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protocolSection identificationModule nctId: NCT06269133, orgStudyIdInfo id: R2810-ONC-22115, briefTitle: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-06-23, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases., conditionsModule conditions: Advanced Non-small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: REGN2810, interventions name: Platinum-doublet chemotherapy, outcomesModule primaryOutcomes measure: Real-world response rate (rwRR), primaryOutcomes measure: Any treatment-emergent immune-mediated adverse event (imAE), primaryOutcomes measure: Any treatment-emergent imAE resulting in hospitalization, primaryOutcomes measure: Any treatment-emergent imAE resulting in death, primaryOutcomes measure: Specific treatment-emergent imAEs, secondaryOutcomes measure: Real-world duration of response (rwDOR), secondaryOutcomes measure: Real-world progression-free survival (rwPFS), secondaryOutcomes measure: Real-world overall survival (rwOS), secondaryOutcomes measure: Treatment-emergent immune-mediated adverse events (imAEs), secondaryOutcomes measure: Infusion-related reaction (IRR), secondaryOutcomes measure: IRR resulting in hospitalization, secondaryOutcomes measure: IRR resulting in death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Regeneron Research Facility, city: Tarrytown, state: New York, zip: 10591, country: United States, geoPoint lat: 41.07621, lon: -73.85875, hasResults: False |
protocolSection identificationModule nctId: NCT06269120, orgStudyIdInfo id: NN9924-7787, secondaryIdInfos id: U1111-1290-8109, type: OTHER, domain: World Health Organization (WHO), briefTitle: SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment., conditionsModule conditions: Type 2 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: Oral Semaglutide, outcomesModule primaryOutcomes measure: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in fasting plasm glucose (FPG), secondaryOutcomes measure: Absolute change in body weight (BW), secondaryOutcomes measure: Relative change in BW, secondaryOutcomes measure: HbA1c less than (<) 7.0%, secondaryOutcomes measure: HbA1c <6.5%, secondaryOutcomes measure: Body weight reduction ≥5%, secondaryOutcomes measure: HbA1c reduction ≥1%-point and BW reduction ≥5%, secondaryOutcomes measure: HbA1c reduction ≥1%-point and BW reduction ≥3%, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in blood pressure (BP) (systolic and diastolic), secondaryOutcomes measure: Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]), secondaryOutcomes measure: Change in high sensitive C-reactive protein (hsCRP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06269107, orgStudyIdInfo id: NN1535-4988, secondaryIdInfos id: U1111-1283-8648, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2022-502484-38-00, type: OTHER, domain: European Medicines Agency (EMA), briefTitle: A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4), acronym: COMBINE 4, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-05, completionDateStruct date: 2025-07-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks)., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 474, type: ESTIMATED, armsInterventionsModule interventions name: IcoSema, interventions name: Insulin glargine, outcomesModule primaryOutcomes measure: Change in glycated haemoglobin (HbA1c), secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]), secondaryOutcomes measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL), secondaryOutcomes measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL), secondaryOutcomes measure: Weekly basal insulin dose, secondaryOutcomes measure: Change in fasting plasma glucose (FPG), secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction, secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), secondaryOutcomes measure: Number of severe hypoglycaemic episodes (level 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scripps Whittier Diabetes Inst, status: RECRUITING, city: La Jolla, state: California, zip: 92037, country: United States, geoPoint lat: 32.84727, lon: -117.2742, locations facility: First Valley Med Grp Lancaster, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: Clinical Trials Research_Sacramento, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Desert Oasis Hlthcr Med Group, status: RECRUITING, city: Palm Springs, state: California, zip: 92262, country: United States, geoPoint lat: 33.8303, lon: -116.54529, locations facility: Northeast Research Institute, status: RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Clinical Research of Central Florida_Winter Haven, status: RECRUITING, city: Winter Haven, state: Florida, zip: 33880, country: United States, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Atlanta Diabetes Associates, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Endo Res Solutions Inc, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, geoPoint lat: 34.02316, lon: -84.36159, locations facility: Elite Clinical Trials, status: RECRUITING, city: Blackfoot, state: Idaho, zip: 83221, country: United States, geoPoint lat: 43.19047, lon: -112.34498, locations facility: Cedar-Crosse Research Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60607, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: NorthShore Univ Hlth Sys, status: RECRUITING, city: Skokie, state: Illinois, zip: 60077, country: United States, geoPoint lat: 42.03336, lon: -87.73339, locations facility: Cotton-O'Neil Diab & Endo Ctr, status: RECRUITING, city: Topeka, state: Kansas, zip: 66606, country: United States, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Methodist Phys. Clinic, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68114, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Albuquerque Clin Trials, Inc., status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87102, country: United States, geoPoint lat: 35.08449, lon: -106.65114, locations facility: Albany Medical College - Endo, status: RECRUITING, city: Albany, state: New York, zip: 12206, country: United States, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Southgate Medical Group, LLP, status: RECRUITING, city: West Seneca, state: New York, zip: 14224, country: United States, geoPoint lat: 42.85006, lon: -78.79975, locations facility: Physician's East Endocrinology, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Diab & Endo Assoc of Stark Co, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Advanced Medical Research, status: RECRUITING, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: New Venture Medical Research, status: RECRUITING, city: Wadsworth, state: Ohio, zip: 44281-9236, country: United States, geoPoint lat: 41.02561, lon: -81.72985, locations facility: Holston Medical Group, status: RECRUITING, city: Kingsport, state: Tennessee, zip: 37660, country: United States, geoPoint lat: 36.54843, lon: -82.56182, locations facility: Amarillo Med Spec LLP, status: RECRUITING, city: Amarillo, state: Texas, zip: 79106, country: United States, geoPoint lat: 35.222, lon: -101.8313, locations facility: Velocity Clinical Research- Cedar Park, status: RECRUITING, city: Cedar Park, state: Texas, zip: 78613, country: United States, geoPoint lat: 30.5052, lon: -97.82029, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: North Texas Endocrine Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Diabetes and Thyroid Ctr of FW, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76132, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Fmc Science, Llc, status: RECRUITING, city: Lampasas, state: Texas, zip: 76550, country: United States, geoPoint lat: 31.06378, lon: -98.1817, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Wade Family Medicine, status: RECRUITING, city: Bountiful, state: Utah, zip: 84010, country: United States, geoPoint lat: 40.88939, lon: -111.88077, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100044, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 404000, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Huizhou Central People's Hospital, status: RECRUITING, city: Huizhou, state: Guangdong, zip: 516001, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanghai Pudong New Area People's Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201200, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Harrison International Peace Hospital, status: WITHDRAWN, city: Hengshui, zip: 053000, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Evangelismos Hospital, status: RECRUITING, city: Athens, zip: GR-10676, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: 'G. Gennimatas' General Hospital of Athens, status: RECRUITING, city: Athens, zip: GR-115 27, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: "Laiko" General Hospital of Athens, status: RECRUITING, city: Athens, zip: GR-11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: General Hospital of Kalamata, status: RECRUITING, city: Kalamata, zip: 24100, country: Greece, geoPoint lat: 37.03913, lon: 22.11265, locations facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, status: RECRUITING, city: Larissa, zip: GR-41110, country: Greece, geoPoint lat: 39.63689, lon: 22.41761, locations facility: "Thermi" Private Hosital, status: RECRUITING, city: Thessaloniki, zip: GR-57001, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Ramaiah Memorial Hospital, status: RECRUITING, city: Bangalore, state: Karnataka, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Ramaiah Memorial Hospital, status: NOT_YET_RECRUITING, city: Bangalore, state: Karnataka, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Mysore Medical College and Research Institute, status: NOT_YET_RECRUITING, city: Mysore, state: Karnataka, zip: 570001, country: India, geoPoint lat: 12.29791, lon: 76.63925, locations facility: BYL Nair Hospital and T N Medical College Department of endo, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400008, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BYL Nair Hospital and T N Medical College Department of endo, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400008, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Seth GS Medical College & KEM Hospital, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Seth GS Medical College & KEM Hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BSES MG hospital, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400058, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: BSES MG hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400058, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Chellaram Diabetes Institute, status: RECRUITING, city: Pune, state: Maharashtra, zip: 411021, country: India, geoPoint lat: 18.51957, lon: 73.85535, locations facility: SMS Medical College & Hospital, status: NOT_YET_RECRUITING, city: Jaipur, state: Rajasthan, zip: 302004, country: India, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Diabetes, Thyroid and Endocrine Centre, status: RECRUITING, city: Jaipur, state: Rajasthan, zip: 302006, country: India, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Madras Diabetes Research Foundation, status: RECRUITING, city: Chennai, state: Tamil Nadu, zip: 600086, country: India, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Madras Diabetes Research Foundation, status: NOT_YET_RECRUITING, city: Chennai, state: Tamil Nadu, zip: 600086, country: India, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Udyaan Health Care, status: RECRUITING, city: Lucknow, state: Uttar Pradesh, zip: 226002, country: India, geoPoint lat: 26.83928, lon: 80.92313, locations facility: Post Graduate Institute of Medical Education & Research, status: NOT_YET_RECRUITING, city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, locations facility: IPGME&R and SSKM Hospital, status: NOT_YET_RECRUITING, city: Kolkata, zip: 700020, country: India, geoPoint lat: 22.56263, lon: 88.36304, locations facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia, status: RECRUITING, city: L'Aquila, state: Abbruzzo, zip: 67100, country: Italy, geoPoint lat: 42.35055, lon: 13.39954, locations facility: Casa Sollievo della Sofferenza reparto endocrinologia, status: RECRUITING, city: San Giovanni Rotondo, state: FG, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani, status: NOT_YET_RECRUITING, city: Ancona, zip: 60127, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Casa della Salute di Ceccano (FR), status: RECRUITING, city: Ceccano (Frosinone), zip: 03023, country: Italy, locations facility: ASL 4 Chiavarese, status: NOT_YET_RECRUITING, city: Chiavari (genova), zip: 16034, country: Italy, locations facility: ASST Grande Ospedale Metropolitano Niguarda, status: RECRUITING, city: Milano, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser, status: RECRUITING, city: Perugia, zip: 06129, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: A.O.U. Policlinico Umberto I, status: RECRUITING, city: Rome, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Heiwadai Hospital, status: RECRUITING, city: Miyazaki-shi, state: Miyazaki, zip: 880-0034, country: Japan, geoPoint lat: 31.91667, lon: 131.41667, locations facility: Tokuyama clinic, status: RECRUITING, city: Chiba, zip: 261-0004, country: Japan, geoPoint lat: 35.6, lon: 140.11667, locations facility: Oodouri Diabetes, Internal medicine Clinic, status: RECRUITING, city: Hokkaido, zip: 060-0001, country: Japan, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Oyama East Clinic, status: RECRUITING, city: Tochigi, zip: 323-0022, country: Japan, geoPoint lat: 36.38333, lon: 139.73333, locations facility: Tokyo-Eki Center-building Clinic, status: RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Juntendo University Hospital, status: RECRUITING, city: Tokyo, zip: 113-8431, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, status: RECRUITING, city: Bialystok, state: Podlaskie, zip: 15-435, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: SNZOZ Lege Artis, status: RECRUITING, city: Bialystok, zip: 15-404, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii, status: RECRUITING, city: Gdansk, zip: 80-214, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Grazyna Pulka Specjalistyczny Osrodek "All-Med", status: RECRUITING, city: Krakow, zip: 30-033, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Gabinet Lekarski Malgorzata Saryusz-Wolska, status: RECRUITING, city: Lodz, zip: 90-132, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Centrum Terapii Wspolczesnej, status: RECRUITING, city: Lodz, zip: 90-338, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Ko-Med Nova Sp.zo.o. Lublin II, status: RECRUITING, city: Lublin, zip: 20-362, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Ko-Med Nova Sp.zo.o. STASZOW, status: RECRUITING, city: Staszow, zip: 28-200, country: Poland, geoPoint lat: 50.56307, lon: 21.16593, locations facility: NBR Polska Tomasz Klodawski, status: RECRUITING, city: Warszawa, zip: 00-710, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA, status: RECRUITING, city: Warszawa, zip: 02-507, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Clinhouse Centrum Medyczne, status: RECRUITING, city: Zabrze, zip: 41-807, country: Poland, geoPoint lat: 50.32492, lon: 18.78576, locations facility: Advanced Clinical Research LLC, status: RECRUITING, city: Bayamon, zip: 00959, country: Puerto Rico, geoPoint lat: 18.39856, lon: -66.15572, locations facility: Dr R Dulabh, status: RECRUITING, city: Johannesburg, state: Gauteng, zip: 1812, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Dr R Dulabh, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 1812, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Newtown Clinical Research, status: RECRUITING, city: Johannesburg, state: Gauteng, zip: 2001, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Roodepoort Medicross Clinical Research Centre, status: RECRUITING, city: Roodepoort, state: Gauteng, zip: 1724, country: South Africa, geoPoint lat: -26.1625, lon: 27.8725, locations facility: Clinical Research Institute of South Africa, status: RECRUITING, city: KwaDukuza, state: KwaZulu Natal, zip: 4449, country: South Africa, geoPoint lat: -29.32816, lon: 31.28954, locations facility: Dr Pillay's Rooms, status: RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4450, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Dr Pillay's Rooms, status: NOT_YET_RECRUITING, city: Durban, state: KwaZulu-Natal, zip: 4450, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Langeberg Clinical Trials, status: RECRUITING, city: Cape Town, state: Western Cape, zip: 7572, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, locations facility: Akdeniz University Tip Fakultesi Hastanesi, status: RECRUITING, city: Antalya, zip: 07058, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, status: RECRUITING, city: Istanbul, zip: 34371, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji, status: RECRUITING, city: Istanbul, zip: 34390, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi, status: RECRUITING, city: Istanbul, zip: 34899, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Tekirdag Namık Kemal UTF, status: RECRUITING, city: Tekirdag, zip: 59030, country: Turkey, geoPoint lat: 40.9781, lon: 27.51101, hasResults: False |
protocolSection identificationModule nctId: NCT06269094, orgStudyIdInfo id: MB-2312, briefTitle: A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Midwest Center for Metabolic and Cardiovascular Research, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach., conditionsModule conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: CGM, outcomesModule primaryOutcomes measure: Qualitative insights on consumer behavior, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Biofortis, Inc., status: RECRUITING, city: Addison, state: Illinois, zip: 60101, country: United States, contacts name: Grace Mooney, MS, role: CONTACT, phone: 630-617-2000, email: [email protected], contacts name: Gina Castiglione, RD, role: CONTACT, phone: 6306172000, email: [email protected], contacts name: Aditi M Shah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.9317, lon: -87.98896, hasResults: False |
protocolSection identificationModule nctId: NCT06269081, orgStudyIdInfo id: R01NR020770, type: NIH, link: https://reporter.nih.gov/quickSearch/R01NR020770, secondaryIdInfos id: R01NR020770, type: NIH, link: https://reporter.nih.gov/quickSearch/R01NR020770, briefTitle: Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 352, type: ESTIMATED, armsInterventionsModule interventions name: Supportive-Expressive Peer Social Support Group Intervention, interventions name: Individual Strengths-Based Case Management Intervention, outcomesModule primaryOutcomes measure: Viral Suppression, primaryOutcomes measure: Antiretroviral Treatment Medication Adherence, primaryOutcomes measure: Health-Related Quality of Life, primaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Loneliness, secondaryOutcomes measure: Internalized HIV Stigma, secondaryOutcomes measure: General Self-Efficacy, secondaryOutcomes measure: HIV Treatment Adherence Self-Efficacy, secondaryOutcomes measure: Accessing Needed Social and Medical Services, secondaryOutcomes measure: Structural Barriers, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for AIDS Intervention Research, Medical College of Wisconsin, status: RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53202, country: United States, contacts name: Jennifer Walsh, role: CONTACT, phone: 414-955-7710, email: [email protected], geoPoint lat: 43.0389, lon: -87.90647, hasResults: False |
protocolSection identificationModule nctId: NCT06269068, orgStudyIdInfo id: 12.01.2024.10, briefTitle: Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic., conditionsModule conditions: Central Sensitisation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Central sensitization inventory, interventions name: Short form-36, interventions name: Oswestry Low Back Pain Disability Questionnaire, interventions name: Douleur Neuropathique 4, interventions name: Visual analogue scale, outcomesModule primaryOutcomes measure: Central Sensitization Inventory (CSI), primaryOutcomes measure: DN4, secondaryOutcomes measure: VAS pain, secondaryOutcomes measure: SF-36, secondaryOutcomes measure: ODI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University School of Medicine, status: RECRUITING, city: Istanbul, state: Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, zip: 34899, country: Turkey, contacts name: Feyza Nur Yücel, role: CONTACT, phone: 5385577059, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06269055, orgStudyIdInfo id: 73151, briefTitle: Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA)., conditionsModule conditions: Gadolinium Deposition Disease, conditions: Ca-DTPA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently, secondaryOutcomes measure: PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a, secondaryOutcomes measure: Sheehan Disability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University Medical Center, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Lorrin Koran, M.D., role: CONTACT, phone: 650-799-1647, email: [email protected], geoPoint lat: 37.42411, lon: -122.16608, hasResults: False |
protocolSection identificationModule nctId: NCT06269042, orgStudyIdInfo id: 0010, briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2024-03-07, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sierra Varona SL, class: OTHER, collaborators name: Universidad Europea de Madrid, descriptionModule briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.In this study, subjects will be divided into three groups: the experimental group, the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory muscle training, outcomesModule primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: Diaphragmatic thickness and thickening fraction, primaryOutcomes measure: Diaphragm movement curve, primaryOutcomes measure: Heart rate variability, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06269029, orgStudyIdInfo id: P.T.Rec/012/004297, briefTitle: Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-17, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease, conditionsModule conditions: Chronic Obstructive Pulmonary Disease Moderate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chest mobility exercises, interventions name: proprioceptive neuromuscular facilitation, outcomesModule primaryOutcomes measure: Pulmonary function test, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo university- faculty of physical therapy, status: RECRUITING, city: Cairo, state: Dokki, zip: 12556, country: Egypt, contacts name: Zahraa Serry, PHD, role: CONTACT, phone: 012854566880, phoneExt: 02, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06269016, orgStudyIdInfo id: P.T.REC/012/003888, briefTitle: Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2023-08-25, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general, conditionsModule conditions: Stress Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: expremental pre and post test, outcomesModule primaryOutcomes measure: hip muscles strengthening exercise., eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mai Mohamed Sherif Mohamed Hassan, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06269003, orgStudyIdInfo id: STUDY00001223, secondaryIdInfos id: 1K99CA281094-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1, briefTitle: Responses to Message Source and Presentation Using Psychophysiology, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape., conditionsModule conditions: Vaping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Expert, interventions name: Peer, interventions name: 1 Sided, interventions name: 2 Sided, outcomesModule primaryOutcomes measure: Visual attention, primaryOutcomes measure: Orienting response, primaryOutcomes measure: Arousal, secondaryOutcomes measure: Attitudes, secondaryOutcomes measure: Behavioral intentions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: UMass Chan Medical School Shaw Building, city: Worcester, state: Massachusetts, zip: 01605, country: United States, geoPoint lat: 42.26259, lon: -71.80229, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-17, uploadDate: 2024-01-31T10:39, filename: SAP_000.pdf, size: 176628, hasResults: False |
protocolSection identificationModule nctId: NCT06268990, orgStudyIdInfo id: FE 1159/6-1, briefTitle: FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT, acronym: DACH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Wiebke Kristin Fenske, class: OTHER, collaborators name: Medical University of Graz, descriptionModule briefSummary: This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects., conditionsModule conditions: Morbid Obesity, conditions: Metabolic Syndrome, conditions: Diabetes, conditions: PreDiabetes, conditions: Insulin Resistance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation, outcomesModule primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Glucose homeostasis, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Fasting lipid profile, secondaryOutcomes measure: Fasting blood liver enzyme levels, secondaryOutcomes measure: Dietary intake levels, secondaryOutcomes measure: Metabolic inflammation, secondaryOutcomes measure: Gut hormones, secondaryOutcomes measure: Hunger and Satiety Scores, secondaryOutcomes measure: Fecal microbiota composition, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Tolerability of repeated FMT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Internal Medicine, Medical University Graz, status: RECRUITING, city: Graz, zip: 8010, country: Austria, contacts name: Julia K Mader, Assoc. Prof., role: CONTACT, phone: +43 316 38582383, email: [email protected], contacts name: Julia K Mader, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Patrizia Kump, PD Dr, role: SUB_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-05-14, uploadDate: 2024-01-29T10:24, filename: Prot_SAP_000.pdf, size: 651727, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-09-15, uploadDate: 2024-02-16T08:19, filename: ICF_001.pdf, size: 276426, hasResults: False |
