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protocolSection identificationModule nctId: NCT06322446, orgStudyIdInfo id: PI23/00299, briefTitle: Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy, acronym: FIQMODE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-12-23, completionDateStruct date: 2025-12-23, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universidad Politecnica de Madrid, class: OTHER, collaborators name: Carlos III Health Institute, collaborators name: Universidad Europea de Madrid, collaborators name: Hospital Universitario La Paz, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, descriptionModule briefSummary: Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Changes in peripheral muscle strength, primaryOutcomes measure: Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O), primaryOutcomes measure: Changes in functional capacity: lower limbs power capacity, primaryOutcomes measure: Changes in functional capacity: walking capacity, primaryOutcomes measure: Change in Cardiorespiratory fitness: maximal oxygen consumption, primaryOutcomes measure: Change in Cardiorespiratory fitness: Ventilatory threshold VT1, secondaryOutcomes measure: Changes in Pulmonary Function: forced vital capacity (FVC), secondaryOutcomes measure: Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1), secondaryOutcomes measure: Changes in the anthropometric and body composition: Weight, secondaryOutcomes measure: Changes in the anthropometric and body composition: Height, secondaryOutcomes measure: Changes in the anthropometric and body composition: BMI, secondaryOutcomes measure: Changes in body composition: Total fat mass, secondaryOutcomes measure: Changes in body composition: FMI, secondaryOutcomes measure: Changes in body composition: lean mass kg, secondaryOutcomes measure: Changes in body composition: lean mass %, secondaryOutcomes measure: Changes in quality of life using the Cystic Fibrosis Questionnaire, secondaryOutcomes measure: Changes in plasma levels muscle damage biomarkers, secondaryOutcomes measure: Changes in plasma levels of inflammation: hs-CRP, secondaryOutcomes measure: Changes in plasma levels of inflammation: Interleukins, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Marcela González Gross, PhD, role: CONTACT, phone: +34910677980, email: marcela.gonzalez.gross@upm.es, contacts name: Margarita M Pérez-Ruiz, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marcela González-Gross, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06322433, orgStudyIdInfo id: 37C301, briefTitle: Follow up of High Myopic Eyes, acronym: FWUPMIOPIA_ E, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: In this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered Changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied., conditionsModule conditions: Pathologic Myopia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: no drugs used for this study, outcomesModule primaryOutcomes measure: Proportion of subjects with neovascularization at follow-up visit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Paolo Milani, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06322420, orgStudyIdInfo id: MoodHab, briefTitle: Behavioral Activation for Depression and Habitual Rumination, acronym: MoodHab, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ragnar Pétur Ólafsson, class: OTHER, collaborators name: The Icelandic Centre for Research, descriptionModule briefSummary: Depressive rumination, a negative thinking style characterized by repetitive and passive thoughts about the causes, meanings, and consequences of one's feelings and distress, is often described as being a habitual response tendency that forms a vulnerability to depression. Behavioural Activation (BA) is an effective treatment for depression but little is known of mechanisms of changes during a successful treatment completion and for whom the treatment benefits the most. The main purpose of the study is to investigate whether habit-like mood-reactive rumination will change during Behavioral Activation treatment for current depression and mediates symptom changes in the treatment. Important moderators of change will also be investigated (i.e. history of early life stress and cognitive flexibility). We aim to provide individual BA treatment for up to 130 currently depressed participants in 12 treatment sessions over 11 weeks. Measures are obtained at pre-treatment, during treatment, at post-treatment and at 6 month follow up., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural Activation (BA), outcomesModule primaryOutcomes measure: Symptom severity measured by the BDI-2, primaryOutcomes measure: Disorder severity assessed with the DIAMOND diagnostic interview - Major Depressive Disorder, primaryOutcomes measure: Diagnostic status assessed with the DIAMOND diagnostic interview - Major Depressive Episode, secondaryOutcomes measure: Symptom severity measured on the PHQ-9, secondaryOutcomes measure: Momentary negative and positive affectivity using items from the PANAS (Positive and Negative Affect Schedule), secondaryOutcomes measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow -up - Major Depressive Episode, secondaryOutcomes measure: Diagnostic status assessed with the DIAMOND diagnostic interview at follow-up- Major Depressive Disorder, secondaryOutcomes measure: The Quality of Life Scale (QOLS), otherOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), otherOutcomes measure: The Snaith-Hamilton Pleasure Scale (SHAPS), otherOutcomes measure: Beck Anxiety Inventory (BAI), otherOutcomes measure: The Ruminative Response Scale (RRS), otherOutcomes measure: The Pearlin Mastery Scale (PMS), otherOutcomes measure: The Environmental Reward Observation Scale (EROS), otherOutcomes measure: Behavioral Activation for Depression Scale (BADS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Iceland, status: RECRUITING, city: Reykjavík, zip: 102, country: Iceland, contacts name: Ragnar P Ólafsson, PhD, role: CONTACT, phone: 8622245, phoneExt: 00354, email: ragnarpo@hi.is, contacts name: Sigurður Viðar, Cand.Psych, role: SUB_INVESTIGATOR, contacts name: Nína B Arnardóttir, MS, role: SUB_INVESTIGATOR, contacts name: Ívar Snorrason, PhD, role: SUB_INVESTIGATOR, contacts name: Igor Marchetti, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 64.13548, lon: -21.89541, hasResults: False
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protocolSection identificationModule nctId: NCT06322407, orgStudyIdInfo id: KY2023-263-03-02, briefTitle: Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy., conditionsModule conditions: Chronic Migraine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single (Outcomes Assessor), whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 206, type: ESTIMATED, armsInterventionsModule interventions name: Stellate Ganglion Block (SGB), interventions name: standardized drug treatment, outcomesModule primaryOutcomes measure: the change from baseline in mean monthly migraine days, secondaryOutcomes measure: Proportion of patients achieved≥50% reduction in monthly migraine days, secondaryOutcomes measure: Total effective rate, secondaryOutcomes measure: The mean Numeric Rating Scale(NRS) score during headache attack, secondaryOutcomes measure: Patients satisfaction (PS), secondaryOutcomes measure: The six item headache impact test (HIT-6), secondaryOutcomes measure: the Migraine Disability Assessment score(MIDAS), secondaryOutcomes measure: The Pittsburgh Sleep Quality Index (PSQI), secondaryOutcomes measure: adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Fang Luo, M.D, role: CONTACT, phone: +86 13611326978, email: 13611326978@163.com, contacts name: Lu Liu, role: CONTACT, phone: +86 18618418228, email: emmaliulu@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06322394, orgStudyIdInfo id: BXOS110-Ⅱ-2023-12, briefTitle: BXOS110 Injection in the Treatment of Acute Ischaemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Biocells (Beijing) Biotech Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study was to evaluate the effectiveness of early administration of BXOS110 for injection in reducing overall disability in patients with acute ischaemic stroke., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: high-dose BXOS110, interventions name: low-dose BXOS110, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of subjects with mRS score 0-2 on day 90, secondaryOutcomes measure: Proportion of subjects with mRS score 0-1 on day 90, secondaryOutcomes measure: Day 90 mRS Displacement Analysis, secondaryOutcomes measure: Proportion of subjects with NIHSS scores ≤1 on day 10 (or at discharge), secondaryOutcomes measure: Proportion of subjects with a ≥4-point reduction in NIHSS score from baseline at day 10 (or at discharge), secondaryOutcomes measure: Proportion of subjects with ≥4 point increase in NIHSS score during hospitalisation, secondaryOutcomes measure: Proportion of subjects with Barthel Index Scale (BI) scores ≥95 on day 90, secondaryOutcomes measure: Day 90 European Five Dimensional Health Scale (EQ-5D) Score, secondaryOutcomes measure: Mortality due to stroke within 90 days, secondaryOutcomes measure: Change in infarct volume from baseline after 24 hours of dosing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yuebei People's Hospital, status: NOT_YET_RECRUITING, city: Shaoguan, state: Guangdong, country: China, contacts name: Junbin Chen, role: CONTACT, phone: 86-13500205898, email: cjbcl0397@163.com, geoPoint lat: 24.8, lon: 113.58333, locations facility: Harrison International Peace Hospital, status: NOT_YET_RECRUITING, city: Hengshui, state: Hebei, country: China, contacts name: Yan Wei, role: CONTACT, phone: 86-18003188568, email: Hayuanwy@163.com, geoPoint lat: 37.73222, lon: 115.70111, locations facility: The First Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: Xiaoyun Liu, role: CONTACT, phone: 86-13191887318, email: a331083909@126.com, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Daqing Oilfield General Hospital, status: NOT_YET_RECRUITING, city: Daqing, state: Heilongjiang, country: China, contacts name: Dan Deng, role: CONTACT, phone: 86-18245977799, email: 707604206@qq.com, geoPoint lat: 46.58333, lon: 125.0, locations facility: Anyang People's Hospital, status: NOT_YET_RECRUITING, city: Anyang, state: Henan, country: China, contacts name: Jiangang Zhang, role: CONTACT, phone: 86-13513722532, email: 709705699@qq.com, geoPoint lat: 36.096, lon: 114.38278, locations facility: Nanshi Hospital of Nanyang, status: NOT_YET_RECRUITING, city: Nanyang, state: Henan, country: China, contacts name: Guang Wu, role: CONTACT, phone: 86-13525687571, email: seizelinni@163.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Nanyang Second General Hospital, status: NOT_YET_RECRUITING, city: Nanyang, state: Henan, country: China, contacts name: Ming Wang, role: CONTACT, phone: 86-15139096969, email: 15139096969@163.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: The First Affiliated Hospital of Nanyang Medicinal College, status: NOT_YET_RECRUITING, city: Nanyang, state: Henan, country: China, contacts name: Tao Feng, role: CONTACT, phone: 86-15638996063, email: 631740898@qq.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: MeiHekou Central Hospital, status: NOT_YET_RECRUITING, city: Meihekou, state: Jilin, country: China, contacts name: Hong Yu, role: CONTACT, phone: 86-13844564195, email: 2823974848@qq.com, geoPoint lat: 42.52722, lon: 125.67528, locations facility: Beipiao Central Hospital, status: RECRUITING, city: Chaoyang, state: Liaoning, country: China, contacts name: Yutong Ma, role: CONTACT, phone: 86-18642143339, email: myt3339@163.com, geoPoint lat: 41.57028, lon: 120.45861, locations facility: Ceneral Hospital of Mining Industry Group Fuxin, status: NOT_YET_RECRUITING, city: Fuxin, state: Liaoning, country: China, contacts name: Yingjie Duan, role: CONTACT, phone: 86-13470363261, email: 451142359@qq.com, geoPoint lat: 42.01556, lon: 121.65889, locations facility: The Affiliated Hospital of Shenyang Medical College, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Runhui Li, role: CONTACT, phone: 86-18002477116, email: lirh710717@163.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The First People's Hospital of Shenyang, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Tie Sui, role: CONTACT, phone: 86-13998352587, email: jakeyisui@icloud.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The People's Hospital of Liaoning Province, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Qiu He, role: CONTACT, phone: 86-17702589222, email: qiuhe6392@sina.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Iron Coal General Hospital of Liaoning Health Industry Group, status: NOT_YET_RECRUITING, city: Tieling, state: Liaoning, country: China, contacts name: Yu Wang, role: CONTACT, phone: 86-13188417658, email: fffoo@sina.com, geoPoint lat: 42.29306, lon: 123.84139, locations facility: Keshketengqi Hospital of Traditional Chinese Medicine and Mongolian Medicine, status: RECRUITING, city: Chifeng, state: Neimenggu, country: China, contacts name: Guozhi Lu, role: CONTACT, phone: 86-13722169555, email: gz9555@sina.com, geoPoint lat: 42.26833, lon: 118.96361, locations facility: Xianyang Hospital of Yan'an University, status: NOT_YET_RECRUITING, city: Xianyang, state: Shaanxi, country: China, contacts name: Wen Liu, role: CONTACT, phone: 86-18740505535, email: 174461442@qq.com, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Liaocheng People's Hospital, status: NOT_YET_RECRUITING, city: Liaocheng, state: Shandong, country: China, contacts name: Cunju Guo, role: CONTACT, phone: 86-13346256168, email: cunjuguo@163.com, geoPoint lat: 36.45596, lon: 115.97766, locations facility: Linyi People's Hospital, status: NOT_YET_RECRUITING, city: Linyi, state: Shandong, country: China, contacts name: Ziran Wang, role: CONTACT, phone: 86-13954993801, email: wzr0806@163.com, geoPoint lat: 35.06306, lon: 118.34278, locations facility: Tengzhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Tengzhou, state: Shandong, country: China, contacts name: Deyang Li, role: CONTACT, phone: 86-13561190369, email: lideyang0632@163.com, geoPoint lat: 35.08357, lon: 117.19071, locations facility: Sinopharm Tongmei General Hospital, status: NOT_YET_RECRUITING, city: Datong, state: Shanxi, country: China, contacts name: Junhai Wang, role: CONTACT, phone: 86-13753265757, email: wjh1964@sohu.com, geoPoint lat: 40.09361, lon: 113.29139, locations facility: Linfen Central Hospital, status: RECRUITING, city: Linfen, state: Shanxi, country: China, contacts name: Hongguo Dai, role: CONTACT, phone: 86-15935767592, email: daihongguo3199@163.com, geoPoint lat: 36.08889, lon: 111.51889, locations facility: Linfen People's Hospital, status: NOT_YET_RECRUITING, city: Linfen, state: Shanxi, country: China, contacts name: Junfang Hao, role: CONTACT, phone: 86-13835360973, email: haojunfang2012@163.com, geoPoint lat: 36.08889, lon: 111.51889, locations facility: Beijing Tiantan Hospital, Capital Medical University, status: NOT_YET_RECRUITING, city: Beijing, country: China, contacts name: Yongjun Wang, role: CONTACT, phone: 86-13911172565, email: yongjunwang111@aliyun.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06322381, orgStudyIdInfo id: Reinsertion AT VS ZO in IAT, briefTitle: Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy., conditionsModule conditions: Insertional Achilles Tendinopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Reinsertion achilles tendon, interventions name: Zadek osteotomy, outcomesModule primaryOutcomes measure: the time needed to return to normal daily activities (functional outcome) assessed by foot and ankle outcome score., secondaryOutcomes measure: Pain assessed by the visual analogue scale., secondaryOutcomes measure: Rate of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06322368, orgStudyIdInfo id: DF002, briefTitle: Myofunctional and Respiratory Intervention on Phonation in Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, descriptionModule briefSummary: Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Myofunctional and respiratory training program, interventions name: Range of motion and thermal and mechanical stimulation exercising, outcomesModule primaryOutcomes measure: Volume during monologue, primaryOutcomes measure: Frequency during monologue, secondaryOutcomes measure: Volumen during sustained phonation of /s/ sound, secondaryOutcomes measure: Communication effectiveness Index, secondaryOutcomes measure: Frequency during sustained phonation of /s/ sound, secondaryOutcomes measure: Volumen during sustained phonation of /a/ sound, secondaryOutcomes measure: Frequency during sustained phonation of /a/ sound, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences, status: RECRUITING, city: Granada, zip: 18016, country: Spain, contacts name: Irene Cabrera Martos, role: CONTACT, email: irenecm@ugr.es, contacts role: CONTACT, phoneExt: Cabrera Martos, email: irenecm@ugr.es, contacts name: Irene Cabrera Martos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.18817, lon: -3.60667, hasResults: False
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protocolSection identificationModule nctId: NCT06322355, orgStudyIdInfo id: ZSUFR01, briefTitle: Comparison of UFR With QFR in Stable Coronary Artery Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 250, type: ACTUAL, armsInterventionsModule interventions name: Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound, outcomesModule primaryOutcomes measure: Compare diagnostic performance of QFR with UFR, secondaryOutcomes measure: Correlation and agreement between QFR and UFR, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University, city: Shanghai, zip: 210000, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06322342, orgStudyIdInfo id: RVL-102-23, secondaryIdInfos id: 9R44CA261240-04A1, type: NIH, link: https://reporter.nih.gov/quickSearch/9R44CA261240-04A1, briefTitle: Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Reveal Pharmaceuticals Inc., class: INDUSTRY, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The Phase 2 trial will assess safety, tolerability, efficacy, imaging pharmacodynamics, and pharmacokinetics of RVP-001, a novel manganese-based MRI contrast agent, at three escalating dose levels when administered as a single IV bolus to subjects with known gadolinium-enhancing central nervous system (CNS) lesions who have recently had a gadolinium-based contrast agent (GBCA)-enhanced MRI of the brain., conditionsModule conditions: Central Nervous System (CNS) Lesions, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: RVP-001, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Lesion visualization criteria for RVP-001 enhanced MRI compared to unenhanced MRI, primaryOutcomes measure: Lesion visualization criteria for RVP-001 compared to gadolinium-based contrast agent (GBCA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale New Haven Hospital, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Kristin DeFancesco, role: CONTACT, phone: 203-785-3852, email: kristin.defrancesco@yale.edu, contacts name: Amit Mahajan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Abi Akinniyi, role: CONTACT, phone: 781-513-0207, email: aakinniyi@mgb.org, contacts name: John Chen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Brigham & Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Cora Nicoll, role: CONTACT, phone: 617-525-3161, email: cnicoll1@bwh.harvard.edu, contacts name: Mathew DeSalvo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Duke University Medical Center, status: RECRUITING, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Helen Zuleta, role: CONTACT, phone: 919-613-0226, email: helen.zuleta@duke.edu, contacts name: Shruti Raja, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06322329, orgStudyIdInfo id: K 2023-10103, briefTitle: RealMove (Lung): Assessing Tumour Motion With Dynamic MRI, acronym: RealMove(lung), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-17, completionDateStruct date: 2036-03-17, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Uppsala University Hospital, descriptionModule briefSummary: The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions., conditionsModule conditions: Lung Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic MRI, outcomesModule primaryOutcomes measure: Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively, primaryOutcomes measure: Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT), primaryOutcomes measure: Difference in the structure of the probability density function, assessed at different times, secondaryOutcomes measure: Anxiety during examinations of tumour motion, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Grade ≥2 toxicity assessed by CTCAE v.5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, zip: 17176, country: Sweden, contacts name: Eva Onjukka, PhD, role: CONTACT, phone: +46765696744, email: eva.onjukka@ki.se, contacts name: Mattias Hedman, MD/PhD, role: CONTACT, phone: +46812370000, email: mattias.hedman@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06322316, orgStudyIdInfo id: MS-492-2022, briefTitle: Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Egypt, class: OTHER, descriptionModule briefSummary: Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM., conditionsModule conditions: Breast Neoplasms, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To determine the analgesic effect of ultrasound guided Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: The Ultrasound-guided Retrolaminar Block Group, interventions name: The Ultrasound-guided Erector Spinae Plane Block Group, outcomesModule primaryOutcomes measure: the total morphine consumed postoperatively for 24 hours, secondaryOutcomes measure: the total intraoperative fentanyl consumption, secondaryOutcomes measure: duration of analgesia, secondaryOutcomes measure: postoperative nausea and vomiting PONV as side effect of morphine, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National cancer Insititute Cairo university, city: Cairo, zip: 11796, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06322303, orgStudyIdInfo id: C-EXP-194-UGR23, briefTitle: Effect of Cannabidiol (CBD) on Vision and Driving, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Universidad de Granada, class: OTHER, descriptionModule briefSummary: The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving., conditionsModule conditions: Cannabis Use, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Placebo (CBD 0%), interventions name: CBD 15%, interventions name: CBD 30%, outcomesModule primaryOutcomes measure: Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization, primaryOutcomes measure: Change in motion detection sensitivity after cannabidiol vaporization, primaryOutcomes measure: Change in contrast sensitivity after cannabidiol vaporization, primaryOutcomes measure: Change in visual acuity after cannabidiol vaporization, primaryOutcomes measure: Change in fixations after cannabidiol vaporization, secondaryOutcomes measure: Driving simulator: standard deviation of the lateral lane position (SDLP), secondaryOutcomes measure: Distance travelled outside the lane, secondaryOutcomes measure: Mean speed, secondaryOutcomes measure: Angular velocity of the steering wheel, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Granada, city: Granada, zip: 18071, country: Spain, geoPoint lat: 37.18817, lon: -3.60667, hasResults: False
