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* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
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* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.
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Participants will perform:
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* walking tests inside parallel bars on flat and/or inclined terrain;
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* walking tests on treadmill;
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* stair climbing/descent tests. conditions: Amputation conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 4 type: ACTUAL name: WRL ATP measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Don Carlo Gnocchi city: Firenze state: FI zip: 50143 country: Italy lat: 43.77925 lon: 11.24626 hasResults: False
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<|newrecord|> nctId: NCT06283992 id: 2024p000095 id: K23MD016439 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016439 briefTitle: Digital Health Navigation for Latino Patients With Type II Diabetes overallStatus: RECRUITING date: 2024-03-31 date: 2026-05-31 date: 2027-05-31 date: 2024-02-28 date: 2024-03-28 name: Brigham and Women's Hospital class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Digital Navigation measure: Proportion of Participants Who Login to the Portal measure: Proportion of Participants that Perform Distinct Portal Functions measure: Proportion of participants that complete a telehealth measure: Proportion of participants that are re-admitted sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02120 country: United States name: Jorge A Rodriguez, MD role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06283979 id: 199723 briefTitle: A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. acronym: BLADE OPU2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-02-29 name: Biocomposites Ltd class: INDUSTRY name: MCRA briefSummary: The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers. conditions: Pressure Ulcer, Stage IV conditions: Osteomyelitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: STIMULAN VG name: Standard of Care measure: Individual patient success and findings at the 8 week follow-up visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283966 id: D5989C00001 briefTitle: A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease acronym: THARROS overallStatus: RECRUITING date: 2024-02-21 date: 2028-03-06 date: 2028-03-06 date: 2024-02-28 date: 2024-03-12 name: AstraZeneca class: INDUSTRY briefSummary: This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk. conditions: COPD (Chronic Obstructive Pulmonary Disease) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 5000 type: ESTIMATED name: BGF MDI 320/14.4/9.6 μg name: GFF MDI 14.4/9.6 μg measure: Time to first severe cardiac or COPD event measure: Time to first severe COPD exacerbation event measure: Time to first severe cardiac event measure: Time to cardiopulmonary death measure: Moderate/severe COPD exacerbation rate measure: Time to Myocardial Infarction (MI) hospitalization or cardiac death measure: Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death measure: Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Athens state: Alabama zip: 35611 country: United States lat: 34.80243 lon: -86.97219 facility: Research Site status: NOT_YET_RECRUITING city: Cullman state: Alabama zip: 35058 country: United States lat: 34.17482 lon: -86.84361 facility: Research Site status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Huntsville state: Alabama zip: 35801 country: United States lat: 34.7304 lon: -86.58594 facility: Research Site status: NOT_YET_RECRUITING city: Mobile state: Alabama zip: 36608 country: United States lat: 30.69436 lon: -88.04305 facility: Research Site status: NOT_YET_RECRUITING city: Sheffield state: Alabama zip: 35660 country: United States lat: 34.76509 lon: -87.69864 facility: Research Site status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85296 country: United States lat: 33.35283 lon: -111.78903 facility: Research Site status: NOT_YET_RECRUITING city: Glendale state: Arizona zip: 85308 country: United States lat: 33.53865 lon: -112.18599 facility: Research Site status: RECRUITING city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Mesa state: Arizona zip: 85213 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Research Site status: NOT_YET_RECRUITING city: Apple Valley state: California zip: 92307 country: United States lat: 34.50083 lon: -117.18588 facility: Research Site status: NOT_YET_RECRUITING city: Banning state: California zip: 92220 country: United States lat: 33.92557 lon: -116.87641 facility: Research Site status: NOT_YET_RECRUITING city: Canoga Park state: California zip: 91303 country: United States lat: 34.20112 lon: -118.59814 facility: Research Site status: NOT_YET_RECRUITING city: Garden Grove state: California zip: 92844 country: United States lat: 33.77391 lon: -117.94145 facility: Research Site status: NOT_YET_RECRUITING city: Gardena state: California zip: 90247 country: United States lat: 33.88835 lon: -118.30896 facility: Research Site status: NOT_YET_RECRUITING city: Inglewood state: California zip: 90301 country: United States lat: 33.96168 lon: -118.35313 facility: Research Site status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: Research Site status: NOT_YET_RECRUITING city: La Palma state: California zip: 90623 country: United States lat: 33.8464 lon: -118.04673 facility: Research Site status: NOT_YET_RECRUITING city: Lomita state: California zip: 90717 country: United States lat: 33.79224 lon: -118.31507 facility: Research Site status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Research Site status: NOT_YET_RECRUITING city: Newport Beach state: California zip: 92660 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: NOT_YET_RECRUITING city: North Hollywood state: California zip: 91602 country: United States lat: 34.17223 lon: -118.37897 facility: Research Site status: NOT_YET_RECRUITING city: Panorama City state: California zip: 91402 country: United States lat: 34.22473 lon: -118.44981 facility: Research Site status: NOT_YET_RECRUITING city: Pomona state: California zip: 91768 country: United States lat: 34.05529 lon: -117.75228 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95831 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Salinas state: California zip: 93901 country: United States lat: 36.67774 lon: -121.6555 facility: Research Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92111 country: United States lat: 32.71533 lon: -117.15726 facility: Research Site status: NOT_YET_RECRUITING city: San Dimas state: California zip: 91773 country: United States lat: 34.10668 lon: -117.80673 facility: Research Site status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92704 country: United States lat: 33.74557 lon: -117.86783 facility: Research Site status: NOT_YET_RECRUITING city: Tarzana state: California zip: 91356 country: United States lat: 34.17334 lon: -118.55397 facility: Research Site status: NOT_YET_RECRUITING city: Thousand Oaks state: California zip: 91360 country: United States lat: 34.17056 lon: -118.83759 facility: Research Site status: NOT_YET_RECRUITING city: Vista state: California zip: 92081 country: United States lat: 33.20004 lon: -117.24254 facility: Research Site status: NOT_YET_RECRUITING city: Westminster state: California zip: 92683 country: United States lat: 33.75918 lon: -118.00673 facility: Research Site status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80012 country: United States lat: 39.72943 lon: -104.83192 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80224 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80228 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20016 country: United States lat: 38.89511 lon: -77.03637 facility: Research Site status: NOT_YET_RECRUITING city: Boynton Beach state: Florida zip: 33435 country: United States lat: 26.52535 lon: -80.06643 facility: Research Site status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34208 country: United States lat: 27.49893 lon: -82.57482 facility: Research Site status: NOT_YET_RECRUITING city: Cape Coral state: Florida zip: 33990 country: United States lat: 26.56285 lon: -81.94953 