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<|newrecord|> nctId: NCT06267001 id: GO45006 id: 2023-506696-10-00 type: REGISTRY domain: EU CT briefTitle: A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy acronym: SKYSCRAPER-15 overallStatus: RECRUITING date: 2024-03-21 date: 2034-03-31 date: 2039-06-30 date: 2024-02-20 date: 2024-04-26 name: Hoffmann-La Roche class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy. conditions: Non-small Cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1150 type: ESTIMATED name: Atezolizumab name: Tiragolumab name: Placebo measure: Disease-free Survival (DFS) measure: Percentage of Participants With Adverse Events (AEs) measure: Overall Survival (OS) measure: DFS Rate measure: Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) measure: Serum Concentration of Tiragolumab measure: Serum Concentration of Atezolizumab measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab measure: Percentage of Participants With ADAs to Atezolizumab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Oncology Institute of Hope and Innovation; Cerritos status: RECRUITING city: Cerritos state: California zip: 90703 country: United States lat: 33.85835 lon: -118.06479 facility: University of California, San Francisco; Medical Center status: RECRUITING city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital status: RECRUITING city: Marietta state: Georgia zip: 30060 country: United States lat: 33.9526 lon: -84.54993 facility: Springfield Clinic status: RECRUITING city: Springfield state: Illinois zip: 62702 country: United States lat: 39.80172 lon: -89.64371 facility: UNM Lovelace status: RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States lat: 35.08449 lon: -106.65114 facility: University of New Mexico Cancer Center status: RECRUITING city: Albuquerque state: New Mexico zip: 87106 country: United States lat: 35.08449 lon: -106.65114 facility: Asante Rogue Regional Medical Center status: RECRUITING city: Medford state: Oregon zip: 97504-8332 country: United States lat: 42.32652 lon: -122.87559 facility: Hospital Britanico; Oncologia status: RECRUITING city: Buenos Aires zip: C1280AEB country: Argentina lat: -34.61315 lon: -58.37723 facility: Centro Oncologico Korben; Oncology status: RECRUITING city: Ciudad Autonoma Buenos Aires zip: C1426AGE country: Argentina lat: -34.61315 lon: -58.37723 facility: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC status: RECRUITING city: Ciudad Autonoma de Buenos Aires zip: C1027AAP country: Argentina lat: -34.61315 lon: -58.37723 facility: Sunshine Coast University Hospital; The Adem Crosby Centre status: RECRUITING city: Birtinya state: Queensland zip: 4575 country: Australia lat: -26.74322 lon: 153.11913 facility: Greenslopes Private Hospital; Gallipoli Research Centre status: RECRUITING city: Greenslopes state: Queensland zip: 4120 country: Australia lat: -27.50815 lon: 153.04951 facility: Cancer Research SA status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia lat: -34.92866 lon: 138.59863 facility: Monash Health status: RECRUITING city: Clayton state: Victoria zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Hospital de Cancer de Barretos status: RECRUITING city: Barretos state: SP zip: 14784-400 country: Brazil lat: -20.55722 lon: -48.56778 facility: Hospital A. C. Camargo; Oncologia status: RECRUITING city: Sao Paulo state: SP zip: 01509-010 country: Brazil lat: -23.5475 lon: -46.63611 facility: Changzhou First People's Hospital; Oncology status: RECRUITING city: Changzhou zip: 213003 country: China lat: 31.77359 lon: 119.95401 facility: The First Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou City zip: 510080 country: China facility: Guangdong General Hospital status: RECRUITING city: Guangzhou zip: 510080 country: China lat: 23.11667 lon: 113.25 facility: Shandong Cancer Hospital status: RECRUITING city: Jinan zip: 250117 country: China lat: 36.66833 lon: 116.99722 facility: Yunnan Cancer Hospital status: RECRUITING city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang City zip: 330008 country: China facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing City zip: 210008 country: China facility: Ningbo No.2 Hospital status: RECRUITING city: Ningbo country: China lat: 29.87819 lon: 121.54945 facility: Zhongshan Hospital Fudan University status: RECRUITING city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Liaoning Provincial Cancer Hospital status: RECRUITING city: Shengyang zip: 110042 country: China facility: Tianjin Cancer Hospital status: RECRUITING city: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology status: RECRUITING city: Wuhan City zip: 430030 country: China facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou country: China lat: 34.18045 lon: 117.15707 facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: Kindai University Hospital status: RECRUITING city: Osaka zip: 589-8511 country: Japan lat: 34.69374 lon: 135.50218 facility: Pusan National University Hospital status: RECRUITING city: Busan zip: 602-739 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Chungbuk National University Hospital status: RECRUITING city: Cheongju si zip: 28644 country: Korea, Republic of lat: 36.63722 lon: 127.48972 facility: Kyungpook National University Chilgok Hospital status: RECRUITING city: Daegu zip: 41404 country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: St. Vincent's Hospital status: RECRUITING city: Gyeonggi-do zip: 16247 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Pusan National University Yangsan Hospital status: RECRUITING city: Gyeongsangnam-do zip: 50612 country: Korea, Republic of facility: Chonnam National University Hwasun Hospital status: RECRUITING city: Jeollanam-do zip: 58128 country: Korea, Republic of facility: Seoul National University Bundang Hospital status: RECRUITING city: Seongnam-si zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Severance Hospital, Yonsei University Health System status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: RECRUITING city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Guro Hospital status: RECRUITING city: Seoul zip: 08308 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ulsan University Hosiptal status: RECRUITING city: Ulsan zip: 44033 country: Korea, Republic of lat: 35.53722 lon: 129.31667 facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Taichung Veterans General Hospital; Dept of Internal Medicine status: RECRUITING city: Taichung zip: 407 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology status: RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Tri-Service General Hospital; Dept. of Internal Medicine status: RECRUITING city: Taipei zip: 114 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06266988 id: SCVL-TFZ-1010 briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Viatris Inc. class: INDUSTRY briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 48 type: ESTIMATED name: Sacubitril and Valsartan Tablets 97mg/103mg name: Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) measure: Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software) measure: Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06266975 id: CKD pts in CML briefTitle: Chronic Kidney Disease Patient in Chronic Myloied Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-11 date: 2026-11 date: 2024-02-20 date: 2024-02-20 name: Sahar Mohammed Gad class: OTHER briefSummary: To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia . conditions: Chronic Myeloid Leukemia in Remission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Biobsy from kidney measure: Chronic Kidney Disease Patient in Chronic Myloied Leukemia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266962 id: 3/24 briefTitle: Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome overallStatus: COMPLETED date: 2020-07-01 date: 2022-09-30 date: 2022-09-30 date: 2024-02-20 date: 2024-02-20 name: University Hospital Olomouc class: OTHER name: Palacky University briefSummary: Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine. conditions: Intraoperative Floppy Iris Syndrome conditions: Cataract conditions: Age-related Cataract conditions: Adrenergic Receptor Antagonist Adverse Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 164 type: ACTUAL name: 1% Atropine drops name: Epinephrine measure: Development of IFIS measure: Severity of IFIS measure: Incidence of intraoperative complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, University Hospital Olomouc city: Olomouc country: Czechia lat: 49.59552 lon: 17.25175 hasResults: False
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<|newrecord|> nctId: NCT06266949 id: 11362 briefTitle: Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-04-01 date: 2024-02-20 date: 2024-02-20 name: University Medical Center Groningen class: OTHER briefSummary: The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour. conditions: Pituitary Tumor conditions: Visual Fields Hemianopsia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: SONDA measure: Convert validity measure: Test-retest reliability measure: Experience sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMCG city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06266936 id: EssaiClinique_SL2i-MSC briefTitle: Smart Life Smart Living Intercontinental - Medical Students' Cohort acronym: SL2i-MSC overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2044-09 date: 2044-12 date: 2024-02-20 date: 2024-04-17 name: University Hospital, Grenoble class: OTHER name: Université Grenoble-Alpes briefSummary: The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.