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protocolSection identificationModule nctId: NCT06322290, orgStudyIdInfo id: SEMBAI, briefTitle: Epidemiological Study on Invasive Bacterial Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-09, primaryCompletionDateStruct date: 2031-12-30, completionDateStruct date: 2032-03-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies., conditionsModule conditions: Invasive Bacterial Diseases (IBD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: assessment of pathogens in blood specimens, outcomesModule primaryOutcomes measure: Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age., primaryOutcomes measure: Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age., primaryOutcomes measure: Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age., secondaryOutcomes measure: Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae., secondaryOutcomes measure: Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy, secondaryOutcomes measure: Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale di Adria, status: NOT_YET_RECRUITING, city: Adria, country: Italy, geoPoint lat: 45.05445, lon: 12.05599, locations facility: Ospedali riuniti di Ancona, status: NOT_YET_RECRUITING, city: Ancona, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale di Andria, status: NOT_YET_RECRUITING, city: Andria, country: Italy, geoPoint lat: 41.23117, lon: 16.29797, locations facility: Ospedale Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bari, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Policlinico S.Orsola-Malpighi IRCCS, status: NOT_YET_RECRUITING, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Fondazione poliambulanza Brescia, status: NOT_YET_RECRUITING, city: Brescia, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale Giovanni XXIII, status: NOT_YET_RECRUITING, city: Brescia, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale di Campobasso, status: NOT_YET_RECRUITING, city: Campobasso, country: Italy, geoPoint lat: 41.55947, lon: 14.66737, locations facility: Ospedale Camposampiero, status: NOT_YET_RECRUITING, city: Camposampiero, country: Italy, geoPoint lat: 45.56368, lon: 11.93534, locations facility: Ospedale di Esine asst Valcamonica, status: NOT_YET_RECRUITING, city: Esine, country: Italy, geoPoint lat: 45.92515, lon: 10.25102, locations facility: Ospedale di Feltre (AULSS 1 Dolomiti), status: NOT_YET_RECRUITING, city: Feltre, country: Italy, geoPoint lat: 46.02085, lon: 11.90031, locations facility: Immunology Laboratory Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Chiara Azzari, MD, role: CONTACT, phone: 00390555662542, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Morgagni, status: NOT_YET_RECRUITING, city: Forlì, country: Italy, geoPoint lat: 44.22177, lon: 12.04144, locations facility: AO Salvini di Garbagnate, status: NOT_YET_RECRUITING, city: Garbagnate, country: Italy, geoPoint lat: 45.77027, lon: 9.29848, locations facility: Azienda sanitaria universitaria Giuliano Isontina (ASU GI), status: NOT_YET_RECRUITING, city: Gorizia, country: Italy, geoPoint lat: 45.94088, lon: 13.62167, locations facility: Ospedale di Macerata, status: NOT_YET_RECRUITING, city: Macerata, country: Italy, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Ospedale di Magenta, status: NOT_YET_RECRUITING, city: Magenta, country: Italy, geoPoint lat: 45.46456, lon: 8.88453, locations facility: Azienda Ospedaliera Policlinico Universitario "G. Martino", status: NOT_YET_RECRUITING, city: Messina, country: Italy, geoPoint lat: 38.19394, lon: 15.55256, locations facility: IRCCS San Raffaele, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: AORN Santobono, status: NOT_YET_RECRUITING, city: Napoli, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: AOU Federico II di Napoli, status: NOT_YET_RECRUITING, city: Napoli, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale di Novara, status: NOT_YET_RECRUITING, city: Novara, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione I.R.C.C.S. Policlinico San Matteo, status: NOT_YET_RECRUITING, city: Pavia, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale spirito santo di Pescara, status: NOT_YET_RECRUITING, city: Pescara, country: Italy, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Azienda sanitaria Friuli occidentale, status: NOT_YET_RECRUITING, city: Pordenone, country: Italy, geoPoint lat: 45.95689, lon: 12.66051, locations facility: Ospedale degli infermi, status: NOT_YET_RECRUITING, city: Rimini, country: Italy, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Ospedale Pediatrico Bambin Gesù IRCCS, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Leonardo di Salerno, status: NOT_YET_RECRUITING, city: Salerno, country: Italy, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Ospedale di Saronno, status: NOT_YET_RECRUITING, city: Saronno, country: Italy, geoPoint lat: 45.62513, lon: 9.03517, locations facility: AOU Sassari, status: NOT_YET_RECRUITING, city: Sassari, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Ospedale di Scorrano, status: NOT_YET_RECRUITING, city: Scorrano, country: Italy, geoPoint lat: 40.09018, lon: 18.29993, locations facility: ASP Trapani, status: NOT_YET_RECRUITING, city: Trapani, country: Italy, geoPoint lat: 38.0176, lon: 12.53617, locations facility: IRCCS Materno Infantile Burlo Garofolo, status: NOT_YET_RECRUITING, city: Trieste, country: Italy, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Azienda sanitaria universitaria Friuli Centrale (ASU FC), status: NOT_YET_RECRUITING, city: Udine, country: Italy, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Azienda ospedaliera universitaria integrata Verona, status: NOT_YET_RECRUITING, city: Verona, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Ospedale civile di Vibo Valentia, status: NOT_YET_RECRUITING, city: Vibo Valentia, country: Italy, geoPoint lat: 38.67618, lon: 16.10094, locations facility: Ospedale Maggiore Carlo Alberto Pizzardi, status: NOT_YET_RECRUITING, city: Bologna, state: Ì, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06322277, orgStudyIdInfo id: NETVAC, briefTitle: Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-04, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network., conditionsModule conditions: Bacterial Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule interventions name: Analysis of biological sample, outcomesModule primaryOutcomes measure: Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae., secondaryOutcomes measure: Frequency of principal serotype, serogroups of pathogens causative for VPDs., secondaryOutcomes measure: Number of meeting to diffuse the NETVAC results in Tuscany network., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ospedale San Donato, status: RECRUITING, city: Arezzo, country: Italy, contacts name: Marco Martini, role: CONTACT, email: marco.martini@uslsudest.toscana.it, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Immunology Laboratory Meyer Children's Hospital, IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Chiara Azzari, role: CONTACT, phone: +390555662542, email: chiara.azzari@unifi.it, contacts name: Silvia Ricci, role: SUB_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Massimo Resti, role: CONTACT, email: massimo.resti@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: UO Pediatria Universitaria Ospedale S.Chiara, status: RECRUITING, city: Pisa, country: Italy, contacts name: Diego peroni, role: CONTACT, email: diego.peroni@unipi.it, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06322264, orgStudyIdInfo id: 2023-05435-01, briefTitle: Promoting Children's Participation in Conventional X-ray Examinations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-12-14, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Lund University, class: OTHER, collaborators name: Skane University Hospital, descriptionModule briefSummary: The goal of this explorative observational study is to map the procedure and child centered approach in the examination for children that undergo conventional X-ray examinations. The main questions aim to answer:* How many images need to be retaken during conventional X-ray examinations?* What is the reason why the pictures need to be redone?* What is the time required for the various examinations?* What experience of the procedure of the examination is there among those involved?* Can the physical impact be observed through variation in heart rate in children that undergo conventional X-ray examinations?Participants will answer questionnaires about the children's participation in the procedure and the variation in heart rate will be measured on the children who undergo the examinations., conditionsModule conditions: Heart Rate Determination, conditions: Patient Participation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Measurement of variation in heart rate, outcomesModule primaryOutcomes measure: Variation in heart rate, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06322251, orgStudyIdInfo id: 2023-03399-01, briefTitle: Identification of Interpesonal Violence, acronym: ViP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Linkoeping University, collaborators name: Karolinska Institutet, collaborators name: Stockholm University, descriptionModule briefSummary: The goal of this study is to increase primary care professional's ability to identify individuals exposed to intimate partner violence (IPV) in primary health care settings.The main questions it aims to answer are1. To what extent do the following three interventions contribute to identify potential victims of IPV: (1) the use of a standardized questionnaire that screens exposure to IPV, (2) staff using tailored virtual patients for clinical training on IPV and (3) a combination of interventions 1 and 2?2. Which intervention do primary care professionals experience as most effective in increasing the ability to identify and respond to victims of IPV?Participants will be divided to apply one of the three interventions in their health care setting: 1) a standardized questionnaire to patients, 2) virtual patients tailored to health professionals, and 3) a combination of 1 and 2.Pre-and post-measurement of the health professionals identification of patients exposed to IPV will will be used to explore the effect of the interventions.Focus group interviews with the participating health professionals will be a qualitative complement. The participants will be asked about what intervention they experience as the most effective in increasing the ability to identify victims of IPV., conditionsModule conditions: Primary Health Care, conditions: Interpersonal Violence, conditions: Youth, conditions: Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Baseline measure - Number of patients that are identified fo being exposed to violence.Intervention:There are three settings:1. Primary Care Health Centers2. Youth Clinics3. Maternity ClinicsAt each type of clinic, the following interventions will be applied:Identification of domestic violence through1. Use of Virtual patient2. use of screening questionnaire3. a combination of a and b above.The clinics will randomised to either condition a, b or c., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Use of instrument to identify exposure to violence in close relationships, outcomesModule primaryOutcomes measure: Number of identified persons seeking healthcare who have been exposed to violence, secondaryOutcomes measure: Number of identified persons seeking healthcae who have been exposed to violence, otherOutcomes measure: Experiences of health care staff, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linköping University, status: RECRUITING, city: Linköping, zip: 581 83, country: Sweden, contacts name: Mia Barimani, Professor, role: CONTACT, phone: +46737083163, email: mia.barimani@liu.se, contacts name: Wibke Jonas, Ass prof, role: CONTACT, phone: +46707482518, email: wibke.jonas@ki.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False
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protocolSection identificationModule nctId: NCT06322238, orgStudyIdInfo id: 23-008706, briefTitle: Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:, acronym: PREPARE-Mayo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug')., conditionsModule conditions: Pharmacogenomic Drug Interaction, conditions: Side Effect of Drug, conditions: Ineffective Drug Action, conditions: Drug Metabolism, Poor, CYP2D6-Related, conditions: Drug Metabolism, Poor, CYP2C19-Related, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: PGx panel test, outcomesModule primaryOutcomes measure: Adverse Drug Reaction (ADR), secondaryOutcomes measure: PREPARE-MAYO Clinicians' and pharmacists' Questionnaire., secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55902, country: United States, contacts name: Elisa Houwink, MD, PhD, role: CONTACT, phone: 507-319-2037, email: houwink.elisa@mayo.edu, contacts name: Mary Johnson, role: CONTACT, email: johnson.mary15@mayo.edu, contacts name: Jessica Wright, PharmD, role: SUB_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06322225, orgStudyIdInfo id: 2023YFC2507401, briefTitle: Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, collaborators name: National Key Research and Development Program of China, descriptionModule briefSummary: Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database., conditionsModule conditions: Colorectal Tubular Adenoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06322212, orgStudyIdInfo id: 23-001083, briefTitle: Type 2 Diabetes and Blood Brain Barrier Improvement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours., conditionsModule conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Compare BBB function, cognition, and mood in T2DM adults with and without Thiamine treatment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be assigned a number to be used instead of their names with double-blind randomization until visits are complete and data is analyzed., whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Thiamine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Assess if BBB function has been repaired., primaryOutcomes measure: Analyze blood serum S100β levels., primaryOutcomes measure: Examine cognition in T2DM adults with thiamine treatment., primaryOutcomes measure: Cognition assessment in T2DM adults after thiamine treatment., primaryOutcomes measure: Examine depression in T2DM adults with thiamine treatment., primaryOutcomes measure: Assess anxiety in T2DM adults with thiamine treatment., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-11-17, uploadDate: 2024-03-07T13:21, filename: Prot_ICF_000.pdf, size: 309752, hasResults: False
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protocolSection identificationModule nctId: NCT06322199, orgStudyIdInfo id: 2021-02504 (Project 3), briefTitle: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3, acronym: NePsyAssip HT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, descriptionModule briefSummary: The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt., conditionsModule conditions: Suicide, Attempted, conditions: Suicidal Ideation, conditions: Feasibility, conditions: Cost-effectiveness, conditions: Process Factors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ASSIP (Attempted Suicide Short Intervention Program) flex, outcomesModule primaryOutcomes measure: Suicidal ideation (Baseline, t0), primaryOutcomes measure: Suicidal ideation and suicidal behavior (Baseline, t0), primaryOutcomes measure: Suicidal ideation (Follow-up, t1), primaryOutcomes measure: Suicidal ideation and suicidal behavior (Follow-up, t1), primaryOutcomes measure: Suicidal ideation (Follow-up, t2), primaryOutcomes measure: Suicidal ideation and suicidal behavior (Follow-up, t2), secondaryOutcomes measure: Treatment costs of treatments 1, otherOutcomes measure: Sociodemographic data, otherOutcomes measure: Depressive symptoms, otherOutcomes measure: General sense of self-efficacy, otherOutcomes measure: Self-Management, otherOutcomes measure: Health Literacy, otherOutcomes measure: Loneliness, otherOutcomes measure: Therapeutic Alliance, otherOutcomes measure: Adherence and Competence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier universitaire vaudois (CHUV), status: RECRUITING, city: Lausanne, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, locations facility: Center Neuchâtelois de Psychiatrie, status: RECRUITING, city: Neuchâtel, country: Switzerland, geoPoint lat: 46.99179, lon: 6.931, locations facility: Psychiatric Hospital, University of Zurich (PUKZH), status: RECRUITING, city: Zürich, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Sanatorium Kilchberg, status: RECRUITING, city: Zürich, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06322186, orgStudyIdInfo id: STAYWARM-2 Trial, briefTitle: Study to Actively Warm Trauma Patients-2, acronym: STAYWARM-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: Massively bleeding trauma patients have higher odds of mortality, increased hospital length of stay, and increased need for transfusion if they become hypothermic. Hypothermia is independently associated with mortality in traumatically injured patients due to its negative physiologic effects on hemostasis, cardiorespiratory and renal function.Current warming strategies increase the logistical difficulty of transferring patients (which is frequent during the initial hours of trauma care) or must be changed at frequent intervals. Prehospital, military, and intraoperative studies have suggested chemical warming blankets as a pragmatic strategy to manage hypothermia. A recent pilot study (manuscript under review) at our institution demonstrated the feasibility of using the Ready-Heat® (TechTrade LLC, Orlando, FL, USA) chemical heating blanket in the initial phases of hospital care in bleeding trauma patients requiring a mass hemorrhage protocol (MHP). These self-warming blankets provide warmth over 8 hours at up to 40 degrees Celsius, carrying the advantage of portability with no continuous electric power requirement. Furthermore, the Ready-Heat blanket may be more effective than current strategies for rewarming patients at high risk of developing hypothermia. STAYWARM-2 will be the first randomized controlled trial performed in-hospital to evaluate a self-warming blanket to address hypothermia in massively bleeding trauma patients within the initial hours of hospital arrival.This study will help to determine the efficacy and feasibility of using chemical heating blankets for hypothermia in the early hours of hospital care. This has potential to reduce the overall workload of direct care clinicians, freeing them for other patient care duties. Additionally, the intervention may achieve enhanced thermoregulation compared to current strategies, improving patient care and comfort, and avoiding the clinical complications related to hypothermia. Findings from this preliminary study may provide data for a future grant to launch a larger randomized controlled trial in the prehospital/in-hospital trauma setting to optimize the care of patients at risk of developing hypothermia., conditionsModule conditions: Trauma Injury, conditions: Hypothermia, conditions: Massive Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible patients will be randomized 1:1 to receive either the experimental or control arm.Experimental arm: 2 Ready-Heat 4-panel blankets Control arm: standard of care (use of warmed blankets and forced air warmed blanket \[FAWB\]), primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Only the statistician will remain blinded during the final analysis., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Ready-Heat Chemical Heating Blankets, interventions name: Warmed blankets or FAWB, outcomesModule primaryOutcomes measure: An increase of 1⁰C at eight hours from the time of blanket placement, primaryOutcomes measure: Adherence to the 2 blankets application in the trauma bay in at least 80% of patients., primaryOutcomes measure: Adherence to body temperature measurements (in degrees Celsius) 80% of each of the phases of initial care up to 8 hours following admission., primaryOutcomes measure: Adherence to maintain the blankets applied on the patient in 80% of each of the phases of initial care up to 8 hours following admission., secondaryOutcomes measure: Concurrent warming strategies, secondaryOutcomes measure: Blood product usage, secondaryOutcomes measure: Coagulation parameter 1: platelet count, secondaryOutcomes measure: Coagulation parameter 2: INR, secondaryOutcomes measure: Coagulation parameter 3: fibrinogen, secondaryOutcomes measure: Perfusion parameter 1: pH, secondaryOutcomes measure: Perfusion parameter 2: base deficit, secondaryOutcomes measure: Perfusion parameter 3: serum lactate, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Blanket placed directly on skin, secondaryOutcomes measure: Skin redness and/or burns, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-08-21, uploadDate: 2024-02-21T15:24, filename: Prot_SAP_000.pdf, size: 1303584, hasResults: False
