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protocolSection identificationModule nctId: NCT06314646, orgStudyIdInfo id: 3747, briefTitle: Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients, acronym: TTSS-REC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis., conditionsModule conditions: Rectal Cancer, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 472, type: ESTIMATED, armsInterventionsModule interventions name: Transanal Transection and Single-Stapled anastomosis (TTSS), interventions name: Double-stapled Total Mesorectal Excision (TME), outcomesModule primaryOutcomes measure: Rate of anastomotic leak, secondaryOutcomes measure: Rate of postoperative complications, secondaryOutcomes measure: Postoperative Recovery Profile (PRP) score, secondaryOutcomes measure: Proportion of patients fit for stoma closure, secondaryOutcomes measure: Healthcare costs, secondaryOutcomes measure: Low Anterior Resection Syndrome (LARS) score, secondaryOutcomes measure: Low Anterior Resection Syndrome (LARS) score, secondaryOutcomes measure: Low Anterior Resection Syndrome (LARS) score, secondaryOutcomes measure: Cancer recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314633, orgStudyIdInfo id: ICO-2023-13, briefTitle: Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children, acronym: PESTIFOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Institut Cancerologie de l'Ouest, class: OTHER, collaborators name: ANSES, descriptionModule briefSummary: PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences., conditionsModule conditions: Healthy Volunteer Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Hair collection and parents questionnaires, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Hair cut, interventions name: Socio-economic questionnaires, outcomesModule primaryOutcomes measure: Describe DNA damage, primaryOutcomes measure: Describe DNA damage, primaryOutcomes measure: Describe socio-economic characteristics., primaryOutcomes measure: Describe socio-economic characteristics., secondaryOutcomes measure: Characterize chemical exposome variations, secondaryOutcomes measure: Characterize chemical exposome variations, secondaryOutcomes measure: Characterize socio-economic indicators, secondaryOutcomes measure: Characterize socio-economic indicators, geographical area, seasons, secondaryOutcomes measure: Characterize socio-economic indicators, geographical area, seasons, secondaryOutcomes measure: Characterize socio-economic indicators, geographical area, seasons, secondaryOutcomes measure: Describe DNA damage, secondaryOutcomes measure: Describe DNA damage, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institut de Cancérologie de l'ouest, status: RECRUITING, city: Saint-Herblain, zip: 44800, country: France, contacts name: Marie ROBERT, MD, role: CONTACT, email: Marie.Robert@ico.unicancer.fr, contacts name: Pierre VIDI, PhD, role: CONTACT, email: Pierre.Vidi@ico.unicancer.fr, contacts name: Marie ROBERT, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: PIERRE VIDI, PhD, role: SUB_INVESTIGATOR, contacts name: Martine BELLANGER, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 47.21765, lon: -1.64841, hasResults: False
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protocolSection identificationModule nctId: NCT06314620, orgStudyIdInfo id: FF-2024-043, briefTitle: Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency, acronym: SENSHIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently, in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion., conditionsModule conditions: Pleural Effusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Heparin saline lock, interventions name: Without heparin saline lock, outcomesModule primaryOutcomes measure: To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock, secondaryOutcomes measure: To determine the onset of intercostal chest catheter occlusions (in hours), secondaryOutcomes measure: To determine the change of hemoglobin (in g/dL) post ICC insertion, secondaryOutcomes measure: To determine the change of platelet (in 10 9/L) post ICC insertion, secondaryOutcomes measure: To determine the adverse effects of heparin saline lock, secondaryOutcomes measure: To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University of Malaysia, status: RECRUITING, city: Kuala Lumpur, state: Wilayah Persekutuan, zip: 53300, country: Malaysia, contacts name: Mohamed Faisal Abdul Hamid, role: CONTACT, phone: 0391455555, phoneExt: 6082, email: faisal.hamid@ppukm.ukm.edu.my, geoPoint lat: 3.1412, lon: 101.68653, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-02-17, uploadDate: 2024-03-13T04:03, filename: Prot_SAP_ICF_000.pdf, size: 521443, hasResults: False
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protocolSection identificationModule nctId: NCT06314607, orgStudyIdInfo id: APHP220498, briefTitle: Genetic and Molecular Characterization of Nervous System Lesions, acronym: ONCONEUROTEK 2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2034-03, completionDateStruct date: 2034-03, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets.Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies).In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile.This project aims to make a decisive contribution to these objectives., conditionsModule conditions: Brain Tumor, conditions: Brain Lesion (General), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Prospective Biological Collection, interventions name: Retrospective Biological Collection, outcomesModule primaryOutcomes measure: Study the clinical markers with the evolution of brain lesions., primaryOutcomes measure: Study the biological markers with the evolution of brain lesions., primaryOutcomes measure: Study the anatomopathological markers with the evolution of brain lesions., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Neurochirurgie - Hôpital de la Pitié Salpêtrière, status: RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Bertand Mathon, Dr, role: CONTACT, phone: 01 84 82 73 63, phoneExt: +33, email: bertrand.mathon@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de Neurologie 2 -Hôpital de la Pitié Salpêtrière, status: RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Marc Sanson, Prof, role: CONTACT, phone: 01 42 16 03 91, phoneExt: +33, email: marc.sanson@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de Radiothérapie - Hôpital de la Pittié Salpêtrière, status: NOT_YET_RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Julian Jacob, Dr, role: CONTACT, phone: 01 84 82 74 90, phoneExt: +33, email: julian.jacob@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06314594, orgStudyIdInfo id: 2024KY920, briefTitle: the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hangzhou Medical College, class: OTHER, descriptionModule briefSummary: Based on the risk factors affecting adolescent scoliosis found in the previous social survey, this project adopts the paradigm based on transfer learning and semi-supervised learning, and uses mathematical methods such as multiple learning methods and Transformer image classification algorithms to develop and verify the early warning model and stepped treatment model of adolescent scoliosis, and conducts cost-effect analysis., conditionsModule conditions: Adolescent Scoliosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Conventional treatment, interventions name: intervention treatment, outcomesModule primaryOutcomes measure: Number of Cobb angles, primaryOutcomes measure: Accuracy of new screening modalities, primaryOutcomes measure: Hamilton Depression Volume, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 311000, country: China, contacts name: Xinyun Dr LI, Doctor, role: CONTACT, phone: 8618069783240, email: lxyjasmine2010@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06314581, orgStudyIdInfo id: 673_BPPV-Teaching, briefTitle: Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department, acronym: BPPV-Teaching, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fondation Hôpital Saint-Joseph, class: OTHER, descriptionModule briefSummary: Acute vertigo accounts for around 4% of emergency room visits. Triggered episodic vestibular syndrome is the most commonly encountered symptomatic context. BPPV (Benign Paroxysmal Positional Vertigo) is the main cause, representing 40-50% of the vertigo cases assessed in emergency departments. It results from the migration of calcium carbonate particles (otoliths), from the sticky membrane of the utricle and saccule of the inner ear, to one of the 3 semicircular canals (SCC), posterior, horizontal or lateral, and anterior. It occurs idiopathically with head movement, through degeneration, or following head trauma. The otolith impulse causes the endolymph to move, temporarily and aberrantly displacing the cup of the affected canal, resulting in the transmission of erroneous information to the vestibular nuclei. This leads to the sudden onset of vertigo and eye deviation, resulting in transient nystagmus. The location of the displaced otoliths determines the variant of BPPV: BPPV of the posterior semicircular canal is the most common (around 65% of BPPVs), followed by BPPV of the horizontal canal, while BPPV of the anterior canal is rare, as it resolves spontaneously and rapidly. Although a benign condition, BPPV leads 9 times out of 10 to a medical consultation, interruption of daily activities, or sick leave. Untreated, it will usually recur, and can impact on patients' quality of life., conditionsModule conditions: Benign Paroxysmal Positional Vertigo, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 185, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: accurate BPPV diagnostics, secondaryOutcomes measure: therapeutic maneuvers performed, secondaryOutcomes measure: Satisfaction of clinicians who received the educational interventio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Groupe Hospitalier Paris Saint-Joseph, status: RECRUITING, city: Paris, zip: 75014, country: France, contacts name: Camille GERLIER, MD, role: CONTACT, phone: +331441228023, email: cgerlier@ghpsj.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06314568, orgStudyIdInfo id: 6350, briefTitle: Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer, acronym: TRIDENT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer, conditionsModule conditions: Vaginal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 278, type: ESTIMATED, armsInterventionsModule interventions name: Radiochemotherapy plus interventional radiotherapy, outcomesModule primaryOutcomes measure: Local Control, secondaryOutcomes measure: Cancer specific overall survival, secondaryOutcomes measure: Toxicities, secondaryOutcomes measure: Overall survivall, secondaryOutcomes measure: Disease free survivall, secondaryOutcomes measure: Metastasis free survival, secondaryOutcomes measure: Changes in quality of life over time, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: VALENTINA LANCELLOTTA, role: CONTACT, phone: +390630155701, email: valentina.lancellotta@policlinicogemelli.it, contacts name: VALENTINA LANCELLOTTA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06314555, orgStudyIdInfo id: CEROG2023, briefTitle: Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-01, primaryCompletionDateStruct date: 2021-01-27, completionDateStruct date: 2021-01-27, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia., conditionsModule conditions: Preeclampsia Possible, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 314, type: ACTUAL, armsInterventionsModule interventions name: Blood sample, interventions name: Vascular-renal sample, outcomesModule primaryOutcomes measure: Doctor's medical care decisions on Hospitalization, secondaryOutcomes measure: Intensive monitoring, secondaryOutcomes measure: Corticosteroid administration for lung maturation, secondaryOutcomes measure: Birth induction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Saint Etienne, city: St Etienne, zip: 42100, country: France, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06314542, orgStudyIdInfo id: REC-001, briefTitle: Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data, statusModule overallStatus: RECRUITING, startDateStruct date: 2013-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50000, type: ESTIMATED, armsInterventionsModule interventions name: relaxing eligibility criteria, outcomesModule primaryOutcomes measure: Scale of eligibility criteria, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, country: China, contacts name: Ning Li, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06314529, orgStudyIdInfo id: 2022-LTF-BHC001, briefTitle: Long-term Follow-up Study of BHC001 for TDT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-14, primaryCompletionDateStruct date: 2036-12-10, completionDateStruct date: 2037-05-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, collaborators name: Xiangya Hospital of Central South University, descriptionModule briefSummary: Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects., conditionsModule conditions: Thalassemia, Beta, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Assessments, outcomesModule primaryOutcomes measure: Incidence of hematologic malignancies, primaryOutcomes measure: Frequency, grade, and relationship of SAEs, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, status: RECRUITING, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Xinhua Zhang, PhD, role: CONTACT, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Xiangya Hospital of Central South University, status: RECRUITING, city: Changsha, state: Hunan, zip: 510510, country: China, contacts name: Bin Fu, PhD, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06314516, orgStudyIdInfo id: CRP17122, briefTitle: Influence of Nutrition and Sarcopenia on Esophageal Cancer Outcomes, acronym: INSPECT, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-12-27, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Benaroya Research Institute, class: OTHER, collaborators name: Imperial College London, descriptionModule briefSummary: Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study., conditionsModule conditions: Esophageal Cancer, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1717, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Longitudinal variation in body composition, secondaryOutcomes measure: Patient and disease-specific factors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Mason Medical Center, city: Seattle, state: Washington, zip: 98101, country: United States, geoPoint lat: 47.60621, lon: -122.33207, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2019-12-10, uploadDate: 2024-03-11T13:52, filename: Prot_000.pdf, size: 1135477, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2019-01-15, uploadDate: 2024-03-11T13:53, filename: ICF_001.pdf, size: 135983, hasResults: False