protocolSection identificationModule nctId: NCT06268977, orgStudyIdInfo id: SGLt2i in diabetic type 2, briefTitle: Using of SGLt2 Inhibitors in Patients With Type 2 DM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.- To detect the side-effects of SGLT2i, conditionsModule conditions: Type 2 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Effect of adding SGLTi on BP, primaryOutcomes measure: Effect of adding SGLTi on BMI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268964, orgStudyIdInfo id: 2023-5, briefTitle: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics, acronym: FAPD_RCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universidad de Colima, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children., conditionsModule conditions: Functional Abdominal Pain Syndrome, conditions: Functional Gastrointestinal Disorders, conditions: Irritable Bowel Syndrome Variant of Childhood, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Trimebutine, interventions name: Lactobacillus rhamnosus, interventions name: Placebo, outcomesModule primaryOutcomes measure: Average Score on Visual Analog Scale for Abdominal Pain, secondaryOutcomes measure: Improvement in Quality of Life with PedsQL 3.0, secondaryOutcomes measure: Improvement in Quality of Life with PedsQL 3.0, secondaryOutcomes measure: Average Score on Visual Analog Scale for Abdominal Pain, otherOutcomes measure: Number of Participants with Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: School of Medicine, University of Colima, status: RECRUITING, city: Colima, zip: 28040, country: Mexico, contacts name: Pablo H Sandoval-Villaseñor, MD, role: CONTACT, phone: +523123007655, email: [email protected], contacts name: Fabián Rojas-Larios, PhD, role: CONTACT, email: [email protected], contacts name: Carmen A Sánchez-Ramírez, PhD, role: SUB_INVESTIGATOR, contacts name: Pablo H Sandoval-Villaseñor, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Fabián Rojas-Larios, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 19.24997, lon: -103.72714, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-09, uploadDate: 2024-02-16T21:12, filename: Prot_SAP_ICF_000.pdf, size: 6823982, hasResults: False |
protocolSection identificationModule nctId: NCT06268951, orgStudyIdInfo id: 23-005485, briefTitle: Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis., conditionsModule conditions: Endometriosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Symptom severity due to abdominal wall endometriosis following ablation., eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06268938, orgStudyIdInfo id: mastoid obliteration, briefTitle: Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2028-11-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery, conditionsModule conditions: Cholesteatoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: Canal wall down tympanomastoidectomy, outcomesModule primaryOutcomes measure: Size of mastoid cavity in mm, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Assiut university hospital, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, locations facility: Rehab Abd Elal Mohammed, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06268925, orgStudyIdInfo id: UAHS, briefTitle: The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-04-22, completionDateStruct date: 2024-05-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Peradeniya, class: OTHER, descriptionModule briefSummary: it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Exercises, outcomesModule primaryOutcomes measure: Efficacy of telerehabilitation program, primaryOutcomes measure: Feasibility and acceptability, secondaryOutcomes measure: lower extremity muscle strength and dynamic balance, secondaryOutcomes measure: pain,, secondaryOutcomes measure: pain stiffness and physical activity, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: M.S.F.Sarjana, city: Puttalam, state: North Western, zip: 61300, country: Sri Lanka, geoPoint lat: 8.0362, lon: 79.8283, hasResults: False |
protocolSection identificationModule nctId: NCT06268912, orgStudyIdInfo id: END-ECL-2022-01, secondaryIdInfos id: END-ECL-2022-01, type: OTHER, domain: UIC, briefTitle: Cryoanalgesia for Irreversible Pulpitis, acronym: CryPain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-07, primaryCompletionDateStruct date: 2023-09-07, completionDateStruct date: 2024-01-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Universitat Internacional de Catalunya, class: OTHER, descriptionModule briefSummary: The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis., conditionsModule conditions: Pulpitis - Irreversible, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Cold Mepivacaine, interventions name: Mepivacaine at room temperature, outcomesModule primaryOutcomes measure: Assessment of Pain and Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gonzalo Gomez, city: Barcelona, zip: 08, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06268899, orgStudyIdInfo id: E-77082166-302.08.01-285977, briefTitle: First Mobilization Protocol for Total Knee Arthroplasty Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-08, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, collaborators name: Baskent University, descriptionModule briefSummary: This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms., conditionsModule conditions: Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participant: the researcher learned the study and control groups after the pre-test data. The study group was trained with the mobilization protocol. The control group received training on the current mobilization procedure of the clinic. Participants did not know which group they were in.Outcomes Assessor. Study and control groups data were coded into the SPSS programme as group one and group two. Analysis of data was done by an independent statistician. The statistician has no information about which group the patients belong to., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: First mobilization protocol, outcomesModule primaryOutcomes measure: Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI), primaryOutcomes measure: Kinesiophobia evaluated using the Tampa Kinesiophobia Scale, primaryOutcomes measure: Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI), primaryOutcomes measure: Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gazi University Health Research and Application Center, city: Ankara, zip: 06560, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06268886, orgStudyIdInfo id: CN008-0003, secondaryIdInfos id: 2023-504840-32-00, type: REGISTRY, domain: EU Trial Number, secondaryIdInfos id: U1111-1290-3539, type: REGISTRY, domain: WHO, briefTitle: Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease, acronym: TargetTau-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-11-16, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease., conditionsModule conditions: Alzheimer Disease, Early Onset, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 475, type: ESTIMATED, armsInterventionsModule interventions name: BMS-986446, interventions name: Placebo, outcomesModule primaryOutcomes measure: Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score, secondaryOutcomes measure: Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET), secondaryOutcomes measure: Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score, secondaryOutcomes measure: Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score, secondaryOutcomes measure: Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score, secondaryOutcomes measure: Mean change from baseline in Mini Mental State Examination (MMSE) score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD First Research - Chandler, status: NOT_YET_RECRUITING, city: Chandler, state: Arizona, zip: 85226-3732, country: United States, contacts name: Hemant Pandey, Site 0068, role: CONTACT, phone: 480-508-1038, geoPoint lat: 33.30616, lon: -111.84125, locations facility: Gilbert Neurology, status: NOT_YET_RECRUITING, city: Gilbert, state: Arizona, zip: 85297-0441, country: United States, contacts name: Jonathan Hodgson, Site 0102, role: CONTACT, phone: 602-761-9631, geoPoint lat: 33.35283, lon: -111.78903, locations facility: Xenoscience Inc. - 21st Century Neurology, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Stephen Flitman, Site 0019, role: CONTACT, phone: 602-265-6500, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Imaging Endpoints LLC, status: NOT_YET_RECRUITING, city: Scottsdale, state: Arizona, zip: 85258-4595, country: United States, contacts name: Nida Laurin, Site 0026, role: CONTACT, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Office of Allan M. Block, MD, status: NOT_YET_RECRUITING, city: Scottsdale, state: Arizona, zip: 85258-5133, country: United States, contacts name: Allan Block, Site 0018, role: CONTACT, phone: 480-471-6132, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Tucson Neuroscience Research, LLC, status: NOT_YET_RECRUITING, city: Tucson, state: Arizona, zip: 85710-6160, country: United States, contacts name: Robert Mutterperl, Site 0128, role: CONTACT, phone: 520-230-1373, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Center for Neurosciences - Tucson, status: NOT_YET_RECRUITING, city: Tucson, state: Arizona, zip: 85718-6522, country: United States, contacts name: Michael Badruddoja, Site 0077, role: CONTACT, phone: 520-320-2147, geoPoint lat: 32.22174, lon: -110.92648, locations facility: The Banner Alzheimer's Institute - Tucson, status: NOT_YET_RECRUITING, city: Tucson, state: Arizona, zip: 85718-6632, country: United States, contacts name: Allan Anderson, Site 0038, role: CONTACT, phone: 520-694-4124, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Local Institution - 0164, status: NOT_YET_RECRUITING, city: Encino, state: California, zip: 91316-1511, country: United States, contacts name: Site 0164, role: CONTACT, geoPoint lat: 34.15917, lon: -118.50119, locations facility: Local Institution - 0139, status: NOT_YET_RECRUITING, city: Fullerton, state: California, zip: 92835-1040, country: United States, contacts name: Site 0139, role: CONTACT, geoPoint lat: 33.87029, lon: -117.92534, locations facility: Local Institution - 0152, status: NOT_YET_RECRUITING, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Site 0152, role: CONTACT, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Local Institution - 0183, status: NOT_YET_RECRUITING, city: Lakewood, state: California, zip: 90805-4590, country: United States, contacts name: Site 0183, role: CONTACT, geoPoint lat: 33.85363, lon: -118.13396, locations facility: Local Institution - 0073, status: ACTIVE_NOT_RECRUITING, city: Lomita, state: California, zip: 90717-2101, country: United States, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Local Institution - 0142, status: NOT_YET_RECRUITING, city: Los Alamitos, state: California, zip: 90720-3589, country: United States, contacts name: Site 0142, role: CONTACT, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Neurovations, status: NOT_YET_RECRUITING, city: Napa, state: California, zip: 94558-2415, country: United States, contacts name: Eric Grigsby, Site 0037, role: CONTACT, phone: 707-252-9666, geoPoint lat: 38.29714, lon: -122.28553, locations facility: UCSF Medical Center- Mission Bay, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94143-2350, country: United States, contacts name: Peter Ljubenkov, Site 0052, role: CONTACT, phone: 415-502-7562, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Local Institution - 0137, status: NOT_YET_RECRUITING, city: Santa Ana, state: California, zip: 92705-8675, country: United States, contacts name: Site 0137, role: CONTACT, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Local Institution - 0135, status: NOT_YET_RECRUITING, city: Seal Beach, state: California, zip: 90740-6653, country: United States, contacts name: Site 0135, role: CONTACT, geoPoint lat: 33.74141, lon: -118.10479, locations facility: California Neuroscience Research Medical Group, Inc (CNR), status: NOT_YET_RECRUITING, city: Sherman Oaks, state: California, zip: 91403-2131, country: United States, contacts name: Thomas Shiovitz, Site 0046, role: CONTACT, phone: 818-986-9716, geoPoint lat: 34.15112, lon: -118.44925, locations facility: Rocky Mountain Movement Disorder Center, status: NOT_YET_RECRUITING, city: Englewood, state: Colorado, zip: 80113-2776, country: United States, contacts name: Rajeev Kumar, Site 0092, role: CONTACT, phone: 303-357-5455, geoPoint lat: 39.64777, lon: -104.98776, locations facility: Associated Neurologists, P.C. - Danbury Office, status: NOT_YET_RECRUITING, city: Danbury, state: Connecticut, zip: 06810-4088, country: United States, contacts name: Behzad Habibi Khameneh, Site 0106, role: CONTACT, phone: 203-748-2551, geoPoint lat: 41.39482, lon: -73.45401, locations facility: Local Institution - 0148, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Site 0148, role: CONTACT, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Hasbani Neurology, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06511-5249, country: United States, contacts name: Mayer Hasbani, Site 0056, role: CONTACT, phone: 212-241-8329, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Local Institution - 0153, status: NOT_YET_RECRUITING, city: Stamford, state: Connecticut, zip: 06905-1206, country: United States, contacts name: Site 0153, role: CONTACT, geoPoint lat: 41.05343, lon: -73.53873, locations facility: Neurology of Central Florida, status: NOT_YET_RECRUITING, city: Altamonte Springs, state: Florida, zip: 32714-2436, country: United States, contacts name: Alicia Cabrera, Site 0022, role: CONTACT, phone: 407-790-4990, geoPoint lat: 28.66111, lon: -81.36562, locations facility: JEM Research Institute, status: NOT_YET_RECRUITING, city: Atlantis, state: Florida, zip: 33462-6631, country: United States, contacts name: Linda Pao, Site 0048, role: CONTACT, phone: 561-968-2933, geoPoint lat: 26.5909, lon: -80.10088, locations facility: Local Institution - 0020, status: NOT_YET_RECRUITING, city: Clermont, state: Florida, zip: 34711-5933, country: United States, contacts name: Site 0020, role: CONTACT, geoPoint lat: 28.54944, lon: -81.77285, locations facility: Arrow Clinical Trials, status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117-5532, country: United States, contacts name: David Billmeier, Site 0009, role: CONTACT, phone: 386-304-7070, geoPoint lat: 29.21081, lon: -81.02283, locations facility: Local Institution - 0059, status: NOT_YET_RECRUITING, city: Greenacres City, state: Florida, zip: 33467, country: United States, contacts name: Site 0059, role: CONTACT, geoPoint lat: 26.62368, lon: -80.12532, locations facility: Local Institution - 0187, status: NOT_YET_RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, contacts name: Site 0187, role: CONTACT, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Charter Research - Lady Lake, status: RECRUITING, city: Lady Lake, state: Florida, zip: 32159, country: United States, contacts name: Jeffrey Norton, Site 0151, role: CONTACT, phone: 352-775-1000, geoPoint lat: 28.91749, lon: -81.92286, locations facility: Local Institution - 0146, status: NOT_YET_RECRUITING, city: Lakeland, state: Florida, zip: 33805-2208, country: United States, contacts name: Site 0146, role: CONTACT, geoPoint lat: 28.03947, lon: -81.9498, locations facility: Local Institution - 0143, status: NOT_YET_RECRUITING, city: Maitland, state: Florida, zip: 32751, country: United States, contacts name: Site 0143, role: CONTACT, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Merritt Island Medical Research, status: RECRUITING, city: Merritt Island, state: Florida, zip: 32952-3616, country: United States, contacts name: Gregory Kirk, Site 0027, role: CONTACT, phone: 386-785-8009, geoPoint lat: 28.53917, lon: -80.672, locations facility: Premier Clinical Research Institute - Miami, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33122-1335, country: United States, contacts name: Emelina Arocha, Site 0058, role: CONTACT, phone: 786-587-9425, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Optimus U, Inc., status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33125-4013, country: United States, contacts name: Yaneicy Gonzalez Rojas, Site 0013, role: CONTACT, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Project 4 Research, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33125-4719, country: United States, contacts name: Ibrahim Menendez Perez, Site 0034, role: CONTACT, phone: 786-536-5755, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Vitae Research Center, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33135-2957, country: United States, contacts name: Mercedes Ponce De Leon, Site 0014, role: CONTACT, phone: 786-288-2598, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Advance Medical Research Center, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33135-2968, country: United States, contacts name: Ana Acosta, Site 0005, role: CONTACT, phone: 786-360-4423, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Miami Jewish Health Systems, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33137-2706, country: United States, contacts name: Marc Agronin, Site 0008, role: CONTACT, phone: 305-514-8710, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Local Institution - 0176, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33155-6540, country: United States, contacts name: Site 0176, role: CONTACT, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Hope Research Network, LLC, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33166-2710, country: United States, contacts name: Jorge Jorge, Site 0071, role: CONTACT, phone: 305-244-8113, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Local Institution - 0156, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33175-3598, country: United States, contacts name: Site 0156, role: CONTACT, geoPoint lat: 25.77427, lon: -80.19366, locations facility: IMIC Research, status: RECRUITING, city: Miami, state: Florida, zip: 33176-7947, country: United States, contacts name: Ramon Leon, Site 0039, role: CONTACT, phone: 786-600-7005, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Suncoast Clinical Research, status: NOT_YET_RECRUITING, city: New Port Richey, state: Florida, zip: 34652-4020, country: United States, contacts name: Cathy Barnes, Site 0017, role: CONTACT, phone: 727-849-4131, geoPoint lat: 28.24418, lon: -82.71927, locations facility: Local Institution - 0144, status: NOT_YET_RECRUITING, city: Ocala, state: Florida, zip: 34471, country: United States, contacts name: Site 0144, role: CONTACT, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Headlands Research - Orlando, status: RECRUITING, city: Orlando, state: Florida, zip: 32819-8031, country: United States, contacts name: Theodore Lee, Site 0035, role: CONTACT, phone: 407-705-3471, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Local Institution - 0141, status: NOT_YET_RECRUITING, city: Palm Beach Gardens, state: Florida, zip: 33410-4303, country: United States, contacts name: Site 0141, role: CONTACT, geoPoint lat: 26.82339, lon: -80.13865, locations facility: Alzheimer's Research and Treatment Center Stuart, status: NOT_YET_RECRUITING, city: Stuart, state: Florida, zip: 34997-5765, country: United States, contacts name: Adam Falchook, Site 0012, role: CONTACT, geoPoint lat: 27.19755, lon: -80.25283, locations facility: Local Institution - 0136, status: NOT_YET_RECRUITING, city: Stuart, state: Florida, zip: 34997-6405, country: United States, contacts name: Site 0136, role: CONTACT, geoPoint lat: 27.19755, lon: -80.25283, locations facility: Baycare Clinical Research, LLC, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33607-6616, country: United States, contacts name: Arnaldo Orellana, Site 0080, role: CONTACT, phone: 813-368-5738, geoPoint lat: 27.94752, lon: -82.45843, locations facility: First Choice Neurology - Tampa Neurology Associates, status: RECRUITING, city: Tampa, state: Florida, zip: 33609-4090, country: United States, contacts name: Susan Steen, Site 0087, role: CONTACT, phone: 813-353-9613, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33613-4808, country: United States, contacts name: Amanda Smith, Site 0042, role: CONTACT, phone: 813-974-4355, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Alzheimer's Research and Treatment Center - Wellington Location, status: NOT_YET_RECRUITING, city: Wellington, state: Florida, zip: 33414-9320, country: United States, contacts name: David Watson, Site 0011, role: CONTACT, phone: 561-209-2400, geoPoint lat: 26.65868, lon: -80.24144, locations facility: Local Institution - 0149, status: NOT_YET_RECRUITING, city: West Palm Beach, state: Florida, zip: 33409-6611, country: United States, contacts name: Site 0149, role: CONTACT, geoPoint lat: 26.71534, lon: -80.05337, locations facility: Waypoint Research LLC, status: RECRUITING, city: Windermere, state: Florida, zip: 34786-8919, country: United States, contacts name: Craig Curtis, Site 0029, role: CONTACT, phone: 352-500-5252, geoPoint lat: 28.49556, lon: -81.5348, locations facility: Conquest Research LLC, status: RECRUITING, city: Winter Park, state: Florida, zip: 32789-1848, country: United States, contacts name: Rekha Gandhi, Site 0101, role: CONTACT, phone: 321-285-2369, geoPoint lat: 28.6, lon: -81.33924, locations facility: Charter Research - Winter Park, status: RECRUITING, city: Winter Park, state: Florida, zip: 32792, country: United States, contacts name: Edgardo Rivera, Site 0154, role: CONTACT, phone: 407-863-1326, geoPoint lat: 28.6, lon: -81.33924, locations facility: Columbus Memory Center, status: NOT_YET_RECRUITING, city: Columbus, state: Georgia, zip: 31909-1692, country: United States, contacts name: Jonathan Liss, Site 0105, role: CONTACT, phone: 706-327-4000, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Great Lakes Clinical Trials, status: RECRUITING, city: Chicago, state: Illinois, zip: 60640-2831, country: United States, contacts name: Jeffrey Ross, Site 0021, role: CONTACT, phone: 847-252-7300, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0161, status: NOT_YET_RECRUITING, city: Elk Grove Village, state: Illinois, zip: 60007-3362, country: United States, contacts name: Site 0161, role: CONTACT, geoPoint lat: 42.00392, lon: -87.97035, locations facility: Great Lakes Clinical Trials d/b/a Flourish Research Gurnee, status: RECRUITING, city: Gurnee, state: Illinois, zip: 60031, country: United States, contacts name: Yevgeniy Bukhman, Site 0003, role: CONTACT, phone: 773-275-3500, geoPoint lat: 42.3703, lon: -87.90202, locations facility: Local Institution - 0145, status: NOT_YET_RECRUITING, city: Park Ridge, state: Illinois, zip: 60068, country: United States, contacts name: Site 0145, role: CONTACT, geoPoint lat: 42.01114, lon: -87.84062, locations facility: Southern Illinois University School of Medicine - SIU Neurology Clinic, status: NOT_YET_RECRUITING, city: Springfield, state: Illinois, zip: 62702-4968, country: United States, contacts name: Jennifer Arnold, Site 0081, role: CONTACT, phone: 217-545-7200, geoPoint lat: 39.80172, lon: -89.64371, locations facility: Boston Clinical Trials, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02131-2515, country: United States, contacts name: Deborah Green-LaRoche, Site 0025, role: CONTACT, phone: 617-636-7606, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Boston Neuropsychiatry, status: NOT_YET_RECRUITING, city: Braintree, state: Massachusetts, zip: 02184-1939, country: United States, contacts name: Malini Nair, Site 0015, role: CONTACT, phone: 617-302-6388, geoPoint lat: 42.22232, lon: -70.99949, locations facility: ActivMed Practices & Research, Inc. - Methuen, status: NOT_YET_RECRUITING, city: Methuen, state: Massachusetts, zip: 01844-5864, country: United States, contacts name: Michael McCartney, Site 0118, role: CONTACT, phone: 19789789696897, geoPoint lat: 42.7262, lon: -71.19089, locations facility: Boston Center for Memory, status: NOT_YET_RECRUITING, city: Newton, state: Massachusetts, zip: 02459-3328, country: United States, contacts name: Paul Solomon, Site 0040, role: CONTACT, phone: 617-699-6927, geoPoint lat: 42.33704, lon: -71.20922, locations facility: Office of Donald S. Marks, M.D., P.C., status: NOT_YET_RECRUITING, city: Plymouth, state: Massachusetts, zip: 02360-7223, country: United States, contacts name: Donald Marks, Site 0120, role: CONTACT, phone: 508-269-0403, geoPoint lat: 41.95844, lon: -70.66726, locations facility: Adams Clinical Trials, LLC, status: NOT_YET_RECRUITING, city: Watertown, state: Massachusetts, zip: 02472-4153, country: United States, contacts name: Stephanie Rutrick, Site 0045, role: CONTACT, phone: 617-697-1843, geoPoint lat: 42.37093, lon: -71.18283, locations facility: Local Institution - 0150, status: NOT_YET_RECRUITING, city: Ozark, state: Missouri, zip: 65721, country: United States, contacts name: Site 0150, role: CONTACT, geoPoint lat: 37.02089, lon: -93.20602, locations facility: Local Institution - 0169, status: NOT_YET_RECRUITING, city: Saint Louis, state: Missouri, zip: 63104-1027, country: United States, contacts name: Site 0169, role: CONTACT, geoPoint lat: 38.62727, lon: -90.19789, locations facility: ActivMed Practices & Research, Inc. - Portsmouth, status: NOT_YET_RECRUITING, city: Portsmouth, state: New Hampshire, zip: 03801-6822, country: United States, contacts name: Marc Shay, Site 0119, role: CONTACT, phone: 603-319-8863, geoPoint lat: 43.07176, lon: -70.76255, locations facility: Princeton Medical Institute, status: NOT_YET_RECRUITING, city: Princeton, state: New Jersey, zip: 08540-2859, country: United States, contacts name: Sanjay Varma, Site 0031, role: CONTACT, phone: 609-921-3555, geoPoint lat: 40.34872, lon: -74.65905, locations facility: Advanced Memory Research Institute of NJ, status: NOT_YET_RECRUITING, city: Toms River, state: New Jersey, zip: 08755-5043, country: United States, contacts name: Sanjiv Sharma, Site 0062, role: CONTACT, phone: 732-341-9500, geoPoint lat: 39.95373, lon: -74.19792, locations facility: Neurology Specialists of Monmouth County, PA, status: NOT_YET_RECRUITING, city: West Long Branch, state: New Jersey, zip: 07764-1021, country: United States, contacts name: Noah Gilson, Site 0130, role: CONTACT, phone: 732-935-1850, geoPoint lat: 40.29039, lon: -74.01764, locations facility: Neurological Associates of Albany, P.C., status: NOT_YET_RECRUITING, city: Albany, state: New York, zip: 12208-3464, country: United States, contacts name: Richard Holub, Site 0060, role: CONTACT, phone: 518-426-0575, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Local Institution - 0157, status: NOT_YET_RECRUITING, city: Amherst, state: New York, zip: 14226-1727, country: United States, contacts name: Site 0157, role: CONTACT, geoPoint lat: 42.97839, lon: -78.79976, locations facility: The Feinstein Institute for Medical Research, status: NOT_YET_RECRUITING, city: Manhasset, state: New York, zip: 11030-3816, country: United States, contacts name: Marc Gordon, Site 0061, role: CONTACT, phone: 516-562-3492, geoPoint lat: 40.79788, lon: -73.69957, locations facility: Neurological Associates of Long Island, status: NOT_YET_RECRUITING, city: New Hyde Park, state: New York, zip: 11042-1028, country: United States, contacts name: David Podwall, Site 0107, role: CONTACT, phone: 516-466-4700, geoPoint lat: 40.7351, lon: -73.68791, locations facility: Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029-6504, country: United States, contacts name: Laili Soleimani, Site 0104, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University Medical Center - The Neurological Institute of New York, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10032-3726, country: United States, contacts name: Lawrence Honig, Site 0133, role: CONTACT, phone: 