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33765 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Research Site status: NOT_YET_RECRUITING city: Cutler Bay state: Florida zip: 33189 country: United States lat: 25.5783 lon: -80.3377 facility: Research Site status: NOT_YET_RECRUITING city: Edgewater state: Florida zip: 32132 country: United States lat: 28.98888 lon: -80.90228 facility: Research Site status: NOT_YET_RECRUITING city: Fort Lauderdale state: Florida zip: 33308 country: United States lat: 26.12231 lon: -80.14338 facility: Research Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 country: United States lat: 26.62168 lon: -81.84059 facility: Research Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33013 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site status: NOT_YET_RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34741 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34746 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Lake City state: Florida zip: 32055 country: United States lat: 30.18968 lon: -82.63929 facility: Research Site status: NOT_YET_RECRUITING city: Lake Worth state: Florida zip: 33467 country: United States lat: 26.61708 lon: -80.07231 facility: Research Site status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33813 country: United States lat: 28.03947 lon: -81.9498 facility: Research Site status: NOT_YET_RECRUITING city: Loxahatchee Groves state: Florida zip: 33470 country: United States lat: 26.68368 lon: -80.27977 facility: Research Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: RECRUITING city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33256 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34102 country: United States lat: 26.14234 lon: -81.79596 facility: Research Site status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32819 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32825 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Ormond Beach state: Florida zip: 32174 country: United States lat: 29.28581 lon: -81.05589 facility: Research Site status: NOT_YET_RECRUITING city: Pembroke Pines state: Florida zip: 33024 country: United States lat: 26.00315 lon: -80.22394 facility: Research Site status: NOT_YET_RECRUITING city: Plantation state: Florida zip: 33324 country: United States lat: 26.13421 lon: -80.23184 facility: Research Site status: NOT_YET_RECRUITING city: Saint Petersburg state: Florida zip: 33713 country: United States lat: 27.77086 lon: -82.67927 facility: Research Site status: NOT_YET_RECRUITING city: Sun City Center state: Florida zip: 33573 country: United States lat: 27.71809 lon: -82.35176 facility: Research Site status: NOT_YET_RECRUITING city: Tamarac state: Florida zip: 33321 country: United States lat: 26.21286 lon: -80.24977 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33625 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30349 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: NOT_YET_RECRUITING city: Buford state: Georgia zip: 30519 country: United States lat: 34.12066 lon: -84.00435 facility: Research Site status: NOT_YET_RECRUITING city: Peachtree Corners state: Georgia zip: 30092 country: United States lat: 33.9701 lon: -84.22159 facility: Research Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Research Site status: NOT_YET_RECRUITING city: Boise state: Idaho zip: 83706 country: United States lat: 43.6135 lon: -116.20345 facility: Research Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Research Site status: NOT_YET_RECRUITING city: Winfield state: Illinois zip: 60190 country: United States lat: 41.8617 lon: -88.1609 facility: Research Site status: NOT_YET_RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States lat: 41.47309 lon: -87.06114 facility: Research Site status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Research Site status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67218 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40503 country: United States lat: 37.98869 lon: -84.47772 facility: Research Site status: NOT_YET_RECRUITING city: Paducah state: Kentucky zip: 42001 country: United States lat: 37.08339 lon: -88.60005 facility: Research Site status: NOT_YET_RECRUITING city: Lafayette state: Louisiana zip: 70508 country: United States lat: 30.22409 lon: -92.01984 facility: Research Site status: NOT_YET_RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States lat: 32.50931 lon: -92.1193 facility: Research Site status: RECRUITING city: Shreveport state: Louisiana zip: 71105 country: United States lat: 32.52515 lon: -93.75018 facility: Research Site status: NOT_YET_RECRUITING city: Zachary state: Louisiana zip: 70791 country: United States lat: 30.64852 lon: -91.1565 facility: Research Site status: NOT_YET_RECRUITING city: Oxon Hill state: Maryland zip: 20745 country: United States lat: 38.80345 lon: -76.9897 facility: Research Site status: NOT_YET_RECRUITING city: Potomac state: Maryland zip: 20854 country: United States lat: 39.01817 lon: -77.20859 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 facility: Research Site status: NOT_YET_RECRUITING city: Lathrup Village state: Michigan zip: 48076 country: United States lat: 42.49642 lon: -83.22271 facility: Research Site status: NOT_YET_RECRUITING city: Southfield state: Michigan zip: 48034 country: United States lat: 42.47337 lon: -83.22187 facility: Research Site status: RECRUITING city: Gulfport state: Mississippi zip: 39503 country: United States lat: 30.36742 lon: -89.09282 facility: Research Site status: NOT_YET_RECRUITING city: Olive Branch state: Mississippi zip: 38654 country: United States lat: 34.96176 lon: -89.82953 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64116 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Liberty state: Missouri zip: 64068 country: United States lat: 39.24611 lon: -94.41912 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: RECRUITING city: Missoula state: Montana zip: 59808 country: United States lat: 46.87215 lon: -113.994 facility: Research Site status: NOT_YET_RECRUITING city: Fremont state: Nebraska zip: 68025 country: United States lat: 41.43333 lon: -96.49808 facility: Research Site status: NOT_YET_RECRUITING city: Grand Island state: Nebraska zip: 68803 country: United States lat: 40.92501 lon: -98.34201 facility: Research Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89101 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89119 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Lawrence Township state: New Jersey zip: 08648 country: United States lat: 40.29588 lon: -74.72009 facility: Research Site status: NOT_YET_RECRUITING city: Mullica Hill state: New Jersey zip: 08062 country: United States lat: 39.73928 lon: -75.22407 facility: Research Site status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States lat: 39.95373 lon: -74.19792 facility: Research Site status: WITHDRAWN city: Union City state: New Jersey zip: 07087 country: United States lat: 40.77955 lon: -74.02375 facility: Research Site status: WITHDRAWN city: Albuquerque state: New Mexico zip: 87109 country: United States lat: 35.08449 lon: -106.65114 facility: Research Site status: NOT_YET_RECRUITING city: Albany state: New York zip: 12205 country: United States lat: 42.65258 lon: -73.75623 facility: Research Site status: NOT_YET_RECRUITING city: Bronxville state: New York zip: 10708 country: United States lat: 40.93815 lon: -73.83208 facility: Research Site status: RECRUITING city: Bronx state: New York zip: 10455 country: United States lat: 40.84985 lon: -73.86641 facility: Research Site status: NOT_YET_RECRUITING city: Massapequa state: New York zip: 11758 country: United States lat: 40.68066 lon: -73.47429 facility: Research Site status: NOT_YET_RECRUITING city: New Windsor state: New York zip: 12553 country: United States lat: 41.47676 lon: -74.02375 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10036 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: Research Site status: NOT_YET_RECRUITING city: Fayetteville state: North Carolina zip: 28303 country: United States lat: 35.05266 lon: -78.87836 facility: Research Site status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: Research Site status: NOT_YET_RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Research Site status: NOT_YET_RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Research