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protocolSection identificationModule nctId: NCT06314503, orgStudyIdInfo id: 23-075_CORDIAL_FIH, secondaryIdInfos id: NL83843.000.23, type: OTHER, domain: CCMO (Centrale Commissie Mensgebonden Onderzoek), briefTitle: First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients, acronym: CORDIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: European Commission, Horizon 2020, collaborators name: Dutch Kidney Foundation, collaborators name: Health Holland, collaborators name: Nanodialysis Ltd, collaborators name: Università degli studi di Modena e Reggio Emilia (UNIMORE), collaborators name: Servicio Madrileno De Salud (SERMAS), collaborators name: PPI Healthcare Consulting Ltd, descriptionModule briefSummary: The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane)., conditionsModule conditions: Renal Insufficiency, Chronic, conditions: Kidney Failure, Chronic, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study has a first-in-human, prospective, open-label, non-randomized, three-center, single-arm design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: WEAKID, outcomesModule primaryOutcomes measure: Serious adverse device effects (SADEs) and device deficiencies (DDs), primaryOutcomes measure: Critical changes in blood pressure, primaryOutcomes measure: Critical changes in heart rate, primaryOutcomes measure: Critical changes in body temperature, primaryOutcomes measure: Critical changes in oxygen saturation, primaryOutcomes measure: Critical changes in plasma potassium, primaryOutcomes measure: Critical changes in plasma calcium, primaryOutcomes measure: Critical changes in plasma bicarbonate, primaryOutcomes measure: Critical changes in intra-abdominal dialysate volume, primaryOutcomes measure: Critical changes in intra-abdominal pressure, secondaryOutcomes measure: Adverse events (AEs) and device deficiencies (DDs), secondaryOutcomes measure: Number of WEAKID treatments, secondaryOutcomes measure: Duration of WEAKID treatments, secondaryOutcomes measure: Dialysate flow rates during WEAKID treatment, secondaryOutcomes measure: Evolution of blood pressure, secondaryOutcomes measure: Evolution of heart rate, secondaryOutcomes measure: Evolution of body temperature, secondaryOutcomes measure: Evolution of oxygen saturation, secondaryOutcomes measure: Ultrafiltration volume, secondaryOutcomes measure: Peak glucose concentration in the device effluent, secondaryOutcomes measure: Ultrafiltration efficiency, secondaryOutcomes measure: Removal of urea by the WEAKID system, secondaryOutcomes measure: Removal of creatinine by the WEAKID system, secondaryOutcomes measure: Removal of phosphate by the WEAKID system, secondaryOutcomes measure: Removal of potassium by the WEAKID system, secondaryOutcomes measure: Removal of uric acid by the WEAKID system, secondaryOutcomes measure: Removal of beta-2 microglobulin by the WEAKID system, secondaryOutcomes measure: Removal of vitamin B12 by the WEAKID system, secondaryOutcomes measure: Mass transfer area coefficient of urea, secondaryOutcomes measure: Mass transfer area coefficient of creatinine, secondaryOutcomes measure: Mass transfer area coefficient of phosphate, secondaryOutcomes measure: Mass transfer area coefficient of potassium, secondaryOutcomes measure: Mass transfer area coefficient of uric acid, secondaryOutcomes measure: Mass transfer area coefficient of beta-2 microglobulin, secondaryOutcomes measure: Mass transfer area coefficient of vitamin B12, secondaryOutcomes measure: Plasma clearance of urea, secondaryOutcomes measure: Plasma clearance of creatinine, secondaryOutcomes measure: Plasma clearance of phosphate, secondaryOutcomes measure: Plasma clearance of potassium, secondaryOutcomes measure: Plasma clearance of uric acid, secondaryOutcomes measure: Plasma clearance of beta-2 microglobulin, secondaryOutcomes measure: Plasma clearance of vitamin B12, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenine, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin hippuric acid, secondaryOutcomes measure: The release of base, secondaryOutcomes measure: Evolution of plasma levels of urea, secondaryOutcomes measure: Evolution of plasma levels of creatinine, secondaryOutcomes measure: Evolution of plasma levels of uric acid, secondaryOutcomes measure: Evolution of plasma levels of beta-2 microglobulin, secondaryOutcomes measure: Evolution of plasma levels of phosphate, secondaryOutcomes measure: Evolution of plasma levels of potassium, secondaryOutcomes measure: Evolution of plasma levels of bicarbonate, secondaryOutcomes measure: Evolution of plasma levels of lactate, secondaryOutcomes measure: Evolution of plasma levels of sodium, secondaryOutcomes measure: Evolution of plasma levels of chloride, secondaryOutcomes measure: Evolution of plasma levels of calcium, secondaryOutcomes measure: Evolution of plasma levels of magnesium, secondaryOutcomes measure: Evolution of plasma levels of glucose, secondaryOutcomes measure: Evolution of plasma levels of lactate dehydrogenase, secondaryOutcomes measure: Evolution of plasma levels of vitamin B12, secondaryOutcomes measure: Evolution of plasma levels of albumin, secondaryOutcomes measure: Evolution of plasma leucocyte count, secondaryOutcomes measure: Evolution of plasma thrombocyte count, secondaryOutcomes measure: Evolution of plasma levels of C-reactive protein (CRP), secondaryOutcomes measure: Evolution of plasma levels of bilirubin, secondaryOutcomes measure: Evolution of plasma levels of aspartate transaminase (ASAT), secondaryOutcomes measure: Evolution of plasma levels of alanine aminotransferase (ALAT), secondaryOutcomes measure: Evolution of sodium levels in dialysate effluent, secondaryOutcomes measure: Evolution of chloride levels in dialysate effluent, secondaryOutcomes measure: Evolution of calcium levels in dialysate effluent, secondaryOutcomes measure: Evolution of magnesium levels in dialysate effluent, secondaryOutcomes measure: Evolution of bicarbonate levels in dialysate effluent, secondaryOutcomes measure: Evolution of lactate levels in dialysate effluent, secondaryOutcomes measure: Evolution of pH of dialysate effluent, secondaryOutcomes measure: Total number of device deficiencies and adverse device effects, secondaryOutcomes measure: Evolution of delta intraperitoneal pressure during WEAKID treatment, secondaryOutcomes measure: Patient tolerance (abdominal discomfort), secondaryOutcomes measure: Evolution of uremic symptoms, secondaryOutcomes measure: Usability, otherOutcomes measure: Baseline characteristics, otherOutcomes measure: Peritoneal equilibrium tests, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università degli studi di Modena e Reggio Emilia (UNIMORE), status: NOT_YET_RECRUITING, city: Modena, zip: 41121, country: Italy, contacts name: Gabriele Donati, Prof., MD, PhD, role: CONTACT, phone: +39-0594225331, email: gabriele.donati@unimore.it, contacts name: Giulia Ligabue, MSc, PhD, role: CONTACT, phone: +39-0594224175, email: giulia.ligabue@unimore.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: University Medical Center Utrecht (UMCU), status: RECRUITING, city: Utrecht, zip: 3584 CX, country: Netherlands, contacts name: Karin GF Gerritsen, MD, PhD, role: CONTACT, phone: +31-887557375, email: k.g.f.gerritsen@umcutrecht.nl, contacts name: Dian P Bolhuis, MSc, role: CONTACT, phone: +31-887557375, email: d.p.bolhuis-3@umcutrecht.nl, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Hospital Universario La Paz (SERMAS), status: NOT_YET_RECRUITING, city: Madrid, zip: 28029, country: Spain, contacts name: Gloria del Peso Gilsanz, MD, PhD, role: CONTACT, phone: +34-913585339, email: gloria.delpeso@salud.madrid.org, contacts name: Maria A Bajo Rubio, MD, PhD, role: CONTACT, phone: +34-913585339, email: mauxiliadora.bajo@salud.madrid.org, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06314490, orgStudyIdInfo id: ASOSCN2A, briefTitle: Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2026-02-16, completionDateStruct date: 2026-02-16, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, collaborators name: California Institute for Regenerative Medicine (CIRM), collaborators name: n-Lorem Foundation, descriptionModule briefSummary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with SCN2A associated developmental epileptic encephalopathy, conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: nL-SCN2A-002, outcomesModule primaryOutcomes measure: Seizure frequency, primaryOutcomes measure: Motor function as measured by Dyskinetic Cerebral Palsy Functional Impact Scale, primaryOutcomes measure: Motor function as measured by the motor skills domain of Vineland Adaptive Behavior Scales, primaryOutcomes measure: Motor function as measured by the motor skills domain of Bayley Scales of Infant and Toddler Development, primaryOutcomes measure: Gastrointestinal assessment as measured by the Bristol Stool Chart, secondaryOutcomes measure: Neurodevelopmental Function as measured by Aberrant Behavior Checklist, secondaryOutcomes measure: Neurodevelopmental Function as measured by Observer-Reported Communication Ability Measure, secondaryOutcomes measure: Neurodevelopmental Function as measured by the Vineland Adaptive Behavior Scales, secondaryOutcomes measure: Neurodevelopmental Function as measured by the Bayley Scales of Infant and Toddler Development, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rady Children's Hospital, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
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protocolSection identificationModule nctId: NCT06314477, orgStudyIdInfo id: HCB/2022/1204, briefTitle: Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA), conditionsModule conditions: Obstructive Sleep Apnea, conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: CPAP treatment, interventions name: Hygienic and dietary advice, outcomesModule primaryOutcomes measure: Asthma control questionnaire, primaryOutcomes measure: Asthma control test, secondaryOutcomes measure: Lung function- forced expiratory volume in the first second (FEV1) in spirometry, secondaryOutcomes measure: Lung function-forced vital capacity (FVC) in spriometry, secondaryOutcomes measure: Prevalence of OSA in severe uncontrolled asthma, secondaryOutcomes measure: Inflammatory profile, secondaryOutcomes measure: Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314464, orgStudyIdInfo id: C2023.055, briefTitle: Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI, acronym: Praxis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: BlueHalo, class: INDUSTRY, collaborators name: Brooke Army Medical Center, collaborators name: University of Pittsburgh, descriptionModule briefSummary: The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI).The main questions this comparative pilot study aims to answer are:* Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI?* Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery?Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including:* gaze stabilization* dual-task balance training* spatial navigation* agility trainingData from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group.Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation., conditionsModule conditions: Brain Concussion, conditions: Vestibular Disorder, conditions: Cognition Disorder, conditions: Mild Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Praxis, interventions name: Supervised cardiovascular exercise, outcomesModule primaryOutcomes measure: Perceived usability of the Praxis system measured by the System Usability Scale (SUS), secondaryOutcomes measure: Change in Dizziness Handicap Inventory (DHI) score, secondaryOutcomes measure: Change in Pittsburgh Sleep Quality Index (PSQI) score, secondaryOutcomes measure: Change in Generalized Anxiety Disorder scale (GAD-7) score, secondaryOutcomes measure: Change in Post-Traumatic Stress Disorder Check List - Military Version (PCL-M) score, secondaryOutcomes measure: Change in Vestibular Activities Avoidance Instrument-9 (VAAI-9) score, secondaryOutcomes measure: Change in Headache Impact Test-6 (HIT-6) score, secondaryOutcomes measure: Change in Santa Barbara Sense of Direction Scale (SBSOD) score, secondaryOutcomes measure: Change in time required to perform 300-yard shuttle run (single- and dual-task), secondaryOutcomes measure: Change in perceived fogginess, secondaryOutcomes measure: Change in time required to perform 5-10-5 shuttle run, secondaryOutcomes measure: Change in score for 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI), secondaryOutcomes measure: Change in time required to perform POrtable WARrior Test Of Tactical AgiLity (POWAR-TOTAL) (single- and dual-task), secondaryOutcomes measure: Change in Vestibular/Ocular Motor Screening (VOMS) total symptom score, secondaryOutcomes measure: Compliance with 20-minute daily dose of gaze stability exercises, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Brooke Army Medical Center, city: Fort Sam Houston, state: Texas, zip: 78234, country: United States, geoPoint lat: 29.45746, lon: -98.4472, hasResults: False
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protocolSection identificationModule nctId: NCT06314451, orgStudyIdInfo id: HAS.22.11.035, briefTitle: Cross-condition Validation of the Steroid PRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of the West of England, class: OTHER, collaborators name: Johns Hopkins University, collaborators name: University of Pittsburgh, descriptionModule briefSummary: Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions, conditionsModule conditions: Inflammatory Disease, conditions: Immune System Disorder, conditions: Gastrointestinal Diseases, conditions: Dermatologic Disease, conditions: Respiratory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Interview, outcomesModule primaryOutcomes measure: Steroid PRO, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of the West of England, status: RECRUITING, city: Bristol, zip: BS2 8HW, country: United Kingdom, contacts name: Joanna C Robson, role: CONTACT, phone: 01173427417, email: Jo.Robson@uwe.ac.uk, geoPoint lat: 51.45523, lon: -2.59665, hasResults: False
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protocolSection identificationModule nctId: NCT06314438, orgStudyIdInfo id: STUDY00017189, secondaryIdInfos id: UL1TR002319, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR002319, briefTitle: Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:* Is the Family Care Project workbook useful for families?* Is the Family Care Project workbook easy to use?* Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?Participants will complete surveys that elicit their feedback on their use of the workbook., conditionsModule conditions: Autism, conditions: Development Delay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ACTUAL, armsInterventionsModule interventions name: Family Care Project, outcomesModule primaryOutcomes measure: Staff Training Feedback Survey of Implementation Properties (self-report), primaryOutcomes measure: Staff Competence in Assisting Families with Children at-autism Likelihood Survey (self-report), primaryOutcomes measure: The Maternal Self-Efficacy Scale Questionnaire, primaryOutcomes measure: Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey, primaryOutcomes measure: Current Services Utilized by Families to Support Children at autism-likelihood Survey, primaryOutcomes measure: Family Care Project Feedback Survey of Implementation Properties, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mother Africa, city: Kent, state: Washington, zip: 98032, country: United States, geoPoint lat: 47.38093, lon: -122.23484, hasResults: False