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The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress. conditions: Mental Health Issue conditions: Student Burnout studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1564 type: ESTIMATED name: No intervention measure: Synthetic score on standardized assessment scale of anxiety measure: Synthetic score on standardized assessment scale of mental health measure: Synthetic score on standardized assessment scale of stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266923 id: SPH6516-101 briefTitle: A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors. overallStatus: COMPLETED date: 2022-01-20 date: 2023-04-20 date: 2023-11-01 date: 2024-02-20 date: 2024-02-20 name: Shanghai Pharmaceuticals Holding Co., Ltd class: INDUSTRY briefSummary: To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: SPH6516 tablets measure: MTD(Maximum tolerated dose) measure: Incidence of Treatment-Emergent Adverse Events measure: Peak Plasma Concentration (Cmax) measure: Peak time(Tmax) measure: Area under the plasma concentration versus time curve (AUC) measure: half-life(T1/2) measure: Objective response rate(ORR) measure: Progression-free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou country: China lat: 23.11667 lon: 113.25 facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06266910 id: 2023KYPJ320 briefTitle: Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-01 date: 2024-10-10 date: 2024-02-20 date: 2024-02-20 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER name: South China University of Technology briefSummary: This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: By employing a single simulation technology for blinding, both the 2D group and the 3D group share identical training equipment and a consistent video background. The only distinction lies in the subtle variation in the configuration of training markers. It is difficult for participants to differentiate their respective groups. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Visual training video measure: Accommodative facility measure: Vergence facility measure: Negative and positive fusional vergence measure: Accommodative response measure: negative and positive relative accommodation measure: Near point of convergence measure: Accommodation amplitude measure: Electroencephalogram (EEG) node efficiency measure: Functional near-infrared spectroscopy (fNIRS) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Zhongshan Opthalmic Center, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510060 country: China name: Yehong Zhuo role: CONTACT phone: 13352828998 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06266897 id: ZhujiangEM briefTitle: A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota overallStatus: RECRUITING date: 2023-06-18 date: 2026-12 date: 2026-12 date: 2024-02-20 date: 2024-02-20 name: Zhujiang Hospital class: OTHER briefSummary: Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED measure: Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition sex: FEMALE minimumAge: 18 Years maximumAge: 52 Years stdAges: ADULT facility: Zhujiang Hospital status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China name: Ying Ma role: CONTACT phone: +8613113361169 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06266884 id: AgriIbrahimCecen briefTitle: The Effect of Kangaroo Care on Father-Baby Attachment overallStatus: COMPLETED date: 2022-12-15 date: 2023-06-15 date: 2023-11-15 date: 2024-02-20 date: 2024-02-20 name: Agri Ibrahim Cecen University class: OTHER name: Kahramanmaras Sutcu Imam University briefSummary: The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared. conditions: Kangaroo Care conditions: Attachment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ACTUAL name: Kangaroo care measure: Fathers' Attachment Level sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Agri Ibrahim Cecen University city: Agri country: Turkey lat: 39.71944 lon: 43.05139 hasResults: False
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<|newrecord|> nctId: NCT06266871 id: WCH-2023-1625 briefTitle: SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2026-06-30 date: 2026-07-30 date: 2024-02-20 date: 2024-02-20 name: West China Hospital class: OTHER briefSummary: Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: SOX+Tislelizumab+LDRT measure: pCR rate measure: R0 resection rate measure: MPR rate measure: ORR measure: 2-year disease-free survival (DFS) rate measure: 2-year OS rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266858 id: SYSKY-2022-407-02 briefTitle: Multimodality Imaging Assessment of the Severity of Mitral Regurgitation overallStatus: RECRUITING date: 2022-12-01 date: 2024-06-30 date: 2024-06-30 date: 2024-02-20 date: 2024-02-20 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To investigate to assess the severity of mitral regurgitation by multimodality imaging. conditions: Mitral Regurgitation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: rehydration name: UCG name: CMR name: fasting measure: effective regurgitant orifice area (EROA) measure: mitral regurgitant volume (RVol) measure: mitral regurgitant fraction (RF) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Maohuan Lin, PhD role: CONTACT phone: 13580575861 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06266845 id: 76082423.1.0000.8093 briefTitle: Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients overallStatus: RECRUITING date: 2024-03-04 date: 2024-06-01 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: University of Brasilia class: OTHER briefSummary: Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing. conditions: Arrythmia conditions: Health Education conditions: Escape-Room studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 53 type: ESTIMATED name: In-person Escape Room name: Virtual Escape-Room measure: Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture measure: Perceived Gains Scale measure: Student Satisfaction and Self-Confidence in Learning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alberto Augusto Martins Paiva status: RECRUITING city: Brasília state: DF zip: 71938360 country: Brazil name: Alberto Augusto M Paiva, Graduate role: CONTACT phone: +5561983470397 email: [email protected] lat: -15.77972 lon: -47.92972 hasResults: False
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<|newrecord|> nctId: NCT06266832 id: 20230727 briefTitle: The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2027-12-31 date: 2024-02-20 date: 2024-02-20 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma. conditions: Rectal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab name: Oxaliplatin name: Capecitabine name: Short-course Radiation name: Biopsy measure: Organ retention rate measure: Total mesorectal excision rate measure: Total mesorectal excision rate after recurrence measure: Tumor regression grade measure: Overall survival measure: Disease free survival measure: TRAEs measure: QoL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310016 country: China name: Xiujun Cai role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06266819 id: OU-HEM-LE-01 briefTitle: The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women. conditions: Hyperemesis Gravidarum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups with chewing mint gum experimental group and a control group primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The study protocol in the research will be created using SPIRIT as a guide. Reporting of the trial will be structured according to the CONSORT checklist. Random distribution of pregnant women included in the study to the intervention and control groups will be made at www.randomizer.org. Which group will be the intervention or control group will be determined by drawing lots at the beginning of the study. Pregnant women in the intervention group will be given the practice of chewing mint-flavored gum.