Site status: NOT_YET_RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States lat: 34.72294 lon: -76.72604 facility: Research Site status: NOT_YET_RECRUITING city: Raleigh state: North Carolina zip: 27612 country: United States lat: 35.7721 lon: -78.63861 facility: Research Site status: NOT_YET_RECRUITING city: Salisbury state: North Carolina zip: 28144 country: United States lat: 35.67097 lon: -80.47423 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28677 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Beavercreek state: Ohio zip: 45431 country: United States lat: 39.70923 lon: -84.06327 facility: Research Site status: NOT_YET_RECRUITING city: Blue Ash state: Ohio zip: 45242 country: United States lat: 39.232 lon: -84.37827 facility: Research Site status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44130 country: United States lat: 41.4995 lon: -81.69541 facility: Research Site status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43235 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Marion state: Ohio zip: 43302 country: United States lat: 40.58867 lon: -83.12852 facility: Research Site status: NOT_YET_RECRUITING city: Toledo state: Ohio zip: 43617 country: United States lat: 41.66394 lon: -83.55521 facility: Research Site status: NOT_YET_RECRUITING city: Norman state: Oklahoma zip: 73071 country: United States lat: 35.22257 lon: -97.43948 facility: Research Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73134 country: United States lat: 35.46756 lon: -97.51643 facility: Research Site status: NOT_YET_RECRUITING city: Tulsa state: Oklahoma zip: 74133 country: United States lat: 36.15398 lon: -95.99277 facility: Research Site status: NOT_YET_RECRUITING city: Grants Pass state: Oregon zip: 97527 country: United States lat: 42.43933 lon: -123.33067 facility: Research Site status: NOT_YET_RECRUITING city: Medford state: Oregon zip: 97504 country: United States lat: 42.32652 lon: -122.87559 facility: Research Site status: NOT_YET_RECRUITING city: Roseburg state: Oregon zip: 97471 country: United States lat: 43.2165 lon: -123.34174 facility: Research Site status: NOT_YET_RECRUITING city: Camp Hill state: Pennsylvania zip: 17011 country: United States lat: 40.23981 lon: -76.91997 facility: Research Site status: NOT_YET_RECRUITING city: DuBois state: Pennsylvania zip: 15801 country: United States lat: 41.11923 lon: -78.76003 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19140 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: RECRUITING city: Anderson state: South Carolina zip: 29621 country: United States lat: 34.50344 lon: -82.65013 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29414 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: South Carolina zip: 29201 country: United States lat: 34.00071 lon: -81.03481 facility: Research Site status: RECRUITING city: Gaffney state: South Carolina zip: 29340 country: United States lat: 35.07179 lon: -81.64982 facility: Research Site status: NOT_YET_RECRUITING city: Spartanburg state: South Carolina zip: 29303 country: United States lat: 34.94957 lon: -81.93205 facility: Research Site status: RECRUITING city: Union state: South Carolina zip: 29379 country: United States lat: 34.71541 lon: -81.62371 facility: Research Site status: NOT_YET_RECRUITING city: North Sioux City state: South Dakota zip: 57049 country: United States lat: 42.52722 lon: -96.48309 facility: Research Site status: NOT_YET_RECRUITING city: Rapid City state: South Dakota zip: 57701 country: United States lat: 44.08054 lon: -103.23101 facility: Research Site status: NOT_YET_RECRUITING city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 facility: Research Site status: NOT_YET_RECRUITING city: Elizabethton state: Tennessee zip: 37643 country: United States lat: 36.34872 lon: -82.21069 facility: Research Site status: NOT_YET_RECRUITING city: Franklin state: Tennessee zip: 37067 country: United States lat: 35.92506 lon: -86.86889 facility: Research Site status: NOT_YET_RECRUITING city: Morristown state: Tennessee zip: 37813 country: United States lat: 36.21398 lon: -83.29489 facility: Research Site status: RECRUITING city: Tullahoma state: Tennessee zip: 37388 country: United States lat: 35.36202 lon: -86.20943 facility: Research Site status: NOT_YET_RECRUITING 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state: Texas zip: 79902 country: United States lat: 31.75872 lon: -106.48693 facility: Research Site status: NOT_YET_RECRUITING city: Forney state: Texas zip: 75126 country: United States lat: 32.74818 lon: -96.47193 facility: Research Site status: NOT_YET_RECRUITING city: Georgetown state: Texas zip: 78633 country: United States lat: 30.63269 lon: -97.67723 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77002 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77024 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77025 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77029 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77084 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77089 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77207 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Katy state: Texas zip: 77450 country: United States lat: 29.78579 lon: -95.8244 facility: Research Site status: NOT_YET_RECRUITING city: Katy state: Texas zip: 77493 country: United States lat: 29.78579 lon: -95.8244 facility: Research Site status: NOT_YET_RECRUITING city: Kerrville state: Texas zip: 78028 country: United States lat: 30.04743 lon: -99.14032 facility: Research Site status: NOT_YET_RECRUITING city: Kingwood state: Texas zip: 77339 country: United States lat: 30.03355 lon: -95.26104 facility: Research Site status: NOT_YET_RECRUITING city: Lewisville state: Texas zip: 75057 country: United States lat: 33.04623 lon: -96.99417 facility: Research Site status: NOT_YET_RECRUITING city: McAllen state: Texas zip: 78504 country: United States lat: 26.20341 lon: -98.23001 facility: Research Site status: NOT_YET_RECRUITING city: McKinney state: Texas zip: 75069 country: United States lat: 33.19762 lon: -96.61527 facility: Research Site status: NOT_YET_RECRUITING city: Paris state: Texas zip: 75462 country: United States lat: 33.66094 lon: -95.55551 facility: Research Site status: NOT_YET_RECRUITING city: Plano state: Texas zip: 75024 country: United States lat: 33.01984 lon: -96.69889 facility: Research Site status: NOT_YET_RECRUITING city: Waco state: Texas zip: 76708 country: United States 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123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Shenyang zip: 110083 country: China lat: 41.79222 lon: 123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Shijiazhuang zip: 50051 country: China lat: 38.04139 lon: 114.47861 facility: Research Site status: NOT_YET_RECRUITING city: Siping zip: 136000 country: China lat: 43.16143 lon: 124.37785 facility: Research Site status: NOT_YET_RECRUITING city: Taicang zip: 215400 country: China facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030001 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030012 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030032 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taizhou zip: 318000 country: China lat: 32.49069 lon: 119.90812 facility: Research Site status: 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zip: 750001 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Zhengzhou zip: 450006 country: China lat: 34.75778 lon: 113.64861 facility: Research Site status: NOT_YET_RECRUITING city: Barranquilla zip: 080020 country: Colombia lat: 10.96854 lon: -74.78132 facility: Research Site status: NOT_YET_RECRUITING city: Bogota zip: 111411 country: Colombia lat: 4.60971 lon: -74.08175 facility: Research Site status: NOT_YET_RECRUITING city: Medellin zip: 050025 country: Colombia lat: 6.25184 lon: -75.56359 facility: Research Site status: NOT_YET_RECRUITING city: Medellin zip: 050030 country: Colombia lat: 6.25184 lon: -75.56359 facility: Research Site status: NOT_YET_RECRUITING city: Rionegro zip: 054047 country: Colombia lat: 6.15515 lon: -75.37371 facility: Research Site status: NOT_YET_RECRUITING city: Brandys nad Labem zip: 250 01 country: Czechia lat: 50.18356 lon: 14.67244 facility: Research Site status: NOT_YET_RECRUITING city: Olomouc zip: 772 00 country: Czechia lat: 49.59552 lon: 17.25175 facility: Research Site status: NOT_YET_RECRUITING city: Ostrava zip: 702 00 country: Czechia lat: 49.83465 lon: 18.28204 facility: Research Site status: NOT_YET_RECRUITING city: Praha 1 zip: 110 00 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Rokycany zip: 337 22 country: Czechia lat: 49.7427 lon: 13.59459 facility: Research Site status: NOT_YET_RECRUITING city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 facility: Research Site status: NOT_YET_RECRUITING city: Esbjerg zip: 6700 country: Denmark lat: 55.47028 lon: 8.45187 facility: Research Site status: NOT_YET_RECRUITING city: Hvidovre zip: 2650 country: Denmark lat: 55.65719 lon: 12.47364 facility: Research Site status: NOT_YET_RECRUITING city: København NV zip: 2400 country: Denmark 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zip: 29680 country: France lat: 48.72381 lon: -3.98709 facility: Research Site status: NOT_YET_RECRUITING city: Vandoeuvre-Les-Nancy Cedex zip: 54511 country: France lat: 48.65 lon: 6.18333 facility: Research Site status: NOT_YET_RECRUITING city: VANNES cedex zip: 56017 country: France lat: 47.66667 lon: -2.75 facility: Research Site status: NOT_YET_RECRUITING city: Augsburg zip: 86150 country: Germany lat: 48.37154 lon: 10.89851 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10625 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10787 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10969 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12157 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12159 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12203 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12627 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 13187 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Bremen zip: 28215 country: Germany lat: 53.07516 lon: 8.80777 facility: Research Site status: NOT_YET_RECRUITING city: Bremen zip: 28259 country: Germany lat: 53.07516 lon: 8.80777 facility: Research Site status: NOT_YET_RECRUITING city: Cottbus zip: 03050 country: Germany lat: 51.75769 lon: 14.32888 facility: Research Site status: NOT_YET_RECRUITING city: Dachau zip: 85221 country: Germany lat: 48.26 lon: 11.43402 facility: Research Site status: NOT_YET_RECRUITING city: Darmstadt zip: 64283 country: Germany lat: 49.87167 lon: 8.65027 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47.31667 lon: 21.11667 facility: Research Site status: NOT_YET_RECRUITING city: Szolnok zip: 5000 country: Hungary lat: 47.18333 lon: 20.2 facility: Research Site status: NOT_YET_RECRUITING city: Százhalombatta zip: 2440 country: Hungary lat: 47.32579 lon: 18.92141 facility: Research Site status: NOT_YET_RECRUITING city: Székesfehérvár zip: 8000 country: Hungary lat: 47.18995 lon: 18.41034 facility: Research Site status: NOT_YET_RECRUITING city: Tapolca zip: 8300 country: Hungary lat: 46.88152 lon: 17.44117 facility: Research Site status: NOT_YET_RECRUITING city: Aligarh zip: 202002 country: India lat: 27.88145 lon: 78.07464 facility: Research Site status: NOT_YET_RECRUITING city: Belagavi zip: 590010 country: India facility: Research Site status: NOT_YET_RECRUITING city: Dehradun zip: 248001 country: India lat: 30.32295 lon: 78.03168 facility: Research Site status: NOT_YET_RECRUITING city: Delhi zip: 110029 country: India lat: 28.65195 lon: 77.23149 facility: Research Site status: 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<|newrecord|> nctId: NCT06283953 id: 2023P001695 id: IHS-2022C1-26100 type: OTHER_GRANT domain: Patient Centered Outcomes Research Institute (PCORI) briefTitle: Boosting Resources for Tracheostomy Care at Home acronym: BREATHE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2027-10-01 date: 2024-02-28 date: 2024-02-28 name: Massachusetts General Hospital class: OTHER name: Children's Hospital Medical Center, Cincinnati name: Children's Hospital of Philadelphia name: Children's Hospitals and Clinics of Minnesota name: Children's National Research Institute name: Rady Children's Hospital, San Diego name: Patient-Centered Outcomes Research Institute briefSummary: The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:
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* How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
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* How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
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Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm. conditions: Tracheostomy conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study.
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The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment. whoMasked: OUTCOMES_ASSESSOR count: 480 type: ESTIMATED name: Trach@Home name: Trach Me Home measure: Caregiver Burden measure: Medical Complications Associated with Tracheostomy measure: 6-month Readmission Rate measure: Frequency of pediatrician communication measure: Primary care pediatrician satisfaction measure: Medical Complications Associated with Tracheostomy measure: Caregiver Burden measure: Number of readmissions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of San Diego Rady Children's Hospital city: La Jolla state: California zip: 92093 country: United States name: Matthew Brigger, MD role: CONTACT email: mbrigger@rchsd.org name: Matthew Brigger, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Children's National Medical Center, Children's Research Institute city: Silver Spring state: Maryland zip: 20910 country: United States name: Habib Zalzal, MD role: CONTACT email: hzalzal@cnmc.org name: Habib Zalzal, MD role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Karen Sepucha, PhD role: CONTACT email: ksepucha@mgh.harvard.edu name: Christopher Hartnick, MD role: CONTACT lat: 42.35843 lon: -71.05977 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States name: Asitha Jayawardena, MD role: CONTACT email: asitha.jayawardena@childrensmn.org name: Asitha Jayawardena, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States name: Matthew Smith, MD role: CONTACT email: matthew.smith@cchmc.org name: Matthew Smith, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19146 country: United States name: Luv Javia, MD role: CONTACT email: javia@chop.edu name: Luv Javia, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06283940 id: 281694 briefTitle: Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation acronym: TAVI overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01 date: 2026-01 date: 2024-02-28 date: 2024-04-24 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.
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Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.
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Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life. conditions: Aortic Valve Stenosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group and matched controls based on age, gender and exercise capacity in watt. primaryPurpose: TREATMENT masking: NONE maskingDescription: Data collection will be conducted by a physiotherapist not involved in the intervention. count: 135 type: ESTIMATED name: Physiotherapist-led exercise based cardiac rehabilitation (PT-X) measure: Exercise capacity in watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Exercise capacity in Watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Muscular endurance test, shoulder flexion measure: Muscular endurance test, shoulder flexion measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, unilateral heel-lift measure: Muscle endurance test, unilateral heel-lift measure: Lower extremity function measure: Lower extremity function measure: Physical activity measure: Physical activity measure: Self-assessed level of physical activity measure: Self-assessed level of physical activity measure: Health Related Quality of Life measure: Health Related Quality of Life measure: Frailty measure: Frailty measure: Hospital admission measure: Hospital admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283927 id: MEC-2020-0812-5 briefTitle: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) acronym: RECSUR overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-28 date: 2024-02-28 name: Jasper Gerritsen class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.
