7 different categories. In this scale, which accepts that the stool form changes with the residence time of the stool in the colon; 1 and 2 type patients have Constipation, 3 and 4 types have normal stools and 5-7. type indicates that the patient has diarrhea.</description> </primary_outcome> <primary_outcome> <measure>The change in quality of life due to constipation</measure> <time_frame>At baseline, at day 15 and at day 30.</time_frame> <description>The change in quality of life due to constipation was assessed with the Constipation Quality of Life Scale. Constipation Quality of Life Scale: The item scores of this Likert-type scale range from 1 to 5. The subscales of this 28-item scale are "Anxiety/Anxiety" (11 items), "Physical Discomfort" (4 items), "Psychosocial Discomfort" (8 items), "Satisfaction" (5 items).</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">101</enrollment> <condition>Opioid Use</condition> <condition>Constipation</condition> <condition>Reflexology</condition> <arm_group> <arm_group_label>Reflexology socks+Walking</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In the first interview; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 30th day of the application, the Constipation Quality of Life Scale will be administered to the patients again.</description> </arm_group> <arm_group> <arm_group_label>Just walking</arm_group_label> <arm_group_type>Other</arm_group_type> <description>In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 130th day of the application, the Constipation Quality of Life Scale will be administered to the patients again.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Reflexology socks+walking</intervention_name> <description>Patients should wear reflexology socks; Wearing clothes and walking 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday)</description> <arm_group_label>Reflexology socks+Walking</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Just walking</intervention_name> <description>Patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks.</description> <arm_group_label>Just walking</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients who are at least 18 years old ( ≥ 18 years old)  - Patients with a maximum age of 85 years (≤ 85 years old)  - Patients who volunteered to participate in the study  - Does not have any disability in communicating cognitively, mentally and verbally.  - Opioid treatment applied for approximately 2 weeks  - Those with constipation complaints  - At least one of the constipation problems (straining during bowel emptying, hard stool, feeling of incomplete evacuation, gas/bloating, rectal pressure/defecation sensation) that have been emptied less than 3 times a week since the opioid treatment started and/or developed due to opioid use patients  - Patients with a foot number between 37-44  Exclusion Criteria:  - Having a complaint of peripheral neuropathy  - Being diagnosed with diabetes  - Having impaired skin integrity  - Having any deformity of flat feet or feet </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ferda AKYÜZ ÖZDEMİR</last_name> <role>Principal Investigator</role> <affiliation>Mugla Sıtkı Koçman University Fethiye Faculty of Health Sciences</affiliation> </overall_official> <location> <facility> <name>Mugla Sitki Kocman University</name> <address> <city>Fethiye</city> <state>Muğla</state> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 11, 2023</last_update_submitted> <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation> <investigator_full_name>Ferda AKYUZ OZDEMIR, MsCN</investigator_full_name> <investigator_title>Research Assistant</investigator_title> </responsible_party> <keyword>Opioid induced Constipation</keyword> <keyword>Reflexology</keyword> <condition_browse>  <mesh_term>Constipation</mesh_term> <mesh_term>Opioid-Induced Constipation</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Opioids are one of the most commonly used treatment approaches in the treatment of severe pain due to cancer and non-cancer causes. The most commonly reported side effect by patients related to opioid use is constipation. Opioid-related constipation, with an overall incidence of between 17% and 88%, requires a reduction in the treatment dose or drug rotation in some patients. It also makes it difficult for patients to comply with treatment. However, if the constipation due to opioid use is not managed properly and continues for a long time, many problems such as hemorrhoids and perforation, rectal pain and burning, intestinal rupture, anal fissure, diarrhea due to partial obstruction, urinary incontinence may develop. It is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply. The aim of this study is to examine whether reflexology stockings are an effective approach in reducing opioid-related constipation. The basis of the physiopathological mechanism of constipation due to opioid use is the reducing effect on intestinal motility. There are opioid receptors called "mu" in the enteric nervous system. In patients using opioids, opioid agonists bind to these receptors. As a result of the binding of opioid agonists to the "mu" receptors, the release of excitatory and inhibitory neurotransmitters is inhibited and the coordinated rhythmic contractions required for bowel movements are reduced, as a result, peristaltic movements in the ileum and colon slow down and opioid-related intestinal dysfunction develops. With the prolonged stay of feces in the intestinal lumen, fluid absorption from the intestine increases and dry, hard stools are formed. Sphincter tone and non-impulsive contractions increase. As a result of all these effects, constipation develops. In the management of constipation; In this study, both the effects of reflexology applied to the foot on the neuropeptide system and the effect of regulating electromagnetic transmissions were utilized. In a study conducted with the participation of children with cerebral palsy with constipation, it was reported that reflexology applied to the foot twice a week for 8 weeks had a positive effect on constipation. In a different study evaluating the effect of foot reflexology in patients with Multiple Sclerosis, it was reported that reflexology massage applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30-40 minutes once a week for 6 weeks reduced constipation. In a different study conducted with the participation of elderly patients, it was reported that foot reflexology applied to the stomach, liver, small intestine, large intestine and solar plexus points for 30 minutes 3 times a week for 1 month resulted in a significant increase in bowel movements. In a systematic review and meta-analysis study evaluating the effect of foot reflexology in the management of functional constipation; It has been concluded that foot reflexology has a positive effect on stool frequency, stool consistency, difficult defecation, incomplete emptying of the intestines, abdominal pain and bloating. However, since the randomized controlled studies included in this study were studies with small sample groups, it was stated that larger studies were needed. In addition to the effects in these studies, it is known that reflexology application applied to the foot increases parasympathetic activity while inhibiting sympathetic activity. Peristalsis and bowel movements are reduced in patients with opioid-related constipation. Reflexology practice; It is thought that an increase in motility can be achieved by increasing parasympathetic activity. However, it is thought that the development of reflexology socks will be more effective due to the difficulties of finding a reflexology specialist, the difficulty of reaching a reflexology specialist and the difficulty of having them applied at home. Thanks to the insoled reflexology socks, which have silicone balls that apply pressure to the stomach, liver, small intestine, large intestine and solar plexus points, patients will be able to wear them easily at home and perform their daily life activities at the same time. It is thought that reflexology stockings can be effective in reducing opioid-related constipation, together with being inexpensive and easy to apply. RESEARCH PROTOCOL The patients will be divided into 2 groups as experimental and control groups according to the predetermined randomization control list. In the first interview with the patients in the experimental group; patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Afterwards, the reflexology socks designed by the researcher for the patients; will be told to wear and walk 30 minutes after breakfast and dinner for 30 minutes 3 days a week (Monday, Wednesday and Friday). Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again. For the patients in the control group; In the first interview, patient diagnosis form and Constipation Quality of Life scale will be applied. In order to evaluate the routine bowel habits of the patients, no application will be made in the first week and the patients will be asked to complete the Defecation Diary, Visual Comparison Scale and the Bristol Stool Consistency Scale for 1 week when defecation occurs. Subsequently, patients will be instructed to walk for 30 minutes, 3 days a week (Monday, Wednesday, and Friday), 30 minutes after breakfast and dinner. Patients will be asked to continue the application for 4 weeks. The patients will be administered the Defecation Diary, the Visual Comparison Scale, and the Bristol Stool Consistency Scale when defecation occurs daily during the application. In addition, on the 15th and 30th days of the application, the Constipation Quality of Life Scale will be administered to the patients again. Inclusion Criteria: - Patients who are at least 18 years old ( ≥ 18 years old) - Patients with a maximum age of 85 years (≤ 85 years old) - Patients who volunteered to participate in the study - Does not have any disability in communicating cognitively, mentally and verbally. - Opioid treatment applied for approximately 2 weeks - Those with constipation complaints - At least one of the constipation problems (straining during bowel emptying, hard stool, feeling of incomplete evacuation, gas/bloating, rectal pressure/defecation sensation) that have been emptied less than 3 times a week since the opioid treatment started and/or developed due to opioid use patients - Patients with a foot number between 37-44 Exclusion Criteria: - Having a complaint of peripheral neuropathy - Being diagnosed with diabetes - Having impaired skin integrity - Having any deformity of flat feet or feet

NCT0531xxxx/NCT05314348.xml

<clinical_study>  <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/NCT05314348</url> </required_header> <id_info> <org_study_id>KCH19-072</org_study_id> <nct_id>NCT05314348</nct_id> </id_info> <brief_title>Surface EMG and Ultrasound in MND</brief_title> <official_title>Exploring the Electro-mechanical Coupling of Fasciculations in Motor Neuron Disease Using Surface Electromyography and Ultrasound: a Feasibility Study</official_title> <sponsors> <lead_sponsor> <agency>King's College Hospital NHS Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Manchester Metropolitan University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>King's College Hospital NHS Trust</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Patients with motor neurone disease typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery.  Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. We predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual.  We have been conducting a 12-month longitudinal study of 25 patients, performing high-density surface EMG every two months. We have validated an automated technique to process these large data sets. Ultrasound is widely used in clinical medicine to assess anatomical structure in a safe and non-invasive way. Dr Emma Hodson-Tole (Manchester Metropolitan University) and her group have been applying this to the analysis of fasciculations in healthy individuals and patients with MND.  This collaborative project will explore combining these two techniques simultaneously in patients with motor neuron disease and control subjects. The goal is to explore the nature of electro-mechanical coupling related to fasciculations and to determine whether any of these properties are pathophysiological. This would complement other studies from our two groups, investigating the natural history and potential utility of fasciculations as a biomarker of motor neuron health in MND. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">June 11, 2019</start_date> <completion_date type="Actual">December 1, 2019</completion_date> <primary_completion_date type="Actual">December 1, 2019</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>12 MND/ALS patients and 13 healthy controls to be assessed at a single time-point each</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Correlation between automated detection of fasciculations by two methods (high-density surface EMG and ultrasound)</measure> <time_frame>Single time-point</time_frame> </primary_outcome> <secondary_outcome> <measure>To assess the practical feasibility of using high-density surface EMG and ultrasound simultaneously in biceps and gastrocnemius.</measure> <time_frame>Single time-point</time_frame> </secondary_outcome> <secondary_outcome> <measure>To highlight potential biomarkers of disease related to the electromechanical coupling of fasciculations (e.g. latency between electrical and mechanical peaks).</measure> <time_frame>Single time-point</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">25</enrollment> <condition>Motor Neuron Disease</condition> <arm_group> <arm_group_label>Motor Neuron Disease</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>High-density surface EMG Ultrasound</description> </arm_group> <arm_group> <arm_group_label>Healthy controls</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>High-density surface EMG Ultrasound</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>High-density surface EMG</intervention_name> <description>High-density surface EMG for fasciculation detection</description> <arm_group_label>Healthy controls</arm_group_label> <arm_group_label>Motor Neuron Disease</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Ultrasound</intervention_name> <description>Ultrasound for fasciculation detection</description> <arm_group_label>Healthy controls</arm_group_label> <arm_group_label>Motor Neuron Disease</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria for MND patients:  (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.  (ii) Diagnosed with MND by a neurologist with expertise in MND. For subjects with bulbar onset there must be objective limb involvement of at least one limb. (iii) Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).  Inclusion criteria for healthy controls (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.  (ii) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol  Exclusion criteria for MND patients:  (i) Neurological (other than the subject's MND) or non neurological co morbidities (e.g. joint disease, respiratory disease) which limit mobility.  (ii) Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).  (iii) Regionally restricted forms of MND, or other atypical variants:  - Isolated corticobulbar pattern of MND with normal ambulation  - Primary lateral sclerosis  - Signs of chronic partial denervation restricted to a single limb  - MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non invasive ventilation for sleep apnoea is allowed).  (v) Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints. (vi) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation.  (vii) History of skin hypersensitivity to adhesives. (viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.  Exclusion criteria for healthy participants:  (i) Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints. (ii) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation.  (iii) History of skin hypersensitivity to adhesives. (iv) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>King's College Hospital NHS Foundation Trust</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <reference> <citation>Bashford J, Wickham A, Iniesta R, Drakakis E, Boutelle M, Mills K, Shaw C. SPiQE: An automated analytical tool for detecting and characterising fasciculations in amyotrophic lateral sclerosis. Clin Neurophysiol. 2019 Jul;130(7):1083-1090. doi: 10.1016/j.clinph.2019.03.032. Epub 2019 Apr 19. Erratum In: Clin Neurophysiol. 2020 Jan;131(1):350.</citation> <PMID>31078984</PMID> </reference> <reference> <citation>Bibbings K, Harding PJ, Loram ID, Combes N, Hodson-Tole EF. Foreground Detection Analysis of Ultrasound Image Sequences Identifies Markers of Motor Neurone Disease across Diagnostically Relevant Skeletal Muscles. Ultrasound Med Biol. 2019 May;45(5):1164-1175. doi: 10.1016/j.ultrasmedbio.2019.01.018. Epub 2019 Mar 8.</citation> <PMID>30857760</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>August 20, 2019</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Motor Neuron Disease</mesh_term> <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Patients with motor neurone disease typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery. Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. We predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual. We have been conducting a 12-month longitudinal study of 25 patients, performing high-density surface EMG every two months. We have validated an automated technique to process these large data sets. Ultrasound is widely used in clinical medicine to assess anatomical structure in a safe and non-invasive way. Dr Emma Hodson-Tole (Manchester Metropolitan University) and her group have been applying this to the analysis of fasciculations in healthy individuals and patients with MND. This collaborative project will explore combining these two techniques simultaneously in patients with motor neuron disease and control subjects. The goal is to explore the nature of electro-mechanical coupling related to fasciculations and to determine whether any of these properties are pathophysiological. This would complement other studies from our two groups, investigating the natural history and potential utility of fasciculations as a biomarker of motor neuron health in MND. Inclusion criteria for MND patients: (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent. (ii) Diagnosed with MND by a neurologist with expertise in MND. For subjects with bulbar onset there must be objective limb involvement of at least one limb. (iii) Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance). Inclusion criteria for healthy controls (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent. (ii) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol Exclusion criteria for MND patients: (i) Neurological (other than the subject's MND) or non neurological co morbidities (e.g. joint disease, respiratory disease) which limit mobility. (ii) Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005). (iii) Regionally restricted forms of MND, or other atypical variants: - Isolated corticobulbar pattern of MND with normal ambulation - Primary lateral sclerosis - Signs of chronic partial denervation restricted to a single limb - MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non invasive ventilation for sleep apnoea is allowed). (v) Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints. (vi) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation. (vii) History of skin hypersensitivity to adhesives. (viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study. Exclusion criteria for healthy participants: (i) Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints. (ii) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation. (iii) History of skin hypersensitivity to adhesives. (iv) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.

NCT0531xxxx/NCT05314361.xml

<clinical_study>  <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/NCT05314361</url> </required_header> <id_info> <org_study_id>PHN1DayCBTPilot</org_study_id> <nct_id>NCT05314361</nct_id> </id_info> <brief_title>Public Health Nurse-Delivered 1-Day CBT Workshops Pilot</brief_title> <official_title>Online Public Health Nurse Delivered 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression Symptoms: Pilot Study</official_title> <sponsors> <lead_sponsor> <agency>McMaster University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>McMaster University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Public Health Nurses received training to deliver a day-long Cognitive Behavioural Therapy-based workshop for treating postpartum depression. Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months.  The study will aim to assess the feasibility of our methods and estimate the treatment effect of the primary outcome in preparation for a larger RCT. Objectives include:  - Recruit and randomize 96 participants within 5 months  - Questionnaire completion - 75% of participants complete all three questionnaires and structured interviews  - Retention - 75% of participants remain in study until completion  - 75% of participants in treatment group complete the intervention  - Estimate treatment effect and variance </textblock> </brief_summary> <detailed_description> <textblock> Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births.  Current clinical practice guidelines (including those written by the NPA) recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but "only when CBT or other evidence-based counseling is available."  While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level.  The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers' needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression.  The purpose of this pilot study is to determine the feasibility of our study procedures and estimate the treatment effect and variance of the primary outcome in preparation for a larger RCT to determine the effectiveness of a Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshop for postpartum depression.  A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months.  The experimental group will receive the Online 1-Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone.  Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 18, 2022</start_date> <completion_date type="Actual">April 1, 2023</completion_date> <primary_completion_date type="Actual">April 1, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> <masking_description>Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.</masking_description> </study_design_info> <primary_outcome> <measure>Number of participants recruited in recruitment period</measure> <time_frame>5 months</time_frame> <description>Recruit and randomize 96 participants within 5 months (48 treatment into four 1-day workshops (12 per workshop) and 48 control)</description> </primary_outcome> <primary_outcome> <measure>Number of participants who complete all data collection procedures</measure> <time_frame>6 months</time_frame> <description>75% of participants complete all data collection procedures at all time points</description> </primary_outcome> <primary_outcome> <measure>Number of participants who complete study (retention)</measure> <time_frame>6 months</time_frame> <description>75% of participants remain enrolled in the study until completion</description> </primary_outcome> <primary_outcome> <measure>Number of participants who complete the intervention (adherence)</measure> <time_frame>6 months</time_frame> <description>75% of participants who are enrolled in the treatment group will complete the 1-Day CBT-based workshop</description> </primary_outcome> <secondary_outcome> <measure>Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)</measure> <time_frame>3 months</time_frame> <description>Estimate treatment effect of primary outcome for later RCT - The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change.</description> </secondary_outcome> <other_outcome> <measure>GAD-7</measure> <time_frame>3 months</time_frame> <description>The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. A cutoff of ≥11 defines clinically important levels of anxiety symptoms.</description> </other_outcome> <other_outcome> <measure>GAD-7</measure> <time_frame>6 months</time_frame> <description>The Generalized Anxiety Disorder 7-Item Scale (GAD-7) (32) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of PPD. Items are scored on a 4-point scale from 0 to 3, with a higher score indicating an increased risk of GAD. A cutoff of ≥11 defines clinically important levels of anxiety symptoms.</description> </other_outcome> <other_outcome> <measure>Multidimensional Scale of Perceived Social Support (MSPSS)</measure> <time_frame>3 months</time_frame> <description>A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.</description> </other_outcome> <other_outcome> <measure>Multidimensional Scale of Perceived Social Support (MSPSS)</measure> <time_frame>6 months</time_frame> <description>A 12-item scale designed to measure perceived social support from three sources: (1) family, (2) friends and (3) significant other. Items are scored on a 7-point scale, and total scores range from 12-84 with higher scores indicating a higher level of perceived social support. A score of 12-35 indicates low perceived social support, 36-60 indicates medium perceived social support and 61-84 indicates high perceived social support.</description> </other_outcome> <other_outcome> <measure>Parenting Stress Index (PSI-SF)</measure> <time_frame>3 months</time_frame> <description>The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.</description> </other_outcome> <other_outcome> <measure>Parenting Stress Index (PSI-SF)</measure> <time_frame>6 months</time_frame> <description>The Parenting Stress Index (short form) is a 36-item parent self-report measure that identifies potentially dysfunctional parent-child systems on three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. The measure also produces a total score that is an indication of overall level of stress a person is feeling in their role as a parent. Higher scores indicate higher levels of stress.</description> </other_outcome> <other_outcome> <measure>The Postpartum Bonding Questionnaire (PBQ)</measure> <time_frame>3 months</time_frame> <description>The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.</description> </other_outcome> <other_outcome> <measure>The Postpartum Bonding Questionnaire (PBQ)</measure> <time_frame>6 months</time_frame> <description>The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.</description> </other_outcome> <other_outcome> <measure>Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)</measure> <time_frame>3 months</time_frame> <description>The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.</description> </other_outcome> <other_outcome> <measure>Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)</measure> <time_frame>6 months</time_frame> <description>The Infant Behaviour Questionnaire-Revised (Very Short Form) (IBQR) is a parent-report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assesses 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items, and Orienting/Regulatory Capacity with 12 items; higher scores indicate greater alignment with the domain.</description> </other_outcome> <other_outcome> <measure>EQ-5D-5L</measure> <time_frame>3 months</time_frame> <description>A utility-based health-related quality of life self-report instrument consisting of five questions covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach).</description> </other_outcome> <other_outcome> <measure>EQ-5D-5L</measure> <time_frame>6 months</time_frame> <description>A utility-based health-related quality of life self-report instrument consisting of five questions covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach).</description> </other_outcome> <other_outcome> <measure>Healthcare Resource Utilization Questionnaire</measure> <time_frame>3 months</time_frame> <description>Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnoses and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those relating to mental health). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.</description> </other_outcome> <other_outcome> <measure>Healthcare Resource Utilization Questionnaire</measure> <time_frame>6 months</time_frame> <description>Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnoses and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those relating to mental health). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.</description> </other_outcome> <other_outcome> <measure>Client Satisfaction Questionnaire (CSQ-8)</measure> <time_frame>1 week</time_frame> <description>Intervention participants only. An 8-item scale that measures and assesses consumer satisfaction with health and human services. Items are scored on a 4-point scale and total scores range from 8-32, with higher scores indicating greater satisfaction.</description> </other_outcome> <other_outcome> <measure>CBT Skills Questionnaire (CBTSQ)</measure> <time_frame>3 months</time_frame> <description>Intervention participants only. A 16-item maternal-report measure designed to assess cognitive and behavioural skills acquisition. Each item is scored on a 5-point scale, and total scores range from 16-80. Higher cognitive restructuring and behavioural activation scores predict reduction of overall psychiatric symptoms and depression.</description> </other_outcome> <other_outcome> <measure>CBT Skills Questionnaire (CBTSQ)</measure> <time_frame>6 months</time_frame> <description>Intervention participants only. A 16-item maternal-report measure designed to assess cognitive and behavioural skills acquisition. Each item is scored on a 5-point scale, and total scores range from 16-80. Higher cognitive restructuring and behavioural activation scores predict reduction of overall psychiatric symptoms and depression.</description> </other_outcome> <other_outcome> <measure>Working Alliance Inventory (WAI-SR)</measure> <time_frame>1 week</time_frame> <description>Intervention participants only. A 12-item maternal-report measure that assesses three aspects of therapeutic alliance:(1) agreement on the tasks of therapy, (2) agreement on the goals of therapy and (3) development of an affective bond. Items are rated on a 5-point scale, and total scores range from 12-60 with higher scores indicating a better therapeutic alliance.</description> </other_outcome> <other_outcome> <measure>Mini International Neuropsychiatric Interview - Major Depressive Disorder Module</measure> <time_frame>3 months</time_frame> <description>10-15 minute structured psychiatric interview will assess current psychiatric syndromes in participants by telephone at baseline to assess study eligibility. The MINI will be conducted again at 3 and 6 months to assess change in psychiatric symptoms over the study period.</description> </other_outcome> <other_outcome> <measure>Mini International Neuropsychiatric Interview - Major Depressive Disorder Module</measure> <time_frame>6 months</time_frame> <description>10-15 minute structured psychiatric interview will assess current psychiatric syndromes in participants by telephone at baseline to assess study eligibility. The MINI will be conducted again at 3 and 6 months to assess change in psychiatric symptoms over the study period.</description> </other_outcome> <other_outcome> <measure>Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)</measure> <time_frame>6 months</time_frame> <description>Estimate treatment effect of primary outcome for later RCT - The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores >4 are accepted as being indicative of clinically significant change.</description> </other_outcome> <other_outcome> <measure>Group cohesion - Therapeutic Factors Inventory - 8 item</measure> <time_frame>1 week</time_frame> <description>Measured using the Therapeutic Factors Inventory-8 item that measures instillation of hope, secure emotional expression, awareness of relational impact and social learning. Items are scored on a likert-scale ranging from 1-7. Higher scores indicate a more cohesive group.</description> </other_outcome> <other_outcome> <measure>Development and testing of treatment fidelity measure</measure> <time_frame>12 weeks</time_frame> <description>The fidelity with which the PHNs deliver the 1-Day CBT Workshop will be assessed using measures of adherence and competence. For this pilot study, adherence and competence measures will be developed and tested for use in a later RCT. Each workshop will be audio-recorded and trained raters will rate the adherence to the workshop model and competence with which the PHNs deliver the workshops.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">119</enrollment> <condition>Postpartum Depression</condition> <arm_group> <arm_group_label>Treatment - 1 Day CBT-Based Workshop</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered by two trained public health nurses in addition to receiving usual care.</description> </arm_group> <arm_group> <arm_group_label>Control - usual care</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>1-Day Cognitive Behavioural Therapy-Based Workshop</intervention_name> <description>The Online Workshop is a day-long intervention delivered by two trained public health nurses consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. We also provide a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD (written by the NPA).</description> <arm_group_label>Treatment - 1 Day CBT-Based Workshop</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 years or older  - have infant <12 months at time of recruitment  - fluent in written/spoken English  Exclusion Criteria:  - current bipolar, psychotic and/or substance use disorders </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>McMaster University</name> <address> <city>Hamilton</city> <state>Ontario</state> <zip>L8S 4L8</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 24, 2023</last_update_submitted> <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>McMaster University</investigator_affiliation> <investigator_full_name>Ryan Van Lieshout, MD, PhD</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Depression, Postpartum</mesh_term> <mesh_term>Depression</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Public Health Nurses received training to deliver a day-long Cognitive Behavioural Therapy-based workshop for treating postpartum depression. Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months. The study will aim to assess the feasibility of our methods and estimate the treatment effect of the primary outcome in preparation for a larger RCT. Objectives include: - Recruit and randomize 96 participants within 5 months - Questionnaire completion - 75% of participants complete all three questionnaires and structured interviews - Retention - 75% of participants remain in study until completion - 75% of participants in treatment group complete the intervention - Estimate treatment effect and variance Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births. Current clinical practice guidelines (including those written by the NPA) recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but "only when CBT or other evidence-based counseling is available." While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level. The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers' needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression. The purpose of this pilot study is to determine the feasibility of our study procedures and estimate the treatment effect and variance of the primary outcome in preparation for a larger RCT to determine the effectiveness of a Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshop for postpartum depression. A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants in both groups will complete all study questionnaires and be compared at baseline, and 3 and 6 months. The experimental group will receive the Online 1-Day workshop (delivered by 2 PHNs) in addition to TAU, and the control group will receive TAU alone. Participants will be mothers who have an infant under 12 months, who are 18 years or older, who are experiencing elevated symptoms of postpartum depression and who are free of current bipolar, psychotic and/or substance use disorders. Inclusion Criteria: - 18 years or older - have infant <12 months at time of recruitment - fluent in written/spoken English Exclusion Criteria: - current bipolar, psychotic and/or substance use disorders

NCT0531xxxx/NCT05314374.xml

<clinical_study>  <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/NCT05314374</url> </required_header> <id_info> <org_study_id>21-008310</org_study_id> <secondary_id>K23DK114460</secondary_id> <nct_id>NCT05314374</nct_id> </id_info> <brief_title>Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype</brief_title> <official_title>Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype</official_title> <sponsors> <lead_sponsor> <agency>Mayo Clinic</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>Mayo Clinic</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight. </textblock> </brief_summary> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">May 12, 2023</start_date> <completion_date type="Anticipated">May 2026</completion_date> <primary_completion_date type="Anticipated">May 2026</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Enteroendocrine L cell (EEC) function</measure> <time_frame>up to 90 days</time_frame> <description>Change in postprandial GLP-1 (ug/ml)</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">36</enrollment> <condition>Obesity</condition> <condition>Healthy</condition> <arm_group> <arm_group_label>Bile Acid Supplement Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements</description> </arm_group> <arm_group> <arm_group_label>Placebo Group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Subjects with obesity and abnormal satiety phenotype will receive matching-placebo</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Ileocolonic-release conjugated bile acid</intervention_name> <description>1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days</description> <arm_group_label>Bile Acid Supplement Group</arm_group_label> <other_name>IC-CBAS</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo looks exactly like the study drug, but it contains no active ingredient. 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days.</description> <arm_group_label>Placebo Group</arm_group_label> <other_name>Matching-placebo</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  I. Patients with obesity BMI> 30 kg/m2 and hungry gut phenotype. II. Age: 18-65 years. III. Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for the gastric emptying study.  IV. Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.  Exclusion criteria:  I. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome.  II. Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.  III. Female subjects who are pregnant or breast-feeding. IV. Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.  V. Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.  VI. Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.  VII. Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and Depression Inventory (HAD) score >11 on depression scale, a self-administered alcoholism screening test (AUDIT-C) score >4 in men or >3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility.  VII. Principal Investigator discretion. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Andres Acosta, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Mayo Clinic</affiliation> </overall_official> <location> <facility> <name>Mayo Clinic in Rochester</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://www.mayo.edu/research/clinical-trials</url> <description>Mayo Clinic Clinical Trials</description> </link> <verification_date>July 2023</verification_date> <study_first_submitted>February 10, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 25, 2023</last_update_submitted> <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mayo Clinic</investigator_affiliation> <investigator_full_name>Andres J. Acosta, M.D., Ph.D.</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>BMI of 30 or greater</keyword> <condition_browse>  <mesh_term>Obesity</mesh_term> <mesh_term>Body Weight</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Bile Acids and Salts</mesh_term> </intervention_browse>  </clinical_study>

The purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight. Inclusion criteria: I. Patients with obesity BMI> 30 kg/m2 and hungry gut phenotype. II. Age: 18-65 years. III. Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for the gastric emptying study. IV. Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes. Exclusion criteria: I. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome. II. Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire. III. Female subjects who are pregnant or breast-feeding. IV. Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs. V. Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease. VI. Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study. VII. Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and Depression Inventory (HAD) score >11 on depression scale, a self-administered alcoholism screening test (AUDIT-C) score >4 in men or >3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility. VII. Principal Investigator discretion.

NCT0531xxxx/NCT05314387.xml

<clinical_study>  <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/NCT05314387</url> </required_header> <id_info> <org_study_id>S-11</org_study_id> <nct_id>NCT05314387</nct_id> </id_info> <brief_title>S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem</brief_title> <official_title>A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem</official_title> <sponsors> <lead_sponsor> <agency>Limacorporate S.p.a</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Limacorporate S.p.a</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 2022</start_date> <completion_date type="Anticipated">April 2029</completion_date> <primary_completion_date type="Anticipated">April 2027</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Proportion of patients reaching a clinical progression from baseline to 24-month follow-up</measure> <time_frame>24 Months</time_frame> <description>The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: Constant score improvement of greater than 10; Adjusted Constant score greater than or equal to 54.</description> </primary_outcome> <secondary_outcome> <measure>Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)</measure> <time_frame>Baseline to 24 and 60 Months</time_frame> <description>The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.</description> </secondary_outcome> <secondary_outcome> <measure>Measure Oxford shoulder score</measure> <time_frame>Baseline to 24 and 60 Months</time_frame> <description>Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.</description> </secondary_outcome> <secondary_outcome> <measure>Measure Constant Score</measure> <time_frame>Baseline to 24 and 60 Months</time_frame> <description>The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function.</description> </secondary_outcome> <secondary_outcome> <measure>Measure Simple Shoulder Test</measure> <time_frame>Baseline to 24 and 60 Months</time_frame> <description>Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. The difference between the shoulder function before treatment and after the recovery period is the effectiveness of the treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Measure Patient Satisfaction</measure> <time_frame>Baseline to 24 and 60 Months</time_frame> <description>The satisfaction of the patients with regard to the effectiveness of the prosthetic treatment is graded on a scale from 1 to 5</description> </secondary_outcome> <secondary_outcome> <measure>Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem</measure> <time_frame>Immediately postoperative to 24 Months</time_frame> <description>Rate of symptomatic radiolucent lines, loosening and subsidence ≥2 mm</description> </secondary_outcome> <secondary_outcome> <measure>System conversion rate, intended as a conversion within the SMR system from anatomic to reverse</measure> <time_frame>24 Months</time_frame> <description>The SMR shoulder system is a modular system and in case of evolution of the pathology it may be easily converted from one configuration to another.</description> </secondary_outcome> <secondary_outcome> <measure>Failure rate, intended as removal of the SMR TT hybrid glenoid component</measure> <time_frame>Immediately postoperative to 24 Months</time_frame> <description>A removal of the glenoid component is intended as a revision and a failure of the implant.</description> </secondary_outcome> <secondary_outcome> <measure>Failure rate, intended as removal of the SMR cementless finned short stem</measure> <time_frame>Immediately postoperative to 24 Months</time_frame> <description>A removal of the stem component is intended as a revision and a failure of the implant.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of device-related AE/SAE (ADE/SADE)</measure> <time_frame>Immediately postoperative to 24 and 60 Months</time_frame> <description>Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points</description> </secondary_outcome> <secondary_outcome> <measure>Survival rate (Kaplan-Meier)</measure> <time_frame>60 Months</time_frame> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">100</enrollment> <condition>Shoulder Arthritis</condition> <condition>Shoulder Osteoarthritis</condition> <condition>Arthrosis</condition> <condition>Osteoarthritis</condition> <condition>Rheumatoid Arthritis</condition> <condition>Arthroplasty</condition> <condition>Avascular Necrosis</condition> <condition>Humeral Fractures</condition> <condition>Cuff Tear Arthropathy</condition> <arm_group> <arm_group_label>SMR TT Hybrid Glenoid without Cementless Finned Short Stem</arm_group_label> <description>Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem</description> </arm_group> <arm_group> <arm_group_label>SMR TT Hybrid Glenoid with Cementless Finned Short Stem</arm_group_label> <description>Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>SMR TT Hybrid Glenoid without Cementless Finned Short Stem</intervention_name> <description>The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.</description> <arm_group_label>SMR TT Hybrid Glenoid without Cementless Finned Short Stem</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>SMR TT Hybrid Glenoid with Cementless Finned Short Stem</intervention_name> <description>The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.</description> <arm_group_label>SMR TT Hybrid Glenoid with Cementless Finned Short Stem</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Orthopedic Clinics </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:(Key)  - Both genders;  - Age ≥ 18 years old;  - Full skeletal maturity;  - Life expectancy over 5 years;  - Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;  - Good bone quality evaluated by the Investigator and the intraoperative evaluation;  - A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:  1. Primary osteoarthritis;  2. Secondary osteoarthritis;  3. Post-traumatic arthritis;  4. Rheumatoid arthritis;  5. Avascular necrosis  6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;  7. cuff tear arthropathy (only in combination with CTA Heads);  8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.  Exclusion Criteria (Key):  - Patient requiring revision shoulder arthroplasty;  - Osteoporosis with a history of non-traumatic fractures;  - Steroid injections within the previous 3 months;  - Contralateral shoulder replacement within the previous 3 months;  - Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;  - Significant neurological or musculoskeletal disorders that may compromise functional recovery;  - Not recovered axillary nerve palsy;  - Non functioning deltoid muscle;  - Known or suspicious hypersensitivity to the metal or other components and materials of the implant;  - Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;  - Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.  These are key eligibility criteria, other eligibility criteria apply. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Laura Sanchez</last_name> <phone>817-233-1686</phone> <email>laura.sanchez@limacorporate.com</email> </overall_contact> <overall_contact_backup> <last_name>Ryan Bacchus</last_name> <phone>817-233-1686</phone> <email>ryan.bacchus@limacorporate.com</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Shoulder Joint</keyword> <keyword>Shoulder Replacement</keyword> <keyword>Arthritis with rotator cuff tear</keyword> <keyword>Post traumatic fracture sequele</keyword> <condition_browse>  <mesh_term>Arthritis</mesh_term> <mesh_term>Osteoarthritis</mesh_term> <mesh_term>Rotator Cuff Tear Arthropathy</mesh_term> <mesh_term>Necrosis</mesh_term> <mesh_term>Humeral Fractures</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem Orthopedic Clinics Inclusion Criteria:(Key) - Both genders; - Age ≥ 18 years old; - Full skeletal maturity; - Life expectancy over 5 years; - Patient is requiring primary unilateral arthroplasty based on physical examination and medical history; - Good bone quality evaluated by the Investigator and the intraoperative evaluation; - A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following: 1. Primary osteoarthritis; 2. Secondary osteoarthritis; 3. Post-traumatic arthritis; 4. Rheumatoid arthritis; 5. Avascular necrosis 6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods; 7. cuff tear arthropathy (only in combination with CTA Heads); 8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification. Exclusion Criteria (Key): - Patient requiring revision shoulder arthroplasty; - Osteoporosis with a history of non-traumatic fractures; - Steroid injections within the previous 3 months; - Contralateral shoulder replacement within the previous 3 months; - Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator; - Significant neurological or musculoskeletal disorders that may compromise functional recovery; - Not recovered axillary nerve palsy; - Non functioning deltoid muscle; - Known or suspicious hypersensitivity to the metal or other components and materials of the implant; - Participation in any experimental drug/device study within the 6 months prior to the preoperative visit; - Women of childbearing potential who are pregnant, nursing, or planning to become pregnant. These are key eligibility criteria, other eligibility criteria apply.

NCT0531xxxx/NCT05314400.xml

<clinical_study>  <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/NCT05314400</url> </required_header> <id_info> <org_study_id>120191</org_study_id> <nct_id>NCT05314400</nct_id> </id_info> <brief_title>Gadoxetate Abbreviated MRI in Metastatic Colorectal Cancer</brief_title> <official_title>A Prospective Study Evaluating Diagnostic Accuracy, Outcome, and Economic Impact of Abbreviated Gadoxetate-enhanced MRI of the Liver in Patients With Metastatic Colorectal Carcinoma</official_title> <sponsors> <lead_sponsor> <agency>Lawson Health Research Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Bayer</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Lawson Health Research Institute</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT.  During the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all.  Unfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings.  The purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed. </textblock> </brief_summary> <detailed_description> <textblock> BACKGROUND  Colorectal cancer (CRC) is the third most commonly diagnosed cancer in Canada and the second leading cause of death in both men, and women (1). In 2021, 24800 Canadians were diagnosed with CRC and 9,600 died from the disease (1). Over their lifetime, 1 in 18 Canadians will be diagnosed with CRC and 1 in 37 will die (1). Accurate staging is essential to improving outcomes, providing appropriate patient management, and improving the health care costs associated with caring for patients with CRC.  London Health Sciences Centre (LHSC) is a tertiary care referral centre for a catchment area of 2 million people in Southwestern Ontario. Annually, approximately 200 patients present to the London Regional Cancer Program with a diagnosis of colorectal cancer. Of these, about 100 patients will have potentially resectable colorectal liver metastasis (CRCLM).  Staging algorithms for CRC include contrast enhanced computed tomography (CECT) of the thorax/abdomen/pelvis, with MRI of the liver in some centres. The objective for performing imaging tests is to accurately determine the extent of local and distant disease to direct patient management. Accurate assessment of the hepatic disease burden is crucial for surgical planning since resection of liver metastases is a core component of CRCLM treatment (2). At LHSC, all patients are initially imaged with CECT of the thorax/abdomen/pelvis. MRI of the liver is reserved for patients that require further characterization of equivocal liver lesions detected on CT. When performed, liver MRI is often performed with extracellular agents such as gadobutrol (Gadovist), i.e. EC-MRI.  Hepatobiliary MRI contrast agents such as gadoxetic acid (aka gadoxetate, trade name Primovist in Canada), i.e. EOB-MRI, provide superior accuracy in detection of CRCLM compared to both CECT (3) and EC-MRI (4). Moreover, the use of EOB-MRI can alter management decisions and improve patient outcomes (3,5,6). It is also the modality of choice in CRCLM patients post-systemic therapy as per the 9th International Forum for Liver MRI Consensus Report (7).  Despite these data, hepatobiliary agents are being used sparingly in most Canadian hospitals, including at LHSC as a problem-solving tool. This is due to two factors: (a) the higher unit cost of gadoxetate compared to gadobutrol and iodine-based CT contrast agents, and (b) the increased MRI scan time required for EOB-MRI compared to EC-MRI or CECT. The increased scan time is a result of the need to acquire images in the "hepatobiliary (HPB) phase" for EOB-MRI, typically 20 minutes post-injection, a longer delay than is required for EC-MRI or CECT. These factors result in increased operational costs for EOB-MRI and opportunity costs from reduced magnet time for other MRI studies.  To address the increased scan time with EOB-MRI, some studies have retrospectively examined the potential role of abbreviated MRI protocols (aMRI) compared to a full protocol (fMRI) (8-11). The premise of EOB-aMRI protocols involves an injection of gadoxetate at the outset of the study, often outside the scanner room. During the 20 min waiting period prior to image acquisition in the HPB phase, an "abbreviated" set of sequences is acquired, usually including DWI/ADC and sometimes T2 weighted images. At the 20 min mark, the HPB phase images are acquired, and the study is complete. The aim of abbreviated protocols is to increase patient throughput without compromising diagnostic accuracy.  The initial results in this relatively nascent field are promising, showing high interobserver agreement and high diagnostic accuracy not significantly different from the full protocol. For example, Canellas et al reported both κ and area under the ROC curve (AUC) of greater than 0.9 for both aMRI and fMRI, with an estimated cost savings of 41% per scan (10). Ghorra et al found similar detection rates of about 86% for both aMRI and fMRI with slightly lower accuracy of the aMRI protocol of about 87% vs 93% for fMRI, but no consistent statistical trends were present (11).  However, existing studies in the literature have simulated an aMRI examination by using a subset of fMRI sequences; some sequences, including the dynamic post contrast sequences acquired before 20 min are removed retrospectively (8-11). Currently there are no published studies comparing fMRI with prospectively acquired aMRI. As retrospective studies may overestimate accuracy and cost savings, there is a need for higher quality, prospective evidence (7). Additionally, retrospective studies are unable to perform a formal economic analysis of costs related to the imaging procedure itself, and importantly downstream costs related to patient management.  RATIONALE  The primary aim of this study is to prospectively compare the diagnostic accuracy of aMRI compared to fMRI regarding CRCLM, using a composite reference standard. Our hypothesis is that aMRI is noninferior to fMRI in this regard, as measured by sensitivity, specificity, and the AUC. If this is the case, it may serve as evidence that EOB-MRI utilization can be increased even within resource constraints inherent to all Healthcare systems. The rationale for using a composite reference standard is that due to varying patient management strategies, the optimal reference standard (surgical pathology) is not always available, and therefore alternative methods must be considered. The rationale for using fMRI as the control group is that this protocol is the current standard of care for EOB-MRI.  A secondary aim is to quantify the economic impact of aMRI vs fMRI both in terms of imaging costs and downstream patient management costs. Our hypothesis is that aMRI will not cost more than fMRI on a per patient basis (i.e. noninferiority). If this is the case, higher patient throughput can be achieved at no increased economic expense.  Another secondary aim is to prospectively compare the diagnostic accuracy of CECT vs aMRI and fMRI for diagnosis of CRCLM, using a composite reference standard. Our hypothesis is that both aMRI and fMRI will be superior to CECT, in line with multiple prior trials (3).  A third secondary aim is to evaluate patient outcomes (overall survival, cancer-specific survival, and hepatic recurrence / progression free survival) at 1-year post-baseline EOB-MRI, using clinical data and the 1-year follow-up CECT. Our hypothesis is that aMRI will be noninferior to fMRI, indicating that there is no adverse effect on patient outcomes from the using an abbreviated protocol.  The fourth secondary aim is to retrospectively compare the diagnostic accuracy of fMRI to a simulated aMRI created from a subset of fMRI pulse sequences. Our hypothesis is that the simulated aMRI will be noninferior to fMRI. This constitutes a 3-factor multireader multicase design, analogous to multiple prior investigations (3,4), enabling direct comparison of our study and adding to the body of literature on the subject.  The final study aim is to compare the diagnostic accuracy and interobserver agreement on aMRI, fMRI, and CECT. Our hypothesis is that there will be no significant difference for diagnostic accuracy. We expect interobserver agreement to be moderate to high.  The rationale for choosing a study cohort comprised of patients with CRCLM is: 1) this is a large patient population / common patient presentation, and 2) EOB-MRI has been shown to provide added value for staging CRCLM but is likely underutilized in Canada, as detailed above.  The rationale for choosing a 1-year follow-up period is that about 30% to 50% of CRCLM will recur or progress within this interval (12,13), enabling a compromise between capturing a significant portion of adverse patient outcomes while minimizing loss to follow-up and unnecessarily prolonging the study, as this is not the primary objective.  STUDY DESIGN  This is a prospective, block randomized, allocation concealed, single-blind, multireader study with case-nested-within-test split-plot design.  The baseline abbreviated or full Primovist MRI will be acquired between day 2 and 14 and a follow-up contrast enhanced CT abdomen pelvis will be performed 1 year from baseline. A combination of histopathology, biological behavior, and imaging findings applied in a hierarchical manner will determine the reference standard for each focal hepatic lesion, i.e. metastasis or not. Sample size is 300 subjects, with equal distribution of 150 per arm.  Statistical analysis of the primary endpoint will be conducted via the updated Obuchowski-Rockette (OR) method (14). </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">May 1, 2025</completion_date> <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Diagnostic</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Diagnostic accuracy of abbreviated versus full MRI protocol</measure> <time_frame>2 years</time_frame> <description>Sensitivity, specificity, area under ROC curve</description> </primary_outcome> <secondary_outcome> <measure>Cost of abbreviated versus full MRI protocol</measure> <time_frame>3 years</time_frame> <description>Sum of the following dollar amounts: technical MRI fees + professional MRI fees + MRI time (cost per hour defined by local institution * number hours used)</description> </secondary_outcome> <secondary_outcome> <measure>Diagnostic accuracy of abbreviated and full MRI protocol versus CT</measure> <time_frame>2 years</time_frame> <description>Sensitivity, specificity, area under ROC curve</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival at 1 year post abbreviated versus full MRI protocol</measure> <time_frame>3 years</time_frame> <description>Proportion of patients alive at 1 year (dimensionless)</description> </secondary_outcome> <secondary_outcome> <measure>Cancer specific survival at 1 year post abbreviated versus full MRI protocol</measure> <time_frame>3 years</time_frame> <description>1 - proportion of patients who died of colorectal cancer or its complications (dimensionless)</description> </secondary_outcome> <secondary_outcome> <measure>Progression free survival at 1 year post abbreviated versus full MRI protocol</measure> <time_frame>3 years</time_frame> <description>1 - proportion of patients with evidence of recurrent or progressive hepatic disease at 1 year (dimensionless)</description> </secondary_outcome> <secondary_outcome> <measure>Diagnostic accuracy of simulated abbreviated versus full MRI protocol</measure> <time_frame>2 years</time_frame> <description>Sensitivity, specificity, area under ROC curve</description> </secondary_outcome> <secondary_outcome> <measure>Inter-reader agreement for all modalities</measure> <time_frame>2 years</time_frame> <description>Sensitivity, specificity, area under ROC curve, and kappa coefficient</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">300</enrollment> <condition>Liver Metastasis Colon Cancer</condition> <arm_group> <arm_group_label>Full Protocol</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Routine Primovist MRI</description> </arm_group> <arm_group> <arm_group_label>Abbreviated Protocol</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Shortened Primovist MRI</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Full Gadoxetate-enhanced liver MRI</intervention_name> <description>Standard pulse sequences</description> <arm_group_label>Full Protocol</arm_group_label> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Shortened Gadoxetate-enhanced liver MRI</intervention_name> <description>Fewer pulse sequences</description> <arm_group_label>Abbreviated Protocol</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male or female, 18 years of age or older  - Diagnosis of colorectal cancer, biopsy proven  - Diagnosis of colorectal liver metastases  - Has CT of the abdomen and pelvis within +/- 30 days from initial surgical consult  - Provision of signed and dated informed consent form  - Willingness to comply with study procedures and availability for the duration of the study  - Able to tolerate MRI required by protocol  Exclusion Criteria:  - Presence of implanted medical device or metallic object that is MR incompatible  - Baseline eGFR of < 30 mL/min/1.73 m2  - Severe claustrophobia not relieved by oral anxiolytics  - Documented severe allergic-like reaction gadolinium-based contrast agent  - Weight greater than allowable on MRI table  - Pregnancy  - Diffuse liver metastases, i.e. definitively unresectable  - Severe liver dysfunction, ALBI grade 3 </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Harry Marshall, MD/PhD</last_name> <phone>519-685-8500</phone> <phone_ext>34700</phone_ext> <email>harry.marshall@lhsc.on.ca</email> </overall_contact> <overall_contact_backup> <last_name>Zahra Kassam, MD</last_name> <phone>519-646-6100</phone> <phone_ext>61595</phone_ext> <email>zahra.kassam@sjhc.london.on.ca</email> </overall_contact_backup> <location> <facility> <name>St. Joseph's Healthcare</name> <address> <city>London</city> <state>Ontario</state> <zip>N6A 4V2</zip> <country>Canada</country> </address> </facility> <contact> <last_name>Zahra Kassam, MD</last_name> <phone>519-646-6100</phone> <phone_ext>61595</phone_ext> <email>zahra.kassam@sjhc.london.on.ca</email> </contact> </location> <location> <facility> <name>London Health Sciences Centre</name> <address> <city>London</city> <state>Ontario</state> <zip>N6A5A5</zip> <country>Canada</country> </address> </facility> <contact> <last_name>Harry Marshall, MD/PhD</last_name> <phone>519-685-8500</phone> <phone_ext>34700</phone_ext> <email>harry.marshall@lhsc.on.ca</email> </contact> </location> <location_countries> <country>Canada</country> </location_countries> <link> <url>https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2021-statistics/2021-pdf-en-final.pdf?rev=2b9d2be7a2d34c1dab6a01c6b0a6a32d&hash=01DE85401DBF0217F8B64F2B7DF43986</url> <description>Link to citation 1 (Canadian Cancer Statistics)</description> </link> <reference> <citation>Canadian Cancer Statistics Advisory Committee in collaboration with the Canadian Cancer Society, Statistics Canada and the Public Health Agency of Canada. (2021).</citation> </reference> <reference> <citation>Yamamoto M, Yoshida M, Furuse J, Sano K, Ohtsuka M, Yamashita S, Beppu T, Iwashita Y, Wada K, Nakajima TE, Sakamoto K, Hayano K, Mori Y, Asai K, Matsuyama R, Hirashita T, Hibi T, Sakai N, Tabata T, Kawakami H, Takeda H, Mizukami T, Ozaka M, Ueno M, Naito Y, Okano N, Ueno T, Hijioka S, Shikata S, Ukai T, Strasberg S, Sarr MG, Jagannath P, Hwang TL, Han HS, Yoon YS, Wang HJ, Luo SC, Adam R, Gimenez M, Scatton O, Oh DY, Takada T. Clinical practice guidelines for the management of liver metastases from extrahepatic primary cancers 2021. J Hepatobiliary Pancreat Sci. 2021 Jan;28(1):1-25. doi: 10.1002/jhbp.868. Epub 2020 Dec 12. Erratum In: J Hepatobiliary Pancreat Sci. 2022 Apr;29(4):500.</citation> <PMID>33200538</PMID> </reference> <reference> <citation>Vreugdenburg TD, Ma N, Duncan JK, Riitano D, Cameron AL, Maddern GJ. Comparative diagnostic accuracy of hepatocyte-specific gadoxetic acid (Gd-EOB-DTPA) enhanced MR imaging and contrast enhanced CT for the detection of liver metastases: a systematic review and meta-analysis. Int J Colorectal Dis. 2016 Nov;31(11):1739-1749. doi: 10.1007/s00384-016-2664-9. Epub 2016 Sep 29.</citation> <PMID>27682648</PMID> </reference> <reference> <citation>Choi SH, Kim SY, Park SH, Kim KW, Lee JY, Lee SS, Lee MG. Diagnostic performance of CT, gadoxetate disodium-enhanced MRI, and PET/CT for the diagnosis of colorectal liver metastasis: Systematic review and meta-analysis. J Magn Reson Imaging. 2018 May;47(5):1237-1250. doi: 10.1002/jmri.25852. Epub 2017 Sep 13.</citation> <PMID>28901685</PMID> </reference> <reference> <citation>Kim C, Kim SY, Kim MJ, Yoon YS, Kim CW, Lee JH, Kim KP, Lee SS, Park SH, Lee MG. Clinical impact of preoperative liver MRI in the evaluation of synchronous liver metastasis of colon cancer. Eur Radiol. 2018 Oct;28(10):4234-4242. doi: 10.1007/s00330-018-5422-2. Epub 2018 Apr 24.</citation> <PMID>29691635</PMID> </reference> <reference> <citation>Jhaveri KS, Fischer SE, Hosseini-Nik H, Sreeharsha B, Menezes RJ, Gallinger S, Moulton CE. Prospective comparison of gadoxetic acid-enhanced liver MRI and contrast-enhanced CT with histopathological correlation for preoperative detection of colorectal liver metastases following chemotherapy and potential impact on surgical plan. HPB (Oxford). 2017 Nov;19(11):992-1000. doi: 10.1016/j.hpb.2017.06.014. Epub 2017 Jul 29.</citation> <PMID>28760631</PMID> </reference> <reference> <citation>Koh DM, Ba-Ssalamah A, Brancatelli G, Fananapazir G, Fiel MI, Goshima S, Ju SH, Kartalis N, Kudo M, Lee JM, Murakami T, Seidensticker M, Sirlin CB, Tan CH, Wang J, Yoon JH, Zeng M, Zhou J, Taouli B. Consensus report from the 9th International Forum for Liver Magnetic Resonance Imaging: applications of gadoxetic acid-enhanced imaging. Eur Radiol. 2021 Aug;31(8):5615-5628. doi: 10.1007/s00330-020-07637-4. Epub 2021 Feb 1.</citation> <PMID>33523304</PMID> </reference> <reference> <citation>Kim JW, Lee CH, Park YS, Lee J, Kim KA. Abbreviated Gadoxetic Acid-enhanced MRI with Second-Shot Arterial Phase Imaging for Liver Metastasis Evaluation. Radiol Imaging Cancer. 2019 Sep 27;1(1):e190006. doi: 10.1148/rycan.2019190006. eCollection 2019 Sep.</citation> <PMID>33778670</PMID> </reference> <reference> <citation>Granata V, Fusco R, Avallone A, Cassata A, Palaia R, Delrio P, Grassi R, Tatangelo F, Grazzini G, Izzo F, Petrillo A. Abbreviated MRI protocol for colorectal liver metastases: How the radiologist could work in pre surgical setting. PLoS One. 2020 Nov 19;15(11):e0241431. doi: 10.1371/journal.pone.0241431. eCollection 2020.</citation> <PMID>33211702</PMID> </reference> <reference> <citation>Canellas R, Patel MJ, Agarwal S, Sahani DV. Lesion detection performance of an abbreviated gadoxetic acid-enhanced MRI protocol for colorectal liver metastasis surveillance. Eur Radiol. 2019 Nov;29(11):5852-5860. doi: 10.1007/s00330-019-06113-y. Epub 2019 Mar 19.</citation> <PMID>30888485</PMID> </reference> <reference> <citation>Ghorra C, Pommier R, Piveteau A, Rubbia-Brandt L, Vilgrain V, Terraz S, Ronot M. The diagnostic performance of a simulated "short" gadoxetic acid-enhanced MRI protocol is similar to that of a conventional protocol for the detection of colorectal liver metastases. Eur Radiol. 2021 Apr;31(4):2451-2460. doi: 10.1007/s00330-020-07344-0. Epub 2020 Oct 6.</citation> <PMID>33025173</PMID> </reference> <reference> <citation>Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.</citation> <PMID>24120480</PMID> </reference> <reference> <citation>Yan TD, Sim J, Black D, Niu R, Morris DL. Systematic review on safety and efficacy of repeat hepatectomy for recurrent liver metastases from colorectal carcinoma. Ann Surg Oncol. 2007 Jul;14(7):2069-77. doi: 10.1245/s10434-007-9388-6. Epub 2007 Apr 14.</citation> <PMID>17440785</PMID> </reference> <reference> <citation>Obuchowski NA, Beiden SV, Berbaum KS, Hillis SL, Ishwaran H, Song HH, Wagner RF. Multireader, multicase receiver operating characteristic analysis: an empirical comparison of five methods. Acad Radiol. 2004 Sep;11(9):980-95. doi: 10.1016/j.acra.2004.04.014.</citation> <PMID>15350579</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation> <investigator_full_name>Harry Marshall</investigator_full_name> <investigator_title>Assistant Professor of Radiology</investigator_title> </responsible_party> <keyword>Colorectal Cancer</keyword> <keyword>Liver Metastasis</keyword> <keyword>Gadoxetate (Primovist / Eovist)</keyword> <keyword>Abbreviated MRI</keyword> <condition_browse>  <mesh_term>Neoplasm Metastasis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Liver Extracts</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT. During the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all. Unfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings. The purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed. BACKGROUND Colorectal cancer (CRC) is the third most commonly diagnosed cancer in Canada and the second leading cause of death in both men, and women (1). In 2021, 24800 Canadians were diagnosed with CRC and 9,600 died from the disease (1). Over their lifetime, 1 in 18 Canadians will be diagnosed with CRC and 1 in 37 will die (1). Accurate staging is essential to improving outcomes, providing appropriate patient management, and improving the health care costs associated with caring for patients with CRC. London Health Sciences Centre (LHSC) is a tertiary care referral centre for a catchment area of 2 million people in Southwestern Ontario. Annually, approximately 200 patients present to the London Regional Cancer Program with a diagnosis of colorectal cancer. Of these, about 100 patients will have potentially resectable colorectal liver metastasis (CRCLM). Staging algorithms for CRC include contrast enhanced computed tomography (CECT) of the thorax/abdomen/pelvis, with MRI of the liver in some centres. The objective for performing imaging tests is to accurately determine the extent of local and distant disease to direct patient management. Accurate assessment of the hepatic disease burden is crucial for surgical planning since resection of liver metastases is a core component of CRCLM treatment (2). At LHSC, all patients are initially imaged with CECT of the thorax/abdomen/pelvis. MRI of the liver is reserved for patients that require further characterization of equivocal liver lesions detected on CT. When performed, liver MRI is often performed with extracellular agents such as gadobutrol (Gadovist), i.e. EC-MRI. Hepatobiliary MRI contrast agents such as gadoxetic acid (aka gadoxetate, trade name Primovist in Canada), i.e. EOB-MRI, provide superior accuracy in detection of CRCLM compared to both CECT (3) and EC-MRI (4). Moreover, the use of EOB-MRI can alter management decisions and improve patient outcomes (3,5,6). It is also the modality of choice in CRCLM patients post-systemic therapy as per the 9th International Forum for Liver MRI Consensus Report (7). Despite these data, hepatobiliary agents are being used sparingly in most Canadian hospitals, including at LHSC as a problem-solving tool. This is due to two factors: (a) the higher unit cost of gadoxetate compared to gadobutrol and iodine-based CT contrast agents, and (b) the increased MRI scan time required for EOB-MRI compared to EC-MRI or CECT. The increased scan time is a result of the need to acquire images in the "hepatobiliary (HPB) phase" for EOB-MRI, typically 20 minutes post-injection, a longer delay than is required for EC-MRI or CECT. These factors result in increased operational costs for EOB-MRI and opportunity costs from reduced magnet time for other MRI studies. To address the increased scan time with EOB-MRI, some studies have retrospectively examined the potential role of abbreviated MRI protocols (aMRI) compared to a full protocol (fMRI) (8-11). The premise of EOB-aMRI protocols involves an injection of gadoxetate at the outset of the study, often outside the scanner room. During the 20 min waiting period prior to image acquisition in the HPB phase, an "abbreviated" set of sequences is acquired, usually including DWI/ADC and sometimes T2 weighted images. At the 20 min mark, the HPB phase images are acquired, and the study is complete. The aim of abbreviated protocols is to increase patient throughput without compromising diagnostic accuracy. The initial results in this relatively nascent field are promising, showing high interobserver agreement and high diagnostic accuracy not significantly different from the full protocol. For example, Canellas et al reported both κ and area under the ROC curve (AUC) of greater than 0.9 for both aMRI and fMRI, with an estimated cost savings of 41% per scan (10). Ghorra et al found similar detection rates of about 86% for both aMRI and fMRI with slightly lower accuracy of the aMRI protocol of about 87% vs 93% for fMRI, but no consistent statistical trends were present (11). However, existing studies in the literature have simulated an aMRI examination by using a subset of fMRI sequences; some sequences, including the dynamic post contrast sequences acquired before 20 min are removed retrospectively (8-11). Currently there are no published studies comparing fMRI with prospectively acquired aMRI. As retrospective studies may overestimate accuracy and cost savings, there is a need for higher quality, prospective evidence (7). Additionally, retrospective studies are unable to perform a formal economic analysis of costs related to the imaging procedure itself, and importantly downstream costs related to patient management. RATIONALE The primary aim of this study is to prospectively compare the diagnostic accuracy of aMRI compared to fMRI regarding CRCLM, using a composite reference standard. Our hypothesis is that aMRI is noninferior to fMRI in this regard, as measured by sensitivity, specificity, and the AUC. If this is the case, it may serve as evidence that EOB-MRI utilization can be increased even within resource constraints inherent to all Healthcare systems. The rationale for using a composite reference standard is that due to varying patient management strategies, the optimal reference standard (surgical pathology) is not always available, and therefore alternative methods must be considered. The rationale for using fMRI as the control group is that this protocol is the current standard of care for EOB-MRI. A secondary aim is to quantify the economic impact of aMRI vs fMRI both in terms of imaging costs and downstream patient management costs. Our hypothesis is that aMRI will not cost more than fMRI on a per patient basis (i.e. noninferiority). If this is the case, higher patient throughput can be achieved at no increased economic expense. Another secondary aim is to prospectively compare the diagnostic accuracy of CECT vs aMRI and fMRI for diagnosis of CRCLM, using a composite reference standard. Our hypothesis is that both aMRI and fMRI will be superior to CECT, in line with multiple prior trials (3). A third secondary aim is to evaluate patient outcomes (overall survival, cancer-specific survival, and hepatic recurrence / progression free survival) at 1-year post-baseline EOB-MRI, using clinical data and the 1-year follow-up CECT. Our hypothesis is that aMRI will be noninferior to fMRI, indicating that there is no adverse effect on patient outcomes from the using an abbreviated protocol. The fourth secondary aim is to retrospectively compare the diagnostic accuracy of fMRI to a simulated aMRI created from a subset of fMRI pulse sequences. Our hypothesis is that the simulated aMRI will be noninferior to fMRI. This constitutes a 3-factor multireader multicase design, analogous to multiple prior investigations (3,4), enabling direct comparison of our study and adding to the body of literature on the subject. The final study aim is to compare the diagnostic accuracy and interobserver agreement on aMRI, fMRI, and CECT. Our hypothesis is that there will be no significant difference for diagnostic accuracy. We expect interobserver agreement to be moderate to high. The rationale for choosing a study cohort comprised of patients with CRCLM is: 1) this is a large patient population / common patient presentation, and 2) EOB-MRI has been shown to provide added value for staging CRCLM but is likely underutilized in Canada, as detailed above. The rationale for choosing a 1-year follow-up period is that about 30% to 50% of CRCLM will recur or progress within this interval (12,13), enabling a compromise between capturing a significant portion of adverse patient outcomes while minimizing loss to follow-up and unnecessarily prolonging the study, as this is not the primary objective. STUDY DESIGN This is a prospective, block randomized, allocation concealed, single-blind, multireader study with case-nested-within-test split-plot design. The baseline abbreviated or full Primovist MRI will be acquired between day 2 and 14 and a follow-up contrast enhanced CT abdomen pelvis will be performed 1 year from baseline. A combination of histopathology, biological behavior, and imaging findings applied in a hierarchical manner will determine the reference standard for each focal hepatic lesion, i.e. metastasis or not. Sample size is 300 subjects, with equal distribution of 150 per arm. Statistical analysis of the primary endpoint will be conducted via the updated Obuchowski-Rockette (OR) method (14). Inclusion Criteria: - Male or female, 18 years of age or older - Diagnosis of colorectal cancer, biopsy proven - Diagnosis of colorectal liver metastases - Has CT of the abdomen and pelvis within +/- 30 days from initial surgical consult - Provision of signed and dated informed consent form - Willingness to comply with study procedures and availability for the duration of the study - Able to tolerate MRI required by protocol Exclusion Criteria: - Presence of implanted medical device or metallic object that is MR incompatible - Baseline eGFR of < 30 mL/min/1.73 m2 - Severe claustrophobia not relieved by oral anxiolytics - Documented severe allergic-like reaction gadolinium-based contrast agent - Weight greater than allowable on MRI table - Pregnancy - Diffuse liver metastases, i.e. definitively unresectable - Severe liver dysfunction, ALBI grade 3

