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Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children. conditions: Functional Abdominal Pain Syndrome conditions: Functional Gastrointestinal Disorders conditions: Irritable Bowel Syndrome Variant of Childhood studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 82 type: ESTIMATED name: Trimebutine name: Lactobacillus rhamnosus name: Placebo measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Improvement in Quality of Life with PedsQL 3.0 measure: Improvement in Quality of Life with PedsQL 3.0 measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Number of Participants with Treatment-Related Adverse Events sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: School of Medicine, University of Colima status: RECRUITING city: Colima zip: 28040 country: Mexico name: Pablo H Sandoval-Villaseñor, MD role: CONTACT phone: +523123007655 email: pablohernan_sandoval@ucol.mx name: Fabián Rojas-Larios, PhD role: CONTACT email: frojas@ucol.mx name: Carmen A Sánchez-Ramírez, PhD role: SUB_INVESTIGATOR name: Pablo H Sandoval-Villaseñor, MD role: PRINCIPAL_INVESTIGATOR name: Fabián Rojas-Larios, PhD role: SUB_INVESTIGATOR lat: 19.24997 lon: -103.72714 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-09 uploadDate: 2024-02-16T21:12 filename: Prot_SAP_ICF_000.pdf size: 6823982 hasResults: False
<|newrecord|> nctId: NCT06268951 id: 23-005485 briefTitle: Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis overallStatus: ENROLLING_BY_INVITATION date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-02-21 date: 2024-04-15 name: Mayo Clinic class: OTHER briefSummary: To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Symptom severity due to abdominal wall endometriosis following ablation. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
<|newrecord|> nctId: NCT06268938 id: mastoid obliteration briefTitle: Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-04 date: 2028-11-01 date: 2028-12-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery conditions: Cholesteatoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 4 type: ACTUAL name: Canal wall down tympanomastoidectomy measure: Size of mastoid cavity in mm sex: ALL minimumAge: 5 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Assiut university hospital city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 facility: Rehab Abd Elal Mohammed city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<|newrecord|> nctId: NCT06268925 id: UAHS briefTitle: The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka overallStatus: ENROLLING_BY_INVITATION date: 2024-02-22 date: 2024-04-22 date: 2024-05-03 date: 2024-02-20 date: 2024-02-20 name: University of Peradeniya class: OTHER briefSummary: it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Exercises measure: Efficacy of telerehabilitation program measure: Feasibility and acceptability measure: lower extremity muscle strength and dynamic balance measure: pain, measure: pain stiffness and physical activity sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: M.S.F.Sarjana city: Puttalam state: North Western zip: 61300 country: Sri Lanka lat: 8.0362 lon: 79.8283 hasResults: False
<|newrecord|> nctId: NCT06268912 id: END-ECL-2022-01 id: END-ECL-2022-01 type: OTHER domain: UIC briefTitle: Cryoanalgesia for Irreversible Pulpitis acronym: CryPain overallStatus: COMPLETED date: 2022-09-07 date: 2023-09-07 date: 2024-01-07 date: 2024-02-20 date: 2024-02-20 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis. conditions: Pulpitis - Irreversible studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Cold Mepivacaine name: Mepivacaine at room temperature measure: Assessment of Pain and Anxiety sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gonzalo Gomez city: Barcelona zip: 08 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
<|newrecord|> nctId: NCT06268899 id: E-77082166-302.08.01-285977 briefTitle: First Mobilization Protocol for Total Knee Arthroplasty Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-08 date: 2024-03-30 date: 2024-03-30 date: 2024-02-20 date: 2024-02-20 name: Gazi University class: OTHER name: Baskent University briefSummary: This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms. conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participant: the researcher learned the study and control groups after the pre-test data. The study group was trained with the mobilization protocol. The control group received training on the current mobilization procedure of the clinic. Participants did not know which group they were in.
Outcomes Assessor. Study and control groups data were coded into the SPSS programme as group one and group two. Analysis of data was done by an independent statistician. The statistician has no information about which group the patients belong to. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ACTUAL name: First mobilization protocol measure: Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI) measure: Kinesiophobia evaluated using the Tampa Kinesiophobia Scale measure: Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI) measure: Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University Health Research and Application Center city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06268886 id: CN008-0003 id: 2023-504840-32-00 type: REGISTRY domain: EU Trial Number id: U1111-1290-3539 type: REGISTRY domain: WHO briefTitle: Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease acronym: TargetTau-1 overallStatus: RECRUITING date: 2024-03-20 date: 2027-08-31 date: 2027-11-16 date: 2024-02-20 date: 2024-04-29 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. conditions: Alzheimer Disease, Early Onset studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 475 type: ESTIMATED name: BMS-986446 name: Placebo measure: Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score measure: Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) measure: Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score measure: Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score measure: Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score measure: Mean change from baseline in Mini Mental State Examination (MMSE) score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD First Research - Chandler status: NOT_YET_RECRUITING city: Chandler state: Arizona zip: 85226-3732 country: United States name: Hemant Pandey, Site 0068 role: CONTACT phone: 480-508-1038 lat: 33.30616 lon: -111.84125 facility: Gilbert Neurology status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85297-0441 country: United States name: Jonathan Hodgson, Site 0102 role: CONTACT phone: 602-761-9631 lat: 33.35283 lon: -111.78903 facility: Xenoscience Inc. - 21st Century Neurology status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Stephen Flitman, Site 0019 role: CONTACT phone: 602-265-6500 lat: 33.44838 lon: -112.07404 facility: Imaging Endpoints LLC status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-4595 country: United States name: Nida Laurin, Site 0026 role: CONTACT lat: 33.50921 lon: -111.89903 facility: Office of Allan M. Block, MD status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-5133 country: United States name: Allan Block, Site 0018 role: CONTACT phone: 480-471-6132 lat: 33.50921 lon: -111.89903 facility: Tucson Neuroscience Research, LLC status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710-6160 country: United States name: Robert Mutterperl, Site 0128 role: CONTACT phone: 520-230-1373 lat: 32.22174 lon: -110.92648 facility: Center for Neurosciences - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6522 country: United States name: Michael Badruddoja, Site 0077 role: CONTACT phone: 520-320-2147 lat: 32.22174 lon: -110.92648 facility: The Banner Alzheimer's Institute - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6632 country: United States name: Allan Anderson, Site 0038 role: CONTACT phone: 520-694-4124 lat: 32.22174 lon: -110.92648 facility: Local Institution - 0164 status: NOT_YET_RECRUITING city: Encino state: California zip: 91316-1511 country: United States name: Site 0164 role: CONTACT lat: 34.15917 lon: -118.50119 facility: Local Institution - 0139 status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835-1040 country: United States name: Site 0139 role: CONTACT lat: 33.87029 lon: -117.92534 facility: Local Institution - 0152 status: NOT_YET_RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Site 0152 role: CONTACT lat: 32.84727 lon: -117.2742 facility: Local Institution - 0183 status: NOT_YET_RECRUITING city: Lakewood state: California zip: 90805-4590 country: United States name: Site 0183 role: CONTACT lat: 33.85363 lon: -118.13396 facility: Local Institution - 0073 status: ACTIVE_NOT_RECRUITING city: Lomita state: California zip: 90717-2101 country: United States lat: 33.79224 lon: -118.31507 facility: Local Institution - 0142 status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720-3589 