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This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
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The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. conditions: Glioblastoma conditions: Glioblastoma Multiforme conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma Multiforme of Brain conditions: Glioblastoma Multiforme, Adult conditions: Recurrent Glioblastoma conditions: Astrocytoma, Malignant conditions: Astrocytoma of Brain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 464 type: ESTIMATED name: Re-resection name: Temozolomide name: Lomustine name: Re-irradiation name: Experimental therapy name: Best supportive care measure: Overall survival measure: Neurological morbidity at 6 weeks measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Progression-free survival measure: Residual tumor volume measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) measure: Serious Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: University Hospital Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, Dr. med. role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 CE country: Netherlands name: Arnaud Vincent, MD PhD role: CONTACT phone: +31639428949 email: a.vincent@erasmusmc.nl name: Jasper Gerritsen, MD role: CONTACT phone: +31629119553 email: j.gerritsen@erasmusmc.nl lat: 51.9225 lon: 4.47917 facility: Medical Center Haaglanden status: RECRUITING city: The Hague state: Zuid-Holland zip: 2261 CP country: Netherlands name: Marike Broekman, MD PhD role: CONTACT phone: +31639758253 email: m.broekman@haaglandenmc.nl lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06283914 id: BIO-2024-0011 briefTitle: Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-09-01 date: 2024-02-28 date: 2024-02-28 name: American University of Beirut Medical Center class: OTHER briefSummary: The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.
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The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age \>18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded. conditions: Oxygen Saturation conditions: Respiratory Distress Syndrome conditions: Anesthesia, General studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: PaO2 measure: SpO2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283901 id: NL82013.018.22 briefTitle: Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness acronym: IMPROVE-DOC overallStatus: RECRUITING date: 2023-01-02 date: 2025-01-01 date: 2025-09-01 date: 2024-02-28 date: 2024-02-28 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome. conditions: Traumatic Brain Injury conditions: Intracranial Hemorrhages conditions: Subarachnoid Hemorrhage conditions: Meningitis conditions: Encephalitis conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Glasgow Outcome Scale Extended measure: Glasgow Outcome Scale Extended sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Astrid Hoedemaekers role: CONTACT lat: 51.8425 lon: 5.85278 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105 AZ country: Netherlands name: Wolmet Haksteen, MD role: CONTACT phone: +31 020 - 566 9111 email: w.e.haksteen@amsterdamumc.nl lat: 52.37403 lon: 4.88969 facility: Haaglanden MC, locatie Westeinde status: RECRUITING city: Den Haag state: Zuid-Holland zip: 2512 VA country: Netherlands name: Sefanja Achterberg role: CONTACT lat: 52.07667 lon: 4.29861 facility: Erasmus MC status: NOT_YET_RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Mathieu van der Jagt role: CONTACT lat: 51.9225 lon: 4.47917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands name: Joukje van der Naalt role: CONTACT lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06283888 id: PRECISE-PCI briefTitle: CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention overallStatus: RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-12-01 date: 2024-02-28 date: 2024-03-20 name: Zunyi Medical College class: OTHER briefSummary: In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice. conditions: ACS - Acute Coronary Syndrome conditions: CYP2C19 Polymorphism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: CYP2C19 Genotype Guided DAPT name: Conventional DAPT measure: NACE (net adverse clinical event) measure: Incidence of clinically significant bleeding measure: Incidence of MACCE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Zunyi Medical University status: RECRUITING city: Zunyi state: Guizhou zip: 563003 country: China name: Cai De Jin, MD role: CONTACT phone: 86+173-8576-9997 email: jincaide@zmu.edu.cn name: Yan Yan Jin, MD, PhD role: CONTACT phone: 86+157-7229-0925 email: jinyanyan850925@163.com name: Cai De Jin, MD role: PRINCIPAL_INVESTIGATOR name: Ran Zun Zhao, MD role: SUB_INVESTIGATOR lat: 27.68667 lon: 106.90722 hasResults: False
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<|newrecord|> nctId: NCT06283875 id: PROMISEPLUS-301 briefTitle: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-30 date: 2029-01-30 date: 2024-02-28 date: 2024-02-28 name: Geneplus-Beijing Co. Ltd. class: INDUSTRY briefSummary: This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: DFS of enrolled patients for 2 years sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China name: Jinhua Zhou role: CONTACT phone: +86 13914024750 email: jsjhzh@126.com name: Songbing Qin role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06283862 id: HUM00231159b id: VMR2022-03 type: OTHER_GRANT domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000 briefTitle: MIVetsCan: Can-Coach Trial (Phase 2) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-02 date: 2027-02 date: 2024-02-28 date: 2024-02-28 name: University of Michigan class: OTHER name: Michigan, State of, Licensing and Regulatory Affairs briefSummary: The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition. primaryPurpose: PREVENTION masking: NONE count: 468 type: ESTIMATED name: Educational Session measure: Patient Global Impression of Change (PGIC) score measure: Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 measure: Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1 measure: Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 measure: Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48105 country: United States name: Vivian Kurtz role: CONTACT phone: 734-998-7156 email: vkurtz@med.umich.edu name: Kevin Boehnke role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06283849 id: SON-2024-32671 briefTitle: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-02-28 date: 2024-02-28 name: University of Minnesota class: OTHER briefSummary: The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.
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Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.
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The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.
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Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.
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The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting. conditions: Cardiovascular Diseases conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: strategies to break up SB measure: sedentary time sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55414 country: United States name: Mary O Whipple, PhD, RN, PHN role: CONTACT phone: 612-625-4470 email: whipp042@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False
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<|newrecord|> nctId: NCT06283836 id: Dexrem ATI 4-6 briefTitle: Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-15 date: 2024-02-28 date: 2024-02-28 name: Iuliu Hatieganu University of Medicine and Pharmacy class: OTHER briefSummary: Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trial
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The goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:
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* to assess the patient's satisfaction with each sedation regimen
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* the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.
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Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered. conditions: Otosclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Dexmedetomidine name: Remifentanil measure: Patient satisfaction measure: Surgeon satisfaction measure: mean arterial pressure measure: Heart Rate measure: the need for adjuncts during intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cluj County Clinical Emergency Hospital city: Cluj Napoca state: Cluj zip: 400006 country: Romania name: Caius Mihai Breazu, MD, PhD role: CONTACT phone: +40743010012 email: csbreazu@yahoo.com name: ioan florin marchis, MD, PhD role: CONTACT phone: +40757065205 email: mosku17@yahoo.com lat: 46.76667 lon: 23.6 hasResults: False
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<|newrecord|> nctId: NCT06283823 id: 41821 briefTitle: Morphological Changes of Removable Orthodontic Retainers During the Use overallStatus: RECRUITING date: 2021-12-21 date: 2024-04-01 date: 2024-12-21 date: 2024-02-28 date: 2024-03-01 name: University of L'Aquila class: OTHER briefSummary: The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage. conditions: Orthodontic Retainer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Thermoformed orthodontic retainer measure: Peer Assessment Rating (PAR) index measure: Volumetric superimposition of digital models measure: Thickness sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of L'Aquila status: RECRUITING city: L'Aquila zip: 67100 country: Italy name: Michele Tepedino, DDS role: CONTACT phone: +39 340 276 1456 email: michele.tepedino@univaq.it lat: 42.35055 lon: 13.39954 hasResults: False
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<|newrecord|> nctId: NCT06283810 id: 2023/168 briefTitle: The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-09-30 date: 2024-02-28 date: 2024-03-06 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.