212-305-0851, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Local Institution - 0095, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 11220, country: United States, contacts name: Site 0095, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Alzheimer's Memory Center, status: NOT_YET_RECRUITING, city: Matthews, state: North Carolina, zip: 28105-8336, country: United States, contacts name: Mohammad Bolouri, Site 0043, role: CONTACT, phone: 7043644000225, geoPoint lat: 35.11681, lon: -80.72368, locations facility: Local Institution - 0155, status: NOT_YET_RECRUITING, city: Beachwood, state: Ohio, zip: 44122, country: United States, contacts name: Site 0155, role: CONTACT, geoPoint lat: 41.4645, lon: -81.50873, locations facility: Abington Neurological Associates (ANA), status: NOT_YET_RECRUITING, city: Abington, state: Pennsylvania, zip: 19001-3816, country: United States, contacts name: David Weisman, Site 0057, role: CONTACT, phone: 215-886-7000, geoPoint lat: 40.12067, lon: -75.11795, locations facility: Hospital of the University of Pennsylvania, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Sanjeev Vaishnavi, Site 0032, role: CONTACT, phone: 215-662-7810, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Keystone Clinical Studies, LLC, status: RECRUITING, city: Plymouth Meeting, state: Pennsylvania, zip: 19462-7401, country: United States, contacts name: Cherian Verghese, Site 0023, role: CONTACT, geoPoint lat: 40.10233, lon: -75.27435, locations facility: Rhode Island Mood & Memory Research Institute, status: NOT_YET_RECRUITING, city: East Providence, state: Rhode Island, zip: 02914-1318, country: United States, contacts name: John Stoukides, Site 0024, role: CONTACT, phone: 401-435-8950, geoPoint lat: 41.81371, lon: -71.37005, locations facility: Rhode Island Hospital - Alzheimer's Disease and Memory Disorders Center, status: NOT_YET_RECRUITING, city: Providence, state: Rhode Island, zip: 02903-4923, country: United States, contacts name: Chuang-Kuo Wu, Site 0098, role: CONTACT, phone: 401-444-5742, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Local Institution - 0163, status: NOT_YET_RECRUITING, city: Providence, state: Rhode Island, zip: 02906-4800, country: United States, contacts name: Site 0163, role: CONTACT, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Neurology Clinic, P.C. - Germantown Park Location, status: NOT_YET_RECRUITING, city: Cordova, state: Tennessee, zip: 38018-4254, country: United States, contacts name: Kendrick Henderson, Site 0132, role: CONTACT, phone: 901-866-9252, geoPoint lat: 35.15565, lon: -89.7762, locations facility: Local Institution - 0140, status: NOT_YET_RECRUITING, city: Franklin, state: Tennessee, zip: 37067-5922, country: United States, contacts name: Site 0140, role: CONTACT, geoPoint lat: 35.92506, lon: -86.86889, locations facility: Senior Adults Specialty Research, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78757-8046, country: United States, contacts name: Jaron Winston, Site 0069, role: CONTACT, phone: 512-476-3556, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Gadolin Research, status: NOT_YET_RECRUITING, city: Beaumont, state: Texas, zip: 77702, country: United States, contacts name: Kandasami Senthilkumar, Site 0033, role: CONTACT, phone: 409-331-6040, geoPoint lat: 30.08605, lon: -94.10185, locations facility: Kerwin Research Center and Memory Care, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75231-4316, country: United States, contacts name: Diana Kerwin, Site 0051, role: CONTACT, phone: 972-433-9100, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Neurology Consultants of Dallas, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75243-1288, country: United States, contacts name: Duc Tran, Site 0134, role: CONTACT, phone: 214-750-0322, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Baylor College of Medicine, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Melissa Yu, Site 0041, role: CONTACT, phone: 713-798-6107, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Memorial Neurological Association - Main Office, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77074-1812, country: United States, contacts name: Nelson Berrios, Site 0016, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Central Texas Neurology Consultants (CTNC), status: NOT_YET_RECRUITING, city: Round Rock, state: Texas, zip: 78681-3578, country: United States, contacts name: Elizabeth Peckham, Site 0129, role: CONTACT, phone: 512-218-1222, geoPoint lat: 30.50826, lon: -97.6789, locations facility: Be Well MD, status: NOT_YET_RECRUITING, city: Round Rock, state: Texas, zip: 78681-3596, country: United States, contacts name: Mark Carlson, Site 0028, role: CONTACT, geoPoint lat: 30.50826, lon: -97.6789, locations facility: Local Institution - 0168, status: NOT_YET_RECRUITING, city: Richmond, state: Virginia, zip: 23294, country: United States, contacts name: Site 0168, role: CONTACT, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Local Institution - 0065, status: NOT_YET_RECRUITING, city: Madison, state: Wisconsin, zip: 53792, country: United States, contacts name: Site 0065, role: CONTACT, geoPoint lat: 43.07305, lon: -89.40123, locations facility: Local Institution - 0002, status: NOT_YET_RECRUITING, city: Darlinghurst, state: New South Wales, zip: 2010, country: Australia, contacts name: Site 0002, role: CONTACT, geoPoint lat: -33.87939, lon: 151.21925, locations facility: Local Institution - 0111, status: NOT_YET_RECRUITING, city: East Gosford, state: New South Wales, zip: 2250, country: Australia, contacts name: Site 0111, role: CONTACT, geoPoint lat: -33.43874, lon: 151.35338, locations facility: Local Institution - 0170, status: NOT_YET_RECRUITING, city: Macquarie Park, state: New South Wales, zip: 2113, country: Australia, contacts name: Site 0170, role: CONTACT, geoPoint lat: -33.7751, lon: 151.11272, locations facility: Local Institution - 0116, status: NOT_YET_RECRUITING, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: Site 0116, role: CONTACT, geoPoint lat: -27.96724, lon: 153.39796, locations facility: Local Institution - 0115, status: NOT_YET_RECRUITING, city: Carlton North, state: Victoria, zip: 3053, country: Australia, contacts name: Site 0115, role: CONTACT, geoPoint lat: -37.78333, lon: 144.96667, locations facility: Local Institution - 0093, status: NOT_YET_RECRUITING, city: Heidelberg, state: Victoria, zip: 3084, country: Australia, contacts name: Site 0093, role: CONTACT, geoPoint lat: -37.75, lon: 145.06667, locations facility: Local Institution - 0001, status: NOT_YET_RECRUITING, city: Malvern, state: Victoria, zip: 3144, country: Australia, contacts name: Site 0001, role: CONTACT, geoPoint lat: -32.02849, lon: 151.32225, locations facility: Local Institution - 0125, status: NOT_YET_RECRUITING, city: Melbourne, state: Victoria, zip: 03181, country: Australia, contacts name: Site 0125, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, locations facility: Local Institution - 0147, status: NOT_YET_RECRUITING, city: Parkville, state: Victoria, zip: 3050, country: Australia, contacts name: Site 0147, role: CONTACT, geoPoint lat: -37.78333, lon: 144.95, locations facility: Local Institution - 0094, status: NOT_YET_RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Site 0094, role: CONTACT, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Local Institution - 0122, status: NOT_YET_RECRUITING, city: Anderlecht, state: Brussels, zip: 1070, country: Belgium, contacts name: Site 0122, role: CONTACT, geoPoint lat: 50.83619, lon: 4.31454, locations facility: Local Institution - 0175, status: NOT_YET_RECRUITING, city: Antwerpen, state: Brussel, zip: 2018, country: Belgium, contacts name: Site 0175, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, locations facility: Local Institution - 0074, status: NOT_YET_RECRUITING, city: Brussel, state: BRU, zip: 1020, country: Belgium, contacts name: Site 0074, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Local Institution - 0082, status: NOT_YET_RECRUITING, city: Kortrijk, state: VWV, zip: 8500, country: Belgium, contacts name: Site 0082, role: CONTACT, geoPoint lat: 50.82803, lon: 3.26487, locations facility: Local Institution - 0078, status: NOT_YET_RECRUITING, city: Liege, state: WLG, zip: 4000, country: Belgium, contacts name: Site 0078, role: CONTACT, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Local Institution - 0097, status: NOT_YET_RECRUITING, city: Brussels, zip: 1200, country: Belgium, contacts name: Site 0097, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Local Institution - 0076, status: NOT_YET_RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Site 0076, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, locations facility: Local Institution - 0064, status: NOT_YET_RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 4N7, country: Canada, contacts name: Site 0064, role: CONTACT, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Local Institution - 0049, status: NOT_YET_RECRUITING, city: West Vancouver, state: British Columbia, zip: V7T 2Z3, country: Canada, contacts name: Site 0049, role: CONTACT, geoPoint lat: 49.36672, lon: -123.16652, locations facility: Local Institution - 0112, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, zip: K1Z 8R7, country: Canada, contacts name: Site 0112, role: CONTACT, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Local Institution - 0162, status: NOT_YET_RECRUITING, city: Peterborough, state: Ontario, zip: K9H 2P4, country: Canada, contacts name: Site 0162, role: CONTACT, geoPoint lat: 44.30012, lon: -78.31623, locations facility: Local Institution - 0047, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M3B 2S7, country: Canada, contacts name: Site 0047, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Local Institution - 0044, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5T 2S8, country: Canada, contacts name: Site 0044, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Local Institution - 0109, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M6A 2E1, country: Canada, contacts name: Site 0109, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Local Institution - 0113, status: NOT_YET_RECRUITING, city: Greenfield Park, state: Quebec, zip: J4V 2J2, country: Canada, contacts name: Site 0113, role: CONTACT, geoPoint lat: 45.48649, lon: -73.46223, locations facility: Local Institution - 0030, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H4H 1R3, country: Canada, contacts name: Site 0030, role: CONTACT, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Local Institution - 0075, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H4H 1R3, country: Canada, contacts name: Site 0075, role: CONTACT, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Local Institution - 0053, status: NOT_YET_RECRUITING, city: Quebec, zip: G3K 2P8, country: Canada, contacts name: Site 0053, role: CONTACT, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Local Institution - 0072, status: NOT_YET_RECRUITING, city: Aarhus N, state: Aarhus, zip: 8200, country: Denmark, contacts name: Site 0072, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Local Institution - 0085, status: NOT_YET_RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Site 0085, role: CONTACT, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Local Institution - 0166, status: NOT_YET_RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Site 0166, role: CONTACT, geoPoint lat: 55.47028, lon: 8.45187, locations facility: Local Institution - 0108, status: NOT_YET_RECRUITING, city: Angers, zip: 49933, country: France, contacts name: Site 0108, role: CONTACT, geoPoint lat: 47.46667, lon: -0.55, locations facility: Local Institution - 0066, status: NOT_YET_RECRUITING, city: Limoges cedex, zip: 87042, country: France, contacts name: Site 0066, role: CONTACT, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Local Institution - 0086, status: NOT_YET_RECRUITING, city: Nantes, zip: 44093, country: France, contacts name: Site 0086, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Local Institution - 0067, status: NOT_YET_RECRUITING, city: Paris, zip: 75010, country: France, contacts name: Site 0067, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Local Institution - 0084, status: NOT_YET_RECRUITING, city: Rouen, zip: 76000, country: France, contacts name: Site 0084, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Local Institution - 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protocolSection identificationModule nctId: NCT06268873, orgStudyIdInfo id: D6972C00003, briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2027-12-10, completionDateStruct date: 2027-12-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued., conditionsModule conditions: Chronic Kidney Disease and Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Placebo controlled, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Baxdrostat/dapagliflozin, interventions name: Dapagliflozin in combination with placebo, outcomesModule primaryOutcomes measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time., secondaryOutcomes measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio)., secondaryOutcomes measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP., secondaryOutcomes measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease)., secondaryOutcomes measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fairhope, state: Alabama, zip: 36532, country: United States, geoPoint lat: 30.52297, lon: -87.90333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85016, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Surprise, state: Arizona, zip: 85374, country: United States, geoPoint lat: 33.63059, lon: -112.33322, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Searcy, state: Arkansas, zip: 72143, country: United States, geoPoint lat: 35.25064, lon: -91.73625, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beverly Hills, state: California, zip: 90211, country: United States, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Canyon Country, state: California, zip: 91351, country: United States, geoPoint lat: 34.42333, lon: -118.47203, locations facility: Research Site, status: RECRUITING, city: Fullerton, state: California, zip: 92835, country: United States, geoPoint lat: 33.87029, lon: -117.92534, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Huntington Park, state: California, zip: 90255, country: United States, geoPoint lat: 33.98168, lon: -118.22507, locations facility: Research Site, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94110, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, 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Pontiac, state: Michigan, zip: 48341, country: United States, geoPoint lat: 42.63892, lon: -83.29105, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint Joseph, state: Michigan, zip: 49085, country: United States, geoPoint lat: 42.10976, lon: -86.48002, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Columbia, state: Missouri, zip: 65201, country: United States, geoPoint lat: 38.95171, lon: -92.33407, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64111, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64128, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64151, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: 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North Carolina, zip: 28546, country: United States, geoPoint lat: 34.75405, lon: -77.43024, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New Bern, state: North Carolina, zip: 28562, country: United States, geoPoint lat: 35.10849, lon: -77.04411, locations facility: Research Site, status: RECRUITING, city: Statesville, state: North Carolina, zip: 28625, country: United States, geoPoint lat: 35.78264, lon: -80.8873, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wilmington, state: North Carolina, zip: 28412, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Columbus, state: Ohio, zip: 43215, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roseburg, state: Oregon, zip: 97471, country: United States, geoPoint lat: 43.2165, lon: -123.34174, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chester, state: Pennsylvania, zip: 19013, country: United States, geoPoint lat: 39.84967, lon: -75.35707, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Langhorne, state: Pennsylvania, zip: 19047, country: United States, geoPoint lat: 40.17455, lon: -74.92267, locations facility: Research Site, status: RECRUITING, city: Uniontown, state: Pennsylvania, zip: 15401, country: United States, geoPoint lat: 39.90008, lon: -79.71643, locations facility: Research Site, status: NOT_YET_RECRUITING, city: East Providence, state: Rhode Island, zip: 02914, country: United States, geoPoint lat: 41.81371, lon: -71.37005, locations facility: Research Site, status: NOT_YET_RECRUITING, city: East Providence, state: Rhode Island, zip: 02915, country: United States, geoPoint lat: 41.81371, lon: -71.37005, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Providence, state: Rhode Island, zip: 02904, country: United States, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Columbia, state: South Carolina, zip: 29203, country: United States, geoPoint lat: 34.00071, lon: -81.03481, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sioux Falls, state: South Dakota, zip: 57103, country: United States, geoPoint lat: 43.54997, lon: -96.70033, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kingsport, state: Tennessee, zip: 37660, country: United States, geoPoint lat: 36.54843, lon: -82.56182, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Memphis, state: Tennessee, zip: 38105, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Memphis, state: Tennessee, zip: 38115, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Research Site, status: RECRUITING, city: Arlington, state: Texas, zip: 76015, country: United States, geoPoint lat: 32.73569, lon: -97.10807, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78751, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75246, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Research Site, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: RECRUITING, city: Houston, state: Texas, zip: 77040, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77084, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77099, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Humble, state: Texas, zip: 77338, country: United States, geoPoint lat: 29.99883, lon: -95.26216, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lewisville, state: Texas, zip: 75057, country: United States, geoPoint lat: 33.04623, lon: -96.99417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Odessa, state: Texas, zip: 79761, country: United States, geoPoint lat: 31.84568, lon: -102.36764, locations facility: Research Site, status: RECRUITING, city: Pasadena, state: Texas, zip: 77504, country: United States, geoPoint lat: 29.69106, lon: -95.2091, locations facility: Research Site, status: RECRUITING, city: San Antonio, state: Texas, zip: 78212, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Antonio, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84115, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Manassas, state: Virginia, zip: 20110, country: United States, geoPoint lat: 38.75095, lon: -77.47527, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Richmond, state: Virginia, zip: 23249, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Salem, state: Virginia, zip: 24153, country: United States, geoPoint lat: 37.29347, lon: -80.05476, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Woodbridge, state: Virginia, zip: 22192, country: United States, geoPoint lat: 38.65817, lon: -77.2497, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Buenos Aires, zip: ARG 1425, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Caba, zip: 1061, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Caba, zip: C1061, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Caba, zip: C1120AAC, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ciudad Autonoma de Bs As, zip: C1013AAB, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cordoba, zip: X5006CBI, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Research Site, status: NOT_YET_RECRUITING, city: La Plata, zip: B1900AVG, country: Argentina, geoPoint lat: -34.92145, lon: -57.95453, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mar del Plata, zip: 7600, country: Argentina, geoPoint lat: -38.00228, lon: -57.55754, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mar del Plata, zip: B7600, country: Argentina, geoPoint lat: -38.00228, lon: -57.55754, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mendoza, zip: M5500, country: Argentina, geoPoint lat: -32.89084, lon: -68.82717, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Nicolás, zip: B2900DMH, country: Argentina, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Birtinya, zip: 4575, country: Australia, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Clayton, zip: 3168, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gosford, zip: 2250, country: Australia, geoPoint lat: -33.4244, lon: 151.34399, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kogarah, zip: 2217, country: Australia, geoPoint lat: -33.98333, lon: 151.11667, locations facility: Research Site, status: SUSPENDED, city: Parkville, zip: 3050, country: Australia, geoPoint lat: -37.78333, lon: 144.95, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Perth, zip: 6000, country: Australia, geoPoint lat: -31.95224, lon: 115.8614, locations facility: Research Site, status: NOT_YET_RECRUITING, city: St Leonards, zip: 2065, country: Australia, geoPoint lat: -33.82344, lon: 151.19836, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wollongong, zip: 2500, country: Australia, geoPoint lat: -34.424, lon: 150.89345, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aalst, zip: 9300, country: Belgium, geoPoint lat: 50.93604, lon: 4.0355, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bonheiden, zip: 2820, country: Belgium, geoPoint lat: 51.02261, lon: 4.54714, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brussel, zip: 1200, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gent, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ieper, zip: 8900, country: Belgium, geoPoint lat: 50.85114, lon: 2.88569, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kortrijk, zip: 8500, country: Belgium, geoPoint lat: 50.82803, lon: 3.26487, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leuven, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Liege, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Liège, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Roeselare, zip: 8800, country: Belgium, geoPoint lat: 50.94653, lon: 3.12269, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ronse, zip: 9600, country: Belgium, geoPoint lat: 50.74574, lon: 3.6005, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Belem, zip: 66073-005, country: Brazil, geoPoint lat: -1.45583, lon: -48.50444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Campina Grande do Sul, zip: 83.430-000, country: Brazil, geoPoint lat: -25.30556, lon: -49.05528, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Campinas, zip: 13060-080, country: Brazil, geoPoint lat: -22.90556, lon: -47.06083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Campinas, zip: 13060-904, country: Brazil, geoPoint lat: -22.90556, lon: -47.06083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Curitiba, zip: 80230-130, country: Brazil, geoPoint lat: -25.42778, lon: -49.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Curitiba, zip: 80440-020, country: Brazil, geoPoint lat: -25.42778, lon: -49.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fortaleza, zip: 60175-047, country: Brazil, geoPoint lat: -3.71722, lon: -38.54306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Joinville, zip: 89227-680, country: Brazil, geoPoint lat: -26.30444, lon: -48.84556, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Maringá, zip: 87060-040, country: Brazil, geoPoint lat: -23.42528, lon: -51.93861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 90035-074, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Porto Alegre, zip: 90160-093, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sao Jose Do Rio Preto, zip: 15090-000, country: Brazil, geoPoint lat: -20.81972, lon: -49.37944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sao Paulo, zip: 05403-9000, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Research Site, status: NOT_YET_RECRUITING, city: São Paulo, zip: 04012-180, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Research Site, status: NOT_YET_RECRUITING, city: São Paulo, zip: 04038-031, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dupnitsa, zip: 2600, country: Bulgaria, geoPoint lat: 42.26667, lon: 23.