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Since the researcher knows which group the pregnant women are included in, the data collection phase of the study is single blind. To avoid selection bias in this study, pregnant women will be randomly assigned to the intervention and control groups by randomization method. To prevent reporting bias, the analysis of the research data will be carried out by an expert statistician. whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: chewing gum measure: Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) measure: Visual Analog Scale (VAS) measure: Stress Coping Styles Scale (SCSS) measure: State-Trait Anxiety Inventory (STAI) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Özel Şar Hospital status: RECRUITING city: Rize zip: 53100 country: Turkey name: M.Akif KUMBUZOĞLU, Uzm. Dr. role: CONTACT phone: +90 464 212 11 03 email: [email protected] lat: 41.02083 lon: 40.52194 hasResults: False
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<|newrecord|> nctId: NCT06266806 id: OndokusMU55 briefTitle: The Effect of Breastfeeding Counseling on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-12-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-21 name: Ondokuz Mayıs University class: OTHER briefSummary: The purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception, breastfeeding self-efficacy and outcomes. The study will involve pregnant women and close others assigned randomly to the intervention (n=50) or control (n=50) groups in a state hospital in Turkey. Individual counseling will be provided to the intervention group within the scope of the EMÖZGEDAP, based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). The Antenatal Breastfeeding Self-Efficacy Scale will be evaluated before the counseling program is given in the antepartum period. Breastfeeding and Nutrition Results, Postpartum Breastfeeding Self-Efficacy Scale, Breastfeeding Self-Efficacy Scale for Fathers, Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy and Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy will be evaluated at the 1st, 3rd, and 6th months postpartum. conditions: Breastfeeding, Exclusive conditions: Nurse's Role conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled experimental study primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources measure: Breastfeeding and Nutrition Results measure: Antenatal Breastfeeding Self-Efficacy Scale Short Form measure: Postpartum Breastfeeding Self-Efficacy Scale-Short Form measure: Breastfeeding Self-Efficacy Scale for Fathers Short Form measure: Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy measure: Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266793 id: 2072488-2 briefTitle: Comparison of Holmium Laser and Thulium Laser for Mini PCNL acronym: HOTLaser overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-06-01 date: 2027-06-01 date: 2024-02-20 date: 2024-02-21 name: MaineHealth class: OTHER name: Boston Scientific Corporation briefSummary: This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting. conditions: Nephrolithiasis conditions: Percutaneous Nephrolithotomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 52 type: ESTIMATED name: Holmium Laser name: Thulium Laser measure: Laser Treatment Time measure: Retreatment rate measure: Total Operative Time measure: Stone-Free Rate measure: Length of stay measure: Safety Profile and Adverse Events measure: Subjective pain scores sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maine Medical Center city: Portland state: Maine zip: 04102 country: United States name: Danielle Landry, RN role: CONTACT phone: 207-662-0111 email: [email protected] lat: 43.66147 lon: -70.25533 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-05 uploadDate: 2024-02-05T13:32 filename: Prot_SAP_000.pdf size: 799007 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-05 uploadDate: 2024-02-05T13:23 filename: ICF_001.pdf size: 397260 hasResults: False
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<|newrecord|> nctId: NCT06266780 id: P1473-2023 briefTitle: Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya overallStatus: RECRUITING date: 2024-02-02 date: 2024-08-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Jacaranda Health class: OTHER name: Harvard School of Public Health (HSPH) name: Jhpiego name: IPSOS briefSummary: The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.
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Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale. conditions: Postpartum Family Planning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 4190 type: ESTIMATED name: PROMPTS Enhanced Family Planning Counselling measure: Use of postpartum family planning at 3 months measure: Use of postpartum family planning at 6 months measure: Knowledge of return to fertility measure: Knowledge of safe birth spacing measure: Knowledge of lactational amenorrhea (LAM) method measure: Intention to continue family planning method measure: Intended duration of continued family planning method use measure: Desired pregnancy spacing of two years or more measure: Short interpregnancy interval measure: Method satisfaction measure: Uptake of most effective family planning methods measure: Time to take-up of most effective methods measure: Discussion of FP at any prenatal visit measure: Discussion of FP at any postnatal visit measure: Reproductive empowerment: health care provider communication measure: Quality of helpdesk team in counselling on family planning measure: Quality of message flow on method selection sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jacaranda Health status: RECRUITING city: Nairobi zip: 00000 country: Kenya name: Anneka Wickramanayake, Masters role: CONTACT phone: +254700164229 email: [email protected] name: Jessica Cohen, Ph.D role: CONTACT phone: +16174327577 email: [email protected] lat: -1.28333 lon: 36.81667 hasResults: False
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<|newrecord|> nctId: NCT06266767 id: MRC-01-18-157 briefTitle: Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia acronym: PIEB overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-04-20 date: 2024-04-30 date: 2024-02-20 date: 2024-02-20 name: Hamad Medical Corporation class: INDUSTRY briefSummary: Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score. conditions: Labor Pain conditions: Obstetric Pain conditions: Analgesia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups.