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protocolSection identificationModule nctId: NCT06314425, orgStudyIdInfo id: IRB_20240714, briefTitle: Zirconia Implants: Practice-based Evidence, acronym: SDS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Swiss Dental Solutions, class: INDUSTRY, collaborators name: VISTA Institute for Therapeutic Innovations, descriptionModule briefSummary: This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments., conditionsModule conditions: Dental Implants, conditions: Ceramic Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Immediate dental implants placements on fresh sockets after tooth extraction, outcomesModule primaryOutcomes measure: Cumulative Survival Rate (CSR), secondaryOutcomes measure: Marginal Bone Loss (MBL), otherOutcomes measure: Pink Esthetic Score (PES), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brighton Periodontal & Implant Dental Group, status: RECRUITING, city: Woodland Hills, state: California, zip: 91367, country: United States, contacts name: Homayoun Zadeh, PhD, DDS, role: CONTACT, phone: 818-703-7733, email: homazadeh@gmail.com, contacts name: Etyene Schnurr, PhD, DDM, role: CONTACT, phone: 0797213110, email: etyene.schnurr@swiss-biohealth.com, geoPoint lat: 34.16834, lon: -118.60592, hasResults: False
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protocolSection identificationModule nctId: NCT06314412, orgStudyIdInfo id: 24C211, briefTitle: Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence, acronym: SANS-REHAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Stoller's Afferent Nerve Stimulation (SANS), outcomesModule primaryOutcomes measure: Measure of variation of incontinence., primaryOutcomes measure: Measure of variation of urinary urgency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Laura Perucca, MD, role: CONTACT, phone: +3902619116247, email: l.perucca@auxologico.it, contacts name: Nicole Bompani, MD, role: CONTACT, phone: +3902619116151, email: n.bompani@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06314399, orgStudyIdInfo id: 2023-18, secondaryIdInfos id: DVO005 2555-CV1837, type: OTHER, domain: Universidad del Rosario Research Ethics Committee, briefTitle: Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy, acronym: BACILO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Mayor Méderi, class: OTHER, collaborators name: Universidad del Rosario, descriptionModule briefSummary: The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations., conditionsModule conditions: Biliary Infection, conditions: Antibiotic Resistant Strain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 703, type: ESTIMATED, armsInterventionsModule interventions name: Bile culture and phenotypic antibiogram resistance test, outcomesModule primaryOutcomes measure: Bile culture positivity, primaryOutcomes measure: Phenotypical antibiogram resistance, secondaryOutcomes measure: Microbial characteristics, secondaryOutcomes measure: Bile culture and antibiotic resistance relationship, secondaryOutcomes measure: Demographical and clinical characteristics, secondaryOutcomes measure: Surgical characteristics and outcomes, secondaryOutcomes measure: Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06314386, orgStudyIdInfo id: 23.139.01, secondaryIdInfos id: R01NR020866, type: NIH, link: https://reporter.nih.gov/quickSearch/R01NR020866, briefTitle: Systems Analysis and Improvement Approach to Prevent TB, acronym: SAIA-TB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-06, primaryCompletionDateStruct date: 2028-02-29, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Boston College, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: Boston University, collaborators name: University of Washington, collaborators name: Medical Research Council, South Africa, collaborators name: National Institute of Nursing Research (NINR), descriptionModule briefSummary: This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to:* Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts* Determine the drivers of SAIA-TB implementation success or failure across clinicsThe investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period., conditionsModule conditions: Tuberculosis, conditions: TPT, conditions: TB - Tuberculosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Stepped Wedge Crossover Cluster, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 19560, type: ESTIMATED, armsInterventionsModule interventions name: Systems Analysis and Improvement Approach for TB (SAIA-TB), outcomesModule primaryOutcomes measure: TB Screening, primaryOutcomes measure: Linkage to care for TB disease treatment, primaryOutcomes measure: TB Evaluation, primaryOutcomes measure: TB Diagnosis, secondaryOutcomes measure: Successful TB Prevention Treatment (TPT) Outcome, secondaryOutcomes measure: Successful TB Outcome, eligibilityModule sex: ALL, minimumAge: 0 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Addo Clinic, city: Addo, country: South Africa, geoPoint lat: -33.54833, lon: 25.6899, locations facility: Lukhanyiso Clinic, city: Addo, country: South Africa, geoPoint lat: -33.54833, lon: 25.6899, locations facility: Kwa-Nonqubela Clinic, city: Alexandria, country: South Africa, locations facility: Marselle Clinic, city: Boesmansriviermond, country: South Africa, geoPoint lat: -33.6863, lon: 26.65604, locations facility: Masakhane Clinic, city: Hankey, country: South Africa, geoPoint lat: -33.83308, lon: 24.88359, locations facility: Humansdorp Clinic, city: Humansdorp, country: South Africa, geoPoint lat: -34.02903, lon: 24.76912, locations facility: Pellsrus Clinic, city: Jeffrey's Bay, country: South Africa, geoPoint lat: -34.05031, lon: 24.90762, locations facility: Joubertina CHC, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Louterwater Clinic, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Twee Riviere Clinic, city: Joubertina, country: South Africa, geoPoint lat: -33.82547, lon: 23.85618, locations facility: Kareedouw Clinic, city: Kareedouw, country: South Africa, geoPoint lat: -33.9528, lon: 24.29053, locations facility: Kenton On Sea Clinic, city: Kenton on Sea, country: South Africa, geoPoint lat: -33.68421, lon: 26.67036, locations facility: Kirkwood Clinic, city: Kirkwood, country: South Africa, geoPoint lat: -33.39829, lon: 25.44279, locations facility: Moses Mabida Clinic, city: Kirkwood, country: South Africa, geoPoint lat: -33.39829, lon: 25.44279, locations facility: Imizamo Yetho Clinic, city: Patensie, country: South Africa, geoPoint lat: -33.76007, lon: 24.81383, locations facility: Nkwenkwezi Clinic, city: Port Alfred, country: South Africa, geoPoint lat: -33.58601, lon: 26.88329, hasResults: False
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protocolSection identificationModule nctId: NCT06314373, orgStudyIdInfo id: HSK39775-101/201, briefTitle: A Study for HSK39775 in Participants With Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2028-02-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xizang Haisco Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 243, type: ESTIMATED, armsInterventionsModule interventions name: HSK39775 Monotherapy, outcomesModule primaryOutcomes measure: AE/SAE, primaryOutcomes measure: DLT, primaryOutcomes measure: MTD/MAD, secondaryOutcomes measure: Maximum Plasma Concentration [Cmax], secondaryOutcomes measure: Area Under Curve[AUC], secondaryOutcomes measure: Time to maximum observed concentration [Tmax], secondaryOutcomes measure: Elimination half-life [t1/2], secondaryOutcomes measure: Overall Response Rate (ORR) per RECIST V1.1, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Time To Response, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Best percentage change in target lesion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06314360, orgStudyIdInfo id: BAP_PFS, briefTitle: Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Patellofemoral Pain Patients and Healthy Subjects, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force.A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings.There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data.The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS., conditionsModule conditions: Patellofemoral Pain Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: No intervention., outcomesModule primaryOutcomes measure: Plantar Pressure, primaryOutcomes measure: Postural Stability, primaryOutcomes measure: Foot posture, primaryOutcomes measure: Functionality, secondaryOutcomes measure: Pain Assessment, secondaryOutcomes measure: Limb dominance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Ankara/Sıhhıye, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06314347, orgStudyIdInfo id: gibtuipekkirmaci, briefTitle: Reference Value of Figure of 8 Walk Test, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Gaziantep Islam Science and Technology University, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the reference values of the Figure 8 Walking Test in healthy adults., conditionsModule conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Figure of 8 walk test, outcomesModule primaryOutcomes measure: Figure of 8 walk test, secondaryOutcomes measure: Age, secondaryOutcomes measure: gender, secondaryOutcomes measure: height, secondaryOutcomes measure: weight, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314334, orgStudyIdInfo id: SHCA-NKT-202301, briefTitle: Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-04, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival., conditionsModule conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were stratified according to the NRI prognostic index obtained from the baseline assessment (NRI \<2, NRI ≥2) and randomly assigned to three groups receiving different experimental treatments.Group A (synchronous treatment group) received 4 cycles of Sintilimab combined with pegaspargase therapy. Concurrently, they received radiotherapy treatment. Group B (sequential treatment group) received 4 cycles of the PGEMOX regimen chemotherapy with sequential radiotherapy.Group C (sandwiched radiotherapy group) received 2 cycles of the GELAD regimen chemotherapy initially, followed by radiotherapy and another two cycles GELAD chemotherapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab+Pegaspargase, interventions name: P-GemOx, interventions name: GELAD, interventions name: IMRT, outcomesModule primaryOutcomes measure: PFS24, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: EFS, secondaryOutcomes measure: TRAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Rong Tao, MD, role: CONTACT, phone: 8621-64175590, email: rtao@shca.org.cn, contacts name: Chuanxu Liu, MD, role: CONTACT, phone: 8621-64175590, email: liuchuanxu@shca.org.cn, contacts name: Rong Tao, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06314321, orgStudyIdInfo id: 2021-K151-01, briefTitle: The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Affiliated Hospital of Nantong University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients. 60 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities., conditionsModule conditions: Hemodialysis Complication, conditions: Shoulder Joint Disorder, conditions: CKD-MBD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Baduanjin exercise, outcomesModule primaryOutcomes measure: Shoulder joint function score, primaryOutcomes measure: Shoulder joint internal rotation function, primaryOutcomes measure: Muscle strength measurement, primaryOutcomes measure: Area of biceps brachii muscle, secondaryOutcomes measure: Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension（EQ-5D-5L）, secondaryOutcomes measure: Changes in the Hospital Anxiety and Depression Scale （HADS）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Nantong University, city: Nantong, state: Jiangsu, zip: 226000, country: China, geoPoint lat: 32.03028, lon: 120.87472, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-11-30, uploadDate: 2024-03-12T09:17, filename: Prot_SAP_000.pdf, size: 148387, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-11-30, uploadDate: 2024-03-12T09:19, filename: ICF_001.pdf, size: 165056, hasResults: False
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protocolSection identificationModule nctId: NCT06314308, orgStudyIdInfo id: AAAU8161, secondaryIdInfos id: 5P30AG064198-05, type: NIH, link: https://reporter.nih.gov/quickSearch/5P30AG064198-05, briefTitle: Community Health Worker Assisted Task Specific and Cognitive Therapy at Home With Exposure After Stroke, acronym: CATCHES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: CATCHES is a novel intervention for preliminary testing, integrating Task Specific Therapy at home guided by Community Health Workers (CHW) under supervision of a licensed Physical Therapist (PT) guided by telehealth based Cognitive Behavioral Therapy (CBT) to reduce task specific fears through repetitive exposure and adaptive behavioral activation strategies and facilitate engagement in physical activity.1. To integrate and establish feasibility of CATCHES intervention. Hypothesis: A multidisciplinary team providing home based TST with exposure therapy tailored to an underserved urban setting will inform a patient-centered behavioral intervention to reduce fear of falling (FOF) among post-acute stroke patients returning home. Feasibility outcomes will include recruitment, retention, and fidelity of implementation.2. Test effects of the intervention on hypothesized treatment mechanism of fear of falling. Hypothesis: Therapy will reduce task specific fear of falling Primary outcome will be change in Activities-specific Balance Confidence Scale.3. Explore physical activity measures subjectively and objectively. Exploratory outcomes include pre and post Timed Up and Go test, patient reported outcome surveys and activity as measured by wearable devices., conditionsModule conditions: Stroke, Acute Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CATCHES, outcomesModule primaryOutcomes measure: Percentage of intervention completers to demonstrate feasibility, secondaryOutcomes measure: Change in Activities-specific Balance Confidence Scale Score, otherOutcomes measure: Timed Up and Go Test Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Neurological Institute of New York, Columbia University, city: New York, state: New York, zip: 10032, country: United States, contacts name: Carmen Castillo, role: CONTACT, phone: 212-305-7755, email: cec34@cumc.columbia.edu, contacts name: Imama Naqvi, MD, role: CONTACT, email: ian2108@cumc.columbia.edu, contacts name: Imama A. Naqvi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lori Quinn, PhD, role: SUB_INVESTIGATOR, contacts name: Olajide A Williams, MD, MS, role: SUB_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06314295, orgStudyIdInfo id: BeijingH-WF, briefTitle: Automated Echocardiographic Detection of Coronary Artery Disease Using Artificial