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gotse Delchev, zip: 2900, country: Bulgaria, geoPoint lat: 41.56667, lon: 23.73333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kozloduy, zip: 3320, country: Bulgaria, geoPoint lat: 43.77867, lon: 23.72067, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lom, zip: 3600, country: Bulgaria, geoPoint lat: 43.81389, lon: 23.23611, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pleven, zip: 5800, country: Bulgaria, geoPoint lat: 43.41667, lon: 24.61667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plovdiv, zip: 4000, country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Plovdiv, zip: 4004, country: Bulgaria, geoPoint lat: 42.15, lon: 24.75, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sandanski, zip: 2800, country: Bulgaria, geoPoint lat: 41.56667, lon: 23.28333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sliven, zip: 8800, country: Bulgaria, geoPoint lat: 42.68583, lon: 26.32917, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Stara Zagora, zip: 6000, country: Bulgaria, geoPoint lat: 42.43278, lon: 25.64194, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Veliko Tarnovo, zip: 5000, country: Bulgaria, geoPoint lat: 43.08124, lon: 25.62904, locations facility: Research Site, status: WITHDRAWN, city: Yambol, zip: 8600, country: Bulgaria, geoPoint lat: 42.48333, lon: 26.5, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yambol, zip: 8600, country: Bulgaria, geoPoint lat: 42.48333, lon: 26.5, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vancouver, state: British Columbia, zip: V6Z 1Y6, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Winnipeg, state: Manitoba, zip: R2V 3M3, country: Canada, geoPoint lat: 49.8844, lon: -97.14704, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Halifax, state: Nova Scotia, zip: B3H 1V7, country: Canada, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sydney, state: Nova Scotia, zip: B1P 1P3, country: Canada, geoPoint lat: 46.13511, lon: -60.1831, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brampton, state: Ontario, zip: L6S 0C6, country: Canada, geoPoint lat: 43.68341, lon: -79.76633, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Concord, state: Ontario, zip: L4K 4M2, country: Canada, geoPoint lat: 43.80011, lon: -79.48291, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, state: Ontario, zip: N6A 5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oshawa, state: Ontario, zip: L1G 2B9, country: Canada, geoPoint lat: 43.90012, lon: -78.84957, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M4G 3E8, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, status: RECRUITING, city: Waterloo, state: Ontario, zip: N2T 0C1, country: Canada, geoPoint lat: 43.4668, lon: -80.51639, locations facility: Research Site, status: RECRUITING, city: Laval, state: Quebec, zip: H7T 2P5, country: Canada, geoPoint lat: 45.56995, lon: -73.692, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sherbrooke, state: Quebec, zip: J1H 5N4, country: Canada, geoPoint lat: 45.40008, lon: -71.89908, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quebec, zip: G1R 2J6, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint John, zip: E2L 4L2, country: Canada, geoPoint lat: 45.2727, lon: -66.06769, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Araucania, zip: 4781151, country: Chile, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santiago, zip: 7500922, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Valdivia, zip: 5090000, country: Chile, geoPoint lat: -39.81422, lon: -73.24589, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Victoria, zip: 4720097, country: Chile, geoPoint lat: -38.23291, lon: -72.33292, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Baotou, zip: 014010, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100034, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100035, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 102218, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changzhou, zip: 272100, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610072, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chongqing, zip: 402260, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chuangchun, zip: 130041, country: China, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dongguan, zip: 523009, country: China, geoPoint lat: 23.01797, lon: 113.74866, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Foshan, zip: 528000, country: China, geoPoint lat: 23.02677, lon: 113.13148, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510800, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guiyang, zip: 550004, country: China, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310014, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hengyang, zip: 50012, country: China, geoPoint lat: 26.88946, lon: 112.61888, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Huai'an, zip: 223300, country: China, geoPoint lat: 33.50389, lon: 119.14417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lanzhou, zip: 730000, country: China, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanchang, zip: 330008, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanjing, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ningbo, zip: 315010, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Panjin, zip: 124009, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pingxiang, zip: 337055, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sanya, zip: 572000, country: China, geoPoint lat: 18.24306, lon: 109.505, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200240, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110004, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenzhen, zip: 518036, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Urumqi, zip: 831118, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430010, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuxi, zip: 214023, country: China, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xiamen, zip: 361004, country: China, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xian, zip: 710061, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yantai, zip: 264000, country: China, geoPoint lat: 37.47649, lon: 121.44081, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Frýdek-Místek, zip: 738 01, country: Czechia, geoPoint lat: 49.68333, lon: 18.35, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jilemnice, zip: 514 01, country: Czechia, geoPoint lat: 50.6089, lon: 15.50653, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Krnov, zip: 794 01, country: Czechia, geoPoint lat: 50.08967, lon: 17.70385, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nachod, zip: 547 01, country: Czechia, geoPoint lat: 50.4167, lon: 16.16289, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Olomouc, zip: 772 00, country: Czechia, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Police nad Metují, zip: 549 54, country: Czechia, geoPoint lat: 50.53687, lon: 16.2335, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Praha 10, zip: 104 00, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Praha 4, zip: 140 21, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Praha 6, zip: 160 00, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Trebic, zip: 674 01, country: Czechia, geoPoint lat: 49.21492, lon: 15.88166, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Uherske Hradiste, zip: 686 01, country: Czechia, geoPoint lat: 49.06975, lon: 17.45969, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aalborg, zip: 9000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, locations facility: Research Site, status: WITHDRAWN, city: Aarhus N, zip: 8200, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aarhus, zip: 8200, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Copenhagen E, zip: 2100, country: Denmark, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, geoPoint lat: 55.47028, lon: 8.45187, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Herlev, zip: 2730, country: Denmark, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Herning, zip: 7400, country: Denmark, geoPoint lat: 56.13932, lon: 8.97378, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Holbæk, zip: 4300, country: Denmark, geoPoint lat: 55.71354, lon: 11.7169, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Amiens Cedex 1, zip: 80054, country: France, geoPoint lat: 49.9, lon: 2.3, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Annonay Cedex, zip: 07103, country: France, geoPoint lat: 45.23969, lon: 4.67075, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bordeaux cedex, zip: 33076, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brest Cedex, zip: 29200, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Clermont Ferrand, zip: 63003, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Research Site, status: NOT_YET_RECRUITING, city: La Roche Sur Yon, zip: 85925, country: France, geoPoint lat: 46.66667, lon: -1.43333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Le Puy-en-Velay, zip: 43000, country: France, geoPoint lat: 45.04366, lon: 3.88523, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lille Cedex, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marseille cedex 6, zip: 13291, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marseille, zip: 13005, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Montpellier, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nimes, zip: 30029, country: France, geoPoint lat: 43.83333, lon: 4.35, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Paris, zip: 75020, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Poitiers, zip: 86021, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pontoise, zip: 95300, country: France, geoPoint lat: 49.05, lon: 2.1, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quimper cedex, zip: 29000, country: France, geoPoint lat: 48.0, lon: -4.1, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sarcelles, zip: 95200, country: France, geoPoint lat: 49.0, lon: 2.38333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toulouse, zip: 31400, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tours, zip: 37000, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Valenciennes, zip: 59300, country: France, geoPoint lat: 50.35, lon: 3.53333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vandoeuvre les Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Aachen, zip: 52074, country: Germany, geoPoint lat: 50.77664, lon: 6.08342, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Amberg, zip: 92224, country: Germany, geoPoint lat: 49.44287, lon: 11.86267, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bad Oeynhausen, zip: 32545, country: Germany, geoPoint lat: 52.20699, lon: 8.80365, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 12203, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 13187, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 13353, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dresden, zip: 1307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Essen, zip: 45355, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Falkensee, zip: 14612, country: Germany, geoPoint lat: 52.56014, lon: 13.0927, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hamburg, zip: 22607, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Herne, zip: 44625, country: Germany, geoPoint lat: 51.5388, lon: 7.22572, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kaiserslautern, zip: 67655, country: Germany, geoPoint lat: 49.443, lon: 7.77161, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04209, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mainz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mannheim, zip: 68167, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Research Site, status: NOT_YET_RECRUITING, city: München, zip: 81675, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Münster, zip: 48145, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nürnberg, zip: 90443, country: Germany, geoPoint lat: 49.45421, lon: 11.07752, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oldenburg, zip: 23758, country: Germany, geoPoint lat: 53.14118, lon: 8.21467, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Reinfeld (Holstein), zip: 23858, country: Germany, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Schwerin, zip: 19055, country: Germany, geoPoint lat: 53.62937, lon: 11.41316, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ulm, zip: 89081, country: Germany, geoPoint lat: 48.39841, lon: 9.99155, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Völklingen, zip: 66333, country: Germany, geoPoint lat: 49.25162, lon: 6.85873, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wiesbaden, zip: 65191, country: Germany, geoPoint lat: 50.08258, lon: 8.24932, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Witten, zip: 58455, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Alexandroupolis, zip: 68100, country: Greece, geoPoint lat: 40.84995, lon: 25.87644, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Athens, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Heraclion, zip: 71500, country: Greece, geoPoint lat: 35.32787, lon: 25.14341, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ioannina, zip: 45500, country: Greece, geoPoint lat: 39.66486, lon: 20.85189, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Patras, zip: 26504, country: Greece, geoPoint lat: 38.24444, lon: 21.73444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Thessaloniki, zip: 54636, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Thessaloniki, zip: 54642, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Budapest, zip: 1115, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Békéscsaba, zip: 5600, country: Hungary, geoPoint lat: 46.68333, lon: 21.1, locations facility: Research Site, status: WITHDRAWN, city: Dunaújváros, zip: 2400, country: Hungary, geoPoint lat: 46.96498, lon: 18.93923, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kecskemét, zip: 6000, country: Hungary, geoPoint lat: 46.90618, lon: 19.69128, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nyíregyháza, zip: 4400, country: Hungary, geoPoint lat: 47.95539, lon: 21.71671, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pécs, zip: 7624, country: Hungary, geoPoint lat: 46.08333, lon: 18.23333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pécs, zip: 7635, country: Hungary, geoPoint lat: 46.08333, lon: 18.23333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Siófok, zip: 8600, country: Hungary, geoPoint lat: 46.90413, lon: 18.058, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Székesfehérvár, zip: 8000, country: Hungary, geoPoint lat: 47.18995, lon: 18.41034, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ahmedabad, zip: 380006, country: India, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bangalore, zip: 560 092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Belagavi, zip: 590010, country: India, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Calicut, zip: 673 008, country: India, geoPoint lat: 11.24802, lon: 75.7804, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chennai, zip: 600037, country: India, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dehradun, zip: 248001, country: India, geoPoint lat: 30.32295, lon: 78.03168, locations facility: Research Site, status: SUSPENDED, city: Hyderabad, zip: 500035, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hyderabad, zip: 500038, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Research Site, status: SUSPENDED, city: Jodhpur, zip: 342005, country: India, geoPoint lat: 26.26841, lon: 73.00594, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kolkata, zip: 700020, country: India, geoPoint lat: 22.56263, lon: 88.36304, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mohali, zip: 160055, country: India, geoPoint lat: 30.67995, lon: 76.72211, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New Delhi, zip: 11029, country: India, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vijayawada, zip: 520 008, country: India, geoPoint lat: 16.50745, lon: 80.6466, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ashkelon, zip: 78278, country: Israel, geoPoint lat: 31.66926, lon: 34.57149, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Haifa, zip: 34362, country: Israel, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jerusalem, zip: 9372212, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kfar Saba, zip: 44410, country: Israel, geoPoint lat: 32.175, lon: 34.90694, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Petah Tikva, zip: 49372, country: Israel, geoPoint lat: 32.08707, lon: 34.88747, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ramat Gan, zip: 52621, country: Israel, geoPoint lat: 32.08227, lon: 34.81065, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rehovot, zip: 76100, country: Israel, geoPoint lat: 31.89421, lon: 34.81199, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tel Aviv, zip: 6423906, country: Israel, geoPoint lat: 32.08088, lon: 34.78057, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bologna, zip: 40138, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Catanzaro, zip: 88100, country: Italy, geoPoint lat: 38.88247, lon: 16.60086, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chiavari, zip: 16034, country: Italy, geoPoint lat: 44.31771, lon: 9.32241, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Desio, zip: 20832, country: Italy, geoPoint lat: 45.61831, lon: 9.20249, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milano, zip: 20142, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Napoli, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Parma, zip: 43126, country: Italy, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rozzano, zip: 20089, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Giovanni Rotondo, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Torino, zip: 10126, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chuo-ku, zip: 103-0002, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chuo-ku, zip: 103-0027, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chuo-ku, zip: 103-0028, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Daito-shi, zip: 574-0074, country: Japan, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fujisawa-shi, zip: 251-8550, country: Japan, geoPoint lat: 35.34926, lon: 139.47666, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fukuoka-shi, zip: 815-8555, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hiroshima-shi, zip: 730-8518, country: Japan, geoPoint lat: 34.4, lon: 132.45, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hiroshima, zip: 732-0057, country: Japan, geoPoint lat: 34.4, lon: 132.45, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ina-shi, zip: 396-8555, country: Japan, geoPoint lat: 35.82756, lon: 137.95378, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kamakura-shi, zip: 247-0056, country: Japan, geoPoint lat: 35.30889, lon: 139.55028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kamakura-shi, zip: 247-8533, country: Japan, geoPoint lat: 35.30889, lon: 139.55028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kasugai-shi, zip: 486-8510, country: Japan, geoPoint lat: 35.24762, lon: 136.97229, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kawaguchi, zip: 332-0015, country: Japan, geoPoint lat: 35.80521, lon: 139.71072, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kofu-shi, zip: 400-8506, country: Japan, geoPoint lat: 35.66669, lon: 138.56668, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kumagaya-shi, zip: 360-0197, country: Japan, geoPoint lat: 36.13497, lon: 139.39004, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marugame-shi, zip: 763-8502, country: Japan, geoPoint lat: 34.28333, lon: 133.78333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Matsuyama-city, zip: 790-0024, country: Japan, geoPoint lat: 33.83916, lon: 132.76574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Naka, zip: 311-0113, country: Japan, geoPoint lat: 36.05, lon: 140.16667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nishinomiya-Shi, zip: 662-0918, country: Japan, geoPoint lat: 34.71562, lon: 135.33199, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Obihiro-shi, zip: 080-0848, country: Japan, geoPoint lat: 42.91722, lon: 143.20444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oita-shi, zip: 870-0033, country: Japan, geoPoint lat: 33.23333, lon: 131.6, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Osaka-shi, zip: 553-0003, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Osaka, zip: 553-0003, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sapporo, zip: 064-8570, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shinjyuku-ku, zip: 160-0022, country: Japan, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shizuoka-shi, zip: 421-0117, country: Japan, geoPoint lat: 34.98333, lon: 138.38333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Takatsuki-shi, zip: 569-8686, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toride-shi, zip: 302-0022, country: Japan, geoPoint lat: 35.9, lon: 140.08333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toyota-Shi, zip: 471-8513, country: Japan, geoPoint lat: 35.08333, lon: 137.15, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tsu-shi, zip: 514-8507, country: Japan, geoPoint lat: 34.73333, lon: 136.51667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ueda-shi, zip: 386-8610, country: Japan, geoPoint lat: 36.40265, lon: 138.28161, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Urayasu, zip: 279-0001, country: Japan, geoPoint lat: 35.67054, lon: 139.88862, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yaizu-shi, zip: 425-8505, country: Japan, geoPoint lat: 34.86876, lon: 138.31951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Goyang-si, zip: 10380, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 03312, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 06273, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seoul, zip: 07061, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Uijeongbu, zip: 11765, country: Korea, Republic of, geoPoint lat: 37.7415, lon: 127.0474, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wonju-si, zip: 26426, country: Korea, Republic of, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yangsan-si, zip: 50612, country: Korea, Republic of, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Klang, zip: 41200, country: Malaysia, geoPoint lat: 3.03333, lon: 101.45, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kota Kinabalu, zip: 88200, country: Malaysia, geoPoint lat: 5.9749, lon: 116.0724, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuala Lumpur, zip: 50586, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuala Lumpur, zip: 59100, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kuantan, zip: 25200, country: Malaysia, geoPoint lat: 3.8077, lon: 103.326, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Seremban, zip: 70300, country: Malaysia, geoPoint lat: 2.7297, lon: 101.9381, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taiping, zip: 34000, country: Malaysia, geoPoint lat: 4.85, lon: 100.73333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Alkmaar, zip: 1815 JD, country: Netherlands, geoPoint lat: 52.63167, lon: 4.74861, locations facility: Research Site, status: WITHDRAWN, city: Almere, zip: 1315 RA, country: Netherlands, geoPoint lat: 52.37535, lon: 5.25295, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Amersfoort, zip: 3813 TZ, country: Netherlands, geoPoint lat: 52.155, lon: 5.3875, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dordrecht, zip: 3318 AT, country: Netherlands, geoPoint lat: 51.81, lon: 4.67361, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hardenberg, zip: 7772 SE, country: Netherlands, geoPoint lat: 52.57583, lon: 6.61944, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Harderwijk, zip: 3844 DG, country: Netherlands, geoPoint lat: 52.34167, lon: 5.62083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hilversum, zip: 1213 XZ, country: Netherlands, geoPoint lat: 52.22333, lon: 5.17639, locations facility: Research Site, status: WITHDRAWN, city: Roosendaal, zip: 4708 AE, country: Netherlands, geoPoint lat: 51.53083, lon: 4.46528, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tilburg, zip: 5042AD, country: Netherlands, geoPoint lat: 51.55551, lon: 5.0913, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Utrecht, zip: 3584 CX, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Arequipa, zip: AREQUIPA01, country: Peru, geoPoint lat: -16.39889, lon: -71.535, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chorrillos, zip: Lima 9, country: Peru, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lima, zip: 15036, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lima, zip: 15046, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, status: NOT_YET_RECRUITING, city: LIma, zip: 15074, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lima, zip: 15088, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lima, zip: LIMA 01, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Piura, zip: 20001, country: Peru, geoPoint lat: -5.19449, lon: -80.63282, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cebu City, zip: 6000, country: Philippines, geoPoint lat: 10.31672, lon: 123.89071, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Davao City, zip: PH-8000, country: Philippines, geoPoint lat: 7.07306, lon: 125.61278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Iloilo City, zip: 5000, country: Philippines, geoPoint lat: 10.69694, lon: 122.56444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Laguna, zip: 4024, country: Philippines, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Manila, zip: 1000, country: Philippines, geoPoint lat: 14.6042, lon: 120.9822, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quezon City, zip: 1000, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Quezon City, zip: 1101, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, status: NOT_YET_RECRUITING, city: San Fernando, zip: 2000, country: Philippines, geoPoint lat: 15.03425, lon: 120.68445, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chrzanów, zip: 32-500, country: Poland, geoPoint lat: 50.13546, lon: 19.40203, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gdynia, zip: 81-157, country: Poland, geoPoint lat: 54.51889, lon: 18.53188, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Krakow, zip: 31-261, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 30-688, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 31-156, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 31-513, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 31-801, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lodz, zip: 91-211, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lublin, zip: 20-954, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Olsztyn, zip: 10-010, country: Poland, geoPoint lat: 53.77995, lon: 20.49416, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Poznań, zip: 60-355, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Poznań, zip: 61-848, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ruda Śląska, zip: 41-709, country: Poland, geoPoint lat: 50.2584, lon: 18.85632, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rzeszów, zip: 35-055, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Szczecin, zip: 70-111, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tczew, zip: 83-110, country: Poland, geoPoint lat: 54.09242, lon: 18.77787, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Warszawa, zip: 03-291, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wrocław, zip: 50-381, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wrocław, zip: 50-981, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wrocław, zip: 53-673, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Łódź, zip: 90-127, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Łódź, zip: 90-549, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Łódź, zip: 91-363, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Łódź, zip: 92-213, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Żywiec, zip: 34-300, country: Poland, geoPoint lat: 49.68529, lon: 19.19243, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bucharest, zip: 014461, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bucharest, zip: 022328, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bucharest, zip: 040883, country: Romania, geoPoint lat: 44.43225, lon: 26.10626, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bucuresti, zip: 010731, country: Romania, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cluj Napoca, zip: 400349, country: Romania, geoPoint lat: 46.76667, lon: 23.6, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Iasi, zip: 700503, country: Romania, geoPoint lat: 47.16667, lon: 27.6, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Targu Mures, zip: 540136, country: Romania, geoPoint lat: 46.54245, lon: 24.55747, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dammam, zip: 31444, country: Saudi