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There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE maskingDescription: This is a randomized double-blinded design. Patients and their attending physicians / clinical anaesthetists / data collection study member / midwives / nurses will be blinded to patient group allocation whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Levobupivacaine and Fentanyl measure: The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score measure: Pain score measure: Total local anesthetic consumption measure: Need for supplementary epidural analgesia measure: Bromage score (lower limb weakness score) measure: Type of delivery measure: Sensory block measure: Fetal Outcome sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hamad Medical Corporation (HMC) city: Doha zip: 3050 country: Qatar lat: 25.28545 lon: 51.53096 hasResults: False
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<|newrecord|> nctId: NCT06266754 id: OPV-IMMUNO-ADULT briefTitle: The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau overallStatus: ENROLLING_BY_INVITATION date: 2024-01-29 date: 2024-07-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Bandim Health Project class: OTHER name: Radboud University Medical Center briefSummary: OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity. These beneficial OPV effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of OPV against polio infection. They have been coined "non-specific effects" (NSEs). Such NSEs have also been observed for other live attenuated vaccines such as BCG vaccine and measles vaccine. The underlying immunological mechanisms are unknown. Other live vaccines with beneficial NSEs have been shown to induce epigenetic changes leading to "trained immunity". They have also been associated with decreased inflammation. In the present study it will be investigates whether OPV can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in Guinea-Bissau. conditions: Vaccine Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised trial primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: A placebo will be used. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Oral polio vaccine name: Placebo measure: Levels of in vitro proinflammatory cytokines such as IL1-beta, TNF-alfa and IFN-gamma after stimulation of peripheral blood mononuclear cells with non-OPV antigens and mitogens measure: Levels of plasma markers of systemic inflammation such as TNF ligand superfamily member 12 (TWEAK) and sirtuin 2 (SIRT2) measure: Amount of pseudo-bulk ATACseq and RNAseq - indicating chromatin accessibility of interferon-stimulated genes associated with the interferon response pathway in PBMCs. measure: Proportions of immune cell subsets sex: MALE minimumAge: 50 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bandim Health Project, Apartado 861 city: Bissau country: Guinea-Bissau lat: 11.86357 lon: -15.59767 hasResults: False
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<|newrecord|> nctId: NCT06266741 id: NCT093509350936 briefTitle: The Predictive Value of Lubricin in Patients With Infective Endocarditis overallStatus: ENROLLING_BY_INVITATION date: 2024-02-11 date: 2024-02-20 date: 2026-02-20 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients conditions: Infective Endocarditis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Lubricin measure: Valve damage indicative sign in infective endocarditis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sevil Gulasti city: Aydın state: Zafer zip: 09010 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06266728 id: IRB00006733 briefTitle: T30 for Astigmatism in Digital Device Users acronym: T30FA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-08-18 date: 2024-02-20 date: 2024-04-22 name: Southern College of Optometry class: OTHER name: Alcon Research briefSummary: This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users. conditions: Contact Lens Complication conditions: Astigmatism conditions: Refractive Errors studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism contact lenses. primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Total30 for Astigmatism Contact Lenses measure: Visual Analog Scale (VAS) Comfort Scores sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kannar Eye Care city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Coldwater VIsion Center city: Coldwater state: Mississippi zip: 38618 country: United States lat: 32.71486 lon: -89.21423 hasResults: False
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<|newrecord|> nctId: NCT06266715 id: NFEC-2024-070 briefTitle: Improvement of Depression With Use of ATP overallStatus: RECRUITING date: 2024-03-04 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-03-19 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus normal saline(NA)) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Scale(HAMD-24), cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: ATP Group name: Placebo Group measure: HAMD-24 measure: Diffusion Tensor Imaging measure: Diffusion Spectral Imaging measure: Quantitative susceptibility mapping measure: Monetary Incentive Delay Task measure: Emotional faces processing task measure: Resting state functional connectivity measure: Hamilton Anxiety Scale measure: Clinical Global Impression measure: Snaith-Hamilton Pleasure Scale measure: Insomnia Severity Index measure: Columbia-Suicide Severity Rating Scale measure: Antidepressants Side Effects measure: C-reactive protein measure: Tumor Necrosis Factor α measure: Interleukin- 6 measure: N-back task measure: Attention network test measure: Psychomotor vigilance task measure: Hamilton Depression Scale measure: Montgomery and asberg Depression Rating Scale measure: Beck Depression Inventory sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Qianqian Xin role: CONTACT phone: 17664175246 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06266702 id: BL71 briefTitle: Evaluation of a Nutritional Technology for Vitamin D Absorption overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Experimental Oil with Phospholipids name: Control Polyunsaturated Oil Blend measure: Vitamin D Absorption measure: Vitamin D Absorption - Peak measure: Vitamin D Absorption - AUC measure: Body Mass Index measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Walsh University city: North Canton state: Ohio zip: 44720 country: United States lat: 40.87589 lon: -81.40234 hasResults: False
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<|newrecord|> nctId: NCT06266689 id: Pro00112671 briefTitle: Project humAn dieTary daTa rEtuRN acronym: PATTERN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Duke University class: OTHER briefSummary: This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation. conditions: Diet Habit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 600 type: ESTIMATED name: Personalized Diet Information measure: Number of participants with diet improvement measure: Number of participants with increased dietary diversity measure: Number of participants with changes in the composition and function of the gut microbiome sex: ALL maximumAge: 12 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06266676 id: 202301775B1 briefTitle: Mobile Micro-course Impact on Perioperative RNs in Heart Surgery Nursing. overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-10 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Ting-Fang Yeh class: OTHER briefSummary: The goal of this clinical trialis to compare in learning effectiveness of nurses. The main questions it aims to answer are:
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1. Can the "Micro-course" teaching enhance the awareness of cardiac surgery nursing among operating room nurses?
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2. Can the "Micro-course" teaching boost the learning motivation and engagement of operating room nurses?
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3. What is the satisfaction level of nurses regarding the use of "Micro-course" in cardiac surgery nursing?
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4. What are the relevant factors influencing the effectiveness of the "Micro-course" teaching intervention?
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Participants will be divided into two groups. The control group will receive online presentations, while the experimental group will engage in mobile learning combined with micro-courses. Both groups of participants will undergo instruction through asynchronous online courses. conditions: periOperative conditions: Cardiac Surgical Procedures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 75 type: ESTIMATED name: micro-course name: slide presentation measure: Cognitive scale measure: motivation scale measure: Engagement Scale measure: learning satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Taoyuan City zip: 33305 country: Taiwan name: Ting-Fang Yeh role: CONTACT phone: +88633281200 phoneExt: 2380 email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06266663 id: 2022-13788 id: CNTO1275IBD4012 type: OTHER domain: Janssen Scientific Affairs, LLC briefTitle: Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease overallStatus: RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-03-04 name: Montefiore Medical Center class: OTHER name: Icahn School of Medicine at Mount Sinai name: Janssen Scientific Affairs, LLC briefSummary: Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity. conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Survey measure: IBD medication adherence measure: Health-related quality of life (HRQoL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Hutchinson Campus status: RECRUITING city: Bronx state: New York zip: 10461 country: United States name: Ruby Greywoode, MD role: CONTACT phone: 347-671-8205 email: [email protected] name: Sheila Benitez role: CONTACT phone: 347-429-0253 email: [email protected] lat: 40.84985 lon: -73.86641 facility: Icahn School of Medicine at Mount Sinai status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Zoe Gottlieb, MD role: CONTACT email: [email protected] lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06266650 id: 19485 briefTitle: Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction acronym: PMEOMT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: The Touro College and University System class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are
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• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?
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Participants will
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* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.
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* be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.
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* be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.
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* These steps are repeated three to five times and then the dysfunction is reevaluated.