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protocolSection identificationModule nctId: NCT06322173, orgStudyIdInfo id: 2022-13, briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods, acronym: ARES_NGS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine., conditionsModule conditions: Resistance Bacterial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: NGS Analysis, outcomesModule primaryOutcomes measure: Microorganism presence (positive/negative), primaryOutcomes measure: Microorganism identification, secondaryOutcomes measure: Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierantonio Orza, role: SUB_INVESTIGATOR, contacts name: Francesca Perandin, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06322160, orgStudyIdInfo id: 5714, briefTitle: The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making, acronym: HANSOM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Royal Marsden NHS Foundation Trust, class: OTHER, collaborators name: ENTUK, descriptionModule briefSummary: Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway., conditionsModule conditions: Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: To explore patients' and clinicians' view and experience of the current decision-making process for low risk differentiated thyroid cancer, primaryOutcomes measure: • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guys & St Thomas, status: RECRUITING, city: London, country: United Kingdom, contacts name: Aleix Mr Rovira, PhD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: UCLH, status: RECRUITING, city: London, country: United Kingdom, contacts name: Francis Mr Vaz, FRCS, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06322147, orgStudyIdInfo id: KYLL-202304-31, briefTitle: Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety., conditionsModule conditions: Colon Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Doublet or triplet chemotherapy combined with cetuximab, outcomesModule primaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Reported adverse events, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: no evidence of disease, secondaryOutcomes measure: depth of response, secondaryOutcomes measure: Early Tumor Shrinkage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: xiangling Wang, Dr., role: CONTACT, phone: 8653182169841, email: xlwang71@163.com, contacts name: Jing Hao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06322134, orgStudyIdInfo id: DROWN_SAR, briefTitle: Drowning Incidents Treated by the Danish SAR Helicopters, acronym: DROWN_SAR, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions., conditionsModule conditions: Drowning, conditions: Drown, conditions: Drowning; Anoxia, conditions: Drowning, Near, conditions: Drowning and Nonfatal Submersion, conditions: Drowning or Immersion of Unknown Intent, conditions: Drowning and Submersion, Undetermined Intent, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion Due to Sailboat Sinking, conditions: Drowning and Submersion Due to Fall Off Ship, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Drowning incident, outcomesModule primaryOutcomes measure: Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023, primaryOutcomes measure: Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023, primaryOutcomes measure: Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023, secondaryOutcomes measure: Drowning to water rescue ratio, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06322121, orgStudyIdInfo id: NL83653.058.23, briefTitle: Vascular Aspects in Dementia: Part 2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology., conditionsModule conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: Vascular reactivity - BOLD amplitude, primaryOutcomes measure: Vascular reactivity - time-to-peak, primaryOutcomes measure: Vascular reactivity - time-to-baseline, secondaryOutcomes measure: Intracranial hemorrhage, secondaryOutcomes measure: Lobar microbleeds, secondaryOutcomes measure: Subarachnoidal hemorrhage, secondaryOutcomes measure: Superficial siderosis, secondaryOutcomes measure: Lacunes, secondaryOutcomes measure: Volume of white matter hyperintensities (WMHs), secondaryOutcomes measure: Perivascular spaces in the basal ganglia, secondaryOutcomes measure: Perivascular spaces in the centrum semiovale, secondaryOutcomes measure: Gray matter volume, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leids Universitair Medisch Centrum, status: RECRUITING, city: Leiden, zip: 2333 ZA, country: Netherlands, contacts name: Suzanne E van Dijk, drs, role: CONTACT, email: S.E.van_Dijk.RADI@lumc.nl, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
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protocolSection identificationModule nctId: NCT06322108, orgStudyIdInfo id: IMMONC0008, briefTitle: Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2030-04, completionDateStruct date: 2030-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Immune Oncology Research Institute, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Botensilimab + Balstilimab, outcomesModule primaryOutcomes measure: 12-Month Progression-Free Survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Next Treatment (TTNT), secondaryOutcomes measure: Overall Survival (OS) Time, secondaryOutcomes measure: Frequency, severity, and duration of treatment emergent adverse events (TEAEs) (Safety and tolerability), secondaryOutcomes measure: Health-related quality of life (HRQoL) according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), secondaryOutcomes measure: Health-related quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC29), secondaryOutcomes measure: Health-related quality of life according to the 5 Level EuroQol 5 Dimension (EQ-5D-5L) questionnaire, secondaryOutcomes measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and 12-month progression-free survival, secondaryOutcomes measure: Correlation between baseline expression of PD-L1 by immunohistochemistry (IHC) and objective response rate, secondaryOutcomes measure: Correlation between existence of liver metastases on imaging at baseline and 12-month progression-free survival, secondaryOutcomes measure: Correlation between existence of liver metastases on imaging at baseline and objective response rate, secondaryOutcomes measure: Level of circulating tumor DNA (ctDNA) at baseline and at different time points after start of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hematology Center named after prof. R. Yeolyan, city: Yerevan, zip: 0014, country: Armenia, contacts name: Samvel Bardakhchyan, MD, PhD, role: CONTACT, phone: +374 (010) 283800, email: samvelbardakhchyan@gmail.com, contacts name: Amalya Sargsyan, MD, role: CONTACT, phone: +374 (010) 283800, email: amalyasargsyan@gmail.com, geoPoint lat: 40.18111, lon: 44.51361, hasResults: False
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protocolSection identificationModule nctId: NCT06322095, orgStudyIdInfo id: GH21C202, briefTitle: A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, descriptionModule briefSummary: This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors., conditionsModule conditions: Patient With Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: GH21+ Previous Target Therapy or Immunotherapy, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of response (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Time to achieve Cmax (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Science, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Ning Li, Doctorate, role: CONTACT, phone: +86-10-87788495, email: lining@cicams.ac.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06322082, orgStudyIdInfo id: 1422024, briefTitle: Pilates Training and Low Intensity Shock Wave Therapy for Post-prostatectomy Stress Incontinence, acronym: Incontinence, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Khadra Mohamed Ali, class: OTHER, collaborators name: Cairo University, descriptionModule briefSummary: 120 Patients with urinary incontinence following radical prostatectomy would be randomly assigned to either 4 groups all receive conventional pelvic floor muscle exercises plus group A receive Pilates exercises and Low Intensity Extracorporeal Shock Wave Therapy, group B receive Low Intensity Extracorporeal Shock Wave Therapy, group C receive Pilates exercises and group D receive conventional pelvic floor muscle exercises. Assessment at baseline, immediately after the intervention, to evaluate the degree of urinary incontinence and quality of life after three months from treatment., conditionsModule conditions: Stress Incontinence, Male, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL AG), outcomesModule primaryOutcomes measure: Cystometry, primaryOutcomes measure: Severity index scale, secondaryOutcomes measure: body mass index, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: faculty of physical therapy, Cairo university, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06322069, orgStudyIdInfo id: 202206260077, briefTitle: The Effect and Mechanism of Self-compassion on Reducing Materialism, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-14, primaryCompletionDateStruct date: 2021-03-03, completionDateStruct date: 2021-03-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Beijing Normal University, class: OTHER, descriptionModule briefSummary: The current study provided an initial investigation of the effect of self-compassion on reducing materialism and explored the basic psychological needs and self-esteem as potential mechanisms. Two studies would be conducted. Study 1 explored the relationships among variables with cross-sectional data, to explore the relationship between self-compassion and materialism, and test the mediating role of basic psychological needs and self-esteem. Study 2 developed a new online self-help self-compassion intervention and conducted a randomized control trial (i.e., intervention group and waitlist group) to further explore the casual effect of self-compassion on materialism, with the mediating effect of basic psychological needs and self-esteem., conditionsModule conditions: Self-Compassion, conditions: Group B, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In study 2, we conducted a randomized control trial, and there are two groups: self-compassion intervention group and waitlist group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 309, type: ACTUAL, armsInterventionsModule interventions name: Self-compassion intervention group, outcomesModule primaryOutcomes measure: Self-compassion, primaryOutcomes measure: Self-Esteem, primaryOutcomes measure: Basic Psychological Needs, primaryOutcomes measure: Materialism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 63 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xianglong Zeng, city: Beijing, state: Beijing, zip: 100875, country: China, geoPoint lat: 39.9075, lon: 116.39723, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-12, uploadDate: 2024-03-12T23:23, filename: Prot_SAP_000.pdf, size: 110133, hasResults: False
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protocolSection identificationModule nctId: NCT06322056, orgStudyIdInfo id: 4-2023-1654, briefTitle: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease, acronym: EXCELSIOR-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2029-05-31, completionDateStruct date: 2029-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design., conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 642, type: ESTIMATED, armsInterventionsModule interventions name: Intensive control of SBP and intensive control of LDL-C, interventions name: Intensive control of SBP and standard control of LDL-C, interventions name: Standard control of SBP and intensive control of LDL-C, interventions name: Standard control of SBP and standard control of LDL-C, outcomesModule primaryOutcomes measure: Renal composite outcome, secondaryOutcomes measure: Individual components of renal composite outcome, secondaryOutcomes measure: eGFR slopes, secondaryOutcomes measure: Cardiovascular composite outcome, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance Hospital, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06322043, orgStudyIdInfo id: VM-APFB-1023, briefTitle: Evaluation of Safety of Filler Injection in Subcutaneous Tissues, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Volumina Medical S.A., class: INDUSTRY, descriptionModule briefSummary: Adipearl is an injectable filler intended to be injected subcutaneously., conditionsModule conditions: Volume Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Adipearl, outcomesModule primaryOutcomes measure: Safety of Investigational Medical Device, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Summit Clinic, city: Crans-Montana, country: Switzerland, contacts name: Summit Clinic, role: CONTACT, geoPoint lat: 46.31316, lon: 7.47914, hasResults: False
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protocolSection identificationModule nctId: NCT06322030, orgStudyIdInfo id: N4281-R, secondaryIdInfos id: RX004281, type: OTHER_GRANT, domain: VA ORD RR&D, secondaryIdInfos id: PRO0120848, type: OTHER, domain: IRB Approval, briefTitle: Weight Loss and ExeRcise, acronym: EMPOWER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Weight loss interventions for neurologically health individuals have established benefits for improving physical and psychosocial function. The investigators believe that Veterans who have had a stroke would realize similar benefits and that the effects would be enhanced with concurrent exercise training. The investigators will study the effects of a 15-week lifestyle management program to determine if it can effectively improve some of the physical and psychosocial problems common in Veterans who have had a stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators will utilize a 2x2 factorial design to assess for changes in our outcomes over time between treatment groups., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The coordinator will not see group assignment, only a patient number which is entered into a software package., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: FOCUS-15 Lifestyle Management Program, interventions name: Exercise Training, outcomesModule primaryOutcomes measure: Change in distance walk in 6 minute Walk Test, secondaryOutcomes measure: Change in daily step activity, secondaryOutcomes measure: Change in score of Stroke Impact Scale (SIS), secondaryOutcomes measure: Change in score of Sheehan Disability Scale (SDS), secondaryOutcomes measure: Change in score of Inventory of Psychosocial Functioning (IPF), otherOutcomes measure: Change in blood lipid profile, otherOutcomes measure: Change in body composition in Dual-energy x-ray absorptiometry, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ralph H. Johnson VA Medical Center, Charleston, SC, city: Charleston, state: South Carolina, zip: 29401-5703, country: United States, contacts name: R. Amanda C LaRue, PhD, role: CONTACT, phone: 843-789-6707, email: Rutha.Larue@va.gov, contacts name: Thad Abrams, MD, role: CONTACT, phone: (319) 338-0581, phoneExt: 7618, email: thad.abrams@va.gov, contacts name: Chris M Gregory, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
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protocolSection identificationModule nctId: NCT06322017, orgStudyIdInfo id: RC22_0450, briefTitle: Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation, acronym: EDearly AF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2028-04-09, completionDateStruct date: 2028-04-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 294, type: ESTIMATED, armsInterventionsModule interventions name: Rhythm control by Pulmonary Vein Isolation (PVI) procedure, interventions name: Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin), outcomesModule primaryOutcomes measure: Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke, secondaryOutcomes measure: Number of PVI peri-procedural complications, secondaryOutcomes measure: Number of complications, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Number of documented episodes of AF, secondaryOutcomes measure: Number of patients treated by cardiovascular drugs, secondaryOutcomes measure: Doses of cardiovascular drugs, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Autonomy score, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Numbers of falls, secondaryOutcomes measure: Physical performance score, secondaryOutcomes measure: Physical performance score, secondaryOutcomes measure: Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion, secondaryOutcomes measure: Evolution of IADL score according to the results of the ICOPE test at inclusion, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, secondaryOutcomes measure: Cognitive assessment, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Jean-Baptiste GOURRAUD, MD, role: CONTACT, phone: 0240165143, email: JeanBaptiste.GOURRAUD@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
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protocolSection identificationModule nctId: NCT06322004, orgStudyIdInfo id: 1718/2022, briefTitle: Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2025-02-05, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: 50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed., conditionsModule conditions: Communication Barriers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Technical Feasibility, primaryOutcomes measure: Usability of video-interpreting, primaryOutcomes measure: Impact on emergency physician's decisions, secondaryOutcomes measure: Demographic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Christina Hafner, DDr., role: CONTACT, email: christina.hafner@meduniwien.ac.at, contacts name: Maike Fink, Dr.med.univ., role: SUB_INVESTIGATOR, contacts name: Christina Hafner, DDr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06321991, orgStudyIdInfo id: S68382, briefTitle: Nodular Shrinking in Dupuytren Disease, acronym: Echo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome., conditionsModule conditions: Dupuytren's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Simple random allocation will be ensured by the principal investigators' designated staff (study nurse of IORT), who will not be involved in recruiting trial participants, medical care, drug administration or follow-up, through the generation of a random numbers table with computer software program. A randomization list will be prepared by the Sponsor's designated staff, not involved in recruiting Trial participants, medical care, drug administration or follow-up., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: To avoid bias, treatment arms will be blinded to Investigators, Trial staff, participants,.. as follows: vitamin E creme will be packaged and labelled in such a way that the visual appearance, nor the smell and/or touch of the creme can be distinguished from placebo (Vaseline)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin E-creme (Remederm®) vs Vaseline (Placebo), interventions name: Ultrasound measurement, outcomesModule primaryOutcomes measure: Downsizing of the largest nodule diameter, secondaryOutcomes measure: VAS questionnaire on pain, secondaryOutcomes measure: VAS questionnaire on satisfaction, secondaryOutcomes measure: QUICK Dash for functionality, secondaryOutcomes measure: Abe Diathesis scoring, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Ilse Degreef, Prof. Dr., role: CONTACT, phone: +3216338843, email: ilse.degreef@uzleuven.be, contacts name: Anna Tarasiuk, role: CONTACT, phone: +3216338818, email: orthopedie.research@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06321978, orgStudyIdInfo id: MxBFlexUP ESP, briefTitle: Mepilex Border Flex Utilization Pilot Spain, acronym: MxBFlexUPESP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Molnlycke Health Care AB, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency., conditionsModule conditions: Wound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mepilex Border Flex, outcomesModule primaryOutcomes measure: Dressing use, secondaryOutcomes measure: Wound characteristics, secondaryOutcomes measure: Wound management, secondaryOutcomes measure: HCP opinion, secondaryOutcomes measure: Patient Experience, secondaryOutcomes measure: Costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CS Ciudad Expo - Mairena de Aljarafe, status: RECRUITING, city: Sevilla, state: Andalusia, zip: 41927, country: Spain, contacts name: Andrés Roldán Valenzuela, Nurse, role: CONTACT, phone: +34609431073, email: andres.roldan.sspa@juntadeandalucia.es, contacts name: Andrés Roldán Valenzuela, Nurse, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
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protocolSection identificationModule nctId: NCT06321965, orgStudyIdInfo id: 69HCL22_0599, briefTitle: Characterization of New Phenotypes of Patients With Spinal Muscular Atrophy Treated With SMN Restoring Therapy, acronym: PHENO SMART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: With the advent of new treatments for ASI, new phenotypes are emerging. The investigators propose to describe these new phenotypes by prospectively following children with ASI of all types treated with TRS and aged under 16 for 2 years.The investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. The investigators also aim to collect the total costs associated with ASI in order to propose a first prospective medico-economic study in France., conditionsModule conditions: Spinal Muscular Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, longitudinal, multicenter, international study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: evaluation of muscle function, interventions name: First-line cognitive assessment, interventions name: second-line cognitive assessment, interventions name: Cardiac evaluation, interventions name: MRI, interventions name: Assessment of activity and muscle fatigue, interventions name: Assessment of bulbar function, interventions name: Evaluation of body composition and metabolism, interventions name: Questionnaires, interventions name: Biocollection, interventions name: Skinfold measurement, outcomesModule primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : muscular and functional, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : muscular and functional, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : muscular and functional, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : muscular and functional, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : muscular and functional, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : Fatigue, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : Fatigue, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at : Fatigue, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at Orthopaedic level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Vineland-II, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Bayley-4, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: BRIEF (Behavioral Rating Inventory of Executive Function), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: Conners-3, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: CELF-5 (Language and communication assessment battery), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: EQ (Empathy quotient), AQ (Autism Quotient), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: M-CHAT-R (Modified Checklist for Autism in Toddlers), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: SRS-2 (Social Responsiveness Scale, Second Edition), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the cognitive level: PVSE (Basic visuo-spatial perception), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the brain level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at Cardiology level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : Anthropometric measurement trends, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level :, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : fractures, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : renal ultrasound, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : Absorptiometry (DXA), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level: Calorimetry, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : Impedancemetry, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at metabolic level : Fibroscan, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at biological analysis, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at In terms of quality of life and autonomy, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio) (up to 3 years), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at respiratory level : Chest/head circumference ratio (PT/PC ratio), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at respiratory level : O2 saturation and nocturnal TcPCO2, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at respiratory level: Respiratory function tests (≥ 6 years), primaryOutcomes measure: Markers of disease progression at respiratory level, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): DDD-pNMD (Diagnostic list for Dysphagia and Dysarthria in pediatric NeuroMuscular Disorders), primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at bulbar level (Evaluation of dysphagia and dysarthria): NdSSS (Neuromuscular Disease Swallowing Status Scale)., primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: age of patient, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion : patient gender, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: SMA TYPE, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: number of copy, primaryOutcomes measure: Markers of disease progression and description of different phenotypes, at the level of Characteristics at inclusion: treatment, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pediatric Rehabilitation Service - L'Escale Mother and Child Hospital, city: Bron, state: Rhone, zip: 69500, country: France, contacts name: Laure LE GOFF, PI, role: CONTACT, phone: 04.72.12.95.04, phoneExt: +33, email: laure.le-goff@chu-lyon.fr, contacts name: Laure LE GOFF, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: CHRU of Brest, city: Brest, zip: 29609, country: France, contacts name: Juliette ROPARS, Dr, role: CONTACT, phone: 02.98.22.33.89, phoneExt: +33, email: Juliette.ropars@chu-brest.fr, contacts name: Juliette ROPARS, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Pediatric Neurology and Resuscitation Raymond-Poincare Hospital, city: Garche, zip: 92380, country: France, contacts name: Susana QUIJANO-ROY, Pr, role: CONTACT, phone: 01.47.10.79.16, phoneExt: +33, email: Susana.quijano-roy@aphp.fr, contacts name: Susana QUIJANO-ROY, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.39419, lon: 6.19818, locations facility: Pediatric Neurology Swynghedauw Hospital, city: Lille, zip: 59037, country: France, contacts name: Jean-Baptiste DAVION, Dr, role: CONTACT, phone: 03.20.44.58.31, phoneExt: +33, email: Jeanbaptiste.davion@chru-lille.fr, contacts name: Jean-Baptiste DAVION, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Marseille University Hospital - Timone Hospital Department of Pediatric Neurology - Specialized Pediatrics and Child Medicine, city: Marseille, zip: 13005, country: France, contacts name: Brigitte CHABROL, Pr, role: CONTACT, phone: 04.91.38.68.08, phoneExt: +33, email: brigitte.chabrol@ap-hm.fr, contacts name: Brigitte CHABROL, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: I-Motion Pediatric Clinical Trial Platform Armand Trousseau Hospital, city: Paris, zip: 75012, country: France, contacts name: Andreea SEFERIAN, Dr, role: CONTACT, phone: 01.71.73.80.50, phoneExt: +33, email: a.seferian@institut-myologie.org, contacts name: Andreea SEFERIAN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hautepierre Hospital - Mother and Child Hospital, city: Strasbourg, zip: 67200, country: France, contacts name: Vincent LAUGEL, Pr, role: CONTACT, phone: 03.88.12.77.43, phoneExt: +33, email: vincent.laugel@chru-strasbourg.fr, contacts name: Vincent LAUGEL, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Department of Pediatrics - Neurology and Infectious Diseases Toulouse University Hospital - Children's Hospital, city: Toulouse, zip: 31059, country: France, contacts name: Claude CANCES, Pr, role: CONTACT, phone: 05.34.55.74.08, phoneExt: +33, email: cances.c@chu-toulouse.fr, contacts name: Claude CANCES, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06321952, orgStudyIdInfo id: GTanareesuchoti, briefTitle: Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-17, primaryCompletionDateStruct date: 2023-10-22, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively., conditionsModule conditions: Knee Arthropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: ROSA robotic assist TKA, interventions name: iassist TKA, outcomesModule primaryOutcomes measure: accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, secondaryOutcomes measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Siriraj Hospital, city: Bangkok, zip: 10700, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06321939, orgStudyIdInfo id: NPCNS 001, briefTitle: Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hunan Cancer Hospital, class: OTHER, descriptionModule briefSummary: The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Herpesvirus 4, Human, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EBV-DNA next generation sequencing, outcomesModule primaryOutcomes measure: Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Distant metastasis failure-free survival, secondaryOutcomes measure: Locoregional failure-free survival, secondaryOutcomes measure: Failure-free survival, secondaryOutcomes measure: Patient reported quality-of-life score, secondaryOutcomes measure: Biomarker analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yaqian Han, role: CONTACT, phone: +8618673176667, email: hanyaqiancs@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06321926, orgStudyIdInfo id: 154/2023, briefTitle: Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ludwig Boltzmann Institute for Digital Health and Prevention, class: OTHER, descriptionModule briefSummary: The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.The main questions it aims to answer are:1. Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?2. Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.Participants in the waitlist control group will have a control period (seven days) before using the app.Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect* on physical activity behaviour and* on quality of life., conditionsModule conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned to the intervention group or the waitlist control group. The intervention group uses the ActiveWaiting App for a week, the waitlist control group starts with a control period (one week), before using the App for a week., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Outcomes will be selected via lime survey. Allocation to the groups will be concealed., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: ActiveWaiting App, outcomesModule primaryOutcomes measure: Amount of physical activity in minutes per day, primaryOutcomes measure: EQ VAS / EQ-5D-5L, secondaryOutcomes measure: App usage - exercise session length, secondaryOutcomes measure: App usage - total duration per session, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FH Campus Wien, status: RECRUITING, city: Vienna, country: Austria, contacts name: Andrea Greisberger, MSc, role: CONTACT, phone: +4316066877, phoneExt: 4717, email: andrea.greisberger@fh-campuswien.ac.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06321913, orgStudyIdInfo id: CIBI343Y002, briefTitle: Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, collaborators name: Innovent Biologics (Suzhou) Co. Ltd., descriptionModule briefSummary: The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma.The exploratory purpose is to evaluate the correlation between CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy.Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase., conditionsModule conditions: Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: IBI343 combined with IBI308, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: AE, primaryOutcomes measure: Treatment-Emergent Adverse Event (TEAE), primaryOutcomes measure: Adverse Event of Special Interest (AESI), primaryOutcomes measure: Serious Adverse Event (SAE), primaryOutcomes measure: laboratory examinations, primaryOutcomes measure: physical examinations, primaryOutcomes measure: vital signs, secondaryOutcomes measure: PFS, secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Overall Survival (OS), otherOutcomes measure: CLDN18.2 expression level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06321900, orgStudyIdInfo id: 09M206, briefTitle: Personalized Risk Prediction of Sudden Cardiac Death, acronym: RESPECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-02, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Sudden cardiac death (SCD) is the final result of cardiac arrest (CA), defined as an abrupt and unexpected loss of cardiovascular function resulting in circulatory collapse and death. Up to 50% of cardiac deaths in Europe are due to CA. The estimated mortality of CA is approximately 90%, and significant functional and/or cognitive disabilities often persist among those who survive. The advent of the implantable cardioverter-defibrillator (ICD) has revolutionized the prevention of SCD in high-risk patients with reduced left ventricular ejection fraction (LVEF\<35%). However, the algorithm recommended by current guidelines based on LVEF, considered the only parameter to identify high-risk patients, cannot stratify the population and the spectrum of risk with high accuracy. Although the risk of CA is higher among patients with LVEF\<35% and NYHA class\>1, because of the enormity of the population size at risk (i.e., with organic heart disease and LVEF\>35%), most SCD does occur in patients with LVEF\>35%. Additionally, the majority of pts who receive the ICD for primary prevention of SCD will not benefit from the device (in the Sudden Cardiac Death in Heart Failure Trial published in 2005, the rate of appropriate ICD therapy was 21% at five years), and/or will experience some side effects of it. In the Israeli registry of patients who underwent ICD (n= 1729) or cardiac resynchronization therapy (n= 1326), the 12-year cumulative incidence of adverse events was 20% for inappropriate shock, 6% for device-related infection, and 17% for lead failure.Moreover, recent improvements in drug treatment for HF and myocardial revascularization have further reduced the incidence of SCD in pts with low LVEF. Finally, pts with advanced HF are unlikely to benefit from ICD therapy because of the high rates of non-arrhythmic deaths. Therefore, improved risk stratification approaches to guide the selection of pts for ICD implantation are needed, and only a multiparametric approach may aim to personalize the risk prediction of SCD across the broad spectrum of the phenotypes of HF patients.The RESPECT project has been designed to personalize the risk of SCD by integrating and interpreting information highly multidisciplinary: clinical and bio-humoral, genetics and electrocardiography, conventional and advanced cardiac imaging, and data science. The investigators hypothesized that machine learning models capable of dealing with non-linearities and complex interactions among predictors, including genetic, clinical, electrocardiographic, bio-humoral, echocardiographic, cardiac magnetic resonance (CMR), and nuclear cardiology data, would have superior accuracy in predicting the occurrence of SCD compared with the currently recommended metrics of NYHA class and LVEF by two-dimensional echocardiography and that the personalized risk prediction of SCD will translate in more cost-effective use of ICDs. In addition, the investigators will use the multiparametric predictive models to develop a cloud-computing app that will allow clinicians to predict the risk of occurrence of SCD based on specific covariate profiles of individual patients., conditionsModule conditions: Sudden Cardiac Death Due to Cardiac Arrhythmia, conditions: Cardiomyopathies, conditions: Ischemic Heart Disease, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Personalized risk model, outcomesModule primaryOutcomes measure: Sudden cardiac death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Luigi Badano, PhD, role: CONTACT, phone: +390261911, phoneExt: 2319, email: l.badano@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321887, orgStudyIdInfo id: 5155, briefTitle: EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD, acronym: CAESAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Liverpool University Hospitals NHS Foundation Trust, class: OTHER_GOV, descriptionModule briefSummary: Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD., conditionsModule conditions: Inflammatory Bowel Disease, conditions: Iron Deficiency Anemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is an adaptive, open label study to compare the efficacy and tolerability of 8 weeks of low dose oral iron, in the treatment of iron deficiency anaemia in patients with inflammatory bowel disease (IBD)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron), interventions name: Ferrous fumarate syrup 2.5ml/70mg(45mg elemental iron), interventions name: Ferrous fumarate syrup 2.5ml/70mg (90mg elemental iron), outcomesModule primaryOutcomes measure: Change in haemoglobin concentration from baseline to week 8., secondaryOutcomes measure: Assessment of iron stores at baseline and week 8, secondaryOutcomes measure: Assessment of faecal calprotectin at baseline and week 8, secondaryOutcomes measure: Assessment of IBD severity. For ulcerative colitis this will be done using simple colitis clinical activity index (SCCAI). Values calculated at week 0 and week 8., secondaryOutcomes measure: Assessment of IBD severity. For Crohn's disease (or IBD-unclassified) the Harvey Bradshaw Index (HBI) will be used. Values calculated at week 0 and week 8., secondaryOutcomes measure: Assessment of quality of life using the IBD-QUK score at baseline and week 8, secondaryOutcomes measure: Assessment of patient global assessment of symptom severity by visual analogue score at baseline and week 8., secondaryOutcomes measure: Assessment of fatigue at baseline and week 8 using IBD-F fatigue score, secondaryOutcomes measure: Assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at baseline and week 8., otherOutcomes measure: Experimental arm 1: Assessment of faecal metabolome composition at baseline and week 8, otherOutcomes measure: Experimental arm 2: Assessment of faecal microbiota composition at baseline and week 8, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liverpool University Foundation NHS Trust, status: RECRUITING, city: Liverpool, country: United Kingdom, contacts name: S Subramanian, role: CONTACT, phone: 01517062000, email: RGT@liverpoolft.nhs.uk, contacts name: T Conley, role: CONTACT, phone: 01517062000, email: RGT@liverpoolft.nhs.uk, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False
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protocolSection identificationModule nctId: NCT06321874, orgStudyIdInfo id: EPHIRAS, briefTitle: Effects of Oxygen After Abdominal Oncological Surgery, acronym: EPHIRAS, statusModule overallStatus: COMPLETED, startDateStruct date: 2011-01-01, primaryCompletionDateStruct date: 2011-11-01, completionDateStruct date: 2011-11-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Jules Bordet Institute, class: OTHER, descriptionModule briefSummary: The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery, conditionsModule conditions: Abdominal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: The belonging to one group or the other was blinded to the laboratory staff., whoMasked: CARE_PROVIDER, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: Oxygen, outcomesModule primaryOutcomes measure: Percentage change in reticulocyte count, secondaryOutcomes measure: haematocrit levels mesure, secondaryOutcomes measure: haemoglobin levels mesure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Khalife Maher, city: Brussels, zip: 1000, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
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protocolSection identificationModule nctId: NCT06321861, orgStudyIdInfo id: Caffeine_motivation, briefTitle: Motivational, Affective and Performance Effects of Caffeine Supplementation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, collaborators name: The Jerzy Kukuczka Academy of Physical Education in Katowice, collaborators name: University School of Physical Education, Krakow, Poland, descriptionModule briefSummary: The main objective of the study is to evaluate the influence of caffeine intake on participants' energetic arousal, affect, motivation to achieve a training goal, satisfaction with training, and the sense of agency during training. Consequently, participants will engage in three sessions: caffeine, placebo, and no substance (in counterbalanced order). During each session, their affective and motivational states will be assessed, along with the performance of a standardized physical exercise test. The investigators hypothesize that participants who consume caffeine (caffeine condition) will exhibit higher levels of energy and motivation compared to the other two groups. Additionally, they are expected to experience greater optimism and expectancy regarding their training goals and achieve better results in the physical exercise test.A secondary aim of the study is to examine the impact of genetic variability on motivational and affective states of participants, as well as their performance in the physical exercise test after caffeine. The investigators will assess the CYP1A2 (-163C \> A, rs762551; characterized such as "fast" (AA genotype) and "slow" caffeine metabolizers (C-carriers)) and ADORA2A (1976T \> C; rs5751876; characterized by "high" (TT genotype) or "low" sensitivity to caffeine (C-carriers))., conditionsModule conditions: Caffeine, conditions: Affect, conditions: Goals, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant will take part in three similar sessions differing by the substance they receive: caffeine (intervention group), placebo, no substance. Sessions will be about one week apart., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine, interventions name: Placebo, interventions name: No substance, outcomesModule primaryOutcomes measure: Energetic arousal pre-test, primaryOutcomes measure: Energetic arousal post-test, primaryOutcomes measure: Optimism, primaryOutcomes measure: Motivation, primaryOutcomes measure: Determination, primaryOutcomes measure: Relative outcome expectancy, primaryOutcomes measure: Success probability, primaryOutcomes measure: Prospective effort, primaryOutcomes measure: Agency, primaryOutcomes measure: Performance in the 1RM test, primaryOutcomes measure: Performance in the bar velocity in the bench press test, primaryOutcomes measure: Performance in the strength-endurance test, primaryOutcomes measure: Performance in the countermovement jump test, primaryOutcomes measure: Satisfaction with the results, primaryOutcomes measure: Retrospective effort, primaryOutcomes measure: Retrospective agency, secondaryOutcomes measure: Goal importance, secondaryOutcomes measure: Prospective difficulty, secondaryOutcomes measure: Expected performance in the 1RM test, secondaryOutcomes measure: Expected performance in the bar velocity in the bench press test, secondaryOutcomes measure: Expected performance in the strength-endurance test, secondaryOutcomes measure: Expected performance in the countermovement jump test, secondaryOutcomes measure: Retrospective difficulty, secondaryOutcomes measure: Energetic arousal post-training, secondaryOutcomes measure: Perceived effect on agency, secondaryOutcomes measure: Tense arousal, secondaryOutcomes measure: Hedonic tone, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Jerzy Kukuczka Academy of Physical Education in Katowice, status: RECRUITING, city: Katowice, country: Poland, contacts name: Aleksandra Filip-Stachnik, role: CONTACT, geoPoint lat: 50.25841, lon: 19.02754, hasResults: False
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protocolSection identificationModule nctId: NCT06321848, orgStudyIdInfo id: DUCGM2426, briefTitle: Weaning Ventilator Using Heart, Lung And Diaphragm Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hanoi Medical University, class: OTHER, descriptionModule briefSummary: Postextubation distress is detrimental to the prognosis of critically ill patients with successful spontaneous breathing trial. Failure to wean is known to be connected with heart, lung, and diaphragm problems. The aim of this study was to investigate how a composite model comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning outcome.Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected along with clinical data about the patients. Either the successful weaning group or the failed weaning group is going to comprised the patients. Multivariate logistic regression analysis is going to be used to identify the variables that may be associated with the likelihood of weaning failure. A multiindicator combination model is going to be developed to increase the predictive accuracy after the possible indicators' accuracy in foretelling the weaning outcome was assessed., conditionsModule conditions: Ventilator Weaning, conditions: Ultrasound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The ventilator weaning outcome, secondaryOutcomes measure: The hospital length of stay, secondaryOutcomes measure: The ICU length of stay, secondaryOutcomes measure: The duration of mechanical ventilation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321835, orgStudyIdInfo id: 16-10/13, briefTitle: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-12-09, primaryCompletionDateStruct date: 2018-01-15, completionDateStruct date: 2018-06-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Inadequate inflation of cuff may lead to inadequate ventilation, aspiration and associated complications, while excessive inflation may cause complications in ranging from postoperative pharyngeal complaints to tracheal rupture due to increased cuff pressure. This study aimed to determine the effect of different patient positions on the endotracheal cuff pressure in patients undergoing urological procedures.Methods: This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough., conditionsModule conditions: Endotracheal Tube Cuff Pressure, conditions: Patient Positions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Endotracheal tube cuff pressure measurement, outcomesModule primaryOutcomes measure: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study, secondaryOutcomes measure: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06321822, orgStudyIdInfo id: EPIEXOME, briefTitle: Genetic Diagnosis and Personalized Medicine for Patients With Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-02, primaryCompletionDateStruct date: 2025-08-02, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Background Epilepsy is a common neurological disorder. It affects 50 million people worldwide and has the highest incidence in pediatric age. According to the latest classification of the ILAE (International League against Epilepsy), epilepsies are divided into lesional (symptomatic) and non-lesional/genetic forms. Symptomatic causes of epilepsy may include scarring, tumors, strokes, and brain developmental disorders such as dysplasias. In approximately 30% of epilepsies a genetic cause of epilepsy can be hypothesized. Since the identification of the first epilepsy gene in 1995, over the next 25 years over 500 genes associated with epilepsy have been identified. The importance of many genes and many gene variants identified in many genes is not yet clear and the mutations identified in different genes require confirmation with functional studies and confirmation on larger series of patients. Furthermore, the genetic defect underlying many patients with epilepsy remains unknown to this day, despite a high level of gene sequencing effort.Molecular studies on these genes have demonstrated how pathogenic variants on these genes determine a protein dysfunction that can cause neuronal hyperexcitability and pathological synchronization of neuronal networks