country: United States name: Site 0142 role: CONTACT lat: 33.80307 lon: -118.07256 facility: Neurovations status: NOT_YET_RECRUITING city: Napa state: California zip: 94558-2415 country: United States name: Eric Grigsby, Site 0037 role: CONTACT phone: 707-252-9666 lat: 38.29714 lon: -122.28553 facility: UCSF Medical Center- Mission Bay status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143-2350 country: United States name: Peter Ljubenkov, Site 0052 role: CONTACT phone: 415-502-7562 lat: 37.77493 lon: -122.41942 facility: Local Institution - 0137 status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92705-8675 country: United States name: Site 0137 role: CONTACT lat: 33.74557 lon: -117.86783 facility: Local Institution - 0135 status: NOT_YET_RECRUITING city: Seal Beach state: California zip: 90740-6653 country: United States name: Site 0135 role: CONTACT lat: 33.74141 lon: -118.10479 facility: California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States name: Thomas Shiovitz, Site 0046 role: CONTACT phone: 818-986-9716 lat: 34.15112 lon: -118.44925 facility: Rocky Mountain Movement Disorder Center status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113-2776 country: United States name: Rajeev Kumar, Site 0092 role: CONTACT phone: 303-357-5455 lat: 39.64777 lon: -104.98776 facility: Associated Neurologists, P.C. - Danbury Office status: NOT_YET_RECRUITING city: Danbury state: Connecticut zip: 06810-4088 country: United States name: Behzad Habibi Khameneh, Site 0106 role: CONTACT phone: 203-748-2551 lat: 41.39482 lon: -73.45401 facility: Local Institution - 0148 status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Site 0148 role: CONTACT lat: 41.30815 lon: -72.92816 facility: Hasbani Neurology status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06511-5249 country: United States name: Mayer Hasbani, Site 0056 role: CONTACT phone: 212-241-8329 lat: 41.30815 lon: -72.92816 facility: Local Institution - 0153 status: NOT_YET_RECRUITING city: Stamford state: Connecticut zip: 06905-1206 country: United States name: Site 0153 role: CONTACT lat: 41.05343 lon: -73.53873 facility: Neurology of Central Florida status: NOT_YET_RECRUITING city: Altamonte Springs state: Florida zip: 32714-2436 country: United States name: Alicia Cabrera, Site 0022 role: CONTACT phone: 407-790-4990 lat: 28.66111 lon: -81.36562 facility: JEM Research Institute status: NOT_YET_RECRUITING city: Atlantis state: Florida zip: 33462-6631 country: United States name: Linda Pao, Site 0048 role: CONTACT phone: 561-968-2933 lat: 26.5909 lon: -80.10088 facility: Local Institution - 0020 status: NOT_YET_RECRUITING city: Clermont state: Florida zip: 34711-5933 country: United States name: Site 0020 role: CONTACT lat: 28.54944 lon: -81.77285 facility: Arrow Clinical Trials status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5532 country: United States name: David Billmeier, Site 0009 role: CONTACT phone: 386-304-7070 lat: 29.21081 lon: -81.02283 facility: Local Institution - 0059 status: NOT_YET_RECRUITING city: Greenacres City state: Florida zip: 33467 country: United States name: Site 0059 role: CONTACT lat: 26.62368 lon: -80.12532 facility: Local Institution - 0187 status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States name: Site 0187 role: CONTACT lat: 30.33218 lon: -81.65565 facility: Charter Research - Lady Lake status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Jeffrey Norton, Site 0151 role: CONTACT phone: 352-775-1000 lat: 28.91749 lon: -81.92286 facility: Local Institution - 0146 status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33805-2208 country: United States name: Site 0146 role: CONTACT lat: 28.03947 lon: -81.9498 facility: Local Institution - 0143 status: NOT_YET_RECRUITING city: Maitland state: Florida zip: 32751 country: United States name: Site 0143 role: CONTACT lat: 28.62778 lon: -81.36312 facility: Merritt Island Medical Research status: RECRUITING city: Merritt Island state: Florida zip: 32952-3616 country: United States name: Gregory Kirk, Site 0027 role: CONTACT phone: 386-785-8009 lat: 28.53917 lon: -80.672 facility: Premier Clinical Research Institute - Miami status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33122-1335 country: United States name: Emelina Arocha, Site 0058 role: CONTACT phone: 786-587-9425 lat: 25.77427 lon: -80.19366 facility: Optimus U, Inc. status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4013 country: United States name: Yaneicy Gonzalez Rojas, Site 0013 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Project 4 Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4719 country: United States name: Ibrahim Menendez Perez, Site 0034 role: CONTACT phone: 786-536-5755 lat: 25.77427 lon: -80.19366 facility: Vitae Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2957 country: United States name: Mercedes Ponce De Leon, Site 0014 role: CONTACT phone: 786-288-2598 lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2968 country: United States name: Ana Acosta, Site 0005 role: CONTACT phone: 786-360-4423 lat: 25.77427 lon: -80.19366 facility: Miami Jewish Health Systems status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33137-2706 country: United States name: Marc Agronin, Site 0008 role: CONTACT phone: 305-514-8710 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0176 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155-6540 country: United States name: Site 0176 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Hope Research Network, LLC status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33166-2710 country: United States name: Jorge Jorge, Site 0071 role: CONTACT phone: 305-244-8113 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0156 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33175-3598 country: United States name: Site 0156 role: CONTACT lat: 25.77427 lon: -80.19366 facility: IMIC Research status: RECRUITING city: Miami state: Florida zip: 33176-7947 country: United States name: Ramon Leon, Site 0039 role: CONTACT phone: 786-600-7005 lat: 25.77427 lon: -80.19366 facility: Suncoast Clinical Research status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652-4020 country: United States name: Cathy Barnes, Site 0017 role: CONTACT phone: 727-849-4131 lat: 28.24418 lon: -82.71927 facility: Local Institution - 0144 status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34471 country: United States name: Site 0144 role: CONTACT lat: 29.1872 lon: -82.14009 facility: Headlands Research - Orlando status: RECRUITING city: Orlando state: Florida zip: 32819-8031 country: United States name: Theodore Lee, Site 0035 role: CONTACT phone: 407-705-3471 lat: 28.53834 lon: -81.37924 facility: Local Institution - 0141 status: NOT_YET_RECRUITING city: Palm Beach Gardens state: Florida zip: 33410-4303 country: United States name: Site 0141 role: CONTACT lat: 26.82339 lon: -80.13865 facility: Alzheimer's Research and Treatment Center Stuart status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-5765 country: United States name: Adam Falchook, Site 0012 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Local Institution - 0136 status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-6405 country: United States name: Site 0136 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Baycare Clinical Research, LLC status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607-6616 country: United States name: Arnaldo Orellana, Site 0080 role: CONTACT phone: 813-368-5738 lat: 27.94752 lon: -82.45843 facility: First Choice Neurology - Tampa Neurology Associates status: RECRUITING city: Tampa state: Florida zip: 33609-4090 country: United States name: Susan Steen, Site 0087 role: CONTACT phone: 813-353-9613 lat: 27.94752 lon: -82.45843 facility: Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33613-4808 country: United States name: Amanda Smith, Site 0042 role: CONTACT phone: 813-974-4355 lat: 27.94752 lon: -82.45843 facility: Alzheimer's Research and Treatment Center - Wellington Location status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33414-9320 country: United States name: David Watson, Site 0011 role: CONTACT phone: 561-209-2400 lat: 26.65868 lon: -80.24144 facility: Local Institution - 0149 status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409-6611 country: United States name: Site 0149 role: CONTACT lat: 26.71534 lon: -80.05337 facility: Waypoint Research LLC status: RECRUITING city: Windermere state: Florida zip: 34786-8919 country: United States name: Craig Curtis, Site 0029 role: CONTACT phone: 352-500-5252 lat: 28.49556 lon: -81.5348 facility: Conquest Research LLC status: RECRUITING city: Winter Park state: Florida zip: 32789-1848 country: United States name: Rekha Gandhi, Site 0101 role: CONTACT phone: 321-285-2369 lat: 28.6 lon: -81.33924 facility: Charter Research - Winter Park status: RECRUITING city: Winter Park state: Florida zip: 32792 country: United States name: Edgardo Rivera, Site 0154 