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Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group. conditions: Pelvic Somatic Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one-sided MET, the second group will be treated with combination MET. Results of post-treatment exams will be collected and statistically analyzed. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Osteopathic Treatment Technique- Muscle Energy Treatment measure: Resolution of pelvic somatic dysfunction measure: Anterior anatomical landmarks assessment measure: Posterior anatomical landmarks assessment sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266637 id: P.T.REC/012/004999 briefTitle: Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-03-01 date: 2024-03-15 date: 2024-02-20 date: 2024-02-20 name: Delta University for Science and Technology class: OTHER name: Benha University briefSummary: PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial
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BACKGROUND:
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Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.
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HYPOTHESES:
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Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.
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RESEARCH QUESTION:
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What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.? conditions: Scoliosis Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: Conventional Physical Therapy Program name: Physiotherapeutic Scoliosis-Specific Exercise (Schroth) measure: Cobb's angle measure: Coronal balance measure: length of the the tibia and femur measure: tibiofemoral angle measure: knee joint line convergence angle measure: lower limb mechanical axis; and mechanical axis deviation sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
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<|newrecord|> nctId: NCT06266624 id: Tourniquet in HHT briefTitle: Tourniquet-Test in HHT overallStatus: ACTIVE_NOT_RECRUITING date: 2020-09-25 date: 2023-07-30 date: 2024-07-30 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Essen class: OTHER briefSummary: The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT. conditions: HHT studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 92 type: ACTUAL name: Tourniquet Test measure: number of positive Tourniquet Test results in HHT patients sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen city: Essen state: Nordrhein Westphalen zip: 45122 country: Germany lat: 51.45657 lon: 7.01228 hasResults: False
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<|newrecord|> nctId: NCT06266611 id: 23-0982 briefTitle: Cannabis for Palliative Care in Cancer acronym: ARCTiC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-07-31 date: 2028-07-31 date: 2024-02-20 date: 2024-02-21 name: University of Colorado, Boulder class: OTHER briefSummary: Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients. conditions: Sleep conditions: Anxiety conditions: Depression conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 185 type: ESTIMATED name: fsCBD Cannabidiol name: Placebo name: bsCBD Cannabidiol measure: Pain Interference measure: Pain Intensity measure: Pain Inventory measure: Sleep Disturbance measure: Sleep-Related Impairment measure: Depression/Anxiety measure: Fatigue measure: Health Related Quality of Life measure: Cognitive Function measure: Cognitive Function measure: Cognitive Function measure: Cognitive Function measure: Plasma Cannabinoids measure: PROMIS Pain Intensity (Right Now) measure: Drug Effects measure: Drug Effects measure: Drug Effects - Mood measure: Drug Effects - Cognitive measure: Drug Effects - Cognitive measure: Drug Effects - Cognitive measure: Drug Effects - Blood Cannabinoids measure: Polypharmacy measure: Polypharmacy measure: Polypharmacy sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anschutz Health Sciences Building city: Aurora state: Colorado zip: 80045 country: United States name: Harmony Soffer, BA role: CONTACT phone: 925-334-4031 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06266598 id: EU-TF-HA-01 briefTitle: Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity overallStatus: COMPLETED date: 2019-11-17 date: 2021-08-20 date: 2021-10-27 date: 2024-02-20 date: 2024-02-20 name: HÜMEYRA ACIKAN class: OTHER briefSummary: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests. conditions: Childhood Obesity conditions: Insulin Resistance studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests. primaryPurpose: TREATMENT masking: NONE count: 52 type: ACTUAL name: Metformin measure: Insulin resistance (HOMA-IR) level measure: Weight loss rate sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Erciyes University city: Kayseri̇ state: Melikgazi zip: 38030 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06266585 id: HX-B-2023090 briefTitle: Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2024-01-01 date: 2024-02-20 date: 2024-02-20 name: Beijing Tiantan Hospital class: OTHER name: Beijing Chao Yang Hospital name: Beijing Friendship Hospital briefSummary: The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation conditions: Cerebral Venous Thrombosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 273 type: ACTUAL measure: Number of Participants with CVT deteriorated on radiology measure: Number of Participants with altered neurological function measure: Number of Participants with altered consciousness measure: Neurological function at 30th day after onset (mRS) measure: Emergency surgery rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Capital Medical University Affiliated Beijing Tiantan Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06266572 id: 1R43DA055182-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R43DA055182-01 briefTitle: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment acronym: OASIS overallStatus: COMPLETED date: 2021-09-30 date: 2023-09-29 date: 2023-09-29 date: 2024-02-20 date: 2024-03-01 name: Center for Social Innovation, Massachusetts class: OTHER briefSummary: C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:
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1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
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2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.
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After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 19 type: ACTUAL name: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) measure: Open Minds Scale for Health Care Providers measure: Brief Opioid Stigma Scale measure: Perceived Stigma of Addiction Scale measure: Knowledge Check measure: System Usability Scale measure: Internalized Stigma of Mental Illness Scale measure: Recovery Empowerment Scale measure: Mental Health Seeking Attitudes Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Haven VA Medical Center city: West Haven state: Connecticut zip: 06516 country: United States lat: 41.27065 lon: -72.94705 hasResults: False
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<|newrecord|> nctId: NCT06266559 id: 202101896A3 briefTitle: Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-03-20 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Chang Gung Memorial Hospital class: OTHER briefSummary: For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients. conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Chang Geng Healthy Drink measure: Fatigue Visual Analogue Scale - Current fatigue level measure: Fatigue Visual Analogue Scale - Other daily specific task fatigue level measure: Laboratory Data (Linver Function Index) measure: Liver stiffness measurement (kPa) measure: Controlled attenuation parameter (dB/m) measure: Number of Participants With Clinical Significant Adverse Avent (Safety Measures) sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266546 id: CRYOTXA briefTitle: Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy acronym: CRYOTXA overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-20 date: 2024-03-26 name: Ascension Via Christi Hospitals Wichita, Inc. class: OTHER briefSummary: Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy. conditions: Hemorrhage Lung conditions: Endobronchial Mass studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The study will be a prospective, single-arm, non-randomized trial primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Tranexamic acid measure: Major Hemorrhage measure: Early termination of the procedure due to bleeding measure: Rate of intermediate hemorrhage measure: Rate of minor hemorrhage measure: Inadequate tissue sampling due to bleeding measure: Graded use of other measures to control bleeding (not prophylactic) measure: Unplanned hospital admission for bleeding complications measure: Acute cardiovascular side effects measure: All cause 28 day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ascension Via Christi city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 hasResults: False
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<|newrecord|> nctId: NCT06266533 id: Pro2023002473 briefTitle: Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project) overallStatus: RECRUITING date: 2024-02-21 date: 2024-07-01 date: 2024-07-01 date: 2024-02-20 date: 2024-03-08 name: Rutgers, The State University of New Jersey class: OTHER briefSummary: This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food. conditions: Food Selection conditions: Environmental Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to a conventional nutrition education or an arts-based education group. primaryPurpose: PREVENTION masking: NONE count: 38 type: ESTIMATED name: Conventional Ultra-processed Food Nutrition Education name: Arts-based Ultra-processed Food Nutrition Education measure: Ultra-Processed Food Knowledge measure: Environmental assessment of ultra-processed food sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leaguers Inc. Head Start status: RECRUITING city: Newark state: New Jersey zip: 07102 country: United States name: Aurthur Nabi role: CONTACT phone: 973-643-0300 email: "[email protected] lat: 40.73566 lon: -74.17237 hasResults: False
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<|newrecord|> nctId: NCT06266520 id: DongyangH briefTitle: MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial overallStatus: RECRUITING date: 2023-01-01 date: 2025-06-01 date: 2025-06-01 date: 2024-02-20 date: 2024-02-20 name: Sen-wei Lu class: OTHER briefSummary: The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.