Intelligence Methods, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-03-11, completionDateStruct date: 2026-04-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, descriptionModule briefSummary: The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Different coronary angiography results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06314282, orgStudyIdInfo id: D3461R00072, briefTitle: INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use, acronym: INTERSTELLAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study., conditionsModule conditions: Systemic Lupus Erythematosus (SLE), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: PGA, primaryOutcomes measure: SLEDAI-2K, primaryOutcomes measure: CLASI, primaryOutcomes measure: FACIT-Fatigue, primaryOutcomes measure: LupusQoL, primaryOutcomes measure: EQ-5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314269, orgStudyIdInfo id: 246810121416, briefTitle: Incidence of Perioperative Cerebrovascular Stroke in Assuit University Hospitals, Hospital Based Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Stroke is the most common cause of disability in elderly people (over 65years of age) and the third most common cause of death in the world . The World Health Organization estimates that one in six people globally will suffer from stroke in their lifetime.Perioperative stroke is the most unwanted complication for patients, as well as for surgeons and anesthesiologists . The reported risk of perioperative stroke varies with the type of surgery. Its incidence is generally not high (approximate 0.1-1.9%) in non-cardiac, non-neurologic, and non-major surgery However, it may occur in up to 10% of patients undergoing high-risk cardiac or brain surgery . Patients with perioperative stroke are less likely to have a good functional outcome and have an eight-fold higher mortality compared with those without perioperative stroke, conditionsModule conditions: Perioperative Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: 1- To determine incidence and prevalence of perioperative cerebrvosacular stroke in General surgery, cardiothorasic surgery and vascular surgery departments, Assuit university hospitalis, Egypt., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06314256, orgStudyIdInfo id: 2023/218, briefTitle: Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-10, completionDateStruct date: 2024-11-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Altinbas University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin (i-PRF) and hyaluronic acid (HA) in reconstruction of interdental papilla loss. The main questions it aims to answer are:* How compareable are above mentioned two interventions (i-PRF\&HA) in reconstruction of interdental papilla loss?* Which treatment option is better accepted by patients? Which treatment option would patients be more satisfied with? Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design. Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes, for how long do they last., conditionsModule conditions: Interdental Papilla Loss, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A type of study used frequently in oral research: the mouth is divided into two or more subunits. Active and control (comparison) treatments are applied to the subunits (e.g., to the left and right sides)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participant will be masked which side of her/his mouth treated with either i-PRF or HA., whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Injection, interventions name: Injection, outcomesModule primaryOutcomes measure: Reduction in Black Triangle Area, primaryOutcomes measure: Reduction in Black Triangle Height, primaryOutcomes measure: Reduction in Black Triangle Width, secondaryOutcomes measure: Volume Gain of Interdental Papilla, secondaryOutcomes measure: Patient Satisfaction Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Altinbas University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Baris Impram, role: CONTACT, phone: +905343148500, email: barisimpram@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06314243, orgStudyIdInfo id: RHDIRB2020110301 REC #241, briefTitle: The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients.The main question it aims to answer is:• Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients?Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile., conditionsModule conditions: Hemodialysis Patients, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Design: Prospective, randomized, Open label - controlled clinical trial.Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups:* Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. "* Group 2 (Control group): consists of 28 patients who will not receive the intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. ", outcomesModule primaryOutcomes measure: To evaluate the effect of PSO supplementation on oxidative stress in hemodialysis patients., primaryOutcomes measure: To evaluate the effect of PSO supplementation on the systemic inflammation in hemodialysis patients., secondaryOutcomes measure: To evaluate the effect of PSO supplementation on the lipid profile in hemodialysis patients., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06314230, orgStudyIdInfo id: AUSCAD, briefTitle: Australian Genomics Of Chronic Allograft Dysfunction Study, acronym: AUSCAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2012-04-26, primaryCompletionDateStruct date: 2040-01-01, completionDateStruct date: 2040-01-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Western Sydney Local Health District, class: OTHER, descriptionModule briefSummary: The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles., conditionsModule conditions: Kidney Transplant Rejection, conditions: Kidney Transplant; Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Graft failure, primaryOutcomes measure: Allograft rejection, primaryOutcomes measure: Gene profile, secondaryOutcomes measure: Death, secondaryOutcomes measure: Major infectious adverse outcomes, secondaryOutcomes measure: Major malignancy related adverse outcomes, secondaryOutcomes measure: Major cardiovascular adverse outcomes, secondaryOutcomes measure: Chronic allograft dysfunction, secondaryOutcomes measure: BK virus associated nephropathy, secondaryOutcomes measure: Albuminuria, secondaryOutcomes measure: Surrogate end-points, secondaryOutcomes measure: Delayed graft function (DGF), secondaryOutcomes measure: Death censored graft loss (DCGL), secondaryOutcomes measure: Treatment resistant rejection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, status: RECRUITING, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Jennifer SY Li, MBBS, FRACP, role: CONTACT, email: jennifer.li@health.nsw.gov.au, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Westmead Institute for Medical Research, status: RECRUITING, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Philip J O'Connell, MBBS, FRACP, role: CONTACT, email: philip.oconnell@sydney.edu.au, geoPoint lat: -33.80383, lon: 150.98768, hasResults: False
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protocolSection identificationModule nctId: NCT06314217, orgStudyIdInfo id: CL-00002, secondaryIdInfos id: 202330714, type: REGISTRY, domain: MOH ISRAEL, briefTitle: Everads Injector in Suprachoroidal Administration of TA Suspension, for Treatment of Patients With DME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Everads Therapy, class: INDUSTRY, descriptionModule briefSummary: This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space.The study population is patients diagnosed with diabetic macular edema (DME) that were previously treated. 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria.The study will involve 6 visits during a period of 6 weeks, conditionsModule conditions: Diabetic Macular Edema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Everads Injector: For targeted suprachoroidal delivery of therapy, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Everads Injector, outcomesModule primaryOutcomes measure: Frequency of treatment-emergent adverse events, primaryOutcomes measure: Frequency of adverse device effects, secondaryOutcomes measure: Confirmation of TA delivery into the suprachoroidal space, secondaryOutcomes measure: Change from baseline in central macular thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rambam MC, status: RECRUITING, city: Haifa, country: Israel, contacts name: Meital Abecassis, role: CONTACT, phone: 047772668, contacts name: Yoreh Barak, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.81841, lon: 34.9885, hasResults: False
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protocolSection identificationModule nctId: NCT06314204, orgStudyIdInfo id: 2015-A01222-47, briefTitle: Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms, acronym: canhope, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-09-20, primaryCompletionDateStruct date: 2025-09-06, completionDateStruct date: 2026-09-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de Ville-Evrard, France, class: OTHER, descriptionModule briefSummary: Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour., conditionsModule conditions: Psychotic; Disorder, Cannabis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: PANSS: Positive and Negative Syndrom Scale, primaryOutcomes measure: PANSS: Positive and Negative Syndrom Scale, primaryOutcomes measure: PANSS: Positive and Negative Syndrom Scale, primaryOutcomes measure: PANSS: Positive and Negative Syndrom Scale, primaryOutcomes measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form, primaryOutcomes measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form), primaryOutcomes measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form), primaryOutcomes measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form), primaryOutcomes measure: CGI: Clinical Global Impression, primaryOutcomes measure: CGI: Clinical Global Impression, primaryOutcomes measure: CGI: Clinical Global Impression, primaryOutcomes measure: CGI: Clinical Global Impression, primaryOutcomes measure: MADRS: Montgomery Åsberg Depression Rating Scale, primaryOutcomes measure: MADRS: Montgomery Åsberg Depression Rating Scale, primaryOutcomes measure: MADRS: Montgomery Åsberg Depression Rating Scale, primaryOutcomes measure: MADRS: Montgomery Åsberg Depression Rating Scale, primaryOutcomes measure: PDS: Psychotic Depression Scale, primaryOutcomes measure: PDS: Psychotic Depression Scale, primaryOutcomes measure: PDS: Psychotic Depression Scale, primaryOutcomes measure: PDS: Psychotic Depression Scale, primaryOutcomes measure: YMRS: Young Mania Rating Scale, primaryOutcomes measure: YMRS: Young Mania Rating Scale, primaryOutcomes measure: YMRS: Young Mania Rating Scale, primaryOutcomes measure: YMRS: Young Mania Rating Scale, primaryOutcomes measure: CDS: Self-Consciousness Revised Scale, primaryOutcomes measure: CTQ: Childhood Trauma Questionnaire, primaryOutcomes measure: BFI: Big Five Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: unité de recherche clinique de l'E.P.S de Ville Evrard, status: RECRUITING, city: Neuilly Sur Marne, zip: 93332, country: France, contacts name: Rusheenthira THAVASEELAN, Msc, role: CONTACT, phone: 0143093232, email: r.thavaseelan@epsve.fr, geoPoint lat: 48.85373, lon: 2.54903, hasResults: False
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protocolSection identificationModule nctId: NCT06314191, orgStudyIdInfo id: 23-AOIP-02, briefTitle: Adipose Tissue and Symptomatic Gonarthrosis, acronym: TAGS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-09-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: 1. Prevalence of osteoarthritis in France Osteoarthritis (OA) is a very common disease, affecting almost 15% of the population. It is responsible for a significant socio-economic cost in connection with the chronic and disabling pain it causes . Gonarthrosis is the most frequently encountered arthritic localization . In a large 2010 meta-analysis, the main risk factors for developing knee OA were shown to be obesity, previous knee trauma, hand OA, female gender and advanced age. Smoking appeared to have a moderate protective effect . The risk of developing gonarthrosis in obese patients is 2.6 times higher than in the general population. Hypercholesterolemia itself is a risk factor for osteoarthritis, as are increased plasma levels of specific fatty acids and lipoproteins Inflammatory mechanism in osteoarthritis. Studies have shown that plasma levels of C-reactive protein, can be used to estimate individual susceptibility to developing osteoarthritis over a lifetime . In osteoarthritis patients, plasma concentrations of TNF-α, IL-6 and IL-1 are abnormally high, which appears to contribute to cartilage loss in these subjects .3. Inflammatory mechanism in obesity. Obesity induces systemic and local joint mechanical stresses that increase the risk of developing gonarthrosis in obese or overweight individuals . Beyond the simple mechanical aspect, a body of evidence supports the assertion that obesity is responsible for a systemic inflammatory state, deleterious to joints. 