NCT0531xxxx/NCT05314413.xml

<clinical_study>  <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/NCT05314413</url> </required_header> <id_info> <org_study_id>A00-M05-22B</org_study_id> <nct_id>NCT05314413</nct_id> </id_info> <brief_title>Examining Sex-based Differences in Metabolic and Mechanistic Responses to Disuse Induced Muscle Atrophy</brief_title> <official_title>Examining Sex-based Differences in Metabolic and Mechanistic Responses to Disuse Induced Muscle Atrophy</official_title> <sponsors> <lead_sponsor> <agency>McGill University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>McGill University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans. </textblock> </brief_summary> <detailed_description> <textblock> Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, resulting in physical impairment or lower quality of life during the recovery phase. When measured as maximal isometric contraction, muscle strength in the immobilized limb decreases at a dramatic rate, around 1.0-1.2%/day. These declines in muscle size and strength may vary between sexes - this remains unclear. Muscle atrophy is thought to be caused by a significant decline in muscle protein synthesis (the main pathway attributing to muscle growth/ hypertrophy). There are also various pathways by which muscle is broken down. It is the sex-based differences in this muscle protein synthesis rate of decline and the pathway by which muscle is broken down that we would like to investigate for their contribution to muscle size and strength decline after a period of immobilization.  The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans.  On the participant's first visit, prior to beginning the study (Day 0), they will be instructed to fill out a health-related questionnaire, screened for all anthropometric characteristics (height, weight, age, sex) and undergo a DXA scan for body composition details. They will be familiarized with all study procedures including the muscle biopsies, strength tests, D2O, diet and exercise recording. They will also be fitted for the immobilization brace. The leg that will be immobilized will be randomized in each participant. This first visit will last approximately 2 hours. When participants return on Day 1 of the study, they will first have a lower-body MRI scan done. Following this, participants will perform single-leg strength tests on the Biodex. Thereafter on Day 2, venous blood draws and saliva samples will be taken. Participants will be administered their loading dose of D2O (5mL·kg body mass-1 of 70% D2O) and provided with daily maintenance doses of 50mL of D2O to continue to take each day for the duration of the experiment. Upon returning for Day 3, participants will undergo a single skeletal muscle biopsy from the vastus lateralis of one leg. Participants will repeat their blood and saliva sample on this day. Participants will then be outfitted with the knee brace and crutches prior to leaving the facility. Participants will also be outfitted with an ActiGraph activity monitor to record physical activity and energy expenditure while they are immobilized for 7 days. This third visit will last approximately 3 hours. Participants will monitor their own dietary intake via diet recording, which they will be instructed to carry out for 2 weekdays (i.e. Monday - Friday) and one weekend day (i.e. Saturday, Sunday). During the 7-day period of immobilization, participants will provide a saliva sample every day for measurement of 2H enrichment in body water. The saliva samples should be taken in the morning right after the participants wake up and before any food intake. Participants should drink the 1 × 50 mL maintenance dose of D2O per day provided right after collecting their saliva samples. On Day 8 participants will return to the facility to undergo post-immobilization testing which will include: a DXA scan, a lower-body MRI, two skeletal muscle biopsies (one in each leg), a blood sample, a saliva sample, and single-leg strength tests on both legs. This final visit will last approximately 4 hours. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 1, 2022</start_date> <completion_date type="Anticipated">October 30, 2023</completion_date> <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Fractional muscle protein synthesis rate</measure> <time_frame>Integrative fractional muscle protein synthesis rates over 7 days</time_frame> <description>Integrative fractional muscle protein synthesis rates in the immobilized and non-immobilized leg</description> </primary_outcome> <secondary_outcome> <measure>Muscle size</measure> <time_frame>Baseline and 7 days</time_frame> <description>Changes in muscle size, measured pre and post immobilization</description> </secondary_outcome> <secondary_outcome> <measure>Muscle strength</measure> <time_frame>Baseline and 7 days</time_frame> <description>Changes in muscle strength, measured pre and post immobilization</description> </secondary_outcome> <secondary_outcome> <measure>mRNA expression</measure> <time_frame>Baseline and 7 days</time_frame> <description>Changes in mRNA gene expression of specific biomarkers pertaining to skeletal muscle atrophy, measured pre and post immobilization</description> </secondary_outcome> <secondary_outcome> <measure>Protein abundance and phosphorylation</measure> <time_frame>Baseline and 7 days</time_frame> <description>Changes in protein abundance and phosphorylation status of select proteins involved in muscle protein synthesis and breakdown, measured pre and post immobilization</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Muscle Atrophy</condition> <condition>Muscle Disuse Atrophy</condition> <arm_group> <arm_group_label>Single Leg Immobilization - Males</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Males will be subjected to 7-days of single-leg immobilization.</description> </arm_group> <arm_group> <arm_group_label>Single Leg Immobilization - Females</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Females will be subjected to 7-days of single-leg immobilization.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Single Leg Immobilization</intervention_name> <description>7-days of single leg immobilization to induce muscle atrophy</description> <arm_group_label>Single Leg Immobilization - Females</arm_group_label> <arm_group_label>Single Leg Immobilization - Males</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Aged between 18-35 years inclusive  - Healthy, recreationally active (active for >5 hours/ week)  - Having given informed consent  Exclusion Criteria:  - Type I or Type II diabetes  - Highly trained (active for > 15 hours/week)  - Lower limb and/or back injuries in the last 6 months  - A history of thrombosis / cardiovascular disease  - Use of anticoagulants  - Musculoskeletal / orthopedic disorders  - Use of tobacco products  - Using medications known to modulate skeletal muscle metabolism including corticosteroids, hormone replacement therapy (HRT), non-steroidal anti-inflammatory drugs (i.e. paracetamol) and over-the-counter supplements including protein powder, creatine monohydrate, and fish oil  - Pregnant  - Currently participating in another clinical trial/ physical intervention research study </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Currie Gynasium 309 - McGill University</name> <address> <city>Montréal</city> <state>Quebec</state> <zip>H2W 1S4</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tyler A Churchward-Venne, PhD</last_name> <phone>514-398-4400</phone> <phone_ext>00839</phone_ext> <email>tyler.churchward-venne@mcgill.ca</email> </contact> <contact_backup> <last_name>Claire A Traversa, MSc</last_name> <phone>519-994-0004</phone> <email>claire.traversa@mail.mcgill.ca</email> </contact_backup> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 13, 2023</last_update_submitted> <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>McGill University</investigator_affiliation> <investigator_full_name>Tyler Churchward-Venne</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Immobilization</keyword> <condition_browse>  <mesh_term>Muscular Disorders, Atrophic</mesh_term> <mesh_term>Muscular Atrophy</mesh_term> <mesh_term>Atrophy</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans. Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, resulting in physical impairment or lower quality of life during the recovery phase. When measured as maximal isometric contraction, muscle strength in the immobilized limb decreases at a dramatic rate, around 1.0-1.2%/day. These declines in muscle size and strength may vary between sexes - this remains unclear. Muscle atrophy is thought to be caused by a significant decline in muscle protein synthesis (the main pathway attributing to muscle growth/ hypertrophy). There are also various pathways by which muscle is broken down. It is the sex-based differences in this muscle protein synthesis rate of decline and the pathway by which muscle is broken down that we would like to investigate for their contribution to muscle size and strength decline after a period of immobilization. The purpose of the proposed research is to define whether there are differences between females and males (i.e. sex-based differences) in the metabolic and mechanistic regulation of disuse-induced muscle atrophy in vivo in humans. On the participant's first visit, prior to beginning the study (Day 0), they will be instructed to fill out a health-related questionnaire, screened for all anthropometric characteristics (height, weight, age, sex) and undergo a DXA scan for body composition details. They will be familiarized with all study procedures including the muscle biopsies, strength tests, D2O, diet and exercise recording. They will also be fitted for the immobilization brace. The leg that will be immobilized will be randomized in each participant. This first visit will last approximately 2 hours. When participants return on Day 1 of the study, they will first have a lower-body MRI scan done. Following this, participants will perform single-leg strength tests on the Biodex. Thereafter on Day 2, venous blood draws and saliva samples will be taken. Participants will be administered their loading dose of D2O (5mL·kg body mass-1 of 70% D2O) and provided with daily maintenance doses of 50mL of D2O to continue to take each day for the duration of the experiment. Upon returning for Day 3, participants will undergo a single skeletal muscle biopsy from the vastus lateralis of one leg. Participants will repeat their blood and saliva sample on this day. Participants will then be outfitted with the knee brace and crutches prior to leaving the facility. Participants will also be outfitted with an ActiGraph activity monitor to record physical activity and energy expenditure while they are immobilized for 7 days. This third visit will last approximately 3 hours. Participants will monitor their own dietary intake via diet recording, which they will be instructed to carry out for 2 weekdays (i.e. Monday - Friday) and one weekend day (i.e. Saturday, Sunday). During the 7-day period of immobilization, participants will provide a saliva sample every day for measurement of 2H enrichment in body water. The saliva samples should be taken in the morning right after the participants wake up and before any food intake. Participants should drink the 1 × 50 mL maintenance dose of D2O per day provided right after collecting their saliva samples. On Day 8 participants will return to the facility to undergo post-immobilization testing which will include: a DXA scan, a lower-body MRI, two skeletal muscle biopsies (one in each leg), a blood sample, a saliva sample, and single-leg strength tests on both legs. This final visit will last approximately 4 hours. Inclusion Criteria: - Aged between 18-35 years inclusive - Healthy, recreationally active (active for >5 hours/ week) - Having given informed consent Exclusion Criteria: - Type I or Type II diabetes - Highly trained (active for > 15 hours/week) - Lower limb and/or back injuries in the last 6 months - A history of thrombosis / cardiovascular disease - Use of anticoagulants - Musculoskeletal / orthopedic disorders - Use of tobacco products - Using medications known to modulate skeletal muscle metabolism including corticosteroids, hormone replacement therapy (HRT), non-steroidal anti-inflammatory drugs (i.e. paracetamol) and over-the-counter supplements including protein powder, creatine monohydrate, and fish oil - Pregnant - Currently participating in another clinical trial/ physical intervention research study

NCT0531xxxx/NCT05314426.xml

<clinical_study>  <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/NCT05314426</url> </required_header> <id_info> <org_study_id>21-013112</org_study_id> <nct_id>NCT05314426</nct_id> </id_info> <brief_title>Mayo Clinic Phage Program Biobank</brief_title> <official_title>Mayo Clinic Phage Program Biobank</official_title> <sponsors> <lead_sponsor> <agency>Mayo Clinic</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mayo Clinic</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment. </textblock> </brief_summary> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">April 19, 2022</start_date> <completion_date type="Anticipated">April 2027</completion_date> <primary_completion_date type="Anticipated">April 2027</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Other</time_perspective> </study_design_info> <target_duration>5 Years</target_duration> <primary_outcome> <measure>Enrollment of study participants</measure> <time_frame>5 years</time_frame> <description>To recruit and enroll participants up to 100 participants who have received or will receive phage therapy treatment</description> </primary_outcome> <primary_outcome> <measure>Collection of biospecimens</measure> <time_frame>5 years</time_frame> <description>Total number of biospecimens collected which may include blood samples and synovial fluid</description> </primary_outcome> <primary_outcome> <measure>Medical record review</measure> <time_frame>5 years</time_frame> <description>Review the medical record of enrolled participants to ascertain any new health outcomes.</description> </primary_outcome> <primary_outcome> <measure>Increase treatment options and level of care for patients with bacterial infections</measure> <time_frame>5 years</time_frame> <description>Total number of collaborations with clinical investigators and researchers at both Mayo Clinic and across the globe.</description> </primary_outcome> <enrollment type="Anticipated">100</enrollment> <condition>Bacteriophage Therapy</condition> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> whole blood and synovial fluid will be stored in the biorepository for future research. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Mayo Clinic patients receiving bacteriophage therapy. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - ≥ 18 years of age.  - Able to provide informed consent.  - Individual must have a future treatment plan to receive or has historically received phage therapy.  Exclusion Criteria:  - Individuals , 18 years of age.  - Unwilling/unable to provide informed consent. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Gina Suh, MD</last_name> <role>Principal Investigator</role> <affiliation>Mayo Clinic</affiliation> </overall_official> <location> <facility> <name>Mayo Clinic Rochester</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://www.mayo.edu/research/clinical-trials</url> <description>Mayo Clinic Clinical Trials</description> </link> <verification_date>May 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 4, 2023</last_update_submitted> <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mayo Clinic</investigator_affiliation> <investigator_full_name>Gina A. Suh</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party>  </clinical_study>

The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment. whole blood and synovial fluid will be stored in the biorepository for future research. Mayo Clinic patients receiving bacteriophage therapy. Inclusion Criteria: - ≥ 18 years of age. - Able to provide informed consent. - Individual must have a future treatment plan to receive or has historically received phage therapy. Exclusion Criteria: - Individuals , 18 years of age. - Unwilling/unable to provide informed consent.

NCT0531xxxx/NCT05314439.xml

<clinical_study>  <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/NCT05314439</url> </required_header> <id_info> <org_study_id>ION904-CS2</org_study_id> <secondary_id>2022-000140-30</secondary_id> <nct_id>NCT05314439</nct_id> </id_info> <brief_title>A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension</brief_title> <official_title>A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Monthly Subcutaneous Administration of ION904 in Patients With Uncontrolled Hypertension</official_title> <sponsors> <lead_sponsor> <agency>Ionis Pharmaceuticals, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Ionis Pharmaceuticals, Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension. </textblock> </brief_summary> <detailed_description> <textblock> This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 26, 2022</start_date> <completion_date type="Actual">February 15, 2023</completion_date> <primary_completion_date type="Actual">January 31, 2023</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Percent Change from Baseline in Plasma Angiotensinogen (AGT)</measure> <time_frame>Baseline up to approximately 15 weeks</time_frame> </primary_outcome> <secondary_outcome> <measure>Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)</measure> <time_frame>Baseline up to approximately 15 weeks</time_frame> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)</measure> <time_frame>Baseline up to approximately 15 weeks</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">48</enrollment> <condition>Hypertension</condition> <arm_group> <arm_group_label>ION904</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Up to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Up to 4 monthly doses of placebo will be administered by SC injection.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>ION904</intervention_name> <description>ION904 will be administered by SC injection.</description> <arm_group_label>ION904</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo will be administered by SC injection.</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> General Inclusion Criteria:  1. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent  2. Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m^2) at screening  3. History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period  General Exclusion Criteria:  1. History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN  2. Unstable/underlying known cardiovascular disease defined as:  - Any history of congestive heart failure (New York Heart Association [NYHA] Class III-IV)  - Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening  - Any hemodynamically unstable atrial or ventricular arrhythmias  - Significant uncorrected valvular heart disease  - Any history of stroke or transient ischemic attack < 6 months prior to screening  3. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Altasciences - Los Angeles</name> <address> <city>Cypress</city> <state>California</state> <zip>90630</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>National Research Institute</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90057</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Clinical Trials Research</name> <address> <city>Sacramento</city> <state>California</state> <zip>95821</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>ALL Medical Research, LLC</name> <address> <city>Cooper City</city> <state>Florida</state> <zip>33024</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Progressive Medical Research</name> <address> <city>Port Orange</city> <state>Florida</state> <zip>32127</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Altasciences</name> <address> <city>Overland Park</city> <state>Kansas</state> <zip>66212</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>NY Scientific</name> <address> <city>Brooklyn</city> <state>New York</state> <zip>11235</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Juno Research, LLC</name> <address> <city>Houston</city> <state>Texas</state> <zip>77040</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 2, 2023</last_update_submitted> <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hypertension</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension. This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period. General Inclusion Criteria: 1. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent 2. Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m^2) at screening 3. History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period General Exclusion Criteria: 1. History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN 2. Unstable/underlying known cardiovascular disease defined as: - Any history of congestive heart failure (New York Heart Association [NYHA] Class III-IV) - Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening - Any hemodynamically unstable atrial or ventricular arrhythmias - Significant uncorrected valvular heart disease - Any history of stroke or transient ischemic attack < 6 months prior to screening 3. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening

NCT0531xxxx/NCT05314452.xml

<clinical_study>  <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/NCT05314452</url> </required_header> <id_info> <org_study_id>MMDU/IEC/2167</org_study_id> <nct_id>NCT05314452</nct_id> </id_info> <brief_title>Reliability and Validity of 10 Meters Walk Test Among Children</brief_title> <official_title>Timed Motor Function Test Using Video Based Observation and Online Based Observation Among Middle School Going Children: A Reliability and Validity Study</official_title> <sponsors> <lead_sponsor> <agency>Asir John Samuel</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Maharishi Markendeswar University (Deemed to be University)</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Hence, the reliability and validity of video based observation and online based observation (VBO and OBO) methods to be explored. Middle school going children age group between 8 and 12 years was recruited for the study on the basis of convenience sampling. Sample size selected for each age group was according to sample size criteria of Interclass coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three methods; VBO, OBO and direct observation for three times to estimate intrarater reliability and three days within a week to estimate test-retest reliability. The mean of three readings was used to find the estimated value. Direct observation method was used as a criterion measure method to report concurrent validity. After concurrent validity, Test-retest Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity of VBO and OBO with direct observation was reported by recording 10 meters walk test in children. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">August 12, 2021</start_date> <completion_date type="Actual">March 15, 2022</completion_date> <primary_completion_date type="Actual">January 31, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>10 meters walk test (Direct observation method)</measure> <time_frame>Immediate after taking anthropometric measurements</time_frame> <description>10 meters walk test (TMFTs) determined the walking abilities of an individual using mobile phone stopwatch.</description> </primary_outcome> <primary_outcome> <measure>10 meters walk test (Video based observation method)</measure> <time_frame>Immediate after measuring 10 meters walk test with direct observation method</time_frame> <description>10 meters walk test using video camera of mobile phone</description> </primary_outcome> <primary_outcome> <measure>10 meters walk test (Online based observation method)</measure> <time_frame>Immediate after measuring 10 meters walk test with Video based observation method</time_frame> <description>10 meters walk test using online mobile based application- WhatsApp</description> </primary_outcome> <enrollment type="Actual">75</enrollment> <condition>The Study Focuses to Find the Intrarater Reliability, Test-retest Reliability and Validity of 10 Meters Walk Test Among Middle School Going Children</condition> <eligibility> <study_pop> <textblock> Middle school going children from tertiary school of Mullana-Ambala region </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Asymptomatic middle school going children  2. Boys and girls in the age group between 8 and 12 years  3. Independent walking has achieved at age of 14 months  4. Able to understand and follow commands of examiner.  Exclusion Criteria:  1. Any Neurological disease  2. Any musculoskeletal disease in Lower Limb  3. Deformity in Lower Limb  4. Past history of surgery in Lower Limb in past 1 year  5. Any cardio-respiratory difficulties. - </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>12 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Amit Kumar, (MPT)</last_name> <role>Principal Investigator</role> <affiliation>Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Asir John Samuel, PhD</last_name> <role>Study Director</role> <affiliation>Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</affiliation> </overall_official> <location> <facility> <name>Maharishi Markandeshwar International school</name> <address> <city>Ambāla</city> <state>Ambala</state> <zip>133207</zip> <country>India</country> </address> </facility> </location> <location_countries> <country>India</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation> <investigator_full_name>Asir John Samuel</investigator_full_name> <investigator_title>Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</investigator_title> </responsible_party> <keyword>Child</keyword> <keyword>Communication media</keyword> <keyword>Health services</keyword> <keyword>Reproducibility of results</keyword> <keyword>Research design</keyword>  </clinical_study>

Timed Motor Function Tests (TMFTs) determined the walking abilities of an individual. During Covid-19 pandemic direct observation may not be feasible to record Timed motor function in children. Hence, the reliability and validity of video based observation and online based observation (VBO and OBO) methods to be explored. Middle school going children age group between 8 and 12 years was recruited for the study on the basis of convenience sampling. Sample size selected for each age group was according to sample size criteria of Interclass coefficient analysis. After anthropometrics, 10 meters walk test was recorded using three methods; VBO, OBO and direct observation for three times to estimate intrarater reliability and three days within a week to estimate test-retest reliability. The mean of three readings was used to find the estimated value. Direct observation method was used as a criterion measure method to report concurrent validity. After concurrent validity, Test-retest Reliability and Intrarater Reliability of VBO and OBO was reported. Reliability and validity of VBO and OBO with direct observation was reported by recording 10 meters walk test in children. Middle school going children from tertiary school of Mullana-Ambala region Inclusion Criteria: 1. Asymptomatic middle school going children 2. Boys and girls in the age group between 8 and 12 years 3. Independent walking has achieved at age of 14 months 4. Able to understand and follow commands of examiner. Exclusion Criteria: 1. Any Neurological disease 2. Any musculoskeletal disease in Lower Limb 3. Deformity in Lower Limb 4. Past history of surgery in Lower Limb in past 1 year 5. Any cardio-respiratory difficulties. -

NCT0531xxxx/NCT05314465.xml

<clinical_study>  <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/NCT05314465</url> </required_header> <id_info> <org_study_id>MMDU/IEC/1935</org_study_id> <secondary_id>U1111-1276-6515</secondary_id> <nct_id>NCT05314465</nct_id> </id_info> <brief_title>Neural Mobilization for Reduction of Spasticity in Stroke</brief_title> <official_title>Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke</official_title> <sponsors> <lead_sponsor> <agency>Asir John Samuel</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Maharishi Markendeswar University (Deemed to be University)</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Outcome measures were Modified Ashworth Scale (MAS), Brunnstrom's grading of hand recovery and Hydraulic hand dynamometer(HHD) for grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength. </textblock> </brief_summary> <detailed_description> <textblock> Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Primary outcome measure was Modified Ashworth Scale (MAS) to assess elbow and wrist flexors spasticity and secondary outcome measures were Brunnstrom's stages for hand recovery and Hydraulic hand dynamometer(HHD) to measure grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">November 22, 2021</start_date> <completion_date type="Actual">March 15, 2022</completion_date> <primary_completion_date type="Actual">February 19, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Modified Ashworth Scale (MAS)</measure> <time_frame>Change from baseline and 4 weeks</time_frame> <description>For spasticity, Total 4 grades are there. Grade 0 means no increase in muscle tone and grade 4 means affected part rigid in flexion or extension. More grade means more spasticity is there.</description> </primary_outcome> <secondary_outcome> <measure>Brunnstrom's stages for hand recovery</measure> <time_frame>Change from baseline and 4 weeks</time_frame> <description>To check recovery of hand functions. Total 7 grades are there. Increase in grade means increase in hand functions.</description> </secondary_outcome> <secondary_outcome> <measure>Hydraulic hand dynamometer</measure> <time_frame>Change from baseline and 4 weeks</time_frame> <description>For grip and pinch strength</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">7</enrollment> <condition>Stroke</condition> <arm_group> <arm_group_label>Median nerve mobilization</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Experimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Median nerve mobilization</intervention_name> <description>Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks.</description> <arm_group_label>Median nerve mobilization</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Participants with subacute and chronic stroke (1month and above) having upper limb spasticity.  2. Participants with haemorrhagic and ischemic stroke.  3. Participants who tolerate the supine position.  4. Participants who are oriented and alert.  5. Both males and females.  6. Participants older than 18 years.  Exclusion Criteria:  1. Participants with a score greater than 3 on The Modified Ashworth Scale.  2. Participants with affected speech.  3. Participants with upper limb deformity.  4. Participants experiencing dizziness.  5. Any increase in the dosage of anti-spastic medications during the intervention period.  6. General health problems or pathologies that affect the nervous system like uncontrolled diabetes, hypertension and recent surgeries.  7. Recent onset of worsening neurological signs. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Rittu Sharma, (MPT)</last_name> <role>Principal Investigator</role> <affiliation>Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Asir John Samuel, Ph.D</last_name> <role>Study Chair</role> <affiliation>Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Akanksha Saxena, (Ph.D)</last_name> <role>Study Director</role> <affiliation>Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation</affiliation> </overall_official> <location> <facility> <name>Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation</name> <address> <city>Ambala</city> <state>Haryana</state> <zip>133207</zip> <country>India</country> </address> </facility> </location> <location> <facility> <name>Healing Hands Physiotherapy & Rehabilitation</name> <address> <city>Hisar</city> <state>Haryana</state> <zip>125001</zip> <country>India</country> </address> </facility> </location> <location> <facility> <name>Bedi Hospital</name> <address> <city>Kaithal</city> <state>Haryana</state> <zip>136027</zip> <country>India</country> </address> </facility> </location> <location_countries> <country>India</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 16, 2022</last_update_submitted> <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 17, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation> <investigator_full_name>Asir John Samuel</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Stroke, spasticity, neural mobilization, Upper limb</keyword> <condition_browse>  <mesh_term>Muscle Spasticity</mesh_term> <mesh_term>Stroke</mesh_term> </condition_browse>  </clinical_study>

Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Outcome measures were Modified Ashworth Scale (MAS), Brunnstrom's grading of hand recovery and Hydraulic hand dynamometer(HHD) for grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength. Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult. There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength. This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke. This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated). Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks. Primary outcome measure was Modified Ashworth Scale (MAS) to assess elbow and wrist flexors spasticity and secondary outcome measures were Brunnstrom's stages for hand recovery and Hydraulic hand dynamometer(HHD) to measure grip and pinch strength. Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength. Inclusion Criteria: 1. Participants with subacute and chronic stroke (1month and above) having upper limb spasticity. 2. Participants with haemorrhagic and ischemic stroke. 3. Participants who tolerate the supine position. 4. Participants who are oriented and alert. 5. Both males and females. 6. Participants older than 18 years. Exclusion Criteria: 1. Participants with a score greater than 3 on The Modified Ashworth Scale. 2. Participants with affected speech. 3. Participants with upper limb deformity. 4. Participants experiencing dizziness. 5. Any increase in the dosage of anti-spastic medications during the intervention period. 6. General health problems or pathologies that affect the nervous system like uncontrolled diabetes, hypertension and recent surgeries. 7. Recent onset of worsening neurological signs.

NCT0531xxxx/NCT05314478.xml

<clinical_study>  <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/NCT05314478</url> </required_header> <id_info> <org_study_id>SP0707</org_study_id> <nct_id>NCT05314478</nct_id> </id_info> <brief_title>Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies</brief_title> <acronym>HALOS</acronym> <official_title>Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study</official_title> <sponsors> <lead_sponsor> <agency>Liverpool University Hospitals NHS Foundation Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Liverpool University Hospitals NHS Foundation Trust</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Exercise-induced laryngeal obstruction (EILO) is a condition in which the larynx, or voice box, narrows during high-intensity exercise, and is often mis-diagnosed. A test called a Continuous Laryngoscopy during Exercise (CLE) test can be performed, where a flexible camera is inserted through the nose and positioned at the back of the throat. While the patient exercises, the camera image can be used to identify the presence of EILO.  During the CLE test it is important that the part of the camera that remains outside the body is held securely in position near the forehead so that a clear and stable image is obtained using a headgear to secure the camera to the patient's head.  There are no headgears available on the market, so we have designed and manufactured one called HALOS (Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies).  This study is to ensure that HALOS is suitable for use, and to check we have understood and minimised the risks associated with the headgear. The headgear can then be used routinely within the Trust, improving the care that offered to patients.  We will recruit 30 male or female participants who need to undergo a CLE test. The study will be conducted at Broadgreen Hospital, Liverpool, UK. Before the CLE test, participants will attend a screening appointment to discuss the procedure. There will be no follow-up appointments.  During the CLE test, the participants will wear the HALOS headgear while exercising, and the clinician will monitor the image from the camera for signs of EILO. After the test, participants will be asked how tolerable the headgear was, and if they have any concerns about any aspect of it. The clinician will also record how clear and stable the camera image was, how easy it was to use, and any concerns about any aspect of it. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 24, 2022</start_date> <completion_date type="Anticipated">September 27, 2023</completion_date> <primary_completion_date type="Anticipated">September 27, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>The study is an interventional clinical trial involving a single group of 30 participants undergoing a continuous laryngoscopy during exercise test with the HALOS headgear.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Device effectiveness</measure> <time_frame>30 minutes</time_frame> <description>The proportion of continuous laryngoscopy during exercise tests where the endoscopy image was clear and stable enough to allow a diagnosis of exercise-induced laryngeal obstruction to be confirmed or ruled out.</description> </primary_outcome> <secondary_outcome> <measure>Device usability rating</measure> <time_frame>60 minutes</time_frame> <description>The fraction of subjective usability ratings ≥ 4 on the post-test questionnaire. Clinician-reported usability will be scored on a five-point LIKERT scale ranging from 1 (very hard to use) to 5 (very easy to use). Observations will be made throughout the session.</description> </secondary_outcome> <secondary_outcome> <measure>Device usability subjective feedback</measure> <time_frame>60 minutes</time_frame> <description>Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.</description> </secondary_outcome> <secondary_outcome> <measure>Device tolerability ratings</measure> <time_frame>60 minutes</time_frame> <description>The fraction of subjective tolerability ratings ≥ 3 on the post-test questionnaire. Participant-reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (very intolerable) to 4 (very tolerable)</description> </secondary_outcome> <secondary_outcome> <measure>Device tolerability subjective feedback</measure> <time_frame>60 minutes</time_frame> <description>Focussing on any participant-reported concerns regarding the comfort of the headgear including how hot their head felt, weight of the headgear, how secure the headgear felt and the impact of the headgear on their performance during the investigation.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Exercise-Induced Laryngeal Obstruction</condition> <arm_group> <arm_group_label>Participants</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be required to attend a single consultation and screening appointment to discuss the investigation procedure, and this will occur at least a week before the Continuous Laryngoscopy during Exercise (CLE) test. Participants will then attend one appointment for the CLE test. There will be no follow up assessments using the headgear.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Continuous laryngoscopy during exercise test using the HALOS headgear</intervention_name> <description>The participant will undergo the CLE test following standard clinical practice. The order of events of the aspects of the investigation related to the headgear will be: The headgear is prepared for use. The headgear is fitted onto the participant's head. The endoscope is inserted into the participant. The endoscope is fitted onto the headgear. The CLE test is carried out. The endoscope is removed from the headgear. The endoscope is removed from the participant. The headgear is removed from the participant. The headgear is cleaned and stored.</description> <arm_group_label>Participants</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Participant is willing and able to give informed consent for participation in the study.  - Male, female or non-binary, aged 18 years or above.  - Able (in the Investigators opinion) and willing to comply with all study requirements.  - Able to undergo a CLE test as judged by the clinician, and where a clinical need of the test for the delivery of healthcare has been identified.  Exclusion Criteria:  - Pain, sore areas, broken skin at the site of contact with the headgear.  - Devices, e.g. cochlear implants, that impede the use of the headgear.  - Head circumference is less than 50cm or greater than 63cm, reflecting the 3rd centile for females and 97th centile for males, respectively (Bushby, 1992).  - Exclusion criteria for endoscopy procedures:  - Skull base/facial surgery or fracture within the previous six weeks  - Major or life threatening epistaxis within the previous six weeks  - Trauma to nasal cavity secondary to surgery or injury within the previous six weeks  - Sino-nasal and anterior skull base tumours/surgery  - Nasopharyngeal stenosis  - Craniofacial anomalies  - Hereditary haemorrhagic telangiectasia  - Severe movement disorders and/or severe agitation  - Vasovagal history  - Bleeding risks  - Any other exclusion criteria as identified by the current endoscopy procedure. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Tristan Payne</last_name> <role>Principal Investigator</role> <affiliation>Liverpool University Hospitals NHS Foundation Trust</affiliation> </overall_official> <overall_contact> <last_name>Heather Rogers</last_name> <phone>01517063320</phone> <email>RGT@liverpoolft.nhs.uk</email> </overall_contact> <location> <facility> <name>Liverpool University Hospitals Nhs Foundation Trust</name> <address> <city>Liverpool</city> <state>Merseyside</state> <zip>L7 8XP</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>George S Ampat</last_name> <phone>07871590593</phone> <email>George.Ampat@liverpoolft.nhs.uk</email> </contact> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 18, 2023</last_update_submitted> <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Laryngoscopy</keyword> <keyword>Exercise-Induced</keyword> <keyword>Laryngeal Obstruction</keyword> <keyword>Headgear</keyword>  </clinical_study>

Exercise-induced laryngeal obstruction (EILO) is a condition in which the larynx, or voice box, narrows during high-intensity exercise, and is often mis-diagnosed. A test called a Continuous Laryngoscopy during Exercise (CLE) test can be performed, where a flexible camera is inserted through the nose and positioned at the back of the throat. While the patient exercises, the camera image can be used to identify the presence of EILO. During the CLE test it is important that the part of the camera that remains outside the body is held securely in position near the forehead so that a clear and stable image is obtained using a headgear to secure the camera to the patient's head. There are no headgears available on the market, so we have designed and manufactured one called HALOS (Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies). This study is to ensure that HALOS is suitable for use, and to check we have understood and minimised the risks associated with the headgear. The headgear can then be used routinely within the Trust, improving the care that offered to patients. We will recruit 30 male or female participants who need to undergo a CLE test. The study will be conducted at Broadgreen Hospital, Liverpool, UK. Before the CLE test, participants will attend a screening appointment to discuss the procedure. There will be no follow-up appointments. During the CLE test, the participants will wear the HALOS headgear while exercising, and the clinician will monitor the image from the camera for signs of EILO. After the test, participants will be asked how tolerable the headgear was, and if they have any concerns about any aspect of it. The clinician will also record how clear and stable the camera image was, how easy it was to use, and any concerns about any aspect of it. Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the study. - Male, female or non-binary, aged 18 years or above. - Able (in the Investigators opinion) and willing to comply with all study requirements. - Able to undergo a CLE test as judged by the clinician, and where a clinical need of the test for the delivery of healthcare has been identified. Exclusion Criteria: - Pain, sore areas, broken skin at the site of contact with the headgear. - Devices, e.g. cochlear implants, that impede the use of the headgear. - Head circumference is less than 50cm or greater than 63cm, reflecting the 3rd centile for females and 97th centile for males, respectively (Bushby, 1992). - Exclusion criteria for endoscopy procedures: - Skull base/facial surgery or fracture within the previous six weeks - Major or life threatening epistaxis within the previous six weeks - Trauma to nasal cavity secondary to surgery or injury within the previous six weeks - Sino-nasal and anterior skull base tumours/surgery - Nasopharyngeal stenosis - Craniofacial anomalies - Hereditary haemorrhagic telangiectasia - Severe movement disorders and/or severe agitation - Vasovagal history - Bleeding risks - Any other exclusion criteria as identified by the current endoscopy procedure.

NCT0531xxxx/NCT05314491.xml

<clinical_study>  <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/NCT05314491</url> </required_header> <id_info> <org_study_id>K-24</org_study_id> <nct_id>NCT05314491</nct_id> </id_info> <brief_title>Multigen Plus CCK and AMF TT Cones Follow Up Study</brief_title> <official_title>A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Total Knee Arthroplasty With Multigen Plus CCK Alone or Involving the AMF TT Cones.</official_title> <sponsors> <lead_sponsor> <agency>Limacorporate S.p.a</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Limacorporate S.p.a</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures. </textblock> </brief_summary> <detailed_description> <textblock> This is a post-market, multicentric, prospective, open label study. It is a post-marketing clinical study because the investigational devices are registered, CE marked, and used according to the intended use.  The assignment of any subject involved in the study is determined preoperatively by the aetiology evaluated by the Investigator and falls within the current practice. The decision to use this specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the subject in the study.  Baseline measurements (pre-operative clinical assessment and radiographic analysis at discharge) serves as internal control for the assessment of post-operative data.  The study will be carried out in 3 sites in Europe for a total number of 68 study subjects, in whom the decision to implant the Multigen Plus CCK system, alone or in combination with the AMF TT cones, has been taken prior to, and independently from, the decision to include the subject in the study.  The enrolment is competitive until the required recruitment target is met.  The expected number of visits for each study subject is 6, and includes:  - a pre-operative visit (before the subject receives the Multigen Plus CCK system alone or involving the AMF TT cones).  - the intra-operative visit (that is the same day of the surgery).  - the discharge visit (after the surgery according to the clinical practice).  - the following follow-up visits: at 3 months, 12 months, and 24 months after the surgery.  All eligible subjects who agree to participate in the study will be recruited and monitored throughout the duration of the study. For each visit and for each single study subject, radiographic and clinical data will be assessed up to the 24-month follow-up visit according to the standard of care of the site, when applicable. Also, Adverse Events and Serious Adverse Events will be collected and assessed. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 21, 2022</start_date> <completion_date type="Anticipated">July 2026</completion_date> <primary_completion_date type="Anticipated">July 2026</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Knee Society Score (KSS)</measure> <time_frame>Month 24</time_frame> <description>Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.</description> </primary_outcome> <secondary_outcome> <measure>KOOS-ADL (Function in Daily Living subdomain)</measure> <time_frame>Month 24</time_frame> <description>Functional changes in the KOOS-ADL (Function in Daily Living subdomain) at 2 years after the surgery.</description> </secondary_outcome> <secondary_outcome> <measure>VISUAL ANALOGUE SCALE (VAS) PAIN</measure> <time_frame>Month 24</time_frame> <description>Changes in the VAS Pain score from pre-operative (baseline) to 2 years after the surgery. Scale is from 0 to 10, where 0 means NO PAIN and 10 VERY SEVERE PAIN.</description> </secondary_outcome> <secondary_outcome> <measure>Kaplan-Meier analysis</measure> <time_frame>Month 24</time_frame> <description>Survival rate of the implant (Kaplan-Meier estimate) at 2 years after the surgery.</description> </secondary_outcome> <secondary_outcome> <measure>Radiographic assessment</measure> <time_frame>Month 24</time_frame> <description>Radiographic implant evaluation and stability assessment at 2 years after the surgery.</description> </secondary_outcome> <secondary_outcome> <measure>Safety evaluation</measure> <time_frame>Intra-operatively, Month 3, Month 12, and Month 24</time_frame> <description>Incidence, type, and severity of all the Device Deficiency (DD), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">68</enrollment> <condition>Total Knee Arthroplasty</condition> <condition>Revision Total Knee Arthroplasty</condition> <arm_group> <arm_group_label>Multigen Plus CCK</arm_group_label> </arm_group> <arm_group> <arm_group_label>Multigen Plus CCK in combination with AMF TT cones</arm_group_label> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Multigen Plus CCK</intervention_name> <description>Total Knee Arthroplasty</description> <arm_group_label>Multigen Plus CCK</arm_group_label> <arm_group_label>Multigen Plus CCK in combination with AMF TT cones</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>AMF TT cones</intervention_name> <description>To fill a proximal tibia or distal femur defect</description> <arm_group_label>Multigen Plus CCK in combination with AMF TT cones</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Male or female.  - Age ≥ 18 years old.  - Given written informed consent approved by the reference Ethics Committee (EC).  - Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.  - Subjects able to comply with the Study Protocol.  Exclusion Criteria:  - Age < 18 years old.  - Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus CCK, as reported in the current Instruction For Use.  - Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.  - Female subjects who are pregnant, nursing, or planning a pregnancy.  - Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS < 70 points. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Hospital Senhora da Oliveira in Guimarães</name> <address> <city>Guimarães</city> <country>Portugal</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ms Daniela Batista</last_name> <email>Daniela Batista <daniela.batista@blueclinical.pt></email> </contact> <investigator> <last_name>Carlos Vilela</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Saints Cyril and Methodius Hospital</name> <address> <city>Bratislava</city> <country>Slovakia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Boris Šteňo</last_name> <email>steno@pe.unb.sk</email> </contact> <investigator> <last_name>Boris Šteňo</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Royal Devon and Exeter Hospital</name> <address> <city>Exeter</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sadie Heddon</last_name> <email>sadie.heddon@nhs.net</email> </contact> <investigator> <last_name>Jonathan Phillips</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Portugal</country> <country>Slovakia</country> <country>United Kingdom</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 15, 2023</last_update_submitted> <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 18, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures. This is a post-market, multicentric, prospective, open label study. It is a post-marketing clinical study because the investigational devices are registered, CE marked, and used according to the intended use. The assignment of any subject involved in the study is determined preoperatively by the aetiology evaluated by the Investigator and falls within the current practice. The decision to use this specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the subject in the study. Baseline measurements (pre-operative clinical assessment and radiographic analysis at discharge) serves as internal control for the assessment of post-operative data. The study will be carried out in 3 sites in Europe for a total number of 68 study subjects, in whom the decision to implant the Multigen Plus CCK system, alone or in combination with the AMF TT cones, has been taken prior to, and independently from, the decision to include the subject in the study. The enrolment is competitive until the required recruitment target is met. The expected number of visits for each study subject is 6, and includes: - a pre-operative visit (before the subject receives the Multigen Plus CCK system alone or involving the AMF TT cones). - the intra-operative visit (that is the same day of the surgery). - the discharge visit (after the surgery according to the clinical practice). - the following follow-up visits: at 3 months, 12 months, and 24 months after the surgery. All eligible subjects who agree to participate in the study will be recruited and monitored throughout the duration of the study. For each visit and for each single study subject, radiographic and clinical data will be assessed up to the 24-month follow-up visit according to the standard of care of the site, when applicable. Also, Adverse Events and Serious Adverse Events will be collected and assessed. The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study. Inclusion Criteria: - Male or female. - Age ≥ 18 years old. - Given written informed consent approved by the reference Ethics Committee (EC). - Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned. - Subjects able to comply with the Study Protocol. Exclusion Criteria: - Age < 18 years old. - Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus CCK, as reported in the current Instruction For Use. - Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation. - Female subjects who are pregnant, nursing, or planning a pregnancy. - Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS < 70 points.

NCT0531xxxx/NCT05314504.xml

<clinical_study>  <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/NCT05314504</url> </required_header> <id_info> <org_study_id>LG-HACL031</org_study_id> <nct_id>NCT05314504</nct_id> </id_info> <brief_title>Clinical Investigation of YVOIRE Y-Solution 360 for Lip Augmentation in China</brief_title> <official_title>A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 for Lip Augmentation</official_title> <sponsors> <lead_sponsor> <agency>LG Chem</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>LG Chem</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To evaluate the effectiveness and safety of the investigational medical device, injected into the lips. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 11, 2022</start_date> <completion_date type="Anticipated">August 2024</completion_date> <primary_completion_date type="Anticipated">December 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Overall LFRS responder rate</measure> <time_frame>at 12 weeks</time_frame> <description>at 12 weeks after the last injection for the test group and at Week 12 for the control group</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">174</enrollment> <condition>Lip Augmentation</condition> <arm_group> <arm_group_label>Test group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Treatment administration to subjects</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>After primary endpoint evaluation, eligible subjects will receive treatment at Week 12</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>YVOIRE Y-Solution 360</intervention_name> <description>Cross-linked sodium hyaluronate gel for injection with lidocaine</description> <arm_group_label>Test group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male or female adults 18 to 65 years of age (inclusive).  2. Subjects whose volume of the overall lips corresponds to score of 0 (none/minimal), 1 (mild), 2 (moderate), or 3 (pronounced) of the 5-point LFRS as assessed by the blinded Evaluating Investigator at Visit 1 (Screening).  3. Subjects who want a filler injection procedure for at least a 1-grade increase on the overall LFRS score after treatment.  4. Subjects who are informed of the purpose, method, and effectiveness of the clinical investigation and who sign the written informed consent form (ICF).  5. Except for surgically sterile male or female subjects, and female subjects with natural menopause (without drug intervention) for more than 2 years after last menstruation, other male or female subjects must agree to use an effective method throughout the entire clinical investigation period to prevent pregnancy  Exclusion Criteria:  1. Subjects who have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area.  2. Subjects who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities.  3. Subjects who have undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 months before enrollment or is planning to undergo any of these procedures during the clinical investigation.  4. Subjects who have received permanent facial implants or fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, autologous fat) in the face or neck, or are planning to be implanted with any of these products during the clinical investigation.  5. Subjects who have received non-permanent filler treatment in the lower face (below the orbital rim) or are planning to undergo during the clinical investigation, including but not limited to receiving calcium hydroxylapatite or poly-L lactic acid within 24 months before enrollment, or hyaluronic acid [HA] or collagen within 12 months before enrollment.  6. Subjects who have undergone the following procedure within 6 months before enrollment or are planning to undergo during the clinical investigation: Facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face (below the orbital rim). messotherapy, face lift, stripping laser, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck.  7. Subjects who have used non-implantable lip plumping products within 10 days before enrollment anywhere in the treatment area or are planning to receive such treatment/intervention during the clinical investigation participation.  8. Subjects who have used any over-the-counter or prescription, oral or topical anti-wrinkle products for the lips or around the mouth within 3 months before enrollment or are planning to use such products during the clinical investigation.  9. Subjects who are on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal anti-inflammatory drugs (NSAIDs; e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with gingko biloba) within 10 days of undergoing investigational medical device injections.  10. Subjects who have history of anaphylaxis, multiple several allergies, or allergy to lidocaine, or amide local anesthetics, HA products, or Streptococcal protein, or are planning to undergo desensitization therapy during the clinical investigation.  11. Subjects with active inflammation, infection sites or unhealed wound in the mouth area.  12. Subjects who have history of herpetic eruption.  13. Subjects who have history of bleeding disorder based on the coagulation laboratory test results (international normalized ratio [INR], prothrombin time, and activated partial thromboplastin time [aPTT]) as per Investigator's discretion.  14. Subjects with abnormal laboratory assessment and judged clinically significant per Investigator's discretion (e.g., alanine aminotransferase [ALT] ≥ 2.5×upper limit of normal [ULN], aspartate aminotransferase [AST] ≥ 2.5×ULN).  15. Subjects who have porphyria.  16. Subjects who have a tendency to develop hypertrophic scar or keloid.  17. Subjects who have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion.  18. Subjects who have malignant tumors or cancerous or precancerous lesion which could affect the clinical investigation.  19. Subjects who have untreated epilepsy.  20. Subjects who are ineligible for this clinical investigation as per Investigator's discretion.  21. Subjects who have participated in another clinical investigation within 1 month prior to Visit 1 (Screening). </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Sodam YANG</last_name> <phone>820269874148</phone> <email>sodam@lgchem.com</email> </overall_contact> <location> <facility> <name>Huashan Hospital Affiliated to Fudan University</name> <address> <city>Shanghai</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Investigator</last_name> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party>  </clinical_study>

To evaluate the effectiveness and safety of the investigational medical device, injected into the lips. Inclusion Criteria: 1. Male or female adults 18 to 65 years of age (inclusive). 2. Subjects whose volume of the overall lips corresponds to score of 0 (none/minimal), 1 (mild), 2 (moderate), or 3 (pronounced) of the 5-point LFRS as assessed by the blinded Evaluating Investigator at Visit 1 (Screening). 3. Subjects who want a filler injection procedure for at least a 1-grade increase on the overall LFRS score after treatment. 4. Subjects who are informed of the purpose, method, and effectiveness of the clinical investigation and who sign the written informed consent form (ICF). 5. Except for surgically sterile male or female subjects, and female subjects with natural menopause (without drug intervention) for more than 2 years after last menstruation, other male or female subjects must agree to use an effective method throughout the entire clinical investigation period to prevent pregnancy Exclusion Criteria: 1. Subjects who have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area. 2. Subjects who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities. 3. Subjects who have undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 months before enrollment or is planning to undergo any of these procedures during the clinical investigation. 4. Subjects who have received permanent facial implants or fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, autologous fat) in the face or neck, or are planning to be implanted with any of these products during the clinical investigation. 5. Subjects who have received non-permanent filler treatment in the lower face (below the orbital rim) or are planning to undergo during the clinical investigation, including but not limited to receiving calcium hydroxylapatite or poly-L lactic acid within 24 months before enrollment, or hyaluronic acid [HA] or collagen within 12 months before enrollment. 6. Subjects who have undergone the following procedure within 6 months before enrollment or are planning to undergo during the clinical investigation: Facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face (below the orbital rim). messotherapy, face lift, stripping laser, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck. 7. Subjects who have used non-implantable lip plumping products within 10 days before enrollment anywhere in the treatment area or are planning to receive such treatment/intervention during the clinical investigation participation. 8. Subjects who have used any over-the-counter or prescription, oral or topical anti-wrinkle products for the lips or around the mouth within 3 months before enrollment or are planning to use such products during the clinical investigation. 9. Subjects who are on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal anti-inflammatory drugs (NSAIDs; e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with gingko biloba) within 10 days of undergoing investigational medical device injections. 10. Subjects who have history of anaphylaxis, multiple several allergies, or allergy to lidocaine, or amide local anesthetics, HA products, or Streptococcal protein, or are planning to undergo desensitization therapy during the clinical investigation. 11. Subjects with active inflammation, infection sites or unhealed wound in the mouth area. 12. Subjects who have history of herpetic eruption. 13. Subjects who have history of bleeding disorder based on the coagulation laboratory test results (international normalized ratio [INR], prothrombin time, and activated partial thromboplastin time [aPTT]) as per Investigator's discretion. 14. Subjects with abnormal laboratory assessment and judged clinically significant per Investigator's discretion (e.g., alanine aminotransferase [ALT] ≥ 2.5×upper limit of normal [ULN], aspartate aminotransferase [AST] ≥ 2.5×ULN). 15. Subjects who have porphyria. 16. Subjects who have a tendency to develop hypertrophic scar or keloid. 17. Subjects who have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion. 18. Subjects who have malignant tumors or cancerous or precancerous lesion which could affect the clinical investigation. 19. Subjects who have untreated epilepsy. 20. Subjects who are ineligible for this clinical investigation as per Investigator's discretion. 21. Subjects who have participated in another clinical investigation within 1 month prior to Visit 1 (Screening).

NCT0531xxxx/NCT05314517.xml

<clinical_study>  <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/NCT05314517</url> </required_header> <id_info> <org_study_id>KIN-1902-2001</org_study_id> <nct_id>NCT05314517</nct_id> </id_info> <brief_title>A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis</brief_title> <acronym>RESOLVE-Lung</acronym> <official_title>A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis</official_title> <sponsors> <lead_sponsor> <agency>Kinevant Sciences GmbH</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Kinevant Sciences GmbH</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE). </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized, double-blind, placebo-controlled study with an OLE.  Participants will be randomized to receive namilumab or placebo in the 26-week Double-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period.  All participants, who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE.  Further details are in the protocol. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 31, 2022</start_date> <completion_date type="Anticipated">January 2025</completion_date> <primary_completion_date type="Anticipated">May 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>A double-blinded, randomized, placebo-controlled, parallel group design has been selected for the study. All participants, regardless of treatment assignment in the Double-blind Treatment Period, may participate in the Open Label Extension period of the study.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>Study drug will be provided in a blinded fashion and packaged and labeled to protect the blind.</masking_description> </study_design_info> <primary_outcome> <measure>Proportion of subjects requiring rescue treatment for worsening of sarcoidosis</measure> <time_frame>Baseline to Week 26</time_frame> </primary_outcome> <secondary_outcome> <measure>Change in Percent Predicted Forced Vital Capacity (ppFVC)</measure> <time_frame>Baseline to Week 26</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time To Rescue Treatment</measure> <time_frame>Baseline to Week 26</time_frame> </secondary_outcome> <secondary_outcome> <measure>Proportion of subjects successfully achieving oral corticosteroid (OCS) taper without rescue treatment</measure> <time_frame>Baseline to Week 26</time_frame> </secondary_outcome> <secondary_outcome> <measure>Change in the modified Kings Sarcoidosis Questionnaire (mKSQ) Lung domain score</measure> <time_frame>Baseline to Week 26</time_frame> </secondary_outcome> <secondary_outcome> <measure>Safety and Tolerability</measure> <time_frame>Baseline to Week 26</time_frame> <description>Number of subjects with adverse events, serious adverse events and other clinically relevant findings.</description> </secondary_outcome> <secondary_outcome> <measure>Number of Subjects positive for ADA to namilumab</measure> <time_frame>Baseline to Week 26</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Sarcoidosis, Pulmonary</condition> <arm_group> <arm_group_label>Treatment Arm 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Namilumab</description> </arm_group> <arm_group> <arm_group_label>Treatment Arm 2</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Namilumab</intervention_name> <description>Namilumab administered subcutaneously</description> <arm_group_label>Treatment Arm 1</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo administered subcutaneously to match namilumab dosing</description> <arm_group_label>Treatment Arm 2</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria :  - Male or female age ≥18 years  - Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form  - Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records  - Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET consistent with pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease  - Body Mass Index (BMI) ≤ 40 kg/m2 at Screening  - Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization  Exclusion Criteria  - Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening  - Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization  - Hemoglobin ≤ 9.5 g/dL  - Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study  - ECG abnormalities that warrant further clinical investigation or management at Screening  - Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening  - Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization  - Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry  - Females who are pregnant or breastfeeding or intend to be during the course of the study  - Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study  - Subjects who are treatment naive  Other protocol-defined inclusion/exclusion criteria apply. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Ted Reiss, MD</last_name> <role>Study Director</role> <affiliation>Kinevant Sciences</affiliation> </overall_official> <overall_contact> <last_name>Gary Barrera</last_name> <phone>650-303-7132</phone> <email>kinevant.resolve-lung@kinevant.com</email> </overall_contact> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Birmingham</city> <state>Alabama</state> <zip>35233</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Palo Alto</city> <state>California</state> <zip>94304</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Valencia</city> <state>California</state> <zip>91355</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Denver</city> <state>Colorado</state> <zip>80206</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32610</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Augusta</city> <state>Georgia</state> <zip>29841</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60612</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Iowa City</city> <state>Iowa</state> <zip>52242</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Kansas City</city> <state>Kansas</state> <zip>66160</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>New Orleans</city> <state>Louisiana</state> <zip>70115</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21234</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Minneapolis</city> <state>Minnesota</state> <zip>55414</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Greenville</city> <state>North Carolina</state> <zip>27834</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Cincinnati</city> <state>Ohio</state> <zip>45219</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44195</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19140</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15213</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Charleston</city> <state>South Carolina</state> <zip>29425</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Rock Hill</city> <state>South Carolina</state> <zip>29732</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75390</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Charlottesville</city> <state>Virginia</state> <zip>22908</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Falls Church</city> <state>Virginia</state> <zip>22042</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Brussels</city> <zip>1200</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Liège</city> <zip>B-4000</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Yvoir</city> <zip>5530</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Bobigny</city> <zip>93000</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Lille</city> <zip>59037</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Paris</city> <zip>75018</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Berlin</city> <zip>14165</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Freiburg</city> <zip>79106</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Hannover</city> <zip>30625</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Heidelberg</city> <zip>69126</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Leiden</city> <zip>2333 ZA</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Leuven</city> <zip>3000</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Nieuwegein</city> <zip>3435 CM</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Rotterdam</city> <zip>3015 GD</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Ankara</city> <zip>06620</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Istanbul</city> <zip>34134</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>İzmir</city> <zip>35100</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>İzmir</city> <zip>35330</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Mersin</city> <zip>33110</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Cambridge</city> <zip>CB20QQ</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>Cottingham</city> <zip>HU165JQ</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kinevant Study Site</name> <address> <city>London</city> <zip>SE59RS</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Belgium</country> <country>France</country> <country>Germany</country> <country>Netherlands</country> <country>Turkey</country> <country>United Kingdom</country> <country>United States</country> </location_countries> <link> <url>http://www.sarcoidosistrial.com</url> <description>For more information and to find out if you may qualify for the RESOLVE-Lung clinical trial.</description> </link> <verification_date>July 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 7, 2023</last_update_submitted> <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Sarcoidosis, Pulmonary</mesh_term> <mesh_term>Sarcoidosis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE). This is a randomized, double-blind, placebo-controlled study with an OLE. Participants will be randomized to receive namilumab or placebo in the 26-week Double-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period. All participants, who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE. Further details are in the protocol. Inclusion Criteria : - Male or female age ≥18 years - Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form - Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records - Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET consistent with pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease - Body Mass Index (BMI) ≤ 40 kg/m2 at Screening - Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization Exclusion Criteria - Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening - Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization - Hemoglobin ≤ 9.5 g/dL - Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study - ECG abnormalities that warrant further clinical investigation or management at Screening - Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening - Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization - Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry - Females who are pregnant or breastfeeding or intend to be during the course of the study - Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study - Subjects who are treatment naive Other protocol-defined inclusion/exclusion criteria apply.

NCT0531xxxx/NCT05314530.xml

<clinical_study>  <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/NCT05314530</url> </required_header> <id_info> <org_study_id>ReTA-model</org_study_id> <nct_id>NCT05314530</nct_id> </id_info> <brief_title>The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector</brief_title> <acronym>ReTA-model</acronym> <official_title>Validation of the ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare</official_title> <sponsors> <lead_sponsor> <agency>Karolinska Institutet</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Karolinska Institutet</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. </textblock> </brief_summary> <detailed_description> <textblock> The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 1, 2022</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">April 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Return to work</measure> <time_frame>12 months</time_frame> <description>At work part or full-time compare to no return to work</description> </primary_outcome> <primary_outcome> <measure>Karolinska Exhaustion Disorder Scale KEDS</measure> <time_frame>12 months</time_frame> <description>Decreased points in the KEDS scale 1-19, qith higher scores reflecting greater exhaustion severity.</description> </primary_outcome> <primary_outcome> <measure>Symptom Checklist - 6</measure> <time_frame>12 months</time_frame> <description>Decreased points on the SCL-6 scale, with a higher number reflecting depression.</description> </primary_outcome> <primary_outcome> <measure>Montgomery Åsberg Depression Rating Scale</measure> <time_frame>12 months</time_frame> <description>Decreased points in the MADRAS scale with score ranging from 0 to 60, with higher scores reflecting greater depression severity.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">64</enrollment> <condition>Burnout</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Will receive a rehabilitation intervention</description> </arm_group> <arm_group> <arm_group_label>Controll</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Will receive conventional rehabilitation</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>ReTA-model</intervention_name> <description>Validating the rehabilitation model ReTA</description> <arm_group_label>Controll</arm_group_label> <arm_group_label>Intervention group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - currently on sick leave for burnout  - employed in the Swedish healthcare services as a nurse or as a physician  Exclusion Criteria:  - </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>Emma Hagqvist</last_name> <role>Principal Investigator</role> <affiliation>Karolinska Institutet</affiliation> </overall_official> <overall_contact> <last_name>Emma Hagqvist, PhD</last_name> <phone>+46730526602</phone> <email>emma.hagqvist@ki.se</email> </overall_contact> <overall_contact_backup> <last_name>Åke Nygren, MD</last_name> </overall_contact_backup> <location> <facility> <name>Karolinska Institutet</name> <address> <city>Stockholm</city> <state>Outside U.S. And Canada</state> <zip>171 77</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Emma Hagqvist, Phd</last_name> <phone>+46730526602</phone> <email>emma.hagqvist@ki.se</email> </contact> </location> <location_countries> <country>Sweden</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Karolinska Institutet</investigator_affiliation> <investigator_full_name>Emma Hagqvist</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>Healthcare</keyword> <keyword>Burnout</keyword> <keyword>Stress</keyword> <keyword>Return to work</keyword> <keyword>Intervention</keyword> <condition_browse>  <mesh_term>Burnout, Psychological</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. Inclusion Criteria: - currently on sick leave for burnout - employed in the Swedish healthcare services as a nurse or as a physician Exclusion Criteria: -

NCT0531xxxx/NCT05314543.xml

<clinical_study>  <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/NCT05314543</url> </required_header> <id_info> <org_study_id>21CH145</org_study_id> <secondary_id>2021-A02341-40</secondary_id> <nct_id>NCT05314543</nct_id> </id_info> <brief_title>Power-speed-endurance Profile (Cycling/Rowing) : Optimize Performance of the French Athletes at the Paris Olympics 2024</brief_title> <acronym>THPCA2024</acronym> <official_title>Description and Determinants of the Power-speed-endurance Profile (PVE) in Cycling and Rowing to Optimize the Performance of the French Athletes at the Paris Olympics 2024</official_title> <sponsors> <lead_sponsor> <agency>Centre Hospitalier Universitaire de Saint Etienne</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Centre Hospitalier Universitaire de Saint Etienne</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> As part of the preparation at the Paris 2024 Olympic Games, the French rowing and cycling federations and a consortium of researchers met to reach an ultimate goal: to increase the number of medals in these two disciplines for Paris 2024 Olympics. </textblock> </brief_summary> <detailed_description> <textblock> The objective of this study is to evaluate the maximum capacity of power production of athletes by describing their power-endurance profile and the physiological factors underlying this maximum power generation capacity. These assessments will guide coaches and athletes for:  1. the best use of athletes' physical abilities (for race strategy, cycling gear ratio or rowing levers)  2. adaptation of training program to improve the maximum capacity of power production of the athletes, in order to increase the number of medals at the Paris Olympics 2024. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 29, 2021</start_date> <completion_date type="Anticipated">August 2024</completion_date> <primary_completion_date type="Anticipated">August 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>This is a prospective multi-center exploratory pilot study of physiology study on athletes, track cyclists or rowers national to international level competitors.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Maximum force produced at zero speed in a fatigue-free condition</measure> <time_frame>Month : 3</time_frame> <description>F0i measurement</description> </primary_outcome> <primary_outcome> <measure>Speed in a fatigue-free condition</measure> <time_frame>Month : 3</time_frame> <description>V0i measurement</description> </primary_outcome> <primary_outcome> <measure>Maximum force produced at zero speed at the end of the 3 min.</measure> <time_frame>Month : 3</time_frame> <description>F0e measurement</description> </primary_outcome> <primary_outcome> <measure>Speed up produced at the end of the 3 min.</measure> <time_frame>Month : 3</time_frame> <description>V0e measurement</description> </primary_outcome> <secondary_outcome> <measure>Maximal oxygen uptake (VO2max)</measure> <time_frame>At inclusion</time_frame> <description>Cardiac stress test</description> </secondary_outcome> <secondary_outcome> <measure>Maximal Ventilation (VEmax)</measure> <time_frame>At inclusion</time_frame> <description>Cardiac stress test</description> </secondary_outcome> <secondary_outcome> <measure>Cardiac output (QCmax)</measure> <time_frame>At inclusion</time_frame> <description>Cardiac stress test</description> </secondary_outcome> <secondary_outcome> <measure>Maximal cardiac frequency (fcmax)</measure> <time_frame>At inclusion</time_frame> <description>Cardiac stress test</description> </secondary_outcome> <secondary_outcome> <measure>Fibre type determination</measure> <time_frame>Month : 2</time_frame> <description>Muscle biopsy of the vastus lateralis</description> </secondary_outcome> <secondary_outcome> <measure>Microvasculature analysis</measure> <time_frame>Month : 2</time_frame> <description>Muscle biopsy of the vastus lateralis</description> </secondary_outcome> <secondary_outcome> <measure>Muscle enzyme activity (Phosphofructokinase (PFK), lactate dehydrogenase (LDH), citrate synthase (CS) et cyclo-oxygenase (COx))</measure> <time_frame>Month : 2</time_frame> <description>Muscle biopsy of the vastus lateralis</description> </secondary_outcome> <secondary_outcome> <measure>Maximal voluntary force (N)</measure> <time_frame>Month : 9</time_frame> <description>Comparison before and after exercise</description> </secondary_outcome> <secondary_outcome> <measure>Rate of force development</measure> <time_frame>Month : 9</time_frame> <description>Comparison of force development</description> </secondary_outcome> <secondary_outcome> <measure>Evoked forces (N)</measure> <time_frame>Month : 9</time_frame> <description>Ratio of evoked force at low and high frequencies</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Healthy Volunteers</condition> <condition>Performance</condition> <arm_group> <arm_group_label>Track cyclists and rowers (males and females)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>All female and male rowing and track cycling athletes at the national or international national or international level, registered in a selection process and likely to represent France at the likely to represent France at the 2024 Olympics will be asked to take part to take part in this study.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Hypoxia</intervention_name> <description>Subjects will be subjected to mild hypoxia simulating an altitude of 1750 m (normobaric hypoxia). Hypoxia decreases oxygen supply to tissue and limit exercise capacity. For this, the subjects will inhale a gas mixture depleted in oxygen (enriched in nitrogen). The barometric pressure at 1500 m being 621 mmHg, PIO2 at this altitude (PIO2 = (621 - 47) x 21%) is 120.5 mmHg. For sea level altitude where the barometric pressure is 760 mmHg, the hypoxic gas mixture should contain (x = 120.5 / (760 - 47)) 16.8% O2. Thus, by inhaling a gas mixture that is oxygen-depleted from 21 to 16.8%, subjects (will simulate the altitude of 1750 and) will experience the equivalent of a 20% reduction in oxygen supply.</description> <arm_group_label>Track cyclists and rowers (males and females)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - experienced, well-trained (national to international level) rowers and cyclists  - written consent  Exclusion Criteria:  - taking medications interfering with measured parameters  - contraindication to competitive sport practice  - currently participating in an other structured exercise program  - muscular, bone or joint injuries  - neurologic disease  - pregnant </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Léonard FEASSON, PhD</last_name> <role>Principal Investigator</role> <affiliation>CHU SAINT-ETIENNE</affiliation> </overall_official> <overall_official> <last_name>Laurent MESSONNIER, PhD</last_name> <role>Study Director</role> <affiliation>Université Savoie Mont Blanc, CHAMBERY</affiliation> </overall_official> <overall_contact> <last_name>Léonard FEASSON, PhD</last_name> <phone>(0)477120383</phone> <phone_ext>+33</phone_ext> <email>leonard.feasson@chu-st-etienne.fr</email> </overall_contact> <overall_contact_backup> <last_name>Laurent MESSONNIER, PhD</last_name> <phone>04 79 75 81 85</phone> <phone_ext>+33</phone_ext> <email>laurent.messonnier@univ-smb.fr</email> </overall_contact_backup> <location> <facility> <name>CEPART</name> <address> <city>Le Bourget-du-Lac</city> <zip>73370</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <investigator> <last_name>Fabrice DESCOMBE, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Etienne DALMAIS, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Chu Nantes</name> <address> <city>Nantes</city> <zip>44000</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> <investigator> <last_name>Raphaël GROSS, MD-PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Chu Saint-Etienne</name> <address> <city>Saint-Étienne</city> <zip>42055</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <investigator> <last_name>Léonard FEASSON, MD PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>France</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>February 2, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 14, 2023</last_update_submitted> <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Biomechanics</keyword> <keyword>Track cyclists and rowers</keyword> <keyword>Energetics</keyword> <keyword>Muscle</keyword> <keyword>Fatigue</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

As part of the preparation at the Paris 2024 Olympic Games, the French rowing and cycling federations and a consortium of researchers met to reach an ultimate goal: to increase the number of medals in these two disciplines for Paris 2024 Olympics. The objective of this study is to evaluate the maximum capacity of power production of athletes by describing their power-endurance profile and the physiological factors underlying this maximum power generation capacity. These assessments will guide coaches and athletes for: 1. the best use of athletes' physical abilities (for race strategy, cycling gear ratio or rowing levers) 2. adaptation of training program to improve the maximum capacity of power production of the athletes, in order to increase the number of medals at the Paris Olympics 2024. Inclusion Criteria: - experienced, well-trained (national to international level) rowers and cyclists - written consent Exclusion Criteria: - taking medications interfering with measured parameters - contraindication to competitive sport practice - currently participating in an other structured exercise program - muscular, bone or joint injuries - neurologic disease - pregnant

NCT0531xxxx/NCT05314556.xml

<clinical_study>  <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/NCT05314556</url> </required_header> <id_info> <org_study_id>2021-01324</org_study_id> <nct_id>NCT05314556</nct_id> </id_info> <brief_title>Group Psychotherapy in Narcolepsy Type 1</brief_title> <official_title>Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1</official_title> <sponsors> <lead_sponsor> <agency>Cantonal Hospital of St. Gallen</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cantonal Hospital of St. Gallen</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">August 1, 2021</start_date> <completion_date type="Actual">December 31, 2022</completion_date> <primary_completion_date type="Actual">March 31, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Fatigue (Severity)</measure> <time_frame>Week 0-24</time_frame> <description>German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)</description> </primary_outcome> <primary_outcome> <measure>Daytime sleepiness</measure> <time_frame>Week 0, Week 6, Week 12, Week 24</time_frame> <description>German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)</description> </primary_outcome> <primary_outcome> <measure>Sleep quality</measure> <time_frame>Week 0-24</time_frame> <description>German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)</description> </primary_outcome> <primary_outcome> <measure>Emotion regulation</measure> <time_frame>Week 0-24</time_frame> <description>German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)</description> </primary_outcome> <secondary_outcome> <measure>Disease processing, acceptance & coping</measure> <time_frame>Week 0, Week 6, Week 12, Week 24</time_frame> <description>German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)</description> </secondary_outcome> <secondary_outcome> <measure>Anxiety & depression</measure> <time_frame>Week 0, Week 6, Week 12, Week 24</time_frame> <description>German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Herrmann-Lingen et al., 2011; Zigmond & Snaith, 1983)</description> </secondary_outcome> <secondary_outcome> <measure>Health-related quality of life (HRQOL)</measure> <time_frame>Week 0-24</time_frame> <description>German version of the questionnaire "Short Form 12 Health Survey" (SF-12; Morfeld et al., 2012)</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">10</enrollment> <condition>Narcolepsy Type 1</condition> <arm_group> <arm_group_label>Intervention</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group psychotherapy</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Group psychotherapy</intervention_name> <description>Additional group psychotherapy for patients with narcolepsy type 1 with standard medication</description> <arm_group_label>Intervention</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 * 062 and orexin A / hypocretin 1  - Age between 18 and 65 years  - Signed informed consent  - Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI>10/h)  Exclusion Criteria:  - Presence of severe psychiatric comorbidity  - Other psychotherapy during the study period  - Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Dagmar A Schmid, Dr. med</last_name> <role>Principal Investigator</role> <affiliation>Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen</affiliation> </overall_official> <location> <facility> <name>Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen</name> <address> <city>St.Gallen</city> <zip>9000</zip> <country>Switzerland</country> </address> </facility> </location> <location_countries> <country>Switzerland</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 7, 2023</last_update_submitted> <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation> <investigator_full_name>Nicolas Germann</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Narcolepsy Type 1</keyword> <keyword>Narcolepsy</keyword> <keyword>Narcolepsy with cataplexy</keyword> <keyword>Group psychotherapy</keyword> <keyword>Group therapy</keyword> <keyword>Psychotherapy</keyword> <condition_browse>  <mesh_term>Narcolepsy</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance. Inclusion Criteria: - Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 * 062 and orexin A / hypocretin 1 - Age between 18 and 65 years - Signed informed consent - Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI>10/h) Exclusion Criteria: - Presence of severe psychiatric comorbidity - Other psychotherapy during the study period - Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis.