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Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment. conditions: Acute Ankle Sprain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: MNK therapy to release the superficial fascia name: acupuncture measure: Visual Analogue Scale (VAS) measure: Kofoed Ankle Score sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China status: RECRUITING city: Dongyang state: Zhejiang zip: 322100 country: China name: Sen-wei Lu, Dr. role: CONTACT phone: +8613989441117 email: [email protected] lat: 29.26778 lon: 120.22528 hasResults: False
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<|newrecord|> nctId: NCT06266507 id: 169 briefTitle: Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-03-15 date: 2024-02-20 date: 2024-02-20 name: Ankara Medipol University class: OTHER briefSummary: Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up. conditions: Feeding Behavior conditions: Mother-Child Relations conditions: Feeding and Eating Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Ergotherapy Based Parent Coaching name: Informative Brochure Distribution measure: Behavioral Pediatric Feeding Assessment Scale measure: Sensory Profile Questionnaire - Oral Sensory Processing Test measure: Feeding Strategies Quesstionnaire measure: Parental Self-Efficacy Scale sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Medipol University city: Ankara state: Ankara/ Altındağ zip: 06110 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06266494 id: 23-1349 id: CDMRP-DM220077 type: OTHER_GRANT domain: Department of Defense briefTitle: Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis acronym: Frostbite overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-05 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: Congressionally Directed Medical Research Programs briefSummary: This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems. conditions: Frostbite studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Long-Acting silver dressings name: Aloe Vera name: Dalbavancin measure: The number of positive microbial wound cultures on admission measure: The number of positive microbial wound cultures on hospital day 4 measure: The number of positive microbial wound cultures on hospital day 8 measure: The number of positive microbial wound cultures on hospital day 12 measure: The number of positive microbial wound cultures on hospital day 16 measure: The number of positive microbial wound cultures on hospital day 20 measure: The number of positive microbial wound cultures on hospital day 24 measure: The number of positive microbial wound cultures on hospital day 28 measure: The number of positive microbial wound cultures on hospital day 32 measure: The number of positive microbial wound cultures on hospital day 36 measure: The number of positive microbial wound cultures on hospital day 40 measure: The number of positive microbial wound cultures on hospital day 44 measure: The number of positive microbial wound cultures on hospital day 48 measure: The number of positive microbial wound cultures on hospital day 52 measure: The number of positive microbial wound cultures on hospital day 56 measure: The number of positive microbial wound cultures on hospital day 60 measure: Number of gram positive cultures at admission measure: Number of gram positive cultures on hospital day 4 measure: Number of gram positive cultures on hospital day 8 measure: Number of gram positive cultures on hospital day 12 measure: Number of gram positive cultures on hospital day 16 measure: Number of gram positive cultures on hospital day 20 measure: Number of gram positive cultures on hospital day 24 measure: Number of gram positive cultures on hospital day 28 measure: Number of gram positive cultures on hospital day 32 measure: Number of gram positive cultures on hospital day 36 measure: Number of gram positive cultures on hospital day 40 measure: Number of gram positive cultures on hospital day 44 measure: Number of gram positive cultures on hospital day 48 measure: Number of gram positive cultures on hospital day 52 measure: Number of gram positive cultures on hospital day 56 measure: Number of gram positive cultures on hospital day 60 measure: Change in serum concentration of dalbavancin in plasma (mcg/ml) over time measure: Dalbavancin concentrations in subcutaneous tissue measure: Change in presence of Augmented Renal Clearance sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Denver Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States name: Blaire Balstad role: CONTACT phone: 303-724-7803 email: [email protected] name: Tracey MacDermott role: CONTACT phone: 303-724-2757 email: [email protected] lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06266481 id: pua04202312313157 briefTitle: Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study acronym: post overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2024-05-30 date: 2024-02-20 date: 2024-02-20 name: Pharos University in Alexandria class: OTHER briefSummary: postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted. conditions: Postoperative Sore Throat studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Topical dexamethasone name: 10% lidocaine was sprayed over the tube for the second group measure: Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Pharos University status: RECRUITING city: Alexandria zip: 21348 country: Egypt name: mona el. massoud, ph anesthesia role: CONTACT phone: 002+01005542232 email: [email protected] name: hatem a. attalla, ph anaesthesia role: CONTACT phone: 002+1001445568 email: [email protected] name: mona el. massoud, lecture role: PRINCIPAL_INVESTIGATOR lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06266468 id: STUDY00149178 briefTitle: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2025-06-30 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: University of Kansas Medical Center class: OTHER briefSummary: The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim:
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1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention.
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2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure.
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3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods.
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4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes. conditions: Diet Quality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention study model is a 2-arm randomized control trial with a 1:1 allocation of participants to the treatment group (Nutricity) or the control group (usual care without Nutricity). After 12 weeks in the control group, participants will be introduced to Nutricity. primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Nutricity measure: Change in Diet quality (Healthy Eating Index) (child) measure: Nutrition Literacy (parent) measure: Body Mass Index (child) measure: Skin Carotenoid measure: Feeding Behaviors of Parent and Children measure: Mediation of Children's Media Use measure: Parent Self-Efficacy measure: Parent Nutrition Attitudes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266455 id: Pro00000615 briefTitle: Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment acronym: THRIVE overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2034-01 date: 2034-01 date: 2024-02-20 date: 2024-02-28 name: Children's National Research Institute class: OTHER briefSummary: Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.
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Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.