1) Obesity is associated with radiographic and symptomatic osteoarthritis in non-weight-bearing joints, such as the hand In overweight and obese adults, plasma levels of tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6) are significantly increased .3)Weight loss in obese subjects with osteoarthritis alleviates joint symptoms through reduced mechanical stress but also through reduced production and response of inflammatory products .4. Common inflammatory mechanisms between adipose tissue and obesity. The relationship between adipose tissue and inflammation is complex given the different types of adipose tissue and the action of cells derived from it. Adipose tissue is an active endocrine organ composed of mature and developing adipocytes, as well as fibroblasts, endothelial cells and a wide range of immune cells, namely adipose tissue macrophages, neutrophils, eosinophils, mast cells, T cells and B cells. Adipose tissue is recognized as an endocrine organ that secretes a large number of inflammatory mediators, including cytokines (IL-1, IL-6, IL-8, TNF-α) and adipokines (leptin, adiponectin, resistin, visfatin). Communication between adipocytes and immune cells maintains tissue homeostasis. Obesity, however, can upset this balance.Lipid metabolism and joint disorders have been shown to be linked . A high-fat diet may contribute to the development of osteoarthritis .White and brown adipose tissue appear to play a complementary role in the development of osteoarthritis. Increased white adipose tissue in obesity is thought to create a systemic environment of increased inflammation through the release of pro-inflammatory cytokines and adipokines such as leptin and visfatin, all of which have been associated with osteoarthritis . Locally, white adipocytes in infra patellar adipose tissue are architecturally different in patients without gonarthrosis compared with those with knee osteoarthritis. This difference suggests that adipocyte gene expression is directly influenced by inflammation . In obese individuals, there is elevated IL-6 production in brown adipose tissue . Furthermore, it would appear that brown adipose tissue, unlike white, down-regulates the inflammatory profile of macrophages ., conditionsModule conditions: Gonarthrosis, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: blood sampling, interventions name: knee radiography, outcomesModule primaryOutcomes measure: lipolytic activity, primaryOutcomes measure: lipolysis measurement, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nice University Hospital, city: Nice, zip: 06000, country: France, contacts name: Christian Roux, role: CONTACT, phone: 0492039220, email: roux.c2@chu-nice.fr, contacts name: Isa Costantini, role: CONTACT, phone: 0492039220, email: constantini.i@chu-nice.fr, contacts name: Christian Roux, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Iannelli, role: SUB_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06314178, orgStudyIdInfo id: p-2024-15469, briefTitle: Assessing Demographic Biases in Deep Learning Model for Fetal Growth Estimation in Clinical Practice. Patients Eligible for Inclusion Are Women With a Gestational Age Between 24-42 Weeks Undergoing a Third-trimester Growth Scan. The Image Data From the Scan Are Used to Calculate Fetal Weight., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Copenhagen Academy for Medical Education and Simulation, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare a new artificial intelligence (AI) feedback tool with the traditional method for estimating fetal weight during ultrasound scans on pregnant women between 24-42 weeks of gestation. The study aims to investigate the presence of demographic bias in the AI model. The demographic factors examined in the study include Body Mass Index (BMI), the number of births, fetal age, mother\'s age, fetal sex, and the presence of preeclampsia. Moreover, the study will compare the accuracy of the AI model and the Hadlock model, a fetal growth formula, in estimating fetal weight. Participants will have their ultrasound scans pseudonymized and securely stored on password-protected removable drives, ensuring their identity and privacy are maintained. Afterward, the ultrasound data will be sent to the Technical University of Denmark (DTU), where the AI model will analyze the images to estimate fetal weight., conditionsModule conditions: Pregnancy Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Demographic biases, secondaryOutcomes measure: Comparing the accuracy of the Hadlock formula and the AI model, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314165, orgStudyIdInfo id: PamukkaleU-SBE-RND-01, briefTitle: Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period., conditionsModule conditions: Menstruation; Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups: comparative experiment and control, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participants included in the study will not know which group they are in. In this way, the study will be carried out in a single-blind manner., whoMasked: PARTICIPANT, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: music medicine practice, outcomesModule primaryOutcomes measure: menstruation symptom scale, secondaryOutcomes measure: Visual Analogue Scale, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University Faculty of Health Sciences, status: RECRUITING, city: Denizli, zip: 20180, country: Turkey, contacts name: Rabia Nur Doğan, role: CONTACT, phone: +905528400797, email: rabianur_1997@hotmail.com, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
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protocolSection identificationModule nctId: NCT06314152, orgStudyIdInfo id: 2023032, briefTitle: 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-10-10, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Nanchong Central Hospital, class: OTHER_GOV, collaborators name: Guang'an People's Hospital, collaborators name: Pengan County People's Hospital, collaborators name: People's Hospital of Yilong County, collaborators name: Nanbu Hospital of County Chinese Medicine, collaborators name: Langzhong People's Hospital, collaborators name: Langzhong Traditional Chinese Medicine Hospital, descriptionModule briefSummary: This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al., conditionsModule conditions: Inguinal Hernia, conditions: Chronic Pain, conditions: Seroma, conditions: Recurrent, conditions: Infections, conditions: Hematoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 337, type: ESTIMATED, armsInterventionsModule interventions name: Lightweight mesh fixation in 3 points or 1 point, outcomesModule primaryOutcomes measure: Rate of recurrence, primaryOutcomes measure: Rate of postoperative pain, secondaryOutcomes measure: Rate of postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yunhong Tian, status: RECRUITING, city: Nanchong, state: Sichuan, zip: 637000, country: China, contacts name: Yunhong Tian, PHD, role: CONTACT, phone: 13508087719, email: drtianyunhong@126.com, geoPoint lat: 30.79508, lon: 106.08473, hasResults: False
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protocolSection identificationModule nctId: NCT06314139, orgStudyIdInfo id: YanmingXu001, briefTitle: Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-04-06, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Essential tremor (ET) is one of the most common movement disorders in adults. The prevalence rate among the elderly over 65 years old is about 4.6%. Tremor usually worsens with age, leading to disability and loss of independence, which has an adverse impact on the quality of life of patients. However, the traditional first-line treatment drugs are neither effective enough nor completely safe for ET patients. Although surgical procedures such as deep brain stimulation (DBS) and thalamotomy can be used to better control unilateral limb tremor, many patients are reluctant to choose surgical treatment because it's invasive. Therefore, there is an urgent need to develop new drugs or non-invasive therapies as a better treatment option for ET.The pathology of the disease is not yet clear, it is generally believed that genetic, aging and environmental factors are related to ET. Hyperactivity of cerebellar function and changes of cerebello-thalamo- cortical (CTC) pathways are currently considered to be the most important pathophysiological mechanisms of ET. Therefore, the cerebellum and cortex may be the best targets for the treatment of tremor.Continuous theta burst stimulation (cTBS) is one of the non-invasive electrophysiological techniques characterized by plexus stimulation, which is similar to low-frequency repetitive transcranial magnetic stimulation (rTMS) but closer to the physiological state of neural activity, and may inhibit the excitability of the stimulated cortex. The stimulation duration is greatly shortened, which is simpler and easier than the low-frequency rTMS of 20-30 minutes. In addition, functional near infrared spectroscopy (fNIRS) is a new non-invasive functional neuroimaging technique. It mainly uses the difference characteristics of oxyhemoglobin and deoxyhemoglobin in brain tissue for near-infrared light absorption at different wavelengths of 600-900nm. The efficacy, safety, and mechanisms involved in non-invasive stimulation therapy for ET patients are still unclear. There are few studies on the treatment of ET with cTBS, and the sample size is small (the largest sample includes only 23 ET patients). Additionally, there was a lack of exploration on the therapeutic mechanism of cTBS for ET patients. Therefore, the investigators conducted a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and efficacy of cTBS in the treatment of ET patients over both cerebellar and cortical area., conditionsModule conditions: Essential Tremor, conditions: Continuous Theta Burst Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: continuous theta-burst stimulation (cTBS), outcomesModule primaryOutcomes measure: Tremor assessment using Fahn-Tolosa-Marin (FTM) tremor-rating scales, secondaryOutcomes measure: Clinical global impression-improvement (CGI-I) rating scores, secondaryOutcomes measure: Electrophysiological evaluation of cortical excitability and inhibition measured by TMS., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurology, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, Sichuan Province 610041, P.R. China., city: Chengdu, state: Sichuan Sheng, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06314126, orgStudyIdInfo id: ENDO-DCI, briefTitle: Evaluation of D-Chiro-Inositol Treatment in Women With Endometriosis, acronym: ENDO-DCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: To date, the treatment for endometriosis is represented by the surgical removal of the lesions. Nonetheless, in the years following surgery, the lesions can recur, often due to excessive estrogen production. To balance estrogen, progestin- or estrogen-progestin-based medications are generally prescribed. On the other hand, progestins and estrogen-progestins act as contraceptives, preventing the onset of a pregnancy. At the same time, these can have side effects that can affect up to 30% of patients. For these and other reasons, some women refuse therapy with progestins or estrogen-progestins, preferring to resort to no treatment.Considering the need to research effective molecules in the prevention of relapses that can maintain fertility and avoid unwanted effects, the research focuses on natural molecules, well tolerated by the body.D-Chiro-Inositol (DCI) is a polyol normally present in human cell membranes, where, from a metabolic point of view, it acts as a second messenger of insulin, while from a hormonal point of view, it exerts an on the biosynthesis of androgens. This effect on steroidogenesis can be attributed to more than one mechanism. In the ovary, DCI stimulates direct testosterone production. Furthermore, it stimulates the accumulation of testosterone by reducing the activity of the aromatase enzyme, responsible for the conversion of androgens into estrogens. Considering the responsiveness of endometriosis to estrogens, and that these constitute a risk factor for recurrences following surgical removal, the use of DCI could be interesting from a clinical point of view.The study plans to verify whether D-Chiro-Inositol dietary supplementation can be effective in reducing systemic estrogen levels in women with endometriosis, thus also reducing the risk of relapses and associated symptoms., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants and investigators will be masked to the treatment allocation. Treatment pills and placebo pills will be the same in shape, taste, color, and size., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: D-Chiro-Inositol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Estradiol, secondaryOutcomes measure: Pelvic pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: "Paolo Giaccone" Hospital, status: RECRUITING, city: Palermo, zip: 90127, country: Italy, contacts name: Antonio Simone Laganà, M.D., Ph.D., role: CONTACT, contacts name: Pietro Serra, M.D., role: SUB_INVESTIGATOR, contacts name: Giuseppe Mascellino, M.D., role: SUB_INVESTIGATOR, contacts name: Andrea Etrusco, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06314113, orgStudyIdInfo id: EGCG-HPV, briefTitle: Evaluation of Oral EGCG Treatment for L-SIL Associated With HPV Infection, acronym: EGCG-HPV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection., conditionsModule conditions: Low-Grade Intraepithelial Neoplasia of Cervix, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Epigallocatechin Gallate, outcomesModule primaryOutcomes measure: Persistence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Paolo Giaccone" Hospital, status: RECRUITING, city: Palermo, zip: 90127, country: Italy, contacts name: Antonio Simone Laganà, M.D., Ph.D., role: CONTACT, phone: +39 3296279579, email: antoniosimone.lagana@unipa.it, contacts name: Giuseppe Mascellino, M.D., role: SUB_INVESTIGATOR, contacts name: Pietro Serra, M.D., role: SUB_INVESTIGATOR, contacts name: Andrea Etrusco, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06314100, orgStudyIdInfo id: IP-2020-02-4027-EB, briefTitle: The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-10-25, completionDateStruct date: 2023-10-25, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Rijeka, class: OTHER, collaborators name: Croatian Science Foundation, descriptionModule briefSummary: Dental caries is a multifactorial disease primarily caused by supragingival dental biofilm. Its progression is influenced by many environmental factors, which include smoking. Tobacco heating systems (THS) are a novel tobacco product whose effect on the microbiome of the supragingival dental biofilm has not yet been investigated.The aim of the proposed research is to determine and compare the composition of the microbiomes of the supragingival dental biofilm of THS smokers, cigarette smokers, and nonsmokers using the Next Generation Sequencing method and to assess and compare the risk of new caries lesion formation between the test groups using the Cariogram method.The results of this research will provide insight into changes in the microbiome of the supragingival dental biofilm resulting from exposure to aerosols from tobacco combustion and tobacco heating., conditionsModule conditions: Dental Caries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Tobacco heating systems, interventions name: cigarette smoking, interventions name: non smoking, outcomesModule primaryOutcomes measure: diversity of bacterial species, primaryOutcomes measure: abundance of bacterial species, primaryOutcomes measure: caries risk, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of dental medicine, University of Rijeka, city: Rijeka, country: Croatia, geoPoint lat: 45.32674, lon: 14.44239, hasResults: False
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protocolSection identificationModule nctId: NCT06314087, orgStudyIdInfo id: Neoantigen Radiotherapy, briefTitle: iTAPVR Study - Phase II Randomized Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong-Shenzhen Hospital, class: OTHER, descriptionModule briefSummary: In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy, conditionsModule conditions: Advanced Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomized, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: Placebo + conventional treatment including radiotherapy, interventions name: Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine, outcomesModule primaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314074, orgStudyIdInfo id: 2023-101143-BO-ff, briefTitle: 2.5 Versus 5 Minutes Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, descriptionModule briefSummary: This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery., conditionsModule conditions: Hypotension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Oscillometric blood pressure monitoring at 2.5-minute intervals, interventions name: Oscillometric blood pressure monitoring at 5-minute intervals, outcomesModule primaryOutcomes measure: Time-weighted average mean arterial pressure <65 mmHg, secondaryOutcomes measure: Episodes of a mean arterial pressure <50 mmHg, secondaryOutcomes measure: Norepinephrine dose, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, status: RECRUITING, city: Hamburg, zip: 20246, country: Germany, contacts name: Karim Kouz, Dr, role: CONTACT, phone: +49 40 7410 52415, email: k.kouz@uke.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