NCT0531xxxx/NCT05314569.xml

<clinical_study>  <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/NCT05314569</url> </required_header> <id_info> <org_study_id>N-11-2022</org_study_id> <nct_id>NCT05314569</nct_id> </id_info> <brief_title>Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open Heart Surgery in Pediatrics</brief_title> <official_title>Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open-heart Surgery in Pediatrics: A Randomized Controlled Double-blinded Study</official_title> <sponsors> <lead_sponsor> <agency>Cairo University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> congenital hearts are very sensitive and irritable to deal with, especially during repair defects, the child's heart is exposed to impaired myocardial function during the entire procedure. Moreover, reperfusion of the heart during open-heart surgery when the myocardium is exposed to a global ischaemic cardioplegic arrest can induce myocardial injury. Myocardial reperfusion injury activates neutrophils, which trigger an inflammatory response resulting in the generation of reactive oxygen species (ROS), cytokine release, and complement activation, which further induce more cardiac injury. In addition to the inflammatory response generated as a result of tissue reperfusion injury, there is a significant systemic inflammatory response that is triggered by cardiopulmonary bypass (CPB) during open-heart surgery </textblock> </brief_summary> <detailed_description> <textblock> Myocardial protection is an important issue. This is reflected in the clinical prognosis of patients undergoing cardiac surgery and this can be measured by the most popular Cardiac biomarkers ( cardiac troponin I (cTnI)). (2)  A large number of anesthetic agents have been implicated in protecting the heart against ischemia and reperfusion injury. Ketamine has an anti-inflammatory effect and has been shown to reduce ROS generation by neutrophils and to decrease endotoxin stimulated IL6 production in human whole blood although it does not impair neutrophil function. (3)  Dexmedetomidine is a highly selective, short-acting, central α2-adrenergic agonist with intense sympatholytic qualities. Dexmedetomidine has been increasingly used as a component of general anesthesia, including cardiac surgical applications due to its sedative/hypnotic and analgesic effects which are enhanced by its cardioprotective properties. (4) Riha et.al showed that ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery. (5) Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery. (6) Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery. These effects are related to improvement in intracellular Ca2+ mobilization and do not seem to be related to the adhesion of neutrophils in the coronary system. (7) To the best of our knowledge, this is the first study comparing the combined effect of Ketamine- Dexmedetomidine versus fentanyl- midazolam against ischemia and reperfusion injury in pediatric congenital heart surgery repair. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 15, 2022</start_date> <completion_date type="Anticipated">September 25, 2022</completion_date> <primary_completion_date type="Anticipated">September 20, 2022</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>patients will be allocated to three groups</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> <masking_description>patients will be allocated to the study using a computer-generated random list and the group assignments will be sealed in opaque envelopes that will be opened after induction. The drugs will be prepared by an anesthetist who is blind to the study groups.</masking_description> </study_design_info> <primary_outcome> <measure>troponin level</measure> <time_frame>6 hours</time_frame> <description>mean troponin level post arotic declamping.</description> </primary_outcome> <secondary_outcome> <measure>heart rates</measure> <time_frame>every 15 minutes</time_frame> <description>records of reading till the end of the surgery</description> </secondary_outcome> <secondary_outcome> <measure>aortic cross clamping</measure> <time_frame>2 hours</time_frame> <description>duration of clamping</description> </secondary_outcome> <secondary_outcome> <measure>inotropic support</measure> <time_frame>6 hours</time_frame> <description>number of patients</description> </secondary_outcome> <secondary_outcome> <measure>blood pressure</measure> <time_frame>every 15 minutes</time_frame> <description>records of reading till the end of the surgery</description> </secondary_outcome> <secondary_outcome> <measure>need of nitroglycerin infusion</measure> <time_frame>6 hours</time_frame> <description>number of patients</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">81</enrollment> <condition>Anesthesia</condition> <arm_group> <arm_group_label>Control group(C)</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>anesthesia will be maintained using Isoflurane 1.2MAC keeping the bispectral index( BIS) between 40-60%.</description> </arm_group> <arm_group> <arm_group_label>Ketamine-dexmedetomidine group( KD)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>After induction of anesthesia , dexmedetomidine will be given(1 ug /kg ) over 10 min, then ketamine(2 m/kg) . maintenance throughout the procedure, with the bispectral index between 40 and 60%. by infusing Dexmedetomidine( 0.5 μg/.kg /.h r)) ketamine,( 1 m/kg/hr),</description> </arm_group> <arm_group> <arm_group_label>. Fentanyl- midazolam group (FM)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>After induction of anesthesia fentanyl( 3 μg/kg), midazolam( 100 ug /kg over 2 to 3 minutes) maintenance throughout the procedure, with the bispectral index between 40 and 60%. by infusing midazolam (1 ug /kg /min)-fentanyl( 2 μg/kg/h ).</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ketamine- dexmedetomidine</intervention_name> <description>ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery</description> <arm_group_label>Ketamine-dexmedetomidine group( KD)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fentanyl- midazolam</intervention_name> <description>Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery.Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery</description> <arm_group_label>. Fentanyl- midazolam group (FM)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Isoflurane</intervention_name> <description>Anesthetic inhalational gas</description> <arm_group_label>Control group(C)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - the American Society of Anesthesiologists II and III  - elective open Congenital cardiac surgery(VSD, AV canal, and partial anomaly) using cardiopulmonary bypass  Exclusion Criteria:  - less than 6 months or more than 24 months.  - weight < 5 kg.  - cyanotic heart disease  - patients with heart failure, an implantable pacemaker, pulmonary hypertension, preoperative administration of inotropic agents, serum creatinine higher than1.5 mg/dL, chronic liver disease, patients receiving sulfonylurea, theophylline, or allopurinol </textblock> </criteria> <gender>All</gender> <minimum_age>6 Months</minimum_age> <maximum_age>24 Months</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Amany H Saleh, MD</last_name> <role>Principal Investigator</role> <affiliation>Cairo University</affiliation> </overall_official> <overall_contact> <last_name>Amany H Saleh, MD</last_name> <phone>+201224259808</phone> <email>dr_amanyhassan@hotmail.com</email> </overall_contact> <overall_contact_backup> <last_name>passaint f hassan, MD</last_name> <phone>01000990952</phone> <email>passaintf@yahoo.com</email> </overall_contact_backup> <location> <facility> <name>Amany Hassan Saleh</name> <address> <city>Giza</city> <zip>02</zip> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amany H Saleh, MD</last_name> <phone>1224259808</phone> <email>dr_amanyhassan@hotmail.com</email> </contact> <contact_backup> <last_name>Passaint H Fahim, MD</last_name> <phone>01000990952</phone> <email>passaintf@yahool.com</email> </contact_backup> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 27, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 19, 2022</last_update_submitted> <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 20, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Amany Hassan Saleh</investigator_full_name> <investigator_title>Associate professor of anesthesia ,surgical intensive care and pain management ,Cairo University</investigator_title> </responsible_party> <intervention_browse>  <mesh_term>Fentanyl</mesh_term> <mesh_term>Midazolam</mesh_term> <mesh_term>Dexmedetomidine</mesh_term> <mesh_term>Ketamine</mesh_term> <mesh_term>Isoflurane</mesh_term> </intervention_browse>  </clinical_study>

congenital hearts are very sensitive and irritable to deal with, especially during repair defects, the child's heart is exposed to impaired myocardial function during the entire procedure. Moreover, reperfusion of the heart during open-heart surgery when the myocardium is exposed to a global ischaemic cardioplegic arrest can induce myocardial injury. Myocardial reperfusion injury activates neutrophils, which trigger an inflammatory response resulting in the generation of reactive oxygen species (ROS), cytokine release, and complement activation, which further induce more cardiac injury. In addition to the inflammatory response generated as a result of tissue reperfusion injury, there is a significant systemic inflammatory response that is triggered by cardiopulmonary bypass (CPB) during open-heart surgery Myocardial protection is an important issue. This is reflected in the clinical prognosis of patients undergoing cardiac surgery and this can be measured by the most popular Cardiac biomarkers ( cardiac troponin I (cTnI)). (2) A large number of anesthetic agents have been implicated in protecting the heart against ischemia and reperfusion injury. Ketamine has an anti-inflammatory effect and has been shown to reduce ROS generation by neutrophils and to decrease endotoxin stimulated IL6 production in human whole blood although it does not impair neutrophil function. (3) Dexmedetomidine is a highly selective, short-acting, central α2-adrenergic agonist with intense sympatholytic qualities. Dexmedetomidine has been increasingly used as a component of general anesthesia, including cardiac surgical applications due to its sedative/hypnotic and analgesic effects which are enhanced by its cardioprotective properties. (4) Riha et.al showed that ketamine - Dexmedetomidine combination had superior cardioprotective effects as measured by cardiac markers as compared to sevoflurane- sufentanil anesthesia after cardiac surgery. (5) Midazolam is known to have potential anti-inflammatory effects and antioxidant activity. They have been proven to provide protective effects for patients who underwent cardiac surgery. (6) Fentanyl is one opioid that has been closely linked to inflammatory mediators and myocardial protection. It reduces the CPB-induced inflammatory response and ischaemic reperfusion injury during cardiac surgery. These effects are related to improvement in intracellular Ca2+ mobilization and do not seem to be related to the adhesion of neutrophils in the coronary system. (7) To the best of our knowledge, this is the first study comparing the combined effect of Ketamine- Dexmedetomidine versus fentanyl- midazolam against ischemia and reperfusion injury in pediatric congenital heart surgery repair. Inclusion Criteria: - the American Society of Anesthesiologists II and III - elective open Congenital cardiac surgery(VSD, AV canal, and partial anomaly) using cardiopulmonary bypass Exclusion Criteria: - less than 6 months or more than 24 months. - weight < 5 kg. - cyanotic heart disease - patients with heart failure, an implantable pacemaker, pulmonary hypertension, preoperative administration of inotropic agents, serum creatinine higher than1.5 mg/dL, chronic liver disease, patients receiving sulfonylurea, theophylline, or allopurinol

NCT0531xxxx/NCT05314582.xml

<clinical_study>  <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/NCT05314582</url> </required_header> <id_info> <org_study_id>196083</org_study_id> <nct_id>NCT05314582</nct_id> </id_info> <brief_title>Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia</brief_title> <official_title>Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia</official_title> <sponsors> <lead_sponsor> <agency>Bezmialem Vakif University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Bezmialem Vakif University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 10, 2022</start_date> <completion_date type="Actual">January 10, 2023</completion_date> <primary_completion_date type="Actual">December 10, 2022</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <target_duration>1 Month</target_duration> <primary_outcome> <measure>Episode of clot retention</measure> <time_frame>Immediately after the surgery up to 1 month</time_frame> <description>Presence of clot retention due to hematuria after the operation which requires manuel irrigation</description> </primary_outcome> <primary_outcome> <measure>Requirement of blood transfusion</measure> <time_frame>Immediately after the surgery up to 1 month</time_frame> <description>Gross hematuria requiring blood transfusion</description> </primary_outcome> <primary_outcome> <measure>Re-operation rates</measure> <time_frame>Immediately after the surgery up to 1 month</time_frame> <description>Re-operation requirement for hematuria</description> </primary_outcome> <primary_outcome> <measure>Duration of hospitalization</measure> <time_frame>Immediately after the surgery up to discharge</time_frame> <description>Duration of hospitalization</description> </primary_outcome> <primary_outcome> <measure>Rate of re-admission</measure> <time_frame>From discharge up to one month</time_frame> <description>Rate of re-admission due to hematuria</description> </primary_outcome> <secondary_outcome> <measure>Postoperative hematocrit/hemoglobin levels</measure> <time_frame>Immediately after the surgery up to discharge</time_frame> <description>Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.</description> </secondary_outcome> <secondary_outcome> <measure>Amount of irrigation volume</measure> <time_frame>Immediately after the surgery up to discharge</time_frame> <description>Amount of postoperative continuous bladder irrigation volume</description> </secondary_outcome> <number_of_groups>6</number_of_groups> <enrollment type="Actual">500</enrollment> <condition>Hematuria</condition> <condition>Retention, Urinary</condition> <condition>Operative Bleeding</condition> <condition>Blood Transfusion Complication</condition> <arm_group> <arm_group_label>TURP patients using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic prostatectomy (TURP).</description> </arm_group> <arm_group> <arm_group_label>TURP patients not using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic prostatectomy (TURP).</description> </arm_group> <arm_group> <arm_group_label>TUR-BT patients using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic bladder tumor resection (TUR-BT).</description> </arm_group> <arm_group> <arm_group_label>TUR-BT patients not using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic bladder tumor resection (TUR-BT).</description> </arm_group> <arm_group> <arm_group_label>Open prostatectomy patients using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent open prostatectomy (OP).</description> </arm_group> <arm_group> <arm_group_label>Open prostatectomy patients not using anticoagulant/antiaggregant medication</arm_group_label> <description>Patients with no history of anticoagulant/antiaggregant medication and underwent open prostatectomy (OP).</description> </arm_group> <eligibility> <study_pop> <textblock> Patients who were referred to endoscopic bladder tumor resection (TUR-BT) or open or endoscopic BPH surgery (TURP or open prostatectomy) will be included in this study. For patients using anticoagulant/antiaggregant medications, relevant specialty (eg: Cardiology, neurology, cardiovascular surgery) or anesthesiologist will decide whether the patient will quit these medications before surgery or not, when to quit and whether low molecular weight heparin will be started instead. The responsible physician of the patient will decide when to restart the anticoagulant therapy after the surgery. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer  - Patients undergoing TURP due to benign prostatic hyperplasia  - Patients undergoing open prostatectomy due to benign prostatic hyperplasia  Exclusion Criteria:  - Patients who underwent incomplete transurethral tumor resection for bladder cancer  - Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion  - Patients who underwent cystectomy for bladder cancer </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>Abdullah Ilktac, MD</last_name> <role>Study Chair</role> <affiliation>Bezmialem Vakif University, Faculty of Medicine, Department of Urology</affiliation> </overall_official> <location> <facility> <name>Bezmialem Vakif University</name> <address> <city>Istanbul</city> <zip>34093</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 27, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 27, 2023</last_update_submitted> <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation> <investigator_full_name>Abdullah İlktaç</investigator_full_name> <investigator_title>Pincipal investigator</investigator_title> </responsible_party> <keyword>bladder cancer</keyword> <keyword>benign prostatic hyperplasia</keyword> <keyword>transurethral resection</keyword> <keyword>hematuria</keyword> <condition_browse>  <mesh_term>Urinary Bladder Neoplasms</mesh_term> <mesh_term>Prostatic Hyperplasia</mesh_term> <mesh_term>Hematuria</mesh_term> <mesh_term>Urinary Retention</mesh_term> <mesh_term>Transfusion Reaction</mesh_term> <mesh_term>Hemorrhage</mesh_term> <mesh_term>Hyperplasia</mesh_term> <mesh_term>Postoperative Hemorrhage</mesh_term> </condition_browse>  </clinical_study>

Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared. Patients who were referred to endoscopic bladder tumor resection (TUR-BT) or open or endoscopic BPH surgery (TURP or open prostatectomy) will be included in this study. For patients using anticoagulant/antiaggregant medications, relevant specialty (eg: Cardiology, neurology, cardiovascular surgery) or anesthesiologist will decide whether the patient will quit these medications before surgery or not, when to quit and whether low molecular weight heparin will be started instead. The responsible physician of the patient will decide when to restart the anticoagulant therapy after the surgery. Inclusion Criteria: - Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer - Patients undergoing TURP due to benign prostatic hyperplasia - Patients undergoing open prostatectomy due to benign prostatic hyperplasia Exclusion Criteria: - Patients who underwent incomplete transurethral tumor resection for bladder cancer - Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion - Patients who underwent cystectomy for bladder cancer

NCT0531xxxx/NCT05314595.xml

<clinical_study>  <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/NCT05314595</url> </required_header> <id_info> <org_study_id>PAS</org_study_id> <nct_id>NCT05314595</nct_id> </id_info> <brief_title>Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS</brief_title> <official_title>The Effect of Bilateral Uterine Artery Ligation as an Added Step for Placental Pouch Closure Technique in Management of Placenta Accreta Spectrum on Reducing Intra-operative Blood Loss: A Comparative Study</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Aim of the study  Primary outcomes:  1. The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.  2. Decrease surgical time.  Secondary outcomes:  1. Associated maternal morbidity and mortality.  2. Amount of blood transfusion  3. Difference in hematocrit value before and after delivery </textblock> </brief_summary> <detailed_description> <textblock> Introduction Placenta accreta spectrum (PAS) is a term that comprises abnormal placental invasion disorders of the uterine wall. According to the depth of invasion, it ranges from placental invasion in contact with myometrium (placenta accreta), into myometrium (placenta increta), or beyond myometrium (placenta percreta) (Tan, Tay et al. 2007, Cal, Ayres-de-Campos et al. 2018). PAS is an obstetric emergency that may be complicated by emergency hysterectomy, intraoperative surgical complications, massive transfusion, hemorrhagic shock, and even maternal death if not managed efficiently (Ye 2017). Previous cesarean deliveries, placenta previa and advanced maternal age are recognized strong risk factors of PAS, all of which, have become more prevalent among contemporary population (Silver, Landon et al. 2006, Zeng, Yang et al. 2018). Therefore, PAS is no longer a rare disorder in modern practice; the incidence of PAS has increased from approximately 1 in 30,000 deliveries before 1950 to 3 in 1000 deliveries in the current decade (Timor-Tritsch, Monteagudo et al. 2012).  Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018).  Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018).  Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure.  Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019). </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">September 1, 2022</completion_date> <primary_completion_date type="Anticipated">August 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>bilateral uterine artery ligation</measure> <time_frame>30 months</time_frame> <description>1. The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">130</enrollment> <condition>Placenta Accreta</condition> <arm_group> <arm_group_label>modified technique</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>women were underwent modified technique (PPC+ bilateral uterine artery ligation)</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>bilateral uterine artery ligation</intervention_name> <description>Spinal anaethesia with intrathecal morphia Transverse skin incision Adequate dissection of the bladder. Incision of the uterus above placental edge. Delivery of the fetus. Delayed cord clamping (60 seconds) if the baby appears well. Exteriorization of the uterus. Start Oxytocin infusion and uterine massage to ensure good uterine contractions immediately after delivery of the fetus. No trials of placental delivery will be made at this point. At this point, a gentile trial to deliver the placenta is performed A catheter is placed in the cervix from above to secure the cervical opening Compression is applied to the site of bleeding from placenta site Placental pouch is marked by multiple allies and is closed down to the multiple-8 suture. Blood loss is measured using the suction device and coated socked towels. In modified PPC, Bilateral uterine artery ligation will be done after exteriorization of the uterus in order to minimize the blood loss.</description> <arm_group_label>modified technique</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - • Previous operations  - Gestational age (28 weeks)  - Prenatally suspected PAS based on sonographic and/or MRI findings and/or intrapartum diagnosis of PAS.  - Authorization to participate in the study  Exclusion Criteria:  - • Coagulopathies  - Chronic renal or hepatic impairment (baseline first trimester labs are beyond normal range for pregnancy)  - Delivery in an outside hospital (patients referred for ongoing massive bleeding due to PAS)  - Patients coming in emergency condition with bleeding or in labour. </textblock> </criteria> <gender>Female</gender> <minimum_age>16 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Kamal M Zahran, Professor</last_name> <role>Study Chair</role> <affiliation>Assiut medical school</affiliation> </overall_official> <overall_contact> <last_name>mostafa hussein</last_name> <phone>01558678842</phone> <email>mostafa.elnazeir1994@gmail.com</email> </overall_contact> <location> <facility> <name>Assiut Medical School</name> <address> <city>Assiut</city> <zip>71511</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <link> <url>https://pubmed.ncbi.nlm.nih.gov/29149470/</url> <description>International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/17954654/</url> <description>Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/28856861/</url> <description>High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/29214633/</url> <description>Placenta accreta spectrum disorder trends in the context of the universal two-child policy in China and the risk of hysterectomy</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/16738145/</url> <description>Maternal morbidity associated with multiple repeat cesarean deliveries</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/22516620/</url> <description>Unforeseen consequences of the increasing rate of cesarean deliveries: early placenta accreta and cesarean scar pregnancy. A review</description> </link> <reference> <citation>Cal M, Ayres-de-Campos D, Jauniaux E. International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2018 Mar;140(3):307-311. doi: 10.1002/ijgo.12391. Epub 2017 Dec 22.</citation> <PMID>29149470</PMID> </reference> <reference> <citation>Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, Tan BS. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol. 2007 Nov;189(5):1158-63. doi: 10.2214/AJR.07.2417.</citation> <PMID>17954654</PMID> </reference> <reference> <citation>Ye M, Yin Z, Xue M, Deng X. High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta. BJOG. 2017 Aug;124 Suppl 3:71-77. doi: 10.1111/1471-0528.14743.</citation> <PMID>28856861</PMID> </reference> <reference> <citation>Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.</citation> <PMID>16738145</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 11, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Mostafa Hussein Abouzeid Ahmed</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Placenta Accreta</mesh_term> </condition_browse>  </clinical_study>

Aim of the study Primary outcomes: 1. The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique. 2. Decrease surgical time. Secondary outcomes: 1. Associated maternal morbidity and mortality. 2. Amount of blood transfusion 3. Difference in hematocrit value before and after delivery Introduction Placenta accreta spectrum (PAS) is a term that comprises abnormal placental invasion disorders of the uterine wall. According to the depth of invasion, it ranges from placental invasion in contact with myometrium (placenta accreta), into myometrium (placenta increta), or beyond myometrium (placenta percreta) (Tan, Tay et al. 2007, Cal, Ayres-de-Campos et al. 2018). PAS is an obstetric emergency that may be complicated by emergency hysterectomy, intraoperative surgical complications, massive transfusion, hemorrhagic shock, and even maternal death if not managed efficiently (Ye 2017). Previous cesarean deliveries, placenta previa and advanced maternal age are recognized strong risk factors of PAS, all of which, have become more prevalent among contemporary population (Silver, Landon et al. 2006, Zeng, Yang et al. 2018). Therefore, PAS is no longer a rare disorder in modern practice; the incidence of PAS has increased from approximately 1 in 30,000 deliveries before 1950 to 3 in 1000 deliveries in the current decade (Timor-Tritsch, Monteagudo et al. 2012). Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018). Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018). Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure. Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019). Inclusion Criteria: - • Previous operations - Gestational age (28 weeks) - Prenatally suspected PAS based on sonographic and/or MRI findings and/or intrapartum diagnosis of PAS. - Authorization to participate in the study Exclusion Criteria: - • Coagulopathies - Chronic renal or hepatic impairment (baseline first trimester labs are beyond normal range for pregnancy) - Delivery in an outside hospital (patients referred for ongoing massive bleeding due to PAS) - Patients coming in emergency condition with bleeding or in labour.

NCT0531xxxx/NCT05314608.xml

<clinical_study>  <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/NCT05314608</url> </required_header> <id_info> <org_study_id>20085</org_study_id> <nct_id>NCT05314608</nct_id> </id_info> <brief_title>Knee Related Subchondral Bone Lesions Treated With IOBP</brief_title> <acronym>IOBP</acronym> <official_title>Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique</official_title> <sponsors> <lead_sponsor> <agency>Arthrex, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Arthrex, Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP). </textblock> </brief_summary> <detailed_description> <textblock> The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution.  The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 17, 2021</start_date> <completion_date type="Anticipated">May 17, 2027</completion_date> <primary_completion_date type="Anticipated">May 17, 2027</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Prevention of additional surgery into the target knee</measure> <time_frame>5 years</time_frame> <description>To evaluate if IOBP® procedure will prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.</description> </primary_outcome> <secondary_outcome> <measure>Visual Analog Pain Scale (VAS)</measure> <time_frame>Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op.</time_frame> <description>Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0</description> </secondary_outcome> <secondary_outcome> <measure>International Knee Documentation Committee Subjective Knee Evaluation Form</measure> <time_frame>knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.</time_frame> <description>A patient-oriented questionnaire that assesses symptoms and function in daily living activities. The purpose of this study was to validate the IKDC Subjective Knee Form in a large patient population with various knee disorders.</description> </secondary_outcome> <secondary_outcome> <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure> <time_frame>Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op</time_frame> <description>A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.</description> </secondary_outcome> <secondary_outcome> <measure>X-rays of the knee</measure> <time_frame>6 months and 1 year</time_frame> <description>Images include weight-bearing AP, 45 degree weight bearing PA, lateral and merchant views. Images taken to determine location and status of subchondral bone lesion.</description> </secondary_outcome> <secondary_outcome> <measure>MRI of the knee</measure> <time_frame>6 months and 1 year</time_frame> <description>Minimum 1.5 Tesla MRI (including coronal, axial, sagittal, lateral femur, and lateral tibial views). Image taken to determine location and status of subchondral bone lesion.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">100</enrollment> <condition>Subchondral Cyst</condition> <arm_group> <arm_group_label>Subjects with subchondral bone pathology</arm_group_label> <description>Subjects with subchondral bone pathology</description> </arm_group> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee</intervention_name> <description>Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion</description> <arm_group_label>Subjects with subchondral bone pathology</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Able to read, understand, sign and complete informed consent  2. Male or female subject between the ages of 18-60 years  3. Subject has had pain for greater than three months  4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure  5. Subject has stable ligaments  6. Subject has neutral alignment (max 5° varus or valgus)  7. Subject has a VAS score greater than or equal to five  8. Subject is scheduled to undergo surgical intervention using IOBP®  Exclusion Criteria:  1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent  2. Subject has had lower extremity surgery within six months  3. Subject has had more than two prior surgical procedures in the operative leg  4. Subject has a neuromuscular condition  5. Subject has a current infection  6. Subject has a BMI >35  7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis  8. Subject has joint surface collapse in late stage avascular necrosis  9. Subject has majority of pain associated with alternate conditions  10. Subject has had subchondral bone pathology caused by acute trauma  11. Subject is not neurologically intact.  12. Subject has history of invasive malignancy (except non-melanoma skin cancer)  13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)  14. Subject has an active substance abuse problem  15. Subject is currently taking narcotic pain medication  16. Subject is pregnant or planning to become pregnant  17. Subject is on worker's compensation  18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body  19. Inability to complete study requirements and follow-up visits  20. Subject that has a bone marrow aspiration that does not meet 60cc </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Adam Anz</last_name> <role>Principal Investigator</role> <affiliation>Andrews Research and Education Foundation</affiliation> </overall_official> <overall_contact> <last_name>Justin W Moss, DHSc</last_name> <phone>770 584 4972</phone> <email>justin.moss@arthrex.com</email> </overall_contact> <overall_contact_backup> <last_name>Alicia Ruiz, MS</last_name> <phone>1 (800) 933-7001</phone> <phone_ext>71970</phone_ext> </overall_contact_backup> <location> <facility> <name>University of Colorado Sports Medicine</name> <address> <city>Denver</city> <state>Colorado</state> <zip>80222</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rachel Frank</last_name> </contact> <investigator> <last_name>Rachel Frank</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Andrews Research and Education Foundation</name> <address> <city>Gulf Breeze</city> <state>Florida</state> <zip>32561</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Adam Anz</last_name> <phone>850-916-8575</phone> </contact> <investigator> <last_name>Adam Anz</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>TidalHealth Peninsula Regional, Inc.</name> <address> <city>Salisbury</city> <state>Maryland</state> <zip>21801</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jason Scopp</last_name> </contact> <investigator> <last_name>Jason Scopp</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>The Ohio State University</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43201</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>David Flanigan</last_name> </contact> <investigator> <last_name>David Flanigan</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Allegheny-Singer Research Institute</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15212</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Brian Mosier</last_name> </contact> <investigator> <last_name>Brian Mosier</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>February 23, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 2, 2022</last_update_submitted> <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 5, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Bone Cysts</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP). The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution. The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. Inclusion Criteria: 1. Able to read, understand, sign and complete informed consent 2. Male or female subject between the ages of 18-60 years 3. Subject has had pain for greater than three months 4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure 5. Subject has stable ligaments 6. Subject has neutral alignment (max 5° varus or valgus) 7. Subject has a VAS score greater than or equal to five 8. Subject is scheduled to undergo surgical intervention using IOBP® Exclusion Criteria: 1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent 2. Subject has had lower extremity surgery within six months 3. Subject has had more than two prior surgical procedures in the operative leg 4. Subject has a neuromuscular condition 5. Subject has a current infection 6. Subject has a BMI >35 7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis 8. Subject has joint surface collapse in late stage avascular necrosis 9. Subject has majority of pain associated with alternate conditions 10. Subject has had subchondral bone pathology caused by acute trauma 11. Subject is not neurologically intact. 12. Subject has history of invasive malignancy (except non-melanoma skin cancer) 13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity) 14. Subject has an active substance abuse problem 15. Subject is currently taking narcotic pain medication 16. Subject is pregnant or planning to become pregnant 17. Subject is on worker's compensation 18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body 19. Inability to complete study requirements and follow-up visits 20. Subject that has a bone marrow aspiration that does not meet 60cc

NCT0531xxxx/NCT05314621.xml

<clinical_study>  <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/NCT05314621</url> </required_header> <id_info> <org_study_id>21-960-0005</org_study_id> <nct_id>NCT05314621</nct_id> </id_info> <brief_title>A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis</brief_title> <official_title>A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis</official_title> <sponsors> <lead_sponsor> <agency>Andover Research Eye Institute</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Andover Research Eye Institute</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This is a single-center, randomized, double-masked, parallel study. </textblock> </brief_summary> <detailed_description> <textblock> At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1.  For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio:  - Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30)  - Tears Naturale® II and Flonase® Allergy Relief (n = 30)  At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing.  At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">December 31, 2021</start_date> <completion_date type="Actual">July 24, 2022</completion_date> <primary_completion_date type="Actual">July 24, 2022</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Ocular itching 3(±1) minutes post-CAC at Visit 3</measure> <time_frame>3(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </primary_outcome> <primary_outcome> <measure>Ocular itching 3(±1) minutes post-CAC at Visit 4b</measure> <time_frame>3(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Vi sit 4b.</description> </primary_outcome> <primary_outcome> <measure>Ocular itching 5(±1) minutes post-CAC at Visit 3</measure> <time_frame>5(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </primary_outcome> <primary_outcome> <measure>Ocular itching 5(±1) minutes post-CAC at Visit 4b</measure> <time_frame>5(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </primary_outcome> <primary_outcome> <measure>Ocular itching 7(±1) minutes post-CAC at Visit 3</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </primary_outcome> <primary_outcome> <measure>Ocular itching 7(±1) minutes post-CAC at Visit 4b</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </primary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3. Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion</measure> <time_frame>7(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion</measure> <time_frame>15(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion</measure> <time_frame>20(±1) minutes post-CAC on Day 1 (Visit 3)</time_frame> <description>Nasal congestion evaluated by the subject 0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Chemosis</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Chemosis</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Eyelid Swelling</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Eyelid Swelling</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Eyelid Swelling</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Tearing</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Tearing</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Tearing</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Rhinorrhea</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Rhinorrhea</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Rhinorrhea</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Pruriti</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Pruritis</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Pruritis</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Congestion</measure> <time_frame>7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3</time_frame> <description>Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Congestion</measure> <time_frame>15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Congestion</measure> <time_frame>20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)</time_frame> <description>Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">61</enrollment> <condition>Allergic Conjunctivitis</condition> <arm_group> <arm_group_label>Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a.</description> </arm_group> <arm_group> <arm_group_label>Tears Naturale® II and Flonase® Allergy Relief</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Tears Naturale® II will be administered bilaterally and Flonase® Allergy Relief (fluticasone propionate) will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>olopatadine hydrochloride ophthalmic solution 0.7%)</intervention_name> <description>Pataday® Once Daily Relief Extra Strength (eyedrop)</description> <arm_group_label>Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray</arm_group_label> <other_name>Pataday® Once Daily Relief Extra Strength</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fluticasone Propionate</intervention_name> <description>Flonase® Allergy Relief (nasal spray)</description> <arm_group_label>Tears Naturale® II and Flonase® Allergy Relief</arm_group_label> <other_name>Flonase® Allergy Relief</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tears Naturale</intervention_name> <description>Tears Naturale® II (eye drop)</description> <arm_group_label>Tears Naturale® II and Flonase® Allergy Relief</arm_group_label> <other_name>Tears Naturale® II</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Saline nasal spray</intervention_name> <description>Saline nasal spray (nasal spray)</description> <arm_group_label>Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Be at least 18 years of age at Visit 1 of either gender and any race;  2. Provide written informed consent and sign the HIPAA form;  3. Be willing and able to follow all instructions and attend all study visits;  4. Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;  5. Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;  6. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);  7. Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period;  8. (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);  9. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;  10. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1;  11. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2.  Exclusion Criteria:  1. Have known contraindications or sensitivities to the use of the investigational product or any of its components;  2. Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);  3. Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;  4. Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;  5. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;  6. Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study:  7 Days  - systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations;  - decongestants;  - monoamine oxidase inhibitors  - all other topical ophthalmic preparations (including artificial tears)  - lid scrubs;  - topical prostaglandins or prostaglandin derivatives  - ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days  - inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers  - ritonavir or other potent cytochrome P450 3A4 inhibitors; 45 Days  - depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed.  7. Have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens;  8. Have received allergy immunotherapy within the last 2 years;  9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed);  10. Have a history of glaucoma;  11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after;  12. Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;  13. Be a female who is currently pregnant, planning a pregnancy, or lactating. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Andover Eye Associates</name> <address> <city>Andover</city> <state>Massachusetts</state> <zip>01810</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>December 17, 2021</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 1, 2022</last_update_submitted> <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 2, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Conjunctivitis</mesh_term> <mesh_term>Conjunctivitis, Allergic</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Fluticasone</mesh_term> <mesh_term>Xhance</mesh_term> <mesh_term>Olopatadine Hydrochloride</mesh_term> <mesh_term>Dextrans</mesh_term> <mesh_term>Ophthalmic Solutions</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a single-center, randomized, double-masked, parallel study. At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1. For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio: - Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30) - Tears Naturale® II and Flonase® Allergy Relief (n = 30) At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing. At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a. Inclusion Criteria: 1. Be at least 18 years of age at Visit 1 of either gender and any race; 2. Provide written informed consent and sign the HIPAA form; 3. Be willing and able to follow all instructions and attend all study visits; 4. Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose; 5. Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months; 6. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6); 7. Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period; 8. (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 9. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart; 10. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1; 11. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2. Exclusion Criteria: 1. Have known contraindications or sensitivities to the use of the investigational product or any of its components; 2. Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye); 3. Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months; 4. Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease; 5. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit; 6. Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study: 7 Days - systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations; - decongestants; - monoamine oxidase inhibitors - all other topical ophthalmic preparations (including artificial tears) - lid scrubs; - topical prostaglandins or prostaglandin derivatives - ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days - inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers - ritonavir or other potent cytochrome P450 3A4 inhibitors; 45 Days - depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed. 7. Have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens; 8. Have received allergy immunotherapy within the last 2 years; 9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed); 10. Have a history of glaucoma; 11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after; 12. Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial; 13. Be a female who is currently pregnant, planning a pregnancy, or lactating.

NCT0531xxxx/NCT05314634.xml

<clinical_study>  <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/NCT05314634</url> </required_header> <id_info> <org_study_id>PACNL_rueihongli_CE</org_study_id> <nct_id>NCT05314634</nct_id> </id_info> <brief_title>The Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study</brief_title> <official_title>The Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study</official_title> <sponsors> <lead_sponsor> <agency>National Taiwan Normal University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>National Taiwan Normal University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. </textblock> </brief_summary> <detailed_description> <textblock> Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 15, 2021</start_date> <completion_date type="Actual">February 15, 2022</completion_date> <primary_completion_date type="Actual">August 15, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Participants were randomly assigned to three group, namely the concurrent exercise group (CE), the aerobic exercise group (AE), and the reading control group (RC). Participants in CE groups were asked to finish 5 min warm-up, 12 min aerobic exercise, 13 min resistance exercise, and 5 min cool down. Participants in the AE group were asked to finish 5 min warm-up, 25 min aerobic exercise, and 5 min cool down. Participants in RC group were required to finish 35 min reading. All groups took a 30 min cognitive test before and after the intervention. The blood lactate were collected before, 17 minutes after, and after the intervention.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>stroop test</measure> <time_frame>30 minutes</time_frame> <description>The Stroop task consists of neutral, congruent, and incongruent trials. In neutral trials, colored rectangles were presented and participants were instructed to respond to whether the squares were red, blue, or green. For congruent and incongruent trials, participants were presented with the names of the three Chinese color words of 紅 (red), 藍 (blue), or 綠 (green) printed in either the same (congruent) or different (incongruent) ink color and instructed to respond to the color of the ink while inhibiting the meaning of the word.</description> </primary_outcome> <secondary_outcome> <measure>task switch test</measure> <time_frame>30 minutes</time_frame> <description>The shifting aspect of executive function was assessed by means of a computer version of the task-switching test. In brief, each participant was presented with six blocks of 64 trials. For the first block, the participant was required to identify whether the stimulus (i.e., digits 1-9, without digit 5) within the solid-line square was greater/less than the digit 5. For the second block, the participant identified whether the stimulus within the dotted-line square was even/odd. The blocks 3-6 consisted of an equal number of stimuli from the first and second blocks forming an alternating-runs paradigm.</description> </secondary_outcome> <other_outcome> <measure>blood lactate</measure> <time_frame>1 minute</time_frame> <description>The lactic acid system is one of the important systems of human energy metabolism. In addition to supplying energy to muscles, it can also be used as an energy source for brain energy metabolism. When people doing exercise, the concentration of blood lactate will be increased, and the lactate acid system will replace the glucose system as the main energy source for the brain. In the present study, blood lactate were collected from fingertip with a lancet and measured by lactate analyzer before, 17 minutes after, and after intervention.</description> </other_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">78</enrollment> <condition>Executive Function</condition> <arm_group> <arm_group_label>concurrent exercise group, CE</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants conduct 5-min warm up, 12-min aerobic exercise, 13-min resistance exercise, and 5-min cool down.</description> </arm_group> <arm_group> <arm_group_label>aerobic exercise group, AE</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants conduct 5-min warm up, 25-min aerobic exercise, and 5-min cool down.</description> </arm_group> <arm_group> <arm_group_label>reading control group, RC</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants conduct reading for 35 minutes.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>concurrent exercise</intervention_name> <description>Participants conduct warm up for 5-min, aerobic exercise for 12-min, resistance exercise for 13-min, and 5-min cool down.</description> <arm_group_label>concurrent exercise group, CE</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>aerobic exercise</intervention_name> <description>Participants conduct warm up for 5-min, resistance training for 25-min, and 5-min cool down.</description> <arm_group_label>aerobic exercise group, AE</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. no history of psychiatric or neurological disorders  2. no history of cardiovascular disease  3. normal or corrected to normal vision and normal color perception  4. right handed  5. 18.5 < BMI < 27  Exclusion Criteria:  1. Diagnosed with epilepsy </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>28 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Yu-Kai Chang, Ph.D.</last_name> <role>Study Director</role> <affiliation>Department of Physical Education and Sport Sciences, National Taiwan Normal University</affiliation> </overall_official> <location> <facility> <name>Department of Physical Education and Sport Sciences, National Taiwan Normal University</name> <address> <city>Taipei</city> <zip>106</zip> <country>Taiwan</country> </address> </facility> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>National Taiwan Normal University</investigator_affiliation> <investigator_full_name>Yu-Kai Chang</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>acute exercise</keyword> <keyword>concurrent exercise</keyword> <keyword>inhibition</keyword> <keyword>cognitive flexibility</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. It is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Therefore, the purposes of present study are: (1) Measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) Measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. Inclusion Criteria: 1. no history of psychiatric or neurological disorders 2. no history of cardiovascular disease 3. normal or corrected to normal vision and normal color perception 4. right handed 5. 18.5 < BMI < 27 Exclusion Criteria: 1. Diagnosed with epilepsy

NCT0531xxxx/NCT05314647.xml

<clinical_study>  <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/NCT05314647</url> </required_header> <id_info> <org_study_id>NorthcentralU</org_study_id> <nct_id>NCT05314647</nct_id> </id_info> <brief_title>Lutein Supplementation in Healthy Children</brief_title> <official_title>Effects of Lutein Supplementation on Cognition and Vision in Healthy Children With Screen Time Exposure: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Northcentral University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Northcentral University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time. </textblock> </brief_summary> <detailed_description> <textblock> Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">July 2023</start_date> <completion_date type="Anticipated">February 2024</completion_date> <primary_completion_date type="Anticipated">November 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>randomized, double-blind, placebo controlled</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> <masking_description>Each participant will be assigned to a group based on a permuted block randomization stratified by participant self-reported sex. Participants may identify male, female or other. If other is selected, assignment as male or female for randomization purposes will be determined by a coin flip. Randomized block lists with a size of 4 will be prepared using a computer generated random number sequence, http://www.jerrydallal.com/random/assigndoc.htm#num (J. Kim & Shin, 2014). Based on group placement, participants will be provided with Bottle A or Bottle B of gummies to last for the next 90 days.</masking_description> </study_design_info> <primary_outcome> <measure>Macular Pigment Optical Density - heterochromatic flicker photometry</measure> <time_frame>6 months</time_frame> <description>Level of macular carotenoids deposited in the eye measured using the psychophysical technique of heterochromatic flicker photometry (QuantifEye MPS-II Device). Minimum score of 0, no maximum. Average values range from 0.0 to 1.0. Higher numbers represent greater macular pigment.</description> </primary_outcome> <primary_outcome> <measure>Macular Pigment Optical Density - haidinger's brushes</measure> <time_frame>6 months</time_frame> <description>Level of macular carotenoids deposited in the eye measured using haidinger's brushes (Azul Optics MP-Eye Device). Minimum score of 0, maximum score of 10. Higher values represent greater macular pigment.</description> </primary_outcome> <secondary_outcome> <measure>Digital Eye strain change from baseline</measure> <time_frame>6 months</time_frame> <description>Visual Fatigue Scale total score. Minimum score of 6, Maximum score of 24. Higher scores indicate higher levels of digital eye strain. Benedetto, S., Drai-Zerbib, V., Pedrotti, M., Tissier, G., & Baccino, T. (2013). E-readers and visual fatigue. PLoS One, 8(12)</description> </secondary_outcome> <secondary_outcome> <measure>Sleep score change from baseline</measure> <time_frame>6 months</time_frame> <description>Total score on the Cleveland Adolescent Sleepiness Questionnaire. Minimum score of 16, Maximum score of 80. Higher scores indicate greater sleepiness. Spilsbury, J. C., et al. (2007). "The Cleveland adolescent sleepiness questionnaire: a new measure to assess excessive daytime sleepiness in adolescents." J Clin Sleep Med 3(6): 603-612.</description> </secondary_outcome> <secondary_outcome> <measure>Verbal Fluency</measure> <time_frame>6 months</time_frame> <description>Letter and semantic fluency using letter and animal naming. Total number of words names in a 60 second time frame. Higher score indicates greater verbal fluency</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">70</enrollment> <condition>Eye Fatigue</condition> <condition>Diet, Healthy</condition> <condition>Cognitive Change</condition> <arm_group> <arm_group_label>Lutein</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>5 mg lutein gummy taken daily for 180 days</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>0 mg lutein gummy taken daily for 180 days</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>lutein</intervention_name> <description>daily dose of 5 mg lutein</description> <arm_group_label>Lutein</arm_group_label> <other_name>FloraGLO Lutein</other_name> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>placebo</intervention_name> <description>daily dose of 0 mg lutein</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age of 8 to 16 years  - guardian-reported general good health  - guardian-reported 4 hours or more of digital screen time daily  Exclusion Criteria:  - Currently using a supplement containing lutein or zeaxanthin </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>16 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Patrick McNamara, PhD</last_name> <role>Study Chair</role> <affiliation>Northcentral University</affiliation> </overall_official> <overall_contact> <last_name>Brenda Fonseca, MA</last_name> <phone>515-421-0680</phone> <email>brenda@brendafonseca.com</email> </overall_contact> <location> <facility> <name>Kemin Industries</name> <address> <city>Des Moines</city> <state>Iowa</state> <zip>50307</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Brenda Fonseca, MA</last_name> <phone>515-421-0680</phone> </contact> <investigator> <last_name>Brenda Fonseca, MA</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 5, 2022</study_first_submitted> <study_first_submitted_qc>April 3, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 28, 2023</last_update_submitted> <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 29, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Northcentral University</investigator_affiliation> <investigator_full_name>Brenda Fonseca</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>lutein</keyword> <keyword>carotenoids</keyword> <keyword>blue light</keyword> <keyword>screen time</keyword> <keyword>digital stress</keyword> <condition_browse>  <mesh_term>Asthenopia</mesh_term> <mesh_term>Fatigue</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time. Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually. Inclusion Criteria: - Age of 8 to 16 years - guardian-reported general good health - guardian-reported 4 hours or more of digital screen time daily Exclusion Criteria: - Currently using a supplement containing lutein or zeaxanthin

NCT0531xxxx/NCT05314660.xml

<clinical_study>  <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/NCT05314660</url> </required_header> <id_info> <org_study_id>A22080120</org_study_id> <nct_id>NCT05314660</nct_id> </id_info> <brief_title>Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children</brief_title> <official_title>Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.</official_title> <sponsors> <lead_sponsor> <agency>Mansoura University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mansoura University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt. </textblock> </brief_summary> <detailed_description> <textblock> 135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.  The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 15, 2020</start_date> <completion_date type="Actual">March 15, 2022</completion_date> <primary_completion_date type="Actual">January 15, 2022</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>3 equal groups receiving 3 different protocols</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> <masking_description>The operator must know the group in which the participant is enrolled so as to provide and carry out the intended treatment protocol. Randomization was preformed by block randomization by the nurse.</masking_description> </study_design_info> <primary_outcome> <measure>Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.</measure> <time_frame>1 year</time_frame> <description>Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.</description> </primary_outcome> <secondary_outcome> <measure>Early childhood oral health impact scale (ECOHIS)</measure> <time_frame>3 months</time_frame> <description>Comprises 13 questions of four domains; child symptoms, function, pscychology and social interactions. Questionnaire answered at the first appointment and 21 days later. Lowest score is 0, highest is 52 and higher score indicates poor oral health related quality of life.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">135</enrollment> <condition>Caries Arrest</condition> <arm_group> <arm_group_label>Silver diamine fluoride group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Application of 38% SDF.</description> </arm_group> <arm_group> <arm_group_label>Atrumatic restorative technique</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Ultra conservative treatment (UCT)</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>38 % silver diamine fluoride</intervention_name> <description>Application of 38% SDF on carious dentine lesions.</description> <arm_group_label>Silver diamine fluoride group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Atraumatic restorative technique</intervention_name> <description>Hand excavation of carious dentine followed by application of Glass ionomer</description> <arm_group_label>Atrumatic restorative technique</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Ultra conservative dentistry</intervention_name> <description>Removal of soft dentine and enlarging of cavity to control bio film</description> <arm_group_label>Ultra conservative treatment (UCT)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - healthy children aged 3-5  - residents of mansoura city  - having at least one carious dentine lesion  Exclusion Criteria:  - large carious lesions approximating the pulp  - signs of pulpitis, fistula, abscess. </textblock> </criteria> <gender>All</gender> <minimum_age>3 Years</minimum_age> <maximum_age>5 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Basma Hamza</name> <address> <city>Mansoura</city> <state>Dakahlia</state> <zip>53111</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>January 2020</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 3, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 14, 2022</last_update_submitted> <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <intervention_browse>  <mesh_term>Fluorides</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>The data regarding the A-ECOHIS will be available to share if needed</ipd_description> </patient_data>  </clinical_study>

Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt. 135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS. The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life. Inclusion Criteria: - healthy children aged 3-5 - residents of mansoura city - having at least one carious dentine lesion Exclusion Criteria: - large carious lesions approximating the pulp - signs of pulpitis, fistula, abscess.

NCT0531xxxx/NCT05314673.xml

<clinical_study>  <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/NCT05314673</url> </required_header> <id_info> <org_study_id>LR18SP09</org_study_id> <nct_id>NCT05314673</nct_id> </id_info> <brief_title>Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients</brief_title> <official_title>Preoperative Intra-lesional Bevacizumab Injection in Primary Pterygium in Tunisian Patients: A Randomized Controlled Prospective Study</official_title> <sponsors> <lead_sponsor> <agency>University Hospital Fattouma Bourguiba</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Hospital Fattouma Bourguiba</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium.  Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. The study included a total of 60 patients (60 eyes) with primary pterygium. The investigators defined two groups of 30 patients each. Group A received an intralesional injection of bevacizumab (Avastin), one month before surgery (lesion excision and conjunctival autograft). Group B (control) had only the surgical treatment. Patients were followed up seven days (D7), one month (M1), three months (M3), and six months (M6) post-operatively. Pre-, per- and post-operatively, photographs of the lesions were taken, as well as a pathological examination. The main outcome measures were the change in functional discomfort following intralesional bevacizumab injection and pterygium recurrence. Recurrence was defined by fibrovascular tissue growth extending more than 1 mm across the limbus. Therapeutic success was defined as the absence of pterygium recurrence in M6. </textblock> </brief_summary> <detailed_description> <textblock> This prospective randomized controlled study adhered to the tenets of the Declaration of Helsinki. The Ethics Committee of our institution approved its modalities. The investigators had informed consent from all participants. The study included a total of 60 eyes of 60 patients with primary pterygium between January 2019 and December 2020. The investigators divided the patients into two groups of 30 patients each. The investigators performed a simple randomization method using a table of random numbers. Group A received an intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment (lesion excision and conjunctival autograft by a single trained surgeon). Group B (control) had only the surgical treatment.  Each patient underwent a complete ocular examination: BSCVA, refraction, slit-lamp biomicroscopy, fundoscopy, and intraocular pressure measurement.  The investigators classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al : 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse). The investigators measured Its corneal surface with Image J software. The study included patients over 18-years-old having primary pterygium with surgical indications:  - Stages 2, 3 and 4  - Significant astigmatism > 1.50 PD  - Patients with significant functional signs: according to a discomfort score that The investigators proposed.  Non-inclusion criteria were recurrent pterygium, suspected pterygium (sentinel vessels, resistant inflammation), and filtering surgery indication. Excluded were patients lost to follow-up or having a bevacizumab contraindication (hypertension, bleeding tendencies, previous myoredial infarction or stroke, pregnant and lactating women).  Pre-operative data gathered included basic demographic information (age and sex), medical and ophthalmological history, and involved eye(s).  The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing, and 5) ocular redness; 6) visual blur, were evaluated according to their severity from 0 to 10 (visual analog scale (VAS)). The investigators assessed this score in each visit.  The surgical technique featured :  1. subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus;  2. excision of the pterygium, starting from its head, followed by pterygium body removal;  3. exposition of a triangular-shaped bare scleral bed (3-4 mm)  4. conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All cases were given dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks.  Patients were examined 30 days before Bevacizumab injection (D-30) and surgery and then at D7, M1, M3, and M6 after surgery. The investigators assessed recurrence at each visit. Both groups (day 0: D0) had a per-operative histopathological examination. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2019</start_date> <completion_date type="Actual">January 1, 2021</completion_date> <primary_completion_date type="Actual">January 1, 2021</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Incidence of recurrence</measure> <time_frame>6 months post-operatively</time_frame> <description>growth of fibrovascular tissue extending more than 1 mm across the limbus.</description> </primary_outcome> <primary_outcome> <measure>Rate of functional discomfort following intralesional bevacizumab injection</measure> <time_frame>6 months post-operatively</time_frame> <description>The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing; 5) ocular redness; and 6) visual blurring, were evaluated according to their severity from 0 to 10 (visual analogue scale (VAS)).</description> </primary_outcome> <secondary_outcome> <measure>Rate of mean changes from baseline in BCSVA</measure> <time_frame>6 months post-operatively</time_frame> <description>one Snellen line</description> </secondary_outcome> <secondary_outcome> <measure>Rate of mean changes from baseline in astigmatism</measure> <time_frame>6 months post-operatively</time_frame> <description>Astigmatism change > 0.25</description> </secondary_outcome> <secondary_outcome> <measure>% of patients with change in morphology of pterygium after injection</measure> <time_frame>one month</time_frame> <description>We classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al: 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">60</enrollment> <condition>Pterygium</condition> <arm_group> <arm_group_label>Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients receiving intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment. Surgical treatment consisted of lesion excision and conjunctival autograft performed by a single trained surgeon.</description> </arm_group> <arm_group> <arm_group_label>pterygium excision+ autograft</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients undergoing only pterygium surgical treatment.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Preoperative Intra-lesional Bevacizumab Injection in primary pterygium</intervention_name> <description>The surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All patients received dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks. Patients were examined 30 days before bevacizumab injection (D-30), before surgery (day 0: D0) and then at D7, M1, M3, and M6 after surgery.</description> <arm_group_label>Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>pterygium surgery without adjunctive therapy</intervention_name> <description>The surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture</description> <arm_group_label>pterygium excision+ autograft</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.  Exclusion Criteria:  - unable to attend the whole follow-up  - Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women). </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Moncef Khairallah</last_name> <role>Principal Investigator</role> <affiliation>Monastir University Hospital</affiliation> </overall_official> <location> <facility> <name>Dhouha Gouider</name> <address> <city>Ariana</city> <state>Illinois</state> <zip>2037</zip> <country>Tunisia</country> </address> </facility> </location> <location_countries> <country>Tunisia</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>February 28, 2022</study_first_submitted> <study_first_submitted_qc>April 3, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 3, 2022</last_update_submitted> <last_update_submitted_qc>April 3, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University Hospital Fattouma Bourguiba</investigator_affiliation> <investigator_full_name>Khairallah Moncef</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>pterygium</keyword> <keyword>bevacizumab</keyword> <keyword>recurrence</keyword> <keyword>Vascularity</keyword> <keyword>subconjunctival</keyword> <condition_browse>  <mesh_term>Pterygium</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Bevacizumab</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_info_type>Analytic Code</ipd_info_type> <ipd_time_frame>They are available</ipd_time_frame> </patient_data>  </clinical_study>

Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium. Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. The study included a total of 60 patients (60 eyes) with primary pterygium. The investigators defined two groups of 30 patients each. Group A received an intralesional injection of bevacizumab (Avastin), one month before surgery (lesion excision and conjunctival autograft). Group B (control) had only the surgical treatment. Patients were followed up seven days (D7), one month (M1), three months (M3), and six months (M6) post-operatively. Pre-, per- and post-operatively, photographs of the lesions were taken, as well as a pathological examination. The main outcome measures were the change in functional discomfort following intralesional bevacizumab injection and pterygium recurrence. Recurrence was defined by fibrovascular tissue growth extending more than 1 mm across the limbus. Therapeutic success was defined as the absence of pterygium recurrence in M6. This prospective randomized controlled study adhered to the tenets of the Declaration of Helsinki. The Ethics Committee of our institution approved its modalities. The investigators had informed consent from all participants. The study included a total of 60 eyes of 60 patients with primary pterygium between January 2019 and December 2020. The investigators divided the patients into two groups of 30 patients each. The investigators performed a simple randomization method using a table of random numbers. Group A received an intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment (lesion excision and conjunctival autograft by a single trained surgeon). Group B (control) had only the surgical treatment. Each patient underwent a complete ocular examination: BSCVA, refraction, slit-lamp biomicroscopy, fundoscopy, and intraocular pressure measurement. The investigators classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al : 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse). The investigators measured Its corneal surface with Image J software. The study included patients over 18-years-old having primary pterygium with surgical indications: - Stages 2, 3 and 4 - Significant astigmatism > 1.50 PD - Patients with significant functional signs: according to a discomfort score that The investigators proposed. Non-inclusion criteria were recurrent pterygium, suspected pterygium (sentinel vessels, resistant inflammation), and filtering surgery indication. Excluded were patients lost to follow-up or having a bevacizumab contraindication (hypertension, bleeding tendencies, previous myoredial infarction or stroke, pregnant and lactating women). Pre-operative data gathered included basic demographic information (age and sex), medical and ophthalmological history, and involved eye(s). The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing, and 5) ocular redness; 6) visual blur, were evaluated according to their severity from 0 to 10 (visual analog scale (VAS)). The investigators assessed this score in each visit. The surgical technique featured : 1. subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; 2. excision of the pterygium, starting from its head, followed by pterygium body removal; 3. exposition of a triangular-shaped bare scleral bed (3-4 mm) 4. conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All cases were given dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks. Patients were examined 30 days before Bevacizumab injection (D-30) and surgery and then at D7, M1, M3, and M6 after surgery. The investigators assessed recurrence at each visit. Both groups (day 0: D0) had a per-operative histopathological examination. Inclusion Criteria: - clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication. Exclusion Criteria: - unable to attend the whole follow-up - Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).