Arabia, geoPoint lat: 26.43442, lon: 50.10326, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Riyadh, zip: 11426, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Riyadh, zip: 11462, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Riyadh, zip: 11525, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Riyadh, zip: 12713, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11120, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kragujevac, zip: 34000, country: Serbia, geoPoint lat: 44.01667, lon: 20.91667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nis, zip: 18000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Novi Sad, zip: 21000, country: Serbia, geoPoint lat: 45.25167, lon: 19.83694, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Banska Bystrica, zip: 974 01, country: Slovakia, geoPoint lat: 48.73946, lon: 19.15349, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dolný Kubín, zip: 02601, country: Slovakia, geoPoint lat: 49.20983, lon: 19.30341, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kosice, zip: 04001, country: Slovakia, geoPoint lat: 48.71395, lon: 21.25808, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lucenec, zip: 984 01, country: Slovakia, geoPoint lat: 48.33249, lon: 19.66708, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Myjava, zip: 90701, country: Slovakia, geoPoint lat: 48.75876, lon: 17.56866, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nitra, zip: 949 01, country: Slovakia, geoPoint lat: 48.30763, lon: 18.08453, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nitra, zip: 949 11, country: Slovakia, geoPoint lat: 48.30763, lon: 18.08453, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Presov, zip: 080 01, country: Slovakia, geoPoint lat: 48.99839, lon: 21.23393, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Puchov, zip: 020 01, country: Slovakia, geoPoint lat: 49.12494, lon: 18.32597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rožňava, zip: 048 01, country: Slovakia, geoPoint lat: 48.66009, lon: 20.53758, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Trnava, zip: 91708, country: Slovakia, geoPoint lat: 48.37741, lon: 17.58723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zilina, zip: 010 01, country: Slovakia, geoPoint lat: 49.22315, lon: 18.73941, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Benoni, zip: 1501, country: South Africa, geoPoint lat: -26.18848, lon: 28.32078, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bloemfontein, zip: 9301, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cape Town, zip: 7570, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cape Town, zip: 7925, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Durban, zip: 4001, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lenasia, zip: 1827, country: South Africa, geoPoint lat: -26.32052, lon: 27.83564, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Midrand, zip: 1685, country: South Africa, geoPoint lat: -25.98953, lon: 28.12843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Newton, zip: 2113, country: South Africa, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Parow, zip: 7505, country: South Africa, geoPoint lat: -33.89723, lon: 18.59992, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Stanger, zip: 4450, country: South Africa, geoPoint lat: -29.32816, lon: 31.28954, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Almeria, zip: 4009, country: Spain, geoPoint lat: 36.83814, lon: -2.45974, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Badalona, zip: 08916, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Research Site, status: NOT_YET_RECRUITING, city: L'Hospitalet de Llobregat, zip: 08907, country: Spain, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Research Site, status: NOT_YET_RECRUITING, city: La Coruna, zip: 15006, country: Spain, geoPoint lat: 43.37135, lon: -8.396, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lugo, zip: 27004, country: Spain, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Malaga, zip: 29010, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Málaga, zip: 29010, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Palma deMallorca, zip: 07010, country: Spain, geoPoint lat: 39.56939, lon: 2.65024, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pamplona, zip: 31008, country: Spain, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sevilla, zip: 41950, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Danderyd, zip: 182 57, country: Sweden, geoPoint lat: 59.3987, lon: 18.02942, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gavle, zip: 80188, country: Sweden, geoPoint lat: 60.67452, lon: 17.14174, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Göteborg, zip: 413 46, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Linkoping, zip: 58185, country: Sweden, geoPoint lat: 58.41086, lon: 15.62157, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Rättvik, zip: 79530, country: Sweden, geoPoint lat: 60.88632, lon: 15.11787, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Stockholm, zip: 141 86, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Uppsala, zip: 751 85, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Varberg, zip: 43281, country: Sweden, geoPoint lat: 57.10557, lon: 12.25078, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kaohsiung City, zip: 80756, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kaohsiung, zip: 81362, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taichung, zip: 402, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taichung, zip: 40447, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taipei City, zip: 110, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taipei, zip: 112, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yung Kang City, zip: 71044, country: Taiwan, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bangkok, zip: 10700, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chiang Mai, zip: 50200, country: Thailand, geoPoint lat: 18.79038, lon: 98.98468, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hat Yai, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Muang, zip: 34000, country: Thailand, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Muang, zip: 40002, country: Thailand, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Phutthamonthon, zip: 73170, country: Thailand, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ratchathewi, zip: 10400, country: Thailand, geoPoint lat: 13.759, lon: 100.53358, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Adana, zip: 01060, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Adapazarı, zip: 54100, country: Turkey, geoPoint lat: 40.78056, lon: 30.40333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Afyonkarahisar, zip: 03030, country: Turkey, geoPoint lat: 38.75667, lon: 30.54333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ankara, zip: 06230, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Antalya, zip: 07059, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bursa, zip: 16059, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kahramanmaras, zip: 46100, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kayseri, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kocaeli, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chernivtsі, zip: 58002, country: Ukraine, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ivano-Frankivsk, zip: 76000, country: Ukraine, geoPoint lat: 48.9215, lon: 24.70972, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyiv, zip: 02081, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyiv, zip: 02125, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyiv, zip: 03037, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyiv, zip: 03057, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kyiv, zip: 04050, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ternopil, zip: 46000, country: Ukraine, geoPoint lat: 49.55589, lon: 25.60556, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ternopil, zip: 46001, country: Ukraine, geoPoint lat: 49.55589, lon: 25.60556, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Uzhhorod, zip: 88018, country: Ukraine, geoPoint lat: 48.61667, lon: 22.3, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinnytsia, zip: 21009, country: Ukraine, geoPoint lat: 49.23278, lon: 28.48097, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinnytsia, zip: 21018, country: Ukraine, geoPoint lat: 49.23278, lon: 28.48097, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinnytsia, zip: 21029, country: Ukraine, geoPoint lat: 49.23278, lon: 28.48097, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinnytsya, zip: 21001, country: Ukraine, geoPoint lat: 49.23278, lon: 28.48097, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bristol, zip: BS105NB, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cambridge, zip: CB2 0XY, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Harrow, zip: HA3 7LT, country: United Kingdom, geoPoint lat: 51.57142, lon: -0.33371, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leicester, zip: LE1 5WW, country: United Kingdom, geoPoint lat: 52.6386, lon: -1.13169, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Liverpool, zip: L9 7AL, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, zip: EC1A 2BE, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, zip: SE5 9RJ, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Newcastle-Under-Lyme, zip: ST4 6QG, country: United Kingdom, geoPoint lat: 53.0, lon: -2.23333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nottingham, zip: NG5 1PB, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wolverhampton, zip: WV10 0QP, country: United Kingdom, geoPoint lat: 52.58547, lon: -2.12296, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bien Hoa, zip: 810000, country: Vietnam, geoPoint lat: 10.94469, lon: 106.82432, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Da Nang, zip: 550000, country: Vietnam, geoPoint lat: 16.06778, lon: 108.22083, locations facility: Research Site, status: WITHDRAWN, city: Ha Noi, zip: 100000, country: Vietnam, geoPoint lat: 20.47366, lon: 106.02292, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ho Chi Minh, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hochiminh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False |
protocolSection identificationModule nctId: NCT06268860, orgStudyIdInfo id: 20220015, briefTitle: A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-08-29, completionDateStruct date: 2024-08-29, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Rocatinlimab vial injection, interventions name: Rocatinlimab prefilled syringe, outcomesModule primaryOutcomes measure: Maximum Observed Serum Concentration (Cmax) of Rocatinlimab, primaryOutcomes measure: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab, primaryOutcomes measure: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab, secondaryOutcomes measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE), secondaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAE), secondaryOutcomes measure: Number of Participants Positive to Anti-rocatinlimab Antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit - Daytona Beach, status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117-5116, country: United States, geoPoint lat: 29.21081, lon: -81.02283, locations facility: Fortrea Clinical Research Unit - Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75247-4968, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Fortrea Clinical Research Unit Limited - Leeds, status: RECRUITING, city: Leeds, state: LDS, zip: LS2 9LH, country: United Kingdom, geoPoint lat: 53.79648, lon: -1.54785, hasResults: False |
protocolSection identificationModule nctId: NCT06268847, orgStudyIdInfo id: DERMATIDYSS, briefTitle: Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2024-06-18, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abyss Ingredients, class: INDUSTRY, collaborators name: Eurofins, descriptionModule briefSummary: This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms., conditionsModule conditions: Atopic Dermatitis, conditions: Eczema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: ACT01, interventions name: ACT02, outcomesModule primaryOutcomes measure: SCORAD (SCORing Atopic Dermatitis), secondaryOutcomes measure: EASI (Eczema Area and Severity Index), secondaryOutcomes measure: Investigator Global Assessment scale, secondaryOutcomes measure: Corneometer, secondaryOutcomes measure: Tewameter, secondaryOutcomes measure: Quality of Life Index - Perceived Stress, secondaryOutcomes measure: Participant's Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Eurofins, status: RECRUITING, city: Barcelona, zip: 08013, country: Spain, contacts name: Jessica Zumaquero, role: CONTACT, phone: +34 932 85 14 46, phoneExt: 1110, email: [email protected], geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06268834, orgStudyIdInfo id: ZonulinPPI, briefTitle: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-04, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels., conditionsModule conditions: Proton Pump Inhibitor Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Blood for zonulin level was drawn from the group., outcomesModule primaryOutcomes measure: Zonulin levels in long-term proton pump inhibitor users, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06268821, orgStudyIdInfo id: ADC-UK-PMS-23059, briefTitle: Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abbott Diabetes Care, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen., conditionsModule conditions: Type 2 Diabetes Treated With Insulin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: FreeStyle Libre 2 Flash Glucose Monitoring System, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Time in range (TIR), secondaryOutcomes measure: Time above range (TAR), secondaryOutcomes measure: Time below range (TBR), secondaryOutcomes measure: Frequency of hypoglycaemia events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pihlajalinna Jämsä, Välikatu 1,, city: Jämsä, zip: 42100, country: Finland, contacts name: Henri Honka, MD, PhD, role: CONTACT, geoPoint lat: 61.8642, lon: 25.19002, locations facility: Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,, city: Tampere, zip: 33100, country: Finland, contacts name: Elina Pimiä, MD, role: CONTACT, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False |
protocolSection identificationModule nctId: NCT06268808, orgStudyIdInfo id: ADC-UK-PMS-23058, briefTitle: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abbott Diabetes Care, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen., conditionsModule conditions: Type 2 Diabetes Treated With Insulin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: FreeStyle Libre 2 Flash Glucose Monitoring System, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Time in range (TIR), secondaryOutcomes measure: Time above range (TAR), secondaryOutcomes measure: Time below range (TBR), secondaryOutcomes measure: Frequency of hypoglycaemia events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, city: Bari, country: Italy, contacts name: Francesco Giorgino, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia, city: Catania, country: Italy, contacts name: Lucia Frittitta, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna, city: Catania, country: Italy, contacts name: Salvatore Piro, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Azienda Ospedaliera - Università di Padova, city: Padova, country: Italy, contacts name: Gian Paolo Fadini, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Ospedaliero-Universitaria di Parma, city: Parma, country: Italy, contacts name: Riccardo Bonadonna, role: CONTACT, geoPoint lat: 44.79935, lon: 10.32618, locations facility: La Sapienza Università di Roma, AOU Policlinico Umberto I, city: Rome, country: Italy, contacts name: Raffaella Buzzetti, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06268795, orgStudyIdInfo id: BASE, briefTitle: A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2028-09-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Wrightington, Wigan and Leigh NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI., conditionsModule conditions: Periprosthetic Joint Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 244, type: ESTIMATED, outcomesModule primaryOutcomes measure: Comparison of diagnostic accuracy, secondaryOutcomes measure: Culture analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust, status: RECRUITING, city: Wigan, state: Lancashire, zip: WN6 9EP, country: United Kingdom, contacts name: Zaid Z Hamoodi, role: CONTACT, email: [email protected], geoPoint lat: 53.54295, lon: -2.63705, hasResults: False |
protocolSection identificationModule nctId: NCT06268782, orgStudyIdInfo id: 1204202118, briefTitle: The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-21, primaryCompletionDateStruct date: 2023-01-24, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Turku, class: OTHER, collaborators name: Finnish Cultural Foundation, descriptionModule briefSummary: The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023., conditionsModule conditions: Quality of Life, conditions: Physical Activity, conditions: Urinary Incontinence, conditions: Pelvic Organ Prolapse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 308, type: ACTUAL, armsInterventionsModule interventions name: Rehabilitate your core, outcomesModule primaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Urinary incontinence, secondaryOutcomes measure: Pelvic organ prolapse, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nursing Science, Faculty of Medicine, University of Turku, city: Turku, zip: 20014, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False |
protocolSection identificationModule nctId: NCT06268769, orgStudyIdInfo id: TaC:Drop, secondaryIdInfos id: 2023-503531-18-00, type: OTHER, domain: EUCT Number, briefTitle: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs, acronym: TaC:Drop, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Edward Geissler, class: OTHER, collaborators name: Chiesi Pharmaceuticals GmbH, descriptionModule briefSummary: The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit., conditionsModule conditions: Immunosuppression, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus Pill, interventions name: Tacrolimus capsule, outcomesModule primaryOutcomes measure: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio), secondaryOutcomes measure: Time to reach the first trough level in target range, secondaryOutcomes measure: Proportion of patients with trough levels lower, within, or higher than the target range, secondaryOutcomes measure: Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels, secondaryOutcomes measure: Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose, secondaryOutcomes measure: Tacrolimus concentration/dose (C/D) ratio, secondaryOutcomes measure: Intra-patient variability of C/D ratio and daily dose, secondaryOutcomes measure: Treatment failure rate, secondaryOutcomes measure: Time to treatment failure after transplantation, secondaryOutcomes measure: Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection, secondaryOutcomes measure: Incidence rate of graft failure, secondaryOutcomes measure: Mortality rate, secondaryOutcomes measure: Graft function measured by eGFR (estimated glomerular filtration rate), secondaryOutcomes measure: Incidence rate of for-cause biopsies, secondaryOutcomes measure: Incidence rate of acute rejection episodes requiring treatment, secondaryOutcomes measure: Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection, secondaryOutcomes measure: Incidence rate of delayed graft function, secondaryOutcomes measure: Incidence rate of primary non-function of the renal allograft, secondaryOutcomes measure: Incidence of hepatotoxicity, secondaryOutcomes measure: Incidence of CMV and BKV infection (including organ manifestation, if relevant), secondaryOutcomes measure: Incidence, type, severity and seriousness of adverse reactions (ARs), secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Incidence of de novo tremor, secondaryOutcomes measure: Incidence of gastrointestinal disorders requiring diagnostic investigation, secondaryOutcomes measure: Incidence of new onset diabetes mellitus after transplantation (NODAT), secondaryOutcomes measure: Recurrence of primary kidney disease, secondaryOutcomes measure: Incidence of de novo DSA, secondaryOutcomes measure: Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34), secondaryOutcomes measure: Doses and duration of glucocorticosteroid treatment, secondaryOutcomes measure: Dose of mycophenolate, secondaryOutcomes measure: Incidence and time to study treatment discontinuation, secondaryOutcomes measure: Incidence, time to and reason for patient withdrawal from study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care, status: NOT_YET_RECRUITING, city: Berlin, zip: 10117, country: Germany, contacts name: Klemens Budde, Prof. Dr., role: CONTACT, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Hospital Dresden, Division of Nephrology, status: RECRUITING, city: Dresden, zip: 01307, country: Germany, contacts name: Christian Hugo, Prof. Dr., role: CONTACT, geoPoint lat: 51.05089, lon: 13.73832, locations facility: University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology), status: NOT_YET_RECRUITING, city: Hamburg, zip: 20251, country: Germany, contacts name: Malte A. Kluger, PD Dr., role: CONTACT, geoPoint lat: 53.57532, lon: 10.01534, locations facility: University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology), status: NOT_YET_RECRUITING, city: Mainz, zip: 55131, country: Germany, contacts name: Julia Weinmann-Menke, Prof. Dr., role: CONTACT, geoPoint lat: 49.98419, lon: 8.2791, locations facility: University Hospital Regensburg, Department of Nephrology, status: RECRUITING, city: Regensburg, zip: 93053, country: Germany, contacts name: Edward K. Geissler, PhD, role: CONTACT, phone: +49 941 944, phoneExt: 6961, email: [email protected], contacts name: Bernhard Banas, MD, PhD, role: CONTACT, phone: +49 941 944, phoneExt: 7301, email: [email protected], geoPoint lat: 49.01513, lon: 12.10161, hasResults: False |
protocolSection identificationModule nctId: NCT06268756, orgStudyIdInfo id: 2023_RIPH_020_RESANXIEST, briefTitle: Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students, acronym: RESANXIEST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-04-07, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Université de Reims Champagne-Ardenne, class: OTHER, descriptionModule briefSummary: Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem., conditionsModule conditions: Self-esteem, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: Rosenberg Self-esteem Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ufr Medecine Urca, status: RECRUITING, city: Reims, zip: 51100, country: France, contacts name: Coralie Barbe, role: CONTACT, phone: 326913665, phoneExt: +33, email: [email protected], geoPoint lat: 49.25, lon: 4.03333, locations facility: Université de Reims Champagne Ardenne, status: RECRUITING, city: Reims, zip: 51100, country: France, contacts name: CURRS CURRS, role: CONTACT, phone: 0326918822, email: [email protected], geoPoint lat: 49.25, lon: 4.03333, hasResults: False |
protocolSection identificationModule nctId: NCT06268743, orgStudyIdInfo id: 2023-114, briefTitle: Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes, acronym: GUTFIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of New Brunswick, class: OTHER, collaborators name: Laval University, descriptionModule briefSummary: The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group, single blinded, randomized trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: High intensity, interventions name: Moderate intensity, outcomesModule primaryOutcomes measure: Glycemic control through glycated hemoglobin, primaryOutcomes measure: Gut microbiome diversity through 16S ribosomal RNA genes, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268730, orgStudyIdInfo id: 23-2437, briefTitle: Effects of SinuSonic on Psychological and Physical Well-Being, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Healthy Humming, LLC, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.The study aims are:* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage., conditionsModule conditions: Nasal Congestion and Inflammations, conditions: Sinus Congestion Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will follow the same procedures., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SinuSonic, outcomesModule primaryOutcomes measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale, primaryOutcomes measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Change in the Body Perception Questionnaire, secondaryOutcomes measure: Change in the Total Nasal Symptom Score, secondaryOutcomes measure: Change in the Patient Global Impression of Change, secondaryOutcomes measure: Adverse Traumatic Experiences Survey at Baseline, secondaryOutcomes measure: Short Form Health Survey (SF-20) at Baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599-7160, country: United States, contacts name: Keri J Heilman, PhD, role: CONTACT, email: [email protected], contacts name: Keri J Heilman, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06268717, orgStudyIdInfo id: 23-0316, briefTitle: GI Alpha-Gal Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2025-10-17, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Revivicor, Inc, descriptionModule briefSummary: This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms., conditionsModule conditions: Alpha-Gal Syndrome, conditions: Irritable Bowel Syndrome, conditions: Diarrhea, conditions: Abdominal Pain, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ground pork containing alpha-gal, interventions name: Pork meat not containing alpha-gal, outcomesModule primaryOutcomes measure: Allergic reaction (food challenge positive), primaryOutcomes measure: No allergic reaction (food challenge negative), primaryOutcomes measure: Lactulose excretion, primaryOutcomes measure: C13 mannitol excretion, primaryOutcomes measure: Basophil activation threshold response at timepoint 0, primaryOutcomes measure: Basophil activation threshold response at 2 hours, primaryOutcomes measure: Basophil activation threshold response at 4 hours, primaryOutcomes measure: Basophil activation threshold response at 6 hours, primaryOutcomes measure: Serum tryptase at timepoint 0, primaryOutcomes measure: Serum tryptase at 2 hours, primaryOutcomes measure: Serum tryptase at 4 hours, primaryOutcomes measure: Serum tryptase at 6 hours, primaryOutcomes measure: Mast cell count on stomach biopsies (per high powered field (hpf)), primaryOutcomes measure: Mast cell count on small bowel biopsies (per high powered field (hpf)), primaryOutcomes measure: Eosinophil cell count on stomach biopsies (per high powered field (hpf)), primaryOutcomes measure: Eosinophil cell count on small bowel biopsies (per high powered field (hpf)), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Sarah McGill, MD, role: CONTACT, phone: 919-966-7047, email: [email protected], contacts name: Sarah McGill, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06268704, orgStudyIdInfo id: UNM HRRC #23-503, briefTitle: Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of New Mexico, class: OTHER, descriptionModule briefSummary: This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain., conditionsModule conditions: Sacroiliac Joint Dysfunction, conditions: Sacro-Iliac Spondylosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Methylprednisolone, interventions name: 2% Lidocaine HCl Injection, outcomesModule primaryOutcomes measure: Pain using Numeric Pain Rating Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of New Mexico Hospital, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87131, country: United States, contacts name: Mark W Shilling, BS, role: CONTACT, phone: 505-925-7599, email: [email protected], geoPoint lat: 35.08449, lon: -106.65114, hasResults: False |