leading to epileptic seizures and brain dysfunction. A notable complication in the field of epilepsy genetics is represented by the fact that the concept of a gene/a disease is valid only in a few cases, as there is a high phenotypic and genotypic heterogeneity so that a gene can present different types of epilepsy even within the same family. This means that there is a complex multigenic and multifactorial genetic substrate for which the impact of a specific genetic variant is conditioned by variants of other genes. This concept is particularly valid for the most common epileptic forms such as idiopathic generalized epilepsies.The integration of genetic analysis with epileptological characterization in clinical practice is increasingly crucial in defining a clear molecular diagnosis in patients whose disease cause would otherwise remain unknown, and potentially allows avoiding other unnecessary diagnostic investigations. It is therefore expected that this will lead to optimizing clinical management and reducing overall costs over time. The genetic finding can constitute a useful biomarker for defining the outcome of the disease and for guiding clinical decisions such as the best choice of therapy. Despite the advantages, before starting the genetic testing process, patients and their family members should be informed about the ethical issues that may arise from genetic testing, the technical limitations, legal aspects and costs of genetic investigation.Aim of the study Characterization of patients with epilepsy recruited at the Hospital Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (Italy) and analysis with exome NGS sequencing of patients with the highest probability of genetic diagnosis with exome (use of a probability score)Endpoints of study are the following:1. Identification of the genetic cause of the forms of genetic epilepsies with the highest probability of molecular diagnosis with exome2. Clinical-instrumental and epileptological characterization according to the ILAE classification of patients with epilepsy followed at the Fondazione IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico3. Correlation of clinical and instrumental parameters (in particular EEG and neuropsychological) of epilepsy recorded on the database with etiology, outcome and response to therapy, conditionsModule conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Whole exome sequencing (WES), outcomesModule primaryOutcomes measure: Identification of the genetic cause in patients with clinically probable genetic epilepsy using WES, secondaryOutcomes measure: Clinical and epileptological characterization of patients with epilepsy according to ILAE seizure and epilepsy classification, secondaryOutcomes measure: Characterization of qualitative Electroencefagraphy (EEG) features of patients with the different epilepsy types, secondaryOutcomes measure: Quantitative EEG (qEEG) characterization of patients with the different epilepsy types, secondaryOutcomes measure: Characterization of the clinical and instrumental features of patients with specific genetic etiology, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milano, zip: 20122, country: Italy, contacts name: Robertino Dilena, MD, role: CONTACT, phone: +390255032406, email: robertino.dilena@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321809, orgStudyIdInfo id: HUTF-FM-DABDCO-01, briefTitle: Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-25, primaryCompletionDateStruct date: 2022-10-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Duygu Ayhan Baser, class: OTHER, collaborators name: Hacettepe University, descriptionModule briefSummary: The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:* effect on anthropometric measurements* effect on lipid profile* effect on weight-related quality of life* observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.* Intervention group: They were given a calorie-restricted diet and exercise plan by a dietician or physiotherapist at their first visit, and were followed up by telephone calls at weeks 2, 4, 6, 8 and 10 over 12 weeks.* Control-1 group: During the initial medical interview, the participants were given a calorie-restricted diet programme by a dietician and an exercise programme by a physiotherapist; they were followed up over 12 weeks with telephone calls at week 4.* Control-2 group: The participants were not provided with any programme, and the importance of weight loss was emphasised by the family physicians. Dietary and physical activity advice was given according to the recommendations in the Turkish Endocrine and Metabolism Association 2019 Obesity Diagnosis and Treatment Guide, and was followed up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks., conditionsModule conditions: Obesity, conditions: Life Style, conditions: Lifestyle, Sedentary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 152, type: ACTUAL, armsInterventionsModule interventions name: intensive lifestyle, outcomesModule primaryOutcomes measure: primary outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06321796, orgStudyIdInfo id: WCG IRB Protocol #20235847, briefTitle: Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Gut-Brain-Axis Therapeutics Inc., class: OTHER, collaborators name: Pitt Hopkins Research Foundation, descriptionModule briefSummary: The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using magnesium citrate, followed by 4 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid., conditionsModule conditions: Pitt Hopkins Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Part 1: Randomized, Double-Blinded, Placebo-Controlled Treatment (14 weeks) Part 2: Open-Label Observation and Cross-over or Treatment Part 3: Follow Up (Group B Only), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: MTP-101P, interventions name: Vancomycin, interventions name: Magnesium Citrate, interventions name: Antacid, interventions name: Placebo MTP-101P, interventions name: Placebo Vancomycin, outcomesModule primaryOutcomes measure: Daily Stool Record (DSR), primaryOutcomes measure: Safety Measures (Adverse Events), secondaryOutcomes measure: Gastrointestinal Symptom Rating Scale (GSRS), secondaryOutcomes measure: Clinical Global Impression - Gastrointestinal (CGI-GI), secondaryOutcomes measure: Clinical Global Impression - Pitt Hopkins (CGI-PTHS), secondaryOutcomes measure: Parent Global Impressions - Pitt Hopkins: Change in Symptoms (PGI-PTHS-2-Change), secondaryOutcomes measure: Gastrointestinal Symptoms common in Pitt Hopkins (GI-PTHS), secondaryOutcomes measure: Revised Face Legs Activity Crying Consolability Pain Questionnaire (FLACC), secondaryOutcomes measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Benefit, secondaryOutcomes measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Adverse E, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Autism/Asperger's Research Group at Arizona State University, status: RECRUITING, city: Tempe, state: Arizona, zip: 85287, country: United States, contacts name: James Adams, Phd, role: CONTACT, phone: 480-818-0741, email: jim.adams@asu.edu, contacts name: Jasmine Kirby, MS, role: CONTACT, phone: 4802343767, email: jkkirby1@gmail.com, contacts name: James Adams, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rosa Krajmalnik-Brown, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
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protocolSection identificationModule nctId: NCT06321783, orgStudyIdInfo id: E-77082166-604.01.02-407303, briefTitle: Relationship Between Cervical Proprioception and Endurance With Hand-eye Coordination and Postural Control, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-06, primaryCompletionDateStruct date: 2024-07-12, completionDateStruct date: 2024-09-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: The aim of our study is to investigate the relationship between cervical proprioception and cervical muscle endurance with hand-eye coordination and postural control in individuals with forward head posture (FHP) and to compare them with a control group with normal head posture. After the demographic information and physical characteristics of the individuals are recorded, their craniovertebral angles (CVA) will be measured and they will be assigned to Group 1 (forward head posture) or Group 2 (normal head posture). Then, the individuals' cervical proprioception, hand-eye coordination, postural control and cervical muscle endurance values will be measured respectively. Cervical muscle endurance will be evaluated last, taking into account possible muscle fatigue, in order not to affect other measurement results. The recorded values will be compared between groups and the relationship of cervical proprioception and muscle endurance with hand-eye coordination and postural control will be examined. All evaluations will be made by the same researcher., conditionsModule conditions: Forward Head Posture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Assessment, outcomesModule primaryOutcomes measure: Cervical Proprioception, primaryOutcomes measure: Hand-Eye Coordination, primaryOutcomes measure: Postural Stability Test, primaryOutcomes measure: Stability Limit Test, primaryOutcomes measure: Modified Sensory Organization Test, primaryOutcomes measure: Endurance of Cervical Muscles, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06490, country: Turkey, contacts name: Tuğçe Çoban, MSc, role: CONTACT, phone: +905454098540, email: fzttugce@yahoo.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06321770, orgStudyIdInfo id: 075-2022, briefTitle: Oral Supplementation With Active Collagen Peptides and Skin Health Improvement, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2023-04-16, completionDateStruct date: 2023-05-24, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Gala Servicios Clinicos S.L., class: OTHER, descriptionModule briefSummary: The present study aims to investigate the efficacy of daily supplementation with COLLinstant® LMW over a 6-week period in improving visible signs of aging. This in-cludes assessing its impact on skin wrinkle reduction, as well as its potential to en-hance skin elasticity and moisturization. COLLinstant® LMW was administered orally in a single-center, randomized, double-blind, placebo-controlled clinical trial. A sec-ondary objective involves comparing skin improvement, product satisfaction, and monitoring adverse events among middle-aged female volunteers., conditionsModule conditions: Facial Wrinkles, conditions: Skin Hydration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Blind, Placebo-Controlled Study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Randomized, Double-Blind, Placebo-Controlled Study, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Bioactive collagen peptides, interventions name: Placebo, outcomesModule primaryOutcomes measure: Skin wrinkling volume (px^3), primaryOutcomes measure: Skin wrinkling area (px^2), primaryOutcomes measure: Skin wrinkling depth (px), primaryOutcomes measure: R0= Skin firmness (mm), primaryOutcomes measure: R2= gross elasticity (%) of the skin, primaryOutcomes measure: R5= Skin net elasticity (%), primaryOutcomes measure: R7= Skin elastic recovery (%), primaryOutcomes measure: R9= Skin fatigue (mm), primaryOutcomes measure: Skin hydration (AU), secondaryOutcomes measure: Subjective perception of product efficacy, secondaryOutcomes measure: Subjective perception of the organoleptic characteristics of the product, secondaryOutcomes measure: Opinion on the degree of satisfaction with the product, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: GALA Laboratories, city: Don Benito, state: Badajoz, zip: 06400, country: Spain, geoPoint lat: 38.95627, lon: -5.86162, hasResults: False
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protocolSection identificationModule nctId: NCT06321757, orgStudyIdInfo id: EPIC30-PARIS, briefTitle: PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients, acronym: PARIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Fundación EPIC, class: OTHER, descriptionModule briefSummary: Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 501, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous Coronary Intervention with DCB and DAPT, outcomesModule primaryOutcomes measure: Effectiveness of DCB therapy, secondaryOutcomes measure: Cardiac death, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Target vessel myocardial infarction, secondaryOutcomes measure: New target lesion revascularization (TLR), secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: Minor bleeding, secondaryOutcomes measure: 1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Clinico San Cecilio, status: RECRUITING, city: Granada, zip: 18016, country: Spain, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Universitario Juan Ramon Jimenez, status: RECRUITING, city: Huelva, zip: 21005, country: Spain, geoPoint lat: 37.26638, lon: -6.94004, locations facility: Hospital Universitario de Leon, status: RECRUITING, city: León, zip: 24071, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, locations facility: Hospital Universitario Y Politecnico La Fe, status: RECRUITING, city: Valencia, zip: 46026, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Clinico Universitario de Valladolid, status: RECRUITING, city: Valladolid, zip: 47003, country: Spain, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False
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protocolSection identificationModule nctId: NCT06321744, orgStudyIdInfo id: 2023/825, briefTitle: Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment, acronym: PREVAPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: adapted physical activity program (APA Program), outcomesModule primaryOutcomes measure: Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment, secondaryOutcomes measure: Describe the evolution of body composition measured by impedancemetry, secondaryOutcomes measure: Describe the evolution of physical parameters functional capacities, secondaryOutcomes measure: Describe the evolution of autonomy in daily life activities, secondaryOutcomes measure: Describe the evolution of muscular strength, secondaryOutcomes measure: Describe the evolution of the quality of life, secondaryOutcomes measure: Describe the evolution of motivation to practice physical activity, secondaryOutcomes measure: Tolerance with the APA program on perception of effort, secondaryOutcomes measure: Tolerance with the APA program on pain and fatigue, secondaryOutcomes measure: Tolerance with the APA program on fatigue, secondaryOutcomes measure: Compliance with the APA program, secondaryOutcomes measure: Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321731, orgStudyIdInfo id: D5980R00096, briefTitle: Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain., acronym: ORESTES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving \~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Annualized rate of exacerbations after BGF initiation, secondaryOutcomes measure: Demographic and clinical profile of patients initiating BGF., secondaryOutcomes measure: Lung Function after BGF initiation, secondaryOutcomes measure: Eosinophils count after BGF initiation, secondaryOutcomes measure: Persistence to treatment (BGF), secondaryOutcomes measure: Need for rescue medication after BGF initiation, secondaryOutcomes measure: Use of oral corticosteroids (OCS) after BGF initiation, secondaryOutcomes measure: HCRUs related to COPD after BGF initiation, otherOutcomes measure: Annualized rate of severe cardiovascular (CV)-related outcomes after initiation of BGF., otherOutcomes measure: Mortality (% and time to event) after BGF initiation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321718, orgStudyIdInfo id: 04-2023-200629, briefTitle: Pericapsular Nerve Group Block vs Supra Inguinal Fascia Iliaca Compartment Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 96 Patients will be enrolled. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. 2 groups well be assessed1. Group (A) will receive PENG + LFCN block2. The second group (B): S-FICB, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Through website computer program randomization program to distribute cases into two groups using their order number, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: PENG + LFCN block versus S-FICB, outcomesModule primaryOutcomes measure: recording time for "return of full muscle power", secondaryOutcomes measure: • The degree of hip flexion on the operative side, secondaryOutcomes measure: • Static and dynamic pain scores., secondaryOutcomes measure: postoperative nausea and vomiting (PONV) scale, secondaryOutcomes measure: • The number of rescue analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06321705, orgStudyIdInfo id: CS1-004, briefTitle: Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Cereno Scientific AB, class: INDUSTRY, collaborators name: Worldwide Clinical Trials, collaborators name: Abbott, descriptionModule briefSummary: CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1., conditionsModule conditions: Pulmonary Arterial Hypertension, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: CS1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fredrik Frick, status: AVAILABLE, city: Gothenburg, country: Sweden, contacts name: Fredrik Frick, role: CONTACT, phone: +46725479566, email: Fredrik.Frick@cerenoscientific.com, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06321692, orgStudyIdInfo id: IEO 1003, briefTitle: Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-10-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome., conditionsModule conditions: Neuroendocrine Tumors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of blood levels of biomarkers of cardiac damage, outcomesModule primaryOutcomes measure: blood levels of biomarkers of cardiac damage, primaryOutcomes measure: blood levels of biomarkers of hemodynamic impairment, primaryOutcomes measure: blood levels of biomarkers of cardiac fibrosis, secondaryOutcomes measure: Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Daniela Cardinale, MD, role: CONTACT, email: daniela.cardinale@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321679, orgStudyIdInfo id: IEO 1269, briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone, acronym: RESPECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-07-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.This is a monocentric, prospective observational study., conditionsModule conditions: Castration-resistant Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Imaging evaluation, outcomesModule primaryOutcomes measure: Time to disease progression in bone metastasis identify by WB-MRI, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IEO Istituto Europeo di Oncologia, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Giuseppe Petralia, role: CONTACT, email: giuseppe.petralia@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321666, orgStudyIdInfo id: IEO 0986, briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone, acronym: RESPECT-MI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-09-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: WB-MRI, outcomesModule primaryOutcomes measure: Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IEO Istituto Europeo di Oncologia, city: Milan, zip: 20141, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321653, orgStudyIdInfo id: IEO 0953, briefTitle: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes, acronym: AXILL-ART, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-04-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections., conditionsModule conditions: Arm Lymphedema, conditions: Breast Cancer, conditions: Radiotherapy Side Effect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hypofractionated radiotherapy scheme, outcomesModule primaryOutcomes measure: Percentage of patients with arm lymphedema, secondaryOutcomes measure: Evaluation of cute locoregional toxicity at breast and axilla, secondaryOutcomes measure: Evaluation of chronic toxicity at breast and axilla, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Maria Cristina Leonardi, role: CONTACT, phone: +39 02 94372156, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321640, orgStudyIdInfo id: IEO 1777, briefTitle: Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies., acronym: POSITive, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-08, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies., conditionsModule conditions: Breast Cancer, conditions: Lung Cancer, conditions: Melanoma, conditions: Head and Neck Cancer, conditions: Urothelial Carcinoma, conditions: Colorectal Cancer, conditions: Liver Metastases, conditions: Lung Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 265, type: ESTIMATED, armsInterventionsModule interventions name: Cohort A: primarily operable disease, candidate to adjuvant, interventions name: Cohort B: locally advanced disease, interventions name: Cohort C: metastatic disease, interventions name: Cohort D: Progressive disease, interventions name: Cohort E: Hematological neoplasms, interventions name: Cohort F: Toxicity, outcomesModule primaryOutcomes measure: Percentage of patients in each cohort that will obtain a full "core" omic characterization., secondaryOutcomes measure: Percentage of patients with complete clinical data collection over the expected follow-up time and with successful biobanking., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Giuseppe Curigliano, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321627, orgStudyIdInfo id: IEO 1811, briefTitle: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach, acronym: ICARUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body., conditionsModule conditions: HPV-Related Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Radiation therapy as curative treatment, outcomesModule primaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Genetic patterns of radiosensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Daniela Alterio, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321614, orgStudyIdInfo id: 2022098, briefTitle: Deep Learning in Classifying Bowel Obstruction Radiographs, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples.Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation., conditionsModule conditions: Digestive System Disease, conditions: Polyp of Colon, conditions: Bowel Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnostic and classification performance, secondaryOutcomes measure: Visualized interpretation of the self-supervised model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TheFirst Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215006, country: China, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