NCT0531xxxx/NCT05314686.xml

<clinical_study>  <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/NCT05314686</url> </required_header> <id_info> <org_study_id>TelerehApp-Valid/Feasib</org_study_id> <nct_id>NCT05314686</nct_id> </id_info> <brief_title>Telerehabilitation - Technical Validity and Clinical Feasibility</brief_title> <official_title>Technical Validity and Clinical Feasibility of Using a Telerehabilitation System Using Advanced Telehealth Technologies</official_title> <sponsors> <lead_sponsor> <agency>ADIR Association</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Union des Kinésithérapeutes Respiratoires</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>CogSci</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>KerNel Biomedical</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Groupe Havrais d'Aide aux Handicapés Respiratoires</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>ADIR Association</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This prospective study will be held in two steps.  The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker.  The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below. </textblock> </brief_summary> <detailed_description> <textblock> Before taking part in the study, participants will undergo an incremental cardiopulmonary exercise testing as their baseline assessment before referral to a pulmonary rehabilitation program.  Participants referred for pulmonary rehabilitation to the ADIR Association will be screened for eligibility. They will be contacted to initiate their program. During the first session, they will be offered to participate in the study.  This protocol will be held in two steps : the first step will aim to assess the clinical validity of the data transmitted remotely through the system (from two different devices) and the second step will aim to assess the clinical feasibility of using the system in the home environment.  Participant recruitment for each of these steps will be performed chronologically (the first twenty eligible participants will participate in the technical validity step of the study and the last twenty eligible participants will participate in the clinical feasibility step).  Step one: Clinical validity. The first step of the study aims to assess the clinical validity of data transmitted remotely from two devices connected to the telerehabilitation system (a. oximetry data during exercise and b. daily step count from a commercially available physical activity tracker).  1. Oxymetry data during exercise on a cycle ergometer.  Participants who agree to participate will be trained to use the system within the pulmonary rehabilitation centre. Training includes different steps such as to turn on the tablet, to connect to the application, to start the session using the app, to synchronise the oximeter with the app, to perform the session and to validate the end of the session.  Participants will be asked to perform five endurance exercise sessions of forty-five minutes each, over five different days, within the centre. During these sessions a connected pulsed oximeter device will record heart rate and transcutaneous oxygen saturation at a frequency of one hertz. These data will be recorded in the internal memory of the oximeter itself as well as transmitted in real-time through Bluetooth to the app. The app will transmit the data to a secured remote server through the Global System for Mobile communication network. These two datasets (those locally stored and those remotely transmitted) will be analysed and compared (proportion of artefact, data deletion, data transformation, comparability etc - see outcomes for further details).  2. Data from a physical activity tracker.  Concurrently, the same participants will be asked to wear a physical activity tracker over a ten-day period. The data (daily step count) will be automatically and daily transmitted to the app through Bluetooth and then from the app to the remote secured server. Participants will be asked to remove the sensor when going to bed and to note the number of steps displayed on the screen on a standardized data sheet.  Step two: Clinical feasibility. The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment), during an eight week period.  During their initial pulmonary rehabilitation session (held in the centre), participants will be offered to perform their pulmonary rehabilitation program at home, using the telerehabilitation system. Those who agree to participate will be taught to use the system during this first face-to-face session. The telerehabilitation system as well as a cycle ergometer will be subsequently provided in their home environment by a local home healthcare provider.  The telerehabilitation program will take place over an eight-week period and includes:  - Endurance exercise training on a cycle ergometer (performed independently with remote monitoring or through video conference (also with remote monitoring), according to the participant's preference), three times per weeks. The duration of the sessions along with the training intensity will be progressively adjusted using an automated algorithm (aimed to first increase the training duration up to forty-five minutes and then workload intensity). The algorithm is based on previous sessions performed, monitored data and perceived exertion.  - Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per weeks (thirty minutes).  - Daily walking (automated coaching based on Demeyer et al. Thorax. 2017).  - Self management education (one to nine sessions according to each individual's needs, scheduled through videoconference).  - A self evaluation of symptoms through daily or weekly questionnaires.  Different types of alerts will be triggered at the center according to remote monitoring : "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".  Participants will be encouraged to contact physiotherapists at the centre for any situation that would require assistance (related to their program or to cope with any technical issue). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 15, 2022</start_date> <completion_date type="Anticipated">March 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>Comparison of paired datasets between the data recorded locally within the internal memory of the pulse oximeter and those collected from the telerehabilitation system.</description> </primary_outcome> <primary_outcome> <measure>Technical validity of the data transmitted remotely - physical activity tracker - concordance between datasets.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>Comparison of paired dataset between the daily data, either automatically collected from the telerehabilitation system or self-reported by the participant (visually displayed on the physical activity tracker).</description> </primary_outcome> <primary_outcome> <measure>Technical validity of the data transmitted remotely - pulse oximeter - proportion of sessions transmitted.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>The number of exercise sessions retrieved from the telerehabilitation system will be expressed in relation to the number of sessions performed.</description> </primary_outcome> <primary_outcome> <measure>Technical validity of the data transmitted remotely - physical activity tracker - proportion of sessions transmitted.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>The number of days with physical activity data retrieved from the telerehabilitation system will be expressed in relation to the number of days that the tracker has been worn by the participant.</description> </primary_outcome> <primary_outcome> <measure>Technical validity of the data transmitted remotely - pulse oximeter - proportion of common usable data.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>The proportion of data without artefacts will be compared between datasets. Artefacts will be identified for heart rate when values indicate two hundred fifty beats per minute and for transcutaneous oxygen saturation when values indicate hundred percent.</description> </primary_outcome> <primary_outcome> <measure>Technical validity of the data transmitted remotely - pulse oximeter - number of session required to be autonomous when using the system.</measure> <time_frame>Data will be recorded immediately after the intervention.</time_frame> <description>Participants will be taught to use the system and they will be requested to set data collection autonomously during the four next sessions. They will be considered autonomous when they will be able to set data collection autonomously without error. The number of sessions (after the first session) required to reach autonomy will be collected.</description> </primary_outcome> <secondary_outcome> <measure>Endurance exercise capacity - constant workload exercise testing.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Time to exhaustion (in second) during a constant workload exercise testing on a cycle ergometer at seventy-five percent of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing.</description> </secondary_outcome> <secondary_outcome> <measure>Endurance exercise capacity - six-minute walking test.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Number of meters performed during the six-minutes walking test, performed in a thirty metre long corridor.</description> </secondary_outcome> <secondary_outcome> <measure>Endurance exercise capacity - six-minute stepper test.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Number of steps performed during the six-minutes stepper test.</description> </secondary_outcome> <secondary_outcome> <measure>Maximal voluntary isometric quadriceps force.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Data will be recorded using a handheld manometer.</description> </secondary_outcome> <secondary_outcome> <measure>Self-reported quality of life.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Saint George's Respiratory Questionnaire.</description> </secondary_outcome> <secondary_outcome> <measure>Functional dyspnea.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Modified Medical Research Council dyspnea scale.</description> </secondary_outcome> <secondary_outcome> <measure>Health status.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Chronic obstructive pulmonary disease Assessment Test.</description> </secondary_outcome> <secondary_outcome> <measure>Anxiety.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Hospital And Anxiety questionnaire - anxiety sub scale.</description> </secondary_outcome> <secondary_outcome> <measure>Depression.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Hospital And Anxiety questionnaire - depression sub scale.</description> </secondary_outcome> <secondary_outcome> <measure>Cognitive Function.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Montreal Cognitive Assessment test.</description> </secondary_outcome> <secondary_outcome> <measure>Objective physical activity.</measure> <time_frame>Baseline and immediately after the intervention.</time_frame> <description>Objective physical activity will be assessed using a physical activity tracker (different from the one used with the telerehabilitation system) and expressed as daily step count over a ten-day period. A given day will be considered as valid if the device is worn at least eight hours and the outcome will be considered as valid for a given participant if the measurement includes at least four valid week days.</description> </secondary_outcome> <secondary_outcome> <measure>Adherence - exercise training.</measure> <time_frame>Data will be collected through study completion, an average of 8 weeks.</time_frame> <description>Adherence will be assessed as the number of exercise training sessions performed in relation to the number of sessions prescribed.</description> </secondary_outcome> <secondary_outcome> <measure>Adherence - self-management education.</measure> <time_frame>Data will be collected through study completion, an average of 8 weeks.</time_frame> <description>Adherence will be assessed as the number of self-management education sessions performed in relation to the number of sessions prescribed.</description> </secondary_outcome> <secondary_outcome> <measure>Adherence - symptoms monitoring questionnaires.</measure> <time_frame>Data will be collected through study completion, an average of 8 weeks.</time_frame> <description>Adherence will be assessed as the number of days with fulfilled questionnaires relative to the number of days.</description> </secondary_outcome> <secondary_outcome> <measure>Use of the telerehabilitation system.</measure> <time_frame>Data will be collected through study completion, an average of 8 weeks.</time_frame> <description>Logs related to the different components of the programs will be retrieved from the telerehabilitation system (number of click to each component of the eight-week period).</description> </secondary_outcome> <secondary_outcome> <measure>Usability of the system.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Usability of the system will be assessed using the System Usability Scale.</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction - standardized questionnaire.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Satisfaction will be assessed using the Client Satisfaction Questionnaire-8.</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction - purpose designed survey.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Satisfaction will be assessed using purpose designed surveys intended for participants, their relatives and healthcare professional in charge of telerehabilitation program (Lickert scale).</description> </secondary_outcome> <secondary_outcome> <measure>Emotional perception of the system.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Emotional perception of the system will be assessed using Emocards.</description> </secondary_outcome> <secondary_outcome> <measure>Participant's flow.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Participant's flow with the system will be assessed using the FKS scale from Rheinberg et al. (2003).</description> </secondary_outcome> <secondary_outcome> <measure>Motivation to participate in the program using the telerehabilitation system.</measure> <time_frame>Data will be collected immediately after the intervention.</time_frame> <description>Motivation will be assessed through a one hour semi-directed interview.</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">40</enrollment> <condition>Chronic Obstructive Pulmonary Disease</condition> <arm_group> <arm_group_label>Technical validity of data transmitted remotely.</arm_group_label> <description>The first twenty participants will participate in the step of the study aimed at assessing the technical validity of data transmitted remotely from devices connected to the telerehabilitation system.</description> </arm_group> <arm_group> <arm_group_label>Clinical feasibility.</arm_group_label> <description>The last twenty participants will perform their pulmonary rehabilitation program at home using the telerehabilitation system over an eight-week period.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker.</intervention_name> <description>Five exercise sessions of forty-five minutes within the centre on a cycle ergometer using a pulse oximetry device connected to the telerehabilitation system through Bluetooth. Data recorded in the internal memory of the pulse oximeter will be compared with those transmitted through the telerehabilitation system. Ten days of use of a physical activity tracker connected to the telerehabilitation system. Self-reported daily step count by the participants (using a standardized data sheet) will be compared with the daily step count transmitted through the telerehabilitation system.</description> <arm_group_label>Technical validity of data transmitted remotely.</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Telerehabilitation</intervention_name> <description>An eight-week program including: Endurance training on a cycle ergometer (performed independently with remote monitoring or through video conference, according to the participant's preference), three times per week. Training prescription is progressively adjusted using an automated algorithm (aimed to first increase the training duration and then workload intensity). Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per week (thirty minutes). Daily walking with automated coaching. Self management education (one to nine sessions according to each individual needs, scheduled through videoconference). A self evaluation of symptoms through daily or weekly questionnaires. Different types of alert will be triggered at the center according to remote monitoring: "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".</description> <arm_group_label>Clinical feasibility.</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Chronic obstructive pulmonary disease </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age superior to eighteen years.  - Stable (> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV  - Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer).  - With or without oxygen during exercise.  Specific inclusion criteria for the first step of the study:  - Able to perform forty-five minutes of exercise training on a cycle ergometer.  Specific inclusion criteria for the second phase of the study:  - Person of legal age who may be present during home exercise sessions (relatives).  Non-inclusion Criteria:  - Pregnancy or likely to be.  - Guardianship.  - Unable to consent.  - Referred to pulmonary rehabilitation before lung cancer surgery.  - Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled in the next few months.  Exclusion Criteria:  - Consent withdrawal </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Tristan Bonnevie, PT, PhD</last_name> <role>Principal Investigator</role> <affiliation>ADIR Association, Rouen University, Rouen, France</affiliation> </overall_official> <overall_official> <last_name>Antoine Cuvelier, MD, Prof</last_name> <role>Study Chair</role> <affiliation>CHU-Hôpitaux de Rouen, Rouen, France.</affiliation> </overall_official> <overall_official> <last_name>Jean-François Muir, MD, Prof</last_name> <role>Study Chair</role> <affiliation>ADIR Association, Rouen, France.</affiliation> </overall_official> <overall_official> <last_name>Francis-Edouard Gravier, PT, PhD</last_name> <role>Study Chair</role> <affiliation>ADIR Association, Rouen, France.</affiliation> </overall_official> <overall_official> <last_name>Aurélie Vallée, PhD</last_name> <role>Study Chair</role> <affiliation>CogSci, Rouen, France.</affiliation> </overall_official> <overall_official> <last_name>Michelle Leclerc, PT, MSc</last_name> <role>Study Chair</role> <affiliation>Union des Kinésithérapeutes Respiratoires, Rouen, France.</affiliation> </overall_official> <overall_official> <last_name>Zoe McKeough, PT, Prof</last_name> <role>Study Chair</role> <affiliation>Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.</affiliation> </overall_official> <overall_contact> <last_name>Tristan Bonnevie, PhD</last_name> <phone>0235592970</phone> <email>t.bonnevie@adir-hautenormandie.com</email> </overall_contact> <location> <facility> <name>ADIR Association</name> <address> <city>Bois-Guillaume</city> <state>ADIR Association</state> <zip>76230</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tristan Bonnevie</last_name> <phone>0235592970</phone> <email>t.bonnevie@adir-hautenormandie.com</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 25, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 3, 2023</last_update_submitted> <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Chronic obstructive pulmonary disease</keyword> <keyword>Pulmonary rehabilitation</keyword> <keyword>Telerehabilitation</keyword> <keyword>Exercise</keyword> <condition_browse>  <mesh_term>Lung Diseases</mesh_term> <mesh_term>Lung Diseases, Obstructive</mesh_term> <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term> </condition_browse>  </clinical_study>

This prospective study will be held in two steps. The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker. The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below. Before taking part in the study, participants will undergo an incremental cardiopulmonary exercise testing as their baseline assessment before referral to a pulmonary rehabilitation program. Participants referred for pulmonary rehabilitation to the ADIR Association will be screened for eligibility. They will be contacted to initiate their program. During the first session, they will be offered to participate in the study. This protocol will be held in two steps : the first step will aim to assess the clinical validity of the data transmitted remotely through the system (from two different devices) and the second step will aim to assess the clinical feasibility of using the system in the home environment. Participant recruitment for each of these steps will be performed chronologically (the first twenty eligible participants will participate in the technical validity step of the study and the last twenty eligible participants will participate in the clinical feasibility step). Step one: Clinical validity. The first step of the study aims to assess the clinical validity of data transmitted remotely from two devices connected to the telerehabilitation system (a. oximetry data during exercise and b. daily step count from a commercially available physical activity tracker). 1. Oxymetry data during exercise on a cycle ergometer. Participants who agree to participate will be trained to use the system within the pulmonary rehabilitation centre. Training includes different steps such as to turn on the tablet, to connect to the application, to start the session using the app, to synchronise the oximeter with the app, to perform the session and to validate the end of the session. Participants will be asked to perform five endurance exercise sessions of forty-five minutes each, over five different days, within the centre. During these sessions a connected pulsed oximeter device will record heart rate and transcutaneous oxygen saturation at a frequency of one hertz. These data will be recorded in the internal memory of the oximeter itself as well as transmitted in real-time through Bluetooth to the app. The app will transmit the data to a secured remote server through the Global System for Mobile communication network. These two datasets (those locally stored and those remotely transmitted) will be analysed and compared (proportion of artefact, data deletion, data transformation, comparability etc - see outcomes for further details). 2. Data from a physical activity tracker. Concurrently, the same participants will be asked to wear a physical activity tracker over a ten-day period. The data (daily step count) will be automatically and daily transmitted to the app through Bluetooth and then from the app to the remote secured server. Participants will be asked to remove the sensor when going to bed and to note the number of steps displayed on the screen on a standardized data sheet. Step two: Clinical feasibility. The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment), during an eight week period. During their initial pulmonary rehabilitation session (held in the centre), participants will be offered to perform their pulmonary rehabilitation program at home, using the telerehabilitation system. Those who agree to participate will be taught to use the system during this first face-to-face session. The telerehabilitation system as well as a cycle ergometer will be subsequently provided in their home environment by a local home healthcare provider. The telerehabilitation program will take place over an eight-week period and includes: - Endurance exercise training on a cycle ergometer (performed independently with remote monitoring or through video conference (also with remote monitoring), according to the participant's preference), three times per weeks. The duration of the sessions along with the training intensity will be progressively adjusted using an automated algorithm (aimed to first increase the training duration up to forty-five minutes and then workload intensity). The algorithm is based on previous sessions performed, monitored data and perceived exertion. - Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per weeks (thirty minutes). - Daily walking (automated coaching based on Demeyer et al. Thorax. 2017). - Self management education (one to nine sessions according to each individual's needs, scheduled through videoconference). - A self evaluation of symptoms through daily or weekly questionnaires. Different types of alerts will be triggered at the center according to remote monitoring : "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms". Participants will be encouraged to contact physiotherapists at the centre for any situation that would require assistance (related to their program or to cope with any technical issue). Chronic obstructive pulmonary disease Inclusion Criteria: - Age superior to eighteen years. - Stable (> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV - Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer). - With or without oxygen during exercise. Specific inclusion criteria for the first step of the study: - Able to perform forty-five minutes of exercise training on a cycle ergometer. Specific inclusion criteria for the second phase of the study: - Person of legal age who may be present during home exercise sessions (relatives). Non-inclusion Criteria: - Pregnancy or likely to be. - Guardianship. - Unable to consent. - Referred to pulmonary rehabilitation before lung cancer surgery. - Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled in the next few months. Exclusion Criteria: - Consent withdrawal

NCT0531xxxx/NCT05314699.xml

<clinical_study>  <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/NCT05314699</url> </required_header> <id_info> <org_study_id>PACNL_rueihongli_CE_Order</org_study_id> <nct_id>NCT05314699</nct_id> </id_info> <brief_title>The Order Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study</brief_title> <official_title>The Order Effect of Acute Concurrent Exercise on Executive Function: An Event-Related Potential Study</official_title> <sponsors> <lead_sponsor> <agency>National Taiwan Normal University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>National Taiwan Normal University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate. </textblock> </brief_summary> <detailed_description> <textblock> Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 15, 2021</start_date> <completion_date type="Actual">February 15, 2022</completion_date> <primary_completion_date type="Actual">November 29, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Participants were randomly assigned to three group, namely the resistance-aerobic exercise group (RA), the aerobic-resistance exercise group (AR), and the reading control group (RC). Participants in RA groups were asked to finish 5 min warm-up, 13 min resistance exercise, 12 min aerobic exercise, and 5 min cool down. Participants in AR groups were asked to finish 5 min warm-up, 12 min aerobic exercise, 13 min resistance exercise, and 5 min cool down. Participants in RC group were required to finish 35 min reading. All groups took a 30 min cognitive test before and after the intervention.The blood lactate were collected before, 17 minutes after, and after the intervention.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Stroop test</measure> <time_frame>30 minutes</time_frame> <description>The Stroop task consists of neutral, congruent, and incongruent trials. In neutral trials, colored rectangles were presented and participants were instructed to respond to whether the squares were red, blue, or green. For congruent and incongruent trials, participants were presented with the names of the three Chinese color words of 紅 (red), 藍 (blue), or 綠 (green) printed in either the same (congruent) or different (incongruent) ink color and instructed to respond to the color of the ink while inhibiting the meaning of the word.</description> </primary_outcome> <primary_outcome> <measure>task switch test</measure> <time_frame>30 minutes</time_frame> <description>The shifting aspect of executive function was assessed by means of a computer version of the task-switching test. In brief, each participant was presented with six blocks of 64 trials. For the first block, the participant was required to identify whether the stimulus (i.e., digits 1-9, without digit 5) within the solid-line square was greater/less than the digit 5. For the second block, the participant identified whether the stimulus within the dotted-line square was even/odd. The blocks 3-6 consisted of an equal number of stimuli from the first and second blocks forming an alternating-runs paradigm.</description> </primary_outcome> <other_outcome> <measure>blood lactate</measure> <time_frame>1 minutes</time_frame> <description>The lactic acid system is one of the important systems of human energy metabolism. In addition to supplying energy to muscles, it can also be used as an energy source for brain energy metabolism. When people doing exercise, the concentration of blood lactate will be increased, and the lactate acid system will replace the glucose system as the main energy source for the brain. In the present study, blood lactate were collected from fingertip with a lancet and measured by lactate analyzer before, 17 minutes after, and after intervention.</description> </other_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">99</enrollment> <condition>Executive Function</condition> <arm_group> <arm_group_label>resistance-aerobic exercise group, RA</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants conduct 5-min warm up, 13-min resistance exercise, 12-min aerobic exercise, and 5-min cool down.</description> </arm_group> <arm_group> <arm_group_label>aerobic-resistance exercise group, AR</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants conduct 5-min warm up, 12-min aerobic exercise, 13-min resistance exercise, and 5-min cool down.</description> </arm_group> <arm_group> <arm_group_label>reading control group, RC</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants conduct reading for 35 minutes.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>resistance-aerobic exercise, RA</intervention_name> <description>Participants conduct 5-min warm up, 13-min resistance exercise, 12-min aerobic exercise, and 5-min cool down.</description> <arm_group_label>resistance-aerobic exercise group, RA</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>aerobic-resistance exercise, AR</intervention_name> <description>Participants conduct warm up for 5-min, aerobic exercise for 12-min, resistance exercise for 13-min, and 5-min cold down.</description> <arm_group_label>aerobic-resistance exercise group, AR</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. no history of psychiatric or neurological disorders  2. no history of cardiovascular disease  3. normal or corrected to normal vision and normal color perception  4. right handed  5. 18.5 < BMI < 27  Exclusion Criteria:  1. Diagnosed with epilepsy </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>28 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Yu-Kai Chang, Ph.D.</last_name> <role>Study Director</role> <affiliation>Department of Physical Education and Sport Sciences, National Taiwan Normal University</affiliation> </overall_official> <location> <facility> <name>Department of Physical Education and Sport Sciences, National Taiwan Normal University</name> <address> <city>Taipei</city> <zip>106</zip> <country>Taiwan</country> </address> </facility> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>National Taiwan Normal University</investigator_affiliation> <investigator_full_name>Yu-Kai Chang</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>acute exercise</keyword> <keyword>concurrent exercise</keyword> <keyword>inhibition</keyword> <keyword>cognitive flexibility</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Executive function is a high-level cognition which plays an important role in our life. Meta-analysis study has demonstrated that acute exercise could improve executive function. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate. Executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. Meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. However, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. Moreover, the sequence of concurrent exercise may result in different blood lactate concentration which may affect executive function. Therefore, the purposes of present study are: (1) Measuring the order effect of acute concurrent exercise on executive function. (2) Measuring whether order effect of acute concurrent exercise on executive function is mediated by blood lactate. Inclusion Criteria: 1. no history of psychiatric or neurological disorders 2. no history of cardiovascular disease 3. normal or corrected to normal vision and normal color perception 4. right handed 5. 18.5 < BMI < 27 Exclusion Criteria: 1. Diagnosed with epilepsy

NCT0531xxxx/NCT05314712.xml

<clinical_study>  <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/NCT05314712</url> </required_header> <id_info> <org_study_id>VG032922</org_study_id> <secondary_id>K01HL146993</secondary_id> <nct_id>NCT05314712</nct_id> </id_info> <brief_title>Assessing Sleep in Blackfeet Families With K-3rd Grade Children</brief_title> <official_title>Developing, Implementing, and Evaluating a Mixed-methods Community-based Participatory Research Sleep Intervention in Families With K-3rd Grade Children Living on the Blackfeet Indian Reservation</official_title> <sponsors> <lead_sponsor> <agency>Montana State University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>Montana State University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This project will investigate traditional sleep routines and the current sleep environment in American Indian children to develop a culturally appropriate and novel sleep intervention to increase total sleep time for families with K-3rd grade children. The outcomes of this study will provide a comprehensive understanding of a relatively unknown behavior (sleep) in American Indians, show results from a novel sleep intervention in a high risk and underserved population, and will also contribute to the research and training development of an American Indian investigator, all defined missions of NHLBI. </textblock> </brief_summary> <detailed_description> <textblock> Children sleep less now than ever before. Despite a growing body of literature in understanding child sleep patterns, sleep interventions are limited. To date, there are no sleep intervention studies that have been done in AI tribal communities. Elders and community members play a critical role in identifying culturally adaptive solutions to address problems in tribal communities. Because of the prevalence of historical trauma and mistrust of outsiders, I am uniquely positioned to do this work in my own tribal community. Preliminary data of sleep patterns showed that Blackfeet children age 2-5 and age 12-15 averaged 10.15 hours and 7.5 hours of weekday sleep. Despite this understanding, evidence-based solutions to increase TST in tribal communities are unknown. Thus, I propose to explore traditional sleep routines coupled with asking Blackfeet families about the current sleep environment in their home to develop a culturally specific sleep intervention with one child and one adult dyad. I hypothesize that the sleep intervention will increase TST (primary outcome) in the dyads. The intervention may also result in improved physical activity and diet, and decreased stress and screen time (secondary outcomes). Data will be measured at 0 and 9 weeks and then at 3 month follow-up. This hypothesis will be tested in the following specific aims:  Specific Aim 1: Develop a culturally appropriate sleep intervention for Blackfeet families with K-3rd grade children using surveys, focus groups, interviews, community input, and evidence-based strategies on sleep.  Specific Aim 2: Feasibility test of the 9-week sleep intervention with K-3rd grade Blackfeet families.  The work proposed in these aims is designed to develop a comprehensive understanding of traditional sleep strategies and the child sleep environment to develop and pilot-test a novel culturally appropriate sleep intervention in the Blackfeet community. Developing culturally specific interventions to increase TST will address two significant gaps in the literature; understanding sleep problems in AI children and pilot-testing culturally adaptive sleep intervention strategies that will inform future research for investigators doing similar work in AI communities and provide direction for an R01 proposal that is one of the outcomes of this work. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">August 15, 2023</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Pre and post test of intervention group</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>total sleep time</measure> <time_frame>9 weeks</time_frame> <description>minutes of total sleep time assessed by actigraphy</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Sleep</condition> <arm_group> <arm_group_label>Sleep Intervention</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Pre and post test of 9-week intervention</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Sleep intervention</intervention_name> <description>Participants will receive a 9-week sleep intervention through text and Facebook that include traditional Blackfoot cultural components combined with scientifically validated strategies for sleep.</description> <arm_group_label>Sleep Intervention</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  • Blackfeet families with K-3rd grade children  Exclusion Criteria:  • Blackfeet families living off the Blackfeet Indian Reservation in Montana </textblock> </criteria> <gender>All</gender> <minimum_age>2 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Vernon M Grant, PhD</last_name> <phone>4065319310</phone> <email>vernon.grant@montana.edu</email> </overall_contact> <overall_contact_backup> <last_name>James S Burroughs, MS</last_name> <phone>4069944407</phone> <email>jburroughs@montana.edu</email> </overall_contact_backup> <location> <facility> <name>Montana State University</name> <address> <city>Bozeman</city> <state>Montana</state> <zip>59718</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>TRACI MIYAKAWA</last_name> <phone>406-994-2381</phone> <email>tracim@montana.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 27, 2023</last_update_submitted> <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 1, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Montana State University</investigator_affiliation> <investigator_full_name>Vernon Grant</investigator_full_name> <investigator_title>Assistant Research Professor</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>All participant data will be confidential</ipd_description> </patient_data>  </clinical_study>

This project will investigate traditional sleep routines and the current sleep environment in American Indian children to develop a culturally appropriate and novel sleep intervention to increase total sleep time for families with K-3rd grade children. The outcomes of this study will provide a comprehensive understanding of a relatively unknown behavior (sleep) in American Indians, show results from a novel sleep intervention in a high risk and underserved population, and will also contribute to the research and training development of an American Indian investigator, all defined missions of NHLBI. Children sleep less now than ever before. Despite a growing body of literature in understanding child sleep patterns, sleep interventions are limited. To date, there are no sleep intervention studies that have been done in AI tribal communities. Elders and community members play a critical role in identifying culturally adaptive solutions to address problems in tribal communities. Because of the prevalence of historical trauma and mistrust of outsiders, I am uniquely positioned to do this work in my own tribal community. Preliminary data of sleep patterns showed that Blackfeet children age 2-5 and age 12-15 averaged 10.15 hours and 7.5 hours of weekday sleep. Despite this understanding, evidence-based solutions to increase TST in tribal communities are unknown. Thus, I propose to explore traditional sleep routines coupled with asking Blackfeet families about the current sleep environment in their home to develop a culturally specific sleep intervention with one child and one adult dyad. I hypothesize that the sleep intervention will increase TST (primary outcome) in the dyads. The intervention may also result in improved physical activity and diet, and decreased stress and screen time (secondary outcomes). Data will be measured at 0 and 9 weeks and then at 3 month follow-up. This hypothesis will be tested in the following specific aims: Specific Aim 1: Develop a culturally appropriate sleep intervention for Blackfeet families with K-3rd grade children using surveys, focus groups, interviews, community input, and evidence-based strategies on sleep. Specific Aim 2: Feasibility test of the 9-week sleep intervention with K-3rd grade Blackfeet families. The work proposed in these aims is designed to develop a comprehensive understanding of traditional sleep strategies and the child sleep environment to develop and pilot-test a novel culturally appropriate sleep intervention in the Blackfeet community. Developing culturally specific interventions to increase TST will address two significant gaps in the literature; understanding sleep problems in AI children and pilot-testing culturally adaptive sleep intervention strategies that will inform future research for investigators doing similar work in AI communities and provide direction for an R01 proposal that is one of the outcomes of this work. Inclusion Criteria: • Blackfeet families with K-3rd grade children Exclusion Criteria: • Blackfeet families living off the Blackfeet Indian Reservation in Montana

NCT0531xxxx/NCT05314725.xml

<clinical_study>  <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/NCT05314725</url> </required_header> <id_info> <org_study_id>REG-094-2021</org_study_id> <nct_id>NCT05314725</nct_id> </id_info> <brief_title>Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial</brief_title> <official_title>Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial</official_title> <sponsors> <lead_sponsor> <agency>Zealand University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Zealand University Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The aim of the study is to investigate the effect of an SGLT-2 inhibitor on postoperative hyperglycemia after acute abdominal surgery in patients without diabetes </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">June 1, 2022</start_date> <completion_date type="Anticipated">June 1, 2023</completion_date> <primary_completion_date type="Anticipated">May 1, 2023</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>time in range</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> <description>percentage of time in range defined as blood glucose between 3.9 and 7.8mmol/l. Blood glucose will be measures continuously while taking the study medication)</description> </primary_outcome> <secondary_outcome> <measure>mean glucose</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> </secondary_outcome> <secondary_outcome> <measure>glucose variability</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> <description>standard deviation divided by the mean and standard deviation</description> </secondary_outcome> <secondary_outcome> <measure>time with level 1 hypoglycemia</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> <description>blood glucose 3.0-3.9mmol/l</description> </secondary_outcome> <secondary_outcome> <measure>time with level 2 hypoglycemia</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> <description>blood glucose less than 3mmol/l</description> </secondary_outcome> <secondary_outcome> <measure>time with hyperglycemia</measure> <time_frame>from inclusion until 10 days after (or when the patient leaves the hospital)</time_frame> <description>blood glucose more than 10mmol/l</description> </secondary_outcome> <secondary_outcome> <measure>Quality of recovery-15</measure> <time_frame>every day while taking the study medication and on postoperative day 30</time_frame> <description>Questionnaire assessing the patient's own sense of recovery after surgery</description> </secondary_outcome> <secondary_outcome> <measure>Nanostring</measure> <time_frame>at inclusion, on day 4 of treatment and at end of treatment</time_frame> <description>changes in up- and downregulation of genes</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">24</enrollment> <condition>Postoperative Hyperglycemia</condition> <condition>Stress Hyperglycemia</condition> <arm_group> <arm_group_label>SGLT-2 inhibitor</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>SGLT2 inhibitor</intervention_name> <description>10 days of SGLT2 inhibitor after surgery</description> <arm_group_label>SGLT-2 inhibitor</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>10 days of placebo after surgery</description> <arm_group_label>placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - - Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital)  - At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery  - Age of 18 to 85  - Must be able to understand and sign informed content  Exclusion Criteria:  - Patients diagnosed with diabetes mellitus  - Impaired kidney function (eGFR < 45mL/min)  - Severe liver disease (defined as transaminases above X 3 normal levels)  - Acute pancreatitis within the last two months or a history of chronic pancreatitis  - Participation in another pharmacological intervention trial  - Predictable poor compliance (for instance mentally impaired)  - Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)  - Allergy to study medication </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Emilie P Palmgren Colov</last_name> <role>Principal Investigator</role> <affiliation>Zealand University Hospital</affiliation> </overall_official> <overall_contact> <last_name>Emilie Palmgren Colov, MD</last_name> <phone>+45 61335122</phone> <email>eco@regionsjaelland.dk</email> </overall_contact> <overall_contact_backup> <last_name>Ismail Gögenur, Dr.med</last_name> <phone>+45 26336426</phone> <email>igo@regionsjaelland.dk</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>acute abdominal surgery</keyword> <keyword>SGLT-2 inhibitor</keyword> <condition_browse>  <mesh_term>Hyperglycemia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Sodium-Glucose Transporter 2 Inhibitors</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The aim of the study is to investigate the effect of an SGLT-2 inhibitor on postoperative hyperglycemia after acute abdominal surgery in patients without diabetes Inclusion Criteria: - - Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital) - At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery - Age of 18 to 85 - Must be able to understand and sign informed content Exclusion Criteria: - Patients diagnosed with diabetes mellitus - Impaired kidney function (eGFR < 45mL/min) - Severe liver disease (defined as transaminases above X 3 normal levels) - Acute pancreatitis within the last two months or a history of chronic pancreatitis - Participation in another pharmacological intervention trial - Predictable poor compliance (for instance mentally impaired) - Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) - Allergy to study medication

NCT0531xxxx/NCT05314738.xml

<clinical_study>  <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/NCT05314738</url> </required_header> <id_info> <org_study_id>NXL-101-KCON</org_study_id> <nct_id>NCT05314738</nct_id> </id_info> <brief_title>Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus</brief_title> <official_title>A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus</official_title> <sponsors> <lead_sponsor> <agency>Glaukos Corporation</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Glaukos Corporation</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> </oversight_info> <brief_summary> <textblock> Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus. </textblock> </brief_summary> <detailed_description> <textblock> This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 8, 2022</start_date> <completion_date type="Anticipated">August 2025</completion_date> <primary_completion_date type="Anticipated">January 2025</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Topography</measure> <time_frame>12 Months</time_frame> <description>Change in Kmax topography value from baseline</description> </primary_outcome> <secondary_outcome> <measure>Distance Uncorrected Visual Acuity (UCVA)</measure> <time_frame>12 Months</time_frame> <description>Change in Distance UCVA</description> </secondary_outcome> <number_of_arms>8</number_of_arms> <enrollment type="Anticipated">150</enrollment> <condition>Progressive Keratoconus</condition> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 1</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 2</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 1</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 2</description> </arm_group> <arm_group> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3</description> </arm_group> <arm_group> <arm_group_label>Placebo Group 2 / Cohort 2B</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Sham Solution with no exposure to NXL System</description> </arm_group> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>NXL Energy 1</intervention_name> <description>Riboflavin drops + NXL System to Total Energy Level 1</description> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A</arm_group_label> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B</arm_group_label> </intervention> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>NXL Energy 2</intervention_name> <description>Riboflavin drops + NXL System to Total Energy Level 2</description> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A</arm_group_label> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B</arm_group_label> </intervention> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>NXL Energy 3</intervention_name> <description>Riboflavin drops + NXL System to Total Energy Level 3</description> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1</arm_group_label> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A</arm_group_label> <arm_group_label>Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B</arm_group_label> </intervention> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>Sham Treatment</intervention_name> <description>Sham Drops and No exposure to NXL system</description> <arm_group_label>Placebo Group 2 / Cohort 2B</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Provide written informed consent  - Ability to hold gaze sufficiently stable for study testing  - Willingness and ability to follow all instructions and comply with schedule for follow-up visits  - Have a diagnosis of keratoconus  Exclusion Criteria:  - Known allergy or sensitivity to the test articles or components  - Any disease causing abnormal topography other than keratoconus  - Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Marco Armijo</last_name> <phone>562-761-7965</phone> <email>marmijo@glaukos.com</email> </overall_contact> <location> <facility> <name>Glaukos Investigative Site</name> <address> <city>Dothan</city> <state>Alabama</state> <zip>36301</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Glaukos Investigative Site</name> <address> <city>Teaneck</city> <state>New Jersey</state> <zip>07666</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Glaukos Investigative Site</name> <address> <city>Westerville</city> <state>Ohio</state> <zip>43082</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 25, 2023</last_update_submitted> <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Eye rubbing</keyword> <keyword>Collagen cross-linking</keyword> <keyword>Keratoconus</keyword> <keyword>Progressive Keratoconus</keyword> <condition_browse>  <mesh_term>Keratoconus</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus. This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus. Inclusion Criteria: - Provide written informed consent - Ability to hold gaze sufficiently stable for study testing - Willingness and ability to follow all instructions and comply with schedule for follow-up visits - Have a diagnosis of keratoconus Exclusion Criteria: - Known allergy or sensitivity to the test articles or components - Any disease causing abnormal topography other than keratoconus - Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications

NCT0531xxxx/NCT05314751.xml

<clinical_study>  <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/NCT05314751</url> </required_header> <id_info> <org_study_id>L2L</org_study_id> <nct_id>NCT05314751</nct_id> </id_info> <brief_title>Learning to Live With Non-severe Haemophilia</brief_title> <official_title>Learning to Live With Non-severe Haemophilia</official_title> <sponsors> <lead_sponsor> <agency>Haemnet</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>BioMarin Pharmaceutical</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Haemnet</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> While the burden of standard treatment may be reduced through the use of gene therapy, converting those with severe haemophilia to a mild or moderate phenotype, the long-term sequelae of previous joint bleeds and associated limitations imposed on those with severe haemophilia may not translate to lessen the biomedical burden of living with a history of severe haemophilia.  We wish to explore these issues further in the Learning to Live study. The study will also seek to identify the ongoing support needs of those who transition to a milder bleeding phenotype. </textblock> </brief_summary> <detailed_description> <textblock> Haemophilia is a rare congenital disorder caused by an inherited genetic defect which affects approximately one in every 5,000 males. Haemophilia A (factor VIII [FVIII] deficiency) occurs in 85% of cases with haemophilia B (factor IX [FIX] deficiency) making up the remainder of affected people. Three severities are reported: "severe" (factor activity is less than 1%), "moderate" (factor activity is 1-5% and "mild" (factor activity is 6-25%).  The aim of haemophilia treatment is to reduce the frequency of bleeds, and consequently morbidity and joint damage, in order to prevent future disability. Historically treatment has been replacement of the missing clotting factor when a bleed occurs (on-demand treatment) or regularly and intermittently (prophylactic treatment). With this in developed countries, life expectancy of persons with haemophilia, is expected to be close to normal. Treatment is burdensome for affected individuals and caregivers with treatment complications, (presence of inhibitors, pain, and arthropathy), psychological (stress and coping, anxiety and depression, stigmatisation and discrimination) and economic aspects.  Whilst those with mild haemophilia usually only experience bleeding with trauma or surgery and are less engaged with haemophilia care, the impact of living with mild haemophilia on quality of life is becoming more recognised and further research within this cohort of people is required.  The present day focus of treatment is on normalising individual's lives and reducing treatment burden by using innovative therapies to limit and/or eliminate bleeding episodes. This results in a cohort of individuals who are now living with a less severe phenotype of haemophilia, who may be less able to recognise and treat bleeds and for whom clinical follow up and outcomes will be considerably different to that of their predecessors.  A holistic approach to follow up is required, and should include patient relevant outcome. Living with mild haemophilia is still limiting and when bleeds occur the impact is not mild; many cannot self-infuse, do not recognise when to attend hospital and suffer pain and mobility issues.  This study, which has been co-created with a person with haemophilia, aims to explore the impact of these new treatments using mixed methods study. This includes quantitative data from patient reported outcome assessment (the PROBE validated haemophilia questionnaire) and through in depth qualitative interviews. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 21, 2022</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">September 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>To Identify and understand the differences between those with genetically mild/moderate haemophilia and those with previously severe haemophilia who have received phenotype altering treatment</measure> <time_frame>3 months</time_frame> <description>Survey using the validated PROBE questionnaire (using 7 point Likert scale)</description> </primary_outcome> <secondary_outcome> <measure>To assess the impact of phenotype altering treatments on those who receive them, and to compare this with those people with genetically mild/moderate haemophilia.</measure> <time_frame>3 months</time_frame> <description>Interview</description> </secondary_outcome> <enrollment type="Anticipated">40</enrollment> <condition>Hemophilia</condition> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Questionnaire and interview</intervention_name> <description>An online survey and an in-depth interview.</description> </intervention> <eligibility> <study_pop> <textblock> People with haemophilia A or B either mild moderate or severe living in the UK. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  Confirmed diagnosis of haemophilia A or B of any severity  Exclusion Criteria:  Diagnosis of any other bleeding disorder </textblock> </criteria> <gender>Male</gender> <minimum_age>16 Years</minimum_age> <maximum_age>100 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Simon Fletcher, MA</last_name> <phone>07891038065</phone> <email>simon@haemnet.com</email> </overall_contact> <overall_contact_backup> <last_name>Mike Holland</last_name> <email>mike@haemnet.com</email> </overall_contact_backup> <location> <facility> <name>Oxford University Hospitals NHS Foundation Trust</name> <address> <city>Oxford</city> <state>Oxfordshire</state> <zip>OX3 9DU</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Simon Fletcher</last_name> <phone>07891038065</phone> <email>simon.fletcher@ouh.nhs.uk</email> </contact> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 28, 2023</last_update_submitted> <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 1, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hemophilia A</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Participant data will not be shared beyond the study group.</ipd_description> </patient_data>  </clinical_study>

While the burden of standard treatment may be reduced through the use of gene therapy, converting those with severe haemophilia to a mild or moderate phenotype, the long-term sequelae of previous joint bleeds and associated limitations imposed on those with severe haemophilia may not translate to lessen the biomedical burden of living with a history of severe haemophilia. We wish to explore these issues further in the Learning to Live study. The study will also seek to identify the ongoing support needs of those who transition to a milder bleeding phenotype. Haemophilia is a rare congenital disorder caused by an inherited genetic defect which affects approximately one in every 5,000 males. Haemophilia A (factor VIII [FVIII] deficiency) occurs in 85% of cases with haemophilia B (factor IX [FIX] deficiency) making up the remainder of affected people. Three severities are reported: "severe" (factor activity is less than 1%), "moderate" (factor activity is 1-5% and "mild" (factor activity is 6-25%). The aim of haemophilia treatment is to reduce the frequency of bleeds, and consequently morbidity and joint damage, in order to prevent future disability. Historically treatment has been replacement of the missing clotting factor when a bleed occurs (on-demand treatment) or regularly and intermittently (prophylactic treatment). With this in developed countries, life expectancy of persons with haemophilia, is expected to be close to normal. Treatment is burdensome for affected individuals and caregivers with treatment complications, (presence of inhibitors, pain, and arthropathy), psychological (stress and coping, anxiety and depression, stigmatisation and discrimination) and economic aspects. Whilst those with mild haemophilia usually only experience bleeding with trauma or surgery and are less engaged with haemophilia care, the impact of living with mild haemophilia on quality of life is becoming more recognised and further research within this cohort of people is required. The present day focus of treatment is on normalising individual's lives and reducing treatment burden by using innovative therapies to limit and/or eliminate bleeding episodes. This results in a cohort of individuals who are now living with a less severe phenotype of haemophilia, who may be less able to recognise and treat bleeds and for whom clinical follow up and outcomes will be considerably different to that of their predecessors. A holistic approach to follow up is required, and should include patient relevant outcome. Living with mild haemophilia is still limiting and when bleeds occur the impact is not mild; many cannot self-infuse, do not recognise when to attend hospital and suffer pain and mobility issues. This study, which has been co-created with a person with haemophilia, aims to explore the impact of these new treatments using mixed methods study. This includes quantitative data from patient reported outcome assessment (the PROBE validated haemophilia questionnaire) and through in depth qualitative interviews. People with haemophilia A or B either mild moderate or severe living in the UK. Inclusion Criteria: Confirmed diagnosis of haemophilia A or B of any severity Exclusion Criteria: Diagnosis of any other bleeding disorder

NCT0531xxxx/NCT05314764.xml

<clinical_study>  <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/NCT05314764</url> </required_header> <id_info> <org_study_id>HHC-2022-0078</org_study_id> <nct_id>NCT05314764</nct_id> </id_info> <brief_title>Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis</brief_title> <official_title>Population Pharmacokinetics of Cefiderocol During Acute Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis</official_title> <sponsors> <lead_sponsor> <agency>Hartford Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Shionogi Inc.</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Keystone Bioanalytical, Inc.</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Indiana University Health Methodist Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Pittsburgh Medical Center</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Texas</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Hartford Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study. </textblock> </brief_summary> <detailed_description> <textblock> Participants will receive 4-6 doses of cefiderocol 2 grams every 6-8 hours, in addition to standard intravenous antibiotic therapy selected by the site. Just prior and then after the final dose, a total of nine blood samples will be collected to measure cefiderocol concentrations. Data will be fit to a population pharmacokinetic model. The final model will be utilized in a Monte Carlo simulation to determine the probability of several different dosing regimens retaining concentrations above the minimum inhibitory concentration (MIC) for at least 75% of the dosing interval. These data will be utilized to determine an optimized dosing regimen for adults with CF. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">June 2023</completion_date> <primary_completion_date type="Anticipated">May 2023</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Open-label, descriptive, pharmacokinetic study</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Clearance</measure> <time_frame>0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose</time_frame> <description>This outcome determines the clearance of cefiderocol over the dosing interval.</description> </primary_outcome> <primary_outcome> <measure>Volume of Distribution</measure> <time_frame>0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose</time_frame> <description>This outcome determines the volume of distribution of cefiderocol over the dosing interval.</description> </primary_outcome> <secondary_outcome> <measure>Probability of Target Attainment at 4 mcg/mL</measure> <time_frame>24 hours</time_frame> <description>This simulated outcome indicates the likelihood that cefiderocol will retain drug concentrations above the MIC for >/= 75% of the dosing interval at an MIC of 4 mcg/ml when administered as a 2g every 8 hour dose infused over 3 hour in patients up to a creatinine clearance of 120 ml/min. This analysis is conducted via a Monte Carlo simulation using the population pharmacokinetic parameter estimates and dispersion from the 12 participants who contributed pharmacokinetic data to the study</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">12</enrollment> <condition>Cystic Fibrosis</condition> <condition>Pneumonia, Bacterial</condition> <arm_group> <arm_group_label>Cefiderocol</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive intravenous cefiderocol at a dosing regimen consistent with the current prescribing information and according estimated renal function. Each dose will be infused over 3 hours.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cefiderocol</intervention_name> <description>Patients will receive intravenous cefiderocol every 6 to 8 hours for 4 to 6 doses.</description> <arm_group_label>Cefiderocol</arm_group_label> <other_name>Fetroja</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Documented diagnosis of CF  - Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment  Exclusion Criteria:  - Females that are pregnant and/or breastfeeding  - History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)  - History of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months  - Moderate to severe renal dysfunction defined as a creatinine clearance < 60 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis  - A hemoglobin less than 8 gm/dL at baseline  - Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Joseph L Kuti, PharmD</last_name> <role>Principal Investigator</role> <affiliation>Hartford Hospital</affiliation> </overall_official> <overall_contact> <last_name>Joseph L Kuti, PharmD</last_name> <phone>860-972-3612</phone> <email>joseph.kuti@hhchealth.org</email> </overall_contact> <location> <facility> <name>Hartford Hospital</name> <address> <city>Hartford</city> <state>Connecticut</state> <zip>06106</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Joseph L Kuti, PharmD</last_name> <phone>860-972-3612</phone> <email>joseph.kuti@hhchealth.org</email> </contact> <investigator> <last_name>Samuel Pope, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>IU Health University Hospital</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>46202</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Colleen M Sakon, PharmD</last_name> <phone>317-962-9363</phone> <email>csakon@iuhealth.org</email> </contact> </location> <location> <facility> <name>UPMC Presbyterian Hospital</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15213</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ryan Shields, PharmD</last_name> <email>shieldsrk@upmc.edu</email> </contact> </location> <location> <facility> <name>UT Southwestern Clements University Hospital</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75390</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Marguerite Monogue, PharmD</last_name> <email>Marguerite.Monogue@UTSouthwestern.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 22, 2022</last_update_submitted> <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Hartford Hospital</investigator_affiliation> <investigator_full_name>Joseph L. Kuti, PharmD</investigator_full_name> <investigator_title>Associate Director, CAIRD</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Pneumonia, Bacterial</mesh_term> <mesh_term>Cystic Fibrosis</mesh_term> <mesh_term>Fibrosis</mesh_term> </condition_browse>  </clinical_study>

There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study. Participants will receive 4-6 doses of cefiderocol 2 grams every 6-8 hours, in addition to standard intravenous antibiotic therapy selected by the site. Just prior and then after the final dose, a total of nine blood samples will be collected to measure cefiderocol concentrations. Data will be fit to a population pharmacokinetic model. The final model will be utilized in a Monte Carlo simulation to determine the probability of several different dosing regimens retaining concentrations above the minimum inhibitory concentration (MIC) for at least 75% of the dosing interval. These data will be utilized to determine an optimized dosing regimen for adults with CF. Inclusion Criteria: - Documented diagnosis of CF - Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment Exclusion Criteria: - Females that are pregnant and/or breastfeeding - History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication) - History of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months - Moderate to severe renal dysfunction defined as a creatinine clearance < 60 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis - A hemoglobin less than 8 gm/dL at baseline - Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)

NCT0531xxxx/NCT05314777.xml

<clinical_study>  <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/NCT05314777</url> </required_header> <id_info> <org_study_id>02032022</org_study_id> <nct_id>NCT05314777</nct_id> </id_info> <brief_title>Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome</brief_title> <official_title>Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) at Different Pulse Numbers in Carpal Tunnel Syndrome</official_title> <sponsors> <lead_sponsor> <agency>University of Beykent</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Beykent</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). </textblock> </brief_summary> <detailed_description> <textblock> The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The sample of the study will consist of patients with carpal tunnel syndrome who were diagnosed in Gaziosmapaşa Training and Research Hospital between April 2022 and December 2022 and whose symptoms have persisted for at least 3 months. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). The evaluation of the patients participating in the study will be made by the physician who is not aware of the groups. Evaluations will be made 3 times before the treatment, at the 1st month and at the 3rd month. In the evaluation, Boston Carpal Tunnel Syndrome Questionnaire to evaluate symptoms and functionality, visual analog scale (VAS) to evaluate pain, SF-36 to evaluate quality of life, hand dynamometer to evaluate grip strength and electrodiagnostic examination to evaluate median nerve conduction velocity will be performed. After the initial evaluations, the patients participating in the study will be randomly divided into 3 groups. Tendon shifting and nerve shifting exercises will be performed in all groups. ESWT will be applied to 2 groups at different beat numbers. One session of ESWT will be applied to both groups each week for 3 consecutive weeks. In addition to the exercises in the low dose ESWT group, 1000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In addition to the exercises in the high-dose ESWT group, 2000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In the control group, in addition to the exercises, sham ESWT will be applied. No energy will be used in Sham ESWT application, only sound will be given. Each group will be given a 15-minute cold-pack application after the ESWT application. The exercises will be taught to the patient before the first ESWT application and the exercises will be given to the patients in brochure form. These exercises will be given to the patient as home exercises. You will be asked to do these exercises at home in 2 sets of 5 repetitions 2 times a day. Tendon gliding exercises are performed with the fingers in 5 different positions as regular grip, hook grip, fist, desktop and normal fist. In the distal median nerve gliding exercise, firstly, in the neutral position of the wrist, the fingers and thumb are flexed, in the second position, all the fingers are in the neutral position, in the third position, when the thumb is in the neutral position, the wrist and other fingers are in extension, in the fourth position, the wrist, thumb and other fingers are in extension, In the fifth position, when the wrist and fingers are in the same position, the forearm is in supination, in the sixth position, in the fifth position, the thumb stretching is applied. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 30, 2022</start_date> <completion_date type="Anticipated">December 20, 2022</completion_date> <primary_completion_date type="Anticipated">August 20, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Factorial Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Boston Carpal Tunnel Syndrome Questionnaire</measure> <time_frame>First month- Third month</time_frame> <description>The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.</description> </primary_outcome> <secondary_outcome> <measure>Hand Grip Force</measure> <time_frame>First month- Third month</time_frame> <description>Hand grip strength will be measured with a Jamar dynamometer.</description> </secondary_outcome> <secondary_outcome> <measure>Nerve Conduction Velocity</measure> <time_frame>First month- Third month</time_frame> <description>The conduction velocity of the median nerve will be measured according to the American Academy of Neurology</description> </secondary_outcome> <secondary_outcome> <measure>Short Form- 36</measure> <time_frame>First month- Third month</time_frame> <description>The quality of life of the patients will be evaluated with short form 36.</description> </secondary_outcome> <secondary_outcome> <measure>Visual analog scale</measure> <time_frame>First month- Third month</time_frame> <description>The pain intensity felt by the participants during rest and activity, respectively, will be evaluated by VAS</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Carpal Tunnel Syndrome</condition> <arm_group> <arm_group_label>Low dose ESWT application group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Exercise Training Low dose ESWT application</description> </arm_group> <arm_group> <arm_group_label>High dose ESWT group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Exercise Training High dose ESWT application</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Exercise Training Sham ESWT</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Low dose ESWT application</intervention_name> <description>Patients trained for low dose ESWT application.</description> <arm_group_label>Low dose ESWT application group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>High dose ESWT application</intervention_name> <description>Patients trained for high dose ESWT application.</description> <arm_group_label>High dose ESWT group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Sham ESWT</intervention_name> <description>Patients trained for sham ESWT.</description> <arm_group_label>Control group</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Exercise Training</intervention_name> <description>Patients trained for exercise training.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>High dose ESWT group</arm_group_label> <arm_group_label>Low dose ESWT application group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Being between the ages of 18-65,  - Clinical symptoms persisting for at least 3 months  - Pain, tingling and paresthesia in the first 3 fingers together with the Phalen and Tinel test makes the patient positive,  - Patients who are positive are evaluated by a specialist in electrodiagnostic testing and the clinical stage of CTS is determined.  - Mild to moderate CTS is diagnosed if the sensory nerve action potential (SNAP) is >6 μV and the combined muscle action potential (CMAP) is >2.1 mV.  - Being diagnosed with mild and moderate CTS  Exclusion Criteria:  - The patient who received CTS operation or corticosteroid treatment,  - Presence of systemic diseases that will affect our treatment such as diabetes, rheumatoid arthritis, gout,  - It has been determined as atrophy in the thenar region of the hand (Xu,2020). </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Yasemin Karaaslan, Ph.D.</last_name> <role>Principal Investigator</role> <affiliation>Beykent University</affiliation> </overall_official> <overall_official> <last_name>Fatih Ozyurt, Pt</last_name> <role>Study Chair</role> <affiliation>Beykent University</affiliation> </overall_official> <overall_contact> <last_name>Yasemin Karaaslan, Ph.D.</last_name> <phone>05358459625</phone> <email>ptyasemindeveci@gmail.com</email> </overall_contact> <location> <facility> <name>Gaziosmanpasa Training and Research Hospital</name> <address> <city>İstanbul</city> <zip>34488</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yasemin Karaaslan</last_name> <email>ptyasemindeveci@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 30, 2022</last_update_submitted> <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 2, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Beykent</investigator_affiliation> <investigator_full_name>Yasemin Karaaslan</investigator_full_name> <investigator_title>Ph.D. Pt.</investigator_title> </responsible_party> <keyword>Carpal Tunnel Syndrome</keyword> <keyword>Extracorporeal Shockwave Therapy</keyword> <keyword>Median Neuropathy</keyword> <condition_browse>  <mesh_term>Carpal Tunnel Syndrome</mesh_term> <mesh_term>Syndrome</mesh_term> </condition_browse>  </clinical_study>

The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The sample of the study will consist of patients with carpal tunnel syndrome who were diagnosed in Gaziosmapaşa Training and Research Hospital between April 2022 and December 2022 and whose symptoms have persisted for at least 3 months. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). The evaluation of the patients participating in the study will be made by the physician who is not aware of the groups. Evaluations will be made 3 times before the treatment, at the 1st month and at the 3rd month. In the evaluation, Boston Carpal Tunnel Syndrome Questionnaire to evaluate symptoms and functionality, visual analog scale (VAS) to evaluate pain, SF-36 to evaluate quality of life, hand dynamometer to evaluate grip strength and electrodiagnostic examination to evaluate median nerve conduction velocity will be performed. After the initial evaluations, the patients participating in the study will be randomly divided into 3 groups. Tendon shifting and nerve shifting exercises will be performed in all groups. ESWT will be applied to 2 groups at different beat numbers. One session of ESWT will be applied to both groups each week for 3 consecutive weeks. In addition to the exercises in the low dose ESWT group, 1000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In addition to the exercises in the high-dose ESWT group, 2000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In the control group, in addition to the exercises, sham ESWT will be applied. No energy will be used in Sham ESWT application, only sound will be given. Each group will be given a 15-minute cold-pack application after the ESWT application. The exercises will be taught to the patient before the first ESWT application and the exercises will be given to the patients in brochure form. These exercises will be given to the patient as home exercises. You will be asked to do these exercises at home in 2 sets of 5 repetitions 2 times a day. Tendon gliding exercises are performed with the fingers in 5 different positions as regular grip, hook grip, fist, desktop and normal fist. In the distal median nerve gliding exercise, firstly, in the neutral position of the wrist, the fingers and thumb are flexed, in the second position, all the fingers are in the neutral position, in the third position, when the thumb is in the neutral position, the wrist and other fingers are in extension, in the fourth position, the wrist, thumb and other fingers are in extension, In the fifth position, when the wrist and fingers are in the same position, the forearm is in supination, in the sixth position, in the fifth position, the thumb stretching is applied. Inclusion Criteria: Being between the ages of 18-65, - Clinical symptoms persisting for at least 3 months - Pain, tingling and paresthesia in the first 3 fingers together with the Phalen and Tinel test makes the patient positive, - Patients who are positive are evaluated by a specialist in electrodiagnostic testing and the clinical stage of CTS is determined. - Mild to moderate CTS is diagnosed if the sensory nerve action potential (SNAP) is >6 μV and the combined muscle action potential (CMAP) is >2.1 mV. - Being diagnosed with mild and moderate CTS Exclusion Criteria: - The patient who received CTS operation or corticosteroid treatment, - Presence of systemic diseases that will affect our treatment such as diabetes, rheumatoid arthritis, gout, - It has been determined as atrophy in the thenar region of the hand (Xu,2020).

NCT0531xxxx/NCT05314790.xml

<clinical_study>  <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/NCT05314790</url> </required_header> <id_info> <org_study_id>FADOI.05.2015</org_study_id> <nct_id>NCT05314790</nct_id> </id_info> <brief_title>Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme</brief_title> <acronym>TIAMO</acronym> <official_title>Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme</official_title> <sponsors> <lead_sponsor> <agency>Fadoi Foundation, Italy</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fadoi Foundation, Italy</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).  Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. </textblock> </brief_summary> <detailed_description> <textblock> Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality.  Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program.  The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2016</start_date> <completion_date type="Actual">January 1, 2019</completion_date> <primary_completion_date type="Actual">January 1, 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>To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient</measure> <time_frame>4 months for each phase</time_frame> <description>To evaluate, in the real-life management of the hypothyroidism therapy, possible deviations from national and international clinical practice recommendations (CPR) in evidence-based guidelines (EBGs). Four EBGs and 39 CPRs have provided the basis on which 22 treatment management indicators have been identified (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)</description> </primary_outcome> <primary_outcome> <measure>Effects of an educational programme</measure> <time_frame>4 months for each phase</time_frame> <description>To evaluate the improvement of some indicators (the same of outcome 1) in the management of patients with hypothyroidism by means of a standardized educational programme (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)</description> </primary_outcome> <secondary_outcome> <measure>Clinical profile evaluation of hypothyroidism</measure> <time_frame>4 months for each phase</time_frame> <description>Assessment of age, gender, weight, hormonal hypothyroidism status (TSH, FT3, FT4), comorbidity, treatment of hypothyroidism and other pharmacological therapies of patients with hypothyroidism</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">1200</enrollment> <condition>Hypothyroidism</condition> <arm_group> <arm_group_label>control group (CG)</arm_group_label> <description>Without intervening Educational Program</description> </arm_group> <arm_group> <arm_group_label>training group (TG)</arm_group_label> <description>Group who has received an Educational Program (EP). The implementation of an EP based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>intervening Educational Program</intervention_name> <description>The implementation of an EP is based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1;</description> <arm_group_label>training group (TG)</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> All patients with known diagnosis of hypothyroidism on the basis of medical history or laboratory results,as hospitalized and as outpatients, in Internal Medicine Units </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition  Exclusion Criteria:  - none </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>MAURO CAMPANINI</last_name> <role>Study Director</role> <affiliation>FADOI FOUNDATION</affiliation> </overall_official> <location> <facility> <name>ULSS1 Belluno San Martino</name> <address> <city>Belluno</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Versilia</name> <address> <city>Camaiore</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale di Canicattì</name> <address> <city>Canicattì</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale di Castiglione del Lago, Medicina del Trasimeno</name> <address> <city>Castiglione Del Lago</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Garibaldi Nesima</name> <address> <city>Catania</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale G.B. Morgagni - P.L. Pierantoni</name> <address> <city>Forlì</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale G.P. Delogu</name> <address> <city>Ghilarza</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Gubbio-Gualdo Tadino</name> <address> <city>Gubbio</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale "F. Veneziale"</name> <address> <city>Isernia</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>ASL Latina</name> <address> <city>Latina</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale S. Andrea</name> <address> <city>Massa Marittima</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale S. Croce di Moncalieri - ASL TO5</name> <address> <city>Moncalieri</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Del Mare</name> <address> <city>Napoli</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Fatebenefratelli</name> <address> <city>Napoli</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Maggiore di Novara</name> <address> <city>Novara</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale Civico di Partinico</name> <address> <city>Palermo</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale "Bianchi-Melacrino-Morelli"</name> <address> <city>Reggio Calabria</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Casa Sollievo della Sofferenza</name> <address> <city>San Giovanni Rotondo</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>AOU di Sassari</name> <address> <city>Sassari</city> <country>Italy</country> </address> </facility> </location> <location> <facility> <name>Ospedale San Paolo</name> <address> <city>Savona</city> <country>Italy</country> </address> </facility> </location> <location_countries> <country>Italy</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>January 20, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hypothyroidism</mesh_term> </condition_browse>  </clinical_study>

There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP). Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization. Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality. Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program. The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients). All patients with known diagnosis of hypothyroidism on the basis of medical history or laboratory results,as hospitalized and as outpatients, in Internal Medicine Units Inclusion Criteria: - known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition Exclusion Criteria: - none

NCT0531xxxx/NCT05314803.xml

<clinical_study>  <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/NCT05314803</url> </required_header> <id_info> <org_study_id>HREBA.CC-20-0098 (sub-study)</org_study_id> <nct_id>NCT05314803</nct_id> </id_info> <brief_title>Yoga for Young Adults Affected by Cancer</brief_title> <official_title>Yoga for Young Adults Affected by Cancer: Exploring Implementation and Effectiveness of an Online Program</official_title> <sponsors> <lead_sponsor> <agency>University of Calgary</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Canadian Cancer Society (CCS)</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Canadian Institutes of Health Research (CIHR)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Calgary</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Yoga may enhance physical and psychological outcomes among young adults affected by cancer. Yet, yoga has rarely been studied in this population. We developed and piloted a yoga program, which is now ready for implementation and evaluation. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 1, 2021</start_date> <completion_date type="Anticipated">December 1, 2028</completion_date> <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Reach</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>The number of people who participate, and reasons why or why not.</description> </primary_outcome> <secondary_outcome> <measure>Attendance</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Number of classes attended out of the number of classes offered by study staff.</description> </secondary_outcome> <secondary_outcome> <measure>Adherence</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Number of classes attended out of the number of classes offered by study staff.</description> </secondary_outcome> <secondary_outcome> <measure>Missing data</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Percentage of missing data on quantitative measures and completion of qualitative interviews.</description> </secondary_outcome> <secondary_outcome> <measure>Barriers and facilitators to exercise participation</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Barrier Self-Efficacy Scale (1). Scale range 0-100; higher scores indicates less barriers to participation.</description> </secondary_outcome> <secondary_outcome> <measure>Physical activity levels</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Changes in Godin Leisure Time Scale (2). Individuals indicate how many times per week and how long per session they exercise at certain intensity (mild, moderate, high). Higher scores indicate higher levels of physical activity.</description> </secondary_outcome> <secondary_outcome> <measure>Fatigue</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (3). Scale range 0-4; selected items are reverse scored; higher score indicate less fatigue.</description> </secondary_outcome> <secondary_outcome> <measure>Cognition</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Changes in Functional Assessment of Cancer Therapy - Cognitive Scale (4). Scale range 1-4; some items are reversed scored; higher scores indicate less cognitive impairment.</description> </secondary_outcome> <secondary_outcome> <measure>Cancer-related symptoms</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Edmonton Symptom Assessment Scale (5). Scale range 0-10; lower scores indicate fewer/less severe symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>General health-related quality of life</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in EuroQual - 5Dimensions (EQ-5D) Scale (6). Scale range 1-5 with lower scores indicating greater quality of life; visual analogue scale range 0-100 with higher scores indicating greater quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>General well-being</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Functional Assessment of Cancer Therapy - General Scale (7). Scale range 0-4; selected items are reversed scored; higher scores indicate greater quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>Mindfulness</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Mindful Attention Awareness Scale (8). Scale range 1-6; higher scores indicate higher levels of dispositional mindfulness.</description> </secondary_outcome> <secondary_outcome> <measure>Self-compassion</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Self-Compassion Scale (9). Scale range 1-5; higher scores indicate greater self-compassion.</description> </secondary_outcome> <secondary_outcome> <measure>Stress</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Perceived Stress Scale (10). Scale range 0-4; some items are reverse scored; higher scores indicate more perceived stress.</description> </secondary_outcome> <secondary_outcome> <measure>Group identification</measure> <time_frame>Post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in Group Identification Scale (11). Scale range 1-7; higher scores indicate greater identification with the group.</description> </secondary_outcome> <secondary_outcome> <measure>Balance</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in one legged stance test (seconds) (see 12).</description> </secondary_outcome> <secondary_outcome> <measure>Shoulder range of motion</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in active shoulder flexion range of motion (degrees) (see 12).</description> </secondary_outcome> <secondary_outcome> <measure>Lower extremity flexibility</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in sit-and-reach test (cm) (see 12).</description> </secondary_outcome> <secondary_outcome> <measure>Functional performance</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in sit-to-stand (number of repetitions in 30 seconds) (see 12).</description> </secondary_outcome> <secondary_outcome> <measure>Aerobic endurance</measure> <time_frame>Baseline (week 0), post-program (week 12), 6-month follow-up (week 24), 1 year follow-up (week 52)</time_frame> <description>Change in 2 minute step test (steps) results (see 12).</description> </secondary_outcome> <secondary_outcome> <measure>Adverse events</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Adverse events will be defined as any negative effect caused (or suspected to be caused by) the yoga program.</description> </secondary_outcome> <secondary_outcome> <measure>Time to implement and deliver</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Time and expertise to deliver the intervention and physical assessments will be tracked.</description> </secondary_outcome> <secondary_outcome> <measure>Yoga program fidelity</measure> <time_frame>Through study completion, an average of 5 years</time_frame> <description>Fidelity of the physical activity program implementation will be assessed via randomly video-auditing a subset of classes.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">500</enrollment> <condition>Young Adult Cancer</condition> <condition>Young Adult Oncology</condition> <arm_group> <arm_group_label>Yoga</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive online, group-based yoga classes 2 times/week for 60 minutes/class over 12 weeks.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Yoga</intervention_name> <description>Participants receive the yoga program, which is delivered by a trained yoga instructor (completed at least a 200-hour yoga teacher training, Yoga Thrive Teacher Training Certification (or similar), and/or practical experience working with individuals affected by cancer). The first class of the week is comprised of 45 minutes of gentle, progressive, hatha-based yoga sequencing and postures with the last 15 minutes focused on guided behaviour change and mindfulness techniques that varies week-to-week, based on the participants in the class. The second class of the week is 60 minutes of gentle, yin-based yoga sequencing and postures with an element of opening and relaxing.</description> <arm_group_label>Yoga</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Adult aged 18 years or older;  2. Diagnosed with cancer between the ages of 18-39 years;  3. At any stage of their cancer experience (i.e., on- or off-treatment);  4. Able to safely engage in yoga, as assessed by completing the Get Active Questionnaire and obtaining medical clearance (if indicated).  5. Willing and able to complete informed consent, questionnaires, physical assessments, and an interview in English.  Exclusion Criteria:  1. Previous enrolment in the study, to avoid contamination and/or ceiling effects. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>S. Nicole Culos-Reed, PhD</last_name> <role>Study Director</role> <affiliation>University of Calgary</affiliation> </overall_official> <overall_contact> <last_name>S. Nicole Culos-Reed, PhD</last_name> <phone>403-220-7540</phone> <email>nculosre@ucalgary.ca</email> </overall_contact> <overall_contact_backup> <last_name>Amanda Wurz, PhD</last_name> <phone>604-504-7441</phone> <phone_ext>2846</phone_ext> <email>amanda.wurz@ufv.ca</email> </overall_contact_backup> <location> <facility> <name>University of Calgary</name> <address> <city>Calgary</city> <state>Alberta</state> <zip>T2N 1N4</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>S. Nicole Culos-Reed, PhD</last_name> <phone>403-220-7540</phone> <email>nculosre@ucalgary.ca</email> </contact> <contact_backup> <last_name>Wellness Lab</last_name> <phone>403-210-8482</phone> <email>wellnesslab@ucalgary.ca</email> </contact_backup> </location> <location_countries> <country>Canada</country> </location_countries> <reference> <citation>Rogers LQ, Courneya KS, Verhulst S, Markwell S, Lanzotti V, Shah P. Exercise barrier and task self-efficacy in breast cancer patients during treatment. Support Care Cancer. 2006 Jan;14(1):84-90. doi: 10.1007/s00520-005-0851-2. Epub 2005 Jul 9.</citation> <PMID>16007455</PMID> </reference> <reference> <citation>Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.</citation> <PMID>4053261</PMID> </reference> <reference> <citation>Acaster S, Dickerhoof R, DeBusk K, Bernard K, Strauss W, Allen LF. Qualitative and quantitative validation of the FACIT-fatigue scale in iron deficiency anemia. Health Qual Life Outcomes. 2015 May 17;13:60. doi: 10.1186/s12955-015-0257-x.</citation> <PMID>25980742</PMID> </reference> <reference> <citation>Wagner L, Sweet J, Butt Z, Lai J-S, Cella D. Measuring patient self-reported cognitive function: development of the functional assessment of cancer therapy-cognitive function instrument. J Support Oncol, 2009. 7(6): W32-W39.</citation> </reference> <reference> <citation>Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.</citation> <PMID>10813730</PMID> </reference> <reference> <citation>Pickard AS, De Leon MC, Kohlmann T, Cella D, Rosenbloom S. Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Med Care. 2007 Mar;45(3):259-63. doi: 10.1097/01.mlr.0000254515.63841.81.</citation> <PMID>17304084</PMID> </reference> <reference> <citation>Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.</citation> <PMID>8445433</PMID> </reference> <reference> <citation>Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.</citation> <PMID>12703651</PMID> </reference> <reference> <citation>Neff KD. Development and validation of a scale to measure self-compassion. Self Ident, 2003. 2: 223-50.</citation> </reference> <reference> <citation>Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.</citation> <PMID>6668417</PMID> </reference> <reference> <citation>Sani F, Madhok V, Norbury M, Dugard P, Wakefield JR. Greater number of group identifications is associated with lower odds of being depressed: evidence from a Scottish community sample. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1389-97. doi: 10.1007/s00127-015-1076-4. Epub 2015 Jun 10.</citation> <PMID>26058588</PMID> </reference> <reference> <citation>McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.</citation> <PMID>31519676</PMID> </reference> <verification_date>February 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse>  </clinical_study>

Yoga may enhance physical and psychological outcomes among young adults affected by cancer. Yet, yoga has rarely been studied in this population. We developed and piloted a yoga program, which is now ready for implementation and evaluation. This single-group, mixed-methods project will explore effectiveness and implementation of the yoga program. Inclusion Criteria: 1. Adult aged 18 years or older; 2. Diagnosed with cancer between the ages of 18-39 years; 3. At any stage of their cancer experience (i.e., on- or off-treatment); 4. Able to safely engage in yoga, as assessed by completing the Get Active Questionnaire and obtaining medical clearance (if indicated). 5. Willing and able to complete informed consent, questionnaires, physical assessments, and an interview in English. Exclusion Criteria: 1. Previous enrolment in the study, to avoid contamination and/or ceiling effects.