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Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age. conditions: Very Preterm Maturity of Infant conditions: Very Low Birth Weight Infant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized-controlled trial comparing the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants randomized to receive one of three nutritional interventions: standardized (control), adjustable, or targeted human milk fortification. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Due to the nature of the nutritional interventions, the clinical and research teams will not be blinded to study intervention. The radiologist and research team members performing MRI interpretation, post-acquisition processing, and quantitative analysis will be blinded to study nutritional intervention arm. Similarly, teams performing neurodevelopmental follow-up will also be blinded to study nutritional intervention arm. whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Standardized Fortification name: Adjustable Fortification name: Adjustable Fortification measure: Weight Gain Velocity measure: Length Growth Velocity measure: Head Circumference Growth Velocity measure: Total and Regional Brain Volumes measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) measure: Mullen Scales of Early Learning (MSEL) measure: Mullen Scales of Early Learning (MSEL) measure: Wechsler Preschool and Primary Scale of Intelligence (4th edition) (WPPSI-IV) measure: Differential Abilities Scale (2nd edition)-(DAS-II) sex: ALL maximumAge: 4 Weeks stdAges: CHILD facility: Children's National Hospital city: Washington state: District of Columbia zip: 20010 country: United States name: Catherine Limperopoulos, Ph.D. role: CONTACT phone: 202-476-5293 email: [email protected] name: Katherine M. Ottolini, M.D. role: CONTACT phone: 202-476-8905 email: [email protected] name: Catherine Limperopoulos, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False
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<|newrecord|> nctId: NCT06266442 id: Mav-WGS briefTitle: M. Avium WGS During Mav-PD Treatment overallStatus: RECRUITING date: 2024-02 date: 2026-09 date: 2026-09 date: 2024-02-20 date: 2024-02-20 name: University Health Network, Toronto class: OTHER name: Western University, Canada name: Public Health Ontario Laboratory, Canada briefSummary: This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere.
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The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection. conditions: Mycobacterium Avium conditions: Mycobacterium Infections, Nontuberculous conditions: Mycobacterium Infections conditions: Nontuberculous Mycobacterial Lung Disease conditions: Respiratory Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Whole genome sequencing testing measure: Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy measure: Whether patients with Mav-PD have evidence of polyclonal infection as demonstrated by the presence of >1 strain of M. avium in the pre-treatment sputum or a sputum sample during treatment measure: Whether there is a source of infection from the home water environment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G country: Canada name: Matty Mehrabi, B.Sc. M. Ed role: CONTACT phone: 416-603-5726 email: [email protected] name: Theodore Marras, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06266429 id: STUDY00001304 briefTitle: Metabolomic Profiling of Racial Disparity overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-20 name: Olubukola Nafiu class: OTHER briefSummary: Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain. conditions: Adenoid Hypertrophy conditions: Tonsillar Hypertrophy conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Blood collection measure: Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry measure: Highest pain score measure: Last pain score sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06266416 id: 115207 briefTitle: IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) acronym: IMAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-05-31 date: 2028-05-31 date: 2024-02-20 date: 2024-04-24 name: University of Illinois at Chicago class: OTHER name: University of Michigan briefSummary: The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence. conditions: Sexually Transmitted Infections (Not HIV or Hepatitis) conditions: HIV Infections conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will evaluate the efficacy of IMAGE with 14-18-year-old Black girls (n=300) and male caregivers (n=300) in a 2-arm individually randomized controlled trial. The researchers will compare SRH outcomes (STI incidence, self-reported sexual behavior) at 6- and 12-months among girls randomized to IMAGE or a time-matched general health promotion control program (FUEL).
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The researchers will simultaneously evaluate implementation determinants (barriers, facilitators, constraints) and processes at Community Based Organizations working through the 3 steps of the implementation model (Prepare, Roll out, and Sustain). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 612 type: ESTIMATED name: IMARA for Black Male Caregivers and Girls Empowerment name: Time-matched control program measure: STI Incidence in Participants measure: Rate of STI History among Participants measure: Number of Participants Using Condoms measure: Number of Sexual Partners of Participants sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois Chicago city: Chicago state: Illinois zip: 60612 country: United States name: LIsa Sharp, PhD role: CONTACT phone: 312-966-1819 email: [email protected] name: Sue Littau role: CONTACT phone: 312.996.3932 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06266403 id: STUDY00024154 briefTitle: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-03 date: 2029-03 date: 2024-02-20 date: 2024-02-20 name: Penn State University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.
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The question is, What are the effects of communicative interaction on verbal communication in people with ALS?
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Participants will read words and sentences while they are in a solo setting and interactive setting. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS.
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Plans for Assignment - This is a single group study in which all participants will engage in the same tasks. primaryPurpose: BASIC_SCIENCE masking: NONE count: 300 type: ESTIMATED name: Structured Communicative Interaction name: Clear Speech name: Unstructured communicative interaction name: Clear Speech Structured Communicative Interaction measure: Formant frequencies of speech sounds measure: Intelligibility of recorded speech measure: Syntactic properties measure: Pragmatic Properties measure: Duration of speech sounds sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266390 id: 855007 briefTitle: Engaging sgACC With TMS for Depression overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-01-30 date: 2026-04 date: 2024-02-20 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: National Institutes of Health (NIH) briefSummary: The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures.