protocolSection identificationModule nctId: NCT06268691, orgStudyIdInfo id: ProjectCOLOMBIA-ZMG.U-Freiburg, briefTitle: Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-04, primaryCompletionDateStruct date: 2019-09-02, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Rocio Cardenas Sanchez, class: OTHER, collaborators name: Göteborg University, collaborators name: Instituto Nacional de Salud, Colombia, collaborators name: Instituto Departamental de Salud de Norte de Santander, collaborators name: Universidad Francisco de Paula de Santander, descriptionModule briefSummary: Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.The main questions it aims to answer are:Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined., conditionsModule conditions: Dengue, conditions: Vector Borne Diseases, conditions: Arbovirus Infections, conditions: Zika, conditions: Chikungunya Fever, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35000, type: ACTUAL, armsInterventionsModule interventions name: Insecticide Coating INESFLY, outcomesModule primaryOutcomes measure: Change of dengue incidence for 12 months, secondaryOutcomes measure: Change of vector densities estimated through larval and pupal indices., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Departamental de Salud de Norte de Santander, city: Cúcuta, state: Norte De Santander, zip: 540001, country: Colombia, geoPoint lat: 7.89391, lon: -72.50782, locations facility: Centre for Medicine and Society, city: Freiburg, state: Baden-Württemberg, zip: 79098, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2019-03-11, uploadDate: 2024-02-12T15:19, filename: Prot_000.pdf, size: 2263350, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2019-03-11, uploadDate: 2024-02-12T15:19, filename: SAP_001.pdf, size: 768947, hasResults: False |
protocolSection identificationModule nctId: NCT06268678, orgStudyIdInfo id: 4539513, briefTitle: The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: Pvolve, descriptionModule briefSummary: The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known., conditionsModule conditions: Menstrual Cycle Phase, conditions: Muscle Protein Synthesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised cross-over design., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Phase of the menstrual cycle, outcomesModule primaryOutcomes measure: Muscle protein synthesis, secondaryOutcomes measure: Plasma amino acid kinetics, secondaryOutcomes measure: Serum insulin concentrations, secondaryOutcomes measure: Sex hormone concentrations, secondaryOutcomes measure: Energy expenditure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX1 2LT, country: United Kingdom, contacts name: Marianna Apicella, role: CONTACT, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False |
protocolSection identificationModule nctId: NCT06268665, orgStudyIdInfo id: UCDCC307, briefTitle: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Eve Rodler, class: OTHER, descriptionModule briefSummary: This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2)., conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, conditions: Breast Cancer Stage IV, conditions: Invasive Breast Cancer, conditions: Ovarian Cancer, conditions: Ovarian Cancer Stage 1, conditions: Ovarian Cancer Stage II, conditions: Ovarian Cancer Stage III, conditions: Ovarian Cancer Stage IV, conditions: Ovarian Cancer Stage IA, conditions: Ovarian Cancer Stage IB, conditions: Ovarian Cancer Stage IC, conditions: Ovarian Cancer Stage 2, conditions: Ovarian Cancer Stage 3, conditions: Ovarian Cancer Stage IIIb, conditions: Ovarian Cancer Stage IIIC, conditions: Breast Cancer Stage IIIA, conditions: Breast Cancer Invasive, conditions: Breast Cancer, Stage IA, conditions: Breast Cancer, Stage IB, conditions: Breast Cancer Stage IIA, conditions: Breast Cancer Stage IIB, conditions: Breast Cancer Stage IIIB, conditions: Breast Cancer Stage IIIc, conditions: Cancer, Breast, conditions: Tumors, Breast, conditions: Mammary Cancer, conditions: Mammary Carcinoma, conditions: Breast Carcinoma, conditions: Breast Neoplasm, conditions: Malignant Breast Neoplasm, conditions: Malignant Tumor of Breast, conditions: Cancer of Ovary, conditions: Ovary Cancer, conditions: Ovary Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Tart Cherry Juice, outcomesModule primaryOutcomes measure: Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy., secondaryOutcomes measure: Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy., secondaryOutcomes measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy., secondaryOutcomes measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice., secondaryOutcomes measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California Davis Comprehensive Cancer Center, city: Sacramento, state: California, zip: 95827, country: United States, contacts name: Eve Rodler, MD, role: CONTACT, phone: 916-734-5409, email: [email protected], contacts name: Eve Rodler, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False |
protocolSection identificationModule nctId: NCT06268652, orgStudyIdInfo id: B2023-686-01, briefTitle: Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2028-01-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer., conditionsModule conditions: Breast Cancer, conditions: Refractory Breast Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 302, type: ESTIMATED, armsInterventionsModule interventions name: Organoid-guided personalized treatment, interventions name: Gemcitabine, interventions name: Capecitabine, interventions name: Vinorelbine, interventions name: Eribulin, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yanxia Shi, status: RECRUITING, city: Guangzhou, state: None Selected, zip: 510060, country: China, contacts name: Yanxia Shi, role: CONTACT, phone: 020-87343368, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-12, uploadDate: 2024-01-23T03:33, filename: Prot_000.pdf, size: 469389, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-12, uploadDate: 2024-01-23T02:42, filename: ICF_001.pdf, size: 330483, hasResults: False |
protocolSection identificationModule nctId: NCT06268639, orgStudyIdInfo id: ECM#2024-216, secondaryIdInfos id: RGP1/347/44, type: OTHER_GRANT, domain: King Khalid University, briefTitle: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique, acronym: BIDOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: King Khalid University, class: OTHER, descriptionModule briefSummary: The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration., conditionsModule conditions: Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: The study employs an open-label design, where no masking is applied. This means that the participants, care providers, investigators, and outcomes assessors are all aware of the intervention being administered. Given the nature of the intervention-osseodensification technique used in dental implant surgery-it is not feasible to blind the study participants or the clinical staff involved in the procedure and assessment to the intervention being studied. The open-label approach allows for direct observation of the intervention's effects on bone density without the complexity of blinding, which is often the case in surgical and procedural interventions where the treatment administered is evident., enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Osseodensification, outcomesModule primaryOutcomes measure: Increase in Bone Density at Implant Sites Using Osseodensification Technique, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268626, orgStudyIdInfo id: H22-02426, secondaryIdInfos id: F22-01302, type: OTHER_GRANT, domain: Canadian Institutes of Health Research (CIHR), secondaryIdInfos id: F21-03695, type: OTHER_GRANT, domain: Canadian Institutes of Health Research (CIHR), briefTitle: Detection of Endometrial Cancer Through Risk Modelling, acronym: DETECTR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later., conditionsModule conditions: Endometrial Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Association Between Risk Factor Data and Endometrial Cancer and It's Precursors., primaryOutcomes measure: Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone., primaryOutcomes measure: Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia., eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VGH Research Pavilion, city: Vancouver, state: British Columbia, zip: V5Z 1M9, country: Canada, contacts name: Aline Talhouk, PhD, role: CONTACT, phone: +1 (604) 875-4111, phoneExt: 21365, email: [email protected], contacts name: Elise Abi Khalil, PhD, role: CONTACT, phone: +1 (604) 875-4111, phoneExt: 21369, email: [email protected], contacts name: Aline Talhouk, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, hasResults: False |
protocolSection identificationModule nctId: NCT06268613, orgStudyIdInfo id: SB27-1005, briefTitle: A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Samsung Bioepis Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:• What the body does to the study drug, which is called "pharmacokinetic"Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda., conditionsModule conditions: Non-small Cell Lung Cancer Stage II, conditions: Non-small Cell Lung Cancer Stage IIIA, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: SB27, interventions name: EU sourced Keytruda, interventions name: US sourced Keytruda, outcomesModule primaryOutcomes measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1, primaryOutcomes measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6, secondaryOutcomes measure: Disease-free Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SB Investigative Site, status: RECRUITING, city: Busan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: SB Investigative Site, status: RECRUITING, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: SB Investigative Site, status: RECRUITING, city: Hwasun, country: Korea, Republic of, geoPoint lat: 35.06125, lon: 126.98746, locations facility: SB Investigative Site, status: RECRUITING, city: Jinju, country: Korea, Republic of, geoPoint lat: 35.19278, lon: 128.08472, locations facility: SB Investigative Site, status: RECRUITING, city: Seongnam, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: SB Investigative Site, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: SB Investigative Site, status: RECRUITING, city: Suwon, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, locations facility: SB Investigative Site, status: RECRUITING, city: Szczecin, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: SB Investigative Site, status: RECRUITING, city: Leganés, state: Madrid, country: Spain, geoPoint lat: 40.32718, lon: -3.7635, locations facility: SB Investigative Site, status: RECRUITING, city: A Coruña, state: Santiago De Compostela, country: Spain, geoPoint lat: 43.37135, lon: -8.396, locations facility: SB Investigative Site, status: RECRUITING, city: Jaén, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, locations facility: SB Investigative Site, status: RECRUITING, city: Málaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, hasResults: False |
protocolSection identificationModule nctId: NCT06268600, orgStudyIdInfo id: NPC-Thyroid function, briefTitle: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Nasopharyngeal Cancer, conditions: Hypothyroidism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Modified neck target volume delineation, outcomesModule primaryOutcomes measure: Regional Recurrence-free Survival, secondaryOutcomes measure: Radiation-induced hypothyroidism, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-free Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital, status: RECRUITING, city: Nanchang, state: None Selected, zip: 330029, country: China, contacts name: Tianzhu Lu, role: CONTACT, phone: 8615270186250, email: [email protected], contacts role: CONTACT, phoneExt: Li, email: [email protected], contacts name: Jingao Li, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Xiaochang Gong, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False |
protocolSection identificationModule nctId: NCT06268587, orgStudyIdInfo id: 2023/80, briefTitle: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-01, primaryCompletionDateStruct date: 2022-02-28, completionDateStruct date: 2022-02-28, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Liege, class: OTHER, descriptionModule briefSummary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain., conditionsModule conditions: Postoperative Pain, conditions: Outpatient Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1423, type: ACTUAL, armsInterventionsModule interventions name: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &gt; 3/10 on day one and who did not take analgesics., outcomesModule primaryOutcomes measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics., secondaryOutcomes measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group, secondaryOutcomes measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one, secondaryOutcomes measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Liège, city: Liège, state: Wallonie, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, hasResults: False |
protocolSection identificationModule nctId: NCT06268574, orgStudyIdInfo id: RIVER-52, briefTitle: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML, acronym: RIVER-52, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ryvu Therapeutics SA, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients., conditionsModule conditions: Acute Myeloid Leukemia (AML), conditions: High-risk Myelodysplastic Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: RVU120, outcomesModule primaryOutcomes measure: Complete Remission (CR), with and without measurable residual disease (MRD), secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Percentage of participants bridged to hematopoietic stem cell transplantation, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Maximum Plasma Concentration (Tmax), secondaryOutcomes measure: Area Under the Concentration Time-Curve (AUC), secondaryOutcomes measure: Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO), secondaryOutcomes measure: Impact of treatment on health-related quality of life (QOL-E), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MTZ Clinical Research, status: RECRUITING, city: Warszawa, state: Mazowieckie Województwo, zip: 02-172, country: Poland, contacts name: Krzysztof Mądry, role: CONTACT, phone: +48 22 572 59 59, email: [email protected], contacts name: Krzysztof Mądry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, locations facility: MICS Centrum Medyczne Toruń, status: RECRUITING, city: Toruń, zip: 87-100, country: Poland, contacts name: Dominik Chraniuk, role: CONTACT, phone: +48 56 300 43, email: [email protected], contacts name: Dominik Chraniuk, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.01375, lon: 18.59814, hasResults: False |
protocolSection identificationModule nctId: NCT06268561, orgStudyIdInfo id: IRBN852023/CHUSTE, briefTitle: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient., conditionsModule conditions: Endophthalmitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Visual acuity analysis, interventions name: Intraocular pressure analysis, interventions name: Analysis of optical coherence tomography (OCT) images, interventions name: Analysis of retinograms, outcomesModule primaryOutcomes measure: Visual acuity, secondaryOutcomes measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation, secondaryOutcomes measure: Tomography, secondaryOutcomes measure: Resumption of intravitreal therapy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Saint Etienne, status: RECRUITING, city: Saint-Étienne, zip: 42000, country: France, contacts name: Thibaud GARCIN, MD PhD, role: CONTACT, phone: (0)477829662, phoneExt: +33, email: [email protected], contacts name: Thibaud GARCIN, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Henri PITEAU, resident, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False |
protocolSection identificationModule nctId: NCT06268548, orgStudyIdInfo id: P.T.REC/012/004790, briefTitle: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease, conditionsModule conditions: Diaphragm Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Manual diaphragmatic activation, outcomesModule primaryOutcomes measure: Diaphragm Excursion, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy, status: RECRUITING, city: Giza, zip: 12613, country: Egypt, contacts name: Nesreen Ghareb Mohamed, Professor, role: CONTACT, phone: 01002227242, email: [email protected], geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06268535, orgStudyIdInfo id: CaenUH_DL_1, briefTitle: Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2022-05-31, completionDateStruct date: 2022-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs., conditionsModule conditions: Heart Failure, conditions: Cancer, Therapy-Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3406383, type: ACTUAL, armsInterventionsModule interventions name: Cancer therapy with FDA and/or EMA approval on the 31st March 2022, outcomesModule primaryOutcomes measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies, secondaryOutcomes measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies, secondaryOutcomes measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed, secondaryOutcomes measure: Description of the drug-drug interactions associated with adverse events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Caen University Hospital, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False |
protocolSection identificationModule nctId: NCT06268522, orgStudyIdInfo id: 2023P001582, briefTitle: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Behavioral, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness-Oriented Recovery Enhancement: (MORE) group, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Pain Interference, primaryOutcomes measure: Opioid Dose, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Opioid Misuse, secondaryOutcomes measure: Opioid Withdrawal, secondaryOutcomes measure: Opioid Craving, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Chestnut Hill, state: Massachusetts, zip: 02467, country: United States, contacts name: Marie Curiel, role: CONTACT, phone: 617-732-9578, email: [email protected], contacts name: Asimina Lazaridou, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Robert Edwards, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.33065, lon: -71.16616, hasResults: False |
protocolSection identificationModule nctId: NCT06268509, orgStudyIdInfo id: MONAS, briefTitle: Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta, acronym: MONAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Dr Cipto Mangunkusumo General Hospital, class: OTHER, collaborators name: Dinas Kesehatan DKI Jakarta, collaborators name: Fakultas Kedokteran Universitas Indonesia, descriptionModule briefSummary: The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?Participants in the intervention group will receive:* Fetomaternal ultrasound examination each trimester* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination* Supplements: multivitamin, minerals, vitamin D, fatty acid* Intervention regarding any abnormal results of nutritional panel* All standard maternal health services according to Indonesian Ministry of Health protocolParticipants in the control group will receive:- All standard maternal health services according to Indonesian Ministry of Health protocol, conditionsModule conditions: Pregnancy Complications, conditions: Maternal Death, conditions: Preeclampsia, conditions: Intrauterine Infection, conditions: Pregnancy Hemorrhage, conditions: Preterm Birth, conditions: Neonatal Death, conditions: Low; Birthweight, Extremely (999 Grams or Less), conditions: Asphyxia Neonatorum, conditions: IUGR, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 245, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional panel laboratory examination, interventions name: Pregnancy supplements (other than provided by Ministry of Health), interventions name: Fetomaternal ultrasound, outcomesModule primaryOutcomes measure: Composite of poor maternal outcomes, primaryOutcomes measure: Composite of poor neonatal outcomes, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office, status: RECRUITING, city: Jakarta, country: Indonesia, contacts name: Risal, M.D., M.Sc., role: CONTACT, email: [email protected], geoPoint lat: -6.21462, lon: 106.84513, hasResults: False |
protocolSection identificationModule nctId: NCT06268496, orgStudyIdInfo id: LRP23021-A serum, briefTitle: Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo., conditionsModule conditions: Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: serum formula 2039125 03, outcomesModule primaryOutcomes measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP), primaryOutcomes measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma, primaryOutcomes measure: Post-Acne Hyperpigmentation Index (PAHPI), primaryOutcomes measure: solar lentigo pigmentation scale, secondaryOutcomes measure: colorimetry measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medcin Instituto da Pele Ltda, city: Osasco, country: Brazil, geoPoint lat: -23.5325, lon: -46.79167, hasResults: False |
protocolSection identificationModule nctId: NCT06268483, orgStudyIdInfo id: JalUrol, secondaryIdInfos id: Policlinico, type: OTHER, domain: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, briefTitle: Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections, acronym: JalUrol, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-03-28, completionDateStruct date: 2023-03-28, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms.Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance.Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI.Methods:Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1).Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms.All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment.Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months.At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment.Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated., conditionsModule conditions: Urinary Tract Infections, Recurrent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized, crossover, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg + cranberry, D-mannose, propolis extract, tumeric and Boswellia, interventions name: cranberry, D-mannose, propolis extract, tumeric and Boswellia, outcomesModule primaryOutcomes measure: Improvement in sexual symptoms, secondaryOutcomes measure: Improvement in urinary symptoms, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, city: Milan, state: MI, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06268470, orgStudyIdInfo id: Chula-ARC 001/18, briefTitle: Antiplatelet Therapy in Chronic Urticaria, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-06-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria, conditionsModule conditions: Chronic Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Identical capsules, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Desloratadine plus cilostazol and dipyridamole, interventions name: Desloratadine, outcomesModule primaryOutcomes measure: Weekly urticaria activity score, secondaryOutcomes measure: D-dimer levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06268457, orgStudyIdInfo id: CE-AVEC 789/2023/Oss/IOR, briefTitle: Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis, acronym: Embodesmo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular., conditionsModule conditions: Desmoid, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Chemoembolization with Doxorubicin, outcomesModule primaryOutcomes measure: Volume reduction in cm, primaryOutcomes measure: Reduction of pain (VAS score), primaryOutcomes measure: Reduction of antalgic therapy (mg), secondaryOutcomes measure: Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire), secondaryOutcomes measure: Improvement in quality of life (EORTC QLQ - BM22), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: Emilia Romagna, zip: 40136, country: Italy, contacts name: Giancarlo Facchini, MD, role: CONTACT, phone: +39 333 650 0944, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06268444, orgStudyIdInfo id: PI2023_843_0077, briefTitle: Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants, acronym: SOLANGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation., conditionsModule conditions: Newborn, conditions: Chemical Pollutants Exposure, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 7-day actimetry sleep recording, interventions name: Determination of environmental pollutants in breast milk, interventions name: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child, interventions name: Continuous recording of the child's temperature for 7 days, interventions name: Use of a sleep diary for 7 days, interventions name: Parental questionnaire of environmental exposure, outcomesModule primaryOutcomes measure: total sleep time per day in infants using actimetry, secondaryOutcomes measure: Concentration of various substances in breast milk, secondaryOutcomes measure: concentration of chemical polluants on newborn bracelets, secondaryOutcomes measure: Child Temperature level (°C), eligibilityModule sex: ALL, maximumAge: 6 Months, stdAges: CHILD, contactsLocationsModule locations facility: CHRU Amiens, status: RECRUITING, city: Amiens, zip: 80054, country: France, contacts name: Karen CHARDON, Pr, role: CONTACT, phone: 03.22.82.78. 65, email: [email protected], contacts name: Elodie HARAUX, HARAUX, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierre TOURNEUX, Pr, role: SUB_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False |