NCT0531xxxx/NCT05314816.xml

<clinical_study>  <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/NCT05314816</url> </required_header> <id_info> <org_study_id>20-0464</org_study_id> <nct_id>NCT05314816</nct_id> </id_info> <brief_title>Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala</brief_title> <official_title>Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala</official_title> <sponsors> <lead_sponsor> <agency>University of Colorado, Denver</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>BioFire Diagnostics, LLC</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>University of Colorado, Denver</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City. </textblock> </brief_summary> <detailed_description> <textblock> A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 7, 2022</start_date> <completion_date type="Actual">November 28, 2022</completion_date> <primary_completion_date type="Actual">November 11, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Diagnostic</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Time to optimal antimicrobial therapy</measure> <time_frame>14 days</time_frame> <description>Calculated from the time of blood culture draw to the time that optimal antimicrobial therapy is started. Optimal antimicrobial therapy is defined based on pre-determined organism-antimicrobial guidelines.</description> </primary_outcome> <secondary_outcome> <measure>Time to organism identification</measure> <time_frame>14 days</time_frame> <description>Calculated from the time of blood culture draw to the time of organism identification.</description> </secondary_outcome> <secondary_outcome> <measure>Time to effective antimicrobial therapy</measure> <time_frame>14 days</time_frame> <description>Calculated from the time of blood culture draw to the time that the effective therapy is started. Effective therapy is determined based on susceptibilities of the organism.</description> </secondary_outcome> <secondary_outcome> <measure>All-cause mortality</measure> <time_frame>30 days</time_frame> </secondary_outcome> <secondary_outcome> <measure>Length of hospital stay</measure> <time_frame>30 days</time_frame> </secondary_outcome> <secondary_outcome> <measure>Intensive care unit days</measure> <time_frame>30 days</time_frame> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">384</enrollment> <condition>Bacteremia</condition> <condition>Sepsis</condition> <arm_group> <arm_group_label>Blood culture identification panel</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>BioFire BCID2 (Blood culture identification panel) will be performed on positive blood culture specimens.</description> </arm_group> <arm_group> <arm_group_label>Concurrent control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Standard blood culture process will be performed concurrently on select positive blood culture specimens during the study period. BCID2 will NOT be performed on these specimens.</description> </arm_group> <arm_group> <arm_group_label>Retrospective control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Standard blood culture process was performed prior to the study period.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Blood culture identification panel</intervention_name> <description>multiplex PCR panel to be performed on positive blood cultures</description> <arm_group_label>Blood culture identification panel</arm_group_label> <other_name>BCID2</other_name> <other_name>BioFire BCID2 Panel</other_name> <other_name>BioFire FilmArray</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age <18 years of age  - First positive blood culture during the hospitalization  Exclusion Criteria:  - Non-blood specimens  - Repeat positive blood cultures from the same admission  - Patients who expire prior to positive culture  - Outpatient blood cultures </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>18 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Samuel Dominguez, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Colorado, Denver</affiliation> </overall_official> <location> <facility> <name>Hospital Roosevelt</name> <address> <city>Guatemala City</city> <country>Guatemala</country> </address> </facility> </location> <location_countries> <country>Guatemala</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 5, 2022</last_update_submitted> <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>bacteremia</keyword> <keyword>sepsis</keyword> <keyword>antimicrobial resistance</keyword> <keyword>BCID2</keyword> <keyword>multiplex PCR</keyword> <keyword>pediatric</keyword> <condition_browse>  <mesh_term>Bacteremia</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City. A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups. Inclusion Criteria: - Age <18 years of age - First positive blood culture during the hospitalization Exclusion Criteria: - Non-blood specimens - Repeat positive blood cultures from the same admission - Patients who expire prior to positive culture - Outpatient blood cultures

NCT0531xxxx/NCT05314829.xml

<clinical_study>  <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/NCT05314829</url> </required_header> <id_info> <org_study_id>Child advocacy centers</org_study_id> <nct_id>NCT05314829</nct_id> </id_info> <brief_title>Trauma Treatment in Norwegian Child Advocacy Centers</brief_title> <official_title>Trauma Treatment in Norwegian Child Advocacy Centers</official_title> <sponsors> <lead_sponsor> <agency>Norwegian Center for Violence and Traumatic Stress Studies</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Norwegian Center for Violence and Traumatic Stress Studies</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere.  The current project will investigate four issues related to these knowledge needs;  1. How do children and parents experience receiving trauma treatment at child advocacy centers?  2. What predicts treatment effects?  3. What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress? </textblock> </brief_summary> <detailed_description> <textblock> Employees in the child advocacy centers (CAC) received training in trauma screening and a sub-sample received training in Trauma-Focused Cognitive Behavioral Therapy (TF-CBT).  To address the knowledge gaps, this project will answer the following research questions, corresponding to four Work Packages (WP):  1. Youth's and caregiver´s experiences with trauma treatment in CACs: How do youth and caregivers experience receiving trauma treatment in Norwegian CACs, and how are their experiences affected by CACs dual role as both a forensic institution and a treatment institution?  2. Response, non-response and dropout in trauma treatment in CACs: What predicts treatment outcomes for youth receiving TF-CBT in Norwegian CACs?  3. Therapists' experiences with trauma treatment in CACs: How do therapists in Norwegian CACs experience job demands and job resources, including burnout and secondary traumatic stress, and how can working with TF-CBT influence this?  4. Descriptive study of leadership, turnover, and secondary traumatic stress among staff in Norwegian Child Advocacy Centers.  To answer research question 1, qualitative interviews with children and caregivers will be conducted following their participation in TF-CBT.  For research question 2, quantitative data will be collected during the TF-CBT sessions. The child advocacy centers identify eligible TF-CBT clients through systematic trauma screening and establish routines for how TF-CBT is offered and delivered.  Research question 3 is qualitative, with semi-structured interviews with therapists.  Lastly, both questionnaire data and interviews will be used to answer research question 4. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 1, 2020</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Ecologic or Community</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>The Child and Adolescent Trauma Screen (CATS)</measure> <time_frame>2021-2023</time_frame> <description>CATS is a screening instrument for PTSD based on the DSM-5 criterias.Total score range is between 0-60. A higher score indicates more symptoms, with a cut-off ≥ 21 as indication of a clinically relevant level of symptoms.</description> </primary_outcome> <secondary_outcome> <measure>Child Post-Traumatic Cognitions Inventory (cPTCI)</measure> <time_frame>2021-2023</time_frame> <description>Measures maladaptive cognitions in children and young people following trauma exposure. Total score range is between 0-60. A higher score indicates more symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Short Moods and Feelings Questionnaire (SMFQ)</measure> <time_frame>2021-2023</time_frame> <description>Measures moods and feelings. Total score range is between 0-26. A higher score indicates more symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Duke-UNC Functional Social Support Questionnaire (FSSQ)</measure> <time_frame>2021-2023</time_frame> <description>Measures social support. Total score range is between 8-40. The higher the average score, the greater the perceived social support.</description> </secondary_outcome> <secondary_outcome> <measure>Project specific questionnaire, inspired by the Working Alliance Inventory (WAI)</measure> <time_frame>2021-2023</time_frame> <description>Measures trust. Total score range is between 12-48. The higher the average score, the greater the perceived alliance.</description> </secondary_outcome> <secondary_outcome> <measure>Client Satisfaction Questionnaire (to the caregiver)</measure> <time_frame>2021-2023</time_frame> <description>Measures cilients satisfaction with TF-CBT. Total score range is between 0-32.The higher the average score, the greater client satisfaction.</description> </secondary_outcome> <secondary_outcome> <measure>Child Satisfaction Questionnaire (developed by NKVTS)</measure> <time_frame>2021-2023</time_frame> <description>3 items (children) developed by NKVTS, to measure child satisfaction with the treatment. Total score range from 3-12. The higher the average score, the higher child satisfaction.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">100</enrollment> <condition>Post Traumatic Stress Disorder</condition> <arm_group> <arm_group_label>Study group</arm_group_label> <description>Data will be collected from 2 child advocacy centers</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Trauma-focused cognitive behavioral therapy (TF-CBT)</intervention_name> <description>TF-CBT is a phase-based evidence-based treatment method for children and adolescents between 6-18 years who experience posttraumatic stress symptoms following trauma exposure. Parents or other close caregivers receive parallel sessions. It is normally provided through 12-16 sessions.</description> <arm_group_label>Study group</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Children and adolescents who receive services at Norwegian child and adolescent advocacy centers. They are screened for posttraumatic reactions to the potential traumatising events that they have experienced, and are offered trauma-focused cognitive behavioral therapy if scoring above the clinical cut-off for PTS: </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Trauma exposure  - Post-traumatic stress symptoms above clinical cut-off  Exclusion Criteria:  - Clinical assessment concludes that the child should receive services in the child and adolescent specialist services </textblock> </criteria> <gender>All</gender> <minimum_age>6 Years</minimum_age> <maximum_age>18 Years</maximum_age> </eligibility> <overall_official> <last_name>Ane-Marthe Solheim Skar</last_name> <role>Principal Investigator</role> <affiliation>Norwegian Center for Violence and Traumatic Stress Studies</affiliation> </overall_official> <overall_contact> <last_name>Ane-Marthe S Skar, PhD</last_name> <phone>+4797661591</phone> <email>a.m.s.skar@nkvts.no</email> </overall_contact> <overall_contact_backup> <last_name>Karina M Egeland, PhD</last_name> <phone>+4790602326</phone> <email>karina.egeland@nkvts.no</email> </overall_contact_backup> <location> <facility> <name>Nowegian Center for Violence and Traumatic Stress Studies</name> <address> <city>Oslo</city> <zip>0655</zip> <country>Norway</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ane-Marthe Skar</last_name> <phone>97661591</phone> <email>amskar@gmail.com</email> </contact> </location> <location_countries> <country>Norway</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>March 24, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 27, 2022</last_update_submitted> <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 30, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Norwegian Center for Violence and Traumatic Stress Studies</investigator_affiliation> <investigator_full_name>Ane-Marthe Solheim Skar</investigator_full_name> <investigator_title>PhD, project leader</investigator_title> </responsible_party> <keyword>PTSD</keyword> <keyword>Child advocacy center</keyword> <keyword>Childhood trauma</keyword> <condition_browse>  <mesh_term>Stress Disorders, Traumatic</mesh_term> <mesh_term>Stress Disorders, Post-Traumatic</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>This is not included in the consent letter to the participants.</ipd_description> </patient_data>  </clinical_study>

Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere. The current project will investigate four issues related to these knowledge needs; 1. How do children and parents experience receiving trauma treatment at child advocacy centers? 2. What predicts treatment effects? 3. What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress? Employees in the child advocacy centers (CAC) received training in trauma screening and a sub-sample received training in Trauma-Focused Cognitive Behavioral Therapy (TF-CBT). To address the knowledge gaps, this project will answer the following research questions, corresponding to four Work Packages (WP): 1. Youth's and caregiver´s experiences with trauma treatment in CACs: How do youth and caregivers experience receiving trauma treatment in Norwegian CACs, and how are their experiences affected by CACs dual role as both a forensic institution and a treatment institution? 2. Response, non-response and dropout in trauma treatment in CACs: What predicts treatment outcomes for youth receiving TF-CBT in Norwegian CACs? 3. Therapists' experiences with trauma treatment in CACs: How do therapists in Norwegian CACs experience job demands and job resources, including burnout and secondary traumatic stress, and how can working with TF-CBT influence this? 4. Descriptive study of leadership, turnover, and secondary traumatic stress among staff in Norwegian Child Advocacy Centers. To answer research question 1, qualitative interviews with children and caregivers will be conducted following their participation in TF-CBT. For research question 2, quantitative data will be collected during the TF-CBT sessions. The child advocacy centers identify eligible TF-CBT clients through systematic trauma screening and establish routines for how TF-CBT is offered and delivered. Research question 3 is qualitative, with semi-structured interviews with therapists. Lastly, both questionnaire data and interviews will be used to answer research question 4. Children and adolescents who receive services at Norwegian child and adolescent advocacy centers. They are screened for posttraumatic reactions to the potential traumatising events that they have experienced, and are offered trauma-focused cognitive behavioral therapy if scoring above the clinical cut-off for PTS: Inclusion Criteria: - Trauma exposure - Post-traumatic stress symptoms above clinical cut-off Exclusion Criteria: - Clinical assessment concludes that the child should receive services in the child and adolescent specialist services

NCT0531xxxx/NCT05314842.xml

<clinical_study>  <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/NCT05314842</url> </required_header> <id_info> <org_study_id>203</org_study_id> <nct_id>NCT05314842</nct_id> </id_info> <brief_title>Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol</brief_title> <official_title>Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.</official_title> <sponsors> <lead_sponsor> <agency>Sarah Abdelbar Mahmoud</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes. </textblock> </brief_summary> <detailed_description> <textblock> Primary outcome:  Soft-tissue pathology  - Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.  - Sinus tract or fistula will be assessed through visual examination by the operator  Secondary outcomes:  1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror  2. mobility will be assessed through the back of two mirrors  3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).  clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.  • These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">May 1, 2023</completion_date> <primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Soft-tissue pathology</measure> <time_frame>at 0 day</time_frame> <description>Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)</description> </primary_outcome> <primary_outcome> <measure>Soft-tissue pathology</measure> <time_frame>at 3 month</time_frame> <description>Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)</description> </primary_outcome> <primary_outcome> <measure>Soft-tissue pathology</measure> <time_frame>at 6 month</time_frame> <description>Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)</description> </primary_outcome> <primary_outcome> <measure>Soft-tissue pathology</measure> <time_frame>at 1 year</time_frame> <description>Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. -Sinus tract or fistula will be assessed through visual examination by the operator. Binary (present or absent)</description> </primary_outcome> <secondary_outcome> <measure>• Pain to the percussion</measure> <time_frame>at 0 day</time_frame> <description>will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>• Pain to the percussion</measure> <time_frame>at 3 month</time_frame> <description>will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>• Pain to the percussion</measure> <time_frame>at 6 month</time_frame> <description>will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>• Pain to the percussion</measure> <time_frame>at 1 year</time_frame> <description>will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>mobility</measure> <time_frame>at 0 day</time_frame> <description>• Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades</description> </secondary_outcome> <secondary_outcome> <measure>mobility</measure> <time_frame>at 3 month</time_frame> <description>• Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades</description> </secondary_outcome> <secondary_outcome> <measure>mobility</measure> <time_frame>at 6 month</time_frame> <description>• Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades</description> </secondary_outcome> <secondary_outcome> <measure>mobility</measure> <time_frame>at 1 year</time_frame> <description>• Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades</description> </secondary_outcome> <secondary_outcome> <measure>radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).</measure> <time_frame>at 0 day</time_frame> <description>Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).</measure> <time_frame>at 3 month</time_frame> <description>Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).</measure> <time_frame>at 6 month</time_frame> <description>Binary (present or absent)</description> </secondary_outcome> <secondary_outcome> <measure>radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).</measure> <time_frame>at 1 year</time_frame> <description>Binary (present or absent)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Caries</condition> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>the group that have caries in primary molars and treat them with formocresol</description> </arm_group> <arm_group> <arm_group_label>experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>the group that have caries in primary molars and treat them with premixed bioceramic MTA</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Formocresol</intervention_name> <description>dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars</description> <arm_group_label>control group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Premixed bioceramic MTA</intervention_name> <description>dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars</description> <arm_group_label>experimental group</arm_group_label> <other_name>Neoputty</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Medically fit and cooperative children.  - Pediatric patients aged 4-6 years.  - A deep carious lesion in vital primary molars.  - Absence of clinical signs and symptoms of pulpal exposure.  - Absence of radiographic signs and symptoms of people degeneration.  - Positive parental informed consent.  Exclusion Criteria:  Uncooperative children.  - Medically compromised children.  - Presence of clinical signs and symptoms of pulpal exposure.  - Presence of radiographic signs and symptoms of pulp degeneration.  - Physiologic root resorption more than one-third. </textblock> </criteria> <gender>All</gender> <minimum_age>4 Years</minimum_age> <maximum_age>6 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>ahmed m Elkhadem, Ass.Prof</last_name> <role>Study Chair</role> <affiliation>Cairo University</affiliation> </overall_official> <overall_contact> <last_name>sarah A Mahmoud, B.D.S</last_name> <phone>01023469565</phone> <email>sarah_mahmoud@dentistry.cu.edu.eg</email> </overall_contact> <overall_contact_backup> <last_name>maiI A Mahmed, PHD</last_name> <phone>01012632608</phone> <email>mai.ali@dentistry.cu.edu.eg</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 25, 2022</study_first_submitted> <study_first_submitted_qc>April 2, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 2, 2022</last_update_submitted> <last_update_submitted_qc>April 2, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Sarah Abdelbar Mahmoud</investigator_full_name> <investigator_title>principal investigator</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes. Primary outcome: Soft-tissue pathology - Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally. - Sinus tract or fistula will be assessed through visual examination by the operator Secondary outcomes: 1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror 2. mobility will be assessed through the back of two mirrors 3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period. • These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline. Inclusion Criteria: - Medically fit and cooperative children. - Pediatric patients aged 4-6 years. - A deep carious lesion in vital primary molars. - Absence of clinical signs and symptoms of pulpal exposure. - Absence of radiographic signs and symptoms of people degeneration. - Positive parental informed consent. Exclusion Criteria: Uncooperative children. - Medically compromised children. - Presence of clinical signs and symptoms of pulpal exposure. - Presence of radiographic signs and symptoms of pulp degeneration. - Physiologic root resorption more than one-third.

NCT0531xxxx/NCT05314855.xml

<clinical_study>  <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/NCT05314855</url> </required_header> <id_info> <org_study_id>NL79698.018.21</org_study_id> <nct_id>NCT05314855</nct_id> </id_info> <brief_title>Brain Clock and Insulin Resistance</brief_title> <official_title>Role of the Central Brain Clock in the Pathophysiology of Insulin Resistance</official_title> <sponsors> <lead_sponsor> <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> In this observational cohort study the investigators will determine the activity rhythm of the suprachiasmatic nucleus in humans with progressive stages of insulin resistance, using advanced functional brain imaging (7 Tesla functional MRI). </textblock> </brief_summary> <detailed_description> <textblock> Type 2 diabetes mellitus (T2DM) has an increasing worldwide incidence. Insulin resistance is a key pathophysiological process in the development of hyperglycemia in patients with T2DM. Disruption of circadian synchrony leads to insulin resistance. Animal studies and post-mortem human brain studies suggest that the master brain clock in the hypothalamic suprachiasmatic nucleus (SCN) plays a role in the development of insulin resistance. Up to now, no-one has investigated whether the in vivo activity rhythm of the SCN is affected in patients with insulin resistance. The investigators hypothesize that the master brain clock has an important role in the development of human insulin resistance. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 4, 2023</start_date> <completion_date type="Anticipated">January 1, 2025</completion_date> <primary_completion_date type="Anticipated">January 4, 2024</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <target_duration>12 Months</target_duration> <primary_outcome> <measure>SCN blood oxygen level dependent (BOLD) response to light: mean SCN activity</measure> <time_frame>mean activity over 24 hours</time_frame> <description>SCN BOLD response to light stimulus (percent BOLD signal change)</description> </primary_outcome> <primary_outcome> <measure>SCN BOLD response to light: time point of peak SCN activity</measure> <time_frame>24 hours</time_frame> <description>time point (zeitgeber time in hh:mm)</description> </primary_outcome> <primary_outcome> <measure>SCN BOLD) response to light: time point of trough SCN activity</measure> <time_frame>24 hours</time_frame> <description>time point (zeitgeber time in hh:mm)</description> </primary_outcome> <primary_outcome> <measure>Amplitude of SCN activity rhythm (peak-trough change in SCN activity)</measure> <time_frame>24 hours</time_frame> <description>Peak-trough difference in SCN activity (percent BOLD signal change)</description> </primary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">30</enrollment> <condition>Insulin Resistance</condition> <condition>Type 2 Diabetes</condition> <arm_group> <arm_group_label>Obese individuals with normal insulin sensitivity</arm_group_label> </arm_group> <arm_group> <arm_group_label>Obese individuals with impaired insulin sensitivity</arm_group_label> </arm_group> <arm_group> <arm_group_label>Obese patients with type 2 diabetes</arm_group_label> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>functional MRI</intervention_name> <description>Subjects will undergo functional MRI at 4 time points in 24 hours.</description> <arm_group_label>Obese individuals with impaired insulin sensitivity</arm_group_label> <arm_group_label>Obese individuals with normal insulin sensitivity</arm_group_label> <arm_group_label>Obese patients with type 2 diabetes</arm_group_label> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Whole blood samples </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Primary care clinics, community sample </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  Group 1: obese people with normal insulin sensitivity  - age 25-65 years  - BMI>30  - fasting plasma insulin ≤62 pmol/L  - fasting plasma glucose <5.6 mmol/L  - Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≤ 4.5  Group 2: obese people with insulin resistance  - age 25-65 years  - BMI>30  - fasting plasma insulin >62 pmol/L  - not fulfilling the American Diabetes Association (ADA) criteria for type 2 DM  Group 3: obese subjects with overt type 2 DM  - age 25-65 years  - BMI>30  - diagnosis type 2 DM according to ADA criteria  Exclusion Criteria:  - An extreme chronotype (midpoint of sleep on free days (MSFsc) before 2:00 or after 6:00).  - Active psychiatric disorder (including circadian rhythm sleep disorder) as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM) 5  - Disorders of the central nervous system (Early-onset dementia, stroke, epilepsy, Parkinson's disease, brain tumor)  - Severe visual impairment (WHO classification)  - Shift workers  - Crossing > 2 time zones in the 3 months before the study  - Patients with type 2 DM receiving insulin treatment or glucagon-like peptide (GLP) 1 agonists  - MRI contraindications </textblock> </criteria> <gender>All</gender> <minimum_age>25 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Dr. D.J. Stenvers</last_name> <role>Principal Investigator</role> <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation> </overall_official> <overall_contact> <last_name>E.M. Speksnijder</last_name> <phone>+31 20 5666071</phone> <email>e.m.speksnijder@amsterdamumc.nl</email> </overall_contact> <location> <facility> <name>Amsterdam University Medical Centers, location AMC</name> <address> <city>Amsterdam</city> <state>Noord-Holland</state> <zip>1105AZ</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Esther Speksnijder</last_name> <phone>+31 20 5666071</phone> <email>e.m.speksnijder@amsterdamumc.nl</email> </contact> </location> <location_countries> <country>Netherlands</country> </location_countries> <reference> <citation>World Health Organization, Global report on diabetes., in WHO Library. 2016</citation> </reference> <reference> <citation>Cleland SJ, Fisher BM, Colhoun HM, Sattar N, Petrie JR. Insulin resistance in type 1 diabetes: what is 'double diabetes' and what are the risks? Diabetologia. 2013 Jul;56(7):1462-70. doi: 10.1007/s00125-013-2904-2. Epub 2013 Apr 24.</citation> <PMID>23613085</PMID> </reference> <reference> <citation>Stenvers DJ, Scheer FAJL, Schrauwen P, la Fleur SE, Kalsbeek A. Circadian clocks and insulin resistance. Nat Rev Endocrinol. 2019 Feb;15(2):75-89. doi: 10.1038/s41574-018-0122-1.</citation> <PMID>30531917</PMID> </reference> <reference> <citation>Hogenboom R, Kalsbeek MJ, Korpel NL, de Goede P, Koenen M, Buijs RM, Romijn JA, Swaab DF, Kalsbeek A, Yi CX. Loss of arginine vasopressin- and vasoactive intestinal polypeptide-containing neurons and glial cells in the suprachiasmatic nucleus of individuals with type 2 diabetes. Diabetologia. 2019 Nov;62(11):2088-2093. doi: 10.1007/s00125-019-4953-7. Epub 2019 Jul 20.</citation> <PMID>31327049</PMID> </reference> <reference> <citation>ter Horst KW, Gilijamse PW, Koopman KE, de Weijer BA, Brands M, Kootte RS, Romijn JA, Ackermans MT, Nieuwdorp M, Soeters MR, Serlie MJ. Insulin resistance in obesity can be reliably identified from fasting plasma insulin. Int J Obes (Lond). 2015 Dec;39(12):1703-9. doi: 10.1038/ijo.2015.125. Epub 2015 Jul 9.</citation> <PMID>26155920</PMID> </reference> <reference> <citation>American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.</citation> <PMID>25537714</PMID> </reference> <reference> <citation>Roenneberg T, Kuehnle T, Pramstaller PP, Ricken J, Havel M, Guth A, Merrow M. A marker for the end of adolescence. Curr Biol. 2004 Dec 29;14(24):R1038-9. doi: 10.1016/j.cub.2004.11.039. No abstract available.</citation> <PMID>15620633</PMID> </reference> <reference> <citation>World report on vision. Geneva: World Health Organization. 2019</citation> </reference> <verification_date>September 2023</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 8, 2023</last_update_submitted> <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation> <investigator_full_name>Dirk Jan Stenvers</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Type 2 Diabetes Mellitus</keyword> <keyword>Insulin resistance</keyword> <keyword>Suprachiasmatic nucleus</keyword> <keyword>functional MRI</keyword> <condition_browse>  <mesh_term>Diabetes Mellitus, Type 2</mesh_term> <mesh_term>Insulin Resistance</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

In this observational cohort study the investigators will determine the activity rhythm of the suprachiasmatic nucleus in humans with progressive stages of insulin resistance, using advanced functional brain imaging (7 Tesla functional MRI). Type 2 diabetes mellitus (T2DM) has an increasing worldwide incidence. Insulin resistance is a key pathophysiological process in the development of hyperglycemia in patients with T2DM. Disruption of circadian synchrony leads to insulin resistance. Animal studies and post-mortem human brain studies suggest that the master brain clock in the hypothalamic suprachiasmatic nucleus (SCN) plays a role in the development of insulin resistance. Up to now, no-one has investigated whether the in vivo activity rhythm of the SCN is affected in patients with insulin resistance. The investigators hypothesize that the master brain clock has an important role in the development of human insulin resistance. Whole blood samples Primary care clinics, community sample Inclusion Criteria: Group 1: obese people with normal insulin sensitivity - age 25-65 years - BMI>30 - fasting plasma insulin ≤62 pmol/L - fasting plasma glucose <5.6 mmol/L - Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≤ 4.5 Group 2: obese people with insulin resistance - age 25-65 years - BMI>30 - fasting plasma insulin >62 pmol/L - not fulfilling the American Diabetes Association (ADA) criteria for type 2 DM Group 3: obese subjects with overt type 2 DM - age 25-65 years - BMI>30 - diagnosis type 2 DM according to ADA criteria Exclusion Criteria: - An extreme chronotype (midpoint of sleep on free days (MSFsc) before 2:00 or after 6:00). - Active psychiatric disorder (including circadian rhythm sleep disorder) as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 - Disorders of the central nervous system (Early-onset dementia, stroke, epilepsy, Parkinson's disease, brain tumor) - Severe visual impairment (WHO classification) - Shift workers - Crossing > 2 time zones in the 3 months before the study - Patients with type 2 DM receiving insulin treatment or glucagon-like peptide (GLP) 1 agonists - MRI contraindications

NCT0531xxxx/NCT05314868.xml

<clinical_study>  <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/NCT05314868</url> </required_header> <id_info> <org_study_id>PHF1901.000-M (11/19)</org_study_id> <nct_id>NCT05314868</nct_id> </id_info> <brief_title>Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium in Cardiac Repair or Reconstruction Surgery</brief_title> <acronym>Retro-C</acronym> <official_title>Postmarket, Retrospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Cardiac Repair or Reconstruction Surgery</official_title> <sponsors> <lead_sponsor> <agency>Artivion Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Artivion Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques. </textblock> </brief_summary> <detailed_description> <textblock> This study will include a review of approximately 300 charts spanning the implant period of January 1, 2018 through June 30, 2019. Those that meet the inclusion and exclusion criteria will undergo full review and data extraction to be captured in the electronic database. Given the retrospective nature of the study design, a Waiver of Consent will be requested from the Institutional Review Board (IRB). Potential subjects this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. Targeted cardiac procedures include intracardiac repair (including annulus and septal repair), great vessel repair (including superior vena cava, inferior vena cava, pulmonary arteries, pulmonary veins, and ascending aorta), and suture line buttressing and pericardial closure. Follow-up data will be abstracted from the subject's medical record. Study specific testing, including imaging and laboratory testing, will not be required. </textblock> </detailed_description> <overall_status>Terminated</overall_status> <why_stopped> Sponsor declined to continue funding the study. </why_stopped> <start_date type="Actual">March 31, 2022</start_date> <completion_date type="Actual">November 30, 2022</completion_date> <primary_completion_date type="Actual">November 30, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Overall survival</measure> <time_frame>Up to 5 years</time_frame> <description>Mortality</description> </primary_outcome> <secondary_outcome> <measure>All-cause reoperation</measure> <time_frame>Up to 5 years</time_frame> <description>The total number of unplanned reoperations required in patients over the follow-up period, which include the repair or alteration of the surgical area around the patch. Patients with planned reoperations, such as CHD staged surgeries, will not be considered.</description> </secondary_outcome> <secondary_outcome> <measure>Device-related reoperation</measure> <time_frame>Up to 5 years</time_frame> <description>The total number of unplanned reoperations required in patients over the follow-up period, which are determined by the surgeon to be device-related.</description> </secondary_outcome> <secondary_outcome> <measure>Explant</measure> <time_frame>Up to 5 years</time_frame> <description>The total number of device explants over the course of follow-up.</description> </secondary_outcome> <secondary_outcome> <measure>Morbidity</measure> <time_frame>Up to 5 years</time_frame> <description>The total number of any adverse event, with specific focus on cardiovascular complications which have the potential to be device-related.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">10</enrollment> <condition>Congenital Heart Disease</condition> <condition>Cardiac Anomaly</condition> <arm_group> <arm_group_label>Primary cohort</arm_group_label> <description>Pediatrics or adults who underwent cardiac repair surgery that nessecitated the use of a PhotoFix patch.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>PhotoFix</intervention_name> <description>Surgical repair with patch.</description> <arm_group_label>Primary cohort</arm_group_label> <other_name>PhotoFix Decellularized Bovine Pericardium</other_name> </intervention> <eligibility> <study_pop> <textblock> Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium  Exclusion Criteria:  - Subject required valve leaflet repair using PhotoFix </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Christopher Baird, MD</last_name> <role>Principal Investigator</role> <affiliation>Boston Children's Hospital</affiliation> </overall_official> <location> <facility> <name>Children's Hospital of Boston</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02115</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 12, 2023</last_update_submitted> <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>bovine pericardium patch</keyword> <keyword>cardiac repair</keyword> <keyword>cardiac reconstruction</keyword> <condition_browse>  <mesh_term>Heart Diseases</mesh_term> <mesh_term>Heart Defects, Congenital</mesh_term> </condition_browse>  </clinical_study>

The objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received PhotoFix® Decellularized Bovine Pericardium (PhotoFix) as a patch within a cardiac surgical repair or reconstruction procedure. PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques. This study will include a review of approximately 300 charts spanning the implant period of January 1, 2018 through June 30, 2019. Those that meet the inclusion and exclusion criteria will undergo full review and data extraction to be captured in the electronic database. Given the retrospective nature of the study design, a Waiver of Consent will be requested from the Institutional Review Board (IRB). Potential subjects this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. Targeted cardiac procedures include intracardiac repair (including annulus and septal repair), great vessel repair (including superior vena cava, inferior vena cava, pulmonary arteries, pulmonary veins, and ascending aorta), and suture line buttressing and pericardial closure. Follow-up data will be abstracted from the subject's medical record. Study specific testing, including imaging and laboratory testing, will not be required. Candidates for this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. Inclusion Criteria: - Subject has undergone a cardiac procedure which falls within the indications for use and required the use of PhotoFix Decellularized Bovine Pericardium Exclusion Criteria: - Subject required valve leaflet repair using PhotoFix

NCT0531xxxx/NCT05314881.xml

<clinical_study>  <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/NCT05314881</url> </required_header> <id_info> <org_study_id>gene polymorphism in SLE</org_study_id> <nct_id>NCT05314881</nct_id> </id_info> <brief_title>NCF Gene & TNFSF4 in SLE Patients</brief_title> <official_title>Polymorphisms of the Tumor Necrosis Factor Superfamily 4 and Neutrophil Cytosolic Factor Gene in SLE Egyptian Patients.</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients. </textblock> </brief_summary> <detailed_description> <textblock> Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. Among the SLE patients, two may share the same clinical manifestations but have different phenotypes.  This is why studies are searching for the different genes that might be associated with SLE susceptibility.  The Neutrophil cytosolic factor (NCF) Gene provide the instruction for the synthesis of group of proteins that form the NADPH oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ROS) which in turn is important in the regulation of immune system.  While the Tumor necrosis factor superfamily 4 (TNFSF4) encodes the ligand for OX40 (OX40L), which delivers a strong costimulatory signal to activated effector T-cells and enhances both Th1 and Th2 responses when engaged with its receptor. Therefore, increased levels of cell surface OX40L may augment B cell differentiation and proliferation. The consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in SLE.  So, NCF and TNFSF4 gene polymorphism are supposed to be associated with SLE risk and pathophysiology. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">July 2022</completion_date> <primary_completion_date type="Anticipated">June 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Concentration of gene polymorphism of the TNFS4 & NCF in SLE Egyptian patients.</measure> <time_frame>3 months</time_frame> <description>Identify the number of Participants with SNP polymorphisms in the TNFS4, and NCF gene in SLE Egyptian patients and the relation between the concentration of polymorphism and disease activity</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">65</enrollment> <condition>System; Lupus Erythematosus</condition> <arm_group> <arm_group_label>SLE patients</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Genetic</intervention_type> <intervention_name>TNFS4, NCF gene</intervention_name> <description>study the gene polymorphisms from the blood sample of the included SLE patients</description> <arm_group_label>SLE patients</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - SLE patients  - patients older than 18 years old  Exclusion Criteria:  - patients with other connective tissue diseases  - patients older than 70 years old </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Yasmine Makarem, Dr</last_name> <phone>+201002929015</phone> <email>yasmine.saad@aun.edu.eg</email> </overall_contact> <overall_contact_backup> <last_name>Marwa Galal, Dr</last_name> <phone>+201006783422</phone> <email>marwa.a.galal@aun.edu.eg</email> </overall_contact_backup> <reference> <citation>Aziz MM, Galal MAA, Elzohri MH, El-Nouby F, Leong KP. Cross-cultural adaptation and validation of Systemic Lupus Erythematosus Quality of Life questionnaire into Arabic. Lupus. 2018 Apr;27(5):780-787. doi: 10.1177/0961203317747714. Epub 2018 Jan 7.</citation> <PMID>29308728</PMID> </reference> <reference> <citation>Kaiser R, Criswell LA. Genetics research in systemic lupus erythematosus for clinicians: methodology, progress, and controversies. Curr Opin Rheumatol. 2010 Mar;22(2):119-25. doi: 10.1097/BOR.0b013e3283361943.</citation> <PMID>20035223</PMID> </reference> <reference> <citation>Holmdahl R, Sareila O, Olsson LM, Backdahl L, Wing K. Ncf1 polymorphism reveals oxidative regulation of autoimmune chronic inflammation. Immunol Rev. 2016 Jan;269(1):228-47. doi: 10.1111/imr.12378.</citation> <PMID>26683156</PMID> </reference> <reference> <citation>Lu MM, Xu WD, Yang J, Ye QL, Feng CC, Li J, Pan HF, Tao JH, Wang J, Ye DQ. Association of TNFSF4 polymorphisms with systemic lupus erythematosus: a meta-analysis. Mod Rheumatol. 2013 Jul;23(4):686-93. doi: 10.1007/s10165-012-0708-8. Epub 2012 Aug 1.</citation> <PMID>22850862</PMID> </reference> <reference> <citation>Lane P. Role of OX40 signals in coordinating CD4 T cell selection, migration, and cytokine differentiation in T helper (Th)1 and Th2 cells. J Exp Med. 2000 Jan 17;191(2):201-6. doi: 10.1084/jem.191.2.201. No abstract available.</citation> <PMID>10637265</PMID> </reference> <reference> <citation>Ito T, Wang YH, Duramad O, Hanabuchi S, Perng OA, Gilliet M, Qin FX, Liu YJ. OX40 ligand shuts down IL-10-producing regulatory T cells. Proc Natl Acad Sci U S A. 2006 Aug 29;103(35):13138-43. doi: 10.1073/pnas.0603107103. Epub 2006 Aug 21.</citation> <PMID>16924108</PMID> </reference> <reference> <citation>Croft M. The role of TNF superfamily members in T-cell function and diseases. Nat Rev Immunol. 2009 Apr;9(4):271-85. doi: 10.1038/nri2526.</citation> <PMID>19319144</PMID> </reference> <reference> <citation>Stuber E, Neurath M, Calderhead D, Fell HP, Strober W. Cross-linking of OX40 ligand, a member of the TNF/NGF cytokine family, induces proliferation and differentiation in murine splenic B cells. Immunity. 1995 May;2(5):507-21. doi: 10.1016/1074-7613(95)90031-4.</citation> <PMID>7749983</PMID> </reference> <reference> <citation>Olsson LM, Johansson AC, Gullstrand B, Jonsen A, Saevarsdottir S, Ronnblom L, Leonard D, Wettero J, Sjowall C, Svenungsson E, Gunnarsson I, Bengtsson AA, Holmdahl R. A single nucleotide polymorphism in the NCF1 gene leading to reduced oxidative burst is associated with systemic lupus erythematosus. Ann Rheum Dis. 2017 Sep;76(9):1607-1613. doi: 10.1136/annrheumdis-2017-211287. Epub 2017 Jun 12.</citation> <PMID>28606963</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 26, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Yasmine Saad Makarem</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>TNFS4, NCF gene</keyword> <condition_browse>  <mesh_term>Lupus Erythematosus, Systemic</mesh_term> </condition_browse>  </clinical_study>

the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. Among the SLE patients, two may share the same clinical manifestations but have different phenotypes. This is why studies are searching for the different genes that might be associated with SLE susceptibility. The Neutrophil cytosolic factor (NCF) Gene provide the instruction for the synthesis of group of proteins that form the NADPH oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ROS) which in turn is important in the regulation of immune system. While the Tumor necrosis factor superfamily 4 (TNFSF4) encodes the ligand for OX40 (OX40L), which delivers a strong costimulatory signal to activated effector T-cells and enhances both Th1 and Th2 responses when engaged with its receptor. Therefore, increased levels of cell surface OX40L may augment B cell differentiation and proliferation. The consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in SLE. So, NCF and TNFSF4 gene polymorphism are supposed to be associated with SLE risk and pathophysiology. Inclusion Criteria: - SLE patients - patients older than 18 years old Exclusion Criteria: - patients with other connective tissue diseases - patients older than 70 years old

NCT0531xxxx/NCT05314894.xml

<clinical_study>  <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/NCT05314894</url> </required_header> <id_info> <org_study_id>AhiEvranU_EAkdeniz_001</org_study_id> <nct_id>NCT05314894</nct_id> </id_info> <brief_title>The Effect of the Education Program Based on the PRECEDE-PROCEED Model on the Smoking Behaviors of Nursing Students</brief_title> <official_title>The Effect of the Program Based on the PRECED-PROCEED Model "I am Giving up Smoking, I am Protecting My Future and My Health" on Smoking Behaviour of Nursing Students</official_title> <sponsors> <lead_sponsor> <agency>Kirsehir Ahi Evran Universitesi</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Kirsehir Ahi Evran Universitesi</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The causes of death due to smoking are responsible for 11.5% of the total deaths in the world. Smoking causes lung cancer, chronic obstructive pulmonary disease (COPD), ischemic heart disease and cerebrovascular diseases. In some studies on nursing students in the world, the prevalence of smoking is between 13.9% and 32%; It is known that it varies between 12.9% and 28% in Turkey. At the end of this study, nursing students are supported in smoking cessation by providing smoking cessation training, they become a role model for the society by gaining the right behavior, creating a society that smokes less, reducing the financial burden on the state as a result of protecting individuals from possible chronic diseases, and guiding health trainings on this subject. It is foreseen that it will be a guide in its implementation in the whole country. The aim of this study is to determine the effect of the I Stop Smoking, Protecting My Future and Health program based on the Preced-Proceed Model on the smoking behavior of nursing students. </textblock> </brief_summary> <detailed_description> <textblock> This study will be conducted in non-randomized groups in a quasi-experimental fashion as pre-test-post-test.  The population of the research was formed by the students in the Nursing Department of the Faculty of Health Sciences of Kırşehir Ahi Evran University. There are two branches of daytime education and two branches of secondary education, and the total number of students in the nursing department is 802. The sample size of the study was calculated using the G*Power (v3.1.9.6) package program. The power of the study was 80% and the sample size was α =0.05; It was calculated as a total of 64 people, 32 of which were interventions and 32 were control groups. However, considering the losses, 20% more than the calculated value was included in the sample and it was planned to include a total of 80 students, 40 of whom were in the intervention group and 40 in the control group.  Selection and Assignment of Individuals to the Intervention and Control Group Before being divided into intervention and control groups, students' consent was obtained and a pre-test was applied. Formal education and secondary education students were coded as A and B. For example, formal education A, secondary education B. The students in the related group were stratified by gender and the layer weight was determined. Random numbers were created in the Excel program and it was determined who would be in the groups with the simple random sampling method. In addition, which of the previously coded groups A and B would be the intervention group and which one would be the control group was determined by drawing lots. All these procedures were carried out by a person other than the researcher. Thus, it was determined who would be in the intervention and control group, and it was explained to the researcher before the training whether group A or group B was the intervention or control group.  Dependent variables:  - Behavior modification level  - Decision equilibrium level  - Self-efficacy level  - Level of encouraging factors  - Level of stages of change  - Number of people who quit smoking  - Nicotine addiction level  - Health perception level  Independent variables:  "I Stop Smoking, I Protect My Future and My Health" program based on the PRECEDE-PROCEED Model.  As data collection tools; Smoker identification form, individual information form, Behavior change process scale, Decision balance scale, Self-efficacy scale, Encouraging factors scale, Classification of stages of change scale, Fagerström nicotine addiction test will be used. The data were also planned to be collected in this environment before the first training (pretest), and after the second and third training (posttest). The first session will be held immediately after the pre-test, the second session will be held 15 days after the first session, and the last session will be held 15 days after the second session. A total of 40 messages will be sent to the students in the initiative group through the WhatsApp program, taking into account the factors that affect, strengthen and enable the main </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 1, 2021</start_date> <completion_date type="Actual">April 1, 2022</completion_date> <primary_completion_date type="Actual">November 1, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>It is expected that the students in the intervention group will be more likely to quit smoking than the students in the control group.</measure> <time_frame>6 months</time_frame> <description>Determining the number of non-smokers, unit of measure: frequency, scale of stages of change, Individual information form</description> </primary_outcome> <primary_outcome> <measure>The level of nicotine addiction in the intervention group is expected to be lower than in the control group.</measure> <time_frame>6 months</time_frame> <description>Measuring nicotine addiction, unit of measure: nicotine addiction level, Fagerström Test for Nicotine Dependence</description> </primary_outcome> <secondary_outcome> <measure>The level of behavior change is expected to be higher in the intervention group than in the control group.</measure> <time_frame>6 months</time_frame> <description>Measuring behavior change, comparison of scale tools between groups. Name of the scale: Behavior Change Processes Scale. A maximum of 110 and a minimum of 22 points are obtained from the scale. A high score on this scale is interpreted as a high chance of success in behavior change, and a low score is interpreted as a low chance of success.</description> </secondary_outcome> <secondary_outcome> <measure>It is expected that there will be a higher level of decision balance in the intervention group than in the control group.</measure> <time_frame>6 months</time_frame> <description>Measurement decision balance, Comparison of scale averages between groups. Name of the scale: Decision Balance Scale. The scale consists of 12 questions about the negative aspects of smoking and 12 questions about the positive aspects of smoking. The total score of the scale is calculated by subtracting the perceived harm total score from the perceived benefit total score of smoking, and a negative (-) result indicates that the perceived harms of smoking dominate in the decision balance and a positive (+) result. shows that the perceived benefits of smoking are more in the decision balance. A minimum of 12 and a maximum of 60 points can be obtained for both sub-dimensions. A high score on the questions about the positive aspects of smoking indicates that he is undecided in changing behavior, and a high score on the negative aspects indicates that he is determined to change and maintain the behavior.</description> </secondary_outcome> <secondary_outcome> <measure>Higher self-efficacy/efficacy levels are expected in the intervention group compared to the control group.</measure> <time_frame>6 months</time_frame> <description>Comparing the scale averages between groups, measuring the level of self-efficacy. Name of the Scale: Self-Efficacy Scale. Maximum 40 and minimum 8 points are taken from the scale. A high score on the scale reveals the success of not smoking even if there are encouraging factors.</description> </secondary_outcome> <secondary_outcome> <measure>The incentive factor level is expected to be lower in the intervention group than in the control group.</measure> <time_frame>6 months</time_frame> <description>Measuring the level of incentive factor, Comparing the scale averages between groups. Name of the scale: Encouragement Factor Scale. A maximum of 40 and a minimum of 8 points can be obtained from the scale. Getting a high score from the scale; Indicates low power to stop smoking despite situations that encourage smoking</description> </secondary_outcome> <secondary_outcome> <measure>A higher level of positive health perception is expected in the intervention group than in the control group.</measure> <time_frame>6 months</time_frame> <description>Measuring health perception, More positive health perception in the intervention group compared to the control group, unit of measure: frequency. Individuals are asked a question about how they perceive their health. Results will be compared with frequency in the intervention and control groups.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">80</enrollment> <condition>Smoking Cessation</condition> <arm_group> <arm_group_label>initiative group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The first session will be right after the pre-test, the second session will be 15 days after the first session, and the last session will be 15 days after the second session. After the training is over, a total of 40 messages will be sent to the students in the initiative group, taking into account the factors that affect, strengthen and activate the main communication via the WhatsApp program.</description> </arm_group> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No intervention will be made</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Education</intervention_name> <description>Giving training to the students in the initiative group to quit smoking in three sessions, sending messages via whatsapp program and telephone counseling</description> <arm_group_label>initiative group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Approving to participate in the study,  - Smoker (according to WHO, a person who smokes at least one cigarette per day),  - According to the Fagerström Test for Nicotine Dependence, nicotine addiction is at least "very low" or higher*,  - Not having any communication barriers to participate in the study,  - Those who are in the stages of "thinking" and "preparation" of the stages of change according to the Classification of Stages of Change Scale for smoking cessation**,  - Not taking any smoking cessation treatment at the time of the study,  - Having a smart mobile phone and using the WhatsApp program,  - Consists of students who have not received training in smoking cessation before  Exclusion Criteria:  - Non-smokers  - Those who do not plan to quit smoking (those who are at the stage of "not thinking" according to the Classification of Stages of Change Scale) </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Kırşehir Ahi Evran University</name> <address> <city>Kırşehir</city> <zip>40100</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>January 1, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Kirsehir Ahi Evran Universitesi</investigator_affiliation> <investigator_full_name>Erdal Akdeniz</investigator_full_name> <investigator_title>Lecturer</investigator_title> </responsible_party> <keyword>Nursing Students</keyword> <keyword>Stopping Smoking</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data> <pending_results> <submitted>January 30, 2023</submitted> </pending_results>  </clinical_study>

The causes of death due to smoking are responsible for 11.5% of the total deaths in the world. Smoking causes lung cancer, chronic obstructive pulmonary disease (COPD), ischemic heart disease and cerebrovascular diseases. In some studies on nursing students in the world, the prevalence of smoking is between 13.9% and 32%; It is known that it varies between 12.9% and 28% in Turkey. At the end of this study, nursing students are supported in smoking cessation by providing smoking cessation training, they become a role model for the society by gaining the right behavior, creating a society that smokes less, reducing the financial burden on the state as a result of protecting individuals from possible chronic diseases, and guiding health trainings on this subject. It is foreseen that it will be a guide in its implementation in the whole country. The aim of this study is to determine the effect of the I Stop Smoking, Protecting My Future and Health program based on the Preced-Proceed Model on the smoking behavior of nursing students. This study will be conducted in non-randomized groups in a quasi-experimental fashion as pre-test-post-test. The population of the research was formed by the students in the Nursing Department of the Faculty of Health Sciences of Kırşehir Ahi Evran University. There are two branches of daytime education and two branches of secondary education, and the total number of students in the nursing department is 802. The sample size of the study was calculated using the G*Power (v3.1.9.6) package program. The power of the study was 80% and the sample size was α =0.05; It was calculated as a total of 64 people, 32 of which were interventions and 32 were control groups. However, considering the losses, 20% more than the calculated value was included in the sample and it was planned to include a total of 80 students, 40 of whom were in the intervention group and 40 in the control group. Selection and Assignment of Individuals to the Intervention and Control Group Before being divided into intervention and control groups, students' consent was obtained and a pre-test was applied. Formal education and secondary education students were coded as A and B. For example, formal education A, secondary education B. The students in the related group were stratified by gender and the layer weight was determined. Random numbers were created in the Excel program and it was determined who would be in the groups with the simple random sampling method. In addition, which of the previously coded groups A and B would be the intervention group and which one would be the control group was determined by drawing lots. All these procedures were carried out by a person other than the researcher. Thus, it was determined who would be in the intervention and control group, and it was explained to the researcher before the training whether group A or group B was the intervention or control group. Dependent variables: - Behavior modification level - Decision equilibrium level - Self-efficacy level - Level of encouraging factors - Level of stages of change - Number of people who quit smoking - Nicotine addiction level - Health perception level Independent variables: "I Stop Smoking, I Protect My Future and My Health" program based on the PRECEDE-PROCEED Model. As data collection tools; Smoker identification form, individual information form, Behavior change process scale, Decision balance scale, Self-efficacy scale, Encouraging factors scale, Classification of stages of change scale, Fagerström nicotine addiction test will be used. The data were also planned to be collected in this environment before the first training (pretest), and after the second and third training (posttest). The first session will be held immediately after the pre-test, the second session will be held 15 days after the first session, and the last session will be held 15 days after the second session. A total of 40 messages will be sent to the students in the initiative group through the WhatsApp program, taking into account the factors that affect, strengthen and enable the main Inclusion Criteria: - Approving to participate in the study, - Smoker (according to WHO, a person who smokes at least one cigarette per day), - According to the Fagerström Test for Nicotine Dependence, nicotine addiction is at least "very low" or higher*, - Not having any communication barriers to participate in the study, - Those who are in the stages of "thinking" and "preparation" of the stages of change according to the Classification of Stages of Change Scale for smoking cessation**, - Not taking any smoking cessation treatment at the time of the study, - Having a smart mobile phone and using the WhatsApp program, - Consists of students who have not received training in smoking cessation before Exclusion Criteria: - Non-smokers - Those who do not plan to quit smoking (those who are at the stage of "not thinking" according to the Classification of Stages of Change Scale)

NCT0531xxxx/NCT05314907.xml

<clinical_study>  <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/NCT05314907</url> </required_header> <id_info> <org_study_id>PI17/01179</org_study_id> <secondary_id>PI17/01456</secondary_id> <secondary_id>PI17/01179</secondary_id> <nct_id>NCT05314907</nct_id> </id_info> <brief_title>Acceptability of Self-sampling for Cervical Cancer Screening</brief_title> <official_title>Acceptability, Optimization and Cost-effectiveness for Self-sampling Cervical Cancer Screening.</official_title> <sponsors> <lead_sponsor> <agency>Institut d'Investigació Biomèdica de Bellvitge</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Complejo Hospitalario Universitario Insular Materno Infantil</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Institut Català de la Salut</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Institut Català d'Oncologia</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Institut d'Investigació Biomèdica de Bellvitge</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Main objectives:  1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method.  1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling.  Project methodology:  Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random:  1. Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic.  2. No prior trainning group): Same training without practicing self-sampling collection.  Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use.  Acceptability will be analyzed according to two definitions:  - proportion of women who returned the self-sampling device,  - proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire.  HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain.  Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche. </textblock> </brief_summary> <detailed_description> <textblock> Women aged 30-65 years regular user of cervical cancer screening, not pregnant and with no history of cervical disease are recruited at the cervical cancer screening clinics.  Women are recruited in two Spanish distant areas, Catalonia with participant clinics in Cerdanyola del Vallés, Barberà del Vallés, Ripollet, Badia del Vallés and Sabadell, and the Canary Islands, including the clinics of Arucas, Gáldar, Prudencio Guzmán, Telde, Vecindario, Maspalomas. In both areas the cervical cancer screening was free of charge, opportunistic with cytology as primary test.  Women who agreed to participate in the study signs an informed consent and are provided with a short questionnaire including sociodemographic and screening history information.  Women are randomised, as they came to the screening visit, in two groups:  1. Training group: The trained provider shows the woman how to use the self-sampling device and asks her to collect her self-sample immediately after, at the health centre. Then, the provider gives her a new device to take a new sample at home and send it back to the health center in a month time.  2. No prior training group: The health provider shows the woman how to use self-sampling device and gives the woman a device for her to take a sample at home in a month interval and send it back to the health center.  Before the process of self-sampling, women proceed with the clinical regular screening visit. The professional collects a liquid based cervical sample. An aliquot of the sample is used for cervical cytology (screening sample) and aliquot for HPV detection (study professional sample) using the Cobas system drom Roche  The provider uses the clinical visit to explain the self-sampling process. Afterwards women in training group proceed to take her vaginal sample. In both groups a cervibrush is given for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, women are requested to return the self-collected sample together with the questionnaire in person to the recruitment centre (acceptability questionnaire).  Information available for each women includes date of birth, nationality, country of birth, educational level, marital status, work, family responsibilities and data on their previous history of cervical cancer screening as if they ever did a cytology, the result of the last cytology and number of screening tests lifetime (sociodemographic questionnaire). Also, among the women who collects the self-sampling there was available information about questions on acceptability and practicalities of sampling procedures (acceptability questionnaire).  The project was approved by the ethical committees of the Bellvitge University Hospital (number PR223/17), IDIAP Jordi Gol (number P18/099) and Maternal and Child Insular University Hospital Complex (number 2018-178-1). Any information regarding the identification of patients is anonymized before analysis.  The self-sample is collected using the Rovers Medical Devices Evalyn Brush from Rovers.  Detection of HPV of all the samples from Catalonia is carried out at the Infections and Cancer laboratory of the Catalan Institute of Oncology in Barcelona, while those from the Canary Islands is processed in the Pathological Anatomy Service of the Maternal and Child Insular University Hospital Complex of Las Palmas de Gran Canaria.  All the samples are processed using Cobas HPV test Roche Cobas 4800 HPV test. Cobas HPV test is an in-vitro quantitative detection technique for high-risk HPV DNA by polymerase chain reaction (PCR) amplification and can detect a total of 14 HR-HPV subtypes and provides the results of HPV 16 and HPV 18, and the pooled results of the other 12 subtypes in the assay.  Data from both sociodemographic and acceptability questionnaires and test results (clinical and self-sampling) are collected using Research Electronic Data Capture call REDCap tools hosted at Catalan Institute of Oncology. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. Personal involved in the project had access to the REDCap platform through a username and password and enter data of each woman who has been anonymized. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 28, 2018</start_date> <completion_date type="Anticipated">June 2022</completion_date> <primary_completion_date type="Anticipated">June 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Screening</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Self-sampling acceptability for cervical cancer screening</measure> <time_frame>2 months</time_frame> <description>Acceptability will be compared by study arm and evaluated as 1) proportion of women that return the self-sampling device, 2) proportion of women that return the self-sampling device and respond to favour future screening with self-sampling. This will be evaluated according to the sociodemographic variables of the participants and the results of the acceptability questionnaire that each woman has filled out.</description> </primary_outcome> <secondary_outcome> <measure>The cost-effectiveness of cervical Self-Sampling on public health system in Spain</measure> <time_frame>This is a mathematical and cost analisis. No participants are assessed (time frame 2 years)</time_frame> <description>A simulation model will be built based on the natural history of HPV and cervical cancer calibrated to data from Spain in reference to age-specific cervical cancer incidence and HPV prevalence. Different strategies will be evaluated that will vary according to some relevant parameters such as age and frequency of screening, self-sampling at the health center or at home. For each of the strategies, health outcomes and costs will be obtained that will allow us to calculate the reduction in lifetime cancer risk, the quality-adjusted life years (QALYs) or the cost per lifetime. Finally a cost-effectiveness analysis will be carried out between the different strategies compared to the current situation. For doing this, incremental cost-effectiveness ratios will be calculated, expressed in € per QALY gained. Finally, the impact that applying the most cost-effective interventions would have on the public health budget will be evaluated.</description> </secondary_outcome> <secondary_outcome> <measure>HPV test agreement between self-sampling and clinician-collected samples</measure> <time_frame>2 months</time_frame> <description>A Kappa index with 95% confidence interval will be performed to observe the concordance between the HPV results from self-sampling compared to HPV results from clinical samples. A description of positivity prevalence will be also provided and the ratio of HPV positivity and the agreement (in %) between the self-sample and clinical samples will be calculated.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">1614</enrollment> <condition>HPV-Related Cervical Carcinoma</condition> <condition>Self-sampling</condition> <condition>Cervical Cancer Screening</condition> <arm_group> <arm_group_label>Training group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The Health professional shows the woman how to use the self-sampling device (Evalyn Brush) and then she collects a self-sample at the health centre as a training.</description> </arm_group> <arm_group> <arm_group_label>No prior training group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>The Health professional shows the woman how to use the self-sampling device (Evalyn Brush).</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Explanation on how to use self-sampling device and training in the screening visit.</intervention_name> <description>During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is collected for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn Brush and after the woman collects an HPV sample by self-sampling in the same medical center as a trainning. Finally, a new cervibrush (Evalyn brush) is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.</description> <arm_group_label>Training group</arm_group_label> <other_name>Evalyn Brush</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Only explanation on how to use self-sampling device.</intervention_name> <description>During the screening visit, woman is offered to participate in the study. If she accepts, informed consent is signed, a sociodemographic questionnaire is collected, and a cervical sample is taken for HPV detection by the health professional in the consultation. Then, the professional informs the woman of how to carry out the self-collection using Evalyn. Finally, a Evalyn brush is given to the woman for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, woman is requested to return the self-collected sample together with the questionnaire in person to the recruitment centre.</description> <arm_group_label>No prior training group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago).  Exclusion Criteria:  - Women under 30 years of age.  - Women over 65 years of age.  - Pregnant women.  - Women with hysterectomy.  - Women between 30 and 65 years of age who underwent the last screening test more than four years ago.  - Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Cervical cancer screening is only for women</gender_description> <minimum_age>30 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Raquel Ibáñez Pérez, Dra.</last_name> <role>Principal Investigator</role> <affiliation>Institut Català d'Oncologia - IDIBELL</affiliation> </overall_official> <overall_official> <last_name>Silvia de Sanjosé Llongueras, Dra.</last_name> <role>Study Director</role> <affiliation>National Cancer Institute (NCI)</affiliation> </overall_official> <overall_official> <last_name>Amelia Acera, Dra.</last_name> <role>Study Chair</role> <affiliation>Institut Català de la Salut</affiliation> </overall_official> <overall_official> <last_name>Miguel Andujar, Dr.</last_name> <role>Principal Investigator</role> <affiliation>Complejo Hospitalario Universitario Insular Materno Infantil</affiliation> </overall_official> <overall_contact> <last_name>Raquel Ibáñez Pérez, Dra.</last_name> <phone>932607812</phone> <email>raquelip@iconcologia.net</email> </overall_contact> <overall_contact_backup> <last_name>Laia Bruni Coccoz, Dra.</last_name> <phone>932607812</phone> <email>lbruni@iconcologia.net</email> </overall_contact_backup> <location> <facility> <name>Institut Català d'Oncologia</name> <address> <city>L'Hospitalet De Llobregat</city> <state>Barcelona</state> <zip>08908</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>CAP II Cerdanyola-Ripollet - Institut Català de la Salut</name> <address> <city>Ripollet</city> <state>Barcelona</state> <zip>08291</zip> <country>Spain</country> </address> </facility> <status>Completed</status> </location> <location> <facility> <name>Complejo Hospitalario Universitario Insular Materno Infantil</name> <address> <city>Las Palmas De Gran Canaria</city> <state>Canary Islands</state> <zip>35016</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Miguel Andujar, Dr.</last_name> <phone>+34928308666</phone> <email>mandsan@gobiernodecanarias.org</email> </contact> <investigator> <last_name>Miguel Andujar, Dr.</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Spain</country> </location_countries> <reference> <citation>Serrano B, Ibanez R, Robles C, Peremiquel-Trillas P, de Sanjose S, Bruni L. Worldwide use of HPV self-sampling for cervical cancer screening. Prev Med. 2022 Jan;154:106900. doi: 10.1016/j.ypmed.2021.106900. Epub 2021 Nov 30.</citation> <PMID>34861338</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 19, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Institut d'Investigació Biomèdica de Bellvitge</investigator_affiliation> <investigator_full_name>Raquel Ibáñez</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>Self-sampling</keyword> <keyword>HPV</keyword> <keyword>Cervical cancer screening</keyword> <keyword>Acceptability</keyword> <keyword>HPV concordance</keyword> <condition_browse>  <mesh_term>Uterine Cervical Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Main objectives: 1.1. To evaluate the use of self-sampling for HPV test in regular attendants of cervical cancer screening as a primary sample collection method. 1.2. To assess the impact on the acceptability of an educational intervention. 1.3 Confirm the concordance of HPV detection in the samples collected by the professional and in self-sampling. Project methodology: Randomized, parallel multicenter clinical trial in women aged 30-65 years regularly attending cervical cancer screening residents in the Autonomous Communities of Catalonia and the Canary Islands (Spain). The woman attends the routine screening visit where the health professional collects a sample from the cervical screening. She then offers her the study and if the woman accepts, she offers her the SS as a screening test. The modality of information and practice of the self-sampling is random: 1. Training group): Educational intervention with self-sampling practice: clinician-led explanation on how to proceed with self-sampling prior to collecting a self-sample at the clinic. 2. No prior trainning group): Same training without practicing self-sampling collection. Both groups has a standard of care cervical sample collection by a clinician. Women are asked to return a self-sampling specimen one month after the baseline visit together with an acceptability questionnaire on self-sampling use. Acceptability will be analyzed according to two definitions: - proportion of women who returned the self-sampling device, - proportion of women who report wanting to use self-sampling in future screens in the acceptability questionnaire. HPV agreement between collection methods will be calculated using Cohen's Kappa coefficient. Cost-effectiveness analisis will be done on public health system by a mathematical model of the cervical cancer natural history and HPV, adjusted for data in Spain. Self-sampling device uses in this trial is Evalyn Brush from Rovers and the HPV detection is COBAS 4800 from Roche. Women aged 30-65 years regular user of cervical cancer screening, not pregnant and with no history of cervical disease are recruited at the cervical cancer screening clinics. Women are recruited in two Spanish distant areas, Catalonia with participant clinics in Cerdanyola del Vallés, Barberà del Vallés, Ripollet, Badia del Vallés and Sabadell, and the Canary Islands, including the clinics of Arucas, Gáldar, Prudencio Guzmán, Telde, Vecindario, Maspalomas. In both areas the cervical cancer screening was free of charge, opportunistic with cytology as primary test. Women who agreed to participate in the study signs an informed consent and are provided with a short questionnaire including sociodemographic and screening history information. Women are randomised, as they came to the screening visit, in two groups: 1. Training group: The trained provider shows the woman how to use the self-sampling device and asks her to collect her self-sample immediately after, at the health centre. Then, the provider gives her a new device to take a new sample at home and send it back to the health center in a month time. 2. No prior training group: The health provider shows the woman how to use self-sampling device and gives the woman a device for her to take a sample at home in a month interval and send it back to the health center. Before the process of self-sampling, women proceed with the clinical regular screening visit. The professional collects a liquid based cervical sample. An aliquot of the sample is used for cervical cytology (screening sample) and aliquot for HPV detection (study professional sample) using the Cobas system drom Roche The provider uses the clinical visit to explain the self-sampling process. Afterwards women in training group proceed to take her vaginal sample. In both groups a cervibrush is given for home self-sampling, together with written and picture-based instructions on how to obtain the sample and an acceptability questionnaire. After one month from the screening visit, women are requested to return the self-collected sample together with the questionnaire in person to the recruitment centre (acceptability questionnaire). Information available for each women includes date of birth, nationality, country of birth, educational level, marital status, work, family responsibilities and data on their previous history of cervical cancer screening as if they ever did a cytology, the result of the last cytology and number of screening tests lifetime (sociodemographic questionnaire). Also, among the women who collects the self-sampling there was available information about questions on acceptability and practicalities of sampling procedures (acceptability questionnaire). The project was approved by the ethical committees of the Bellvitge University Hospital (number PR223/17), IDIAP Jordi Gol (number P18/099) and Maternal and Child Insular University Hospital Complex (number 2018-178-1). Any information regarding the identification of patients is anonymized before analysis. The self-sample is collected using the Rovers Medical Devices Evalyn Brush from Rovers. Detection of HPV of all the samples from Catalonia is carried out at the Infections and Cancer laboratory of the Catalan Institute of Oncology in Barcelona, while those from the Canary Islands is processed in the Pathological Anatomy Service of the Maternal and Child Insular University Hospital Complex of Las Palmas de Gran Canaria. All the samples are processed using Cobas HPV test Roche Cobas 4800 HPV test. Cobas HPV test is an in-vitro quantitative detection technique for high-risk HPV DNA by polymerase chain reaction (PCR) amplification and can detect a total of 14 HR-HPV subtypes and provides the results of HPV 16 and HPV 18, and the pooled results of the other 12 subtypes in the assay. Data from both sociodemographic and acceptability questionnaires and test results (clinical and self-sampling) are collected using Research Electronic Data Capture call REDCap tools hosted at Catalan Institute of Oncology. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. Personal involved in the project had access to the REDCap platform through a username and password and enter data of each woman who has been anonymized. Inclusion Criteria: Women aged 30 to 65 years (both inclusive) with a adequate prior history of cervical cancer screening (last cytological screening test no more than four years ago). Exclusion Criteria: - Women under 30 years of age. - Women over 65 years of age. - Pregnant women. - Women with hysterectomy. - Women between 30 and 65 years of age who underwent the last screening test more than four years ago. - Women between the ages of 30 and 65 who attend for follow-up of some ongoing cervical pathology.