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Translated with DeepL.com (free version) conditions: Midwifery Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: psychotherapy of interpersonal relationships name: laughter therapy name: Plasebo measure: self-reflection skills measure: problem solving skills measure: interpersonal relationship skills sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa status: RECRUITING city: Istanbul zip: 34320 country: Turkey name: Betül Uncu role: CONTACT phone: +095078421227 email: betul.uncu@iuc.edu.tr name: Nurten Kaya role: SUB_INVESTIGATOR name: Betül Uncu role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06283797 id: RECHMPL22_0346 id: 2023-A01661-44 type: OTHER domain: ANSM briefTitle: Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes acronym: APATDIAGNOSIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2027-05 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Montpellier class: OTHER name: Hopital Universitaire Robert-Debre name: University Hospital, Tours name: University Hospital, Angers name: University of Virginia briefSummary: The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.
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The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.
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An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control study in parallel groups, followed by a non randomized extension primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: OmniPod 5 name: Dexcom G6 name: PAID questionnaires measure: Glycated hemoglobin (HbA1c) level measure: Percent of time spent in the 70-180 mg/dl glucose range measure: Percent of time spent in the 70-140 mg/dl glucose range measure: Mean glucose level measure: Percent of time spent with glucose level below 70 mg/dl measure: Percent of time spent with glucose level below 54 mg/dl measure: Percent of time spent with glucose level above 180 mg/dl measure: Percent of time spent with glucose level above 250 mg/dl measure: Coefficient of glucose variability measure: Score of PAID questionnaire for parents measure: Score of PAID questionnaire for children measure: Stimulated plasma C-peptide level 10-min after 1mg IV glucagon measure: Number of needed interventions by the parents/guardians or care providers measure: Change of HbA1c level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-180 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent in the 70-140 mg/dl glucose range between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of mean glucose level between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 70 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level below 54 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 180 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of percent of time spent with glucose level above 250 mg/dl between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of coefficient of glucose variability between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for parents between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of score of PAID questionnaire for children between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of stimulated plasma C-peptide level 10-min after 1mg IV glucagon between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Change of number of needed interventions by the parents/guardians or care providers between 1st and 2nd year of use in the group who started HCL early after diagnosis measure: Difference in the HbA1c level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-180 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent in the 70-140 mg/dl glucose range between the 2 initially randomized groups at the end of the extension period measure: Difference in the mean glucose level between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 70 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level below 54 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 180 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the percent of time spent with glucose level above 250 mg/dl between the 2 initially randomized groups at the end of the extension period measure: Difference in the coefficient of glucose variability between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for parents between the 2 initially randomized groups at the end of the extension period measure: Difference in the score of PAID questionnaire for children between the 2 initially randomized groups at the end of the extension period measure: Difference in the stimulated plasma C-peptide level 10-min after 1mg IV glucagon between the 2 initially randomized groups at the end of the extension period measure: Difference in the number of needed interventions by the parents/guardians or care providers between the 2 initially randomized groups at the end of the extension period measure: Incidence of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Relatedness of treatment-emergent SUSARs, SAEs, ARs and AEs measure: Severity of treatment-emergent SUSARs, SAEs, ARs and AEs sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University Hospital, Angers city: Angers country: France name: Régis Coutant, MD role: CONTACT phone: 02 41 35 56 55 phoneExt: +33 email: recoutant@chu-angers.fr lat: 47.46667 lon: -0.55 facility: University Hospital, Montpellier city: Montpellier country: France name: Eric Renard, MD role: CONTACT phone: 04 67 33 83 82 phoneExt: +33 email: e-renard@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Robert Debré Hospital, AP-HP city: Paris country: France name: Elise Bismuth Reisman, MD role: CONTACT phone: 01 40 03 20 67 phoneExt: +33 email: elise.bismuth@aphp.fr lat: 48.85341 lon: 2.3488 facility: University Hospital, Tours city: Tours country: France name: Yannis Chartier, MD role: CONTACT phone: 06 85 67 93 35 phoneExt: +33 email: Y.CHARTIER@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False
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<|newrecord|> nctId: NCT06283784 id: YOVIS Capsules briefTitle: Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients overallStatus: COMPLETED date: 2021-09-05 date: 2021-11-02 date: 2022-05-18 date: 2024-02-28 date: 2024-03-18 name: Biofarma class: INDUSTRY name: Hippocrates Research briefSummary: This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.
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The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days) conditions: Diarrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double blind, randomized, placebo-controlled study. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable.
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Investigational food supplement products will be packed in an individual way for each subject included in the investigation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ACTUAL name: Yovis Capsules name: Placebo measure: Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy measure: Severity and duration of AAD measure: Severity and duration of AAD measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Evaluation of duration and severity of gastrointestinal symptoms measure: Impact of bowel habits on QoL measure: Effects of YOVIS, versus placebo, at each visit on the overall health status measure: Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo measure: Global Patient's self-reported acceptance at the end of study measure: Global acceptability (investigator) at the end of study sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Practitioner Ambulatory city: Sanremo state: Italy/Imperia zip: 18038 country: Italy lat: 43.81725 lon: 7.7772 hasResults: False
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<|newrecord|> nctId: NCT06283771 id: TU-BOZKUL-007 briefTitle: The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-03-01 name: Tarsus University class: OTHER name: Mersin University briefSummary: In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy conditions: Wearable Technology conditions: Hypothermia conditions: Shivering conditions: Thermal Comfort Perception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study primaryPurpose: OTHER masking: TRIPLE maskingDescription: An independent biostatistician, who is not involved in the study, will select 70 individuals from the list of students enrolled between 1-250 by computer-generated randomization. The information that the volunteers included in the research sample were assigned to group A (experimental) and B (control) according to the randomization table will be kept by the researcher and the socks with the same appearance, with and without heating feature will be numbered from 1 to 70 according to the randomization table and given to the researcher. Thus, the practitioner will be blinded as he/she does not know which sock has a heating feature and which one does not. Healthy volunteers will be blinded because they do not know which group they are in. The data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Heated socks to be developed with wearable technology measure: Body temperature measure: Shivering level measure: Thermal comfort perception measure: Descriptive Characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283758 id: PARADISE HTN-III briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-07 date: 2026-10 date: 2024-02-28 date: 2024-03-04 name: Suzhou Municipal Hospital class: OTHER name: The Affiliated Jiangning Hospital of Nanjing Medical University name: The First Affiliated