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protocolSection identificationModule nctId: NCT06321601, orgStudyIdInfo id: 20230070, briefTitle: Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2030-04-28, completionDateStruct date: 2030-04-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV., conditionsModule conditions: Vasculitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Avacopan, outcomesModule primaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS), primaryOutcomes measure: Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS, secondaryOutcomes measure: Plasma Concentrations of Avacopan, secondaryOutcomes measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE), secondaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Birmingham Vasculitis Activity Score (BVAS), secondaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 52 According to the BVAS, secondaryOutcomes measure: Proportion of Participants With PVAS of 0 Over Time Through Week 52, secondaryOutcomes measure: Proportion of Participants With BVAS of 0 Over Time Through Week 52, secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Urinary Albumin-Creatinine Ratio (UACR), secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Estimated Glomerular Filtration Rate (eGFR), secondaryOutcomes measure: Change From Baseline Over 52 Weeks In Physician Global Assessment (PGA) of Disease Activity, secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Pediatric Vasculitis Damage Index (PVDI), secondaryOutcomes measure: Number of Glucocorticoid Dosages Administered, secondaryOutcomes measure: Proportion of Participants Across the Taste Score Categories of the TASTY Faces Scale, secondaryOutcomes measure: Taste and Acceptability Score of Avacopan per TASTY Faces Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321588, orgStudyIdInfo id: GR-2021-12373134, briefTitle: Autoimmune Dementia: Predictors of Neuronal Synaptic Antibodies in Patients With New-ONset Cognitive Impairment, acronym: ADONIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Azienda Usl di Bologna, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to investigate the frequency and the possible pathogenic role of neuronal synaptic antibodies (NSAb) in patients with cognitive impairment (CI). The main questions it aims to answer are:1. the frequency and associated features of NSAb in patients with CI and the usefulness of a clinical score in improving autoimmune dementia (AID) diagnosis;2. the clinical significance of NSAb in patients with CI not fulfilling the autoimmune encephalitis (AE) criteria and serum NSAb (NSAb-pos-CI);3. the impact of blood-brain-barrier (BBB) dysfunction on their pathogenicity., conditionsModule conditions: Cognitive Impairment, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: frequency of antibodies against neuronal antigens, primaryOutcomes measure: frequency of antibodies against neuronal antigens, primaryOutcomes measure: creation of a score that predicts the presence of NSAb, secondaryOutcomes measure: changes of neurodegeneration biomarkers, secondaryOutcomes measure: changes of neurodegeneration biomarkers, secondaryOutcomes measure: changes of neuroanatomy, secondaryOutcomes measure: changes of neuroanatomy, secondaryOutcomes measure: changes of inflammatory biomarkers, secondaryOutcomes measure: changes of inflammatory biomarkers, secondaryOutcomes measure: changes of brain blood barrier biomarkers, secondaryOutcomes measure: changes of brain blood barrier biomarkers, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, status: RECRUITING, city: Bologna, zip: 40139, country: Italy, contacts name: Maria Pia Giannoccaro, Dr., role: CONTACT, phone: 0514966117, email: mariapia.giannoccaro@ausl.bologna.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milano, zip: 20095, country: Italy, contacts name: Federico Verde, Dr., role: CONTACT, phone: +3902619112247, email: f.verde@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, status: RECRUITING, city: Milano, zip: 20133, country: Italy, contacts name: Chiara Maria Giulia De Luca, Dr., role: CONTACT, phone: +390223942498, email: chiara.deluca@istituto-besta.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06321575, orgStudyIdInfo id: AVA-CL-5000, briefTitle: The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial), acronym: GREAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Avantec Vascular, class: INDUSTRY, collaborators name: Bright Research Partners, collaborators name: Yale Cardiovascular Research Group, descriptionModule briefSummary: The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 15 investigational sites in the U.S., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 159, type: ESTIMATED, armsInterventionsModule interventions name: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS), outcomesModule primaryOutcomes measure: Freedom from major adverse events (MAE), primaryOutcomes measure: Technical success, secondaryOutcomes measure: Change in % stenosis in target lesion after treatment with Golazo Peripheral AS, secondaryOutcomes measure: Procedural Success Rate, secondaryOutcomes measure: Clinical Success Rate, secondaryOutcomes measure: Rates of all adverse events classified as MAEs, secondaryOutcomes measure: Incidence of minor target limb amputation, secondaryOutcomes measure: Incidence of myocardial infarction, secondaryOutcomes measure: Incidence of target vessel revascularization (TVR) in the target limb, secondaryOutcomes measure: Incidence of angiographic procedural distal embolization in the target limb, secondaryOutcomes measure: Time to primary patency of the target vessels, secondaryOutcomes measure: Time to assisted primary patency of the target vessels, secondaryOutcomes measure: Time to secondary patency of the target vessels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321562, orgStudyIdInfo id: EyeD-010-003, secondaryIdInfos id: 2020-002354-24, type: EUDRACT_NUMBER, secondaryIdInfos id: CIV-21-12-038426, type: OTHER, domain: EUDAMED, briefTitle: Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: EyeD Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia. The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.The study will also check:* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,* how safe different doses of timolol are and how the body handles taking it,* the amount of Timolol released in the bloodstream,* if there is any positive effect on the pressure inside the eye., conditionsModule conditions: Primary Open-angle Glaucoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: TimoD implant, interventions name: Injector system, outcomesModule primaryOutcomes measure: Number and proportion of participants experiencing one or more serious adverse events (SAEs), primaryOutcomes measure: Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU - Service d'Ophtalmologie, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Nathalie Collignon, Prof. MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Breyer, Kaymak & Klabe Augenchirurgie, status: RECRUITING, city: Düsseldorf, zip: 40212, country: Germany, contacts name: Karsten Klabe, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.22172, lon: 6.77616, locations facility: Universitäts-Augenklinik Heidelberg, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69120, country: Germany, contacts name: Gerd Auffarth, Prof. MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Universitätsaugenklinik Magdeburg, status: RECRUITING, city: Magdeburg, zip: 39120, country: Germany, contacts name: Giulia Reineri, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.12773, lon: 11.62916, locations facility: Augenklinik Sulzbach, status: RECRUITING, city: Sulzbach, zip: 66280, country: Germany, contacts name: Karl Boden, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.29882, lon: 7.05696, locations facility: Universitäts-Augenklinik Tübingen, status: RECRUITING, city: Tübingen, zip: 72076, country: Germany, contacts name: Bogomil Voykov, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
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protocolSection identificationModule nctId: NCT06321549, orgStudyIdInfo id: 202201562B0, briefTitle: New Era of DIEP With Minimally Invasive Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-03, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2023-10-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced., conditionsModule conditions: Breast Reconstruction, conditions: Mastectomy; Lymphedema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 278, type: ACTUAL, armsInterventionsModule interventions name: The reference point of minimally invasive mastectomy procedure conducted, outcomesModule primaryOutcomes measure: Endoscopy mastectomy, primaryOutcomes measure: Robotic mastectomy, primaryOutcomes measure: Incision, primaryOutcomes measure: Usage of SIEV, primaryOutcomes measure: Inclusion of bipedicle, primaryOutcomes measure: Location of recipient artery/vein, primaryOutcomes measure: Recipient artery/vein selection, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung Memorial Hospital, city: Taoyuan, zip: 33305, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06321536, orgStudyIdInfo id: STUDY00007230, secondaryIdInfos id: U54CK000601, type: NIH, link: https://reporter.nih.gov/quickSearch/U54CK000601, briefTitle: Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: Centers for Disease Control and Prevention, descriptionModule briefSummary: REACT is a phase two, open-label, cluster randomized, crossover study of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO. The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation., conditionsModule conditions: Multi-Drug Resistant Organism Colonization, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Allogeneic Microbiota in Glycerol (9%) (AMG), outcomesModule primaryOutcomes measure: Difference in number of solicited Adverse Events (AEs), primaryOutcomes measure: Difference in severity of solicited AEs, primaryOutcomes measure: Difference in number of unsolicited AEs, primaryOutcomes measure: Difference in severity of unsolicited AEs, primaryOutcomes measure: Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants, secondaryOutcomes measure: Count of serious AEs (SAEs), secondaryOutcomes measure: Count of AEs of Special Interest (AESIs), secondaryOutcomes measure: Proportion of stool cultures at Day 28 positive for category-specific MDROs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Michael Woodworth, MD, role: CONTACT, phone: 404-778-1691, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06321523, orgStudyIdInfo id: B3461122, briefTitle: A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective., conditionsModule conditions: Transthyretin Amyloid Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Tafamidis 61 milligrams, outcomesModule primaryOutcomes measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification, primaryOutcomes measure: Change from baseline in six-minute walk test, primaryOutcomes measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), primaryOutcomes measure: Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration, primaryOutcomes measure: Change From Baseline in Troponin I and Troponin T, primaryOutcomes measure: number of participants with Any Heart Block, primaryOutcomes measure: number of participants with Atrioventricular (AV) block, primaryOutcomes measure: Change From Baseline in Left Ventricular Ejection Fraction, primaryOutcomes measure: Change From a Baseline in Diastolic function grades, primaryOutcomes measure: Change from Baseline in Left Ventricular Wall Thickness, primaryOutcomes measure: Change From Baseline in Global Longitudinal Strain scores, secondaryOutcomes measure: Frequency of cardiovascular hospitalizations, secondaryOutcomes measure: Frequency of death due to any cause, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pfizer, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06321510, orgStudyIdInfo id: A7471070, briefTitle: A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.This study is seeking participants who:* have lung cancer that could not be controlled.* have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.* have received dacomitinib for their lung cancer.All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Percentage of patients with dacomitinib dosage change and reasons, primaryOutcomes measure: Percentage of patients with dacomitinib treatment discontinuation, secondaryOutcomes measure: Real-world overall survival (rwOS), secondaryOutcomes measure: Real-world progression-free survival, secondaryOutcomes measure: Real-world best objective response rate (rwORR), secondaryOutcomes measure: real-world intracranial response rate (rwIC-ORR), secondaryOutcomes measure: real-world extracranial response rate (rwEC-ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321497, orgStudyIdInfo id: 85711, briefTitle: Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2028-02-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Peninsula Health, class: OTHER_GOV, collaborators name: Monash University, collaborators name: Baxter Healthcare Corporation, descriptionModule briefSummary: Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure., conditionsModule conditions: ARDS, Human, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal carbon dioxide removal, outcomesModule primaryOutcomes measure: Reduction in driving airway pressures, secondaryOutcomes measure: Reduction in pulmonary inflammation assessed by interleukins in lung, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Frankston Hospital, status: RECRUITING, city: Frankston, state: Victoria, zip: 3199, country: Australia, contacts name: Ravindranath Tiruvoipati, PhD, role: CONTACT, phone: 0431279347, email: rtiruvoipati@phcn.vic.gov.au, contacts name: Sachin Gupta, FCICM, role: CONTACT, email: sachingupta@phcn.vic.gov.au, geoPoint lat: -38.14458, lon: 145.12291, hasResults: False
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protocolSection identificationModule nctId: NCT06321484, orgStudyIdInfo id: 23-493, briefTitle: Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2031-10-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: ImmunityBio, Inc., descriptionModule briefSummary: The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy combined with IL-15 superagonist (N-803) in recurrent, high grade ovarian cancer (HGOC).Names of the study therapies involved in this study are:* CIML NK (cellular therapy)* N-803 (a novel immune-cell stimulator), conditionsModule conditions: Platinum-resistant Ovarian Cancer, conditions: Recurrent Ovary Cancer, conditions: Ovarian Cancer, conditions: Ovarian Carcinoma, conditions: Ovarian Carcinoma, Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Cytokine-Induced Memory-like Natural Killer Cells, interventions name: IL-15 Superagonist, outcomesModule primaryOutcomes measure: Maximum Tolerated Dose (MTD) (Cohort 1), primaryOutcomes measure: Dose Limiting Toxicity (DLT) (Cohort 1), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Median Progression Free Survival (PFS), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: 6 months Progression Free Survival (PFS6), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Rebecca Porter, MD, PhD, role: CONTACT, phone: 617-632-2334, email: rebecca_porter@dfci.harvard.edu, contacts name: Rebecca Porter, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Rebecca Porter, MD, PhD, role: CONTACT, phone: 617-632-2334, email: Rebecca_Porter@dfci.harvard.edu, contacts name: Rebecca Porter, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06321471, orgStudyIdInfo id: STUDY00002858, briefTitle: AeviceMD for Pediatric Asthma Management, acronym: APAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Irina Dralyuk, class: OTHER, collaborators name: AEvice Health Pte Ltd, descriptionModule briefSummary: A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations., conditionsModule conditions: Asthma, conditions: Asthma in Children, conditions: Pediatric Asthma, conditions: Chronic Respiratory Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: AeviceMD, outcomesModule primaryOutcomes measure: To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients., secondaryOutcomes measure: To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cedars-Sinai Medical Center, city: Los Angeles, state: California, zip: 90048, country: United States, contacts name: Bobby Marker, role: CONTACT, phone: 310-423-0901, email: Robert.Marker@cshs.org, contacts name: Irina Dralyuk, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06321458, orgStudyIdInfo id: LightWAY, briefTitle: Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity, acronym: LightWAY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2048-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Carsten Dirksen, class: OTHER, collaborators name: University of Copenhagen, collaborators name: University of Southern Denmark, collaborators name: University of Oxford, collaborators name: University of Bristol, collaborators name: Copenhagen Trial Unit, Center for Clinical Intervention Research, descriptionModule briefSummary: In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Intensive weight loss intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: MetS-Z, primaryOutcomes measure: Weight, secondaryOutcomes measure: Short-Form-36, mental component score, secondaryOutcomes measure: Gait speed, secondaryOutcomes measure: Weight loss (20%), otherOutcomes measure: SAE, otherOutcomes measure: Incident eating disorders, otherOutcomes measure: Bone mineral density (BMD) assessed by DXA, otherOutcomes measure: Body composition - waist circumference, otherOutcomes measure: Body composition - fat percentage, otherOutcomes measure: Body composition - weight loss (10%), otherOutcomes measure: Physical functioning - SENS, otherOutcomes measure: Physical functioning - SF-36, otherOutcomes measure: Physical functioning - sit to stand test, otherOutcomes measure: Sleep, otherOutcomes measure: Medications during the intervention period, otherOutcomes measure: Metabolic health - blood pressure, otherOutcomes measure: Metabolic health - pulse, otherOutcomes measure: Metabolic health - Hb1Ac, otherOutcomes measure: Metabolic health - insulin, otherOutcomes measure: Metabolic health - HOMA2-IR, otherOutcomes measure: Metabolic health - lipids, otherOutcomes measure: Metabolic health - eGFR, otherOutcomes measure: Metabolic health - hsCRP, otherOutcomes measure: Metabolic health - Fib4, otherOutcomes measure: Metabolic health - proteinuria, otherOutcomes measure: Metabolic health - TSH, otherOutcomes measure: Mental health - MDI, otherOutcomes measure: Mental health - WBIS-M, otherOutcomes measure: Mental health - EDE-Q, otherOutcomes measure: Labour market attachment - WPAI, otherOutcomes measure: Labour market attachment - days of sick leave, otherOutcomes measure: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, index score, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, VAS, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - costs, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios, otherOutcomes measure: Long-term effects - mortality and major cardiovascular disease (CVD), otherOutcomes measure: Long-term effects - prescription patterns, otherOutcomes measure: Long-term effects - incident cancer, otherOutcomes measure: Long-term effects - fracture risk, otherOutcomes measure: Long-term effects - health economic and labour market attachment, employment status, otherOutcomes measure: Long-term effects - health economic and labour market attachment, salary, otherOutcomes measure: Long-term effects - health economic and labour market attachment, absence, otherOutcomes measure: Long-term effects - health economic and labour market attachment, sick leave, otherOutcomes measure: Long-term effects - health economic and labour market attachment, long-term sick leave, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet, status: NOT_YET_RECRUITING, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Addie J Frederiksen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg, status: NOT_YET_RECRUITING, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Sofus C Larsen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse, status: NOT_YET_RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Maria Bleiback Clausen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, status: RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Carsten Dirksen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering, status: NOT_YET_RECRUITING, city: Søborg, zip: 2860, country: Denmark, contacts name: Julie Borgen Braget, role: CONTACT, geoPoint lat: 56.08481, lon: 12.31803, locations facility: IHR CRN: Thames Valley and South Midlands, status: NOT_YET_RECRUITING, city: Oxford, country: United Kingdom, contacts name: Susan Jebb, role: CONTACT, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06321445, orgStudyIdInfo id: ChatGptASAscore, briefTitle: The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores, acronym: ASA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Kanuni Sultan Suleyman Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Patients applied to the anesthesia clinics of Health Science University Istanbul Kanuni Sultan Suleyman Training and Research Hospital and Basaksehir Cam and Sakura City Hospital were included in the study. Evaluation forms which will be filled in every preoperative examinations will be saved in the hospitals systems. Patients datas without indentification informations will be asked to ChatGpt to give anesthesiological risc scores. This scores will be compared with the scores already given by anesthesiologists., conditionsModule conditions: Artificial Intelligence, conditions: Preoperative Evaluation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: providing ASA score, outcomesModule primaryOutcomes measure: The Success of ChatGPT in Providing American Society of Anesthesiologist (ASA) Scores, secondaryOutcomes measure: The Success of ChatGPT in clinical decisions, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital, status: RECRUITING, city: Istanbul, zip: 34303, country: Turkey, contacts name: Engin ihsan Turan, role: CONTACT, phone: 05382431114, email: enginihsan@hotmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06321432, orgStudyIdInfo id: LightCARE, briefTitle: Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity, acronym: LightCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2048-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Carsten Dirksen, class: OTHER, collaborators name: University of Copenhagen, collaborators name: University of Southern Denmark, collaborators name: University of Oxford, collaborators name: University of Bristol, collaborators name: Copenhagen Trial Unit, Center for Clinical Intervention Research, descriptionModule briefSummary: In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with obesity class I or uncomplicated obesity class II or higher., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee ill write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Intensive weight loss intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: Weight, secondaryOutcomes measure: Weight loss (20%), secondaryOutcomes measure: Short-Form-36, mental component score, secondaryOutcomes measure: Gait speed, secondaryOutcomes measure: MetS-Z, otherOutcomes measure: Safety - SAE, otherOutcomes measure: Safety - eating disorder, otherOutcomes measure: Safety - bone mineral density (BMD) assessed by DXA, otherOutcomes measure: Body composition - waist circumference, otherOutcomes measure: Body composition - fat percentage, otherOutcomes measure: Body composition - weight loss (10%), otherOutcomes