NCT0531xxxx/NCT05314920.xml

<clinical_study>  <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/NCT05314920</url> </required_header> <id_info> <org_study_id>PsicAP-Costs2</org_study_id> <nct_id>NCT05314920</nct_id> </id_info> <brief_title>Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care</brief_title> <acronym>PsicAP-Costs2</acronym> <official_title>Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Instituto de Investigación Marqués de Valdecilla</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Instituto de Investigación Marqués de Valdecilla</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2020</start_date> <completion_date type="Anticipated">June 1, 2023</completion_date> <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Single (Participant)</masking> <masking_description>Outcomes assessors will be blinded during pre- and post-treatment. Participants will be blinded during pretreatment assessment; however, it cannot be guaranteed that they will keep blinded in post-treatment.</masking_description> </study_design_info> <primary_outcome> <measure>Change in cost-effectiveness data</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>Cost-effectiveness results will be calculated by the ICER, defined as the difference in mean costs between interventions divided by the difference in their effectiveness according to the symptom questionnaires' mean scores. The healthcare data collected will be used for cost calculations. To calculate healthcare-related costs, an ad hoc questionnaire will be used to collect emotional disorder-related healthcare data (public and private healthcare consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology).</description> </primary_outcome> <primary_outcome> <measure>Change in cost-utility data</measure> <time_frame>Baseline, immediately after the intervention, and 12 month follow-up</time_frame> <description>Cost-utility will be measured through the healthcare data collected above and the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990), calculating the QALYS and the ICURs, defined as the difference in mean cost divided by the difference in mean QALYs. The Spanish version of the 5-domain, 5-level EuroQol (EQ-5D-5L) (Badia et al., 1999; van Reenen et al., 2019) will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).</description> </primary_outcome> <secondary_outcome> <measure>Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)</measure> <time_frame>Baseline, immediately after the intervention, and 12 month follow-up</time_frame> <description>The PHQ-9 (Kroenke et al., 2001) is the depression module of the PHQ (Díez-Quevedo et al., 2001; Spitzer et al., 1999) that scores the 9 DSM-IV depression criteria in the last two weeks. Is a nine item, self-report scale that ranges from 0 to 27 (higher scores means a worse outcome).</description> </secondary_outcome> <secondary_outcome> <measure>Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)</measure> <time_frame>Baseline, immediately after the intervention, and 12 month follow-up</time_frame> <description>The GAD-7 (Spitzer et al., 2006) assesses common anxiety symptoms in the last two weeks. It is composed of seven self-report items ranging from 0 to 21 points. Higher scores means a greater presence of anxiety symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)</measure> <time_frame>Baseline, immediately after the intervention, and 12 month follow-up</time_frame> <description>The PHQ-15 (Kroenke et al., 2002) is the somatization module of the PHQ and scores symptoms present in the past four weeks. The scale is composed of fifteen self-report items, ranging from 0 to 30. Higher scores means a worse outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Change in functioning: Sheehan Disability Scale (SDS)</measure> <time_frame>Baseline, immediately after the intervention, and 12 month follow-up</time_frame> <description>The SDS (Sheehan et al., 1996) is a five item self-reported scale composed of three main domains (work, family and social functioning) and two optional items (perceived stress and perceived social support). It ranges from 0 to 50, with higher scores indicating a worse outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Change in treatment satisfaction</measure> <time_frame>Immediately after the intervention and 12-month follow-up</time_frame> <description>Posttreatment and 12-month follow-up assessments will also collect an additional question about treatment satisfaction, through a Likert-type question, ranging from 0 to 10.</description> </secondary_outcome> <other_outcome> <measure>Change in rumination: Ruminative Responses Scales (brooding subscale) (RRS-B)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The RRS-B (Nolen-Hoeksema & Morrow, 1991) is composed of five self-reported items, ranging from 5 to 20. Higher scores means a worse outcome.</description> </other_outcome> <other_outcome> <measure>Change in worry: Penn State Worry Questionnaire - Abbreviated (PSWQ-A)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The PSWQ-A (Meyer et al., 1990) measures the pathological worry as an uncontrollable and general state. The scale is composed of eight self-reported items, ranging from 5 to 40. Higher scores means a worse outcome</description> </other_outcome> <other_outcome> <measure>Change in attentional and interpretative biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The IACTA was originally developed by Cano-Vindel (2001). It includes subscales that assess distortions according to Eysenck's four-factor theory (Eysenck, 2000). The scale is composed of five self-reported items, ranging from 0 to 20. Higher scores means a worse outcome.</description> </other_outcome> <other_outcome> <measure>Change in emotion regulation: Cognitive Emotion Regulation Questionnaire (CERQ)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The CERQ-36 (Garnefski et al., 2001) was developed for measuring the specific cognitive emotion regulation strategies that a person uses to face a stressful event (self-blame, acceptance, rumination, positive refocus, refocus on planning, positive reappraisal, putting into perspective, catastrophizing or blaming others). It scores from 1 ("almost never") to 5 ("almost always") how often the participant thinks as described. The 27-item shortened version will be used (Holgado-Tello et al., 2018). Each cognitive strategy is assessed by means of three items, ranging from 3 to 15. Higher scores means a greater use of the strategy.</description> </other_outcome> <other_outcome> <measure>Change in metacognitive beliefs: Metacognitions Questionnaire (negative beliefs subscale) (MCQ)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The MCQ-NB (Wells & Cartwright-Hatton, 2004) is a short form of the original MCQ (Cartwright-Hatton & Wells, 1997), which measures the beliefs about the own thinking processes. The scale is composed of six self-reported items, ranging from 6 to 24. Higher scores means a worse outcome.</description> </other_outcome> <other_outcome> <measure>Change in cognitive Distortions in Emotional Disorders (CDTE)</measure> <time_frame>Baseline, immediately after the intervention, and 12-month follow-up</time_frame> <description>The CDTE (The PsicAP Group, unpublished) measures the frequency of certain cognitive biases. It includes sixteen self-reported items that measure the presence of four factors: sustained attention bias, divided attention bias, magnification interpretational bias, and catastrophization interpretational bias. It ranges from 0 to 4. Higher scores means a greater presence of the cognitive bias.</description> </other_outcome> <other_outcome> <measure>Change in alliance: Working Alliance Inventory Patient Form (WAI-P) and Group Session Rating Scale (GSRS)</measure> <time_frame>In therapy sessions number 1, 4 and 7</time_frame> <description>The WAI-P (Andrade-González & Fernández-Liria, 2015) is a thirty-six self-report scale that measure perceived therapeutic alliance. It ranges from 36 to 252 with higher scores indicating better alliance between patient and clinical professional. The GSRS (Duncan & Miller, 2007) is a four self-reported scale that assess alliance to the group. It ranges from 0 to 40, with higher scores indicating better alliance between the patient and the group of therapy.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">300</enrollment> <condition>Emotional Disorder</condition> <arm_group> <arm_group_label>transdiagnostic cognitive-behavioural therapy (TD-CBT)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Transdiagnostic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12-week period.</description> </arm_group> <arm_group> <arm_group_label>relaxation therapy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. Patients will receive 7 sessions (1.5 hr/session) in groups of 8-10 individuals over a 12-week period.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Transdiagnostic cognitive-behavioral therapy (TD-CBT)</intervention_name> <description>Transdiagnostic cognitive-behavioral therapy (TD-CBT)</description> <arm_group_label>transdiagnostic cognitive-behavioural therapy (TD-CBT)</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Bernstein and Borkovec progressive muscle relaxation (PMR)</intervention_name> <description>Bernstein and Borkovec progressive muscle relaxation (PMR)</description> <arm_group_label>relaxation therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms.  - Scores above the predetermined cut-off points on the GAD-7 (>= 10), the PHQ-9 (>= 10) or the PHQ-15 (>=10 plus a score of 2 in three or more somatic symptoms).  - Agreement to participate in the study, with written informed consent.  Exclusion Criteria:  - Major depressive disorder (PHQ-9> 24) and/or severe disability (SDS > 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder.  - Presence of severe or recent suicide attempts  - Presence of intellectual disability (IQ < 70).  - Be receiving psychological treatment or any type of specialized care related to mental health.  - Insufficient Spanish language skills </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>César González-Blanch Bosch, PhD</last_name> <phone>+34-942-202537</phone> <email>cesar.gonzalezblanch@scsalud.es</email> </overall_contact> <location> <facility> <name>Centro Sanitario "Sardinero"</name> <address> <city>Santander</city> <zip>39005</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centro Sanitario "Dávila"</name> <address> <city>Santander</city> <zip>39006</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centro Sanitario "Camargo Costa"</name> <address> <city>Santander</city> <zip>39600</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centro Sanitario "Camargo Interior"</name> <address> <city>Santander</city> <zip>39600</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Spain</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>January 25, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 19, 2022</last_update_submitted> <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 20, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>transdiagnostic therapy</keyword> <keyword>emotional disorders</keyword> <keyword>primary care</keyword> <keyword>cost-benefit analysis</keyword> <keyword>brief psychological treatments</keyword> <keyword>cognitive behavioral therapy</keyword> <keyword>randomized controlled trial</keyword> <keyword>depression</keyword> <keyword>anxiety disorders</keyword> <keyword>somatoform disorders</keyword> <condition_browse>  <mesh_term>Mood Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care. Inclusion Criteria: - Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms. - Scores above the predetermined cut-off points on the GAD-7 (>= 10), the PHQ-9 (>= 10) or the PHQ-15 (>=10 plus a score of 2 in three or more somatic symptoms). - Agreement to participate in the study, with written informed consent. Exclusion Criteria: - Major depressive disorder (PHQ-9> 24) and/or severe disability (SDS > 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder. - Presence of severe or recent suicide attempts - Presence of intellectual disability (IQ < 70). - Be receiving psychological treatment or any type of specialized care related to mental health. - Insufficient Spanish language skills

NCT0531xxxx/NCT05314933.xml

<clinical_study>  <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/NCT05314933</url> </required_header> <id_info> <org_study_id>2-DG-01</org_study_id> <nct_id>NCT05314933</nct_id> </id_info> <brief_title>Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers</brief_title> <official_title>A Single/Multiple Ascending Dose Phase 1 Study Of The Safety, Tolerability, And Pharmacokinetics Of Intranasal 2-Deoxy-D-Glucose In Normal Healthy Volunteers</official_title> <sponsors> <lead_sponsor> <agency>G.ST Antivirals GmbH</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>G.ST Antivirals GmbH</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> 2-DG-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study assessing safety, tolerability and pharmacokinetics of 2-DG in normal healthy volunteers (NHV). The safety and pharmacokinetics of 2-DG are assessed after single or multiple intranasal administrations. </textblock> </brief_summary> <detailed_description> <textblock> 2-DG-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose phase 1 study in normal healthy male and female volunteers aged 18 years or older.  The primary objective of this study is to assess the clinical safety and tolerability of intranasal 2-DG in NHVs.  The secondary objective of this study is to assess the human pharmacokinetics of 2-DG.  The study is divided in two sub-parts: Part A, a single ascending dose (SAD) study of 2-DG and Part B, a multiple ascending dose (MAD) study.  Part A consists of 3 cohorts: Cohorts 1 and 2 with a randomization ratio for 2-DG to placebo of 4:1 and Cohort 3 with a randomization ratio for 2-DG to placebo of 8:2.  Part B consists of 3 cohorts: Cohort 4 with a a randomization ratio for 2-DG to placebo of 4:1 and Cohorts 5 and 6 with a randomization ratio for 2-DG to placebo of 8:2.  Cohorts 1, 2 and 4 will also be controlled by randomized intranasal application of placebo into the opposite nostril to obtain an intra-individual estimate for local tolerability. Other cohorts will receive either 2-DG or placebo into both nostrils.  Interim safety reviews are performed by a Data Monitoring Committee. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 3, 2022</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">June 2023</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Adverse drug reactions (ADRs)</measure> <time_frame>until 24 hours after single drug dosing</time_frame> <description>Number of ADRs after a single dose of 2-DG assessed by type, frequency and severity of ADRs graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </primary_outcome> <primary_outcome> <measure>Adverse drug reactions (ADRs)</measure> <time_frame>until 168 hours after start of multiple drug dosing</time_frame> <description>Number of ADRs after multiple doses of 2-DG assessed by type, frequency and severity of ADRs graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </primary_outcome> <secondary_outcome> <measure>Biodistribution of a single dose of 2-DG</measure> <time_frame>baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing</time_frame> <description>Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Biodistribution of multiple doses of 2-DG</measure> <time_frame>baseline, 12 hours, 15 hours, 24 hours, 72 hours, 168 hours after start of multiple drug dosing</time_frame> <description>Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Local tolerability of a single dose of 2-DG</measure> <time_frame>baseline, 6 hours, 24 hours after single drug dosing</time_frame> <description>Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms).</description> </secondary_outcome> <secondary_outcome> <measure>Local tolerability of multiple doses of 2-DG</measure> <time_frame>baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing</time_frame> <description>Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms).</description> </secondary_outcome> <secondary_outcome> <measure>Olfactory function after a single dose of 2-DG</measure> <time_frame>baseline, 24 hours after single drug dosing</time_frame> <description>Change in olfactory capacity using sniffing sticks measured by Threshold-Discrimination-Identification score (TDI score). Minimum value = 0 , maximum value= 48. A higher score means a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Olfactory function after multiple doses of 2-DG</measure> <time_frame>baseline, 24 hours, 72 hours, 168 hours after start of multiple drug dosing</time_frame> <description>Change in olfactory capacity using sniffing sticks measured by Threshold-Discrimination-Identification score (TDI score). Minimum value = 0 , maximum value= 48. A higher score means a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Premature terminations due to ADRs after a single dose of 2-DG</measure> <time_frame>until 24 hours after single drug dosing</time_frame> <description>Number of premature terminations due to ADRs that are assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </secondary_outcome> <secondary_outcome> <measure>Premature terminations due to ADRs after multiple doses of 2-DG</measure> <time_frame>until 168 hours after start of multiple drug dosing</time_frame> <description>Number of premature terminations due to ADRs that are assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </secondary_outcome> <secondary_outcome> <measure>Adverse events after single dose 2-DG</measure> <time_frame>until 24 hours after single drug dosing</time_frame> <description>Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </secondary_outcome> <secondary_outcome> <measure>Adverse events after multiple doses 2-DG</measure> <time_frame>until 168 hours after start of multiple drug dosing</time_frame> <description>Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">45</enrollment> <condition>Acute Nasopharyngitis</condition> <arm_group> <arm_group_label>Study drug</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Each subject receives either a single dose (SAD) or a multiple dose (MAD) of a 3.5% 2-Deoxyglucose as nasal spray solution. The starting dose for the first cohort is 3.5 mg/day up to a maximum of 84 mg/day at cohort 6.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Each subject receives either a single (SAD) or multiple (MAD) dose of placebo. The dose for each cohort is corresponding the amount of solution needed in the verum group.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>2-Deoxyglucose</intervention_name> <description>Intranasal administration</description> <arm_group_label>Study drug</arm_group_label> <other_name>2-DG</other_name> <other_name>2-Deoxy-D-glucose</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Intranasal administration</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy male or female volunteers, age ≥ 18 years old at screening  - Females must be post-menopausal (> 1 year since last menstruation)  - Able to comprehend and to give informed consent  - Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures  - Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health)  Exclusion Criteria:  - Frequent epistaxis (equal to or greater than 1/month)  - Hypo- or anosmia  - Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation  - Medical history of diabetes mellitus of any type  - Clinically relevant abnormal findings at screening  - Preceding nasal surgery or sinus surgery  - Medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening  - SARS-CoV-2 infection positive by PCR test at screening  - Vulnerable subjects as defined by GCP  - Subjects in a dependency relationship towards the investigators, e.g. as employees  - Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures  - Use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results  - Concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start  - Scheduled vaccination appointments during the study period </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Medical University of Vienna</name> <address> <city>Vienna</city> <zip>1090</zip> <country>Austria</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Christa Firbas, MD</last_name> <phone>+43 1 40400</phone> <phone_ext>0</phone_ext> <email>klin-pharmakologie@meduniwien.ac.at</email> </contact> <investigator> <last_name>Christa Firbas, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Austria</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>February 3, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 11, 2023</last_update_submitted> <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Virus disease</keyword> <keyword>Respiratory infection</keyword> <keyword>Common cold virus</keyword> <keyword>Rhinovirus</keyword> <condition_browse>  <mesh_term>Nasopharyngitis</mesh_term> <mesh_term>Common Cold</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Deoxyglucose</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

2-DG-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study assessing safety, tolerability and pharmacokinetics of 2-DG in normal healthy volunteers (NHV). The safety and pharmacokinetics of 2-DG are assessed after single or multiple intranasal administrations. 2-DG-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose phase 1 study in normal healthy male and female volunteers aged 18 years or older. The primary objective of this study is to assess the clinical safety and tolerability of intranasal 2-DG in NHVs. The secondary objective of this study is to assess the human pharmacokinetics of 2-DG. The study is divided in two sub-parts: Part A, a single ascending dose (SAD) study of 2-DG and Part B, a multiple ascending dose (MAD) study. Part A consists of 3 cohorts: Cohorts 1 and 2 with a randomization ratio for 2-DG to placebo of 4:1 and Cohort 3 with a randomization ratio for 2-DG to placebo of 8:2. Part B consists of 3 cohorts: Cohort 4 with a a randomization ratio for 2-DG to placebo of 4:1 and Cohorts 5 and 6 with a randomization ratio for 2-DG to placebo of 8:2. Cohorts 1, 2 and 4 will also be controlled by randomized intranasal application of placebo into the opposite nostril to obtain an intra-individual estimate for local tolerability. Other cohorts will receive either 2-DG or placebo into both nostrils. Interim safety reviews are performed by a Data Monitoring Committee. Inclusion Criteria: - Healthy male or female volunteers, age ≥ 18 years old at screening - Females must be post-menopausal (> 1 year since last menstruation) - Able to comprehend and to give informed consent - Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures - Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health) Exclusion Criteria: - Frequent epistaxis (equal to or greater than 1/month) - Hypo- or anosmia - Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation - Medical history of diabetes mellitus of any type - Clinically relevant abnormal findings at screening - Preceding nasal surgery or sinus surgery - Medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening - SARS-CoV-2 infection positive by PCR test at screening - Vulnerable subjects as defined by GCP - Subjects in a dependency relationship towards the investigators, e.g. as employees - Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures - Use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results - Concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start - Scheduled vaccination appointments during the study period

NCT0531xxxx/NCT05314946.xml

<clinical_study>  <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/NCT05314946</url> </required_header> <id_info> <org_study_id>HSREB #120816</org_study_id> <nct_id>NCT05314946</nct_id> </id_info> <brief_title>Nutritional Support During Induction Therapy for Esophageal Cancer</brief_title> <official_title>Nutritional Support in Patient Undergoing Induction Therapy for Esophageal Cancer</official_title> <sponsors> <lead_sponsor> <agency>Mehdi Qiabi</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Lawson Health Research Institute</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Patients diagnosed with esophageal cancer have difficulty eating, as the food pipe becomes obstructed by the cancer. This may impair the ability for the patient to receive appropriate calorie intake, especially during administration of chemotherapy and radiation therapy given prior to surgical resection.  A strategy is to place a feeding tube directly in the stomach or in the small bowel to have an access to the patient's gastrointestinal tract during administration of chemo radiation therapy. However, these feeding tubes may lead to adverse events, including dislodgement, infection, the tube may be plugged, etc. If these complications were to happen, patients may have their treatment delayed, may have to come to the emergency department or even be admitted. In some cases, patients may need to have a surgery performed to treat the complication. Most centres in Canada have moved away from placement of these feeding tubes due to the high incidence of complications associated with the feeding tubes placement, and due to the high efficacy from the chemoradiation therapy in shrinking the tumour, allowing for the patient to swallow.  In London, the preference from the Medical and Radiation Oncologists was to have these feeding tubes placed to avoid delay in treating the patients. There is therefore significant controversy as to what is the best approach in this patient population. Our goal is to run a feasibility randomized controlled trial studying this question. </textblock> </brief_summary> <detailed_description> <textblock> Esophageal cancer is highly lethal. In Ontario in 2020, an estimated 900 patients were diagnosed with esophageal cancer, while 860 died from it. In Canada, the figures are 2400 diagnoses and 2260 deaths. The incidence of esophageal cancer in Canada is projected to increase over time, especially in males who are more likely to be obese and to suffer from reflux disease.  Esophageal cancer is the malignancy associated with the highest risk for malnutrition. Before their diagnosis, 80% of all patients with esophageal cancer have over 10-15% unintentional weight loss. Strategies to palliate malnutrition in cancer patients and its consequences on outcomes have been developed. In patient with severe nutritional risk, use of nutritional support for at least 10-14 days has been recommended in a non-surgical, oncology population. The European Society for Clinical Nutrition and Metabolism have recommended preoperatively enteral nutrition for 5-7 days in cancer patients undergoing major abdominal surgery. In addition, dietary counselling and oral nutritional supplement were suggested to prevent weight loss and interruption of radiotherapy on patients undergoing radiation treatments for head/neck or gastrointestinal malignancies. Routine enteral nutrition was not suggested during chemotherapy-only treatments.  The type of supplements administered may have an impact on recovery. It was shown that esophageal cancer patients receiving enriched glutamine, fibers and oligosaccharide perioperative enteral supplementation had a shorter systemic inflammatory response syndrome postoperatively and less surgical stress, which could in turn lead to reduced postoperative immunosuppressive conditions. A recent retrospective study from Taiwan did show a slightly improved 4-year overall survival rate and less mucositis on patients supported by enteral feeding tubes with esophageal squamous cell carcinoma and undergoing neoadjuvant therapy.  However, there is still equipoise in the literature and most centers in Canada have moved away from feeding tubes. At LHSC, feeding tubes were historically placed on every patient during their induction treatment. Efforts are being made to spare patients from unnecessary procedure, but patient selection is variable. Standardization of this practice is needed. A recent retrospective study evaluating the effect of surgical enteral access prior to induction treatment did not show nutritional or perioperative benefit. There was no difference in postoperative complication rates and weight loss was similar. In fact, dysphagia is felt to be significantly relieved after a single cycle of chemotherapy. Percutaneous feeding tubes may not be required on all patients during induction therapy for esophageal cancer.  Those feeding tubes are associated with high morbidity. Kidane et al have shown that 39.3% of visits to the ED after an esophagectomy are due to feeding tubes problems (dislodgement, blockage, infection). Of those ED visits for feeding tubes issues, 17% resulted to an admission. Small bowel obstruction is also associated to percutaneous feeding tube placement and selective use has been recommended. Perioperative use of feeding jejunostomy in gastroesophageal cancer has been associate with a complication rate as high as 44%. Given the related-morbidity, guidelines now recommend selective use of feeding tubes on high-risk patients after esophagectomy. When patients undergoing chemotherapy present to the emergency department with fever or infectious signs, data from the Ontario Cancer Registry show that 46% are admitted, increasing healthcare burden. At baseline, patients undergoing chemotherapy are at high risk of presenting to the emergency department or having unplanned visit to the cancer center, this figure going as high as 49% within 4 weeks of initiation of chemotherapy in comparable jurisdictions. Efforts must be made to save an already strained system.  According to the 2020 Surgical Quality Indicator Report Summary from OH-CCO, our center has the worst 30-day unplanned ED visit rate (45%, provincial mean 27%) after esophagectomy in the province of Ontario. Anecdotally, it is felt that most of those cases are related to feeding tubes complications. If these patients present to the ED due to feeding tubes concerns after an esophagectomy, it is likely they would have presented during induction treatment if they had a tube.  Alternative to feeding tubes exist (home IV hydration) which could become a less invasive and more interesting solution.  The objective of this study is to assess the feasibility of a larger randomized controlled trial evaluating unplanned visit to the ED or the outpatient clinic in patients eligible for trimodality for esophageal cancer during their induction treatment, randomized into receiving percutaneous enteral access for nutritional support versus not. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Feasibility of the trial</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>The trial will be deemed feasible if 60% or more of eligible patients are recruited, 80% or more of data is collected, and 5% or less patients are lost to follow-up.</description> </primary_outcome> <secondary_outcome> <measure>Rate of unplanned visits (ED or outpatient clinic)</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>Rate of unplanned visits (ED or outpatient clinic) from randomization to esophagectomy</description> </secondary_outcome> <secondary_outcome> <measure>Time from PET scan to beginning of induction treatment</measure> <time_frame>From randomization to 90-day post-operative</time_frame> </secondary_outcome> <secondary_outcome> <measure>Total weight loss (kilograms)</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>Change in kilograms from baseline measured at each visit</description> </secondary_outcome> <secondary_outcome> <measure>Nutritional status</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>Measured using serum albumin</description> </secondary_outcome> <secondary_outcome> <measure>Any grade adverse event rate</measure> <time_frame>From randomization to 90-day post-operative</time_frame> </secondary_outcome> <secondary_outcome> <measure>Interruption or dose-reduction of the induction treatment</measure> <time_frame>From randomization to 90-day post-operative</time_frame> </secondary_outcome> <secondary_outcome> <measure>Rate of completion of planned induction treatment</measure> <time_frame>From randomization to 90-day post-operative</time_frame> </secondary_outcome> <secondary_outcome> <measure>Quality of life using the Health Related Quality of Life Functional Assessment of Cancer Therapy - Esophageal (HRQOL FACT-E) questionnaire</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>Higher scores for the scales and subscales indicate better quality of life</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophago-gastric 25 (EORTC QLQ-OG25) questionnaire</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>A high score on the functional scales or the global quality of life scale indicates a high function or high level of global quality of life, conversely a high score on a symptom scale represents a high level (severity or frequency, depending on the specific question) of the symptom in question.</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life using the EuroQOL 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire</measure> <time_frame>From randomization to 90-day post-operative</time_frame> <description>The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.</description> </secondary_outcome> <secondary_outcome> <measure>Post-operative morbidity</measure> <time_frame>From surgery to 90-day post-operative</time_frame> </secondary_outcome> <secondary_outcome> <measure>Post-operative mortality</measure> <time_frame>From surgery to 90-day post-operative</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">26</enrollment> <condition>Esophageal Cancer</condition> <condition>Nutrition Aspect of Cancer</condition> <arm_group> <arm_group_label>Percutaneous enteral access</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Feeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed)</description> </arm_group> <arm_group> <arm_group_label>No percutaneous enteral access</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>No feeding tube placed.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>No feeding tube placed</intervention_name> <description>The experimental arm will forego placement of a feeding tube.</description> <arm_group_label>No percutaneous enteral access</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Placement of a percutaneous feeding tube</intervention_name> <description>The standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube)</description> <arm_group_label>Percutaneous enteral access</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adult patient  - Non-cervical biopsy-proven esophageal or gastroesophageal junction (Siewert I or II) cancer  - Patient eligible for induction therapy then esophagectomy (stage Ib to III)  Exclusion Criteria:  - Impossibility to pass an endoscope beyond the tumour  - metastatic disease  - early-stage disease with either upfront esophagectomy or endoscopic resection planned  - patient refusal of the feeding tube  - inability to swallow their pill  - inability to tolerate a full fluid diet </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Deb Lewis</last_name> <phone>5196858500</phone> <phone_ext>75685</phone_ext> <email>deb.lewis@lhsc.on.ca</email> </overall_contact> <overall_contact_backup> <last_name>Mehdi Qiabi, MD MSc</last_name> <phone>519-667-6572</phone> <email>mehdi.qiabi@lhsc.on.ca</email> </overall_contact_backup> <location> <facility> <name>London Health Sciences Centre - Victoria Hospital</name> <address> <city>London</city> <state>Ontario</state> <zip>N6A 5W9</zip> <country>Canada</country> </address> </facility> <investigator> <last_name>Mehdi Qiabi, MD MSc</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Richard A Malthaner, MD MSc</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Rahul Nayak, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>David Palma, MD PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Michael Sanatani, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Daniel Breadner, MD MSc</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>March 5, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 4, 2022</last_update_submitted> <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation> <investigator_full_name>Mehdi Qiabi</investigator_full_name> <investigator_title>Associate Scientist</investigator_title> </responsible_party> <keyword>cancer</keyword> <keyword>esophagus</keyword> <keyword>enteral nutrition</keyword> <keyword>feeding tube</keyword> <keyword>adverse events</keyword> <keyword>randomized controlled trial</keyword> <keyword>feasibility</keyword> <condition_browse>  <mesh_term>Esophageal Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Patients diagnosed with esophageal cancer have difficulty eating, as the food pipe becomes obstructed by the cancer. This may impair the ability for the patient to receive appropriate calorie intake, especially during administration of chemotherapy and radiation therapy given prior to surgical resection. A strategy is to place a feeding tube directly in the stomach or in the small bowel to have an access to the patient's gastrointestinal tract during administration of chemo radiation therapy. However, these feeding tubes may lead to adverse events, including dislodgement, infection, the tube may be plugged, etc. If these complications were to happen, patients may have their treatment delayed, may have to come to the emergency department or even be admitted. In some cases, patients may need to have a surgery performed to treat the complication. Most centres in Canada have moved away from placement of these feeding tubes due to the high incidence of complications associated with the feeding tubes placement, and due to the high efficacy from the chemoradiation therapy in shrinking the tumour, allowing for the patient to swallow. In London, the preference from the Medical and Radiation Oncologists was to have these feeding tubes placed to avoid delay in treating the patients. There is therefore significant controversy as to what is the best approach in this patient population. Our goal is to run a feasibility randomized controlled trial studying this question. Esophageal cancer is highly lethal. In Ontario in 2020, an estimated 900 patients were diagnosed with esophageal cancer, while 860 died from it. In Canada, the figures are 2400 diagnoses and 2260 deaths. The incidence of esophageal cancer in Canada is projected to increase over time, especially in males who are more likely to be obese and to suffer from reflux disease. Esophageal cancer is the malignancy associated with the highest risk for malnutrition. Before their diagnosis, 80% of all patients with esophageal cancer have over 10-15% unintentional weight loss. Strategies to palliate malnutrition in cancer patients and its consequences on outcomes have been developed. In patient with severe nutritional risk, use of nutritional support for at least 10-14 days has been recommended in a non-surgical, oncology population. The European Society for Clinical Nutrition and Metabolism have recommended preoperatively enteral nutrition for 5-7 days in cancer patients undergoing major abdominal surgery. In addition, dietary counselling and oral nutritional supplement were suggested to prevent weight loss and interruption of radiotherapy on patients undergoing radiation treatments for head/neck or gastrointestinal malignancies. Routine enteral nutrition was not suggested during chemotherapy-only treatments. The type of supplements administered may have an impact on recovery. It was shown that esophageal cancer patients receiving enriched glutamine, fibers and oligosaccharide perioperative enteral supplementation had a shorter systemic inflammatory response syndrome postoperatively and less surgical stress, which could in turn lead to reduced postoperative immunosuppressive conditions. A recent retrospective study from Taiwan did show a slightly improved 4-year overall survival rate and less mucositis on patients supported by enteral feeding tubes with esophageal squamous cell carcinoma and undergoing neoadjuvant therapy. However, there is still equipoise in the literature and most centers in Canada have moved away from feeding tubes. At LHSC, feeding tubes were historically placed on every patient during their induction treatment. Efforts are being made to spare patients from unnecessary procedure, but patient selection is variable. Standardization of this practice is needed. A recent retrospective study evaluating the effect of surgical enteral access prior to induction treatment did not show nutritional or perioperative benefit. There was no difference in postoperative complication rates and weight loss was similar. In fact, dysphagia is felt to be significantly relieved after a single cycle of chemotherapy. Percutaneous feeding tubes may not be required on all patients during induction therapy for esophageal cancer. Those feeding tubes are associated with high morbidity. Kidane et al have shown that 39.3% of visits to the ED after an esophagectomy are due to feeding tubes problems (dislodgement, blockage, infection). Of those ED visits for feeding tubes issues, 17% resulted to an admission. Small bowel obstruction is also associated to percutaneous feeding tube placement and selective use has been recommended. Perioperative use of feeding jejunostomy in gastroesophageal cancer has been associate with a complication rate as high as 44%. Given the related-morbidity, guidelines now recommend selective use of feeding tubes on high-risk patients after esophagectomy. When patients undergoing chemotherapy present to the emergency department with fever or infectious signs, data from the Ontario Cancer Registry show that 46% are admitted, increasing healthcare burden. At baseline, patients undergoing chemotherapy are at high risk of presenting to the emergency department or having unplanned visit to the cancer center, this figure going as high as 49% within 4 weeks of initiation of chemotherapy in comparable jurisdictions. Efforts must be made to save an already strained system. According to the 2020 Surgical Quality Indicator Report Summary from OH-CCO, our center has the worst 30-day unplanned ED visit rate (45%, provincial mean 27%) after esophagectomy in the province of Ontario. Anecdotally, it is felt that most of those cases are related to feeding tubes complications. If these patients present to the ED due to feeding tubes concerns after an esophagectomy, it is likely they would have presented during induction treatment if they had a tube. Alternative to feeding tubes exist (home IV hydration) which could become a less invasive and more interesting solution. The objective of this study is to assess the feasibility of a larger randomized controlled trial evaluating unplanned visit to the ED or the outpatient clinic in patients eligible for trimodality for esophageal cancer during their induction treatment, randomized into receiving percutaneous enteral access for nutritional support versus not. Inclusion Criteria: - Adult patient - Non-cervical biopsy-proven esophageal or gastroesophageal junction (Siewert I or II) cancer - Patient eligible for induction therapy then esophagectomy (stage Ib to III) Exclusion Criteria: - Impossibility to pass an endoscope beyond the tumour - metastatic disease - early-stage disease with either upfront esophagectomy or endoscopic resection planned - patient refusal of the feeding tube - inability to swallow their pill - inability to tolerate a full fluid diet

NCT0531xxxx/NCT05314959.xml

<clinical_study>  <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/NCT05314959</url> </required_header> <id_info> <org_study_id>215830</org_study_id> <nct_id>NCT05314959</nct_id> </id_info> <brief_title>Physician Awareness of Patients' Preferred Level of Involvement in Decision Making</brief_title> <official_title>Physician Awareness of Patients' Preferred Level of Involvement in Decision Making</official_title> <sponsors> <lead_sponsor> <agency>Loyola University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Loyola University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process. </textblock> </brief_summary> <detailed_description> <textblock> Many health systems are shifting policies to promote greater patient involvement in healthcare delivery. Studies have shown that general medical patients who are more active in their care are more satisfied, more committed, have a better understanding of treatment plans, and experience greater improvements in health and patient-centered outcomes when compared to more passive patients. That being said, studies have found that patients have varying preferences when it comes to decision making. Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.  This awareness of decision-making preferences could be beneficial in treating quality of life conditions. Patients seeking care for pelvic floor disorders make medical decisions aimed toward improving symptoms, function, and quality of life. In a recent study, researchers found that 50% of women preferred active involvement, 45% collaborative and 5% passive. However, patients were 1.56 (95% CI:1.06-2.29) times more likely to report collaborative or passive involvement after their visit (p=0.02) with 40% of patients rating their actual role as active, 48% as collaborative, and 11% as passive. In this study, 37% of women did not experience their preferred level of decision-making. Other studies have similar findings with reported 20-40% discordance between patients' preferred involvement and what was achieved.  Discordance can negatively impact patients' outcomes and experiences of care. Interventions to minimize discordance between patients' preferred and perceived involvement in decision-making may significantly improve their overall experience and satisfaction. One possible intervention is eliciting women's preferred level of involvement in decision making prior to the visit and making this information available to the physician. The current study aims to determine whether physicians' awareness of patients' preferred involvement in decision making prior to their initial urogynecologist visit affects patients' perceived involvement in decision making after their visit. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 24, 2022</start_date> <completion_date type="Actual">October 1, 2022</completion_date> <primary_completion_date type="Actual">September 9, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation</intervention_model_description> <primary_purpose>Health Services Research</primary_purpose> <masking>Single (Participant)</masking> <masking_description>The control group will have usual care, meaning that the physician will NOT see the patient's survey results. The patient is blinded to randomization and will not know whether or not the physician is aware of their preferred level of shared decision making.</masking_description> </study_design_info> <primary_outcome> <measure>Discordance rate for the Control Preference Scale</measure> <time_frame>1 day visit</time_frame> <description>The Control Preference Scale assesses patients' preferences for involvement in decision-making. The scale ranks patients' preferences for involvement in their healthcare as either active, collaborative, or passive. Patients' CPS responses will be compared between the intervention and usual care cohorts.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">107</enrollment> <condition>Preferred Level of Involvement in Decision Making</condition> <arm_group> <arm_group_label>Physician Awareness</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group</description> </arm_group> <arm_group> <arm_group_label>Usual Care</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Physician Awareness</intervention_name> <description>The patients' pre-visit Control Preference Scale responses are shared with their physician.</description> <arm_group_label>Physician Awareness</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Usual Care</intervention_name> <description>The patients' pre-visit Control Preference Scale responses are not shared with their physician.</description> <arm_group_label>Usual Care</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Present to Loyola's Urogynecology clinic for their initial evaluation  - Agree to complete the study questionnaires  - Must be at least 18 years of age  - Must be able to read, speak and write in English  Exclusion Criteria:  - Established patients at Loyola's Urogynecology clinic  - Unable to complete the study questionnaires  - Less than 18 years of age  - Unable to read, speak and write in English </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Thythy Pham, MD</last_name> <role>Principal Investigator</role> <affiliation>Loyola Medical Center</affiliation> </overall_official> <location> <facility> <name>Loyola University Medical Center</name> <address> <city>Maywood</city> <state>Illinois</state> <zip>60153</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Crawford MJ, Rutter D, Manley C, Weaver T, Bhui K, Fulop N, Tyrer P. Systematic review of involving patients in the planning and development of health care. BMJ. 2002 Nov 30;325(7375):1263. doi: 10.1136/bmj.325.7375.1263.</citation> <PMID>12458240</PMID> </reference> <reference> <citation>Hubbard G, Kidd L, Donaghy E. Preferences for involvement in treatment decision making of patients with cancer: a review of the literature. Eur J Oncol Nurs. 2008 Sep;12(4):299-318. doi: 10.1016/j.ejon.2008.03.004. Epub 2008 May 16.</citation> <PMID>18486552</PMID> </reference> <reference> <citation>Sung VW, Raker CA, Myers DL, Clark MA. Treatment decision-making and information-seeking preferences in women with pelvic floor disorders. Int Urogynecol J. 2010 Sep;21(9):1071-8. doi: 10.1007/s00192-010-1155-8. Epub 2010 Apr 28.</citation> <PMID>20424822</PMID> </reference> <reference> <citation>Beaver K, Bogg J, Luker KA. Decision-making role preferences and information needs: a comparison of colorectal and breast cancer. Health Expect. 1999 Dec;2(4):266-276. doi: 10.1046/j.1369-6513.1999.00066.x.</citation> <PMID>11281903</PMID> </reference> <reference> <citation>Degner LF, Sloan JA. Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol. 1992 Sep;45(9):941-50. doi: 10.1016/0895-4356(92)90110-9.</citation> <PMID>1432023</PMID> </reference> <reference> <citation>Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1145-1151. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25.</citation> <PMID>19940010</PMID> </reference> <reference> <citation>Moth E, McLachlan SA, Veillard AS, Muljadi N, Hudson M, Stockler MR, Blinman P. Patients' preferred and perceived roles in making decisions about adjuvant chemotherapy for non-small-cell lung cancer. Lung Cancer. 2016 May;95:8-14. doi: 10.1016/j.lungcan.2016.02.009. Epub 2016 Feb 21.</citation> <PMID>27040845</PMID> </reference> <reference> <citation>Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.</citation> <PMID>9505581</PMID> </reference> <reference> <citation>Padilla-Garrido N, Aguado-Correa F, Ortega-Moreno M, Bayo-Calero J, Bayo-Lozano E. [Shared decision making from the perspective of the cancer patient: participatory roles and evaluation of the process]. An Sist Sanit Navar. 2017 Apr 30;40(1):25-33. doi: 10.23938/ASSN.0003. Spanish.</citation> <PMID>28534548</PMID> </reference> <verification_date>January 2023</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>January 23, 2023</last_update_submitted> <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Loyola University</investigator_affiliation> <investigator_full_name>Thythy Pham</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process. Many health systems are shifting policies to promote greater patient involvement in healthcare delivery. Studies have shown that general medical patients who are more active in their care are more satisfied, more committed, have a better understanding of treatment plans, and experience greater improvements in health and patient-centered outcomes when compared to more passive patients. That being said, studies have found that patients have varying preferences when it comes to decision making. Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process. This awareness of decision-making preferences could be beneficial in treating quality of life conditions. Patients seeking care for pelvic floor disorders make medical decisions aimed toward improving symptoms, function, and quality of life. In a recent study, researchers found that 50% of women preferred active involvement, 45% collaborative and 5% passive. However, patients were 1.56 (95% CI:1.06-2.29) times more likely to report collaborative or passive involvement after their visit (p=0.02) with 40% of patients rating their actual role as active, 48% as collaborative, and 11% as passive. In this study, 37% of women did not experience their preferred level of decision-making. Other studies have similar findings with reported 20-40% discordance between patients' preferred involvement and what was achieved. Discordance can negatively impact patients' outcomes and experiences of care. Interventions to minimize discordance between patients' preferred and perceived involvement in decision-making may significantly improve their overall experience and satisfaction. One possible intervention is eliciting women's preferred level of involvement in decision making prior to the visit and making this information available to the physician. The current study aims to determine whether physicians' awareness of patients' preferred involvement in decision making prior to their initial urogynecologist visit affects patients' perceived involvement in decision making after their visit. Inclusion Criteria: - Present to Loyola's Urogynecology clinic for their initial evaluation - Agree to complete the study questionnaires - Must be at least 18 years of age - Must be able to read, speak and write in English Exclusion Criteria: - Established patients at Loyola's Urogynecology clinic - Unable to complete the study questionnaires - Less than 18 years of age - Unable to read, speak and write in English

NCT0531xxxx/NCT05314972.xml

<clinical_study>  <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/NCT05314972</url> </required_header> <id_info> <org_study_id>foot alignment and pressure</org_study_id> <nct_id>NCT05314972</nct_id> </id_info> <brief_title>Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement</brief_title> <official_title>Assessment of Foot Alignment and Pressure After Correction of Varus Knee by High Tibial Osteotomy or Total Knee Replacement</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study evaluated the change in foot alignment after TKA or HTO by prospectively analyzing the correlation between the knee joint and the foot deformity, the post-operative improvement in the foot deformity, and the long-term post-operative changes in foot alignment. </textblock> </brief_summary> <detailed_description> <textblock> The mechanical alignment of the lower extremity is an important consideration in the long-term outcome following total knee arthroplasty (TKA) or high tibial osteotomy (HTO) . Alignment between the hip and the ankle through the knee joint has been used in determining coronal alignment, based on the assumption that weight-bearing forces pass through the centre of the knee joint during neutral mechanical. However, the weight-bearing vector can be affected by hindfoot and midfoot alignment because load is transmitted not from the ankle joint, but from the ground reaction point. Thus hindfoot alignment after knee correction may critically affect the longevity of the prosthesis  Most patients with some degree of knee joint deformity, which in turn may be associated with a deformity of the foot. In fact, an association between varus alignment of the knee joint and valgus alignment of the foot in osteoarthritis patients has been reported. Because the subtalar joint compensates for the knee joint deformity , correction of the deformity after TKA or HTO can affect foot alignment. Improvements in midfoot and hindfoot alignment have been noted in patients with osteoarthritis after correction of deformity. However, foot valgus may also persist, with little improvement after knee correction. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">March 1, 2023</completion_date> <primary_completion_date type="Anticipated">January 1, 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>: Radiological changes in hindfoot and midfoot alignment after correction of varus knee by High tibial osteotomy (HTO) or total knee arthroplasty(TKA)</measure> <time_frame>6-12 months</time_frame> <description>This study evaluated the change in foot alignment after TKA or HTO by: prospectively analyzing the correlation between the knee joint and the foot deformity. post-operative improvement in the foot deformity. the long-term post-operative changes in foot alignment.</description> </primary_outcome> <secondary_outcome> <measure>clinical assessment of the foot by american orthopedic foot&ankle society ( AOFAS) before and after knee correction</measure> <time_frame>6-12 months</time_frame> <description>AOFAS covers four different regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes.These four anatomic regions have their own version of the AOFAS survey. Each c is designed to be used independent of the others. However, each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points</description> </secondary_outcome> <enrollment type="Anticipated">200</enrollment> <condition>Varus Deformity</condition> <eligibility> <study_pop> <textblock> total coverage of all cases admitted to Assiut University Hospitals in one year </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) .  Exclusion Criteria:  - patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee. </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>abdelrhman abdelaziz khalaf</last_name> <phone>01096836732</phone> <email>Zizoo23295@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Wael yossef El-adly</last_name> <phone>01224265850</phone> <email>eladlyw@aun.edu.eg</email> </overall_contact_backup> <reference> <citation>Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.</citation> <PMID>6825330</PMID> </reference> <reference> <citation>Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009 Sep;24(6 Suppl):39-43. doi: 10.1016/j.arth.2009.04.034. Epub 2009 Jun 24.</citation> <PMID>19553073</PMID> </reference> <reference> <citation>Jeffery RS, Morris RW, Denham RA. Coronal alignment after total knee replacement. J Bone Joint Surg Br. 1991 Sep;73(5):709-14. doi: 10.1302/0301-620X.73B5.1894655.</citation> <PMID>1894655</PMID> </reference> <reference> <citation>Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. Good alignment after total knee arthroplasty leads to faster rehabilitation and better function. J Arthroplasty. 2009 Jun;24(4):570-8. doi: 10.1016/j.arth.2008.03.002. Epub 2008 May 19.</citation> <PMID>18534396</PMID> </reference> <reference> <citation>Cho WS, Cho HS, Byun SE. Changes in hindfoot alignment after total knee arthroplasty in knee osteoarthritic patients with varus deformity. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3596-3604. doi: 10.1007/s00167-016-4278-8. Epub 2016 Aug 16.</citation> <PMID>27527338</PMID> </reference> <reference> <citation>Norton AA, Callaghan JJ, Amendola A, Phisitkul P, Wongsak S, Liu SS, Fruehling-Wall C. Correlation of knee and hindfoot deformities in advanced knee OA: compensatory hindfoot alignment and where it occurs. Clin Orthop Relat Res. 2015 Jan;473(1):166-74. doi: 10.1007/s11999-014-3801-9.</citation> <PMID>25024033</PMID> </reference> <reference> <citation>Hara Y, Ikoma K, Arai Y, Ohashi S, Maki M, Kubo T. Alteration of hindfoot alignment after total knee arthroplasty using a novel hindfoot alignment view. J Arthroplasty. 2015 Jan;30(1):126-9. doi: 10.1016/j.arth.2014.07.026. Epub 2014 Jul 25.</citation> <PMID>25155238</PMID> </reference> <reference> <citation>Mullaji A, Shetty GM. Persistent hindfoot valgus causes lateral deviation of weightbearing axis after total knee arthroplasty. Clin Orthop Relat Res. 2011 Apr;469(4):1154-60. doi: 10.1007/s11999-010-1703-z. Epub 2010 Dec 1.</citation> <PMID>21120711</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>December 31, 2021</study_first_submitted> <study_first_submitted_qc>March 27, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 27, 2022</last_update_submitted> <last_update_submitted_qc>March 27, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Abdelrhman Abdelaziz Khalaf Mohamed</investigator_full_name> <investigator_title>principal investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Congenital Abnormalities</mesh_term> </condition_browse>  </clinical_study>

This study evaluated the change in foot alignment after TKA or HTO by prospectively analyzing the correlation between the knee joint and the foot deformity, the post-operative improvement in the foot deformity, and the long-term post-operative changes in foot alignment. The mechanical alignment of the lower extremity is an important consideration in the long-term outcome following total knee arthroplasty (TKA) or high tibial osteotomy (HTO) . Alignment between the hip and the ankle through the knee joint has been used in determining coronal alignment, based on the assumption that weight-bearing forces pass through the centre of the knee joint during neutral mechanical. However, the weight-bearing vector can be affected by hindfoot and midfoot alignment because load is transmitted not from the ankle joint, but from the ground reaction point. Thus hindfoot alignment after knee correction may critically affect the longevity of the prosthesis Most patients with some degree of knee joint deformity, which in turn may be associated with a deformity of the foot. In fact, an association between varus alignment of the knee joint and valgus alignment of the foot in osteoarthritis patients has been reported. Because the subtalar joint compensates for the knee joint deformity , correction of the deformity after TKA or HTO can affect foot alignment. Improvements in midfoot and hindfoot alignment have been noted in patients with osteoarthritis after correction of deformity. However, foot valgus may also persist, with little improvement after knee correction. total coverage of all cases admitted to Assiut University Hospitals in one year Inclusion Criteria: - all varus aligned knee admitted to Assiut University Hospitals (Total Knee Arthroplasty or High Tibial Osteotomy) . Exclusion Criteria: - patient with prior surgery of knee or foot . -secondary osteoarthritis. -valgus knee.

NCT0531xxxx/NCT05314985.xml

<clinical_study>  <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/NCT05314985</url> </required_header> <id_info> <org_study_id>BASEC-Nr. 2020-03060</org_study_id> <nct_id>NCT05314985</nct_id> </id_info> <brief_title>Prehab Intervention in Patients Awaiting Total Knee Arthroplasty (TKA)</brief_title> <official_title>Effect of Preoperative Training and Education on Pre- and Postoperative Functional Performance in Patients Awaiting TKA; A Randomized Controlled Trial - a Pilot Study</official_title> <sponsors> <lead_sponsor> <agency>Balgrist University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Maastricht University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Balgrist University Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The objectives of this study are to investigate the feasibility primarily and furthermore the effects of a four to eight-weeks program of a combined clinic- and home-based preoperative physical therapy (exercise training and education) versus usual care in patients awaiting unilateral primary TKA up to 3 months after surgery. </textblock> </brief_summary> <detailed_description> <textblock> The patients randomized into the intervention group are going to pass through a three-week therapy program. This program is based on MD's prescription and provides 9 sessions of physical therapy per prescription. All patients carry out their therapy at University Center for Prevention and Sports Medicine (UCePS) Balgrist. Before the evaluation phase starts, each patient is introduced by a member of the research team and gets a written information sheet about the goal of the study and the following procedure. The patients have to signature an informed consent to their participation in our investigation. Both groups are to be tested four times: The first assessment is appointed at a minimum of four weeks before surgery. Their baseline characteristics are noted, knee ROM, SCT, TUG, 5STS, 2MWT, handgrip strength and pain score are assessed and they need to fill in the KOOS, the Short Form 12 (SF-12) and the Tegner Activity Scale. After the first assessment, the Intervention Group (IG) is allowed to start the physical therapy exercise and education intervention. Each Physical Therapist treating a participant was previously introduced to the study protocol and the intended intervention. They conduct a total of 9 sessions over a 4 to 8-weeks period before surgery with one to two appointments per week. The Control Group (CG) is asked to keep its activity level as it is before the baseline measure. It is not desired, that anyone in this group starts a new type of therapy or training in preoperative stage. Patients in both groups keep their diary about changes concerning pain, medicament intake, training and therapies during the full length of intervention and follow-up phase.  One monitoring visit at the investigator's site prior to the start, one visit within one year after inclusion of the first participant and approximately once visit per annum during the course of the study will be organised by the Sponsor. Furthermore, there will be a monitoring visit at the study end. During the monitoring, all documents including source data/documents will be accessible for the monitor and all questions will be answered. Data will be entered in REDCap and retrieved from the clinic's information system.  If a subject is withdrawn, all previous collected data will be used for the final evaluation. All collected data will be used. An intention to treat analysis will be performed.  Data Handling and Record Keeping / Archiving:  - Case Report Forms (CRF): For each enrolled study participant, a printed CRF is maintained. Appropriate coded identification is used: Initials followed by birth year. CRF data is entered into an electronic database for analysis (double data entry).  - Specification of Source Documents: Source data is available at the site to document the existence of the study participants. Source includes the original documents relating to the study, as well as medical history of the participant. Source documents in this study are CRF, hardcopy of printed hearing thresholds (audiograms), informed consent forms and patient list. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI.  - Record Keeping / Archiving: All study data is archived for a minimum of 10 years after study termination or premature termination of the clinical trial. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI.  Data management:  - Data Management System: Data is entered in REDCap® electronic data capture system, provided by the University Hospital Balgrist.  - Data Security, Access and Back-up: Data is saved on the personal account. Backup system is in place and hosted by the IT department of the University Hospital Balgrist.  - Analysis and Archiving: Data is entered into an electronic database for analysis (SPSS).  - Electronic and Central Data Validation: All data collected for this research project will be registered in encrypted form in an automatic secure online processing (REDCap® electronic data capture system). Data entry is performed exclusively by authorized persons involved in the research project. Data processing and storage also takes place in REDCap®. Only encrypted data will be used for data analysis and statistical evaluation.  Reporting of Serious Adverse Events (SAE):  Clinical investigators and ultimately the Principal Investigator (PI) have the primary responsibility for SAE identification, documentation, grading, and assignment of attribution to the intervention under study. Clinical study participants will be routinely questioned about Adverse Events (AE) at study visits. The well-being of the participants will be ascertained by neutral questioning ("How are you?"). Observed or volunteered SAE, regardless of treatment group or suspected causal relationship to the study treatment(s) will be recorded in the patient file and subsequently in the electronic CRF (eCRF) if a relationship to the study intervention cannot be excluded. All SAEs in which a relation to the study intervention cannot be excluded, will be fully documented in the appropriate eCRF. For each such SAE, the investigator will provide the onset, duration, intensity, treatment required, outcome and action taken with the investigational device or study related procedure.The investigator shall report these events: a.) to the sponsor within 24 hours after they become known; and b.) to the responsible ethics committee via Business Administration System for Ethic Committees (BASEC) within 15 days. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 29, 2021</start_date> <completion_date type="Actual">April 30, 2023</completion_date> <primary_completion_date type="Actual">September 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Preoperative functional performance compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare functional performance immediately pre-surgery after preoperative physical therapy in patients awaiting a TKA to baseline. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </primary_outcome> <secondary_outcome> <measure>Preoperative functional performance compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare functional performance immediately pre-surgery after preoperative physical therapy to patients with usual care. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative stair climbing before TKA compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare stair climbing after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA. Assessment is an indicator for stair climbing: - Stair Climbing Test (SCT)</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative stair climbing before TKA compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare stair climbing after preoperative physical therapy immediately before TKA to usual care. Assessment is an indicator for stair climbing: - Stair Climbing Test (SCT)</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative walking performance before TKA compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare walking performance after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA. Assessment are indicators for walking performance: 2-minute walking test (2MWT) Timed-Up and Go (TUG)</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative walking performance before TKA compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare walking performance after preoperative physical therapy immediately pre-surgery to usual care in patients awaiting a TKA. Assessment are indicators for walking performance: 2-minute walking test (2MWT) Timed-Up and Go (TUG)</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative strength before TKA compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare strength after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA. Assessments are indicators for strength: 5-times Sit To Stand (5STS): indicator for knee strength Handgrip Strength (HGS): indicator for strength of lower extremities</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative strength before TKA compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare strength after preoperative physical therapy immediately pre-surgery to usual care in patients awaiting a TKA. Assessments are indicators for strength: 5-times Sit To Stand (5STS): indicator for knee strength Handgrip Strength (HGS): indicator for strength of lower extremities</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative activity level before TKA compared to baseline</measure> <time_frame>2-10 days before surgery</time_frame> <description>To compare activity level before TKA to baseline. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative activity level beforeTKA compared to usual care</measure> <time_frame>2-10 days before surgery</time_frame> <description>To compare activity level before TKA to patients with usual care. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative level of pain compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare the level of pain after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative level of pain compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare the level of pain after preoperative physical therapy immediately pre-surgery to patients with usual care. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative quality of life compared to baseline</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare the quality of life after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA. Assessment: - Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative quality of life compared to usual care</measure> <time_frame>2-10 days before sugery</time_frame> <description>To compare the quality of life after preoperative physical therapy immediately pre-surgery to patients with usual care. Assessment: - Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative knee joint mobility compared to baseline</measure> <time_frame>2-10 days before surgery</time_frame> <description>To assess preoperative range of motion (ROM) compared to baseline. Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible. Assessment: Degrees [°] Notation: Neutral-zero-method</description> </secondary_outcome> <secondary_outcome> <measure>Preoperative knee joint mobility compared to usual care</measure> <time_frame>2-10 days before surgery</time_frame> <description>To assess preoperative range of motion (ROM) compared to patients awaiting TKA with usual care. Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible. Assessment: Degrees [°] Notation: Neutral-zero-method</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative functional performance 6 weeks after TKA compared to baseline</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare functional performance 6 weeks after TKA compared to baseline. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative functional performance 6 weeks after TKA compared to usual care</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare functional performance 6 weeks after TKA to patients with usual care. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative activity level 6 weeks after TKA compared to baseline</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare activity level 6 weeks after TKA to baseline. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative activity level 6 weeks after TKA compared to usual care</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare activity level 6 weeks after TKA to patients with usual care. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative level of pain 6 weeks after TKA compared to usual care</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare the level of pain 6 weeks after TKA to patients with usual care. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative level of pain 6 weeks after TKA compared to baseline</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare the level of pain 6 weeks after TKA to baseline. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Feasibility of prehabilitation program: Number of participants with adherence to the therapy sessions of at least 80%</measure> <time_frame>6 weeks postoperative</time_frame> <description>To assess feasibility of preoperative physical therapy intervention in patients awaiting a TKA (defined as adherence to the therapy sessions of at least 80%).</description> </secondary_outcome> <secondary_outcome> <measure>Dischargeability: Length of Stay in hospital (LoS)</measure> <time_frame>6 weeks postoperative</time_frame> <description>To compare readiness for discharge from the hospital after surgery after preoperative physical therapy in patients awaiting a TKA to patients treated with usual care.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative functional performance 3 months after TKA compared to baseline</measure> <time_frame>3 months postoperative</time_frame> <description>To compare functional performance 3 months after TKA to baseline. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative functional performance 3 months after TKA compared to usual care</measure> <time_frame>3 months postoperative</time_frame> <description>To compare functional performance 3 months after TKA to patients with usual care. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative stair climbing 3 months after TKA compared to baseline</measure> <time_frame>3 months after sugery</time_frame> <description>To compare stair climbing 3 months after TKA to baseline. Assessment is an indicator for stair climbing: - Stair Climbing Test (SCT)</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative stair climbing 3 months after TKA compared to usual care</measure> <time_frame>3 months after sugery</time_frame> <description>To compare stair climbing 3 months after TKA to usual care. Assessment is an indicator for stair climbing: - Stair Climbing Test (SCT)</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative walking performance 3 months after TKA compared to baseline</measure> <time_frame>3 months after surgery</time_frame> <description>To compare walking performance 6 weeks after TKA to baseline. Assessment are indicators for walking performance: 2-minute walking test (2MWT) Timed-Up and Go (TUG)</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative walking performance 3 months after TKA compared to usual care</measure> <time_frame>3 months after surgery</time_frame> <description>To compare walking performance 6 weeks after TKA to usual care. Assessment are indicators for walking performance: 2-minute walking test (2MWT) Timed-Up and Go (TUG)</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative strength 3 months after TKA compared to baseline</measure> <time_frame>3 months after sugery</time_frame> <description>To compare strength 3 months after TKA to baseline. Assessments are indicators for strength: 5-times Sit To Stand (5STS): indicator for knee strength Handgrip Strength (HGS): indicator for strength of lower extremities</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative strength 3 months after TKA compared to usual care</measure> <time_frame>3 months after sugery</time_frame> <description>To compare strength 3 months after TKA to ususal care. Assessments are indicators for strength: 5-times Sit To Stand (5STS): indicator for knee strength Handgrip Strength (HGS): indicator for strength of lower extremities</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative activity level 3 months after TKA compared to baseline</measure> <time_frame>3 months postoperative</time_frame> <description>To compare activity level 3 months after TKA to baseline. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative activity level 3 months after TKA compared to usual care</measure> <time_frame>3 months postoperative</time_frame> <description>To compare activity level 3 months after TKA to usual care. Assessments: - Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative level of pain 3 months after TKA compared to baseline</measure> <time_frame>3 months postoperative</time_frame> <description>To compare the level of pain 3 months after TKA to baseline. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative level of pain 3 months after TKA compared to usual care</measure> <time_frame>3 months postoperative</time_frame> <description>To compare the level of pain 3 months after TKA to patients with usual care. Assessment: - Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative quality of life 3 months after TKA compared to baseline</measure> <time_frame>3 months postoperative</time_frame> <description>To compare the quality of life 3 months after TKA compared to baseline. Assessment: - Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative quality of life 3 months after TKA compared to usual care</measure> <time_frame>3 months postoperative</time_frame> <description>To compare the quality of life 3 months after TKA to patients with usual care. Assessment: - Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative knee joint mobility 3 months after TKA compared to baseline</measure> <time_frame>3 months after surgery</time_frame> <description>To assess postoperative range of motion (ROM) 3months after TKA compared to baseline. Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible. Assessment: Degrees [°] Notation: Neutral-zero-method</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative knee joint mobility 3 months after TKA compared to usual care</measure> <time_frame>3 months after surgery</time_frame> <description>To assess postoperative range of motion (ROM) 3 months after TKA compared to baseline. Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible. Assessment: Degrees [°] Notation: Neutral-zero-method</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative Global Impression of Change compared to usual care</measure> <time_frame>3 months after surgery</time_frame> <description>To assess postoperative Global Impression of Change 3 months after TKA compared to usual care. Assessment: Patient Global Impression of Change (PGIC)-Score: The minimum score = 0, the maximum score = 7, where a lower score indicates a better outcome</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">20</enrollment> <condition>Osteoarthritis, Knee</condition> <arm_group> <arm_group_label>Prehab Group / Intervention Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>4 to 8 weeks of preoperative physical therapy training and education intervention before total knee replacement surgery.</description> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Usual care / no treatment before total knee replacement surgery.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Prehab intervention</intervention_name> <description>Individual training program containing strengthening, sensori-motor, joint mobilisation and endurance exercises as well as educational inputs concerning perioperative procedure and instructions on e.g. how to walk with crutches.</description> <arm_group_label>Prehab Group / Intervention Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adult male and female participants (≥18 years)  - Patients receiving a unilateral TKA  - Signed informed consent after being informed  Exclusion Criteria:  - BMI >35  - Patella alta (Caton Deschamps Index >1.2)  - Muscle weakness due to neurological diagnosis  - Known or suspected non-compliance  - Known depression or other psychiatric disorders  - Acute pain exacerbations or inflammation  - Patellar instability  - Contradictions on ethical grounds  - Non-German speaking </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Johannes Scherr, Prof.</last_name> <role>Principal Investigator</role> <affiliation>Balgrist University Hospital</affiliation> </overall_official> <location> <facility> <name>University Hospital Balgrist</name> <address> <city>Zürich</city> <zip>8008</zip> <country>Switzerland</country> </address> </facility> </location> <location_countries> <country>Switzerland</country> </location_countries> <link> <url>https://www.balgrist.ch/angebot/zentren/zentrum-fuer-sportmedizin/praehabilitation/</url> <description>Information on the prehabilitation program at University Hospital Balgrist.</description> </link> <verification_date>August 2023</verification_date> <study_first_submitted>July 20, 2021</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 14, 2023</last_update_submitted> <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Preoperative Exercise</keyword> <keyword>Physical Therapy Modalities</keyword> <keyword>Arthroplasty, Replacement, Knee</keyword> <condition_browse>  <mesh_term>Osteoarthritis, Knee</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>There is not a plan to make Individual Participant Data (IPD) available.</ipd_description> </patient_data>  </clinical_study>