Hospital with Nanjing Medical University name: Affiliated Hospital of Nantong University briefSummary: This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control. conditions: Hypertension conditions: Blood Pressure conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: focused power ultrasound mediate inferior perirenal adipose tissue modification name: Sham-control group measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Office Systolic Blood Pressure measure: Office Systolic Blood Pressure measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Home Blood Pressure measure: Home Blood Pressure measure: Blood pressure control rate measure: Antihypertensive drug load index measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Jiangning Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Yuqing Zhang role: CONTACT phone: 13851672168 name: Qin Tao role: CONTACT phone: 1585062208 name: Yuqing Zhang role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The first Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Fang Zhou role: CONTACT phone: 13815401066 email: zhoufang7408@163.com name: Wei Sun role: CONTACT phone: 13815860536 email: shunwee@126.com name: Fang Zhou role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Affiliated Hospital of Nantong University city: Nantong state: Jiangsu zip: 210000 country: China name: Hongzhuan Sheng role: CONTACT phone: 13515203348 name: Jian Zhuo role: CONTACT phone: 18206297131 name: Hongzhuan Sheng role: PRINCIPAL_INVESTIGATOR lat: 32.03028 lon: 120.87472 facility: Suzhou Municipal Hospital city: Suzhou state: Jiangsu zip: 210000 country: China name: Yanhui Sheng role: CONTACT phone: 13851647530 email: yhshengnjmu@163.com name: Yang Hua role: CONTACT phone: 13851624359 email: 759150674@qq.com name: Yanhui Sheng role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06283745 id: 73225 briefTitle: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2027-03-22 date: 2027-03-22 date: 2024-02-28 date: 2024-02-28 name: Stanford University class: OTHER briefSummary: This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia. conditions: Paraosmia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PRP injections will be given to one arm while sham saline injections will be given to the other arm. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Platelet-rich Plasma (PRP) name: Saline measure: Change in Sniffin Sticks Parosmia Test (SSParoT) measure: Change in questionnaire of olfactory disorders (QOD) scale score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford Sinus Center / Stanford University School of Medicine city: Palo Alto state: California zip: 94304 country: United States name: Homer Abaya, BS role: CONTACT phone: 650-725-6500 email: habaya@stanford.edu name: Maxime Fieux, MD, PhD role: CONTACT phone: +33621611643 email: fieuxma@stanford.edu name: Zara Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False
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<|newrecord|> nctId: NCT06283732 id: 20392 briefTitle: A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience. overallStatus: COMPLETED date: 2023-11-15 date: 2024-02-15 date: 2024-02-15 date: 2024-02-28 date: 2024-03-05 name: Amway Corp class: INDUSTRY name: Citruslabs briefSummary: The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires. conditions: Digestive System Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 70 type: ACTUAL name: Greens powder measure: Digestive Health Improvement measure: Quality of Life and Well-being Enhancement sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Citruslabs city: Santa Monica state: California zip: 90404 country: United States lat: 34.01945 lon: -118.49119 hasResults: False
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<|newrecord|> nctId: NCT06283719 id: ZG006-002 briefTitle: Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-28 date: 2024-02-28 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: This is a multicenter, open-label phase I/II study, divided into 2 parts:
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Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.
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Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer. conditions: Small Cell Lung Cancer conditions: Neuroendocrine Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: ZG006 measure: Objective response rate (ORR) measure: Number of participants with adverse events (AEs) measure: Number of participants with serious adverse events (SAEs) measure: Duration of response (DOR) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai country: China name: Shun Lu role: CONTACT name: Shun Lu, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06283706 id: 1000081113 briefTitle: The Tryptophan Requirement in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2025-12-01 date: 2024-02-28 date: 2024-03-01 name: The Hospital for Sick Children class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.
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The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Tryptophan measure: Determination of tryptophan requirement in adults >60 years of age. sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283693 id: RojdaBAYARYILDIRIM briefTitle: The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-05-10 date: 2025-06-10 date: 2024-02-28 date: 2024-02-28 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.
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Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. conditions: Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels conditions: Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled classical experimental study primaryPurpose: OTHER masking: SINGLE maskingDescription: Computer-assisted randomization will be used in the study, and participants will be randomized to an intervention or control list control group in a 1:1 ratio by entering the number of samples to be reached through the program whose URL address is https://www.randomizer.org. Women who apply to the infertility outpatient clinic by the researcher and volunteer for the study who meet the sample selection criteria will be given numbers according to the order of outpatient clinic registration. A randomization sequence will be created according to these numbers and women will be assigned to the intervention and control groups by computer-assisted randomization. Since the study is a thesis, blinding will not be possible due to its nature. whoMasked: PARTICIPANT count: 86 type: ESTIMATED name: mindfulness-based stress reduction measure: Informed Voluntary Consent Form (Annex 1) measure: Identifying Characteristics Information Form (Annex 2) measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples measure: Perceived Stress Scale (Appendix 3): measure: Depression-Anxiety-Stress Scale (Appendix 4) measure: Collection and study of salivary cortisol samples sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Saglık Bilimleri Universitesi city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06283680 id: 2024 briefTitle: The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-28 date: 2024-04-28 date: 2024-05-31 date: 2024-02-28 date: 2024-04-08 name: Aylin Seylam Küşümler class: OTHER name: Koşuyolu Yüksek İhtisas Training and Research Hospital briefSummary: The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list. conditions: Lung Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 213 type: ESTIMATED name: Lung transplantation measure: BMI measure: Nutrition risk index sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OkanU city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06283667 id: NN9536-4872 id: U1111-1266-3863 type: OTHER domain: World Health Organization (WHO) briefTitle: Special Use - Results Surveillance on Long-term Use With Wegovy® overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2025-06-30 date: 2028-01-31 date: 2024-02-28 date: 2024-02-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks). conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Semaglutide measure: Number of Adverse Reactions (ARs) measure: Number of Adverse Events (AEs) measure: Number of serious adverse events (SAEs) measure: Number of Serious Adverse Reactions (SARs) measure: Change in body weight (Percent (%)) measure: Change in body weight (Kilograms (Kg)) measure: Change in waist circumference measure: Change in BMI (Body Mass Index) measure: Change in body weight after treatment discontinuation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Tokyo state: Chiyoda City zip: 100-0005 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
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<|newrecord|> nctId: NCT06283654 id: VUmc 2018.539 briefTitle: Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation acronym: relievED overallStatus: COMPLETED date: 2018-09-30 date: 2021-09-30 date: 2023-01-31 date: 2024-02-28 date: 2024-04-26 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 204 type: ACTUAL name: 1-lead ECG measure: number of ED visits measure: ratio of the number of cardioversions emergency vs planned sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC -vumc city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06283641 id: NN8022-7780 id: U1111-1289-9747 type: OTHER domain: World Health Organization (WHO) briefTitle: Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-23 date: 2025-02-28 date: 2025-02-28 date: 2024-02-28 date: 2024-04-04 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.