role: CONTACT phone: 407-863-1326 lat: 28.6 lon: -81.33924 facility: Columbus Memory Center status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909-1692 country: United States name: Jonathan Liss, Site 0105 role: CONTACT phone: 706-327-4000 lat: 32.46098 lon: -84.98771 facility: Great Lakes Clinical Trials status: RECRUITING city: Chicago state: Illinois zip: 60640-2831 country: United States name: Jeffrey Ross, Site 0021 role: CONTACT phone: 847-252-7300 lat: 41.85003 lon: -87.65005 facility: Local Institution - 0161 status: NOT_YET_RECRUITING city: Elk Grove Village state: Illinois zip: 60007-3362 country: United States name: Site 0161 role: CONTACT lat: 42.00392 lon: -87.97035 facility: Great Lakes Clinical Trials d/b/a Flourish Research Gurnee status: RECRUITING city: Gurnee state: Illinois zip: 60031 country: United States name: Yevgeniy Bukhman, Site 0003 role: CONTACT phone: 773-275-3500 lat: 42.3703 lon: -87.90202 facility: Local Institution - 0145 status: NOT_YET_RECRUITING city: Park Ridge state: Illinois zip: 60068 country: United States name: Site 0145 role: CONTACT lat: 42.01114 lon: -87.84062 facility: Southern Illinois University School of Medicine - SIU Neurology Clinic status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62702-4968 country: United States name: Jennifer Arnold, Site 0081 role: CONTACT phone: 217-545-7200 lat: 39.80172 lon: -89.64371 facility: Boston Clinical Trials status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02131-2515 country: United States name: Deborah Green-LaRoche, Site 0025 role: CONTACT phone: 617-636-7606 lat: 42.35843 lon: -71.05977 facility: Boston Neuropsychiatry status: NOT_YET_RECRUITING city: Braintree state: Massachusetts zip: 02184-1939 country: United States name: Malini Nair, Site 0015 role: CONTACT phone: 617-302-6388 lat: 42.22232 lon: -70.99949 facility: ActivMed Practices & Research, Inc. - Methuen status: NOT_YET_RECRUITING city: Methuen state: Massachusetts zip: 01844-5864 country: United States name: Michael McCartney, Site 0118 role: CONTACT phone: 19789789696897 lat: 42.7262 lon: -71.19089 facility: Boston Center for Memory status: NOT_YET_RECRUITING city: Newton state: Massachusetts zip: 02459-3328 country: United States name: Paul Solomon, Site 0040 role: CONTACT phone: 617-699-6927 lat: 42.33704 lon: -71.20922 facility: Office of Donald S. Marks, M.D., P.C. status: NOT_YET_RECRUITING city: Plymouth state: Massachusetts zip: 02360-7223 country: United States name: Donald Marks, Site 0120 role: CONTACT phone: 508-269-0403 lat: 41.95844 lon: -70.66726 facility: Adams Clinical Trials, LLC status: NOT_YET_RECRUITING city: Watertown state: Massachusetts zip: 02472-4153 country: United States name: Stephanie Rutrick, Site 0045 role: CONTACT phone: 617-697-1843 lat: 42.37093 lon: -71.18283 facility: Local Institution - 0150 status: NOT_YET_RECRUITING city: Ozark state: Missouri zip: 65721 country: United States name: Site 0150 role: CONTACT lat: 37.02089 lon: -93.20602 facility: Local Institution - 0169 status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63104-1027 country: United States name: Site 0169 role: CONTACT lat: 38.62727 lon: -90.19789 facility: ActivMed Practices & Research, Inc. - Portsmouth status: NOT_YET_RECRUITING city: Portsmouth state: New Hampshire zip: 03801-6822 country: United States name: Marc Shay, Site 0119 role: CONTACT phone: 603-319-8863 lat: 43.07176 lon: -70.76255 facility: Princeton Medical Institute status: NOT_YET_RECRUITING city: Princeton state: New Jersey zip: 08540-2859 country: United States name: Sanjay Varma, Site 0031 role: CONTACT phone: 609-921-3555 lat: 40.34872 lon: -74.65905 facility: Advanced Memory Research Institute of NJ status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755-5043 country: United States name: Sanjiv Sharma, Site 0062 role: CONTACT phone: 732-341-9500 lat: 39.95373 lon: -74.19792 facility: Neurology Specialists of Monmouth County, PA status: NOT_YET_RECRUITING city: West Long Branch state: New Jersey zip: 07764-1021 country: United States name: Noah Gilson, Site 0130 role: CONTACT phone: 732-935-1850 lat: 40.29039 lon: -74.01764 facility: Neurological Associates of Albany, P.C. status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208-3464 country: United States name: Richard Holub, Site 0060 role: CONTACT phone: 518-426-0575 lat: 42.65258 lon: -73.75623 facility: Local Institution - 0157 status: NOT_YET_RECRUITING city: Amherst state: New York zip: 14226-1727 country: United States name: Site 0157 role: CONTACT lat: 42.97839 lon: -78.79976 facility: The Feinstein Institute for Medical Research status: NOT_YET_RECRUITING city: Manhasset state: New York zip: 11030-3816 country: United States name: Marc Gordon, Site 0061 role: CONTACT phone: 516-562-3492 lat: 40.79788 lon: -73.69957 facility: Neurological Associates of Long Island status: NOT_YET_RECRUITING city: New Hyde Park state: New York zip: 11042-1028 country: United States name: David Podwall, Site 0107 role: CONTACT phone: 516-466-4700 lat: 40.7351 lon: -73.68791 facility: Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10029-6504 country: United States name: Laili Soleimani, Site 0104 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Columbia University Medical Center - The Neurological Institute of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10032-3726 country: United States name: Lawrence Honig, Site 0133 role: CONTACT phone: 212-305-0851 lat: 40.71427 lon: -74.00597 facility: Local Institution - 0095 status: NOT_YET_RECRUITING city: New York state: New York zip: 11220 country: United States name: Site 0095 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Alzheimer's Memory Center status: NOT_YET_RECRUITING city: Matthews state: North Carolina zip: 28105-8336 country: United States name: Mohammad Bolouri, Site 0043 role: CONTACT phone: 7043644000225 lat: 35.11681 lon: -80.72368 facility: Local Institution - 0155 status: NOT_YET_RECRUITING city: Beachwood state: Ohio zip: 44122 country: United States name: Site 0155 role: CONTACT lat: 41.4645 lon: -81.50873 facility: Abington Neurological Associates (ANA) status: NOT_YET_RECRUITING city: Abington state: Pennsylvania zip: 19001-3816 country: United States name: David Weisman, Site 0057 role: CONTACT phone: 215-886-7000 lat: 40.12067 lon: -75.11795 facility: Hospital of the University of Pennsylvania status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Sanjeev Vaishnavi, Site 0032 role: CONTACT phone: 215-662-7810 lat: 39.95233 lon: -75.16379 facility: Keystone Clinical Studies, LLC status: RECRUITING city: Plymouth Meeting state: Pennsylvania zip: 19462-7401 country: United States name: Cherian Verghese, Site 0023 role: CONTACT lat: 40.10233 lon: -75.27435 facility: Rhode Island Mood & Memory Research Institute status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914-1318 country: United States name: John Stoukides, Site 0024 role: CONTACT phone: 401-435-8950 lat: 41.81371 lon: -71.37005 facility: Rhode Island Hospital - Alzheimer's Disease and Memory Disorders Center status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02903-4923 country: United States name: Chuang-Kuo Wu, Site 0098 role: CONTACT phone: 401-444-5742 lat: 41.82399 lon: -71.41283 facility: Local Institution - 0163 status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02906-4800 country: United States name: Site 0163 role: CONTACT lat: 41.82399 lon: -71.41283 facility: Neurology Clinic, P.C. - Germantown Park Location status: NOT_YET_RECRUITING city: Cordova state: Tennessee zip: 38018-4254 country: United States name: Kendrick Henderson, Site 0132 role: CONTACT phone: 901-866-9252 lat: 35.15565 lon: -89.7762 facility: Local Institution - 0140 status: NOT_YET_RECRUITING city: Franklin state: Tennessee zip: 37067-5922 country: United States name: Site 0140 role: CONTACT lat: 35.92506 lon: -86.86889 facility: Senior Adults Specialty Research status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78757-8046 country: United States name: Jaron Winston, Site 0069 role: CONTACT phone: 512-476-3556 lat: 30.26715 lon: -97.74306 facility: Gadolin Research status: NOT_YET_RECRUITING city: Beaumont state: Texas zip: 77702 country: United States name: Kandasami Senthilkumar, Site 0033 role: CONTACT phone: 409-331-6040 lat: 30.08605 lon: -94.10185 facility: Kerwin Research Center and Memory Care status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231-4316 country: United States name: Diana Kerwin, Site 0051 role: CONTACT phone: 972-433-9100 lat: 32.78306 lon: -96.80667 facility: Neurology Consultants of Dallas status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75243-1288 country: United States name: Duc Tran, Site 0134 role: CONTACT phone: 214-750-0322 lat: 32.78306 lon: -96.80667 facility: Baylor College of Medicine status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Melissa Yu, Site 0041 role: CONTACT phone: 713-798-6107 lat: 29.76328 lon: -95.36327 facility: Memorial Neurological Association - Main Office status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074-1812 country: United States name: Nelson Berrios, Site 0016 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Central Texas Neurology Consultants (CTNC) status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3578 country: United States name: Elizabeth Peckham, Site 0129 role: CONTACT phone: 512-218-1222 lat: 30.50826 lon: -97.6789 facility: Be Well MD status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3596 country: United States name: Mark Carlson, Site 0028 role: CONTACT lat: 30.50826 lon: -97.6789 facility: Local Institution - 0168 status: NOT_YET_RECRUITING city: Richmond state: Virginia zip: 23294 country: United States name: Site 0168 role: CONTACT lat: 37.55376 lon: -77.46026 facility: Local Institution - 0065 status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Site 0065 role: CONTACT lat: 43.07305 lon: -89.40123 facility: Local Institution - 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<|newrecord|> nctId: NCT06268873 id: D6972C00003 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-10 date: 2027-12-10 date: 2024-02-20 date: 2024-04-25 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.
Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued. conditions: Chronic Kidney Disease and Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Baxdrostat/dapagliflozin name: Dapagliflozin in combination with placebo measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Surprise state: Arizona zip: 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Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100035 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 102218 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Changsha zip: 410013 country: China lat: 28.19874 lon: 112.97087 facility: Research Site status: NOT_YET_RECRUITING city: Changzhou zip: 272100 country: China lat: 31.77359 lon: 119.95401 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610072 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chongqing zip: 402260 country: China lat: 29.56278 lon: 106.55278 facility: Research Site status: 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country: Italy lat: 45.07049 lon: 7.68682 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0002 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0027 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0028 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Daito-shi zip: 574-0074 country: Japan facility: Research Site status: NOT_YET_RECRUITING city: Fujisawa-shi zip: 251-8550 country: Japan lat: 35.34926 lon: 139.47666 facility: Research Site status: NOT_YET_RECRUITING city: Fukuoka-shi zip: 815-8555 country: Japan lat: 33.6 lon: 130.41667 facility: Research Site status: NOT_YET_RECRUITING city: Hiroshima-shi zip: 730-8518 country: Japan lat: 34.4 lon: 132.45 facility: Research Site status: NOT_YET_RECRUITING city: Hiroshima zip: 732-0057 country: Japan lat: 34.4 lon: 132.45 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133.78333 facility: Research Site status: NOT_YET_RECRUITING city: Matsuyama-city zip: 790-0024 country: Japan lat: 33.83916 lon: 132.76574 facility: Research Site status: NOT_YET_RECRUITING city: Naka zip: 311-0113 country: Japan lat: 36.05 lon: 140.16667 facility: Research Site status: NOT_YET_RECRUITING city: Nishinomiya-Shi zip: 662-0918 country: Japan lat: 34.71562 lon: 135.33199 facility: Research Site status: NOT_YET_RECRUITING city: Obihiro-shi zip: 080-0848 country: Japan lat: 42.91722 lon: 143.20444 facility: Research Site status: NOT_YET_RECRUITING city: Oita-shi zip: 870-0033 country: Japan lat: 33.23333 lon: 131.6 facility: Research Site status: NOT_YET_RECRUITING city: Osaka-shi zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Osaka zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo zip: 064-8570 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: NOT_YET_RECRUITING city: Shinjyuku-ku zip: 160-0022 country: Japan facility: Research Site status: NOT_YET_RECRUITING city: Shizuoka-shi zip: 421-0117 country: Japan lat: 34.98333 lon: 138.38333 facility: Research Site status: NOT_YET_RECRUITING city: Takatsuki-shi zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Research Site status: NOT_YET_RECRUITING city: Toride-shi zip: 302-0022 country: Japan lat: 35.9 lon: 140.08333 facility: Research Site status: NOT_YET_RECRUITING city: Toyota-Shi zip: 471-8513 country: Japan lat: 35.08333 lon: 137.15 facility: Research Site status: NOT_YET_RECRUITING city: Tsu-shi zip: 514-8507 country: Japan lat: 34.73333 lon: 136.51667 facility: Research Site status: NOT_YET_RECRUITING city: Ueda-shi zip: 386-8610 country: Japan lat: 36.40265 lon: 138.28161 facility: Research Site status: NOT_YET_RECRUITING city: Urayasu zip: 279-0001 country: Japan lat: 35.67054 lon: 139.88862 facility: Research Site status: NOT_YET_RECRUITING city: Yaizu-shi zip: 425-8505 country: Japan lat: 34.86876 lon: 138.31951 facility: Research Site status: NOT_YET_RECRUITING city: Goyang-si zip: 10380 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 03312 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 07061 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Uijeongbu zip: 11765 country: Korea, Republic of lat: 37.7415 lon: 127.0474 facility: Research Site status: NOT_YET_RECRUITING city: Wonju-si zip: 26426 country: Korea, Republic of facility: Research Site status: NOT_YET_RECRUITING city: Yangsan-si zip: 50612 country: Korea, Republic of facility: Research Site status: NOT_YET_RECRUITING city: Klang zip: 41200 country: Malaysia lat: 3.03333 lon: 101.45 facility: Research Site status: NOT_YET_RECRUITING city: Kota Kinabalu zip: 88200 country: Malaysia lat: 5.9749 lon: 116.0724 facility: Research Site status: NOT_YET_RECRUITING city: Kuala Lumpur zip: 50586 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site status: NOT_YET_RECRUITING city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site status: NOT_YET_RECRUITING city: Kuantan zip: 25200 country: Malaysia lat: 3.8077 lon: 103.326 facility: Research Site status: NOT_YET_RECRUITING city: Seremban zip: 70300 country: Malaysia lat: 2.7297 lon: 101.9381 facility: Research Site status: NOT_YET_RECRUITING city: Taiping zip: 34000 country: Malaysia lat: 4.85 lon: 100.73333 facility: Research Site status: 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NOT_YET_RECRUITING city: Tilburg zip: 5042AD country: Netherlands lat: 51.55551 lon: 5.0913 facility: Research Site status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Netherlands lat: 52.09083 lon: 5.12222 facility: Research Site status: NOT_YET_RECRUITING city: Arequipa zip: AREQUIPA01 country: Peru lat: -16.39889 lon: -71.535 facility: Research Site status: NOT_YET_RECRUITING city: Chorrillos zip: Lima 9 country: Peru facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15036 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15046 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: LIma zip: 15074 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15088 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: LIMA 01 country: Peru lat: 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Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Yung Kang City zip: 71044 country: Taiwan facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10700 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Chiang Mai zip: 50200 country: Thailand lat: 18.79038 lon: 98.98468 facility: Research Site status: NOT_YET_RECRUITING city: Hat Yai zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 34000 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 40002 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Phutthamonthon zip: 73170 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Ratchathewi zip: 10400 country: Thailand lat: 13.759 lon: 100.53358 facility: Research Site status: NOT_YET_RECRUITING city: Adana zip: 01060 country: Turkey lat: 37.00167 lon: 35.32889 facility: Research Site status: NOT_YET_RECRUITING city: Adapazarı zip: 54100 country: Turkey lat: 40.78056 lon: 30.40333 facility: Research Site status: NOT_YET_RECRUITING city: Afyonkarahisar zip: 03030 country: Turkey lat: 38.75667 lon: 30.54333 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Antalya zip: 07059 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site status: NOT_YET_RECRUITING city: Bursa zip: 16059 country: Turkey lat: 40.19559 lon: 29.06013 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site status: NOT_YET_RECRUITING city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site status: NOT_YET_RECRUITING city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site status: NOT_YET_RECRUITING city: Chernivtsі zip: 58002 country: Ukraine facility: Research Site status: NOT_YET_RECRUITING city: Ivano-Frankivsk zip: 76000 country: Ukraine lat: 48.9215 lon: 24.70972 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02081 