The objectives of this study are to investigate the feasibility primarily and furthermore the effects of a four to eight-weeks program of a combined clinic- and home-based preoperative physical therapy (exercise training and education) versus usual care in patients awaiting unilateral primary TKA up to 3 months after surgery. The patients randomized into the intervention group are going to pass through a three-week therapy program. This program is based on MD's prescription and provides 9 sessions of physical therapy per prescription. All patients carry out their therapy at University Center for Prevention and Sports Medicine (UCePS) Balgrist. Before the evaluation phase starts, each patient is introduced by a member of the research team and gets a written information sheet about the goal of the study and the following procedure. The patients have to signature an informed consent to their participation in our investigation. Both groups are to be tested four times: The first assessment is appointed at a minimum of four weeks before surgery. Their baseline characteristics are noted, knee ROM, SCT, TUG, 5STS, 2MWT, handgrip strength and pain score are assessed and they need to fill in the KOOS, the Short Form 12 (SF-12) and the Tegner Activity Scale. After the first assessment, the Intervention Group (IG) is allowed to start the physical therapy exercise and education intervention. Each Physical Therapist treating a participant was previously introduced to the study protocol and the intended intervention. They conduct a total of 9 sessions over a 4 to 8-weeks period before surgery with one to two appointments per week. The Control Group (CG) is asked to keep its activity level as it is before the baseline measure. It is not desired, that anyone in this group starts a new type of therapy or training in preoperative stage. Patients in both groups keep their diary about changes concerning pain, medicament intake, training and therapies during the full length of intervention and follow-up phase. One monitoring visit at the investigator's site prior to the start, one visit within one year after inclusion of the first participant and approximately once visit per annum during the course of the study will be organised by the Sponsor. Furthermore, there will be a monitoring visit at the study end. During the monitoring, all documents including source data/documents will be accessible for the monitor and all questions will be answered. Data will be entered in REDCap and retrieved from the clinic's information system. If a subject is withdrawn, all previous collected data will be used for the final evaluation. All collected data will be used. An intention to treat analysis will be performed. Data Handling and Record Keeping / Archiving: - Case Report Forms (CRF): For each enrolled study participant, a printed CRF is maintained. Appropriate coded identification is used: Initials followed by birth year. CRF data is entered into an electronic database for analysis (double data entry). - Specification of Source Documents: Source data is available at the site to document the existence of the study participants. Source includes the original documents relating to the study, as well as medical history of the participant. Source documents in this study are CRF, hardcopy of printed hearing thresholds (audiograms), informed consent forms and patient list. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI. - Record Keeping / Archiving: All study data is archived for a minimum of 10 years after study termination or premature termination of the clinical trial. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI. Data management: - Data Management System: Data is entered in REDCap® electronic data capture system, provided by the University Hospital Balgrist. - Data Security, Access and Back-up: Data is saved on the personal account. Backup system is in place and hosted by the IT department of the University Hospital Balgrist. - Analysis and Archiving: Data is entered into an electronic database for analysis (SPSS). - Electronic and Central Data Validation: All data collected for this research project will be registered in encrypted form in an automatic secure online processing (REDCap® electronic data capture system). Data entry is performed exclusively by authorized persons involved in the research project. Data processing and storage also takes place in REDCap®. Only encrypted data will be used for data analysis and statistical evaluation. Reporting of Serious Adverse Events (SAE): Clinical investigators and ultimately the Principal Investigator (PI) have the primary responsibility for SAE identification, documentation, grading, and assignment of attribution to the intervention under study. Clinical study participants will be routinely questioned about Adverse Events (AE) at study visits. The well-being of the participants will be ascertained by neutral questioning ("How are you?"). Observed or volunteered SAE, regardless of treatment group or suspected causal relationship to the study treatment(s) will be recorded in the patient file and subsequently in the electronic CRF (eCRF) if a relationship to the study intervention cannot be excluded. All SAEs in which a relation to the study intervention cannot be excluded, will be fully documented in the appropriate eCRF. For each such SAE, the investigator will provide the onset, duration, intensity, treatment required, outcome and action taken with the investigational device or study related procedure.The investigator shall report these events: a.) to the sponsor within 24 hours after they become known; and b.) to the responsible ethics committee via Business Administration System for Ethic Committees (BASEC) within 15 days. Inclusion Criteria: - Adult male and female participants (≥18 years) - Patients receiving a unilateral TKA - Signed informed consent after being informed Exclusion Criteria: - BMI >35 - Patella alta (Caton Deschamps Index >1.2) - Muscle weakness due to neurological diagnosis - Known or suspected non-compliance - Known depression or other psychiatric disorders - Acute pain exacerbations or inflammation - Patellar instability - Contradictions on ethical grounds - Non-German speaking

NCT0531xxxx/NCT05314998.xml

<clinical_study>  <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/NCT05314998</url> </required_header> <id_info> <org_study_id>ESPAC-6</org_study_id> <secondary_id>AIO-PAK-0121/ass</secondary_id> <secondary_id>2020-004906-79</secondary_id> <nct_id>NCT05314998</nct_id> </id_info> <brief_title>Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature</brief_title> <official_title>An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature</official_title> <sponsors> <lead_sponsor> <agency>John Neoptolemos</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Molecular Health GmbH</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Deutsches Krebsforschungszentrum (DKFZ)</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Nationales Centrum für Tumorerkrankungen</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Institut für Medizinische Biometrie</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Heidelberg University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm). </textblock> </brief_summary> <detailed_description> <textblock> The main purpose and primary objective of the study is to determine whether disease free survival in patients with resected pancreatic ductal adenocarcinoma (PDAC) treated with standard adjuvant chemotherapy regimens (oxaliplatin- or gemcitabine-based), is superior using allocation based on a treatment specific signature (TSS), compared to the same chemotherapy regimens allocated according to standard clinical criteria.  Secondary objectives of the study are to assess overall survival (median, 3 year survival rate), metastasis free survival; survival based on targeted signatures (TSS) in test versus control arms, and survival using targeted therapies initially on relapse compared to standard first-line therapies on relapse.  In addition, ESPAC-6 optional translational research programme will obtain tumor specimens and blodd samples to identify biomarkers that may predict response to chemotherapy or relapse.  ESPAC-6 will also generate a biobank of matched patient-derived organoids (PDOs) to provide an experimentally tractable model system for the development and testing of biomarker-driven personalised therapies.  ESPAC-6 translational research programme, will also develop a longitudinal blood biobank to analyse clinically relevant circulating biomarkers, such as blood proteins, metabolites and/or circulating-free tumour DNA. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">July 1, 2023</start_date> <completion_date type="Anticipated">September 1, 2029</completion_date> <primary_completion_date type="Anticipated">January 1, 2029</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Therapeutic intervention of standard adjuvant chemotherapy comprising oxaliplatin- or gemcitabine-based regimens based on standard clinical criteria, compared to selection using a treatment specific signature and prediction model.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Disease free survival</measure> <time_frame>76 months</time_frame> <description>Disease free survival will be defined as time from ramdomisation to disease recurrence (growth or metastasis) or death from any cause all patients fulfilling the in- and exclusion criteria.</description> </primary_outcome> <secondary_outcome> <measure>Overall survival</measure> <time_frame>76 months</time_frame> <description>Overall survival is defined as the time from randomization to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.</description> </secondary_outcome> <secondary_outcome> <measure>Metastasis free survival</measure> <time_frame>76 months</time_frame> <description>Metastasis free survival is defined as the time from randomization to detection of metastasis or death from any cause. The time of metastasis is defined as the date of metastasis determined and recorded by the Pancreas Tumour Board (Multidisciplinary Team). If the patient is eligible for first line therapy the recurrence must be performed by a positive biopsy or cytology. If a patient is lost to follow up, metastasis free survival time is censored at the time of last contact.</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival from recurrence</measure> <time_frame>76 months</time_frame> <description>Overall survival is defined as the time from recurrence to death due to any cause. If a patient is lost to follow up, overall survival time is censored at the time of last contact.</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life (QoL EORTC QLQ-C-30)</measure> <time_frame>76 months</time_frame> <description>QoL will be assessed by the EORTC QLQ-C30 questionnaire in its most current version every three months starting from V1.</description> </secondary_outcome> <secondary_outcome> <measure>Safety: (serious) adverse events and Grade 3 and 4 toxicities according to NCI-CTC v.5.0.</measure> <time_frame>47 months</time_frame> <description>Safety assessments will include adverse events. The proportion of grade 3 and 4 toxicity will be compared across treatments using time to event methods and frequency counts. Adverse and serious adverse events are collected throughout the study and will be tabulated and compared between study arms. The analysis of all safety endpoints is conducted on the safety set, which contains all patients who received at least one cycle of treatment.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">394</enrollment> <condition>Pancreatic Ductal Adenocarcinoma</condition> <arm_group> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>mFOLFIRINOX-therapy (5-FU, Folinic Acid, Irinotecan, Oxaliplatin) according to individual transcriptomic treatment specific signature or Gem/Cap-therapy (Gemcitabine and Capecitabine) according to individual transcriptomic treatment specific signature</description> </arm_group> <arm_group> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>mFOLFIRINOX-therapy (5-FU, Folinic Acid, Irinotecan, Oxaliplatin) according to standard clinical criteria or Gem/Cap-therapy (Gemcitabine and Capecitabine) according to standard clinical criteria</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Oxaliplatin</intervention_name> <description>85 mg/m2 D1 over 2 hours every; 14 days, 12 cycles, 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Irinotecan</intervention_name> <description>150 mg/m2 D1 over 90 minutes to begin 30 min after the Folinic acid infusion is started; every 14 days, 12 cycles, 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Folinic acid</intervention_name> <description>400 mg/m2 (racemic mixture) (or 200 mg/m2 if L-folinic acid is used), IV infusion over 2 hours; every 14 days, 12 cycles, 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>5-fluorouracil</intervention_name> <description>2.4 g/m2 IV continuous infusion over 46 hours (1200 mg/m2/ day); every 14 days, 12 cycles, 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Gemcitabine</intervention_name> <description>1000mg/m2 is given as an IV infusion over 30 minutes; on day 1, 8 and 15 out of 28 days (= 1 cycle); Repeated 6 times (i.e., 6 cycles) for 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Capecitabine</intervention_name> <description>1660mg/m2/day in two divided doses administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles i.e. 24 weeks</description> <arm_group_label>Control Arm B: mFOLFIRINOX or Gem/Cap according to standard clinical criteria</arm_group_label> <arm_group_label>Test Arm A: mFOLFIRINOX or Gem/Cap according to transcriptomic treatment specific signature</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria  1. Histologically proven pancreatic ductal adenocarcinoma including variants, and acinar cell carcinoma.  2. Patient had provided tumour tissue at resection for RNAseq.  3. Macroscopically complete resection (R0 or R1 resection).  4. Female and male Patients aged from 18 to 79 years.  5. WHO performance status 0-1.  6. No prior radiotherapy and no previous chemotherapy.  7. Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting.  8. Adequate hematologic function: Absolute neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted).  9. Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal.  10. Creatinine clearance ≥ 50 mL/min.  11. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use highly effective methods of contraception during the study and for 4 months after the last study treatment for women and 6 months for men.  12. Intended interval since surgery between 21 and 84 days at date of randomization.  13. Public or private health insurance cover.  14. Ability of subject to understand character and individual consequences of the clinical trial.  15. Not legally incapacitated.  16. Written informed consent.  Exclusion Criteria  1. Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer.  2. Distant metastases, including ascites or malignant pleural effusion.  3. Macroscopic incomplete tumour removal (R2 resection).  4. CA 19-9> 180 U / ml within 21 days of registration on study.  5. Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms.  6. Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or untreated chronic hepatitis B or active hepatitis C) or uncontrolled diabetes.  7. Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28.  8. Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea.  9. Known Dihydropyrimidine dehydrogenase (DPD) deficiency.  10. Pregnancy and lactation.  11. Participation in other clinical trials or observation period of competing trials, respectively.  12. History of hypersensitivity or other known contraindication to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.  13. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score ≤7) with normal PSA levels.  14. Any other concurrent antineoplastic treatment including irradiation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>79 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>John Neoptolemos, Prof. Dr.</last_name> <role>Study Director</role> <affiliation>Universität Heidelberg</affiliation> </overall_official> <overall_contact> <last_name>John Neoptolemos, Prof. Dr.</last_name> <phone>0049 6221 56-39020</phone> <email>john.neoptolemos@med.uni-heidelberg.de</email> </overall_contact> <overall_contact_backup> <last_name>Claudia Pauligk, Dr.</last_name> <phone>0049 69 6301 - 3906</phone> <email>pauligk.claudia@ikf-khnw.de</email> </overall_contact_backup> <location> <facility> <name>Universitätsklinikum Aachen, Studienzentrum Viszeralmedizin Klinik für Allgemeine-, Viszeral und Transplatationschirurgie</name> <address> <city>Aachen</city> <zip>52074</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Augsburg, III. medizinische Klinik</name> <address> <city>Augsburg</city> <zip>86156</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum, Abteilung für Hämatologie, Onkologie und Palliativmedizin, Studienambulanz</name> <address> <city>Bochum</city> <zip>44791</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Bonn, Chirurgische Abteilung</name> <address> <city>Bonn</city> <zip>53127</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>DIK Deggendorf, Onkologische Ambulanz</name> <address> <city>Deggendorf</city> <zip>94469</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie</name> <address> <city>Dresden</city> <zip>01307</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Erlangen, Chirurgische Klinik Zentrum für klinische Studien</name> <address> <city>Erlangen</city> <zip>91054</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie,</name> <address> <city>Frankfurt</city> <zip>60590</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Freiburg, Klinik für Allgemein und Viszeralchirurgie, Abteilung Chirurgie</name> <address> <city>Freiburg</city> <zip>79106</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin I</name> <address> <city>Halle (Saale)</city> <zip>06120</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Hamburg Eppendort, Zentrum für operative Medizin, Klinik und Poliklinik für Allgemein-, Viszeral- und Thoraxchirurgie</name> <address> <city>Hamburg</city> <zip>20246</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie</name> <address> <city>Hannover</city> <zip>30625</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Heidelberg, Abteilung für Allgemein-, Viszeral- und Transplantationschirurgie und Nationales Zentrum für Tumorerkrankungen, Medizinische Onkologie</name> <address> <city>Heidelberg</city> <zip>69120</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II und Klinik für Allgemeine Viszeral Gefäß und Kinderchirurgie</name> <address> <city>Homburg/Saar</city> <zip>66421</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Univeristätsklinikum Jena</name> <address> <city>Jena</city> <zip>07743</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>UKSH Campus Kiel, Medizinische Klinik II</name> <address> <city>Kiel</city> <zip>24105</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universität Leipzig, Medizinische Fakultät, Klinik für Gastroenterologie, Hepatologie, Infektiologie und Pneumologie</name> <address> <city>Leipzig</city> <zip>04103</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie, Onkologisches Zentrum Campus Lübeck</name> <address> <city>Lübeck</city> <zip>23538</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz, I. medizinische Klinik, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie</name> <address> <city>Mainz</city> <zip>55131</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Mannheim, II. medizinische Klinik, Klinik für Gastroenterologie, Hepatologie, Infektiologie und Ernährungsmedizin</name> <address> <city>Mannheim</city> <zip>68167</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Marburg, Klinik für Innere Medizin, Gastroenterologie, Stoffwechsel und Endokrinologie</name> <address> <city>Marburg</city> <zip>35043</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Klinikum der Universität München, AG Onkologie der Med Klinik III</name> <address> <city>München</city> <zip>81377</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Klinikum Rechts der Isar der TU München, Klinik und Poliklinik für Chirurgie</name> <address> <city>München</city> <zip>81675</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie</name> <address> <city>Regensburg</city> <zip>93053</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsmedizin Rostock, Klinik III (Hämatologie, Onkologie, Palliativmedizin), Zentrum für Innere Medizin</name> <address> <city>Rostock</city> <zip>18055</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Caritasklinikum Saarbrücken St. Theresia</name> <address> <city>Saarbrücken</city> <zip>66113</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Ulm, Klinik für Innere Medizin I Gastroenterologie-Endokrinologie-, Nephrologie-, Ernährung und Stoffwechselkrankheiten</name> <address> <city>Ulm</city> <zip>89081</zip> <country>Germany</country> </address> </facility> </location> <location> <facility> <name>Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II Zentrum für Innere Medizin</name> <address> <city>Würzburg</city> <zip>97080</zip> <country>Germany</country> </address> </facility> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 9, 2023</last_update_submitted> <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Heidelberg University</investigator_affiliation> <investigator_full_name>John Neoptolemos</investigator_full_name> <investigator_title>Prof. Dr. med.</investigator_title> </responsible_party> <keyword>Pancreatic Ductal Adenocarcinoma</keyword> <keyword>PDAC</keyword> <condition_browse>  <mesh_term>Adenocarcinoma</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Leucovorin</mesh_term> <mesh_term>Folic Acid</mesh_term> <mesh_term>Gemcitabine</mesh_term> <mesh_term>Fluorouracil</mesh_term> <mesh_term>Capecitabine</mesh_term> <mesh_term>Oxaliplatin</mesh_term> <mesh_term>Irinotecan</mesh_term> <mesh_term>Levoleucovorin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm). The main purpose and primary objective of the study is to determine whether disease free survival in patients with resected pancreatic ductal adenocarcinoma (PDAC) treated with standard adjuvant chemotherapy regimens (oxaliplatin- or gemcitabine-based), is superior using allocation based on a treatment specific signature (TSS), compared to the same chemotherapy regimens allocated according to standard clinical criteria. Secondary objectives of the study are to assess overall survival (median, 3 year survival rate), metastasis free survival; survival based on targeted signatures (TSS) in test versus control arms, and survival using targeted therapies initially on relapse compared to standard first-line therapies on relapse. In addition, ESPAC-6 optional translational research programme will obtain tumor specimens and blodd samples to identify biomarkers that may predict response to chemotherapy or relapse. ESPAC-6 will also generate a biobank of matched patient-derived organoids (PDOs) to provide an experimentally tractable model system for the development and testing of biomarker-driven personalised therapies. ESPAC-6 translational research programme, will also develop a longitudinal blood biobank to analyse clinically relevant circulating biomarkers, such as blood proteins, metabolites and/or circulating-free tumour DNA. Inclusion Criteria 1. Histologically proven pancreatic ductal adenocarcinoma including variants, and acinar cell carcinoma. 2. Patient had provided tumour tissue at resection for RNAseq. 3. Macroscopically complete resection (R0 or R1 resection). 4. Female and male Patients aged from 18 to 79 years. 5. WHO performance status 0-1. 6. No prior radiotherapy and no previous chemotherapy. 7. Full recovery from surgery and patient able to receive chemotherapy: adequate oral nutrition of ≥ 1500 calories per day and free of significant nausea and vomiting. 8. Adequate hematologic function: Absolute neutrophil count ≥ 1,500 cells/mm3, platelets ≥ 100,000 cells/mm3 and haemoglobin ≥ 8 g/L (transfusion permitted). 9. Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. 10. Creatinine clearance ≥ 50 mL/min. 11. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use highly effective methods of contraception during the study and for 4 months after the last study treatment for women and 6 months for men. 12. Intended interval since surgery between 21 and 84 days at date of randomization. 13. Public or private health insurance cover. 14. Ability of subject to understand character and individual consequences of the clinical trial. 15. Not legally incapacitated. 16. Written informed consent. Exclusion Criteria 1. Solid pseudopapillary neoplasm, neuroendocrine neoplasm, pancreatoblastoma, bile duct cancer, and ampullary cancer. 2. Distant metastases, including ascites or malignant pleural effusion. 3. Macroscopic incomplete tumour removal (R2 resection). 4. CA 19-9> 180 U / ml within 21 days of registration on study. 5. Cardiomyopathy or congestive heart failure, NYHA III-IV or coronary heart disease symptoms. 6. Major comorbidity that may preclude the delivery of treatment or known active infection (HIV or untreated chronic hepatitis B or active hepatitis C) or uncontrolled diabetes. 7. Pre-existing neuropathy, Gilbert's disease or known genotype UGT1A1*28 /*28. 8. Inflammatory disease of the colon or rectum, or intestinal obstruction, or severe postoperative uncontrolled diarrhoea. 9. Known Dihydropyrimidine dehydrogenase (DPD) deficiency. 10. Pregnancy and lactation. 11. Participation in other clinical trials or observation period of competing trials, respectively. 12. History of hypersensitivity or other known contraindication to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 13. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix or bladder, or low/intermediate risk prostate cancer (Gleason score ≤7) with normal PSA levels. 14. Any other concurrent antineoplastic treatment including irradiation

NCT0531xxxx/NCT05315011.xml

<clinical_study>  <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/NCT05315011</url> </required_header> <id_info> <org_study_id>RECHMPL20_0614</org_study_id> <secondary_id>2021-A02372-39</secondary_id> <nct_id>NCT05315011</nct_id> </id_info> <brief_title>Assessment of Cryotherapy's Analgesic Impact in Anti-aromatase-induced Arthralgia</brief_title> <acronym>CRYOMATASE</acronym> <official_title>Evaluation of the Analgesic Effect of Cryotherapy in Anti-aromatase-induced Arthralgia: a Prospective Randomized Study</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Montpellier</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>CryoMed Millenaire</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University Hospital, Montpellier</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The first aim of this comparative, randomized, prospective, multicenter study is to evaluate the analgesic effect at 6 weeks of whole-body cryotherapy, compared to placebo cryotherapy, in patients suffering from arthralgia under aromatase inhibitor treatment for hormone-dependent breast cancer in adjuvant situation.  The secondary objectives are to evaluate the tolerance of cryotherapy sessions and the evaluation of the impact of the cryotherapy sessions on the consumption of analgesics, the compliance of the treatment by anti-aromatases, the quality of life.  The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group:  - Whole Body Cryotherapy group (Arm A), or  - Placebo Cryotherapy group (Arm B). Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent.  The sessions will be performed according to the randomization arm as follows  - Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds.  - Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute.  Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit.  Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit.  Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit).  The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call. </textblock> </brief_summary> <detailed_description> <textblock> In 2018, the number of new cases of breast invasive cancer in France was estimated to be over 58 500, with a median age at diagnosis of 63 years.  The 5-year survival rate (as measured by age) has improved over time thanks to various treatments . Hormonotherapy is one of the disease's treatment options, and it includes a variety of molecules, including aromatase inhibitors. Despite their effectiveness, aromatase inhibitors cause a variety of side effects, including arthralgia in 35 percent to 50% of patients. The physiopathological mechanisms underlying these arthralgies would include articular inflammation, increased intra-articular fluid, and the appearance of a tenosynovitis. These side effects are frequently responsible for the premature discontinuation of hormone therapy and, as a result, the therapeutic effect of molecules. In order to improve the management of arthralgias caused by aromatase inhibitors, and because current recommendations are unclear, the effects of whole-body cryotherapy in patients who are taking an aromatase inhibitor for a hormono-dependent cancer in an adjuvant setting will be investigated. In fact, cryotherapy has already demonstrated its efficacy in the treatment of arthritic pain in a variety of diseases (rheumatoid arthritis,..).  This is a category 1, comparative, randomized, prospective, multicenter study. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group.  Randomization will be performed after information and signature of informed consent on the day of the inclusion visit.  Patients will be randomized to either  - either in the Whole Body Cryotherapy group (Arm A),  - or in the placebo Cryotherapy group (Arm B). Randomization will be stratified by center, initial BPI score of most severe pain (greater than or equal to 7 vs. less than 7) and duration of initial pain exposure (greater than or equal to 6 months vs. less than 6 months). It will be centralized, accessible online (on the Internet) and programmed by minimization using the Ennov Clinical software (CSRandomization module) by the Clinical Research Unit of the Medical Information Department (DIM) of the Montpellier University Hospital. Patients will be recruited from the gynecological consultation service of the Arnaud de Villeneuve Hospital in Montpellier and the Caremeau Hospital in Nîmes. Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent.  Oral and written information will be given at the inclusion visit. Written consent will be collected at the end of the same visit after a reflection period.  Prior to the cryotherapy sessions, the patient will be asked not to exercise, take a shower or take any stimulant (tea or coffee) before a cryotherapy session. Before the first cryotherapy session, after a new verification of the absence of contraindication to cryotherapy, a blood pressure and temperature measurement will be taken (questionnaire before/after cryotherapy). The patient will receive information on the course of a cryotherapy session and will then be prepared: protection of recent skin wounds, wearing of a bathing suit and a surgeon's mask, protection of the extremities by gloves, slippers and a polar cap provided by the CryoMed.  Before each of the following sessions, a blood pressure reading and a skin temperature reading between the Achilles heel and the triceps will be taken. The occurrence of undesirable events since the last session will be investigated (questionnaire before/after cryotherapy).  After the patient enters the cryotherapy chamber (CryoAir, MecoTec), a permanent visual contact is kept on the patient throughout the session, thanks to a glass window. It is also possible to hear and communicate with the patient throughout the session.  The sessions will be performed according to the randomization arm as follows  - Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds.  - Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute.  Patients can stop the cryotherapy session at any time. The duration of each session will be noted on the Before-After Cryotherapy questionnaire.  Finally, after the cyrotherapy sessions:  - Whole body cryotherapy group: In order to better understand the thermal shock and to adjust the following sessions, the patient's temperature will be recorded between her Achilles tendon and her triceps, as soon as she leaves the cryotherapy chamber:  - If > 12°C, the duration of exposure to -85°C will be increased by 20 seconds during the following sessions.  - If < 5°C, the duration of exposure to -85°C will be decreased by 20 seconds during the following sessions.  This process will be repeated with each new cryotherapy session.  • Placebo Cryotherapy Group: In order to promote blindness, the patient's temperature will be recorded between her Achilles tendon and her triceps, as soon as she leaves the cryotherapy chamber, but no change will be made to the duration of the following sessions.  Adverse events will be investigated at the end of each session (before/after cryotherapy questionnaire).  Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit.  Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit. A calendar will be given to each patient: the patient will indicate the use of hormone therapy and analgesics during the 15 days preceding the visits.  Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit).  The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call.  A difference of 2 points or more in the BPI-SF score is considered as clinically significant. Under this assumption and that of a standard deviation of 2.3 points in both groups, the number of subjects to be analyzed to demonstrate a difference between the groups, with a two-sided alpha risk of 5% and a power of 80%, is 42 subjects, i.e. 21 subjects per group. In this study, there is a risk of attrition during or after the sessions, evaluated at 20%, and a risk of attrition of 20% between inclusion and the first session, due to organizational constraints and the possible appearance of contraindications to cryotherapy. In case of attrition between the inclusion and the first session, for a provisional reason, the patients could be re-included. A total of 70 inclusions are finally possible. As soon as 56 patients (28 per group) have completed at least one session, recruitment can be stopped.  The threshold of significance is set at 0.05 bilaterally for all analyses. Qualitative variables will be described by their number and percentage. Quantitative variables will be described by their mean, standard deviation, extrema, median and quartiles, in the randomized population, in the ITT population, in the PP population, in the safety population, and in each of the two groups within each of these populations. In addition, all baseline variables will be described in the included population. A flow-chart will be performed.  The main analysis will be performed in the ITT population by comparing the mean of the primary endpoint (most severe pain at 6 weeks) between the two groups by a test appropriate to the distribution of the data. Missing data will not be imputed.  The primary analysis will be supplemented by a secondary analysis of the YAC in which missing data will be imputed by multiple imputation, in the randomized population, and by an analysis in the PP population.  Secondary endpoints will be compared between the two groups, in the ITT population and in the PP population, without imputation for missing data:  - Mean comparisons for  - Most severe pain at 3 and 6 months  - BPI-SF composite pain severity and interference scores at 6 weeks, 3 and 6 months.  - Health Assessment Questionnaire (HAQ) scores at 6 weeks, 3 and 6 months  - Number of days on anti-aromatase therapy at 6 weeks, 3 and 6 months after cryotherapy.  - Comparison of percentages for the use of the different levels of analgesics at 6 weeks, 3 and 6 months.  Adverse events will be compared between the two groups in the safety population. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 5, 2023</start_date> <completion_date type="Anticipated">February 4, 2026</completion_date> <primary_completion_date type="Anticipated">February 4, 2025</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>The most intense pain</measure> <time_frame>2 weeks before the first cryotherapy session</time_frame> <description>The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF) at baseline (question 3 of BPI-SF). The two domains measured by the BPI-SF pain intensity (severity) and the impact of pain on functioning (interference). It is a pain and quality of life assessment measure used to examine pain intensity (sensory dimension) and functional impact (reactive dimension) in patients. Numerical scales from 0 to 10 indicate overall pain intensity, worst pain, least pain and current pain. A figure representing the human body is included to allow the patient to mark in which part of the body the pain is located.</description> </primary_outcome> <primary_outcome> <measure>The most intense pain</measure> <time_frame>6 weeks after the last cryotherapy session</time_frame> <description>The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF) The two domains measured by the BPI-SF pain intensity (severity) and the impact of pain on functioning (interference). It is a pain and quality of life assessment measure used to examine pain intensity (sensory dimension) and functional impact (reactive dimension) in patients. Numerical scales from 0 to 10 indicate overall pain intensity, worst pain, least pain and current pain. A figure representing the human body is included to allow the patient to mark in which part of the body the pain is located.</description> </primary_outcome> <secondary_outcome> <measure>The most intense pain</measure> <time_frame>3 months and 6 months after the last cryotherapy session</time_frame> <description>The most intense pain, on the Brief Pain Inventory Short Form (BPI-SF)</description> </secondary_outcome> <secondary_outcome> <measure>Pain severity score</measure> <time_frame>6 weeks, 3 months, 6 months after the last cryotherapy session</time_frame> <description>The BPI assesses pain severity at its "worst," "least," "average," and "now" (current pain) with the questions 3, 4, 5 and 6. Responses to these 4 items are rated from 0 (No pain) to 10 (Pain as bad as you can imagine). The average of these 4 items is the composite pain interference score.</description> </secondary_outcome> <secondary_outcome> <measure>Pain interference score</measure> <time_frame>6 weeks, 3 months, 6 months after the last cryotherapy session</time_frame> <description>The question 9 of BPI-SF measures how much pain interfered with seven daily activities: general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. These 7 items are measured from 0 (Does not interference) to 10 (Completely interferes). BPI pain interference is scored as the mean of the seven interference items. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration.</description> </secondary_outcome> <secondary_outcome> <measure>HAQ score</measure> <time_frame>6 weeks, 3 months, 6 months after the last cryotherapy session</time_frame> <description>The Health Assessment Questionnaire (HAQ) Each question is given the following score: 0 = without any difficulty = with some difficulty = with great difficulty = unable to do so The rating for each of the 8 domains (dressing, body care, getting up, eating, walking, hygiene, catching, grasping, other activities) is the one corresponding to the highest score of the questions in that domain. If there is missing data for one or more questions in a particular domain, the rating is the highest score of the questions with an answer (missing data is not taken into account). The notion of the need for assistance from a third party and/or the use of devices can modify this scoring system. In this case the score for the domain concerned must be at least equal to 2 (a score of 3 is given if the highest score is equal to 3: in all other cases a score of 2 is given). The functional index is the sum of the scores of the various domains divided by the number of domains assessed (normally 8</description> </secondary_outcome> <secondary_outcome> <measure>Number of days of anti-aromatases taken during the 15 days preceding the visit</measure> <time_frame>6 weeks, 3 months, 6 months after the last cryotherapy session</time_frame> <description>Number of days of taking anti-aromatase treatment at 6 weeks, 3 and 6 months after cryotherapy.</description> </secondary_outcome> <secondary_outcome> <measure>Number of analgesics</measure> <time_frame>6 weeks, 3 months, 6 months after the last cryotherapy session</time_frame> <description>Use of analgesics taken during the 15 days preceding the visit classified into three categories: stage 1, 2 and 3, at 6 weeks, 3 and 6 months after cryotherapy.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">70</enrollment> <condition>Breast Cancer</condition> <condition>Aromatase Inhibitors</condition> <arm_group> <arm_group_label>Whole-body cryotherapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Placebo cryotherapy</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Whole-body cryotherapy</intervention_name> <description>The term "cryotherapy" refers to the process of chilling the body for medicinal purposes. WBC is carried out in a dedicated temperature and humidity controlled cryogenic chamber, which includes a brief exposure to extremely cold air. To avoid frostbite, only a few layers of clothes will be worn during the exposure. To avoid skin burns and necrosis, each participant must first remove their sweat before entering the cryochamber and a surgical mask is also worn to prevent moist air from being exhaled. Subjects will move their fingers and legs in the cryochamber and avoid holding their breath. The exposure time will be 4 minutes and 30 seconds in -85°C.</description> <arm_group_label>Whole-body cryotherapy</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo cryotherapy</intervention_name> <description>The patient will be placed in a -85°C chamber for 1 minute as part of the placebo treatment.</description> <arm_group_label>Placebo cryotherapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Major non-menopausal patient  - Patient managed for histologically proven breast cancer  - Patient undergoing adjuvant anti-aromatase treatment (letrozole, anastrozole or exemestane) for at least 6 months  - Patient with arthralgias affecting one or more joints that have occurred or been exacerbated since the anti-aromatase treatment  - Patient with a score for the most severe pain experienced in the last week on the Brief Pain Inventory-Short Form (BPI-SF) ≥ 3.  - Patient with stable analgesic treatment for at least 15 days (without dose increase or change in step).  Exclusion Criteria:  - Infectious state  - Inflammatory, neurological or metabolic arthropathy  - Fracture or surgery of the painful extremity within the last 6 months  - Concomitant use of corticosteroid therapy  - Treatment with cryotherapy within 6 months prior to study inclusion  - Uncontrolled hypertension / Known coronary artery disease / History of myocardial infarction / History of cardiac rhythm disorder / Valvulopathy  - Pacemaker  - Previous venous thromboembolic event in progress  - Stage 3-4 arterial disease  - Hypothyroidism  - Severe Raynaud's syndrome  - Cryoglobulinemia  - Chronic respiratory insufficiency  - Polyneuropathy  - Acute renal or urinary pathology  - Epilepsy  - Alcohol and/or drug abuse  - Healing disorders  - Known allergy to cold  - Claustrophobia  - Uncontrolled hyperhydrosis  - Patient participating in another interventional research involving the human being  - Patient deprived of liberty by judicial or administrative decision.  - Patient protected by law under guardianship or curatorship  - Failure to obtain free, informed and written consent after a period of reflection  - Patient not affiliated or beneficiary of a national health insurance system </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Martha DURAES, MD</last_name> <role>Principal Investigator</role> <affiliation>Montpellier University Hospital</affiliation> </overall_official> <overall_contact> <last_name>Martha DURAES, MD</last_name> <phone>+334.67.33.65.32</phone> <email>m-duraes@chu-montpellier.fr</email> </overall_contact> <overall_contact_backup> <last_name>Gauthier RATHAT, MD</last_name> <phone>+334.67.33.65.32</phone> <email>g-rathat@chu-montpellier.fr</email> </overall_contact_backup> <location> <facility> <name>CHU de Montpellier</name> <address> <city>Montpellier</city> <zip>34295</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Martha DURAES, MD</last_name> <phone>+334.67.33.65.32</phone> <email>m-duraes@chu-montpellier.fr</email> </contact> <investigator> <last_name>Martha DURAES, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Sarah FRANCINI, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Gauthier RATHAT, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Lucie REBEL, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>CHU de Nîmes</name> <address> <city>Nîmes</city> <zip>30029</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Renaud DE TAYRAC, MD PhD</last_name> <email>renaud.detayrac@chu-nimes.fr</email> </contact> <contact_backup> <last_name>Nathalie RUMEAU, CRA</last_name> <email>nathalie.rumeau@chu-montpellier.fr</email> </contact_backup> <investigator> <last_name>Renaud DE TAYRAC, MD PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Catherine MARSOLLIER FERRER, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>France</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>September 1, 2023</last_update_submitted> <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 5, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Aromatase Inhibitor</keyword> <keyword>Arthralgias</keyword> <keyword>Cryotherapy</keyword> <keyword>Breast cancer</keyword> <condition_browse>  <mesh_term>Arthralgia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The first aim of this comparative, randomized, prospective, multicenter study is to evaluate the analgesic effect at 6 weeks of whole-body cryotherapy, compared to placebo cryotherapy, in patients suffering from arthralgia under aromatase inhibitor treatment for hormone-dependent breast cancer in adjuvant situation. The secondary objectives are to evaluate the tolerance of cryotherapy sessions and the evaluation of the impact of the cryotherapy sessions on the consumption of analgesics, the compliance of the treatment by anti-aromatases, the quality of life. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group: - Whole Body Cryotherapy group (Arm A), or - Placebo Cryotherapy group (Arm B). Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent. The sessions will be performed according to the randomization arm as follows - Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds. - Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute. Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit. Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit. Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit). The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call. In 2018, the number of new cases of breast invasive cancer in France was estimated to be over 58 500, with a median age at diagnosis of 63 years. The 5-year survival rate (as measured by age) has improved over time thanks to various treatments . Hormonotherapy is one of the disease's treatment options, and it includes a variety of molecules, including aromatase inhibitors. Despite their effectiveness, aromatase inhibitors cause a variety of side effects, including arthralgia in 35 percent to 50% of patients. The physiopathological mechanisms underlying these arthralgies would include articular inflammation, increased intra-articular fluid, and the appearance of a tenosynovitis. These side effects are frequently responsible for the premature discontinuation of hormone therapy and, as a result, the therapeutic effect of molecules. In order to improve the management of arthralgias caused by aromatase inhibitors, and because current recommendations are unclear, the effects of whole-body cryotherapy in patients who are taking an aromatase inhibitor for a hormono-dependent cancer in an adjuvant setting will be investigated. In fact, cryotherapy has already demonstrated its efficacy in the treatment of arthritic pain in a variety of diseases (rheumatoid arthritis,..). This is a category 1, comparative, randomized, prospective, multicenter study. The patient and investigator will be blinded to the treatment. Only the cryotherapist will have knowledge of the treatment group. Randomization will be performed after information and signature of informed consent on the day of the inclusion visit. Patients will be randomized to either - either in the Whole Body Cryotherapy group (Arm A), - or in the placebo Cryotherapy group (Arm B). Randomization will be stratified by center, initial BPI score of most severe pain (greater than or equal to 7 vs. less than 7) and duration of initial pain exposure (greater than or equal to 6 months vs. less than 6 months). It will be centralized, accessible online (on the Internet) and programmed by minimization using the Ennov Clinical software (CSRandomization module) by the Clinical Research Unit of the Medical Information Department (DIM) of the Montpellier University Hospital. Patients will be recruited from the gynecological consultation service of the Arnaud de Villeneuve Hospital in Montpellier and the Caremeau Hospital in Nîmes. Patients consulting for the follow-up of a breast cancer and presenting arthralgias under anti-aromatase will be included in the study after verification of the inclusion and non-inclusion criteria and collection of consent. Oral and written information will be given at the inclusion visit. Written consent will be collected at the end of the same visit after a reflection period. Prior to the cryotherapy sessions, the patient will be asked not to exercise, take a shower or take any stimulant (tea or coffee) before a cryotherapy session. Before the first cryotherapy session, after a new verification of the absence of contraindication to cryotherapy, a blood pressure and temperature measurement will be taken (questionnaire before/after cryotherapy). The patient will receive information on the course of a cryotherapy session and will then be prepared: protection of recent skin wounds, wearing of a bathing suit and a surgeon's mask, protection of the extremities by gloves, slippers and a polar cap provided by the CryoMed. Before each of the following sessions, a blood pressure reading and a skin temperature reading between the Achilles heel and the triceps will be taken. The occurrence of undesirable events since the last session will be investigated (questionnaire before/after cryotherapy). After the patient enters the cryotherapy chamber (CryoAir, MecoTec), a permanent visual contact is kept on the patient throughout the session, thanks to a glass window. It is also possible to hear and communicate with the patient throughout the session. The sessions will be performed according to the randomization arm as follows - Whole body cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 4 minutes 30 seconds. - Placebo cryotherapy group: 10 sessions will be performed daily, over a period of 12 to 21 days. For each session, the patient enters a chamber at -85°C for 1 minute. Patients can stop the cryotherapy session at any time. The duration of each session will be noted on the Before-After Cryotherapy questionnaire. Finally, after the cyrotherapy sessions: - Whole body cryotherapy group: In order to better understand the thermal shock and to adjust the following sessions, the patient's temperature will be recorded between her Achilles tendon and her triceps, as soon as she leaves the cryotherapy chamber: - If > 12°C, the duration of exposure to -85°C will be increased by 20 seconds during the following sessions. - If < 5°C, the duration of exposure to -85°C will be decreased by 20 seconds during the following sessions. This process will be repeated with each new cryotherapy session. • Placebo Cryotherapy Group: In order to promote blindness, the patient's temperature will be recorded between her Achilles tendon and her triceps, as soon as she leaves the cryotherapy chamber, but no change will be made to the duration of the following sessions. Adverse events will be investigated at the end of each session (before/after cryotherapy questionnaire). Each patient will complete the BPI-SF and HAQ questionnaires 15 days +/- 7 days prior to the start of cryotherapy, at the 6 week, 3 and 6 month post-cryotherapy visit. Each patient will indicate the number of days of anti-aromatase therapy in the 6 months prior to inclusion and at 6 weeks, 3 and 6 months after cryotherapy. For this purpose, each patient will indicate the number of hormone therapy tablets taken in the 15 days prior to the inclusion visit, the 6 week, 3 and 6 month visit. A calendar will be given to each patient: the patient will indicate the use of hormone therapy and analgesics during the 15 days preceding the visits. Each patient will indicate the analgesic treatments used, classified in three categories: levels 1, 2 and 3 at the inclusion consultation and at 6 weeks, 3 and 6 months after cryotherapy (analgesics taken during the 15 days preceding the visit). The evaluation of the tolerance with the collection of the undesirable effects will be made before and at the end of each session by the professionals of the CryoMed. It will also be evaluated in the week following the end of cryotherapy during a telephone call. A difference of 2 points or more in the BPI-SF score is considered as clinically significant. Under this assumption and that of a standard deviation of 2.3 points in both groups, the number of subjects to be analyzed to demonstrate a difference between the groups, with a two-sided alpha risk of 5% and a power of 80%, is 42 subjects, i.e. 21 subjects per group. In this study, there is a risk of attrition during or after the sessions, evaluated at 20%, and a risk of attrition of 20% between inclusion and the first session, due to organizational constraints and the possible appearance of contraindications to cryotherapy. In case of attrition between the inclusion and the first session, for a provisional reason, the patients could be re-included. A total of 70 inclusions are finally possible. As soon as 56 patients (28 per group) have completed at least one session, recruitment can be stopped. The threshold of significance is set at 0.05 bilaterally for all analyses. Qualitative variables will be described by their number and percentage. Quantitative variables will be described by their mean, standard deviation, extrema, median and quartiles, in the randomized population, in the ITT population, in the PP population, in the safety population, and in each of the two groups within each of these populations. In addition, all baseline variables will be described in the included population. A flow-chart will be performed. The main analysis will be performed in the ITT population by comparing the mean of the primary endpoint (most severe pain at 6 weeks) between the two groups by a test appropriate to the distribution of the data. Missing data will not be imputed. The primary analysis will be supplemented by a secondary analysis of the YAC in which missing data will be imputed by multiple imputation, in the randomized population, and by an analysis in the PP population. Secondary endpoints will be compared between the two groups, in the ITT population and in the PP population, without imputation for missing data: - Mean comparisons for - Most severe pain at 3 and 6 months - BPI-SF composite pain severity and interference scores at 6 weeks, 3 and 6 months. - Health Assessment Questionnaire (HAQ) scores at 6 weeks, 3 and 6 months - Number of days on anti-aromatase therapy at 6 weeks, 3 and 6 months after cryotherapy. - Comparison of percentages for the use of the different levels of analgesics at 6 weeks, 3 and 6 months. Adverse events will be compared between the two groups in the safety population. Inclusion Criteria: - Major non-menopausal patient - Patient managed for histologically proven breast cancer - Patient undergoing adjuvant anti-aromatase treatment (letrozole, anastrozole or exemestane) for at least 6 months - Patient with arthralgias affecting one or more joints that have occurred or been exacerbated since the anti-aromatase treatment - Patient with a score for the most severe pain experienced in the last week on the Brief Pain Inventory-Short Form (BPI-SF) ≥ 3. - Patient with stable analgesic treatment for at least 15 days (without dose increase or change in step). Exclusion Criteria: - Infectious state - Inflammatory, neurological or metabolic arthropathy - Fracture or surgery of the painful extremity within the last 6 months - Concomitant use of corticosteroid therapy - Treatment with cryotherapy within 6 months prior to study inclusion - Uncontrolled hypertension / Known coronary artery disease / History of myocardial infarction / History of cardiac rhythm disorder / Valvulopathy - Pacemaker - Previous venous thromboembolic event in progress - Stage 3-4 arterial disease - Hypothyroidism - Severe Raynaud's syndrome - Cryoglobulinemia - Chronic respiratory insufficiency - Polyneuropathy - Acute renal or urinary pathology - Epilepsy - Alcohol and/or drug abuse - Healing disorders - Known allergy to cold - Claustrophobia - Uncontrolled hyperhydrosis - Patient participating in another interventional research involving the human being - Patient deprived of liberty by judicial or administrative decision. - Patient protected by law under guardianship or curatorship - Failure to obtain free, informed and written consent after a period of reflection - Patient not affiliated or beneficiary of a national health insurance system

NCT0531xxxx/NCT05315024.xml

<clinical_study>  <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/NCT05315024</url> </required_header> <id_info> <org_study_id>21-290</org_study_id> <nct_id>NCT05315024</nct_id> </id_info> <brief_title>Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children</brief_title> <official_title>Prevalence, Genetic Risk Factor and the Use of Intradermally-administered Inactivated Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children</official_title> <sponsors> <lead_sponsor> <agency>The University of Hong Kong</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>The University of Hong Kong</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Aims and hypotheses to be tested:  Primary objective  - To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders.  Secondary objectives  - To determine the IIV non-responder rate in healthy Hong Kong children.  - To investigate the association between HLA molecules and IIV non-responsiveness.  Hypotheses  - The investigators hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose.  - The investigators hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population.  - The investigators hypothesize that certain HLA alleles are associated with IIV non-responders. </textblock> </brief_summary> <detailed_description> <textblock> This study is a cross-over randomized-controlled trial (RCT). The outline of the study is shown in Figure 1. This study is divided into two parts: (i) screening for vaccine non-responders; and (ii) RCT for vaccine responsiveness using second dose IIV-IM, IIV-ID or IIV-Q-ID.  Children and adolescents between 8 and 18 years old will be recruited through our network of primary and secondary schools that have participated the Seasonal Influenza Vaccination School Outreach Programme before the influenza vaccination campaign. Information sheets, a consent form and a health demographics form indicating that they fulfill the inclusion and exclusion criteria (see below) will be distributed to the parents through the participating schools. A study hotline will be available for parents to contact the study team to answer any enquiries.  In the health demographics form, apart from questions related to the inclusion and exclusion criteria, the study team will also enquire about the subjects' demographics, including birth, gender, past medical history, and body weight and height. Previous influenza vaccination history will also be sought, including age at receiving the first influenza vaccine, whether the subjects have received influenza vaccines in the last season and the type of influenza vaccines they received.  All subjects should be receiving 0.5ml IM quadrivalent IIV, which contains 15micrograms hemagglutinin of each influenza strain, through the Seasonal Influenza Vaccination School Outreach Programme. Consented subjects will have 5-10ml clotted blood and 3ml EDTA blood draw at day 21 post-vaccination at school by our outreach study team. The parents of all participating subjects will receive an incentive equivalent to HKD 100. They will also receive their influenza vaccine response results in concealed envelops distributed through the schools.  Post-vaccination HAI titer against the Influenza B Yamagata strain ≤10 will be considered as "preliminary no seroconversion". The same serum taken on day 21 post-vaccination will be further processed to confirm that their HAI titer against the other Influenza A H1N1 and H3N2 and Influenza B Victoria strains are also ≤10. MN assay for all four strains will also be performed as the baseline for the part 2 RCT.  Non-responders will be called back to attend a research clinic and will be randomized to one of the following revaccination strategies: (i) repeat 0.5ml IM Quadrivalent IIV (IIV-IM) (15micrograms haemagglutinin per vaccine strain); (ii) 0.1ml ID Quadrivalent IIV (IIV-ID) (3micrograms haemagglutinin per vaccine strain); or (iii) 0.1ml ID Quadrivalent IIV (3micrograms haemagglutinin antigen per vaccine strain) + 5% imiquimod cream (IIV-Q-ID). Subjects randomized to receive 5% imiquimod cream will have the injection site disinfected by 70% alcohol swab followed by application of the imiquimod cream for 5 minutes before the intradermal injection over a 16cm2 skin area of the deltoid described in previous studies. 0.1ml IIV, which contains 3micrograms hemagglutinin of each influenza strain, will be administered intradermally using a MicronJetTM microneedle. All subjects will be observed for 15 to 30 minutes in the waiting area for any local adverse reactions. These subjects will be called back on day 7 and 21 after the second dose of vaccination for blood testing. 5- 10ml clotted blood will be obtained to measure the vaccine response. HAI and MN assays against the four vaccine strains will be performed.  To determine the association between HLA alleles and IIV non-responsiveness, HLA genotyping will be performed among non-responders and responders in 1:2 ratios. Assuming that there will be 72-100 IIV non-responders from our cohort, HLA genotyping will be performed in 200 age- and gender-matched IIV responder controls. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 30, 2022</start_date> <completion_date type="Anticipated">October 30, 2023</completion_date> <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders</measure> <time_frame>2 years</time_frame> </primary_outcome> <secondary_outcome> <measure>The IIV non-responder rate in healthy Hong Kong children. The association between HLA molecules and IIV non-responsiveness.</measure> <time_frame>2 years</time_frame> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">72</enrollment> <condition>Influenza</condition> <arm_group> <arm_group_label>Repeat 0.5ml IM Quadrivalent IIV (IIV-IM)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Repeat 0.5ml IM Quadrivalent IIV (IIV-IM) (15micrograms haemagglutinin per vaccine strain)</description> </arm_group> <arm_group> <arm_group_label>0.1ml ID Quadrivalent IIV (IIV-ID)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>0.1ml ID Quadrivalent IIV (IIV-ID) (3micrograms haemagglutinin per vaccine strain)</description> </arm_group> <arm_group> <arm_group_label>0.1ml ID Quadrivalent IIV</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>0.1ml ID Quadrivalent IIV (3micrograms haemagglutinin antigen per vaccine strain) + 5% imiquimod cream (IIV-Q-ID)</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fluarix Tetra</intervention_name> <description>Fluarix Tetra</description> <arm_group_label>0.1ml ID Quadrivalent IIV</arm_group_label> <arm_group_label>0.1ml ID Quadrivalent IIV (IIV-ID)</arm_group_label> <arm_group_label>Repeat 0.5ml IM Quadrivalent IIV (IIV-IM)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Imiquimod cream</intervention_name> <description>Imiquimod cream</description> <arm_group_label>0.1ml ID Quadrivalent IIV</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 8-18 years old  - Subjects receiving IIV influenza vaccination through the Seasonal Influenza Vaccination School Outreach Programme.  Exclusion Criteria:  - Age <8 years old to avoid the need for second dose vaccine in case the subjects have never had influenza vaccines before  - Age >18 years old  - Received any forms of influenza vaccines, including the intranasal live-attenuated influenza vaccines or inactivated vaccines, in the past six months  - Underlying chronic illnesses, including immunodeficiencies or autoimmune diseases  - Using immunosuppressive reagents, such as long-term corticosteroids, and other steroid-sparing reagents 6 months prior to the recruitment  - Received intravenous immunoglobulin or other blood products 3 months prior to the recruitment  - Had upper respiratory tract infection symptoms within two weeks before the vaccination, including fever, cough, sore throat, and coryza  - Previous allergic reactions to imiquimod, influenza vaccines, and their excipients. </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>18 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Gilbert T Chua</last_name> <role>Principal Investigator</role> <affiliation>The University of Hong Kong</affiliation> </overall_official> <overall_contact> <last_name>Gilbert T Chua</last_name> <phone>85222554482</phone> <email>cgt560@hku.hk</email> </overall_contact> <verification_date>April 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 10, 2022</last_update_submitted> <last_update_submitted_qc>April 10, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>The University of Hong Kong</investigator_affiliation> <investigator_full_name>Gilbert Chua</investigator_full_name> <investigator_title>Clinical Assistant Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Influenza, Human</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Imiquimod</mesh_term> </intervention_browse>  </clinical_study>

Aims and hypotheses to be tested: Primary objective - To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders. Secondary objectives - To determine the IIV non-responder rate in healthy Hong Kong children. - To investigate the association between HLA molecules and IIV non-responsiveness. Hypotheses - The investigators hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose. - The investigators hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population. - The investigators hypothesize that certain HLA alleles are associated with IIV non-responders. This study is a cross-over randomized-controlled trial (RCT). The outline of the study is shown in Figure 1. This study is divided into two parts: (i) screening for vaccine non-responders; and (ii) RCT for vaccine responsiveness using second dose IIV-IM, IIV-ID or IIV-Q-ID. Children and adolescents between 8 and 18 years old will be recruited through our network of primary and secondary schools that have participated the Seasonal Influenza Vaccination School Outreach Programme before the influenza vaccination campaign. Information sheets, a consent form and a health demographics form indicating that they fulfill the inclusion and exclusion criteria (see below) will be distributed to the parents through the participating schools. A study hotline will be available for parents to contact the study team to answer any enquiries. In the health demographics form, apart from questions related to the inclusion and exclusion criteria, the study team will also enquire about the subjects' demographics, including birth, gender, past medical history, and body weight and height. Previous influenza vaccination history will also be sought, including age at receiving the first influenza vaccine, whether the subjects have received influenza vaccines in the last season and the type of influenza vaccines they received. All subjects should be receiving 0.5ml IM quadrivalent IIV, which contains 15micrograms hemagglutinin of each influenza strain, through the Seasonal Influenza Vaccination School Outreach Programme. Consented subjects will have 5-10ml clotted blood and 3ml EDTA blood draw at day 21 post-vaccination at school by our outreach study team. The parents of all participating subjects will receive an incentive equivalent to HKD 100. They will also receive their influenza vaccine response results in concealed envelops distributed through the schools. Post-vaccination HAI titer against the Influenza B Yamagata strain ≤10 will be considered as "preliminary no seroconversion". The same serum taken on day 21 post-vaccination will be further processed to confirm that their HAI titer against the other Influenza A H1N1 and H3N2 and Influenza B Victoria strains are also ≤10. MN assay for all four strains will also be performed as the baseline for the part 2 RCT. Non-responders will be called back to attend a research clinic and will be randomized to one of the following revaccination strategies: (i) repeat 0.5ml IM Quadrivalent IIV (IIV-IM) (15micrograms haemagglutinin per vaccine strain); (ii) 0.1ml ID Quadrivalent IIV (IIV-ID) (3micrograms haemagglutinin per vaccine strain); or (iii) 0.1ml ID Quadrivalent IIV (3micrograms haemagglutinin antigen per vaccine strain) + 5% imiquimod cream (IIV-Q-ID). Subjects randomized to receive 5% imiquimod cream will have the injection site disinfected by 70% alcohol swab followed by application of the imiquimod cream for 5 minutes before the intradermal injection over a 16cm2 skin area of the deltoid described in previous studies. 0.1ml IIV, which contains 3micrograms hemagglutinin of each influenza strain, will be administered intradermally using a MicronJetTM microneedle. All subjects will be observed for 15 to 30 minutes in the waiting area for any local adverse reactions. These subjects will be called back on day 7 and 21 after the second dose of vaccination for blood testing. 5- 10ml clotted blood will be obtained to measure the vaccine response. HAI and MN assays against the four vaccine strains will be performed. To determine the association between HLA alleles and IIV non-responsiveness, HLA genotyping will be performed among non-responders and responders in 1:2 ratios. Assuming that there will be 72-100 IIV non-responders from our cohort, HLA genotyping will be performed in 200 age- and gender-matched IIV responder controls. Inclusion Criteria: - Age 8-18 years old - Subjects receiving IIV influenza vaccination through the Seasonal Influenza Vaccination School Outreach Programme. Exclusion Criteria: - Age <8 years old to avoid the need for second dose vaccine in case the subjects have never had influenza vaccines before - Age >18 years old - Received any forms of influenza vaccines, including the intranasal live-attenuated influenza vaccines or inactivated vaccines, in the past six months - Underlying chronic illnesses, including immunodeficiencies or autoimmune diseases - Using immunosuppressive reagents, such as long-term corticosteroids, and other steroid-sparing reagents 6 months prior to the recruitment - Received intravenous immunoglobulin or other blood products 3 months prior to the recruitment - Had upper respiratory tract infection symptoms within two weeks before the vaccination, including fever, cough, sore throat, and coryza - Previous allergic reactions to imiquimod, influenza vaccines, and their excipients.

NCT0531xxxx/NCT05315037.xml

<clinical_study>  <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/NCT05315037</url> </required_header> <id_info> <org_study_id>21.0565</org_study_id> <nct_id>NCT05315037</nct_id> </id_info> <brief_title>Resistance Training in Type 1 Diabetes Mellitus</brief_title> <official_title>Resistance Training Methods Impact On Glycemic Excursion and Metabolic Pathways in Type 1 Diabetes Mellitus</official_title> <sponsors> <lead_sponsor> <agency>University of Louisville</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Norton Healthcare</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Louisville</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM. </textblock> </brief_summary> <detailed_description> <textblock> Strength and condition training to improve sport performance has been greatly emphasized over the past 20 years. Formal strength and conditioning (S&C) programming is performed by S&C coaches who are educated in the field of exercise program with the intentions to bring about particular athletic adaptations through exercise. S&C programs, previously limited to programs at the college and professional level, are now commonly seen in secondary school athletic programs. With such broad adoption, many athletes that manage chronic diseases, such as type 1 diabetes mellitus, are exposed to elements of these programs.  Diabetes mellitus impacts more than 10% of the United States population. Of these, 5.2% have identified type 1 diabetes mellitus (T1DM) which includes approximately 210,000 individuals under the age of 20. In addition to insulin and dietary management, exercise and physical activity is recommended as an important therapeutic tool for most patients with T1DM. Physical activity has been shown to significantly improve glycemic control in individuals with diabetes. Additional benefits of exercise include improved cardiovascular fitness, muscle strength, insulin sensitivity and blood glucose control. S&C programs offer benefits to those living with T1DM as different exercises can be tailored to preserve health. However, there are no exercise prescription or guidelines specifically for adolescent athletes diagnosed with type 1 diabetes participating in strength and conditioning programs. Furthermore, there is no available data that states the predictability of glucose response and insulin needs to any of the specific strength and conditioning goals.  Objective: To assess the impact of different strength and conditioning programming on glycemic control in athletes with T1DM.  Primary Aim: Assess glucose response to different resistance training methods. Secondary Aims: To assess for correlation between lactate and glucose using different resistance training methods. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2023</start_date> <completion_date type="Anticipated">June 30, 2024</completion_date> <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Blood glucose and lactate measurements will be collected prior to any physical activity, post workout, and then 10- and 20-minutes post workout. Using a standard lancet device, capillary blood glucose values will be obtained using a Contour Next Glucometer.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Assess glucose response to different resistance training methods</measure> <time_frame>3 months</time_frame> <description>Blood glucose</description> </primary_outcome> <secondary_outcome> <measure>To assess for correlation between lactate and glucose using different resistance training methods</measure> <time_frame>3 months</time_frame> <description>Blood glucose, lactate</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">15</enrollment> <condition>Type 1 Diabetes</condition> <arm_group> <arm_group_label>Resistance Training</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Bench press, Deadlift, Seated overhead press machine</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Resistance Training</intervention_name> <description>Bench press: Exercise performed with participant lying supine with hands in prone position. Barbell is lowered vertically from fully extended elbow position to sternum, then returned to starting position. Barbell will be weighted with plates dependent on their strength and workout demands. Deadlift: Consists of gripping bar while in a squat position. Extension of ankles, knees, and hips while gripping the bar brings the weight up until joints are locked completing the exercise concentric portion. The eccentric lowering of the weight follows and consists of flexion of joints. Seated overhead press machine: This multi-joint exercise, deltoid and trapezius are the prime movers and triceps are secondary movers, with hands on the grips and a position allowing back and buttocks to be completely supported. They push against a load vertically until glenohumeral joint fully extends, then load is returned to starting position and process continues until all repetitions desired are achieved</description> <arm_group_label>Resistance Training</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - ≥ 13 years of age  - ≥2 years from date of T1DM diagnosis  - Prior exposure to strength and conditioning  - HbA1C ≤ 10%  - Actively utilizing continuous glucose monitoring for diabetes management  Exclusion Criteria:  - Physical limitation that may impede ability to complete study procedures  - Non-English-speaking individual </textblock> </criteria> <gender>All</gender> <minimum_age>13 Years</minimum_age> <maximum_age>17 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Brad J Thrasher, DO</last_name> <phone>5025883400</phone> <email>bjthra01@louisville.edu</email> </overall_contact> <overall_contact_backup> <last_name>Sarah P King, BS,BA</last_name> <phone>5026292721</phone> <email>slpenn03@louisville.edu</email> </overall_contact_backup> <location> <facility> <name>Norton Healthcare</name> <address> <city>Louisville</city> <state>Kentucky</state> <zip>40202</zip> <country>United States</country> </address> </facility> <contact> <last_name>Brad J Thrasher, DO</last_name> <phone>502-588-3400</phone> <email>bjthra01@louisville.edu</email> </contact> <contact_backup> <last_name>Sarah P King, BA,BS</last_name> <phone>5026292721</phone> <email>slpenn03@louisville.edu</email> </contact_backup> </location> <location> <facility> <name>University of Louisville</name> <address> <city>Louisville</city> <state>Kentucky</state> <zip>40202</zip> <country>United States</country> </address> </facility> <contact> <last_name>Brad J Thrasher, DO</last_name> <phone>502-588-3400</phone> <email>bjthra01@louisville.edu</email> </contact> <contact_backup> <last_name>Sarah P King, BS,BA</last_name> <phone>5026292721</phone> <email>slpenn03@louisville.edu</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 12, 2023</last_update_submitted> <last_update_submitted_qc>February 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Louisville</investigator_affiliation> <investigator_full_name>Bradly Thrasher</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <keyword>Resistance Training in type 1 diabetes</keyword> <condition_browse>  <mesh_term>Diabetes Mellitus</mesh_term> <mesh_term>Diabetes Mellitus, Type 1</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM. Strength and condition training to improve sport performance has been greatly emphasized over the past 20 years. Formal strength and conditioning (S&C) programming is performed by S&C coaches who are educated in the field of exercise program with the intentions to bring about particular athletic adaptations through exercise. S&C programs, previously limited to programs at the college and professional level, are now commonly seen in secondary school athletic programs. With such broad adoption, many athletes that manage chronic diseases, such as type 1 diabetes mellitus, are exposed to elements of these programs. Diabetes mellitus impacts more than 10% of the United States population. Of these, 5.2% have identified type 1 diabetes mellitus (T1DM) which includes approximately 210,000 individuals under the age of 20. In addition to insulin and dietary management, exercise and physical activity is recommended as an important therapeutic tool for most patients with T1DM. Physical activity has been shown to significantly improve glycemic control in individuals with diabetes. Additional benefits of exercise include improved cardiovascular fitness, muscle strength, insulin sensitivity and blood glucose control. S&C programs offer benefits to those living with T1DM as different exercises can be tailored to preserve health. However, there are no exercise prescription or guidelines specifically for adolescent athletes diagnosed with type 1 diabetes participating in strength and conditioning programs. Furthermore, there is no available data that states the predictability of glucose response and insulin needs to any of the specific strength and conditioning goals. Objective: To assess the impact of different strength and conditioning programming on glycemic control in athletes with T1DM. Primary Aim: Assess glucose response to different resistance training methods. Secondary Aims: To assess for correlation between lactate and glucose using different resistance training methods. Inclusion Criteria: - ≥ 13 years of age - ≥2 years from date of T1DM diagnosis - Prior exposure to strength and conditioning - HbA1C ≤ 10% - Actively utilizing continuous glucose monitoring for diabetes management Exclusion Criteria: - Physical limitation that may impede ability to complete study procedures - Non-English-speaking individual

NCT0531xxxx/NCT05315050.xml

<clinical_study>  <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/NCT05315050</url> </required_header> <id_info> <org_study_id>Mahrukh Usmani</org_study_id> <nct_id>NCT05315050</nct_id> </id_info> <brief_title>Menstrual Health Education's Impact on Knowledge, Attitudes and Self Care Behavior of Dysmenorrheal Adolescents</brief_title> <official_title>Impact of Menstrual Health Education on Knowledge, Attitudes and Self Care Behavior of Female Adolescents With Primary Dysmenorrhea</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Group A will receive Educational sessions and informational pamphlet while Group B will only receive the pamphlets. Experimental group will receive for 4 sessions (2 per week). The outcome measures Menstrual Attitude Questionnaire (MAQ), Dysmenorrhoeic Knowledge Scale (DKS) and Dysmenorrhoeic Self-Care behavior Scale (DSCBS) will be measured at baseline, and at the end of week 2 and after 3 months. Data will be analyzed by SPSS 21. </textblock> </brief_summary> <detailed_description> <textblock> Dysmenorrhea, characterized by painful cramps of the uterus during menstruation. It affects up to 95% of menstruating women. Dysmenorrhea is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea is defined as menstrual cramping pain that occurs immediately before or during menstruation in the absence of any pelvic pathology. The pain commonly starts within 3 years of menarche (the first menstrual period). Prevalence of primary dysmenorrhea varies from between 16 to 91% in reproductive aged women. Primary dysmenorrhea is the leading women hood problem that affects 90% of adolescent girls. Its prevalence decreases with increasing age in a large percentage of sufferers.  A study conducted in China concluded that nurse-managed education program improved adolescent girls' menstrual knowledge, promoted a more positive attitude, encouraged confidence, and improved pain relief practice. Another study conducted in Taiwan showed that the prevalence in dysmenorrhea in female adolescents was high, but they were lacking in dysmenorrhea related self-care knowledge. An Australian study concluded that the prevalence and impact of dysmenorrhea on Grade 11 and 12 girls is high, girls need more education on this area to prevent unnecessary suffering and interruption to school routine as they lack knowledge of and experience with effective treatment. A cross-sectional, internet-based survey was conducted, concluded that one in 3 women quit daily activities owing to menstrual symptoms. Half of all women did not mention menstrual complaints being the reason for transferring tasks in a family setting. However, considering the impact of menstrual symptoms on daily activities in a large group of women, it is time to open the societal dialogue and improve education for both patients and doctors. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 2022</start_date> <completion_date type="Anticipated">November 2022</completion_date> <primary_completion_date type="Anticipated">October 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Menstrual Attitude Questionnaire (MAQ)</measure> <time_frame>3 months</time_frame> <description>This scale was originally developed by Brooks-Gunn and Ruble and modified by Li. It consists of 32 items with five dimensions, including menstruation as a debilitating event, menstruation as a bothersome event, menstruation as a natural event, anticipation and prediction of the onset of menstruation, and denial of any effect of menstruation. Each item is scored on a 7-point Likert scale from 1 (disagree strongly) to 7 (agree strongly). Total scores range from 32 to 224, with the higher score representing a more positive attitude toward menstruation.</description> </primary_outcome> <primary_outcome> <measure>Dysmenorrhoeic Knowledge Scale (DKS)</measure> <time_frame>3 months</time_frame> <description>The DKS was designed based on the researchers' clinical experiences and previous studies. The scale included 20 questions with yes/no answers. If the subject answered correctly, it was rated as 1; if answered incorrectly, it was rated as 0. Total scores ranged from 0 to 20 with the higher score representing a better knowledge of dysmenorrhea</description> </primary_outcome> <primary_outcome> <measure>Dysmenorrhoeic Self-Care behavior Scale (DSCBS)</measure> <time_frame>3 months</time_frame> <description>This scale was designed based on the researchers' clinical experiences and previous literature. It contains 22 items. Each item is scored on a 4-point Likert scale from 0 (never) to 3 (always). Total scores ranged from 0 to 66, with the higher score representing a more positive self-care behavior.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">138</enrollment> <condition>Primary Dysmenorrhea</condition> <arm_group> <arm_group_label>Educational session and Informational Pamphlet</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Informational Pamphlet</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Educational session and Information Pamphlet</intervention_name> <description>Each session will last for 50 minutes that will consist on lecturing, discussion about improving adolescent girls' menstrual knowledge, promoting a more positive attitude, encourage confidence, self-care behavior, physical activity and improve pain relief practice. Exercise advice: The exercise protocol will include aerobic exercise such as jogging, which perform in the interventional group, three times a week, and for 10 to 30 min. Stretching's advice: Piriformis stretching (5 repitition×20seconds), Cobra Pose. (5 repitition×20seconds), Adductor stretching. (5 repitition×20seconds), Sit up (10 repetition × 3 sets), Bridge exercise (10 repetition × 3 sets), Kegel exercise (10repetition × 3 sets), Pelvic eleva¬tion (10repetition × 3 sets), three times a week.</description> <arm_group_label>Educational session and Informational Pamphlet</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Information Pamphlet</intervention_name> <description>Pamphlets consist of information about primary dysmenorrhea its causes, symptoms (onset, duration, location, prognosis) and treatment strategies (taking hot bath, heating pad, yoga, exercise, maintaining hygiene, modifying life style) Emphasized on that menstruation is a not a disease it's a natural life experience.</description> <arm_group_label>Informational Pamphlet</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adolescent girls aged 13-19 years of age.  - Experienced dysmenorrhea cramps 2 or more times during the last 6 months.  - Dysmenorrhea diagnosed using working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score.  Exclusion Criteria:  - • Unwilling to participate.  - Known cases of depression, anxiety, bipolar disorder, and other mood disorder  - Minors whose parents do not allow. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <minimum_age>13 Years</minimum_age> <maximum_age>19 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hadia Nadeem, M.Phil PT</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <overall_contact> <last_name>Hadia Nadeem, M.Phil PT</last_name> <phone>03351852442</phone> <email>hadia.nadeem@riphah.edu.pk</email> </overall_contact> <overall_contact_backup> <last_name>Imran Amjad, PhD</last_name> <phone>+923324390125</phone> <email>imran.amjad@riphah.edu.pk</email> </overall_contact_backup> <location> <facility> <name>Islamabad Model College for Girls</name> <address> <city>Islamabad</city> <state>Punjab</state> <zip>44000</zip> <country>Pakistan</country> </address> </facility> <contact> <last_name>Hadia Nadeem, M. Phil</last_name> <phone>+923351852442</phone> <email>hadia.nadeem@riphah.edu.pk</email> </contact> <contact_backup> <last_name>Mahrukh Usmani, MSPT*</last_name> <phone>+923367403964</phone> <email>mahrukh.usmani22@gmail.com</email> </contact_backup> <investigator> <last_name>Mahrukh Usmani, MSPT*</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Dysmenorrhea</keyword> <keyword>Menstruation</keyword> <keyword>Adolescent</keyword> <keyword>Knowledge</keyword> <keyword>Attitude</keyword> <condition_browse>  <mesh_term>Dysmenorrhea</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study will be a randomized controlled trial. This study will be conducted in F G modal for girls' I/8-4, Federal Government College for Women and Islamabad Model College for Girls. A sample size of 138 patients will be taken. Patients will be divided into two groups by lottery method. Group A will receive Educational sessions and informational pamphlet while Group B will only receive the pamphlets. Experimental group will receive for 4 sessions (2 per week). The outcome measures Menstrual Attitude Questionnaire (MAQ), Dysmenorrhoeic Knowledge Scale (DKS) and Dysmenorrhoeic Self-Care behavior Scale (DSCBS) will be measured at baseline, and at the end of week 2 and after 3 months. Data will be analyzed by SPSS 21. Dysmenorrhea, characterized by painful cramps of the uterus during menstruation. It affects up to 95% of menstruating women. Dysmenorrhea is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea is defined as menstrual cramping pain that occurs immediately before or during menstruation in the absence of any pelvic pathology. The pain commonly starts within 3 years of menarche (the first menstrual period). Prevalence of primary dysmenorrhea varies from between 16 to 91% in reproductive aged women. Primary dysmenorrhea is the leading women hood problem that affects 90% of adolescent girls. Its prevalence decreases with increasing age in a large percentage of sufferers. A study conducted in China concluded that nurse-managed education program improved adolescent girls' menstrual knowledge, promoted a more positive attitude, encouraged confidence, and improved pain relief practice. Another study conducted in Taiwan showed that the prevalence in dysmenorrhea in female adolescents was high, but they were lacking in dysmenorrhea related self-care knowledge. An Australian study concluded that the prevalence and impact of dysmenorrhea on Grade 11 and 12 girls is high, girls need more education on this area to prevent unnecessary suffering and interruption to school routine as they lack knowledge of and experience with effective treatment. A cross-sectional, internet-based survey was conducted, concluded that one in 3 women quit daily activities owing to menstrual symptoms. Half of all women did not mention menstrual complaints being the reason for transferring tasks in a family setting. However, considering the impact of menstrual symptoms on daily activities in a large group of women, it is time to open the societal dialogue and improve education for both patients and doctors. Inclusion Criteria: - Adolescent girls aged 13-19 years of age. - Experienced dysmenorrhea cramps 2 or more times during the last 6 months. - Dysmenorrhea diagnosed using working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score. Exclusion Criteria: - • Unwilling to participate. - Known cases of depression, anxiety, bipolar disorder, and other mood disorder - Minors whose parents do not allow.