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Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS. conditions: Depression conditions: Major Depressive Disorder conditions: Persistent Depressive Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will receive rTMS to one of two targets. Participants will be randomly assigned to receive the TMS treatment intervention in one of two target conditions: half to their positive sgACC correlation target, while the remaining half to their negative sgACC correlation target. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not be informed on which target they have been assigned to. whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) measure: sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off) measure: Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Almaris Figueroa-González role: CONTACT email: [email protected] name: Ethan Hammett role: CONTACT email: [email protected] name: Desmond J Oathes, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06266377 id: 11122023 briefTitle: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-06-01 date: 2025-11-30 date: 2024-02-20 date: 2024-02-20 name: University of Pavia class: OTHER name: Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA) briefSummary: The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder name: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder measure: Food acceptance of canteen menus by individuals enrolled in the study measure: Reduction in food selectivity as a result of the targeted nutrition education course sex: ALL minimumAge: 5 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Milano Ristorazione S.p.A. city: Milano zip: 20139 country: Italy lat: 45.46427 lon: 9.18951 facility: Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci". city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 facility: Istituto Tecnico Agrario Statale "Giuseppe Garibaldi" city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06266364 id: IRB-24-22 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-20 date: 2024-03-05 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06266351 id: LASIKIOP briefTitle: EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2024-06-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: Intuor Technologies, Inc. class: INDUSTRY briefSummary: The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes. conditions: Glaucoma conditions: Ocular Hypertension conditions: Normal Tension Glaucoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: This is observational IOP measurement measure: IOP measurement difference between CATS and GAT in LASIK patients sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona Eye Consultants city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Eye Specialty Group city: Memphis state: Tennessee zip: 38120 country: United States name: Sean Dodson role: CONTACT phone: 520-327-3487 email: [email protected] lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06266338 id: STU-2023-1118 briefTitle: Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) overallStatus: RECRUITING date: 2024-03-11 date: 2025-10-31 date: 2026-10-31 date: 2024-02-20 date: 2024-03-13 name: University of Texas Southwestern Medical Center class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors. conditions: Cervix Cancer conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Pembrolizumab name: Lenvatinib measure: Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 measure: Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1 sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Annette Paulsen role: CONTACT phone: 214-648-7097 role: CONTACT email: [email protected] lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06266325 id: 6138 briefTitle: Development and Validation of a Dementia Life Expectancy Tool overallStatus: COMPLETED date: 2010-04-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-03-04 name: University of Toronto class: OTHER name: Sunnybrook Research Institute name: Ottawa Hospital Research Institute name: ICES briefSummary: Individuals with dementia and their caregivers are faced with challenging decisions throughout the course of the disease. These decisions may be about medical care (e.g., continuation of routine cancer screening, pursuit of cardiopulmonary resuscitation, initiation of palliative care services), institutionalization (i.e., transition to a long-term care facility), or financial planning. These inherently difficult decisions are made more difficult by prognostic uncertainty. Indeed, life expectancy is challenging to predict in dementia. Consequently, prognosis is infrequently discussed by healthcare providers with individuals with dementia and their families, which compromises their ability to plan for the future. A lack of prognostic awareness makes it difficult for patients, their caregivers, and their healthcare providers to make medical decisions that strike the appropriate balance between prolonging life and promoting the quality of it. A clinical prediction tool has the promise to provide personalized and accurate estimations of life expectancy in individuals with dementia. Therefore, similar to the existing clinical prediction tools on our Project Big Life platform (www.projectbiglife.ca), we seek to create and to test a statistical model to predict survival, and to implement the model as a user-friendly, web-based calculator. The calculator will use self-reported sociodemographic, clinical, cognitive, functional, and nutritional information that is entered by patients, their caregivers, and/or their healthcare providers to output an estimated life expectancy. This estimate could inform the shared decision-making process, thereby empowering decisions that are compatible with a patient's clinical reality and concordant with their life goals. conditions: Dementia conditions: Death studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 202217 type: ACTUAL name: There is no intervention. Exposures are predictor variables of mortality. measure: Mortality sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266312 id: Maastricht UMC+ briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer acronym: APRIORI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-20 name: Maastricht University Medical Center class: OTHER name: Nationaal Fonds tegen Kanker briefSummary: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy. conditions: Breast Cancer conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer. primaryPurpose: PREVENTION masking: NONE count: 11 type: ESTIMATED name: A multimodal prehabilitation programme measure: Recruitment rate (%) measure: Characteristics of included participants measure: Attendance rate for MIET sessions (%) measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) measure: Reasons for not having executed a training session as intended measure: Attendance rate HIIT + strength sessions (%) measure: Adherence rate, ExRDI HIIT training (%) measure: Adherence rate, ErXDI strength training (%) measure: Attendance rate for dietary consultations (%) measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%) measure: Percentage of days on which nutritional requirements were achieved (%) measure: Reasons for not achieving the nutritional requirements as intended measure: Drop-out rate (%) measure: Time point of drop-out measure: Reasons for drop-out measure: Serious adverse events (SAE) measure: Study related adverse events measure: Acceptance - Experiences with the multimodal lifestyle intervention measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures measure: Acceptance - Barriers and enablers regarding participation in the study measure: Fatigue measure: Cardiorespiratory fitness measure: Muscle strength measure: Nutritional status measure: Weight (kg) measure: Height (cm) measure: Body Mass Index (BMI) measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day) measure: Energy requirements (kcal) measure: Protein requirements measure: Circumference of upper arm and waist (cm) measure: Chemotherapy Relative Dose Intensity (RDI) measure: Treatment-related Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06266299 id: 2269-001 briefTitle: A Study of KK2269 in Adult Participants With Solid Tumors overallStatus: RECRUITING date: 2024-01-25 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-04-26 name: Kyowa Kirin, Inc. class: INDUSTRY briefSummary: This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
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In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.
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In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible. conditions: Advanced Solid Tumor conditions: Metastatic Solid Tumor conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma conditions: Esophageal Adenocarcinoma conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 71 type: ESTIMATED name: KK2269 name: Docetaxel measure: Number of Subjects Experiencing Dose-limiting Toxicity measure: Number of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East status: RECRUITING city: Kashiwa City state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: National Cancer Center Hospital status: RECRUITING city: Chuo-ku state: Tokyo zip: 104-0045 country: Japan lat: 35.57779 lon: 139.71685 hasResults: False
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<|newrecord|> nctId: NCT06266286 id: 2022-A00233-40 briefTitle: EXOPULSE Mollii Suit & Cerebral Palsy acronym: EXOCEP overallStatus: RECRUITING date: 2023-09-13 date: 2025-06-30 date: 2025-10-30 date: 2024-02-20 date: 2024-02-20 name: Institut De La Colonne Vertebrale Et Des Neurosciences class: OTHER briefSummary: Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators designes a randomized crossover, sham-controlled, double- blind trial to demonstrate the improvement of motor functions and cerebral palsy related symptoms following two weeks of daily sessions of "active" versus "sham" EXOPULSE Mollii suit. A two-week washout period should be enough to prevent a potential carry- over effect.
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Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit and will consist of six months of active stimulation (sessions performed on a daily basis with the same parameters used for the active session in phase 1) on cerebral palsy related symptoms.
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Summary:
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* Phase 1: randomized sham controlled crossover study (active versus sham condition)
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* Phase 2: Open label study (active condition) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: EXOPULSE MOLLII SUIT (active) name: EXOPULSE MOLLII SUIT (sham) measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS) measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG) measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y) measure: Pain will be assessed using the Pain Scale Chart (PSC) measure: Evaluation of overall improvement using the Clinical Global Impression (CGI) sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Centre Hospitalier Intercommunal D'Aix Pertuis status: RECRUITING city: Aix-en-Provence country: France name: PASCAL GRANIER, MD role: PRINCIPAL_INVESTIGATOR name: HELENE RAUSCENT, MD role: SUB_INVESTIGATOR lat: 43.5283 lon: 5.44973 facility: Centre Medico Chirurgical de Readaptation Des Massues status: NOT_YET_RECRUITING city: Lyon country: France name: EMMANUELLE CHALEAT - VALAYER, MD role: PRINCIPAL_INVESTIGATOR name: Marie-Charlotte D'ANJOU, MD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Centre de Sante Rossetti status: RECRUITING city: Nice country: France name: GAUTIER DE CHELLE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Centre de Readaptation Pediatrique D'Oleron status: RECRUITING city: Saint-Trojan-les-Bains country: France name: SOLENE VIOT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.84134 lon: -1.20728 hasResults: False
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