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02125 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03037 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03057 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 04050 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46000 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46001 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Uzhhorod zip: 88018 country: Ukraine lat: 48.61667 lon: 22.3 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21009 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21018 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21029 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsya zip: 21001 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Bristol zip: BS105NB country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0XY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: Harrow zip: HA3 7LT country: United Kingdom lat: 51.57142 lon: -0.33371 facility: Research Site status: NOT_YET_RECRUITING city: Leicester zip: LE1 5WW country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Research Site status: NOT_YET_RECRUITING city: Liverpool zip: L9 7AL country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Research Site status: NOT_YET_RECRUITING city: London zip: EC1A 2BE country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RJ country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Newcastle-Under-Lyme zip: ST4 6QG country: United Kingdom lat: 53.0 lon: -2.23333 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Research Site status: NOT_YET_RECRUITING city: Wolverhampton zip: WV10 0QP country: United Kingdom lat: 52.58547 lon: -2.12296 facility: Research Site status: NOT_YET_RECRUITING city: Bien Hoa zip: 810000 country: Vietnam lat: 10.94469 lon: 106.82432 facility: Research Site status: NOT_YET_RECRUITING city: Da Nang zip: 550000 country: Vietnam lat: 16.06778 lon: 108.22083 facility: Research Site status: WITHDRAWN city: Ha Noi zip: 100000 country: Vietnam lat: 20.47366 lon: 106.02292 facility: Research Site status: NOT_YET_RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site status: NOT_YET_RECRUITING city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 hasResults: False
<|newrecord|> nctId: NCT06268860 id: 20220015 briefTitle: A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants overallStatus: RECRUITING date: 2024-02-15 date: 2024-08-29 date: 2024-08-29 date: 2024-02-20 date: 2024-04-12 name: Amgen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: Rocatinlimab vial injection name: Rocatinlimab prefilled syringe measure: Maximum Observed Serum Concentration (Cmax) of Rocatinlimab measure: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab measure: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Number of Participants Positive to Anti-rocatinlimab Antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fortrea Clinical Research Unit - Daytona Beach status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5116 country: United States lat: 29.21081 lon: -81.02283 facility: Fortrea Clinical Research Unit - Dallas status: RECRUITING city: Dallas state: Texas zip: 75247-4968 country: United States lat: 32.78306 lon: -96.80667 facility: Fortrea Clinical Research Unit Limited - Leeds status: RECRUITING city: Leeds state: LDS zip: LS2 9LH country: United Kingdom lat: 53.79648 lon: -1.54785 hasResults: False
<|newrecord|> nctId: NCT06268847 id: DERMATIDYSS briefTitle: Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms overallStatus: RECRUITING date: 2024-01-09 date: 2024-06-18 date: 2024-06-18 date: 2024-02-20 date: 2024-02-20 name: Abyss Ingredients class: INDUSTRY name: Eurofins briefSummary: This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms. conditions: Atopic Dermatitis conditions: Eczema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Placebo name: ACT01 name: ACT02 measure: SCORAD (SCORing Atopic Dermatitis) measure: EASI (Eczema Area and Severity Index) measure: Investigator Global Assessment scale measure: Corneometer measure: Tewameter measure: Quality of Life Index - Perceived Stress measure: Participant's Satisfaction sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Eurofins status: RECRUITING city: Barcelona zip: 08013 country: Spain name: Jessica Zumaquero role: CONTACT phone: +34 932 85 14 46 phoneExt: 1110 email: JessicaZumaquero@eurofins.com lat: 41.38879 lon: 2.15899 hasResults: False
<|newrecord|> nctId: NCT06268834 id: ZonulinPPI briefTitle: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome overallStatus: COMPLETED date: 2023-10-04 date: 2023-12-31 date: 2023-12-31 date: 2024-02-20 date: 2024-02-20 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels. conditions: Proton Pump Inhibitor Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: PREVENTION masking: NONE count: 75 type: ACTUAL name: Blood for zonulin level was drawn from the group. measure: Zonulin levels in long-term proton pump inhibitor users sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06268821 id: ADC-UK-PMS-23059 briefTitle: Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pihlajalinna Jämsä, Välikatu 1, city: Jämsä zip: 42100 country: Finland name: Henri Honka, MD, PhD role: CONTACT lat: 61.8642 lon: 25.19002 facility: Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1, city: Tampere zip: 33100 country: Finland name: Elina Pimiä, MD role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False
<|newrecord|> nctId: NCT06268808 id: ADC-UK-PMS-23058 briefTitle: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari city: Bari country: Italy name: Francesco Giorgino role: CONTACT lat: 41.11148 lon: 16.8554 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia city: Catania country: Italy name: Lucia Frittitta role: CONTACT lat: 37.49223 lon: 15.07041 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna city: Catania country: Italy name: Salvatore Piro role: CONTACT lat: 37.49223 lon: 15.07041 facility: Azienda Ospedaliera - Università di Padova city: Padova country: Italy name: Gian Paolo Fadini role: CONTACT lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma city: Parma country: Italy name: Riccardo Bonadonna role: CONTACT lat: 44.79935 lon: 10.32618 facility: La Sapienza Università di Roma, AOU Policlinico Umberto I city: Rome country: Italy name: Raffaella Buzzetti role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False
<|newrecord|> nctId: NCT06268795 id: BASE briefTitle: A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study) overallStatus: RECRUITING date: 2024-03-20 date: 2028-09-01 date: 2028-09-01 date: 2024-02-20 date: 2024-04-24 name: Wrightington, Wigan and Leigh NHS Foundation Trust class: OTHER briefSummary: The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI. conditions: Periprosthetic Joint Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 244 type: ESTIMATED measure: Comparison of diagnostic accuracy measure: Culture analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust status: RECRUITING city: Wigan state: Lancashire zip: WN6 9EP country: United Kingdom name: Zaid Z Hamoodi role: CONTACT email: zaid.hamoodi@nhs.net lat: 53.54295 lon: -2.63705 hasResults: False
<|newrecord|> nctId: NCT06268782 id: 1204202118 briefTitle: The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women overallStatus: COMPLETED date: 2021-09-21 date: 2023-01-24 date: 2023-09-19 date: 2024-02-20 date: 2024-02-22 name: University of Turku class: OTHER name: Finnish Cultural Foundation briefSummary: The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023. conditions: Quality of Life conditions: Physical Activity conditions: Urinary Incontinence conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 308 type: ACTUAL name: Rehabilitate your core measure: Quality of Life measure: Physical activity measure: Urinary incontinence measure: Pelvic organ prolapse sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nursing Science, Faculty of Medicine, University of Turku city: Turku zip: 20014 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False