NCT0531xxxx/NCT05315063.xml

<clinical_study>  <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/NCT05315063</url> </required_header> <id_info> <org_study_id>REC 01208 Mehwish Iqbal</org_study_id> <nct_id>NCT05315063</nct_id> </id_info> <brief_title>Comparison of Muscle Energy Technique and Eccentric Training on Hamstring Flexibility in Healthy Young Adults</brief_title> <official_title>Comparison of Muscle Energy Technique and Eccentric Training on Hamstring Flexibility in Healthy Young Adults</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Flexibility is the ability of a muscle to lengthen and allow one joint (or more than one joint in series) to move through a full range of motion (ROM).Adequate flexibility is important to maintain balance, agility and musculoskeletal function. A decrease in muscular flexibility does not only reduces functional level of individual but also causes musculoskeletal injuries. Loss of muscle flexibility or muscle tightness is decreased ability of a muscle to lengthen which results in decreased ROM,and for hamstring reduced flexibility is the inability to achieve more than 160 degree of knee extension while the hip is flexed at 90 degree.  Muscle energy technique (MET) is an manual technique developed by osteopaths and is now used in many different manual therapy professions, to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.  Eccentric training allows the muscle to elongate naturally, this elongation is achieved by having the subjects eccentrically contract the antagonist muscle to move the joint through the full available range in slow controlled manner. </textblock> </brief_summary> <detailed_description> <textblock> Flexibility is the ability of a muscle to lengthen and allow one joint (or more than one joint in series) to move through a full range of motion (ROM). Adequate flexibility is important to maintain balance, agility and musculoskeletal function. A decrease in muscular flexibility does not only reduces functional level of individual but also causes musculoskeletal injuries. Loss of muscle flexibility or muscle tightness is decreased ability of a muscle to lengthen which results in decreased ROM. and for hamstring reduced flexibility is the inability to achieve more than 160 degree of knee extension while the hip is flexed at 90 degree. Hamstring muscles have a great tendency to shortening even in normal circumstances, due to their multi-joint function and their tonic postural character. Techniques previously investigated for hamstring flexibility include static, ballistic and active assisted stretching exercise, ice, heat, soft tissue massage, ultra sound, Short Wave Diathermy, myofascial release, (PNF), kinesio taping, MET Each of these interventions has demonstrated clinical and experimental success; no agreement has been reached on a standard protocol for treatment.  Muscle energy technique (MET) is an manual technique developed by osteopaths and is now used in many different manual therapy professions, to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.  Eccentric training allows the muscle to elongate naturally, this elongation is achieved by having the subjects eccentrically contract the antagonist muscle to move the joint through the full available range in slow controlled manner. Eccentric resistance exercise may prevent injury to the muscle tendon unit by improving the muscle's ability to absorb more energy before failing and it is a better training strategy to improve the flexibility as it also increases strength and protects against muscle damage. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Actual">February 5, 2023</completion_date> <primary_completion_date type="Actual">February 1, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Active Knee Extension Test</measure> <time_frame>two weeks</time_frame> <description>Active knee extension test is an objective test for measuring flexibility/tightness of hamstring muscles with goniometer. Every subject is set in recumbent position with hip and knee flexed in 90°.A wooden box is utilized to keep up the correct position of hip. The pelvis is strapped down to the table for stabilization and controlling any accessory movement and the participant's head is kept in a neutral position to avoid any neural tension. For goniometer the landmarks used are the greater trochanter of the femur, lateral femoral condyle and lateral malleolus. The subject is then asked to extend the dominant lower extremity as far as possible until a mild stretch sensation is felt and a full circle goniometer is then used to measure the angle. Assessment to be done at baseline,3rd session and 6th session.</description> </primary_outcome> <primary_outcome> <measure>Sit and Reach Test:</measure> <time_frame>two weeks</time_frame> <description>The test involves sitting on the floor with back and head against the wall, legs stretched out straight ahead. Shoes are removed and the sole of feet are placed flat against the box. Both knees should be locked and pressed flat on the floor with the palms facing downwards and the hands-on top of each other. Subject reaches forward along the measuring line as far as possible. assessment to be done at baseline,3rd session and 6th session.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Healthy</condition> <arm_group> <arm_group_label>Eccentric Training</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Once achieved, this flexed hip position will be held for 5 seconds. This procedure will be repeated 6 times with no rest between repetitions</description> </arm_group> <arm_group> <arm_group_label>Muscle Energy Technique (PIR)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>muscle energy technique</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Eccentric Training</intervention_name> <description>Once achieved, this flexed hip position will be held for 5 seconds. This procedure will be repeated 6 times with no rest between repetitions</description> <arm_group_label>Eccentric Training</arm_group_label> <arm_group_label>Muscle Energy Technique (PIR)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Muscle Energy Technique (PIR)</intervention_name> <description>The participant will be asked to resist the movement with no more than 25% of strength. The contraction will be held for 7-10 seconds followed by complete relaxation of the limb. On exhalation, the knee joint will be straightened (extended) towards its new barrier and through that barrier a stretch was applied and maintained for 30 seconds.3 repetitions of this process will be done</description> <arm_group_label>Eccentric Training</arm_group_label> <arm_group_label>Muscle Energy Technique (PIR)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  • A deficit of >20° of knee extension with the hip at 90°  Exclusion Criteria:  - lower extremities pathology.  - any history of hamstring injuries.  - acute or chronic low back pain.  - history of lower limb fracture.  - surgery of hamstring or back.  - pelvis, hip or knee deformity.  - Involved in any stretching routine </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>25 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Maria Khalid, MSOMPT</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <location> <facility> <name>Rawal Institute of Rehabilitation Sciences</name> <address> <city>Islamabad</city> <state>Punjab</state> <zip>46000</zip> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 20, 2023</last_update_submitted> <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>muscle energy technique</keyword> <keyword>eccentric training</keyword> <keyword>hamstring flexibility</keyword> <keyword>active knee extension</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Flexibility is the ability of a muscle to lengthen and allow one joint (or more than one joint in series) to move through a full range of motion (ROM).Adequate flexibility is important to maintain balance, agility and musculoskeletal function. A decrease in muscular flexibility does not only reduces functional level of individual but also causes musculoskeletal injuries. Loss of muscle flexibility or muscle tightness is decreased ability of a muscle to lengthen which results in decreased ROM,and for hamstring reduced flexibility is the inability to achieve more than 160 degree of knee extension while the hip is flexed at 90 degree. Muscle energy technique (MET) is an manual technique developed by osteopaths and is now used in many different manual therapy professions, to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage. Eccentric training allows the muscle to elongate naturally, this elongation is achieved by having the subjects eccentrically contract the antagonist muscle to move the joint through the full available range in slow controlled manner. Flexibility is the ability of a muscle to lengthen and allow one joint (or more than one joint in series) to move through a full range of motion (ROM). Adequate flexibility is important to maintain balance, agility and musculoskeletal function. A decrease in muscular flexibility does not only reduces functional level of individual but also causes musculoskeletal injuries. Loss of muscle flexibility or muscle tightness is decreased ability of a muscle to lengthen which results in decreased ROM. and for hamstring reduced flexibility is the inability to achieve more than 160 degree of knee extension while the hip is flexed at 90 degree. Hamstring muscles have a great tendency to shortening even in normal circumstances, due to their multi-joint function and their tonic postural character. Techniques previously investigated for hamstring flexibility include static, ballistic and active assisted stretching exercise, ice, heat, soft tissue massage, ultra sound, Short Wave Diathermy, myofascial release, (PNF), kinesio taping, MET Each of these interventions has demonstrated clinical and experimental success; no agreement has been reached on a standard protocol for treatment. Muscle energy technique (MET) is an manual technique developed by osteopaths and is now used in many different manual therapy professions, to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage. Eccentric training allows the muscle to elongate naturally, this elongation is achieved by having the subjects eccentrically contract the antagonist muscle to move the joint through the full available range in slow controlled manner. Eccentric resistance exercise may prevent injury to the muscle tendon unit by improving the muscle's ability to absorb more energy before failing and it is a better training strategy to improve the flexibility as it also increases strength and protects against muscle damage. Inclusion Criteria: • A deficit of >20° of knee extension with the hip at 90° Exclusion Criteria: - lower extremities pathology. - any history of hamstring injuries. - acute or chronic low back pain. - history of lower limb fracture. - surgery of hamstring or back. - pelvis, hip or knee deformity. - Involved in any stretching routine

NCT0531xxxx/NCT05315076.xml

<clinical_study>  <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/NCT05315076</url> </required_header> <id_info> <org_study_id>REC 01211 Muhammad Saad Hassan</org_study_id> <nct_id>NCT05315076</nct_id> </id_info> <brief_title>Comparison of Thoracic Manipulation and Muscle Energy Technique in Non-specific Mechanical Neck Pain</brief_title> <official_title>Comparison of Thoracic Manipulation and Muscle Energy Technique in Non-specific Mechanical Neck Pain</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability. </textblock> </brief_summary> <detailed_description> <textblock> Neck pain is a common musculoskeletal disorder. Mechanical neck pain is also known as non-specific neck pain and is defined as the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck in which pain is provoked by sustained neck posture, neck movement, pain on palpation of cervical musculature without pathologies. In most patients, neck pain can be a common cause of disability: it is associated with daily activity limitations, reduction of work productivity and decrease in quality of life. Mechanical neck pain is commonly seen in people involved in occupation like computer processing, clerical job, students and people with sedentary life style awkward occupational posture, heavy lifting and physically demanding work.  thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine.  Muscle energy technique (MET) is a method of treatment that involves the voluntary contraction of subject's muscles in a precisely controlled direction, against a counterforce and producing post isometric relaxation through the influence of the Golgi tendon. MET is used to decrease pain, stretch tight structures muscle and fascia, reduce muscle tone, improve local circulation, and mobilize joint restriction </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Actual">February 5, 2023</completion_date> <primary_completion_date type="Actual">February 1, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Numeric Pain Rating Scale</measure> <time_frame>three weeks</time_frame> <description>The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.Assesment to be done at baseline,1st session,3rd session and 6th session.</description> </primary_outcome> <primary_outcome> <measure>Inclinometer</measure> <time_frame>three weeks</time_frame> <description>it is used for measurements of cervical flexion, extension, lateral flexion, and rotation.Assesment to be done at baseline,1st session,3rd session and 6th session.</description> </primary_outcome> <primary_outcome> <measure>Neck Disability Index</measure> <time_frame>three weeks</time_frame> <description>The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. .Assessment to be done at baseline,1st session,3rd session and 6th session.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Neck Pain</condition> <arm_group> <arm_group_label>Thoracic Manipulation Posterior anterior and conventional therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Thoracic Manipulation Posterior anterior and conventional therapy</description> </arm_group> <arm_group> <arm_group_label>Muscle Energy Technique (PIR) and conventional treatment</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Muscle Energy Technique (PIR) and conventional treatment</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>thoracic Manipulation Posterior anterior and conventional therapy</intervention_name> <description>A high-velocity, end range force directed to both sides of the respective zygapophyseal joint as indicated by the segmental examination. This procedure will be performed for a maximum of two attempts. When a cracking sound occurred, the therapist will move on to the next segmental restriction from an upper level to a lower level.</description> <arm_group_label>Muscle Energy Technique (PIR) and conventional treatment</arm_group_label> <arm_group_label>Thoracic Manipulation Posterior anterior and conventional therapy</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Muscle Energy Technique (PIR) and conventional treatment</intervention_name> <description>sustain the Isometric contraction for 7-10 and hold the breath. Then the patient will be asked to breathe out and relax while the therapist stretches further up to the neck barrier and hold this for 30 seconds.3 to 5 repetition</description> <arm_group_label>Muscle Energy Technique (PIR) and conventional treatment</arm_group_label> <arm_group_label>Thoracic Manipulation Posterior anterior and conventional therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients who present with a primary complaint of mechanical neck pain (defined as pain in the region between the superior nuchal line and first thoracic spinous process) with limited Range of motion.  - Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS).  - Subacute or chronic cases (4 -12 weeks)  - Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)  - Dull aching neck pain increased by sustained postures, neck movement  Exclusion Criteria:  - Patients with a positive history of trauma, fracture or surgery of the cervical spine.  - Neck pain with radiation to the arm and upper extremity  - Diagnosed cases of torticollis, and scoliosis  - History of osteoporosis, Any heart disease  - Taken previous physiotherapy session. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Maria Khalid, MSOMPT</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <location> <facility> <name>Rawal dental and general hospital,</name> <address> <city>Islamabad</city> <state>Punjab</state> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 20, 2023</last_update_submitted> <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Pain</keyword> <keyword>thoracic manipulation</keyword> <keyword>muscle energy technique</keyword> <keyword>disability</keyword> <keyword>range of motion</keyword> <condition_browse>  <mesh_term>Neck Pain</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability. Neck pain is a common musculoskeletal disorder. Mechanical neck pain is also known as non-specific neck pain and is defined as the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck in which pain is provoked by sustained neck posture, neck movement, pain on palpation of cervical musculature without pathologies. In most patients, neck pain can be a common cause of disability: it is associated with daily activity limitations, reduction of work productivity and decrease in quality of life. Mechanical neck pain is commonly seen in people involved in occupation like computer processing, clerical job, students and people with sedentary life style awkward occupational posture, heavy lifting and physically demanding work. thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Muscle energy technique (MET) is a method of treatment that involves the voluntary contraction of subject's muscles in a precisely controlled direction, against a counterforce and producing post isometric relaxation through the influence of the Golgi tendon. MET is used to decrease pain, stretch tight structures muscle and fascia, reduce muscle tone, improve local circulation, and mobilize joint restriction Inclusion Criteria: - Patients who present with a primary complaint of mechanical neck pain (defined as pain in the region between the superior nuchal line and first thoracic spinous process) with limited Range of motion. - Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS). - Subacute or chronic cases (4 -12 weeks) - Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale) - Dull aching neck pain increased by sustained postures, neck movement Exclusion Criteria: - Patients with a positive history of trauma, fracture or surgery of the cervical spine. - Neck pain with radiation to the arm and upper extremity - Diagnosed cases of torticollis, and scoliosis - History of osteoporosis, Any heart disease - Taken previous physiotherapy session.

NCT0531xxxx/NCT05315089.xml

<clinical_study>  <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/NCT05315089</url> </required_header> <id_info> <org_study_id>REC/01245 Iqra Butt</org_study_id> <nct_id>NCT05315089</nct_id> </id_info> <brief_title>Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke</brief_title> <official_title>Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method. </textblock> </brief_summary> <detailed_description> <textblock> Stroke is the leading cause of disability worldwide Approximately 80% of stroke survivors regain ability to walk, 30 - 66% of survivors are not able to use their affected upper limb mobility. With improving survival rates and longer life expectancy in general, the burden of caring for stroke survivors is likely to increase. As a lack of upper limb recovery results in significant dependence and a reduced quality of life. Persistent upper limb (UL) dysfunction after a stroke is one of the most challenging issues in rehabilitation. Effective upper limb treatment interventions have therefore been identified as a priority for stroke research. One of the rehabilitation strategies include performing self-administered exercises using VR games technology. Effective treatment interventions post-stroke is characterized by high intensity and repetitive practice of a meaningful task. However, changes in infrastructure, an emphasis on mobility during early rehabilitation ,to reduce hospital length of stay and a lack of therapy on discharge home have resulted in challenges delivering the amount of rehabilitation necessary to optimize recovery. A promising technique, which has the capability of creating an interactive environment in which practice intensity and feedback can be manipulated to retrain movement in the upper limb in people with stroke, is virtual reality (VR) technology .VR provides a sense of illusion: of being immersed in a world where objects can he visualized and interact with. The system is usually a controlled one, where the objects and interaction styles (point, touch, grasp) are defined prior to the controlling program being executed. There are a number of ways in which the virtual environment (VE) can he presented to the user. Most common are desktop (fish tank) VR systems where the VE is displayed on a standard desktop monitor. The user can interact with the environment via standard hardware (keyboard, mouse) or via specialized VR devices such as data gloves, hut is conscious of 'looking at' the environment rather than 'immersed in' the environment. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">December 30, 2022</completion_date> <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Fugl- Meyer assessment upper extremity</measure> <time_frame>Change from Baseline , motor functions to 3 Week, to 6 week</time_frame> <description>The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia</description> </primary_outcome> <primary_outcome> <measure>Chedoke Arm and Hand Inventory</measure> <time_frame>Change from Baseline , motor functions of hand to 3 Week, to 6 week</time_frame> <description>The Chedoke Arm and Hand Activity Inventory (CAHAI) is a functional assessment of the recovering arm and hand after stroke</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Stroke</condition> <arm_group> <arm_group_label>Interventional Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Virtual reality games +conventional exercises</description> </arm_group> <arm_group> <arm_group_label>control Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Conventional exercises</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Virtual reality games +conventional exercises</intervention_name> <description>Virtual reality games +conventional exercises</description> <arm_group_label>Interventional Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Conventional exercises</intervention_name> <description>Conventional exercises</description> <arm_group_label>control Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1- Subacute and chronic stroke patient > 3 months post stroke till 1 year. 2. Both gender 3. Age: 40-70 years 4. Modified Ashworth scale1-3 5. MMSE>25 6. Able to follow verbal instructions related to the use of VR devices  Exclusion Criteria:  1. Neurological disorders other than stroke.  2. Aphasia that would limit the ability to follow verbal instructions.  3. Participation in other upper extremity therapies during the study </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Misbah Ghous, MSNMPT</last_name> <role>Principal Investigator</role> <affiliation>Riphah college of Rehabilitation and Allied Health sciences Islamabad</affiliation> </overall_official> <overall_contact> <last_name>Imran Amjad, PHD</last_name> <phone>03324390125</phone> <email>imran.amjad@riphah.edu.pk</email> </overall_contact> <location> <facility> <name>Misbah Ghous</name> <address> <city>Rawalpindi</city> <state>Punjab</state> <zip>46000</zip> <country>Pakistan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Misbah Ghous</last_name> <phone>03086152722</phone> <email>drmisbahghous@gmail.com</email> </contact> </location> <location_countries> <country>Pakistan</country> </location_countries> <reference> <citation>Hughes AM, Burridge JH, Demain SH, Ellis-Hill C, Meagher C, Tedesco-Triccas L, Turk R, Swain I. Translation of evidence-based Assistive Technologies into stroke rehabilitation: users' perceptions of the barriers and opportunities. BMC Health Serv Res. 2014 Mar 12;14:124. doi: 10.1186/1472-6963-14-124.</citation> <PMID>24620739</PMID> </reference> <reference> <citation>Ward N, Kelly K, Brander F. The future of stroke rehabilitation: upper limb recovery. ACNR. 2015;15(4):6-8.</citation> </reference> <reference> <citation>Elnady A, Mortenson WB, Menon C. Perceptions of Existing Wearable Robotic Devices for Upper Extremity and Suggestions for Their Development: Findings From Therapists and People With Stroke. JMIR Rehabil Assist Technol. 2018 May 15;5(1):e12. doi: 10.2196/rehab.9535.</citation> <PMID>29764799</PMID> </reference> <reference> <citation>Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.</citation> <PMID>24681826</PMID> </reference> <verification_date>May 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 10, 2022</last_update_submitted> <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 17, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>intensive virtual reality</keyword> <keyword>upper limb functions</keyword> <condition_browse>  <mesh_term>Stroke</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method. Stroke is the leading cause of disability worldwide Approximately 80% of stroke survivors regain ability to walk, 30 - 66% of survivors are not able to use their affected upper limb mobility. With improving survival rates and longer life expectancy in general, the burden of caring for stroke survivors is likely to increase. As a lack of upper limb recovery results in significant dependence and a reduced quality of life. Persistent upper limb (UL) dysfunction after a stroke is one of the most challenging issues in rehabilitation. Effective upper limb treatment interventions have therefore been identified as a priority for stroke research. One of the rehabilitation strategies include performing self-administered exercises using VR games technology. Effective treatment interventions post-stroke is characterized by high intensity and repetitive practice of a meaningful task. However, changes in infrastructure, an emphasis on mobility during early rehabilitation ,to reduce hospital length of stay and a lack of therapy on discharge home have resulted in challenges delivering the amount of rehabilitation necessary to optimize recovery. A promising technique, which has the capability of creating an interactive environment in which practice intensity and feedback can be manipulated to retrain movement in the upper limb in people with stroke, is virtual reality (VR) technology .VR provides a sense of illusion: of being immersed in a world where objects can he visualized and interact with. The system is usually a controlled one, where the objects and interaction styles (point, touch, grasp) are defined prior to the controlling program being executed. There are a number of ways in which the virtual environment (VE) can he presented to the user. Most common are desktop (fish tank) VR systems where the VE is displayed on a standard desktop monitor. The user can interact with the environment via standard hardware (keyboard, mouse) or via specialized VR devices such as data gloves, hut is conscious of 'looking at' the environment rather than 'immersed in' the environment. Inclusion Criteria: 1- Subacute and chronic stroke patient > 3 months post stroke till 1 year. 2. Both gender 3. Age: 40-70 years 4. Modified Ashworth scale1-3 5. MMSE>25 6. Able to follow verbal instructions related to the use of VR devices Exclusion Criteria: 1. Neurological disorders other than stroke. 2. Aphasia that would limit the ability to follow verbal instructions. 3. Participation in other upper extremity therapies during the study

NCT0531xxxx/NCT05315102.xml

<clinical_study>  <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/NCT05315102</url> </required_header> <id_info> <org_study_id>REC/01285 Imran Amjad</org_study_id> <nct_id>NCT05315102</nct_id> </id_info> <brief_title>Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.</brief_title> <official_title>To Investigate the Effects of Two Weeks of Intensive Chiropractic Care When Added to Usual Care for Children With Cerebral Palsy.</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 7, 2022</start_date> <completion_date type="Actual">October 1, 2022</completion_date> <primary_completion_date type="Actual">October 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Research</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Gross Motor Function Measure</measure> <time_frame>3 weeks</time_frame> <description>The gross motor function measure is a standard instrument that measures the change in motor function with time in Cerebral palsy subjects. It assesses the number of motor tasks a child can perform. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. the higher score, the greater is Gross motor function.</description> </primary_outcome> <primary_outcome> <measure>Trunk Control Measurement Scale (TCMS)</measure> <time_frame>3 weeks</time_frame> <description>TCMS is an extended version of the trunk impairment scale with a total score of 58, which assesses the quality of static and dynamic trunk control. The maximum value for the total TCMS is 58 points (20 for the category 'static sitting balance', 28 for 'selective movement control', and 10 for 'dynamic reaching'). A higher TCMS score indicates better performance in trunk control.</description> </primary_outcome> <primary_outcome> <measure>Melbourne Assessment of Unilateral Upper Limb Function (MUUL)</measure> <time_frame>3 weeks</time_frame> <description>Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered as one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Scoring is completed across the 30 score items using a three, four or five-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale.</description> </primary_outcome> <primary_outcome> <measure>Canadian Occupation Performance Measure (COPM)</measure> <time_frame>3 weeks</time_frame> <description>It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing them by the number of problems. At reassessment, the client scores each problem again for performance and satisfaction.</description> </primary_outcome> <primary_outcome> <measure>Cerebral Palsy Quality Of Life scale (CP-QOL)</measure> <time_frame>3 weeks</time_frame> <description>The CP-QOL-child is a condition-specific QOL questionnaire designed for children with CP. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The greater the score, the better is the quality of life.</description> </primary_outcome> <primary_outcome> <measure>Smartphone app for gait and Balance Assessment</measure> <time_frame>3 weeks</time_frame> <description>This embedded inertial sensor-based smartphone application can provide a valid and reliable estimation of several gaits and balance parameters. The smartphone app for gait and balance assessment will be used on the subject who can walk independently.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">39</enrollment> <condition>Cerebral Palsy</condition> <arm_group> <arm_group_label>Experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Sham intervention</intervention_name> <description>The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust</description> <arm_group_label>Control group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Chiropractic Care</intervention_name> <description>A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.</description> <arm_group_label>Experimental group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Physical therapy intervention</intervention_name> <description>The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Cerebral Palsy children, where Conventional Therapy will be provided according to the respective needs of the individual patient.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>Experimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Participants will be recruited into the study according to the following criteria.  - Both gender (Male and Female).  - Age between 2 to 15 years.  - Spastic Cerebral Palsy children.  Exclusion Criteria:  Participants will be excluded from the study according to the following criteria.  - Cerebral Palsy children due to Traumatic Brain Injury.  - Patients having cognitive impairments.  - Patients having associated Neurological Pathologies.  - Patients who are unable to follow treatment plan. </textblock> </criteria> <gender>All</gender> <minimum_age>2 Years</minimum_age> <maximum_age>15 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>IMRAN AMJAD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <location> <facility> <name>National Institute of rehabilitation medicine.</name> <address> <city>Islamabad</city> <state>Federal</state> <zip>44000</zip> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>November 8, 2022</last_update_submitted> <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 9, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Cerebral Palsy</mesh_term> </condition_browse>  </clinical_study>

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children. Inclusion Criteria: Participants will be recruited into the study according to the following criteria. - Both gender (Male and Female). - Age between 2 to 15 years. - Spastic Cerebral Palsy children. Exclusion Criteria: Participants will be excluded from the study according to the following criteria. - Cerebral Palsy children due to Traumatic Brain Injury. - Patients having cognitive impairments. - Patients having associated Neurological Pathologies. - Patients who are unable to follow treatment plan.

NCT0531xxxx/NCT05315115.xml

<clinical_study>  <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/NCT05315115</url> </required_header> <id_info> <org_study_id>REC/01287 Imran Amjad</org_study_id> <nct_id>NCT05315115</nct_id> </id_info> <brief_title>Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.</brief_title> <official_title>To Investigate the Effects of Two Weeks of Intensive Chiropractic Care When Added to Usual Care for Adults With Spinal Cord Injuries.</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 7, 2022</start_date> <completion_date type="Actual">December 1, 2022</completion_date> <primary_completion_date type="Actual">December 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Research</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Functional Independence Measure (FIM)</measure> <time_frame>Baseline</time_frame> <description>The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured at baseline.</description> </primary_outcome> <primary_outcome> <measure>Functional Independence Measure (FIM)</measure> <time_frame>4 weeks</time_frame> <description>The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured after 4 weeks.</description> </primary_outcome> <primary_outcome> <measure>ASIA scale</measure> <time_frame>Baseline</time_frame> <description>The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured at baseline.</description> </primary_outcome> <primary_outcome> <measure>ASIA scale</measure> <time_frame>4 weeks</time_frame> <description>The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured after 4 weeks.</description> </primary_outcome> <primary_outcome> <measure>Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)</measure> <time_frame>Baseline</time_frame> <description>The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention.</description> </primary_outcome> <primary_outcome> <measure>Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)</measure> <time_frame>4 weeks</time_frame> <description>The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention. This tool will be measured after 4 weeks.</description> </primary_outcome> <primary_outcome> <measure>36-Item Short Form Survey (SF-36)</measure> <time_frame>Baseline</time_frame> <description>The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. A baseline assessment of a participant will be done before the start of the intervention.</description> </primary_outcome> <primary_outcome> <measure>36-Item Short Form Survey (SF-36)</measure> <time_frame>4 weeks</time_frame> <description>The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. This tool will be measured after 4 weeks.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">29</enrollment> <condition>Spinal Cord Injuries</condition> <arm_group> <arm_group_label>Experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Sham intervention</intervention_name> <description>The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust.</description> <arm_group_label>Control group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Chiropractic Care</intervention_name> <description>A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.</description> <arm_group_label>Experimental group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Physical therapy intervention</intervention_name> <description>The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Spinal Cord Injuries children, where Conventional Therapy will be provided according to the respective needs of the individual patient.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>Experimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adults with both genders (Male and Female).  - Age above 20 years.  - Spinal Cord Injuries adults.  Exclusion criteria  - Spinal Cord Injury due to Traumatic Brain Injury.  - Patients having cognitive impairments.  - Patients having associated Neurological Pathologies.  - Patients who are unable to follow the treatment plan. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>IMRAN AMJAD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <location> <facility> <name>National Institute of rehabilitation medicine.</name> <address> <city>Islamabad</city> <state>None Selected</state> <zip>46000</zip> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 18, 2023</last_update_submitted> <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Spinal Cord Injuries</mesh_term> <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults. Inclusion Criteria: - Adults with both genders (Male and Female). - Age above 20 years. - Spinal Cord Injuries adults. Exclusion criteria - Spinal Cord Injury due to Traumatic Brain Injury. - Patients having cognitive impairments. - Patients having associated Neurological Pathologies. - Patients who are unable to follow the treatment plan.

NCT0531xxxx/NCT05315128.xml

<clinical_study>  <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/NCT05315128</url> </required_header> <id_info> <org_study_id>IRB# 6029/-6-7-2020</org_study_id> <nct_id>NCT05315128</nct_id> </id_info> <brief_title>Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers</brief_title> <official_title>Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers</official_title> <sponsors> <lead_sponsor> <agency>Zagazig University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Zagazig University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management </textblock> </brief_summary> <detailed_description> <textblock> Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">July 6, 2020</start_date> <completion_date type="Actual">December 6, 2021</completion_date> <primary_completion_date type="Actual">August 10, 2021</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Care Provider)</masking> <masking_description>Double-blinded</masking_description> </study_design_info> <primary_outcome> <measure>Reduction in size and number of tumors</measure> <time_frame>up to 1 month after the last session</time_frame> <description>Patients were divided into 3 groups: responders (if the tumor has regressed by > 50%), partial responders (tumor regression < 50%), and non- responders (no improvement at all or worsening).</description> </primary_outcome> <secondary_outcome> <measure>Adverse effects</measure> <time_frame>Starting from the first session and up to 6-months after the last session</time_frame> </secondary_outcome> <secondary_outcome> <measure>Recurrence</measure> <time_frame>till the end of follow up duration (6 months)</time_frame> <description>after achieving response greater than 50% of the tumor</description> </secondary_outcome> <secondary_outcome> <measure>New NMSC lesions elsewhere</measure> <time_frame>from the start of the study and till the end of follow up period (6 months)</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">60</enrollment> <condition>Non-melanoma Skin Cancers</condition> <arm_group> <arm_group_label>Intralesional methotrexate</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group A 30 patients received intralesional injection of MTX with an insulin syringe into the tumor at a dose ranging between 12.5 mg to 25 mg according to the tumor size every week until complete improvement or for a maximum of 8 sessions.</description> </arm_group> <arm_group> <arm_group_label>Intramuscular methotrexate</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group B 30 patients received systemic MTX (SC, or IM) was injected at a dose of 25 mg every week until clearance or for a maximum of 8 sessions.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Methotrexate</intervention_name> <description>A randomized comparative effectiveness clinical trial</description> <arm_group_label>Intralesional methotrexate</arm_group_label> <arm_group_label>Intramuscular methotrexate</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  • Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study.  Exclusion Criteria:  • Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Zagazig university</name> <address> <city>Zagazig</city> <state>Sharkia</state> <zip>44519</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>February 15, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Zagazig University</investigator_affiliation> <investigator_full_name>Basma Magdy Elkholy, MD</investigator_full_name> <investigator_title>Dr</investigator_title> </responsible_party> <keyword>Non-melanoma skin cancer</keyword> <keyword>Intralesional methotrexate</keyword> <keyword>Systemic methotrexate</keyword> <keyword>Intramuscular methotrexate</keyword> <keyword>Keratoacanthoma</keyword> <keyword>Basal cell carcinoma</keyword> <keyword>Squamous cell carcinoma</keyword> <condition_browse>  <mesh_term>Skin Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Methotrexate</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC. Inclusion Criteria: • Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study. Exclusion Criteria: • Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.

NCT0531xxxx/NCT05315141.xml

<clinical_study>  <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/NCT05315141</url> </required_header> <id_info> <org_study_id>202108374</org_study_id> <nct_id>NCT05315141</nct_id> </id_info> <brief_title>Multicenter Cohort Study of AAV in Hunan of China</brief_title> <official_title>Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China</official_title> <sponsors> <lead_sponsor> <agency>Xiangya Hospital of Central South University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Central South University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The Third Xiangya Hospital of Central South University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Hunan Provincial People's Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Xiangtan Central Hospital</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Xiangya Hospital of Central South University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death. </textblock> </brief_summary> <detailed_description> <textblock> The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.  The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.  The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 16, 2022</start_date> <completion_date type="Anticipated">March 16, 2027</completion_date> <primary_completion_date type="Anticipated">March 16, 2027</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <target_duration>5 Years</target_duration> <primary_outcome> <measure>Death</measure> <time_frame>from date of baseline examination until the date of death from any cause, up to 60 months</time_frame> <description>death from any cause</description> </primary_outcome> <primary_outcome> <measure>End stage renal disease or significant loss of renal function</measure> <time_frame>from date of baseline examination until the date of first documented end stage renal disease or date of death from any cause, whichever came first, up to 60 months</time_frame> <description>start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2)</description> </primary_outcome> <secondary_outcome> <measure>Disease activity</measure> <time_frame>Five years</time_frame> <description>assessed by the proportion of patients with severe flares</description> </secondary_outcome> <secondary_outcome> <measure>Adverse events</measure> <time_frame>Five years</time_frame> <description>a. deaths (from all causes); b. grade 3 or higher infections; c. malignant conditions; d. venous thromboembolic events; e. cardiovascular events; f. hospitalizations</description> </secondary_outcome> <number_of_groups>5</number_of_groups> <enrollment type="Anticipated">500</enrollment> <condition>ANCA Associated Vasculitis</condition> <arm_group> <arm_group_label>Xiangya Hospital</arm_group_label> </arm_group> <arm_group> <arm_group_label>The Second Xiangya Hospital</arm_group_label> </arm_group> <arm_group> <arm_group_label>The Third Xiangya Hospital</arm_group_label> </arm_group> <arm_group> <arm_group_label>Hunan Provincial People's Hospital</arm_group_label> </arm_group> <arm_group> <arm_group_label>Xiangtan Central Hospital</arm_group_label> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>No Intervention</intervention_name> <description>No Intervention</description> <arm_group_label>Hunan Provincial People's Hospital</arm_group_label> <arm_group_label>The Second Xiangya Hospital</arm_group_label> <arm_group_label>The Third Xiangya Hospital</arm_group_label> <arm_group_label>Xiangtan Central Hospital</arm_group_label> <arm_group_label>Xiangya Hospital</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent  Exclusion Criteria:  - Do not agree to sign informed consent </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>Xiangcheng Xiao, doctor</last_name> <role>Principal Investigator</role> <affiliation>Xiangya Hospital of Central South University</affiliation> </overall_official> <overall_contact> <last_name>Yong Zhong, doctor</last_name> <phone>+86073189753025</phone> <email>zhongyong121@163.com</email> </overall_contact> <overall_contact_backup> <last_name>Ting Meng, doctor</last_name> <phone>+86073184327431</phone> <email>mengting252@163.com</email> </overall_contact_backup> <location> <facility> <name>Xiangya hospital</name> <address> <city>Changsha</city> <state>Hunan</state> <zip>410008</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yong Zhong, doctor</last_name> <phone>+86073189753025</phone> <email>zhongyong121@163.com</email> </contact> <contact_backup> <last_name>Ting Meng, doctor</last_name> <phone>+86073184327431</phone> <email>mengting252@163.com</email> </contact_backup> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Xiangya Hospital of Central South University</investigator_affiliation> <investigator_full_name>Xiangcheng Xiao</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>ANCA Associated Vasculitis</keyword> <keyword>ESRD</keyword> <keyword>Outcome</keyword> <condition_browse>  <mesh_term>Vasculitis</mesh_term> <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term> </condition_browse>  </clinical_study>

This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death. The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up. The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection. The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown. The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed Inclusion Criteria: - Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent Exclusion Criteria: - Do not agree to sign informed consent

NCT0531xxxx/NCT05315154.xml

<clinical_study>  <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/NCT05315154</url> </required_header> <id_info> <org_study_id>06805118.2.1001.5404</org_study_id> <secondary_id>RBR-8g6jbf</secondary_id> <nct_id>NCT05315154</nct_id> </id_info> <brief_title>Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer</brief_title> <acronym>VENUS</acronym> <official_title>Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Early Breast Cancer Clinically and Ultrasonographically Node-negative</official_title> <sponsors> <lead_sponsor> <agency>University of Campinas, Brazil</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Campinas, Brazil</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor <5cm) and node-negative after clinical palpation and axillary ultrasound. </textblock> </brief_summary> <detailed_description> <textblock> The standard approach to women with early breast cancer (BC) and clinically negative nodes is sentinel lymph node dissection (SLND). Studies showed that axillary lymph node dissection (ALND) can be safely omitted in presence of positive sentinel lymph node in patients treated with breast conserving therapy.Therefore, the pertinence of SLND in the approach to women with early BC is being questioned, once it is not injury-free.  The ACOSOG Z0011 trial examined the safety of omitting ALND in patients with early BC and up to 2 positive nodes at SLND, undergoing conservative surgery plus breast radiotherapy. The 10-year worth of data from this trial strongly suggested that omitting the procedure in these restrict, well-selected, subsets of patients maybe safe. Neoadjuvant chemotherapy (NAC) may be the starting treatment step for women with aggressive BC subtypes even in early stages.The SENTINA and ACOSOG Z1071 trials revealed that for women with three or more negative nodes in SLND, the procedure's accuracy and false-negative rate lie within acceptable boundaries. Our hypothesis is that for patients with early BC (regardless of neoadjuvant systemic therapy), with clinically and ultrasound negative axilla, avoiding SLND may be safe from the oncological perspective.The VENUS trial will investigate whether there may be still room for further de-escalation of the approach to the axilla in well-selected subsets of BC patients, by including women for whom the de-escalation has not been tested in previous trials dealing with the subject.  The VENUS trial is a prospective, noninferiority, multicenter, randomized controlled clinical trial that was approved by the Local Research Ethic Committee .The trial will compare SLND with no axillary surgery in women with T1-2 invasive BC and N0 disease, as ascertained after clinical palpation and axillary ultrasound. Mastectomy and primary systemic therapy are allowed whether node negative previous start the treatment . All women accrued to the trial must sign the informed consent. Randomization 1:1 will be stratified by age (≤50 and >50 years old) and clinical tumor size (≤2 cm and >2 cm).  The sample size estimated is 364 women in each arm (400 to account for losses to follow-up). Sample size was calculated according to the following parameters: 90% disease-free survival in patients undergoing SLND and a minimum 85% in those not undergoing the procedure, 80% power and 95% confidence intervals, with a tolerated risk ratio of 0.8. After surgery, regardless of adjuvant therapies, and for at least 48 months, patients will undergo physical examination of their breasts and axilla every 6 months and mammography will be performed annually or at closer intervals if indicated. Adjuvant chemotherapy and radiotherapy will be performed according to the protocol of each participating center and patients without axillary surgery should be considered N0 for decision making. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 2, 2019</start_date> <completion_date type="Anticipated">October 2, 2030</completion_date> <primary_completion_date type="Anticipated">October 2, 2025</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Disease free survival (DFS)</measure> <time_frame>5 years</time_frame> <description>Interval between the end of treatment and the diagnosis of any disease recurrence (breast, axilla or distant) by image exams or biopsy</description> </primary_outcome> <secondary_outcome> <measure>Overall survival (OS)</measure> <time_frame>5 years</time_frame> <description>Defined time period between the end of treatment and the patient's death from any cause.</description> </secondary_outcome> <secondary_outcome> <measure>Locoregional free survival</measure> <time_frame>5 years</time_frame> <description>Interval between the end of treatment and the diagnosis of any recorrence locoregional (breast or axilla) by biopsy</description> </secondary_outcome> <secondary_outcome> <measure>Axillary recurrence rate</measure> <time_frame>5 years</time_frame> <description>Percentage of patients with disease recurrence in axilla by biopsy in each grup</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">800</enrollment> <condition>Breast Cancer</condition> <arm_group> <arm_group_label>No axillary surgery</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Sentinel lymph node biopsy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>No axillary surgery</intervention_name> <description>In the study arm will be omitted surgery in axilla</description> <arm_group_label>No axillary surgery</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>SLNB</intervention_name> <description>in the control arm will be realized SLNB</description> <arm_group_label>Sentinel lymph node biopsy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Women  - Aged 18 years or older  - Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status  - Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams  - Clinically negative axilla  - Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample)  - Planned breast conservative surgery or mastectomy  - Written informed consent  Exclusion Criteria:  - Previous diagnostic of any invasive neoplasia (excluded skin cancer no melanoma)  - Metastatic disease in biopsy or image before treatment  - Withdrawal from participating of the study  - Initiated treatment for current breast cancer prior to study enrollment  - Pregnancy  - Breastfeed </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Giuliano Duarte, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Universidade Estadual de Campinas, Unicamp</affiliation> </overall_official> <overall_contact> <last_name>Giuliano Duarte, MD, PhD</last_name> <phone>+55 19 35219305</phone> <email>estudovenus@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Danielle Cristina Myamoto de Araujo, MD</last_name> </overall_contact_backup> <location> <facility> <name>Hospital Geral de Fortaleza</name> <address> <city>Fortaleza</city> <state>CE</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Francisco Pimentel Cavalcante</last_name> </contact> </location> <location> <facility> <name>Maternidade Dona Iris</name> <address> <city>Goiânia</city> <state>GO</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Leonardo R Soares, MD PhD</last_name> </contact> </location> <location> <facility> <name>Universidade Federal de Goiás</name> <address> <city>Goiânia</city> <state>GO</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rosemar Rahal, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Hospital de Clínica da Universidade Federal de Minas Gerais</name> <address> <city>Belo Horizonte</city> <state>MG</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Clécio Enio M de Lucena, MD PhD</last_name> </contact> </location> <location> <facility> <name>Hospital do Câncer de Muriaé da Fundação Cristiano Varella</name> <address> <city>Muriaé</city> <state>MG</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>René Aloisio C Vieira, MD PhD</last_name> </contact> </location> <location> <facility> <name>Hospital Barão de Lucena</name> <address> <city>Recife</city> <state>PE</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Darley de Lima Ferreira Filho, MD</last_name> </contact> </location> <location> <facility> <name>Universidade Federal do Paraná</name> <address> <city>Curitiba</city> <state>PR</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Vinícius Budel, MD PhD</last_name> </contact> </location> <location> <facility> <name>Hospital Federal da Lagoa</name> <address> <city>Rio De Janeiro</city> <state>RJ</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rafael Henrique S Machado, MD PhD</last_name> </contact> </location> <location> <facility> <name>Liga Norte Riograndense Contra o Câncer</name> <address> <city>Natal</city> <state>RN</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Roberta D Jales Alves de Andrade, MD</last_name> </contact> </location> <location> <facility> <name>Hospital de Clínicas de Porto Alegre - UFRS</name> <address> <city>Porto Alegre</city> <state>RS</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Andréa PS Damin, MD PhD</last_name> </contact> </location> <location> <facility> <name>Hospital de Amor - Fundação Pio XII</name> <address> <city>Barretos</city> <state>SP</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Idan Oliveira, MD PhD</last_name> </contact> </location> <location> <facility> <name>Unesp</name> <address> <city>Botucatu</city> <state>SP</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Eduardo Pessoa, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Hospital Celso Pierro - PUCC</name> <address> <city>Campinas</city> <state>SP</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Julio César N Gomes</last_name> </contact> </location> <location> <facility> <name>Hospital da Mulher Prof.Dr. J A Pinotti - UNICAMP</name> <address> <city>Campinas</city> <state>SP</state> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Giuliano M Duarte, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Hospital do Servidor Público Estadual</name> <address> <city>São Paulo</city> <state>SP</state> <country>Brazil</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Marcelo Antonini</last_name> </contact> </location> <location_countries> <country>Brazil</country> </location_countries> <reference> <citation>Araujo DCM, Duarte GM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FP, Esteves SCB, Sarian LO. Sentinel lymph node biopsy vs no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A prospective randomized controlled trial-VENUS trial. Breast J. 2020 Oct;26(10):2087-2089. doi: 10.1111/tbj.13994. Epub 2020 Jul 30. No abstract available.</citation> <PMID>32729181</PMID> </reference> <reference> <citation>Duarte GM, Araújo DCM, Jales RM, Shinzato JY, Cardoso Filho C, Torresan RZ, Brenelli FB, Kraft MBPL, Esteves SCB, Sarian LOZ, Rahal RMS, Freitas Jr R, Pessoa EC, Lucena CEM, Damin APS, Biazus JV, Budel VM, Oliveira Jr I, Vieira RAC, Gomes JCN. Sentinel lymph node biopsy versus no axillary surgery in early breast cancer clinically and ultrasonographically node negative: A multicentre prospective randomized controlled trial (VENUS trial. Cancer Research. 2022 82 (4_Supplement): OT1-04-03. DOI: https://doi.org/10.1158/1538-7445.SABCS21-OT1-04-03 Published: 15 February 2022</citation> </reference> <verification_date>May 2023</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 10, 2023</last_update_submitted> <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation> <investigator_full_name>Giuliano Mendes Duarte</investigator_full_name> <investigator_title>MD PhD</investigator_title> </responsible_party> <keyword>Breast cancer</keyword> <keyword>Sentinel Lymph Node</keyword> <condition_browse>  <mesh_term>Breast Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The VENUS trial is a prospective, multicenter, noninferiority, randomized, controlled clinical trial that compares sentinel lymph node biopsy versus no axillary surgery in women with early breast cancer (tumor <5cm) and node-negative after clinical palpation and axillary ultrasound. The standard approach to women with early breast cancer (BC) and clinically negative nodes is sentinel lymph node dissection (SLND). Studies showed that axillary lymph node dissection (ALND) can be safely omitted in presence of positive sentinel lymph node in patients treated with breast conserving therapy.Therefore, the pertinence of SLND in the approach to women with early BC is being questioned, once it is not injury-free. The ACOSOG Z0011 trial examined the safety of omitting ALND in patients with early BC and up to 2 positive nodes at SLND, undergoing conservative surgery plus breast radiotherapy. The 10-year worth of data from this trial strongly suggested that omitting the procedure in these restrict, well-selected, subsets of patients maybe safe. Neoadjuvant chemotherapy (NAC) may be the starting treatment step for women with aggressive BC subtypes even in early stages.The SENTINA and ACOSOG Z1071 trials revealed that for women with three or more negative nodes in SLND, the procedure's accuracy and false-negative rate lie within acceptable boundaries. Our hypothesis is that for patients with early BC (regardless of neoadjuvant systemic therapy), with clinically and ultrasound negative axilla, avoiding SLND may be safe from the oncological perspective.The VENUS trial will investigate whether there may be still room for further de-escalation of the approach to the axilla in well-selected subsets of BC patients, by including women for whom the de-escalation has not been tested in previous trials dealing with the subject. The VENUS trial is a prospective, noninferiority, multicenter, randomized controlled clinical trial that was approved by the Local Research Ethic Committee .The trial will compare SLND with no axillary surgery in women with T1-2 invasive BC and N0 disease, as ascertained after clinical palpation and axillary ultrasound. Mastectomy and primary systemic therapy are allowed whether node negative previous start the treatment . All women accrued to the trial must sign the informed consent. Randomization 1:1 will be stratified by age (≤50 and >50 years old) and clinical tumor size (≤2 cm and >2 cm). The sample size estimated is 364 women in each arm (400 to account for losses to follow-up). Sample size was calculated according to the following parameters: 90% disease-free survival in patients undergoing SLND and a minimum 85% in those not undergoing the procedure, 80% power and 95% confidence intervals, with a tolerated risk ratio of 0.8. After surgery, regardless of adjuvant therapies, and for at least 48 months, patients will undergo physical examination of their breasts and axilla every 6 months and mammography will be performed annually or at closer intervals if indicated. Adjuvant chemotherapy and radiotherapy will be performed according to the protocol of each participating center and patients without axillary surgery should be considered N0 for decision making. Inclusion Criteria: - Women - Aged 18 years or older - Histologically confirmed invasive breast carcinoma (core or open biopsy), independent of hormone receptor and HER2 status - Tumor smaller than 5 cm (T1 or T2) in clinical and radiological exams - Clinically negative axilla - Sonographically negative axilla or negative core biopsy/ fine needle biopsy (FNB) when ultrasound is suspect (lymph node tissue is required in core/FNB sample) - Planned breast conservative surgery or mastectomy - Written informed consent Exclusion Criteria: - Previous diagnostic of any invasive neoplasia (excluded skin cancer no melanoma) - Metastatic disease in biopsy or image before treatment - Withdrawal from participating of the study - Initiated treatment for current breast cancer prior to study enrollment - Pregnancy - Breastfeed

NCT0531xxxx/NCT05315167.xml

<clinical_study>  <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/NCT05315167</url> </required_header> <id_info> <org_study_id>PRJ1-3024-001</org_study_id> <secondary_id>CXHL2101725</secondary_id> <nct_id>NCT05315167</nct_id> </id_info> <brief_title>A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors</brief_title> <official_title>A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Prime Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors</official_title> <sponsors> <lead_sponsor> <agency>Zhuhai Yufan Biotechnologies Co., Ltd</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Zhuhai Yufan Biotechnologies Co., Ltd</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D. </textblock> </brief_summary> <detailed_description> <textblock> Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.  Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors.  This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 30, 2022</start_date> <completion_date type="Anticipated">March 15, 2025</completion_date> <primary_completion_date type="Anticipated">November 15, 2024</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <intervention_model_description>Part 1 is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024. Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 to confirm the tolerability and efficacy of the RP2D of PRJ1-3024 .</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period</measure> <time_frame>Day 1 to Day 21</time_frame> <description>Safety listings and pharmacokinetic listings will be used for evaluation</description> </primary_outcome> <secondary_outcome> <measure>Incidence of adverse events (AEs)</measure> <time_frame>24 months</time_frame> <description>Characterized by type, seriousness, relationship to study treatment, timing, and severity.</description> </secondary_outcome> <secondary_outcome> <measure>Pharmacokinetic parameter# Accumulation ratio</measure> <time_frame>24 months</time_frame> <description>to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration</description> </secondary_outcome> <secondary_outcome> <measure>Objective response rate (ORR)</measure> <time_frame>24 months</time_frame> <description>estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of response (DOR)</measure> <time_frame>24 months</time_frame> <description>defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.</description> </secondary_outcome> <secondary_outcome> <measure>Pharmacokinetic parameter#AUC0-last#</measure> <time_frame>24 months</time_frame> <description>Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration</description> </secondary_outcome> <secondary_outcome> <measure>Pharmacokinetic parameter#Maximum observed concentration (Cmax)</measure> <time_frame>24 months</time_frame> <description>assessed as time from time 0 to the time of the last quantifiable concentration</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">267</enrollment> <condition>Advanced Solid Tumor</condition> <condition>Advanced Solid Malignancies</condition> <arm_group> <arm_group_label>Monotherapy Escalation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level. PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.</description> </arm_group> <arm_group> <arm_group_label>Monotherapy Exploration of the recommended dose</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Upon completing Phase 1 and depending on data obtained, dose expansion may proceed in Phase 2 with several cohorts enrolled to confirm the tolerability of the RP2D of PRJ1-3024 (determined in Phase 1). PRJ1-3024 is administered orally once daily. The starting dose is determined by clinical effecacy data from Phase 1, and treatment may continue for up to 2 years as long as the subject experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>PRJ1-3024</intervention_name> <description>PRJ1-3024 is provided as capsules and is administered orally once a day.</description> <arm_group_label>Monotherapy Escalation</arm_group_label> <arm_group_label>Monotherapy Exploration of the recommended dose</arm_group_label> </intervention> <eligibility> <criteria> <textblock> - Key Inclusion Criteria:  - Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.  - Male or non-pregnant, non-lactating female subjects age ≥18 years.  - ECOG Performance Status 0~1.  - Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .  - Life expectancy of >3 months, in the opinion of the Investigator.  - Able to take oral medications and willing to record daily adherence to investigational product.  - Adequate hematologic parameters unless clearly due to the disease under study.  - Adequate renal and hepatic function  - Able to understand and willing to sign a written informed consent form.  Key Exclusion Criteria:  - History of another malignancy  - Known symptomatic brain metastases requiring >10 mg/day of prednisolone.  - Significant cardiovascular disease.  - Known active HBV, HCV, AIDS-related illness.  - Has received a live vaccine within 30 days.  - History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing .  - Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2.  - Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .  - Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hui ouyang, Dr.</last_name> <role>Study Director</role> <affiliation>VP</affiliation> </overall_official> <overall_contact> <last_name>Liting Lai</last_name> <phone>8617728075858</phone> <email>vivi.lai@ming-med.com</email> </overall_contact> <location> <facility> <name>The first affiliated hospital of Zhengzhou University</name> <address> <city>Zhengzhou</city> <state>Henan</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yanru Qin</last_name> </contact> </location> <location> <facility> <name>West China Hospital of Sichuan University</name> <address> <city>Chengdu</city> <state>Sichuan</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yongsheng Wang</last_name> </contact> </location> <location> <facility> <name>Cancer hospital of the University of Chinese Academy of Sciences</name> <address> <city>Hangzhou</city> <state>Zhejiang</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ji Zhu</last_name> </contact> </location> <location> <facility> <name>Beijing Cancer Hospital</name> <address> <city>Beijing</city> <zip>100142</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Lin Shen, Dr.</last_name> <phone>8610-88196561</phone> <email>doctorshenlin@sina.com</email> </contact> </location> <location> <facility> <name>The Fifth Medical Center of PLA General Hospital</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Guanghai Dai</last_name> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 12, 2022</last_update_submitted> <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Maximum tolerated dose</keyword> <keyword>Recommended Phase 2 dose</keyword> <keyword>Dose Escalation</keyword> <keyword>Hematopoietic progenitor kinase 1</keyword> <keyword>PRJ1-3024</keyword> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D. Using dose escalation, the study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors. Participants with advanced solid tumor will receive PRJ1-3024 daily as an oral therapy and test the impact of of PRJ1-3024 on tumors. This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the RP2D to assess the preliminary efficacy of PRJ1-3024 in a long-term extension study. - Key Inclusion Criteria: - Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. - Male or non-pregnant, non-lactating female subjects age ≥18 years. - ECOG Performance Status 0~1. - Has at least 1 measurable lesion as defined by RECIST 1.1 criteria . - Life expectancy of >3 months, in the opinion of the Investigator. - Able to take oral medications and willing to record daily adherence to investigational product. - Adequate hematologic parameters unless clearly due to the disease under study. - Adequate renal and hepatic function - Able to understand and willing to sign a written informed consent form. Key Exclusion Criteria: - History of another malignancy - Known symptomatic brain metastases requiring >10 mg/day of prednisolone. - Significant cardiovascular disease. - Known active HBV, HCV, AIDS-related illness. - Has received a live vaccine within 30 days. - History of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing . - Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to < Grade 2. - Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) . - Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.

NCT0531xxxx/NCT05315180.xml

<clinical_study>  <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/NCT05315180</url> </required_header> <id_info> <org_study_id>BTP-661311</org_study_id> <nct_id>NCT05315180</nct_id> </id_info> <brief_title>A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors</brief_title> <official_title>A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors</official_title> <sponsors> <lead_sponsor> <agency>Betta Pharmaceuticals Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Betta Pharmaceuticals Co., Ltd.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.  Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 24, 2021</start_date> <completion_date type="Anticipated">July 31, 2023</completion_date> <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies</measure> <time_frame>20 months</time_frame> <description>Number of subjects with treatment related adverse events</description> </primary_outcome> <primary_outcome> <measure>determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen</measure> <time_frame>20 months</time_frame> <description>Number of subjects with dose limiting toxicity</description> </primary_outcome> <secondary_outcome> <measure>Evaluate the pharmacokinetics of BPI-421286</measure> <time_frame>20 months</time_frame> <description>Blood plasma concentration</description> </secondary_outcome> <secondary_outcome> <measure>To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-421286</measure> <time_frame>20 months</time_frame> <description>Evaluate clinical activity/efficacy of BPI-421286</description> </secondary_outcome> <secondary_outcome> <measure>To evaluate the duration of response (DOR) in subjects with CR or PR as best response</measure> <time_frame>20 months</time_frame> <description>Evaluate clinical activity/efficacy of BPI-421286</description> </secondary_outcome> <secondary_outcome> <measure>to evaluate the disease control rate (DCR)</measure> <time_frame>20 months</time_frame> <description>Evaluate clinical activity/efficacy of BPI-421286</description> </secondary_outcome> <secondary_outcome> <measure>To evaluate progression-free survival (PFS) following initiation of BPI-421286</measure> <time_frame>20 months</time_frame> <description>Evaluate clinical activity/efficacy of BPI-421286</description> </secondary_outcome> <secondary_outcome> <measure>To evaluate overall (OS) following initiation of BPI-421286</measure> <time_frame>20 months</time_frame> <description>Evaluate clinical activity/efficacy of BPI-421286</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">80</enrollment> <condition>Malignant Neoplasms</condition> <condition>Metastatic Cancer</condition> <arm_group> <arm_group_label>dose exploration</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort</description> </arm_group> <arm_group> <arm_group_label>dose expansion</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>BPI-421286</intervention_name> <description>Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation</description> <arm_group_label>dose expansion</arm_group_label> <arm_group_label>dose exploration</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Pathologically documented, locally-advanced or metastatic malignancy  - Standard treatment is not available or patient declines  - Adequate organ function  Exclusion Criteria:  - Active brain metastases from non-brain tumors.  - Gastrointestinal (GI) tract disease causing the inability to take oral medication.  - Other protocol specified criteria </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Shun Lu, Ph.D</last_name> <phone>13601813062</phone> <email>shun_lu@hotmail.com</email> </overall_contact> <location> <facility> <name>Shun Lu, Ph.D</name> <address> <city>Shanghai</city> <state>Shanghai</state> <zip>200030</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Shun Lu, Ph.D</last_name> <phone>13601813062</phone> <email>shun_lu@hotmail.com</email> </contact> </location> <location> <facility> <name>Dingzhi Huang, Ph.D</name> <address> <city>Tianjin</city> <state>Tianjin</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dingzhi Huang, Ph.D</last_name> <phone>18622221232</phone> <email>dingzhi72@163.com</email> </contact> </location> <location> <facility> <name>Wen Li, Ph.D</name> <address> <city>Hangzhou</city> <state>Zhejiang</state> <zip>310009</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>310009 Li, Ph.D</last_name> <phone>13958194313</phone> <email>liwenzjhz0408@163.com</email> </contact> </location> <location> <facility> <name>Yun Fan,Ph.D</name> <address> <city>Hangzhou</city> <state>Zhejiang</state> <zip>310022</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yun Fan, Ph.D</last_name> <phone>0571-88122092</phone> <email>fanyun@zjcc.org.cn</email> </contact> </location> <location> <facility> <name>Shun Lu, Ph.D</name> <address> <city>Shanghai</city> <zip>200030</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Shun Lu, Ph.D</last_name> <phone>13601813062</phone> <email>shun_lu@hotmail.com</email> </contact> <investigator> <last_name>Shun Lu, Ph.D</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>China</country> </location_countries> <verification_date>February 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Antineoplastic Agents</keyword> <keyword>KRAS</keyword> <keyword>NSCLC</keyword> <keyword>Colorectal Cancer</keyword> <keyword>Pancreatic Cancer</keyword> <keyword>KRAS G12C</keyword> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors. Inclusion Criteria: - Pathologically documented, locally-advanced or metastatic malignancy - Standard treatment is not available or patient declines - Adequate organ function Exclusion Criteria: - Active brain metastases from non-brain tumors. - Gastrointestinal (GI) tract disease causing the inability to take oral medication. - Other protocol specified criteria