measure: Physical functioning - SENS, otherOutcomes measure: Physical functioning - SF-36, otherOutcomes measure: Physical functioning - sit to stand test, otherOutcomes measure: Physical functioning - quality of life, otherOutcomes measure: Sleep, otherOutcomes measure: Medications during the intervention period, otherOutcomes measure: Metabolic health - blood pressure, otherOutcomes measure: Metabolic health - pulse, otherOutcomes measure: Metabolic health - glucose, otherOutcomes measure: Metabolic health - Hb1Ac, otherOutcomes measure: Metabolic health - insulin, otherOutcomes measure: Metabolic health - HOMA2-IR, otherOutcomes measure: Metabolic health - lipids, otherOutcomes measure: Metabolic health - eGFR, otherOutcomes measure: Metabolic health - hsCRP, otherOutcomes measure: Metabolic health - Fib4, otherOutcomes measure: Metabolic health - Proteinuria, otherOutcomes measure: Metabolic health - TSH, otherOutcomes measure: Mental health - MDI, otherOutcomes measure: Mental health - WBIS-M, otherOutcomes measure: Mental health - EDE-Q, otherOutcomes measure: Labour market attachment - WPAI, otherOutcomes measure: Labour market attachment - days of sick leave, otherOutcomes measure: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - costs, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios, otherOutcomes measure: Long-term effects - mortality and major cardiovascular disease (CVD), otherOutcomes measure: Long-term effects - prescription patterns, otherOutcomes measure: Long-term effects - incident cancer, otherOutcomes measure: Long-term effects - fracture risk, otherOutcomes measure: Long-term effects - health economic and labour market attachment, employment status, otherOutcomes measure: Long-term effects - health economic and labour market attachment, salary, otherOutcomes measure: Long-term effects - health economic and labour market attachment, absence, otherOutcomes measure: Long-term effects - health economic and labour market attachment, sick leave, otherOutcomes measure: Long-term effects - health economic and labour market attachment, long-term sick leave, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, city: Copenhagen, zip: 2650, country: Denmark, contacts name: Carsten Dirksen, role: CONTACT, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Addie J Frederiksen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Sofus C Larsen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Maria Bleiback Clausen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering, city: Søborg, zip: 2860, country: Denmark, contacts name: Julie Borgen Braget, role: CONTACT, geoPoint lat: 56.08481, lon: 12.31803, locations facility: NIHR CRN: Thames Valley and South Midlands, city: Oxford, country: United Kingdom, contacts name: Paul Aveyard, role: CONTACT, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06321419, orgStudyIdInfo id: atls-vs-standard-care, briefTitle: ATLS vs Standard Care Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2029-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: The George Institute for Global Health, India, descriptionModule briefSummary: Rationale:Trauma is a massive global health issue. Many training programmes have been developed to help physicians in the initial management of trauma patients. Among these programmes, Advanced Trauma Life Support® (ATLS®) is the most popular, having trained over one million physicians worldwide. Despite its widespread use, there are no controlled trials showing that ATLS® improves patient outcomes. Multiple systematic reviews emphasise the need for such trials.Aim:To compare the effects of ATLS® training with standard care on outcomes in adult trauma patients.Trial Population:Adult trauma patients presenting to the emergency department of a participating hospital.Eligibility Criteria:Hospitals are secondary or tertiary hospitals in India that admit or refer/transfer for admission at least 400 patients with trauma per year. Clusters are one or more units of physicians providing initial trauma care in the emergency department of tertiary hospitals in India. Patients participants are adult trauma patients who presents to the emergency department of participating hospitals and are admitted or transferred for admission.Ethical Considerations:The study will use an opt-out consent approach for in-hospital collection of routinely recorded data, in which consent is presumed unless actively declined. Informed consent for non-routinely recorded data including out of hospital follow up will be obtained. Patients who are unconscious or lack a legally authorized representative will be included under a waiver of informed consent. Note that consent here refers to consent to data collection, as it will not be possible for patients to opt out from being subjected to the intervention. This approach is justified because the trial can be considered to involve only minimal risk and the data collection is non-invasive and mostly involve extracting routinely collected data from medical records.Funding:Swedish Research Council (reg. no. 2023-03128), Laerdal Foundation (reg. no. 2023-0297).Special considerations:This trial is not yet fully funded. The Trial Management Group has decided to proceed with the trial with the expectation that additional funding will be secured. The Joint Trial Steering and Data Monitoring Committee will be informed of the funding status at each meeting. If funding is not secured, the trial will be stopped. This will likely result in an underpowered trial. The justification for this decision is that the intervention is considered standard of care in many countries and the data collection is considered minimal risk. There is therefore a very small risk of harm to patient participants, but a potential direct benefit to those., conditionsModule conditions: Wounds and Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Batched stepped-wedge cluster randomised trial. We will roll out the interventions to 30 clusters over six batches, so there will be five clusters in each batch. The clusters in each batch will be randomised to one of five implementation sequences, with one hospital randomised to each implementation sequence. All clusters will transition through three phases, first a standard care phase, then a one month transition phase during which the training is delivered, and finally an intervention phase, for a total of 13 months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4320, type: ESTIMATED, armsInterventionsModule interventions name: Advanced Trauma Life Support training, outcomesModule primaryOutcomes measure: All-cause mortality within 30 days of arrival at the emergency department., eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321406, orgStudyIdInfo id: KayseriCHdysphagia, briefTitle: Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks., conditionsModule conditions: Dysphagia, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: NMES (neuromuscular electrical stimulation), interventions name: Exercise, outcomesModule primaryOutcomes measure: Ultrasonographic measurements, secondaryOutcomes measure: Functional Oral Intake Scale (FOIS), secondaryOutcomes measure: Swallowing Function Screening Test (EAT-10), secondaryOutcomes measure: GUSS (Gagging Swallowing Screening Test), secondaryOutcomes measure: Modified Mann Swallowing Ability Assessment Test (MMASA), secondaryOutcomes measure: SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: health sciences university Kayseri medicine faculty, city: Kayseri, zip: 38080, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06321393, orgStudyIdInfo id: HE662176, briefTitle: Effects of a CSE With ADIM in Chronic Non-specific Low Back Pain With Lumbar Instability Using Telerehabilitation., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effectiveness of telerehabilitation-based and clinic-based methods to deliver a Core Stabilization Exercise Program with the Abdominal Drawing-In Maneuver Technique (CSE with ADIM) on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability.The main question it aims to answer is: Is there a difference between the effectiveness of telerehabilitation-based and clinic-based CSE with ADIM on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability?Participants will perform a 7-week core stabilization exercise with the abdominal drawing-in maneuver technique, consisting of an exercise program for 20-minute sessions with 3 sessions per week. These exercise programs will be provided to the participants via a weekly video call with the main researcher as a telerehabilitation program. At the first session of each week, the researcher will provide supervision via video call with the participant for the exercise program. The participants will perform the exercise by following the video demonstration. After completing weekly training, participants will perform their exercise routine as part of their daily home program.If there is a comparison group: researchers will compare The control group (clinical-base group) will be provided the 7-week core stabilization exercise with abdominal drawing-in maneuver technique, the same as the experimental group, but control groups received the exercise program at the clinic according to the usual methods. At the first session of each week, an appointment will be set, and then the specific exercise for each week will be delivered and trained by the main researcher at the clinic. After completing weekly training, participants will perform their exercise routine as part of their daily home program to see if there are any differences in pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability between the experimental and control groups., conditionsModule conditions: Chronic Low-back Pain, conditions: Lumbar Instability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 7-week Core stabilization exercise with abdominal drawing-in maneuver technique, outcomesModule primaryOutcomes measure: 11-ponits Numerical Rating Scale (0-10 NRS), secondaryOutcomes measure: Oswestry disability index (ODI), secondaryOutcomes measure: Roland Morris Disability Questionnaire (RMDQ), secondaryOutcomes measure: 36-item Short Form Survey (SF-36), secondaryOutcomes measure: Lumbar joint reposition sense error, secondaryOutcomes measure: Satisfaction questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Miss Chutimon Kongsa, status: RECRUITING, city: Maha Sarakham, state: Mahasarakham, zip: 44000, country: Thailand, contacts name: Chutimon Kongsa, role: CONTACT, phone: +66852736773, email: chutimon.ko@kkumail.com, contacts name: Torkamol Hunsawong, role: CONTACT, phone: 043202399, email: tkmhun@kku.ac.th, geoPoint lat: 16.18483, lon: 103.30067, hasResults: False
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protocolSection identificationModule nctId: NCT06321380, orgStudyIdInfo id: 38RC23.0381, briefTitle: Working Memory Functioning in Alzheimer's Disease and Vascular Dementia, acronym: MEMTRAV-COG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, collaborators name: University Grenoble Alps, collaborators name: Université Savoie Mont Blanc, collaborators name: Centre National de la Recherche Scientifique, France, collaborators name: Laboratoire de Psychologie et NeuroCognition, descriptionModule briefSummary: The aim of the present study is to investigate potential cognitive mechanisms contributing to working memory impairment in Alzheimer's disease and vascular dementia. The investigators consider a new hypothesis suggesting that difficulties in mobilizing maintenance strategies of information could explain this working memory deficit. More specifically, the investigators assume that patient groups will have difficulties in employing both refreshing and elaborative strategies during a working memory task (i.e., complex span task), as compared to a control group., conditionsModule conditions: Alzheimer Disease, conditions: Vascular Dementia, conditions: Mixed Dementias, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Complex span task, interventions name: Clinical neuropsychological assessment, interventions name: Clinical neurospychological assessement, outcomesModule primaryOutcomes measure: Memory performance in the Working memory task, primaryOutcomes measure: Processing performance in the Working memory task, primaryOutcomes measure: Reaction time, secondaryOutcomes measure: Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Digit span forward WAIS IV (digit number), secondaryOutcomes measure: Digit span forward WAIS IV (standard note), secondaryOutcomes measure: Digit span backward WAIS IV (digit number), secondaryOutcomes measure: Digit span backward WAIS IV (standard note), secondaryOutcomes measure: Stroop Test - denomination part, secondaryOutcomes measure: Stroop Test - minor interference part (Time), secondaryOutcomes measure: Stroop Test - minor interference part (errors), secondaryOutcomes measure: Stroop Test - major interference part (time), secondaryOutcomes measure: Stroop Test - major interference part (errors), secondaryOutcomes measure: Trail Making Test - Part A (time), secondaryOutcomes measure: Trail Making Test - Part A (errors), secondaryOutcomes measure: Trail Making Test - Part B (time), secondaryOutcomes measure: Trail Making Test - Part B (errors), secondaryOutcomes measure: Category fluences, secondaryOutcomes measure: Memory evaluation (16-item Free and Cued Recall, or GERIA-12), secondaryOutcomes measure: Naming task, secondaryOutcomes measure: Behavior rating inventory of executive function, secondaryOutcomes measure: Instrumental Activities of Daily Living, secondaryOutcomes measure: Activities of Daily Living, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321367, orgStudyIdInfo id: 202401002, secondaryIdInfos id: 82070613, type: OTHER_GRANT, domain: the National Natural Sciences Foundation of China, secondaryIdInfos id: 82370638, type: OTHER_GRANT, domain: the National Natural Sciences Foundation of China, secondaryIdInfos id: 2022RC1212, type: OTHER_GRANT, domain: the Science and Technology Innovation Program of Hunan Province, secondaryIdInfos id: 2023JJ10095, type: OTHER_GRANT, domain: he Natural Science Foundation of Hunan Province China, briefTitle: Model to Predict Coinfection in Elderly Patients With COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-20, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure., conditionsModule conditions: Covid19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Coinfection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangya Hospital of Central South University, city: Changsha, state: Hunan, zip: 410000, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06321354, orgStudyIdInfo id: KY 2018-066-02-3, briefTitle: Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-18, completionDateStruct date: 2024-11-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: Beijing Children's Hospital, descriptionModule briefSummary: At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children., conditionsModule conditions: Pain, conditions: Postoperative Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: The diprospan plus ropivacaine group, interventions name: The ropivacaine group, outcomesModule primaryOutcomes measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS), secondaryOutcomes measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS), secondaryOutcomes measure: The time to the first rescue analgesic, secondaryOutcomes measure: Patient satisfactory scale (PSS), secondaryOutcomes measure: Length of stay (LOS), secondaryOutcomes measure: The occurrence of postoperative nausea and vomiting (PONV), secondaryOutcomes measure: Ramsay Sedation Scale (RSS), secondaryOutcomes measure: The occurrence of respiratory depression, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: The total consumption of opioids during the operation, secondaryOutcomes measure: The total consumption of anaesthetic during the operation, secondaryOutcomes measure: Wound Healing Score, secondaryOutcomes measure: Incisional related adverse events, secondaryOutcomes measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Beijing Children's hospital affiliated to capital medical university, status: RECRUITING, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Ge Ming, M.D, role: CONTACT, phone: 010-59616408, email: geming88@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100070, country: China, contacts name: Luo Fang, M.D, role: CONTACT, phone: +86 13611326978, email: 13611326978@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06321341, orgStudyIdInfo id: BUSP-04-04-2023, briefTitle: Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Study of efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo., conditionsModule conditions: Vertigo, conditions: Autonomic Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Vespireit, interventions name: Arlevert, outcomesModule primaryOutcomes measure: Change in Mean vertigo score (MVS) at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1, secondaryOutcomes measure: Change in mean MVS score at Visit 1-2 of the Primary Therapy Period relative to baseline at Visit 1-1., secondaryOutcomes measure: Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in mean MVS score at the visit of completion of study participation compared with the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response))., secondaryOutcomes measure: Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1., secondaryOutcomes measure: Percentage of patients with a ≥50% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1., secondaryOutcomes measure: Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1., secondaryOutcomes measure: Percentage of patients with a ≥25% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1., secondaryOutcomes measure: Change in total score on the DHI at Visit 1-3 of the Primary Therapy Period compared with Visit 1-1., secondaryOutcomes measure: Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in total score on the DHI at the study participation completion visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response))., secondaryOutcomes measure: Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period., secondaryOutcomes measure: Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period., secondaryOutcomes measure: Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visit 1-3 of the Primary Therapy Period., secondaryOutcomes measure: Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visits 2-3 and 2-4 of the Retreatment Period., secondaryOutcomes measure: Change in total score on the Hamilton Anxiety Rating Scale HARS at Visit 1-3 of the Primary Treatment Period compared with Visit 1-1., secondaryOutcomes measure: Change in total score on the Hamilton Anxiety Rating Scale HARS at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in VSS-SF total score at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1., secondaryOutcomes measure: Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in VSS-SF total score at the study participation completion visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response))., secondaryOutcomes measure: Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Primary Therapy Period., secondaryOutcomes measure: Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period., secondaryOutcomes measure: Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 2-2, 2-3, and 2-4 in the Retreatment Period., secondaryOutcomes measure: Evaluation of the effectiveness of therapy on the CGI-i scale by the physician at Visits 2-2, 2-3, 2-4 in the Re-Treatment Period., secondaryOutcomes measure: Proportion of patients with exacerbation (relapse) of the disease after treatment in the Primary Treatment Period during the entire follow-up period (until the visit of completion of participation in the study), secondaryOutcomes measure: Duration of remission period after treatment in the Primary Therapy Period. Remission means absence of episodes of exacerbations (relapses), secondaryOutcomes measure: Clinically significant abnormalities on physical and/or neurologic examination, secondaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Рatients with at least one AE, secondaryOutcomes measure: Patients discontinued due to AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Clinic LLC, status: RECRUITING, city: Bryansk, zip: 241050, country: Russian Federation, contacts name: Marina A Agafonova, MD, PhD, role: CONTACT, phone: +7-4832-72-58-28, email: agafonova.marina.sm@mail.ru, geoPoint lat: 53.25209, lon: 34.37167, locations facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation, status: RECRUITING, city: Kirov, zip: 610027, country: Russian Federation, contacts name: Nadezhda S Trushnikova, MD, role: CONTACT, phone: +7-8332-62-75-68, email: uddefola@mail.ru, geoPoint lat: 58.59665, lon: 49.66007, locations facility: State Budgetary Institution of Healthcare of the City of Moscow "V.P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow", status: RECRUITING, city: Moscow, zip: 109263, country: Russian Federation, contacts name: Kamila B Gadjialieva, MD, role: CONTACT, phone: +7-925-710-00-97, email: demikhovadzm@mail.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk", status: RECRUITING, city: Smolensk, zip: 214025, country: Russian Federation, contacts name: Natalia A Belyaeva, MD, role: CONTACT, phone: +7-4812-24-50-60, email: n.makar1973@mail.ru, geoPoint lat: 54.7818, lon: 32.0401, hasResults: False
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protocolSection identificationModule nctId: NCT06321328, orgStudyIdInfo id: ChatGpt postoperative ICU, briefTitle: Success of ChatGPT in Determining the Need for Postoperative Intensive Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2024-04-16, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Kanuni Sultan Suleyman Training and Research Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, observational study to be conducted at Sağlık Bilimleri University Istanbul Kanuni Sultan Süleyman Training and Research Hospital and Başakşehir Çam and Sakura City Hospital. The study aims to record various preoperative and postoperative data of patients who have undergone surgeries, specifically those with ASA scores of III and IV or those indicated to potentially need postoperative intensive care. Data points include patient demographics, type of surgery, ASA score, comorbidities, lab and imaging findings, and both actual and ChatGPT version 4 predicted outcomes regarding postoperative intensive care needs, anesthesia methods, duration of stay in intensive care and the hospital, and 30-day mortality rates. ChatGPT version 4's predictions will be compared with actual outcomes and anesthesiologist decisions., conditionsModule conditions: Artificial Intelligence, conditions: Intensive Care Unit, conditions: PACU Length of Stay, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 398, type: ESTIMATED, outcomesModule primaryOutcomes measure: Intensive care predictions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: istanbul Kanuni Sultan Süleyman Education and Training Hospital, city: Istanbul, zip: 34303, country: Turkey, contacts name: Yeşim Özay, role: CONTACT, phone: 0090212 404 15 00, phoneExt: 2144, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06321315, orgStudyIdInfo id: KSUESRAKARATASOKYAY006, briefTitle: The Effect of Case-based Teaching on Midwifery Undergraduate Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: Case-based teaching will be applied to second year midwifery undergraduate students. The intervention group (case-based teaching implementation group) and the control group each consist of 35 students., conditionsModule conditions: Midwifery Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group (Case-based instruction group) Control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Case-based instruction, outcomesModule primaryOutcomes measure: Determination of Critical Thinking Motivation, primaryOutcomes measure: Determination of Critical Thinking Motivation, secondaryOutcomes measure: Determining the level of Academic Motivation, secondaryOutcomes measure: Determining the level of Academic Motivation, secondaryOutcomes measure: Determining the status of access to information, secondaryOutcomes measure: Determining the status of access to information, secondaryOutcomes measure: Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice, secondaryOutcomes measure: Evaluation of satisfaction with the training methods used and the effect of training methods on perceptions of competence during clinical practice, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kahramanmaras Sutcu Imam University, status: RECRUITING, city: Kahramanmaraş, state: Kahramanmaras, zip: 46050, country: Turkey, contacts name: Esra KARATAŞ OKYAY, PhD, role: CONTACT, phone: 05432125225, email: esrakaratas44@hotmail.com, contacts name: Pınar KARA, PhD, role: CONTACT, phone: 0507 957 0859, email: karapinar@hotmail.com, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