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The study will last for about 26 weeks. conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 288 type: ESTIMATED name: Liraglutide measure: Incidence of adverse events (AEs) by preferred term (PT) measure: Number of adverse drug reaction (ADRs) measure: Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) measure: Number of unexpected AEs and unexpected ADRs measure: Number of unexpected SAEs and unexpected SADRs measure: Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label measure: Body weight loss Percent (%) (Adult) measure: Body weight loss (%) (Adult) measure: Body weight loss Kilogram(Kg) (Adult) measure: Body weight loss (kg) (Adult) measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing at least 5% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of adult subjects losing more than 10% of baseline body weight measure: The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (kg/m^2) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index (BMI) (%) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Change in body mass index standard deviation score (BMI SDS) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (%) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: Body weight loss (kg) (Adolescent) measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 4% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of adolescent subjects losing at least 10% of baseline BMI measure: The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda® sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei City zip: 100229 country: Taiwan lat: 25.04776 lon: 121.53185 facility: National Taiwan University Hospital city: Taipei City zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06283628 id: STUDY00023737 briefTitle: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves acronym: LMB-RFA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-02-28 date: 2024-02-28 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation. conditions: Lumbar Spondylosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right, primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 25 type: ESTIMATED name: Radiofrequency ablation of lumbar medial branch nerves. measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Oswestry Disability index (ODI) measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia measure: Number of subjects who ceased requiring analgesia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State Hershey College of Medicine city: Hershey state: Pennsylvania zip: 17033 country: United States name: Nancy Ruth Jarbadan, BS role: CONTACT phone: 717-531-6135 email: njarbadan@pennstatehealth.psu.edu lat: 40.28592 lon: -76.65025 hasResults: False
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<|newrecord|> nctId: NCT06283615 id: 2024-01-01 briefTitle: Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency overallStatus: RECRUITING date: 2024-03-12 date: 2024-11-30 date: 2024-11-30 date: 2024-02-28 date: 2024-03-22 name: Jinling Hospital, China class: OTHER briefSummary: Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.
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The primary and secondary outcomes will be collected. conditions: Intestinal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Vitamin D measure: Quality of life score measure: Muscle function status measure: Serum vitamin D levels measure: Hepatic and renal function measure: Bone mineral density measure: Thyroid and parathyroid-related hormones measure: Nutritional status indicators measure: Number of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinying Wang status: RECRUITING city: Nanning state: Jiangsu zip: 210002 country: China name: Xinying Wang, MD role: CONTACT phone: +86 13913028866 email: wangxinying@nju.edu.cn name: Xuejin Gao, MD role: CONTACT phone: +86 18251937684 email: 547625433@qq.com name: Xinying Wang, MD role: PRINCIPAL_INVESTIGATOR name: Xuejin Gao, MD role: SUB_INVESTIGATOR lat: 22.81667 lon: 108.31667 hasResults: False
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<|newrecord|> nctId: NCT06283602 id: 2020/17 briefTitle: Oral Health in Children and Adolescents With Obesity and Normal Weight overallStatus: COMPLETED date: 2020-01-01 date: 2021-03-05 date: 2021-04-29 date: 2024-02-28 date: 2024-02-28 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.
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82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD). conditions: Pediatric Obesity conditions: Pediatric Dentistry studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 82 type: ACTUAL name: oral health status measure: the results of DMFT, plaque and gingival indies measure: the results of dmft, BEWE, ICDAS-II, probing dept measure: Comparison of demographic attributes between obese and normal weights measure: biochemical parameters of obese individuals measure: other biochemical parameters of obese individuals sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Aslı Soğukpınar Önsüren city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06283589 id: INZ701-401 briefTitle: The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis overallStatus: RECRUITING date: 2024-02-12 date: 2024-07-19 date: 2024-08-19 date: 2024-02-28 date: 2024-02-28 name: Inozyme Pharma class: INDUSTRY briefSummary: The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the PK of INZ-701 and PPi levels will be evaluated. conditions: Calciphylaxis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The SEAPORT 1 (INZ701-401) study is a Phase 1, open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of INZ-701, given once per week over 4 weeks, in study participants with end-stage kidney disease undergoing hemodialysis. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: INZ-701 measure: Determine if INZ-701 increases PPi levels measure: Assess the Time to Maximum Serum Concentration (Tmax) measure: Assess the Maximum Serum Concentration (Cmax) of INZ-701 measure: Assess the Area under the concentration-time curve over the dosing interval (AUCtau) measure: Assess the Clearance after extravascular administration of drug (CL/F) sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Florida Nephrology Research status: RECRUITING city: Coral Springs state: Florida zip: 33071 country: United States name: Ashgar Chaudhry, MD role: CONTACT phone: 954-510-7620 email: info@flkidney.com lat: 26.27119 lon: -80.2706 facility: Elixia Health status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States name: Steven Zeig role: CONTACT phone: 954-900-1101 email: info@elixiacrc.com lat: 26.0112 lon: -80.14949 hasResults: False
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<|newrecord|> nctId: NCT06283576 id: PANCAID-00-08 briefTitle: Pancreatic Cancer Initial Detection Via Liquid Biopsy acronym: PANCAID overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-28 date: 2024-04-24 name: Karolinska University Hospital class: OTHER name: Umeå University briefSummary: The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM). conditions: Pancreatic Cancer conditions: IPMN, Pancreatic conditions: Individuals at Risk conditions: Chronic Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Liquid biopsy measure: Cancer detection measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastrocentrum, KarolinskaUniversity Hospital city: Stockholm zip: 14186 country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06283563 id: 2023/5474 briefTitle: Online Physical Activity Tracking in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-02-15 date: 2025-02-28 date: 2024-02-28 date: 2024-02-28 name: Inonu University class: OTHER briefSummary: This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Physical activity tracking name: No physical activity tracking measure: Smartphone pedometer measure: Smartphone pedometer measure: International Physical Activity Questionnaire - Short Form measure: International Physical Activity Questionnaire - Short Form measure: Beck Depression Inventory II measure: Beck Depression Inventory II measure: Beck Anxiety Inventory measure: Beck Anxiety Inventory measure: Fatigue Severity Scale measure: Fatigue Severity Scale measure: Multiple Sclerosis Quality of Life-54 measure: Multiple Sclerosis Quality of Life-54 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283550 id: INNO-6052 briefTitle: Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-08 date: 2024-02-28 date: 2024-02-29 name: Innovaderm Research Inc. class: OTHER briefSummary: This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping. conditions: Chronic Hand Eczema studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Abrocitinib 200 mg name: Abrocitinib 100 mg name: Placebo measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) measure: Reduction from baseline in hand Physician's Global Assessment (PGA) measure: Change from baseline in Hand Eczema Severity Index (HECSI) measure: Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE) measure: Patient Global Assessment (PaGA) measurements measure: Change from baseline in hand Dermatology Life Quality Index (DLQI) measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) measure: Change from baseline in pain Numerical Rating Scale (NRS) measure: Change from baseline in itch Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Rosanna Ottoni, BSc role: CONTACT phone: 514-521-4285 phoneExt: 107 email: rottoni@innovaderm.com lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06283537 id: KÜBAP-01/2023-39 briefTitle: Online Episiotomy Simulation Training for Midwifery Students overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-05-30 date: 2024-02-28 date: 2024-02-28 name: Kastamonu University class: OTHER briefSummary: Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.
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