protocolSection identificationModule nctId: NCT06268431, orgStudyIdInfo id: 43084, briefTitle: Oxytocin Rest to Reduce Cesarean Delivery, acronym: ORCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Christiana Care Health Services, class: OTHER, descriptionModule briefSummary: Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery., conditionsModule conditions: Prolonged Labor, conditions: Failed Induction, conditions: Labor Dystocia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin rest, outcomesModule primaryOutcomes measure: Cesarean rate, secondaryOutcomes measure: Time to delivery (hours), secondaryOutcomes measure: Time to vaginal delivery (hours), secondaryOutcomes measure: Time to active labor (hours), secondaryOutcomes measure: Duration of active labor (hours), secondaryOutcomes measure: Composite maternal adverse outcome, secondaryOutcomes measure: Composite neonatal adverse outcome, secondaryOutcomes measure: Labor Agentry Scale score, secondaryOutcomes measure: Rate of intraamniotic infection (IAI), secondaryOutcomes measure: Rate of postpartum endometritis, secondaryOutcomes measure: Rate of postpartum hemorrhage, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ChristianaCare Health System, status: RECRUITING, city: Newark, state: Delaware, zip: 19718, country: United States, contacts name: Teresa C Logue, role: CONTACT, phone: 302-733-6563, email: [email protected], geoPoint lat: 39.68372, lon: -75.74966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-21, uploadDate: 2024-02-11T17:37, filename: Prot_SAP_000.pdf, size: 239099, hasResults: False |
protocolSection identificationModule nctId: NCT06268418, orgStudyIdInfo id: 2024PI020, briefTitle: Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy, acronym: PADL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging, conditionsModule conditions: Radionucleide Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Artificial intelligence, outcomesModule primaryOutcomes measure: Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images, secondaryOutcomes measure: Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268405, orgStudyIdInfo id: 22-5806, briefTitle: Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-21, primaryCompletionDateStruct date: 2024-09-21, completionDateStruct date: 2024-09-21, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Liquid Biopsy, interventions name: Positron Emission Mammography (PEM), outcomesModule primaryOutcomes measure: Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, contacts name: Samira Taeb, MSc, role: CONTACT, phone: 416-946-4501, phoneExt: 5853, email: [email protected], contacts name: Vivianne Freitas, role: CONTACT, phone: 416-946-2000, phoneExt: 5608, email: [email protected], contacts name: Vivianne Freitas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06268392, orgStudyIdInfo id: CT-2023-11-20-001, briefTitle: A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Copenhagen Academy for Medical Education and Simulation, class: OTHER, collaborators name: Slagelse Hospital, collaborators name: Technical University of Denmark, collaborators name: Rigshospitalet, Denmark, descriptionModule briefSummary: This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model., conditionsModule conditions: Fetal Growth Retardation, conditions: Fetal Macrosomia, conditions: Fetal Growth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Fetal weight, primaryOutcomes measure: Ultrasound fetal weight estimation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268379, orgStudyIdInfo id: #08-01-03-23, briefTitle: BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-02-15, primaryCompletionDateStruct date: 2021-12-15, completionDateStruct date: 2021-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cabrini Health, class: OTHER, descriptionModule briefSummary: This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram., conditionsModule conditions: Colon Cancer, conditions: Model Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 2475, type: ACTUAL, armsInterventionsModule interventions name: Surgery, outcomesModule primaryOutcomes measure: OS, primaryOutcomes measure: RFS, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 101 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cabrini Health, city: Melbourne, state: Victoria, zip: 3144, country: Australia, geoPoint lat: -37.814, lon: 144.96332, hasResults: False |
protocolSection identificationModule nctId: NCT06268366, orgStudyIdInfo id: UEvansville, briefTitle: Effects of Exercise-Based Interventions on Symmio Self-Movement Screen, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Evansville, class: OTHER, descriptionModule briefSummary: Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults., conditionsModule conditions: Movement Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The primary investigators and statisticians will be blinded to the group allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Symmio Self-Movement Screen, secondaryOutcomes measure: Global Rating of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268353, orgStudyIdInfo id: 109324-1, briefTitle: Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study, acronym: CAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, collaborators name: Stanford University, descriptionModule briefSummary: Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.Purpose:The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Non-pregnant controls and pregnant women, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: blood sampling, outcomesModule primaryOutcomes measure: CAPGDF15 levels in plasma, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268340, orgStudyIdInfo id: ABIntl-23-25, briefTitle: Hearing and Structure Preservation Via ECochG, acronym: PRESERVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance., conditionsModule conditions: Hearing Loss, Sensorineural, conditions: Severe-to-profound Hearing Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: ECochG monitored CI surgery incl. corrective action guide, interventions name: Routine CI surgery without ECochG monitoring, outcomesModule primaryOutcomes measure: Hearing Preservation, secondaryOutcomes measure: Structure Preservation, secondaryOutcomes measure: Speech perception, otherOutcomes measure: Surgeons' feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitair Ziekenhuis Gent, city: Gent, zip: 9000, country: Belgium, contacts name: Lara Derycke, Ms, role: CONTACT, phone: +3293321246, email: [email protected], contacts name: Ingeborg Dhooge, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Freya Swinnen, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: Le Centre Hospitalier Régional Universitaire de Tours, city: Tours, zip: 37000, country: France, contacts name: Mme Nollet, role: CONTACT, email: [email protected], contacts name: David Bakhos, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Mathieu Robier, Mr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Universitätsklinikum Freiburg Klinik, city: Freiburg, zip: 79106, country: Germany, contacts name: Claudia Greulich, Ms, role: CONTACT, email: [email protected], contacts name: Antje Aschendorff, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Thomas Wesarg, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.9959, lon: 7.85222, locations facility: Ospedale Martini, city: Torino, state: TO, zip: 10141, country: Italy, contacts name: Diego Di Lisi, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrizia Consolino, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, locations facility: World Hearing Center, city: Warsaw, state: Nadarzyn, zip: 05-830, country: Poland, contacts name: Iwona Tomaszewska-Hert, Ms, role: CONTACT, email: [email protected], contacts name: Piotr Skarżyński, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Adam Walkowiak, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Cambridge University Hospitals NHS Foundation Trust, city: Cambridge, state: England, zip: CB2 0QQ, country: United Kingdom, contacts name: Sophie McKenny, Ms, role: CONTACT, phone: +441223586625, email: [email protected], contacts name: Matthew E Smith, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrick Axon, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.2, lon: 0.11667, hasResults: False |
protocolSection identificationModule nctId: NCT06268327, orgStudyIdInfo id: Adjuvant treatment in BC, briefTitle: Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatin injection and gemcitabine, interventions name: Capecitabine tablets, outcomesModule primaryOutcomes measure: Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy, secondaryOutcomes measure: Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268314, orgStudyIdInfo id: hypoalbuminemia in pediatrics., briefTitle: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, outcomesModule primaryOutcomes measure: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268301, orgStudyIdInfo id: TAK-721-1003, briefTitle: A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2023-02-17, completionDateStruct date: 2023-02-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Budesonide, outcomesModule primaryOutcomes measure: Maximum Observed Concentration (Cmax), primaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast), primaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞), secondaryOutcomes measure: Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death, secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormal Vital Sign Values, secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values, secondaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12), secondaryOutcomes measure: Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%), secondaryOutcomes measure: Time to First Occurrence of Cmax (tmax), secondaryOutcomes measure: Lag Time to First Quantifiable Concentration (tlag), secondaryOutcomes measure: Terminal Disposition Phase Half-life (t1/2z), secondaryOutcomes measure: Terminal Disposition Phase Rate Constant (λz)., secondaryOutcomes measure: Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration, secondaryOutcomes measure: Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, city: Lincoln, state: Nebraska, zip: 68502, country: United States, geoPoint lat: 40.8, lon: -96.66696, hasResults: False |
protocolSection identificationModule nctId: NCT06268288, orgStudyIdInfo id: 22-011492, briefTitle: Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-07-22, completionDateStruct date: 2024-12-22, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management., conditionsModule conditions: Postural Tachycardia Syndrome, conditions: Autonomic Dysfunction, conditions: Postural Orthostatic Tachycardia Syndrome, conditions: POTS - Postural Orthostatic Tachycardia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Half of the patient population will be randomized to standard management only. The other half of the population will be randomized to standard management plus use of the vagal nerve stimulator, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: GammaCore intervention, interventions name: STEPS management protocol, outcomesModule primaryOutcomes measure: The change in COMPASS-31 scores between individuals in both arms of the study, primaryOutcomes measure: The change in Child Functional Disability Inventory scores between individuals in both arms of the study, primaryOutcomes measure: The change in heart rate increase in head up tilt table tests in individuals in both arms of the study, secondaryOutcomes measure: Does nVNS influence headache frequency in adolescent patients with POTS, secondaryOutcomes measure: Does nVNS influence ability to increase exercise duration in adolescent patients with POTS, secondaryOutcomes measure: Does use of nVNS influence degree of depression in adolescent patients with POTS, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06268275, orgStudyIdInfo id: HE651314, briefTitle: Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-19, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-13, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia., conditionsModule conditions: Hemodynamic Instability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Scalp block, interventions name: Esmolol, outcomesModule primaryOutcomes measure: MAP, primaryOutcomes measure: SBP, primaryOutcomes measure: DBP, primaryOutcomes measure: HR, secondaryOutcomes measure: BIS, secondaryOutcomes measure: Cumulative postoperative opioids consumption, secondaryOutcomes measure: Postoperative adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Khon Kaen University, city: Khon Kaen, state: Naimuang, Muang, zip: 40002, country: Thailand, geoPoint lat: 16.44671, lon: 102.833, hasResults: False |
protocolSection identificationModule nctId: NCT06268262, orgStudyIdInfo id: XYFY2023-KL045-01, briefTitle: Surgical-imaging Research on Obesity (SIRO), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Xuzhou Medical University, class: OTHER, descriptionModule briefSummary: The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery., conditionsModule conditions: Overweight and Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Imaging parameters of obesity, primaryOutcomes measure: Imaging parameters of obesity, primaryOutcomes measure: Imaging parameters of obesity, secondaryOutcomes measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample, secondaryOutcomes measure: Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample, secondaryOutcomes measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample, secondaryOutcomes measure: Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, contacts name: Kai Liu, M.D/Ph.D, role: CONTACT, phone: +86-15920157720, email: [email protected], geoPoint lat: 34.18045, lon: 117.15707, hasResults: False |
protocolSection identificationModule nctId: NCT06268249, orgStudyIdInfo id: TJ-IRB20231224, briefTitle: Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2022-12-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Qin Zhang, class: OTHER, descriptionModule briefSummary: This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes., conditionsModule conditions: Cardiac Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 7065, type: ACTUAL, armsInterventionsModule interventions name: Ulinastatin, outcomesModule primaryOutcomes measure: POCD - Postoperative Cognitive Dysfunction, secondaryOutcomes measure: Survival time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06268236, orgStudyIdInfo id: BF2023-252, briefTitle: Electro-acupuncture to Treat Disorder of Consciousness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments., conditionsModule conditions: Disorder of Consciousness, conditions: Electroacupuncture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Electroacupuncture, interventions name: Sham electroacupuncture, outcomesModule primaryOutcomes measure: Coma Recovery Scale - Revised score, secondaryOutcomes measure: phase locking value, secondaryOutcomes measure: amplitude of low-frequency fluctuation, secondaryOutcomes measure: Amide proton transfer-weighted signal, secondaryOutcomes measure: f value, secondaryOutcomes measure: neurite density index, secondaryOutcomes measure: latency value of N20, secondaryOutcomes measure: latency between III and V potentials, secondaryOutcomes measure: Glasgow Outcome Scale-Extended score, secondaryOutcomes measure: Glasgow Outcome Scale-Extended score, secondaryOutcomes measure: brain-computer interface accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Fang Yuan, PhD, role: CONTACT, phone: +86-20-81887233, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06268223, orgStudyIdInfo id: 2023/315, briefTitle: Home-Based Action Observation Training for Chewing and Swallowing Function, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-13, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, collaborators name: Hacettepe University, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study., conditionsModule conditions: Cerebral Palsy, conditions: Chewing Disease, conditions: Action Obervation Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Chewing Exercise Training, outcomesModule primaryOutcomes measure: Karaduman Chewing Performance Scale, primaryOutcomes measure: Turkish version of the Mastication Observation and Evaluation Instrument, primaryOutcomes measure: Test of Masticating and Swallowing Solids in Children, primaryOutcomes measure: Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative, primaryOutcomes measure: The Pediatric version of the Eating Assessment Tool, primaryOutcomes measure: Dysphagia Disorder Survey, primaryOutcomes measure: Behavioral Pediatrics Feeding Assessment Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer, status: RECRUITING, city: Samsun, state: Atakum, zip: 55200, country: Turkey, contacts name: Seda Nur Kemer, 1, role: CONTACT, phone: +9005467861866, email: [email protected], geoPoint lat: 41.27976, lon: 36.3361, hasResults: False |
protocolSection identificationModule nctId: NCT06268210, orgStudyIdInfo id: 4-2023-1546, briefTitle: Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer, acronym: NeoLazer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Lazertinib+Pemetrexed+Carboplatin, interventions name: Lazertinib, outcomesModule primaryOutcomes measure: Primary pathological response, secondaryOutcomes measure: Surgical Resection Methods (Segmentectomy or Lobectomy), secondaryOutcomes measure: Pathologic Complete Response, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Event-Free Survival, secondaryOutcomes measure: Disease-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of patients with Adverse events according to CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance hospital, city: Seoul, country: Korea, Republic of, contacts name: Hye Ryun Kim, role: CONTACT, phone: 82-2-2228-8125, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06268197, orgStudyIdInfo id: IRB23-0329, briefTitle: Interoception-Based Yoga for Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, descriptionModule briefSummary: The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Yoga Intervention, outcomesModule primaryOutcomes measure: Feasibility, primaryOutcomes measure: Acceptability, secondaryOutcomes measure: Interoceptive Sensibility, secondaryOutcomes measure: PROMIS Pain Interference, otherOutcomes measure: Interoceptive Accuracy, otherOutcomes measure: Mindfulness, otherOutcomes measure: PROMIS Pain Intensity, otherOutcomes measure: Quality of Life, otherOutcomes measure: Spiritual Wellbeing, otherOutcomes measure: Pain Impact, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Illinois Urbana-Champaign, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Project Coordinator, role: CONTACT, phone: 217-265-0741, email: [email protected], contacts name: Neha P Gothe, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Steven Petruzzello, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.11059, lon: -88.20727, hasResults: False |
protocolSection identificationModule nctId: NCT06268184, orgStudyIdInfo id: omega3 in oxidative stress, briefTitle: Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-10-04, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis, conditionsModule conditions: Oxidative Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: D3 LAB SYRUP, interventions name: placebo capsule, outcomesModule primaryOutcomes measure: decrease oxidative stress, primaryOutcomes measure: increase antioxidant activity, primaryOutcomes measure: improvement of nutritional status assessed by anthropometric measurements., primaryOutcomes measure: mid upper arm circumference in centimeters, primaryOutcomes measure: triceps skin fold thickness in millimeter's, primaryOutcomes measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA), primaryOutcomes measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA), primaryOutcomes measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA), primaryOutcomes measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA), primaryOutcomes measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA), primaryOutcomes measure: improvement of nutritional status assessed by laboratory investigations., primaryOutcomes measure: s. ionized calcium level, primaryOutcomes measure: s.phosphorus level, primaryOutcomes measure: alkaline phosphatase level, primaryOutcomes measure: parathormone hormone level, primaryOutcomes measure: 25(oh)vitamin D level, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, status: RECRUITING, city: Tanta, state: Gharbia, country: Egypt, contacts name: Noha sayed ahmed, M.Sc, role: CONTACT, phone: 01016919217, phoneExt: 01097722167, email: [email protected], contacts name: rasha gamal elshafaay, MD, role: CONTACT, phone: 01227405988, phoneExt: 01114277784, email: [email protected], geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06268171, orgStudyIdInfo id: 2023_0214, secondaryIdInfos id: 2023-A02390-45, type: OTHER, domain: ANSM, briefTitle: Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation, acronym: EchoSS-TP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-09-04, completionDateStruct date: 2025-11-05, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hopital Foch, class: OTHER, descriptionModule briefSummary: In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies., conditionsModule conditions: Lung Transplant, conditions: Physiotherapy, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound measurement of the cross-sectional area of the rectus femoris, outcomesModule primaryOutcomes measure: Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation, secondaryOutcomes measure: Measure change in CSA-RF at D7 according to LT pattern, secondaryOutcomes measure: Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7, secondaryOutcomes measure: Determine the relationship between CSA-RF at D-1 and Body Mass Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268158, orgStudyIdInfo id: 2023/45, briefTitle: The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used., conditionsModule conditions: Abdominal Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Eye patch, outcomesModule primaryOutcomes measure: Richard-Campbell Sleep Scale, primaryOutcomes measure: Nursing Delirium Screening Scale, secondaryOutcomes measure: Richmond Agitation-Sedation Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, status: RECRUITING, city: Kayseri, state: Talas, zip: 38080, country: Turkey, contacts name: Yeliz Sürme, PhD, role: CONTACT, phone: +0905532051130, email: [email protected], contacts name: Tuğçe TOPAL, role: CONTACT, phone: +9005075698312, email: [email protected], contacts name: Tuğçe TOPAL, Msn, role: PRINCIPAL_INVESTIGATOR, contacts name: Yeliz SÜRME, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06268145, orgStudyIdInfo id: EC0006, briefTitle: ECC5004 RBA FE Study in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Eccogene, class: INDUSTRY, descriptionModule briefSummary: This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants, conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: ECC5004, outcomesModule primaryOutcomes measure: ECC5004 PK parameters: AUC0-tlast, primaryOutcomes measure: ECC5004 PK parameters: AUC0-inf, primaryOutcomes measure: ECC5004 PK parameters: Cmax, primaryOutcomes measure: ECC5004 PK parameters: tmax, secondaryOutcomes measure: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations, secondaryOutcomes measure: ECC5004 PK parameters: AUC0-tau, secondaryOutcomes measure: ECC5004 PK parameters: AUC 0-24, secondaryOutcomes measure: ECC5004 PK parameters: tlag, secondaryOutcomes measure: ECC5004 PK parameters: t1/2, secondaryOutcomes measure: ECC5004 PK parameters: CL/F, secondaryOutcomes measure: ECC5004 PK parameters: AUC(extr), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eccogene Investigational Site, status: RECRUITING, city: Anaheim, state: California, zip: 92801, country: United States, contacts name: Eccogene, role: CONTACT, geoPoint lat: 33.83529, lon: -117.9145, hasResults: False |
protocolSection identificationModule nctId: NCT06268132, orgStudyIdInfo id: MLS90, briefTitle: Longevity in Russia, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-12-25, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Center for Strategic Planning, of the Federal Medical and Biological Agency, class: OTHER, collaborators name: Pirogov Russian National Research Medical University, descriptionModule briefSummary: This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration., conditionsModule conditions: LONGEVITY 1, conditions: Frailty, conditions: Aging, conditions: Age-related Cognitive Decline, conditions: Aging Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mortality among long-living adults, primaryOutcomes measure: Morbidity among long-living adults, secondaryOutcomes measure: Aging phenotypes, secondaryOutcomes measure: Social, economic, and medical- history-related determinants, secondaryOutcomes measure: Genetic determinants, secondaryOutcomes measure: Epigenetic determinants, secondaryOutcomes measure: Metagenomic determinants, eligibilityModule sex: ALL, minimumAge: 90 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation, status: RECRUITING, city: Moscow, zip: 129226, country: Russian Federation, contacts name: Irina D. Strazhesko, M.D., Ph.D, role: CONTACT, phone: +7 (499) 187-64-67, email: [email protected], geoPoint lat: 55.75222, lon: 37.61556, hasResults: False |
protocolSection identificationModule nctId: NCT06268119, orgStudyIdInfo id: MustafaKU-SBF-GKS-01, briefTitle: Effectiveness of Delirium Care Protocol After Cardiac Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-06, primaryCompletionDateStruct date: 2023-05-15, completionDateStruct date: 2023-05-22, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Gonul Kara Soylemez, class: OTHER, descriptionModule briefSummary: This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery., conditionsModule conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium., outcomesModule primaryOutcomes measure: Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU), secondaryOutcomes measure: Glasgow Coma Scale (GCS), secondaryOutcomes measure: Richmond Agitation-Sedation Scale (RASS), secondaryOutcomes measure: Information Assessment Form for Postoperative Delirium (Pretest-Posttest), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antalya Training and Research Hospital, city: Antalya, state: Center, zip: 07000, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False |