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protocolSection identificationModule nctId: NCT06314061, orgStudyIdInfo id: WARD-glucose RCT v.2.2, briefTitle: The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes., acronym: WARD-glucose, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Christian S. Meyhoff, class: OTHER, collaborators name: Rigshospitalet, Denmark, collaborators name: Steno Diabetes Center Copenhagen, collaborators name: Zealand University Hospital, descriptionModule briefSummary: The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.The main question it aims to answer is:• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge., conditionsModule conditions: Diabetes Mellitus, conditions: Dysglycemia, conditions: Perioperative Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel, 2-group randomised trial blinded for participants, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will not be alerted of dysglycaemia by the Dexcom G7 application, which will be muted. Thus, the alerts on deviating glucose levels will only be given to the care provider (the nursing staff at the ward), whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7), outcomesModule primaryOutcomes measure: Time in range (TIR) of CGM glucose levels, secondaryOutcomes measure: Duration of hypoglycaemia, secondaryOutcomes measure: Duration of hyperglycaemia, secondaryOutcomes measure: Number of hypoglycaemia events, secondaryOutcomes measure: Number of hyperglycaemia events, secondaryOutcomes measure: Complications, otherOutcomes measure: Serious adverse events, otherOutcomes measure: Serious adverse Device-related events, otherOutcomes measure: Adverse events, otherOutcomes measure: Length of stay, otherOutcomes measure: Readmission, otherOutcomes measure: ICU admission, otherOutcomes measure: Days alive and out of hospital, otherOutcomes measure: Patient experience, otherOutcomes measure: Staff experience, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, city: Copenhagen, state: The Capital Region Of Denmark, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital, city: Copenhagen, state: The Capital Region Of Denmark, zip: 2400, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Zealand University Hospital, city: Køge, zip: 4600, country: Denmark, contacts name: Annelotte Philipsen, MD, PhD, role: CONTACT, email: annph@regionsjaelland.dk, geoPoint lat: 55.45802, lon: 12.18214, hasResults: False
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protocolSection identificationModule nctId: NCT06314048, orgStudyIdInfo id: 74212, briefTitle: 4T Sustainability Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities., conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.2. Continue refining automated decision-support tools that use CGM data to support setting personalized goals and identify the need for insulin dose adjustments between quarterly endocrinology standard of care visits. Continue to evaluate the use of the Timely Interventions for Diabetes Excellence (TIDE) tool to analyze and prioritize the CGM data of participants requiring review.3. Continue the systematic screening for patient-reported outcomes, both assessment of PROs and delivery of care linked to screening as a core component of the 4T program., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: CGM and RPM, outcomesModule primaryOutcomes measure: HbA1c trajectory observed 4-12 months post-diagnosis, primaryOutcomes measure: Diabetes distress measured at baseline and 12 months post-diagnosis., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314035, orgStudyIdInfo id: CIC2023003, briefTitle: Decision Support on End-of-life Care Planning in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: National Taipei University of Nursing and Health Sciences, class: OTHER, collaborators name: Chinese University of Hong Kong, descriptionModule briefSummary: This study aims to test the effects of a patient decision aid (PDA) on planning for end-of-life (EOL) care among older adults with COPD. The main questions it aims to answer are:1. Does a PDA improve the process of a person to make decisions on EOL care?2. Does a PDA improve the readiness of a person to join advance care planning (ACP) communication?3. Does a person make an advance directive after using a PDA?Participants in this study will:1. Be randomly assigned to one of two groups.2. In the experimental group, participants will receive two 60-minute interactive consultations over four weeks, using a PDA to help clarify values and preferences for future medical care. A guidebook summarising these future care options will be provided.3. In the control group, participants will receive two 60-minute sessions on lifestyle modification and self-care management over four weeks using a guidebook with coaching. A guidebook summarising general health information will be provided.Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care, the readiness of a person to join ACP communication and the chance to make an advance directive., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will be blinded to their group assignment. The personnel administering the interventions will not be blinded, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: COPD Patient Decision Aid, interventions name: General Health Coaching Intervention, outcomesModule primaryOutcomes measure: Patients' decisional conflict regarding EOL care, secondaryOutcomes measure: Patients' confidence level regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and medical doctors., secondaryOutcomes measure: Patients' readiness for ACP, secondaryOutcomes measure: Participant's completion of an Advance Directive (AD), secondaryOutcomes measure: Participants' understanding of the PDA, secondaryOutcomes measure: Participant's subjective clarity of content, comfort during reading and viewing, and the usefulness of the information of the PDA., secondaryOutcomes measure: Semi-structured Interviews, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06314022, orgStudyIdInfo id: 22-PI113, briefTitle: A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP), acronym: PREPCOLON, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hospital del Río Hortega, class: OTHER, descriptionModule briefSummary: Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake., conditionsModule conditions: Colorectal Cancer, conditions: Premalignant Colon Lesions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Each subject will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: they will be given the instructions in writing and will also be indicated how to install the APP., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Patients who agree to participate in the study are randomized by a 1:1 block computer program (an attempt will be made to balance the groups according to the type of laxative) into two groups: group A: control group, which receives the standard information given in writing, and group B: APP group, which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.Patients scheduled for a screening colonoscopy will be contacted by telephone, those who agree to participate will be scheduled with the nurse, after giving their consent they are randomized. Group B will indicate how to download the APP and its management. The endoscopist performing the examination is blind for randomization and will assess colon cleansing according to the Boston Bowel Scale (Lai EJ. et al Gastroinest Endosc 2009)., whoMasked: INVESTIGATOR, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: Mobile application for colonoscopy preparation instructions, outcomesModule primaryOutcomes measure: Compliance with the diet and intake of laxatives with the use of a mobile application, primaryOutcomes measure: Evaluate the quality of colon cleansing with mobile application as an experimental factor, primaryOutcomes measure: Assessment of the usability of the APP, primaryOutcomes measure: Compliance with the laxative intake with the use of the mobile application, secondaryOutcomes measure: Assessment of the difficulty of the preparation instructions, secondaryOutcomes measure: Evaluate colonoscopy quality indicators:, secondaryOutcomes measure: Evaluate attendance at the scheduled colonoscopy appointment, secondaryOutcomes measure: Evaluate colonoscopy quality indicators, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Rio Hortega, city: Valladolid, zip: 47012, country: Spain, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False
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protocolSection identificationModule nctId: NCT06314009, orgStudyIdInfo id: EH23-302, briefTitle: Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NorthShore University HealthSystem, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks., conditionsModule conditions: Placenta Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: functional Magnetic Resonance Imaging (fMRI), outcomesModule primaryOutcomes measure: Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL), primaryOutcomes measure: Mean placental perfusion in second and third trimester, primaryOutcomes measure: Mean R2* relaxation rates in second and third trimester, secondaryOutcomes measure: Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313996, orgStudyIdInfo id: CA082-011, secondaryIdInfos id: 2023-507477-18, type: EUDRACT_NUMBER, briefTitle: A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2031-10-16, completionDateStruct date: 2031-10-16, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, class: INDUSTRY, collaborators name: Celgene Corporation, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma., conditionsModule conditions: Relapsed or Refractory Follicular Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Doxorubicin, interventions name: Vincristine, interventions name: Rituximab, interventions name: Prednisone, interventions name: Bendamustine, interventions name: Lenalidomide, interventions name: Fludarabine, interventions name: Liso-cel, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Complete response (CR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response (OR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Time to next anti-cancer therapy (TTNLT), secondaryOutcomes measure: PFS rate, secondaryOutcomes measure: EFS rate, secondaryOutcomes measure: OS rate, secondaryOutcomes measure: Progression-free survival on the next line of treatment (PFS-2), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with adverse event of special interest (AESIs), secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with laboratory abnormalities, secondaryOutcomes measure: Frequency and length of hospitalizations, secondaryOutcomes measure: Number of participants with intensive care unit (ICU) inpatient days, secondaryOutcomes measure: Number of participants with non-ICU inpatient days, secondaryOutcomes measure: Mean change from baseline in key health-related quality of life (HRQoL) domains., secondaryOutcomes measure: Time to meaningful improvement/deterioration in key HRQoL domains., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313983, orgStudyIdInfo id: HM022BC3C01, briefTitle: A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tianjin Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 339, type: ESTIMATED, armsInterventionsModule interventions name: Hemay022+AI, interventions name: Lapatinib+Capecitabine, outcomesModule primaryOutcomes measure: Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) of the two group according to RECIST v1.1, secondaryOutcomes measure: Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1, secondaryOutcomes measure: Clinical benefit rate (CBR) according to RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) according to RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Huiping Li, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06313970, orgStudyIdInfo id: QLMA-PC-IIT-001, briefTitle: First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer, conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: QL1706, interventions name: Nab-paclitaxel, interventions name: Gemcitabine, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Time to response(TTR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313957, orgStudyIdInfo id: LB2302-0001, briefTitle: A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma., conditionsModule conditions: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: LUCAR-20SP cells, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT) rate, primaryOutcomes measure: Incidence, severity, and type of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Recommended Phase 2 Dose (RP2D) regimen finding, primaryOutcomes measure: Pharmacokinetics in peripheral blood, primaryOutcomes measure: Pharmacokinetics in bone marrow, secondaryOutcomes measure: Objective Response Rate (ORR) after administration, secondaryOutcomes measure: Time to Response (TTR) after administration, secondaryOutcomes measure: Duration of Remission (DoR) after administration, secondaryOutcomes measure: Progression-free Survival (PFS) after administration, secondaryOutcomes measure: Overall Survival (OS) after administration, secondaryOutcomes measure: Incidence of anti-LUCAR-20SP antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital & Institute, status: RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yuqin Song, role: CONTACT, phone: 13683398726, email: songyq22622@163.com, contacts name: Yan Xie, role: CONTACT, phone: 13671376201, email: xieyan9@263.net, contacts name: Yuqin Song, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06313944, orgStudyIdInfo id: GE-R-A-TPS, briefTitle: German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation, acronym: GE-R-A-TPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Heinrich-Heine University, Duesseldorf, class: OTHER, collaborators name: Storz Medical AG, descriptionModule briefSummary: This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores., conditionsModule conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Registry, outcomesModule primaryOutcomes measure: Number of (Serious) Adverse Events, primaryOutcomes measure: Number of adverse device effects, secondaryOutcomes measure: ADAS, secondaryOutcomes measure: Mini Mental State Examination (MMSE) baseline and follow- up, secondaryOutcomes measure: BDI-II, secondaryOutcomes measure: Clinical Dementia Rating Sum of Boxes Score (CDR-SB), secondaryOutcomes measure: Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL), otherOutcomes measure: Numeric Rating Scale (NRS) for the main symptom, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313931, orgStudyIdInfo id: UTI-IIDI-074-2023, briefTitle: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI), statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-03, primaryCompletionDateStruct date: 2023-09-14, completionDateStruct date: 2023-09-14, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Universidad de Zaragoza, class: OTHER, descriptionModule briefSummary: This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: cognitive training via immersive virtual reality, interventions name: cognitive training via paper and pencil, interventions name: motor stimulation, outcomesModule primaryOutcomes measure: Spanish version of the Montreal Cognitive Assessment (MoCA-S), primaryOutcomes measure: Short Geriatric Depression Scale (SGDS-S), primaryOutcomes measure: Instrumental Activities of Daily Living Scale (IADL-S), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zaragoza, city: Teruel, zip: 44003, country: Spain, geoPoint lat: 40.3456, lon: -1.10646, hasResults: False