<|newrecord|> nctId: NCT06268769 id: TaC:Drop id: 2023-503531-18-00 type: OTHER domain: EUCT Number briefTitle: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs acronym: TaC:Drop overallStatus: RECRUITING date: 2024-03-09 date: 2026-12 date: 2029-09 date: 2024-02-20 date: 2024-04-08 name: Edward Geissler class: OTHER name: Chiesi Pharmaceuticals GmbH briefSummary: The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit. conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Tacrolimus Pill name: Tacrolimus capsule measure: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) measure: Time to reach the first trough level in target range measure: Proportion of patients with trough levels lower, within, or higher than the target range measure: Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels measure: Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose measure: Tacrolimus concentration/dose (C/D) ratio measure: Intra-patient variability of C/D ratio and daily dose measure: Treatment failure rate measure: Time to treatment failure after transplantation measure: Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection measure: Incidence rate of graft failure measure: Mortality rate measure: Graft function measured by eGFR (estimated glomerular filtration rate) measure: Incidence rate of for-cause biopsies measure: Incidence rate of acute rejection episodes requiring treatment measure: Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection measure: Incidence rate of delayed graft function measure: Incidence rate of primary non-function of the renal allograft measure: Incidence of hepatotoxicity measure: Incidence of CMV and BKV infection (including organ manifestation, if relevant) measure: Incidence, type, severity and seriousness of adverse reactions (ARs) measure: Blood pressure measure: Incidence of de novo tremor measure: Incidence of gastrointestinal disorders requiring diagnostic investigation measure: Incidence of new onset diabetes mellitus after transplantation (NODAT) measure: Recurrence of primary kidney disease measure: Incidence of de novo DSA measure: Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34) measure: Doses and duration of glucocorticosteroid treatment measure: Dose of mycophenolate measure: Incidence and time to study treatment discontinuation measure: Incidence, time to and reason for patient withdrawal from study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care status: NOT_YET_RECRUITING city: Berlin zip: 10117 country: Germany name: Klemens Budde, Prof. Dr. role: CONTACT lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden, Division of Nephrology status: RECRUITING city: Dresden zip: 01307 country: Germany name: Christian Hugo, Prof. Dr. role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology) status: NOT_YET_RECRUITING city: Hamburg zip: 20251 country: Germany name: Malte A. Kluger, PD Dr. role: CONTACT lat: 53.57532 lon: 10.01534 facility: University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology) status: NOT_YET_RECRUITING city: Mainz zip: 55131 country: Germany name: Julia Weinmann-Menke, Prof. Dr. role: CONTACT lat: 49.98419 lon: 8.2791 facility: University Hospital Regensburg, Department of Nephrology status: RECRUITING city: Regensburg zip: 93053 country: Germany name: Edward K. Geissler, PhD role: CONTACT phone: +49 941 944 phoneExt: 6961 email: edward.geissler@ukr.de name: Bernhard Banas, MD, PhD role: CONTACT phone: +49 941 944 phoneExt: 7301 email: bernhard.banas@ukr.de lat: 49.01513 lon: 12.10161 hasResults: False
<|newrecord|> nctId: NCT06268756 id: 2023_RIPH_020_RESANXIEST briefTitle: Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students acronym: RESANXIEST overallStatus: RECRUITING date: 2024-02-07 date: 2024-04-07 date: 2024-06-07 date: 2024-02-20 date: 2024-02-20 name: Université de Reims Champagne-Ardenne class: OTHER briefSummary: Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.
The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.
People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem. conditions: Self-esteem studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Data collection measure: Rosenberg Self-esteem Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ufr Medecine Urca status: RECRUITING city: Reims zip: 51100 country: France name: Coralie Barbe role: CONTACT phone: 326913665 phoneExt: +33 email: coralie.barbe1@univ-reims.fr lat: 49.25 lon: 4.03333 facility: Université de Reims Champagne Ardenne status: RECRUITING city: Reims zip: 51100 country: France name: CURRS CURRS role: CONTACT phone: 0326918822 email: currs@univ-reims.fr lat: 49.25 lon: 4.03333 hasResults: False
<|newrecord|> nctId: NCT06268743 id: 2023-114 briefTitle: Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes acronym: GUTFIT overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-08 date: 2026-08 date: 2024-02-20 date: 2024-03-01 name: University of New Brunswick class: OTHER name: Laval University briefSummary: The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.
Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.
Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group, single blinded, randomized trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: High intensity name: Moderate intensity measure: Glycemic control through glycated hemoglobin measure: Gut microbiome diversity through 16S ribosomal RNA genes sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06268730 id: 23-2437 briefTitle: Effects of SinuSonic on Psychological and Physical Well-Being overallStatus: RECRUITING date: 2024-03-28 date: 2024-07 date: 2024-07 date: 2024-02-20 date: 2024-03-29 name: University of North Carolina, Chapel Hill class: OTHER name: Healthy Humming, LLC briefSummary: The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.
The study aims are:
* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;
* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;
* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.
Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage. conditions: Nasal Congestion and Inflammations conditions: Sinus Congestion Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will follow the same procedures. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: SinuSonic measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Body Perception Questionnaire measure: Change in the Total Nasal Symptom Score measure: Change in the Patient Global Impression of Change measure: Adverse Traumatic Experiences Survey at Baseline measure: Short Form Health Survey (SF-20) at Baseline sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7160 country: United States name: Keri J Heilman, PhD role: CONTACT email: keri_heilman@med.unc.edu name: Keri J Heilman, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<|newrecord|> nctId: NCT06268717 id: 23-0316 briefTitle: GI Alpha-Gal Study overallStatus: RECRUITING date: 2023-10-17 date: 2024-10-17 date: 2025-10-17 date: 2024-02-20 date: 2024-02-20 name: University of North Carolina, Chapel Hill class: OTHER name: Revivicor, Inc briefSummary: This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms. conditions: Alpha-Gal Syndrome conditions: Irritable Bowel Syndrome conditions: Diarrhea conditions: Abdominal Pain conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Ground pork containing alpha-gal name: Pork meat not containing alpha-gal measure: Allergic reaction (food challenge positive) measure: No allergic reaction (food challenge negative) measure: Lactulose excretion measure: C13 mannitol excretion measure: Basophil activation threshold response at timepoint 0 measure: Basophil activation threshold response at 2 hours measure: Basophil activation threshold response at 4 hours measure: Basophil activation threshold response at 6 hours measure: Serum tryptase at timepoint 0 measure: Serum tryptase at 2 hours measure: Serum tryptase at 4 hours measure: Serum tryptase at 6 hours measure: Mast cell count on stomach biopsies (per high powered field (hpf)) measure: Mast cell count on small bowel biopsies (per high powered field (hpf)) measure: Eosinophil cell count on stomach biopsies (per high powered field (hpf)) measure: Eosinophil cell count on small bowel biopsies (per high powered field (hpf)) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Sarah McGill, MD role: CONTACT phone: 919-966-7047 email: mcgills@email.unc.edu name: Sarah McGill, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<|newrecord|> nctId: NCT06268704 id: UNM HRRC #23-503 briefTitle: Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection overallStatus: RECRUITING date: 2024-03-27 date: 2025-01-01 date: 2025-05-01 date: 2024-02-20 date: 2024-03-29 name: University of New Mexico class: OTHER briefSummary: This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain. conditions: Sacroiliac Joint Dysfunction conditions: Sacro-Iliac Spondylosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 230 type: ESTIMATED name: Dexamethasone name: Methylprednisolone name: 2% Lidocaine HCl Injection measure: Pain using Numeric Pain Rating Score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of New Mexico Hospital status: RECRUITING city: Albuquerque state: New Mexico zip: 87131 country: United States name: Mark W Shilling, BS role: CONTACT phone: 505-925-7599 email: mwshilling@salud.unm.edu lat: 35.08449 lon: -106.65114 hasResults: False
<|newrecord|> nctId: NCT06268691 id: ProjectCOLOMBIA-ZMG.U-Freiburg briefTitle: Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating overallStatus: COMPLETED date: 2019-02-04 date: 2019-09-02 date: 2023-07-31 date: 2024-02-20 date: 2024-02-20 name: Rocio Cardenas Sanchez class: OTHER name: Göteborg University name: Instituto Nacional de Salud, Colombia name: Instituto Departamental de Salud de Norte de Santander name: Universidad Francisco de Paula de Santander briefSummary: Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.