protocolSection identificationModule nctId: NCT06268106, orgStudyIdInfo id: IRB N/A, briefTitle: Graphic Novel for Patients Undergoing EUS-FNB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, class: OTHER, descriptionModule briefSummary: Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment., conditionsModule conditions: Anxiety, conditions: Pancreatic Cancer, conditions: Pancreatic Cystic Lesions, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Graphic novel will be visualized by interventional group before EUS-FNB, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Graphic novel visualization, outcomesModule primaryOutcomes measure: Anxiety and stress level according to BAI, primaryOutcomes measure: Anxiety and stress level according to mASS-14, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs - Ismett, city: Palermo, state: PA, zip: 90127, country: Italy, contacts name: Giacomo Emanuele Maria Rizzo, MD, role: CONTACT, phoneExt: +393406602502, email: [email protected], contacts name: Ilaria Tarantino, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Giacomo Emanuele Maria Rizzo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mario Traina, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False |
protocolSection identificationModule nctId: NCT06268093, orgStudyIdInfo id: XWTETS, briefTitle: The Therapeutic Effect of Thalidomide in Syringomyelia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage., conditionsModule conditions: Syringomyelia, conditions: Thalidomide, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Thalidomide, outcomesModule primaryOutcomes measure: ASIA Score, secondaryOutcomes measure: syringomyelia remission, secondaryOutcomes measure: The evoked electromyographic signal (eEMG) potential, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Klekamp and Sammi syringomyelia scale, secondaryOutcomes measure: modified Japanese Orthopaedic Association Scores (mJOA), secondaryOutcomes measure: xuanwu syringomyelia scale, secondaryOutcomes measure: Incidence of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fengzeng Jian, status: RECRUITING, city: Beijing, state: Beijing City, zip: 100032, country: China, contacts name: fengzeng jian, md, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06268080, orgStudyIdInfo id: A+9317, briefTitle: Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery, acronym: Balanced-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Auckland City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars., conditionsModule conditions: Delirium, Postoperative, conditions: Anesthesia, conditions: Surgery-Complications, conditions: Cognition Disorder, conditions: Delirium, conditions: Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2766, type: ESTIMATED, armsInterventionsModule interventions name: Depth of anesthesia titration using pEEG, outcomesModule primaryOutcomes measure: Incidence of postoperative delirium (POD), secondaryOutcomes measure: Incidence of severe delirium, secondaryOutcomes measure: Incidence of new mild and major postoperative neurocognitive disorders, secondaryOutcomes measure: Postoperative cognitive decline, secondaryOutcomes measure: Functional decline, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Duration of delirium, otherOutcomes measure: Incidence of awareness, otherOutcomes measure: Adverse and serious adverse events, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268067, orgStudyIdInfo id: Renal uptake at F18 FDG PET/CT, briefTitle: Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD., conditionsModule conditions: Renal Uptake at F-18-FDG PET/CT, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 97, type: ESTIMATED, armsInterventionsModule interventions name: PET/CT, outcomesModule primaryOutcomes measure: significance of renal uptake at F18-FDG PET CT studies, secondaryOutcomes measure: Early detection of patients with CKD, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268054, orgStudyIdInfo id: DEH113-III-0123, briefTitle: Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea, acronym: LIBERTÀ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-02, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: EMS, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea., conditionsModule conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: DEH113, interventions name: Placebo Comparator, outcomesModule primaryOutcomes measure: Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose, secondaryOutcomes measure: Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose, secondaryOutcomes measure: Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose., secondaryOutcomes measure: Use of rescue medication, secondaryOutcomes measure: Number of additional drug intake, secondaryOutcomes measure: Patients' Global Impression of Change (PGIC), secondaryOutcomes measure: Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06268041, orgStudyIdInfo id: 427659, secondaryIdInfos id: R01HD093694, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD093694, briefTitle: HIT-Stroke Trial 2, acronym: HST2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Cincinnati, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: University of Kansas Medical Center, collaborators name: University of Delaware, descriptionModule briefSummary: People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Moderate-Intensity Aerobic Training, interventions name: High-Intensity Interval Training, outcomesModule primaryOutcomes measure: 6-Minute Walk Test Distance, secondaryOutcomes measure: 6-Minute Walk Test Distance, secondaryOutcomes measure: Self-Selected Gait Speed, secondaryOutcomes measure: Fastest Gait Speed, secondaryOutcomes measure: PROMIS-Fatigue Scale version 8a, secondaryOutcomes measure: Aerobic Capacity, secondaryOutcomes measure: EuroQol-5D-5L, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Delaware, status: RECRUITING, city: Newark, state: Delaware, zip: 19713, country: United States, contacts name: Jane Diehl, role: CONTACT, email: [email protected], contacts name: Darcy Reisman, PT, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.68372, lon: -75.74966, locations facility: University of Kansas Medical Center, status: RECRUITING, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Sasha Moores, role: CONTACT, phone: 913-588-2697, email: [email protected], contacts name: Sandra Billinger, PT, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False |
protocolSection identificationModule nctId: NCT06268028, orgStudyIdInfo id: BELMA TA, briefTitle: Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-11-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.The research is a pre-test-post-test, randomized controlled experimental study., conditionsModule conditions: Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Training, outcomesModule primaryOutcomes measure: A pre-test will be applied to 70 women who constitute the sample of the research., secondaryOutcomes measure: Apost-test will be applied to 70 women who constitute the sample of the research., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aydın Maternity and Child Health Hospital, city: Aydın, zip: 09010, country: Turkey, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False |
protocolSection identificationModule nctId: NCT06268015, orgStudyIdInfo id: Pro00115311, briefTitle: Botensilimab and Balstilimab Optimization in Colorectal Cancer, acronym: BBOpCo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Nicholas DeVito, MD, class: OTHER, collaborators name: Gateway for Cancer Research, collaborators name: Agenus Inc., descriptionModule briefSummary: This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Botensilimab, interventions name: Balstilimab, interventions name: Oxaliplatin, interventions name: Leucovorin, interventions name: Fluorouracil, interventions name: Bevacizumab, interventions name: Panitumumab, outcomesModule primaryOutcomes measure: Disease control rate based on iRECIST at second restaging scan, primaryOutcomes measure: Proportion of subjects with a best overall response of complete response or partial response according to iRECIST, secondaryOutcomes measure: Disease control rate based on RECIST v1.1 at second restaging scan, secondaryOutcomes measure: Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1, secondaryOutcomes measure: Months of overall survival, secondaryOutcomes measure: Months of progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Nicholas C. DeVito, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False |
protocolSection identificationModule nctId: NCT06268002, orgStudyIdInfo id: 5876557033, briefTitle: Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-09-01, primaryCompletionDateStruct date: 2021-09-30, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 93, type: ACTUAL, armsInterventionsModule interventions name: Vernonia cinerea, interventions name: Placebo, outcomesModule primaryOutcomes measure: continuous abstinence rate, secondaryOutcomes measure: continuous abstinence rate (CAR) and point prevalence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Krittin Bunditanukul, city: Bangkok, zip: 10600, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06267989, orgStudyIdInfo id: Gothenburg University, briefTitle: The Effectiveness of Early Intervention to Correct the Position of PDC:s, acronym: PDC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Region Örebro County, class: OTHER, descriptionModule briefSummary: Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided., conditionsModule conditions: Ectopic Tooth Eruption, conditions: Palatal Expansion Technique, conditions: Randomized Clinical Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 318, type: ESTIMATED, armsInterventionsModule interventions name: Extraction of the primary canine teeth, interventions name: Expansion, outcomesModule primaryOutcomes measure: Succeful eruption of the palatally displaced canines into the dental arch, secondaryOutcomes measure: Cost effectiveness of the interventions, secondaryOutcomes measure: Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Gothenbrug University, status: RECRUITING, city: Gothenburg, country: Sweden, contacts name: Farhan Bazargani, DDS, PhD, role: CONTACT, contacts name: Björn Ludwig, DDS, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Martyn Coborune, DDS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False |
protocolSection identificationModule nctId: NCT06267976, orgStudyIdInfo id: REB23-1003, briefTitle: Validation of the ProSomnus® RPMO2 Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: ProSomnus Sleep Technologies, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to:1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range., conditionsModule conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: ProSomnus RPMO2, outcomesModule primaryOutcomes measure: SpO2 accuracy, primaryOutcomes measure: Pulse rate accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Calgary, city: Calgary, state: Alberta, zip: T2N4N1, country: Canada, contacts name: Brad Hansen, role: CONTACT, phone: 403-210-8925, email: [email protected], geoPoint lat: 51.05011, lon: -114.08529, hasResults: False |
protocolSection identificationModule nctId: NCT06267963, orgStudyIdInfo id: C4391010, secondaryIdInfos id: 2023-507074-40-00, type: REGISTRY, domain: CTIS (EU), briefTitle: A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-04-18, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.The study is seeking for participants who:* are males aged 18 to 65 years and are healthy.* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2* have a total body weight of at least 50 kilograms.The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Oral [14C]PF-07220060, interventions name: Oral PF-07220060, interventions name: IV [14C] PF-07220060, outcomesModule primaryOutcomes measure: Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered., primaryOutcomes measure: Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces., secondaryOutcomes measure: Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit), secondaryOutcomes measure: The absolute oral bioavailability (F) of PF-07220060, secondaryOutcomes measure: The fraction of PF-07220060 dose absorbed (Fa), secondaryOutcomes measure: Number of participants with treatment emergent clinically significant laboratory abnormalities, secondaryOutcomes measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements, secondaryOutcomes measure: Number of participants with treatment emergent clinically significant abnormal vital measurements, secondaryOutcomes measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of participants with treatment emergent clinically significant abnormal physical examination, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PRA Health Sciences, city: Groningen, zip: 9728 NZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06267950, orgStudyIdInfo id: PILUO-INFANT, briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared., conditionsModule conditions: Pierre Robin Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: systematic therapy, interventions name: intermittent oro-esophageal tube feeding, interventions name: gastric tube feeding, outcomesModule primaryOutcomes measure: Number of patients diagnosed as the pulmonary infection "Positive", secondaryOutcomes measure: Nutritional status-total protein, secondaryOutcomes measure: Nutritional status-hemoglobin, secondaryOutcomes measure: Nutritional status-albumin, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: The Functional Oral Intake Scale for Infants, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hsinchu Rehabilitation Hospital, status: RECRUITING, city: Xinzhu, country: Taiwan, contacts name: Haim Liu, Master, role: CONTACT, geoPoint lat: 22.46205, lon: 120.47335, hasResults: False |
protocolSection identificationModule nctId: NCT06267937, orgStudyIdInfo id: 101, briefTitle: Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2023-03-10, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Chile, class: OTHER, collaborators name: Instituto Sistemas Complejos de Ingeniería, Universidad de Chile, Santiago, Chile, descriptionModule briefSummary: Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018., conditionsModule conditions: Hip Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 46380, type: ACTUAL, armsInterventionsModule interventions name: Access to surgery, interventions name: type of intitution, outcomesModule primaryOutcomes measure: survival after hip fracture, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: hospital Clinico Universidad de Chile, city: Santiago, state: Region Metropolitana, zip: 8380456, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False |
protocolSection identificationModule nctId: NCT06267924, orgStudyIdInfo id: Olith10703, briefTitle: SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Otolith Labs, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.Participants will be:* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)* Randomized and stratified into groups based on the referring clinic to be assigned one study device* Asked to use the study device as instructed by the study coordinator* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators* Asked to provide their vertigo diagnosis from their physician* Compensated for their participationResearchers will compare the randomized groups to determine which group responds better to which device., conditionsModule conditions: Vestibular Migraine, conditions: Migraine Associated Vertigo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Otoband Experimental, interventions name: Otoband Sham, outcomesModule primaryOutcomes measure: DHI Change in Scores, secondaryOutcomes measure: Number of related adverse events, secondaryOutcomes measure: Change in number of vestibular migraine episodes weekly, secondaryOutcomes measure: Global Impression of Change (severity of episodes), secondaryOutcomes measure: DHI change from transition to end of study, secondaryOutcomes measure: Device responder rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Otolith Labs, city: Washington, state: District of Columbia, zip: 20001, country: United States, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False |
protocolSection identificationModule nctId: NCT06267911, orgStudyIdInfo id: 202223-10, secondaryIdInfos id: 160/U/2022, type: OTHER_GRANT, domain: Fundació La Marató de TV3, briefTitle: Rehabilitation Gaming System for Intensive Care Units, acronym: RGS-ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of the Balearic Islands, class: OTHER, collaborators name: Corporacion Parc Tauli, collaborators name: Hospital Son Llatzer, collaborators name: Fundació La Marató de TV3, descriptionModule briefSummary: Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders., conditionsModule conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive stimulation and psychological support (RGS-ICU), outcomesModule primaryOutcomes measure: Attention performance, primaryOutcomes measure: Working memory performance, primaryOutcomes measure: Learning/memory performance, primaryOutcomes measure: Executive function performance, primaryOutcomes measure: Processing speed performance, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety], secondaryOutcomes measure: Dyspnea intensity, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Worry intensity, secondaryOutcomes measure: Sadness intensity, secondaryOutcomes measure: Comfort experienced, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: Symptoms of depression, secondaryOutcomes measure: Symptoms of post-traumatic stress disorder, otherOutcomes measure: Subjective cognition, otherOutcomes measure: Functionality, otherOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of the Balearic Islands, city: Palma De Mallorca, state: Balearic Islands, zip: 07122, country: Spain, contacts name: Guillem Navarra-Ventura, PhD, role: CONTACT, phone: +34971259888, email: [email protected], geoPoint lat: 39.56939, lon: 2.65024, locations facility: Hospital Universitari Son Llàtzer, city: Palma De Mallorca, state: Balearic Islands, zip: 07198, country: Spain, contacts name: Gemma Rialp, MD, PhD, role: CONTACT, phone: +34871202000, email: [email protected], geoPoint lat: 39.56939, lon: 2.65024, locations facility: Corporacion Parc Tauli, city: Sabadell, state: Catalonia, zip: 08208, country: Spain, contacts name: Sol Fernández-Gonzalo, PhD, role: CONTACT, phone: +34937236673, email: [email protected], geoPoint lat: 41.54329, lon: 2.10942, hasResults: False |
protocolSection identificationModule nctId: NCT06267898, orgStudyIdInfo id: EBMT- 842205547, briefTitle: Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML, statusModule overallStatus: COMPLETED, startDateStruct date: 2009-11-01, primaryCompletionDateStruct date: 2015-01-29, completionDateStruct date: 2015-05-21, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: European Society for Blood and Marrow Transplantation, class: NETWORK, collaborators name: Novartis, descriptionModule briefSummary: Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards., conditionsModule conditions: MDS, conditions: CMML, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 222, type: ACTUAL, outcomesModule primaryOutcomes measure: non-relapse mortality (treatment related mortality)., secondaryOutcomes measure: treatment-related toxic effects, secondaryOutcomes measure: relapse rate, secondaryOutcomes measure: event-free survival, secondaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antwerp University Hospital (UZA), city: Antwerp, zip: 2650, country: Belgium, geoPoint lat: 51.21989, lon: 4.40346, locations facility: University Hospital Gasthuisberg, city: Leuven, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, locations facility: University of Liege, city: Liege, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Charles University Hospital, city: Pilsen, zip: 304 60, country: Czechia, geoPoint lat: 49.74747, lon: 13.37759, locations facility: University Hospital, city: Essen, zip: 45122, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: University Hospital Leipzig, city: Leipzig, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, hasResults: False |
protocolSection identificationModule nctId: NCT06267885, orgStudyIdInfo id: Children NOF fracture fixation, briefTitle: Fixation of Fracture Neck of Femur in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique, conditionsModule conditions: Fracture Neck of Femur, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Cannulated screws vs wagner's technique, outcomesModule primaryOutcomes measure: The better method for fixation of fracture neck of femur, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Assiut university, city: Assiut, country: Egypt, contacts name: Mina Maged, role: CONTACT, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06267872, orgStudyIdInfo id: HVTN 309, briefTitle: A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2026-07-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, collaborators name: National Institutes of Health (NIH), collaborators name: Department of Health and Human Services, collaborators name: Duke University, collaborators name: Access to Advanced Health Institute (AAHI), descriptionModule briefSummary: This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: CD4BS CH505M5 Pr-NP1, interventions name: CH505TF chTrimer, interventions name: 3M-052-AF (labeled as AP 60-702), interventions name: Aluminum Hydroxide Suspension (Alum), interventions name: ACU-026-001-1 (labeled as empty LNP), outcomesModule primaryOutcomes measure: Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine, primaryOutcomes measure: Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine, primaryOutcomes measure: Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry, primaryOutcomes measure: Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay, primaryOutcomes measure: Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA), secondaryOutcomes measure: Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA), secondaryOutcomes measure: Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay, secondaryOutcomes measure: Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay, secondaryOutcomes measure: Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry, secondaryOutcomes measure: Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry, secondaryOutcomes measure: Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alabama CRS (Site ID: 31788), city: Birmingham, state: Alabama, zip: 35222, country: United States, contacts name: Heather Logan, A.N.P., role: CONTACT, phone: 205-873-8686, email: [email protected], geoPoint lat: 33.52066, lon: -86.80249, locations facility: The Ponce de Leon Center CRS (Site ID: 5802), city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Ericka Patrick, M.S.N, role: CONTACT, phone: 404-616-6313, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, locations facility: Vanderbilt Vaccine (VV) CRS (Site ID: 30352), city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Shonda E. Sumner, B.S.N., role: CONTACT, phone: 615-343-6906, email: [email protected], geoPoint lat: 36.16589, lon: -86.78444, locations facility: Setshaba Research Centre CRS (Site ID: 31829), city: Soshanguve, state: Gauteng, zip: 0152, country: South Africa, contacts name: Magdeline K. Molapo, role: CONTACT, phone: 27-12-7992422, email: [email protected], locations facility: Isipingo CRS (Site ID: 31635), city: Isipingo, state: Kwa Zulu Natal, zip: 4110, country: South Africa, contacts name: Girisha Kistnasami, B.Sc., D.P.M., role: CONTACT, phone: 27-31-2423600, email: [email protected], geoPoint lat: -29.98639, lon: 30.91853, locations facility: Klerksdorp CRS (Site ID: 30325), city: Klerksdorp, state: North West Province, zip: 2571, country: South Africa, contacts name: Olebogeng Jonkane, role: CONTACT, phone: None Listed, email: [email protected], geoPoint lat: -26.85213, lon: 26.66672, hasResults: False |
protocolSection identificationModule nctId: NCT06267859, orgStudyIdInfo id: No. 2 of 2023/11/7, briefTitle: Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-08, primaryCompletionDateStruct date: 2033-12-30, completionDateStruct date: 2034-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Tashkent Pediatric Medical Institute, class: OTHER, descriptionModule briefSummary: The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.The main questions it aims to answer:* Analysis of common congenital diseases among children;* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;* Based on the results of the primary research, common diseases among children will be identified;* Analysis of existing treatment methods and their effectiveness;* Development of modern methods of treatment and rehabilitation of children., conditionsModule conditions: Respiratory Diseases, conditions: Congenital Heart Defects, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: identification of children from the group of "frequently ill children", primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: working with children from the "frequently ill children" group, whoMasked: PARTICIPANT, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: The use of a combination of microelements and vitamins against the background of physiotherapy, outcomesModule primaryOutcomes measure: Working with archival documentation., primaryOutcomes measure: Formation of a group of patients to study immunity and the antioxidant system in venous blood., primaryOutcomes measure: Clinical scientific research., primaryOutcomes measure: Clinical trial evaluation., eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Turdieva Shokhida Tolkunovna, status: RECRUITING, city: Tashkent, state: Yunus-obad District, zip: 100140, country: Uzbekistan, contacts name: Shokhida T Turdieva, M.D., D.Sc., role: CONTACT, phone: +998935872570, email: [email protected], contacts name: Kholida B Abdurashidova, role: CONTACT, phone: +998935092934, email: [email protected], contacts name: Gulmira R Nasirova, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 41.26465, lon: 69.21627, hasResults: False |
protocolSection identificationModule nctId: NCT06267846, orgStudyIdInfo id: NBI-1070770-MDD2029, briefTitle: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Neurocrine Biosciences, class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD)., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: NBI-1070770, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5, secondaryOutcomes measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Rogers, state: Arkansas, zip: 72758, country: United States, geoPoint lat: 36.33202, lon: -94.11854, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Lemon Grove, state: California, zip: 91945, country: United States, geoPoint lat: 32.74255, lon: -117.03142, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Long Beach, state: California, zip: 90806, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Gaithersburg, state: Maryland, zip: 20877, country: United States, geoPoint lat: 39.14344, lon: -77.20137, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: North Canton, state: Ohio, zip: 44730, country: United States, geoPoint lat: 40.87589, lon: -81.40234, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Houston, state: Texas, zip: 77008, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
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