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protocolSection identificationModule nctId: NCT06313918, orgStudyIdInfo id: REK nr. 428096, briefTitle: Exercise Therapy in Mental Disorders-study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2026-09-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective., conditionsModule conditions: Schizophrenia and Related Disorders, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: High intensity training (HIT), outcomesModule primaryOutcomes measure: Adherence, secondaryOutcomes measure: Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score, secondaryOutcomes measure: Change of the Calgary Depression Scale in Schizophrenia score, secondaryOutcomes measure: Change of the Clinical Global Impression (CGI) score, secondaryOutcomes measure: Change of the Global Assessment of Funtioning (GAF) score, secondaryOutcomes measure: Change of quality of life (QOL10) score, secondaryOutcomes measure: Change of the International Physical Activity Questionaire (IPAQ) score, secondaryOutcomes measure: Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score, secondaryOutcomes measure: Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score, secondaryOutcomes measure: Change of the Difficulties in Emotion Regulation (DERS) score, secondaryOutcomes measure: Change in heart rate (beats per minute), secondaryOutcomes measure: Change of maximal oxygene extraction (VO2max), secondaryOutcomes measure: Change of level of inflammatory markers in blood, secondaryOutcomes measure: Change of body weight (kilograms), secondaryOutcomes measure: Change of hip- and waist circumference (centimetres), secondaryOutcomes measure: Change of serum glucose (mmol/L), secondaryOutcomes measure: Change of serum cholesterols (mmol/L), secondaryOutcomes measure: Change of serum triglyceride (mmol/L), secondaryOutcomes measure: Change of gene expression, secondaryOutcomes measure: Change of methylation of DNA, secondaryOutcomes measure: Change of the Young Mania Rating Scale (YMRS) score, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5020, country: Norway, contacts name: Erik Johnsen, MD, PhD, role: CONTACT, phone: +47 55958400, email: erik.johnsen@helse-bergen.no, contacts name: Rune A Kroken, MD, PhD, role: CONTACT, phone: +47 55958400, email: rune.andreas.kroken@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
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protocolSection identificationModule nctId: NCT06313905, orgStudyIdInfo id: DRYLESS1, secondaryIdInfos id: CHU La Rabta, type: OTHER, domain: La Rabta hospital, briefTitle: EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome, acronym: DRYLESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind randomized study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: EVADRY, interventions name: Placebo, outcomesModule primaryOutcomes measure: salivary flow rate (SFR), secondaryOutcomes measure: Xerostomia Inventory in French version, secondaryOutcomes measure: Oral Health-related quality of life (OHIP-14) questionnaire, secondaryOutcomes measure: Hospital anxiety and depression (HAD) scale, secondaryOutcomes measure: Buccal Schirmer test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313892, orgStudyIdInfo id: PA24HD-2-05, briefTitle: The Effect of Home Based Tel-Exercise on Dialysis Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Pardis Specialized Wellness Institute, class: OTHER, descriptionModule briefSummary: The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy., conditionsModule conditions: End Stage Renal Disease, conditions: Hemodialysis Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly allocate to intervention group or control group and will be examined in the same way., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Home based Exercise, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rates, primaryOutcomes measure: Adherence rate, secondaryOutcomes measure: Rate of changes of daily physical activity level, secondaryOutcomes measure: Rate of changes of Frailty level, secondaryOutcomes measure: Rate of changes of physical function level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Khorshid Dialysis Center, city: Isfahan, country: Iran, Islamic Republic of, geoPoint lat: 32.65246, lon: 51.67462, locations facility: Pardis specialized wellness institute, city: Isfahan, country: Iran, Islamic Republic of, geoPoint lat: 32.65246, lon: 51.67462, hasResults: False
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protocolSection identificationModule nctId: NCT06313879, orgStudyIdInfo id: PamukkaleU-SBE-SA-01, briefTitle: The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy., conditionsModule conditions: Hydrocephalus in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups: comparative experiment and control, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: online education, outcomesModule primaryOutcomes measure: State and Trait Anxiety Scale, secondaryOutcomes measure: General Self-Efficacy Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University Hospital, status: RECRUITING, city: Denizli, zip: 20180, country: Turkey, contacts name: Sevinç Aka, role: CONTACT, phone: +905057323842, email: sevincakaa@gmail.com, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
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protocolSection identificationModule nctId: NCT06313866, orgStudyIdInfo id: 2024ZL368, briefTitle: the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hangzhou Medical College, class: OTHER, descriptionModule briefSummary: The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: control, interventions name: Electronuchal acupuncture group treatment, interventions name: Smell therapy group treatment, interventions name: Electronuchal acupuncture combined with smell and inhalation therapy group treatment, outcomesModule primaryOutcomes measure: MMSE, primaryOutcomes measure: MoCA, primaryOutcomes measure: MBI, secondaryOutcomes measure: TCD, secondaryOutcomes measure: Near-infrared functional imaging of the brain, secondaryOutcomes measure: Magnetic resonance scanning, eligibilityModule sex: ALL, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 311000, country: China, contacts name: Xinyun Dr LI, Doctor, role: CONTACT, phone: 8618069783240, email: lxyjasmine2010@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06313853, orgStudyIdInfo id: STUDY00007068, briefTitle: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision, acronym: COACH-Cog, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: Building upon prior work, the investigator team developed a communication intervention for older adults with ADRD who are considering a decision about cancer management (adapted intervention: COACH-Cog). The investigators hypothesize that for patients with dual diagnoses of ADRD and cancer, COACH-Cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. The investigators are conducting a pilot randomized controlled trial (RCT; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of COACH-Cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication., conditionsModule conditions: Cancer, conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster-randomized, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 305, type: ESTIMATED, armsInterventionsModule interventions name: COACH-Cog, outcomesModule primaryOutcomes measure: Care Partner: Health Care Climate Questionnaire (HCCQ), secondaryOutcomes measure: Montgomery Borgatta Caregiving Burden Scale, secondaryOutcomes measure: World Health Organization Quality of Life Brief Version (WHOQOL-BREF), secondaryOutcomes measure: Care Partner PROMIS Depression, secondaryOutcomes measure: Care partner PROMIS Anxiety, secondaryOutcomes measure: Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca), secondaryOutcomes measure: Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age), secondaryOutcomes measure: Care partner: Qualitative assessment of goal concordance, secondaryOutcomes measure: Care partner: Decision Regret Scale, otherOutcomes measure: Patient: Patient-Centered Communication in Cancer Care (PCC-Ca), otherOutcomes measure: Patient: Health Care Climate Questionnaire (HCCQ), otherOutcomes measure: Patient: Health Care Climate Questionnaire - Age (HCCQ-Age), otherOutcomes measure: Patient Decision Regret Scale, otherOutcomes measure: Physician Decision Regret Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Rochester Wilmot Cancer Institute, city: Rochester, state: New York, zip: 14620, country: United States, contacts name: Allison Magnuson, DO, MS, role: CONTACT, email: Allison_magnuson@urmc.rochester.edu, contacts name: Jessica Bauer, role: CONTACT, email: JessicaC_Bauer@URMC.Rochester.edu, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06313840, orgStudyIdInfo id: CIP3125, briefTitle: Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients With Heart Failure With Reduced or Mildly Reduced Left Ventricular Ejection Fraction, acronym: COG01, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Zoll Medical Corporation, class: INDUSTRY, descriptionModule briefSummary: Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function, conditionsModule conditions: Heart Failure, conditions: Central Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Prevalence of CSA in tested HFrEF/HFmrEF patients, secondaryOutcomes measure: Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment., eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Przychodnia na Teczowej, status: RECRUITING, city: Wrocław, country: Poland, contacts name: Anna Basinska, role: CONTACT, contacts name: Ewa Jankowska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.1, lon: 17.03333, locations facility: Szpital Uniwersytecki we Wrocławiu, status: RECRUITING, city: Wrocław, country: Poland, contacts name: Anna Basinska, role: CONTACT, contacts name: Ewa Jankowska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.1, lon: 17.03333, hasResults: False
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protocolSection identificationModule nctId: NCT06313827, orgStudyIdInfo id: UV-INV_3165929, briefTitle: e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: Asociación de Fibrosis Quística - Comunidad Valenciana, descriptionModule briefSummary: The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.Participants will be assigned to one of 3 study groups:Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Participants will be randomly assigned to one of three study groups by the person conducting the intervention.All participants receive usual physiotherapy treatment, and both intervention groups receive monitoring and follow-up of their clinical situation.The evaluators are unaware of the assignment at all times., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Exercise plus Monitoring Group (TG-2), interventions name: Exercise plus monitoring and follow-up group (TGF-3), interventions name: Exercise Group (CG-1), outcomesModule primaryOutcomes measure: Clinical exacerbation, secondaryOutcomes measure: Dyspnea, secondaryOutcomes measure: Spirometric function, secondaryOutcomes measure: Oxigenation, secondaryOutcomes measure: Functional capacity, secondaryOutcomes measure: Quality of life (QoL), otherOutcomes measure: Motivation to engage in physical activity, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitat de Valencia, city: Valencia, zip: 46010, country: Spain, contacts name: Francisco Martinez Arnau, PhD, role: CONTACT, contacts name: Anna Arnal Gomez, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Cortes Amador, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Francisco Martínez Arnau, PhD, role: SUB_INVESTIGATOR, contacts name: Carlos Gomez Chinesta, PT, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06313814, orgStudyIdInfo id: DE RKEB/IKEB 5622-2020, briefTitle: The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Debrecen, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia.The main question\[s\] it aims to answer are:1. Does ginger intake improve functional dyspepsia symptoms?2. Does ginger intake decrease the body fat content among patients with functional dyspepsia? Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day. Researchers will assess if there is an improvement in the symptoms of the disease and the fat content. \[ to see if gingers effect., conditionsModule conditions: Functional Dyspepsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Swanson ginger capsule, outcomesModule primaryOutcomes measure: Functional Dyspepsia Symptom Severity, primaryOutcomes measure: Body Fat Content Analysis, secondaryOutcomes measure: Improvement in Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Debrecen, city: Debrecen, zip: 4032, country: Hungary, geoPoint lat: 47.53333, lon: 21.63333, hasResults: False
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protocolSection identificationModule nctId: NCT06313801, orgStudyIdInfo id: DPNCD-2309, briefTitle: Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-19, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2026-01-19, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nizhny Novgorod Regional Clinical Oncology Center, class: OTHER_GOV, descriptionModule briefSummary: After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd, the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd, the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Docetaxel, interventions name: Oxaliplatin, interventions name: Calcium folinate, interventions name: Fluorouracil, interventions name: Diagnostic laparoscopy, interventions name: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC))., outcomesModule primaryOutcomes measure: The progression-free survival., primaryOutcomes measure: Complications from polychemotherapy., secondaryOutcomes measure: The overall survival., secondaryOutcomes measure: The completeness of the planned therapy., secondaryOutcomes measure: Percentage of patient conversions to Су- and PCI- rate., secondaryOutcomes measure: Surgical complications of operated patients, secondaryOutcomes measure: Аssessment of the quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", status: RECRUITING, city: Nizhny Novgorod, zip: 603126, country: Russian Federation, contacts name: Sergey Klimin, role: CONTACT, phone: +79875403280, email: kliminsergey7@gmail.com, geoPoint lat: 56.32867, lon: 44.00205, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-17, uploadDate: 2024-03-10T15:27, filename: Prot_SAP_000.pdf, size: 393857, hasResults: False