The main questions it aims to answer are:
Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.
Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.
The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.
The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.
In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined. conditions: Dengue conditions: Vector Borne Diseases conditions: Arbovirus Infections conditions: Zika conditions: Chikungunya Fever studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings. primaryPurpose: PREVENTION masking: NONE count: 35000 type: ACTUAL name: Insecticide Coating INESFLY measure: Change of dengue incidence for 12 months measure: Change of vector densities estimated through larval and pupal indices. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Departamental de Salud de Norte de Santander city: Cúcuta state: Norte De Santander zip: 540001 country: Colombia lat: 7.89391 lon: -72.50782 facility: Centre for Medicine and Society city: Freiburg state: Baden-Württemberg zip: 79098 country: Germany lat: 47.9959 lon: 7.85222 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: Prot_000.pdf size: 2263350 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: SAP_001.pdf size: 768947 hasResults: False
<|newrecord|> nctId: NCT06268678 id: 4539513 briefTitle: The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis overallStatus: RECRUITING date: 2023-12-08 date: 2025-01-30 date: 2025-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Exeter class: OTHER name: Pvolve briefSummary: The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known. conditions: Menstrual Cycle Phase conditions: Muscle Protein Synthesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised cross-over design. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Phase of the menstrual cycle measure: Muscle protein synthesis measure: Plasma amino acid kinetics measure: Serum insulin concentrations measure: Sex hormone concentrations measure: Energy expenditure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LT country: United Kingdom name: Marianna Apicella role: CONTACT lat: 50.7236 lon: -3.52751 hasResults: False
<|newrecord|> nctId: NCT06268665 id: UCDCC307 briefTitle: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2027-02 date: 2027-06 date: 2024-02-20 date: 2024-02-20 name: Eve Rodler class: OTHER briefSummary: This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.
Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2). conditions: Breast Cancer conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III conditions: Breast Cancer Stage IV conditions: Invasive Breast Cancer conditions: Ovarian Cancer conditions: Ovarian Cancer Stage 1 conditions: Ovarian Cancer Stage II conditions: Ovarian Cancer Stage III conditions: Ovarian Cancer Stage IV conditions: Ovarian Cancer Stage IA conditions: Ovarian Cancer Stage IB conditions: Ovarian Cancer Stage IC conditions: Ovarian Cancer Stage 2 conditions: Ovarian Cancer Stage 3 conditions: Ovarian Cancer Stage IIIb conditions: Ovarian Cancer Stage IIIC conditions: Breast Cancer Stage IIIA conditions: Breast Cancer Invasive conditions: Breast Cancer, Stage IA conditions: Breast Cancer, Stage IB conditions: Breast Cancer Stage IIA conditions: Breast Cancer Stage IIB conditions: Breast Cancer Stage IIIB conditions: Breast Cancer Stage IIIc conditions: Cancer, Breast conditions: Tumors, Breast conditions: Mammary Cancer conditions: Mammary Carcinoma conditions: Breast Carcinoma conditions: Breast Neoplasm conditions: Malignant Breast Neoplasm conditions: Malignant Tumor of Breast conditions: Cancer of Ovary conditions: Ovary Cancer conditions: Ovary Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Tart Cherry Juice measure: Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice. measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Davis Comprehensive Cancer Center city: Sacramento state: California zip: 95827 country: United States name: Eve Rodler, MD role: CONTACT phone: 916-734-5409 email: erodler@ucdavis.edu name: Eve Rodler, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
<|newrecord|> nctId: NCT06268652 id: B2023-686-01 briefTitle: Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer overallStatus: RECRUITING date: 2024-01-15 date: 2026-02-15 date: 2028-01-15 date: 2024-02-20 date: 2024-02-20 name: Sun Yat-sen University class: OTHER briefSummary: This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer. conditions: Breast Cancer conditions: Refractory Breast Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 302 type: ESTIMATED name: Organoid-guided personalized treatment name: Gemcitabine name: Capecitabine name: Vinorelbine name: Eribulin measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Incidence of Treatment-related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yanxia Shi status: RECRUITING city: Guangzhou state: None Selected zip: 510060 country: China name: Yanxia Shi role: CONTACT phone: 020-87343368 email: shiyx@sysucc.org.cn lat: 23.11667 lon: 113.25 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-01-23T03:33 filename: Prot_000.pdf size: 469389 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-12 uploadDate: 2024-01-23T02:42 filename: ICF_001.pdf size: 330483 hasResults: False
<|newrecord|> nctId: NCT06268639 id: ECM#2024-216 id: RGP1/347/44 type: OTHER_GRANT domain: King Khalid University briefTitle: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique acronym: BIDOS overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-30 date: 2024-06-30 date: 2024-02-20 date: 2024-03-15 name: King Khalid University class: OTHER briefSummary: The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration. conditions: Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention. primaryPurpose: TREATMENT masking: NONE maskingDescription: The study employs an open-label design, where no masking is applied. This means that the participants, care providers, investigators, and outcomes assessors are all aware of the intervention being administered. Given the nature of the intervention-osseodensification technique used in dental implant surgery-it is not feasible to blind the study participants or the clinical staff involved in the procedure and assessment to the intervention being studied. The open-label approach allows for direct observation of the intervention's effects on bone density without the complexity of blinding, which is often the case in surgical and procedural interventions where the treatment administered is evident. count: 32 type: ESTIMATED name: Osseodensification measure: Increase in Bone Density at Implant Sites Using Osseodensification Technique sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06268626 id: H22-02426 id: F22-01302 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) id: F21-03695 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) briefTitle: Detection of Endometrial Cancer Through Risk Modelling acronym: DETECTR overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-01 date: 2027-01 date: 2024-02-20 date: 2024-02-20 name: University of British Columbia class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.
This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.
In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Association Between Risk Factor Data and Endometrial Cancer and It's Precursors. measure: Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone. measure: Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia. sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VGH Research Pavilion city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada name: Aline Talhouk, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21365 email: a.talhouk@ubc.ca name: Elise Abi Khalil, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21369 email: elise.abikhalil@ubc.ca name: Aline Talhouk, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False
<|newrecord|> nctId: NCT06268613 id: SB27-1005 briefTitle: A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy overallStatus: RECRUITING date: 2024-01-16 date: 2025-05 date: 2025-12 date: 2024-02-20 date: 2024-04-19 name: Samsung Bioepis Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:
• What the body does to the study drug, which is called "pharmacokinetic"
Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.
Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda. conditions: Non-small Cell Lung Cancer Stage II conditions: Non-small Cell Lung Cancer Stage IIIA studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: SB27 name: EU sourced Keytruda name: US sourced Keytruda measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 measure: Disease-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Investigative Site status: RECRUITING city: Busan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: SB Investigative Site status: RECRUITING city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: SB Investigative Site status: RECRUITING city: Hwasun country: Korea, Republic of lat: 35.06125 lon: 126.98746 facility: SB Investigative Site status: RECRUITING city: Jinju country: Korea, Republic of lat: 35.19278 lon: 128.08472 facility: SB Investigative Site status: RECRUITING city: Seongnam country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: SB Investigative Site status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: SB Investigative Site status: RECRUITING city: Suwon country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: SB Investigative Site status: RECRUITING city: Szczecin country: Poland lat: 53.42894 lon: 14.55302 facility: SB Investigative Site status: RECRUITING city: Leganés state: Madrid country: Spain lat: 40.32718 lon: -3.7635 facility: SB Investigative Site status: RECRUITING city: A Coruña state: Santiago De Compostela country: Spain lat: 43.37135 lon: -8.396 facility: SB Investigative Site status: RECRUITING city: Jaén country: Spain lat: 37.76922 lon: -3.79028 facility: SB Investigative Site status: RECRUITING city: Málaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False
<|newrecord|> nctId: NCT06268600 id: NPC-Thyroid function briefTitle: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2019-01-01 date: 2024-11-30 date: 2025-11-30 date: 2024-02-20 date: 2024-04-11 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area. conditions: Nasopharyngeal Carcinoma conditions: Nasopharyngeal Cancer conditions: Hypothyroidism studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Modified neck target volume delineation measure: Regional Recurrence-free Survival measure: Radiation-induced hypothyroidism measure: Overall Survival measure: Progression-free Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital status: RECRUITING city: Nanchang state: None Selected zip: 330029 country: China name: Tianzhu Lu role: CONTACT phone: 8615270186250 email: lutianzhu2008@163.com role: CONTACT phoneExt: Li email: lijingao@hotmail.com name: Jingao Li, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaochang Gong, PhD role: SUB_INVESTIGATOR lat: 28.68396 lon: 115.85306 hasResults: False
<|newrecord|> nctId: NCT06268587 id: 2023/80 briefTitle: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery overallStatus: COMPLETED date: 2019-09-01 date: 2022-02-28 date: 2022-02-28 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Liege class: OTHER briefSummary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:
- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.
The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain. conditions: Postoperative Pain conditions: Outpatient Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1423 type: ACTUAL name: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &amp;gt; 3/10 on day one and who did not take analgesics. measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics. measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Liège city: Liège state: Wallonie zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False
<|newrecord|> nctId: NCT06268574 id: RIVER-52 briefTitle: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML acronym: RIVER-52 overallStatus: RECRUITING date: 2024-01-23 date: 2026-02 date: 2026-09 date: 2024-02-20 date: 2024-02-20 name: Ryvu Therapeutics SA class: INDUSTRY briefSummary: The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients. conditions: Acute Myeloid Leukemia (AML) conditions: High-risk Myelodysplastic Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: RVU120 measure: Complete Remission (CR), with and without measurable residual disease (MRD) measure: Overall response rate measure: Duration of response measure: Progression-free survival measure: Overall survival measure: Incidence of Adverse Events (Safety and Tolerability) measure: Percentage of participants bridged to hematopoietic stem cell transplantation measure: Maximum Plasma Concentration (Cmax) measure: Maximum Plasma Concentration (Tmax) measure: Area Under the Concentration Time-Curve (AUC) measure: Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO) measure: Impact of treatment on health-related quality of life (QOL-E) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MTZ Clinical Research status: RECRUITING city: Warszawa state: Mazowieckie Województwo zip: 02-172 country: Poland name: Krzysztof Mądry role: CONTACT phone: +48 22 572 59 59 email: info@pratia.com name: Krzysztof Mądry, MD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: MICS Centrum Medyczne Toruń status: RECRUITING city: Toruń zip: 87-100 country: Poland name: Dominik Chraniuk role: CONTACT phone: +48 56 300 43 email: d.chraniuk@naszlekarz.pl name: Dominik Chraniuk, MD role: PRINCIPAL_INVESTIGATOR lat: 53.01375 lon: 18.59814 hasResults: False
<|newrecord|> nctId: NCT06268561 id: IRBN852023/CHUSTE briefTitle: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months overallStatus: RECRUITING date: 2023-06-05 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient. conditions: Endophthalmitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ESTIMATED name: Visual acuity analysis name: Intraocular pressure analysis name: Analysis of optical coherence tomography (OCT) images name: Analysis of retinograms measure: Visual acuity measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation measure: Tomography measure: Resumption of intravitreal therapy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Saint Etienne status: RECRUITING city: Saint-Étienne zip: 42000 country: France name: Thibaud GARCIN, MD PhD role: CONTACT phone: (0)477829662 phoneExt: +33 email: thibaud.garcin@chu-st-etienne.fr name: Thibaud GARCIN, MD PhD role: PRINCIPAL_INVESTIGATOR name: Henri PITEAU, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
<|newrecord|> nctId: NCT06268548 id: P.T.REC/012/004790 briefTitle: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease overallStatus: RECRUITING date: 2023-09-15 date: 2024-02-20 date: 2024-02-27 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease conditions: Diaphragm Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Manual diaphragmatic activation measure: Diaphragm Excursion sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of physical therapy status: RECRUITING city: Giza zip: 12613 country: Egypt name: Nesreen Ghareb Mohamed, Professor role: CONTACT phone: 01002227242 email: nesreen.elnahas@pt.cu.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False
<|newrecord|> nctId: NCT06268535 id: CaenUH_DL_1 briefTitle: Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis overallStatus: COMPLETED date: 2022-04-01 date: 2022-05-31 date: 2022-05-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Caen class: OTHER briefSummary: Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.
Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.
Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.
The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.
Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs. conditions: Heart Failure conditions: Cancer, Therapy-Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3406383 type: ACTUAL name: Cancer therapy with FDA and/or EMA approval on the 31st March 2022 measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed measure: Description of the drug-drug interactions associated with adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Caen University Hospital city: Caen country: France lat: 49.18585 lon: -0.35912 hasResults: False
<|newrecord|> nctId: NCT06268522 id: 2023P001582 briefTitle: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study) overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Brigham and Women's Hospital class: OTHER briefSummary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Behavioral primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness-Oriented Recovery Enhancement: (MORE) group name: Psychoeducation measure: Pain Interference measure: Opioid Dose measure: Pain Intensity measure: Opioid Misuse measure: Opioid Withdrawal measure: Opioid Craving sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Chestnut Hill state: Massachusetts zip: 02467 country: United States name: Marie Curiel role: CONTACT phone: 617-732-9578 email: MCURIEL@mgh.harvard.edu name: Asimina Lazaridou, PhD role: PRINCIPAL_INVESTIGATOR name: Robert Edwards, PhD role: SUB_INVESTIGATOR lat: 42.33065 lon: -71.16616 hasResults: False
<|newrecord|> nctId: NCT06268509 id: MONAS briefTitle: Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta acronym: MONAS overallStatus: RECRUITING date: 2023-04-01 date: 2024-06 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Dr Cipto Mangunkusumo General Hospital class: OTHER name: Dinas Kesehatan DKI Jakarta name: Fakultas Kedokteran Universitas Indonesia briefSummary: The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:
1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?
Participants in the intervention group will receive:
* Fetomaternal ultrasound examination each trimester