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protocolSection identificationModule nctId: NCT06321302, orgStudyIdInfo id: 1436-0007, secondaryIdInfos id: 2023-508891-12-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1299-0915, type: REGISTRY, domain: Universal Trial Number, briefTitle: A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-11-11, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study.The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy.Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Diabetic Retinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 175, type: ESTIMATED, armsInterventionsModule interventions name: BI 764524, interventions name: Sham comparator to BI 764524, interventions name: Aflibercept (Eylea®) - US only, outcomesModule primaryOutcomes measure: Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52, secondaryOutcomes measure: Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52, secondaryOutcomes measure: Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52, secondaryOutcomes measure: Absolute change from baseline of central retinal thickness [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52, secondaryOutcomes measure: Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52, secondaryOutcomes measure: Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52, secondaryOutcomes measure: Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52, secondaryOutcomes measure: Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS), secondaryOutcomes measure: Occurrence of ocular AEs in the study eye between baseline and EOS, secondaryOutcomes measure: Occurrence of ocular AEs of special interest in the study eye between baseline and EOS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321289, orgStudyIdInfo id: CHN-PLAGH-BT-084, briefTitle: Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03-20, completionDateStruct date: 2027-03-20, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r/r B-NHL., conditionsModule conditions: Non-hodgkin Lymphoma,B Cell, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Allogeneic CD19-STAR T cell, interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Phase 1: Incidence of Adverse Events (AEs) defined as DLT, primaryOutcomes measure: Phase 1: RP2D, primaryOutcomes measure: Phase 2: Best objective Response Rate, secondaryOutcomes measure: Phase 2: Overall Survival (OS), secondaryOutcomes measure: Phase 2: Progression Free Survival (PFS), secondaryOutcomes measure: Phase 2: Time to response (TTR), secondaryOutcomes measure: Phase 2: Duration of Response (DOR), secondaryOutcomes measure: Pharmacokinetics: Number and copy number of CD19-STAR T cells (phase 1 and phase 2), secondaryOutcomes measure: Pharmacokinetics: Persistence of CD19-STAR T (phase 1 and phase 2), secondaryOutcomes measure: Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2), otherOutcomes measure: Phase 1: Levels of donor-specific anti-HLA antibodies (DSA) in blood., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biotherapeutic Department of Chinese PLA General Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Weidong Han, M.D, role: CONTACT, phone: +86-010-66937463, email: hanwdrsw@sina.com, contacts name: Qingming Yang, M.D, role: SUB_INVESTIGATOR, contacts name: Yang Liu, M.D, role: SUB_INVESTIGATOR, contacts name: Jinhong Shi, M.S, role: SUB_INVESTIGATOR, contacts name: Chunmeng Wang, M.S, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: School of medicine, Tsinghua University & Changping Laboratory, status: RECRUITING, city: Beijing, country: China, contacts name: Xin Lin, Ph.D, role: CONTACT, phone: +86-010-62796319, email: linxin307@mail.tsinghua.edu.cn, contacts name: Xin Lin, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06321276, orgStudyIdInfo id: AEU-FTR-ID-01, briefTitle: Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ahi Evran University Education and Research Hospital, class: OTHER, descriptionModule briefSummary: Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: three groups with a conventional therapy control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patient, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: extracorporeal shockwave therapy, outcomesModule primaryOutcomes measure: Visual analogue scale (VAS), primaryOutcomes measure: Boston Carpal Tunnel Syndrome Questionnaire, secondaryOutcomes measure: Hand grip strength measurement, secondaryOutcomes measure: Electromyoneurography (EMNG), secondaryOutcomes measure: Ultrasonography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kirsehir Ahi Evran University, status: RECRUITING, city: Kırşehir, zip: 40100, country: Turkey, contacts name: ibrahim Doğru, MD, role: CONTACT, phone: 5353127880, phoneExt: +90, email: www.skillcraft@hotmail.com, contacts name: ismail ceylan, PhD, role: CONTACT, phone: 5364634679, phoneExt: +90, email: fztceylan@gmail.com, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False
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protocolSection identificationModule nctId: NCT06321263, orgStudyIdInfo id: 798307, briefTitle: Comparison of the Effects of Peripheral Muscle Training and Inspiratory Muscle Training in Geriatric Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2025-03-21, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: In geriatric individuals, there is a decrease in muscle strength, muscle mass and physical performance with ageing. These physiological changes occurring in geriatric individuals make maintaining the physical activity necessary for a healthy life difficult. Weakness of respiratory muscles in geriatric individuals can increase the prevalence of diseases and disability. It has been shown in the literature that peripheral muscle training and inspiratory muscle training increase exercise capacity similarly. The effectiveness of moderate-intensity peripheral muscle training and inspiratory muscle training in sarcopenic geriatric individuals was compared and found to have similar effects on muscle strength.Our study aims to compare the effects of inspiratory and peripheral muscle training in addition to aerobic exercise on muscle strength, physical performance, respiratory muscle strength, functional capacity, sarcopenia, and quality of life., conditionsModule conditions: Muscle Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Peripheral Muscle Training and step aerobics training, interventions name: Inspiratory Muscle Training and step aerobics training, outcomesModule primaryOutcomes measure: The sociodemographic data form, primaryOutcomes measure: Hand grip strength, primaryOutcomes measure: Maximal inspiratory and expiratory pressures (MIP, MEP), primaryOutcomes measure: 6-Minute Walk Test (6MWT), primaryOutcomes measure: The Short Physical Performance Battery (SPPB), primaryOutcomes measure: Assessment of seniors᾽ quality of life: WHOQOL-OLD questionnaire, secondaryOutcomes measure: SARC-F questionnaire, otherOutcomes measure: Canadian Occupational Performance Measure, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 80 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321250, orgStudyIdInfo id: JY-JM3948-101, briefTitle: A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Jemincare, class: INDUSTRY, collaborators name: Zhejiang Hangyu Pharmaceutical Co., Ltd, descriptionModule briefSummary: This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma., conditionsModule conditions: Renal Cell Carcinoma Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: JMKX003948, outcomesModule primaryOutcomes measure: Dose Escalation: Number of participants with dose limiting toxicities (DLTs), primaryOutcomes measure: Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), primaryOutcomes measure: Dose Expansion: Objective Response Rate (ORR), secondaryOutcomes measure: maximum plasma concentration (Cmax), secondaryOutcomes measure: maximum plasma concentration (Tmax), secondaryOutcomes measure: Duration of Response (DoR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321237, orgStudyIdInfo id: TJ-IRB202402130, briefTitle: Influence of Ear Vagus Nerve Stimulator on Patients With IBS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-26, completionDateStruct date: 2024-06-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Huaping Xie, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) is a very common functional digestive disorder characterized by chronic abdominal pain and altered bowel habits in the absence of biological or structural abnormalities. In the field of IBS, effective drug treatments are very limited, and patients are urgently looking for alternatives, including probiotics, hypnotherapy, osteopathy, dietary changes, and fecal microbiota transplants. In recent years, with the continuous elucidation of vagus nerve mechanisms, IBS patients are increasingly interested in bioelectrical regulation, and these patients are often skeptical of traditional drug treatment and believe that drugs are prone to side effects. For several reasons, vagus nerve stimulation (VNS) may be a promising option for improving IBS symptoms. In this experiment, the portable ear nail stimulator produced by Ruishen Medical can accurately stimulate the ear nail, transdermal stimulation of the ear vagus nerve, and give full play to its therapeutic effect. Therefore, the purpose of this clinical trial is to use ear nail stimulator in patients with IBS to explore whether it has therapeutic effects on patients with IBS. To explore the influence of tVNS therapy on irritable bowel syndrome compared with drug therapy, it is hoped that the use of TVNS therapy can reduce the use of related drugs, or even replace drugs. This study intends to recruit a group of patients with irritable bowel syndrome to use the portable ear nail stimulator, (1) to observe whether the symptoms of irritable bowel syndrome patients are improved; (2) To analyze the changes of intestinal microbes in patients with IBS; (3) Verify whether the level of intestinal inflammation is reduced and discover metabolic markers in the intestine., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Vagus nerve stimulation for 8 weeks, interventions name: Vagus nerve stimulation for the first 4 weeks, interventions name: Vagus nerve stimulation for the last 4 weeks, interventions name: Pseudostimulus, outcomesModule primaryOutcomes measure: Changes in irritable bowel symptoms, primaryOutcomes measure: Changes in the diversity of intestinal flora, primaryOutcomes measure: Changes in the relative abundance of species of intestinal flora, primaryOutcomes measure: Changes in the number of intestinal flora, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-07, uploadDate: 2024-03-11T05:59, filename: Prot_SAP_000.pdf, size: 2489139, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-07, uploadDate: 2024-03-11T06:13, filename: ICF_001.pdf, size: 273802, hasResults: False
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protocolSection identificationModule nctId: NCT06321224, orgStudyIdInfo id: 2024/03/08, briefTitle: Effects of Breathing Exercises on Women With Primary Dysmenorhea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea., conditionsModule conditions: Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Breathing exercises, interventions name: Control, outcomesModule primaryOutcomes measure: Menstrual pain intensity, secondaryOutcomes measure: Menstrual symptoms, secondaryOutcomes measure: Life quality, secondaryOutcomes measure: Stress level, secondaryOutcomes measure: Sleep quality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06321211, orgStudyIdInfo id: RECAS-0244, briefTitle: Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD, acronym: aMed, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-27, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Singapore Institute of Technology, class: OTHER, collaborators name: Singapore Health Services, descriptionModule briefSummary: The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.The main question\[s\] it aims to answer are:1. Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.2. Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD., conditionsModule conditions: Fatty Liver, Nonalcoholic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Sensory Evaluation Test Score NAFLD, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-02, uploadDate: 2024-02-29T00:58, filename: Prot_SAP_000.pdf, size: 135277, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: Consent Form Only, date: 2024-03-02, uploadDate: 2024-03-06T09:36, filename: ICF_001.pdf, size: 732118, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: Participant Information Sheet, date: 2024-03-02, uploadDate: 2024-03-13T21:38, filename: ICF_002.pdf, size: 861264, hasResults: False
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protocolSection identificationModule nctId: NCT06321198, orgStudyIdInfo id: iMSC-2001, briefTitle: A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2027-03-02, completionDateStruct date: 2027-03-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD, conditionsModule conditions: Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: iMSC, outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity(DLT), primaryOutcomes measure: Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE), secondaryOutcomes measure: Objective Response Rate(ORR), secondaryOutcomes measure: Overall Survival(OS), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, state: Anhui, zip: 230036, country: China, contacts name: Zhu Xiaoyu, Ph.D, role: CONTACT, phone: +86 15255456091, email: xiaoyuz@ustc.edu.cn, contacts name: Sun Guangyu, role: CONTACT, phone: +86 13956970687, email: sunguangyu_vip@foxmail.com, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06321185, orgStudyIdInfo id: 2024/177, briefTitle: Laparoscopic Cholecystectomy and Quality of Recovery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2024-08-25, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: This clinical trial aims to compare the Quality of Recovery-15 (QoR-15) scale scores in three groups of patients undergoing laparoscopic cholecystectomy. The first group will be applied subcostal transversus abdominis plane (subcostal TAP) block, the second group will receive local anesthetic infiltration into port sites, and the third group will receive only IV analgesics., conditionsModule conditions: Laparoscopic Cholecystectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients will be allocated randomly into three groups. Two groups will receive subcostal TAP block or port site local anesthetic infiltration, and the third group will not receive any intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The subcostal TAP block and port-site infiltration will be applied after the patient has general anesthesia, so the patient will not know the allocated group. The healthcare providers who work in the ward and are responsible for the analgesic treatments will be blinded to the patient's group. The outcomes assessor who will question the QoR-15 scale at the 24th hour will also be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Subcostal TAP block, interventions name: Port site local anesthetic infiltration, interventions name: No intervention or local anesthetic administration, outcomesModule primaryOutcomes measure: Quality of Recovery-15 (QoR-15) scale, secondaryOutcomes measure: Postoperative rescue analgesic requirement, secondaryOutcomes measure: Consumption of postoperative opioid analgesics, secondaryOutcomes measure: Numerical Rating Scale (NRS) scores, secondaryOutcomes measure: Postoperative nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34093, country: Turkey, contacts name: Muserref B Dincer, role: CONTACT, phone: +905321624712, email: mberildincer@gmail.com, contacts name: Ahmet K Koltka, role: CONTACT, email: koltkak@yahoo.com, contacts name: Muserref B Dincer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06321172, orgStudyIdInfo id: 785, briefTitle: Muscle and Bone Changes After 6 Months of FES Cycling, acronym: FES-Bike, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-09, primaryCompletionDateStruct date: 2024-01-22, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, collaborators name: Politecnico di Milano, collaborators name: Villa Beretta Rehabilitation Center, collaborators name: National Research Council, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question\[s\] it aims to answer are:* Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?* Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?* Does the training performance improve during the training with FES cycling?* Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?* Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: FES Bike, outcomesModule primaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in bone quality, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Pilots' motivation in carrying out a sporting activity, secondaryOutcomes measure: Pilots' motivation in carrying out a sporting activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06321159, orgStudyIdInfo id: Nursing Dep., briefTitle: Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: Hypertension is a prevalent health concern, affecting one in three adults globally, with the potential to lead to fatal complications. However, an alarming proportion of those diagnosed-four out of five individuals-struggle to effectively manage this condition. As such, the effective management of hypertension becomes paramount. A study conducted post-earthquake by a principal investigator and a scholarship recipient revealed that 47.9% of participants received a hypertension diagnosis, and a significant 67.8% ceased active management of the condition. Existing literature suggests a notable decline in the quality of life among individuals unable to manage hypertension effectively. While current research emphasizes the components of nutrition, exercise, and medication adherence in hypertension management, the integration of these components into mobile applications is notably lacking. This project seeks to enhance disease management for users by integrating crucial elements, including blood pressure measurement, into a user-friendly mobile application, thereby providing a distinctive contribution. The proposed application encompasses the recording of vital signs, integration of customized diet and exercise programs tailored for hypertension, and provision of consultancy services for identifying deviations in health status and implementing appropriate interventions. The integration of these components is anticipated to contribute to preventing or minimizing potential complications for the patient. Comprehensive studies incorporating such an approach are rarely encountered in the existing literature, enhancing the originality of this research. The project\&#39;s overarching goal is to enable individuals to manage hypertension even in extraordinary circumstances, such as earthquakes. Consequently, the study will assess how the mobile application influences individuals\&#39; quality of life and disease self-efficacy.Conducted between April 2024 and January 2026, the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces. It involves 614 individuals diagnosed with hypertension, residing in temporary living space in Malatya, Hatay, Kahramanmaraş, and Adıyaman, with 78, 77, and 74 participants in Malatya, Hatay, and Adıyaman, respectively. Data collection tools include the Personal Identification Information Form, Hypertension Self-Efficacy Scale, SF-36 Quality of Life Scale, and International Physical Activity Scale-Short Form, administered through face-to-face interviews. The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians. For the diet program within the application, eight questions will be used to uncover individuals\&#39; dietary preferences. Calculations based on Body Mass Index, basal metabolic rate, and daily energy requirements will inform the diet program, which will encompass five food groups and their caloric values. Notifications about diet adherence will be sent for each meal. In the exercise program, individuals will measure and record blood pressure and medication intake. Those with a blood pressure of 140/90 mmHg or higher will be included based on expert physician recommendations, with notifications for those exceeding 160/100 mmHg to consult a physician. A personalized exercise program will be created based on the OMRİ-RİS scale, supported by animations. Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners. Data analysis will utilize appropriate statistical tests conducted through computer programs. The project is anticipated to contribute significantly to researcher development, enhance quality of life and disease management, increase productivity, and establish new projects., conditionsModule conditions: Hypertension, Essential Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Our study has two groups of 78 participants each. Our study is an experimental study with pretest-posttest control group., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will be determined blindly by being assigned by a site., whoMasked: PARTICIPANT, enrollmentInfo count: 614, type: ESTIMATED, armsInterventionsModule interventions name: mobile application, outcomesModule primaryOutcomes measure: SF- 36 Life Quality Scale, primaryOutcomes measure: Hypertension Self-Efficacy Scale, secondaryOutcomes measure: International Physical Activity Scale-Short Form, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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