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protocolSection identificationModule nctId: NCT06313788, orgStudyIdInfo id: EC007-2324, briefTitle: Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Lingnan University, class: OTHER, descriptionModule briefSummary: Pain is common among children. Given that children are not as mature and independent in assessing or treating their pain as adults, they are a relatively vulnerable group in terms of pain management and are in need of additional attention. However, there is still insufficient recognition and treatment of pain in children. Taken the procedure of injection/vaccination in children as an example, child patients usually wait for their turn to take the injection from the nurse/doctor, during which anxiety and fear of pain develop. As children are less able to manage their pain than adults, the fear they develop during the waiting time, together with the pain they actually felt after the treatment, can bring negative experiences to them. In this proposed project, the investigators aim to apply a minor procedure prior to a treatment that induces pain (e.g., injection / vaccination) to help managing pediatric pain., conditionsModule conditions: Pediatric Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: One group of the participants will be told that they are involved in a marketing survey and will be given a band-aid as a token of appreciation for their participation. This constitutes the mere possession group., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Possession of a customized placebo analgesic band-aid prior to vaccination or injection, outcomesModule primaryOutcomes measure: Pain intensity Rating (rating how much pain participants feel), primaryOutcomes measure: Pain intensity Measurement (measure how much pain participants feel), primaryOutcomes measure: Pain Threshold (record the first-time participants feel the pain), primaryOutcomes measure: Pain unpleasantness (rating how unpleasant participants feel about the pain), secondaryOutcomes measure: Mood (rating the positive and negative emotions of the participants), secondaryOutcomes measure: State-anxiety (Rating the participants' current anxiety level), secondaryOutcomes measure: Fear of pain Rating, secondaryOutcomes measure: Magical thinking Rating, secondaryOutcomes measure: Pain Self-Efficacy, secondaryOutcomes measure: Self-efficacy to tackle pain, secondaryOutcomes measure: Expectation of Pain Severity, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313775, orgStudyIdInfo id: SPS005, briefTitle: Comparison of Spinal Anesthesia and Spermatic Cord Block for Bilateral Orchiectomy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sanpasitthiprasong Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:• Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients., conditionsModule conditions: Orchiectomy, conditions: Spermatic Cord Block, conditions: Spinal Anesthesia, conditions: Pain Score, conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Simple random sampling, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: bilateral orchiectomy, outcomesModule primaryOutcomes measure: intraoperative pain score, secondaryOutcomes measure: post-operative pain score, secondaryOutcomes measure: morphine consumption, secondaryOutcomes measure: post-operative complications, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sanpasitthiprasong hospital, city: Ubon Ratchathani, zip: 33000, country: Thailand, geoPoint lat: 15.23844, lon: 104.84866, hasResults: False
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protocolSection identificationModule nctId: NCT06313762, orgStudyIdInfo id: Codi CEIm: 21/132-P, briefTitle: Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-18, primaryCompletionDateStruct date: 2024-01-24, completionDateStruct date: 2024-02-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, class: OTHER, descriptionModule briefSummary: The objective of this randomized, multicenter, open-label, parallel, controlled clinical trial is to evaluate pain reduction during the administration of two vaccines in children aged 3 and 6 years through virtual reality.The main question\[s\] it aims to answer are:1. To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.2. To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.3. Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.4. Evaluate the Safety of the use of virtual reality glasses in children aged 3 and 6 years during the administration of vaccines.The study population will include children aged 3 and 6 years who are included in the patient registry and are being seen in a primary care center of the Catalan Institute of Health in Central Catalonia.The clinical trial has two assigned groups: a control group and an intervention group.The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller.The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home.International Registered Report Identifier (IRRID): PRR1-10.2196/35910, conditionsModule conditions: Pain, conditions: Pediatrics, conditions: Vaccination, conditions: Virtual Reality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller.The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, interventions name: Traditional Distractors, interventions name: Triple Viral + Varicella Vaccine at 3 years of age, interventions name: Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age., outcomesModule primaryOutcomes measure: Evaluation of pain perception during the administration of two vaccines in children aged 3 and 6 years, through the Wong-Baker Pain Scale., secondaryOutcomes measure: Evaluation of anxiety during the administration of two vaccines in children aged 3 and 6 years, through heart rate and the Children's Fear Scale., secondaryOutcomes measure: Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale., secondaryOutcomes measure: Number of patients who experienced adverse effects during the administration of vaccines and who used virtual reality glasses, through the registration of the effects presented., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Catalan Institute of Health. Territorial Management of Central Catalonia., city: Manresa, state: Barcelona, zip: 08260, country: Spain, geoPoint lat: 41.72815, lon: 1.82399, hasResults: False
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protocolSection identificationModule nctId: NCT06313749, orgStudyIdInfo id: MMS-US-1, briefTitle: Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sanoculis Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C., conditionsModule conditions: Primary Open Angle Glaucoma, conditions: Open Angle Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This clinical study is observer masked only when measuring intraocular pressure (using Goldmann Applanation Tonometry). Intraocular pressure measurements will be determined using the 2-person method to reduce bias. Observer 1 (masked to real time reading) will look through the slit lamp and turn the Goldmann Tonometer dial, and Observer 2 will read and record the intraocular pressure readings. Observer 1 will be unable to see the readings with the use of a masking card., enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: Minimally Invasive Micro Sclerostomy Device, outcomesModule primaryOutcomes measure: Surgical success rate of the MIMS® device/procedure at 12 months after surgery, secondaryOutcomes measure: Exploratory Effectiveness Endpoint 1, secondaryOutcomes measure: Exploratory Effectiveness Endpoint 2, secondaryOutcomes measure: Exploratory Effectiveness Endpoint 3, secondaryOutcomes measure: Exploratory Effectiveness Endpoint 4, secondaryOutcomes measure: Safety Outcome 1, secondaryOutcomes measure: Safety Outcome 2, secondaryOutcomes measure: Safety Outcome 3, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06313736, orgStudyIdInfo id: STU00220591_shortening, secondaryIdInfos id: 2T32MH115882-06A1, type: NIH, link: https://reporter.nih.gov/quickSearch/2T32MH115882-06A1, briefTitle: What SSI Duration is Most Effective? An Online Experiment With American Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to one of four different conditions., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. They will know that the study compares multiple interventions but will not know to which arm they have been assigned. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. There will be no interaction between participants and investigators., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Action Brings Change Project (15-minute adult version), interventions name: Action Brings Change Project (10-minute adult version), interventions name: Action Brings Change Project (6-minute adult version), interventions name: Action Brings Change Project (2-minute adult version), outcomesModule primaryOutcomes measure: Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009), secondaryOutcomes measure: Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013), secondaryOutcomes measure: Change in Beck Hopelessness Scale - 4-item at post-intervention, secondaryOutcomes measure: Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004), secondaryOutcomes measure: Presence of an "Aha! moment" at post-intervention, secondaryOutcomes measure: Presence of an "Aha! moment" at 8 weeks post-intervention, secondaryOutcomes measure: Significance of the "Aha! moment" at immediately post-intervention, secondaryOutcomes measure: Significance of the "Aha! moment" at 8 weeks post-intervention, secondaryOutcomes measure: Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016), secondaryOutcomes measure: Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004), secondaryOutcomes measure: Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004), secondaryOutcomes measure: Intervention satisfaction star rating at post-intervention, secondaryOutcomes measure: Intervention satisfaction star rating at 8 week follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University Medical Social Sciences, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-17, uploadDate: 2024-03-17T16:12, filename: Prot_SAP_000.pdf, size: 81821, hasResults: False
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protocolSection identificationModule nctId: NCT06313723, orgStudyIdInfo id: SBÜ-AYDINKARTAL-030, briefTitle: The Effect of Mother's Anxiety, Fear and Prenatal Connection in the Prenatal Education Given to Pregnant Women Via Podcast During the Non-stress Test, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: YASEMİN AYDIN KARTAL, class: OTHER, descriptionModule briefSummary: This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The research, planned in a randomized controlled quasi-experimental design, will be carried out with nulliparous pregnant women (n:104) who apply to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital. Pregnant women who voluntarily participate in the research will be divided into intervention (n: 52) and control (n: 52) groups according to the computer-assisted simple random sampling technique. The intervention group, nulliparous pregnant women, will listen to 3 podcasts of 5-6 minutes. Pregnant women in the control group will be given a booklet on the pregnancy and birth process from the Ministry of Health as part of routine care. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study., conditionsModule conditions: Prenatal Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled single-blind quasi-experimental study, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Single (Participant) Which of the participants is the control or intervention group will be selected by randomization., whoMasked: PARTICIPANT, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Prenatal education management delivered via podcast, outcomesModule primaryOutcomes measure: Introductory Information Form, primaryOutcomes measure: State-Trait Anxiety Inventory(D-SKE), primaryOutcomes measure: Wijma Birth Expectation/Experience Scale Version A (W-DEQ A), primaryOutcomes measure: Prenatal Attachment Inventory (PBI), secondaryOutcomes measure: State-Trait Anxiety Inventory(D-SKE), secondaryOutcomes measure: Wijma Birth Expectation/Experience Scale Version A (W-DEQ A), secondaryOutcomes measure: Prenatal Attachment Inventory (PBI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Health Sciences, city: Istanbul, zip: 34668, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06313710, orgStudyIdInfo id: Y (2024) 058, briefTitle: Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES4), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: General Hospital of Shenyang Military Region, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: head down position, outcomesModule primaryOutcomes measure: Changes in National Institute of Health stroke scale (NIHSS), secondaryOutcomes measure: proportion of excellent functional outcome, secondaryOutcomes measure: proportion of favorable functional outcome, secondaryOutcomes measure: ordinal distribution of modified Rankin Score (mRS), secondaryOutcomes measure: early neurological improvement (ENI), secondaryOutcomes measure: changes in infarct volume, secondaryOutcomes measure: changes in cerebral edema, secondaryOutcomes measure: Changes in National Institute of Health stroke scale (NIHSS), secondaryOutcomes measure: new stroke or other vascular event(s), secondaryOutcomes measure: proportion of sympomatic intracranial hemorrhage, secondaryOutcomes measure: proportion of intraparenchymal hemorrhage (PH), secondaryOutcomes measure: percentage of severe adverse events, secondaryOutcomes measure: all-cause mortality, otherOutcomes measure: changes in dynamic cerebral autoregulation (dCA), otherOutcomes measure: changes in cortical oxygen saturation, otherOutcomes measure: changes in serum biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurology, General Hospital of Northern Theater Command, city: Shenyang, zip: 110016, country: China, contacts name: Hui-Sheng Chen, Ph.D., role: CONTACT, phone: +86 13352452086, email: chszh@aliyun.com, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
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protocolSection identificationModule nctId: NCT06313697, orgStudyIdInfo id: GR2102-001, briefTitle: A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-24, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-12-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Genrix (Shanghai) Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。, conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: GR2102 injection, interventions name: placebo, outcomesModule primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Maximum Observed Serum Concentration, secondaryOutcomes measure: Terminal Elimination Half Life, secondaryOutcomes measure: anti-respiratory syncytial virus neutralizing antibodies titer levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Shandong First Medical University, city: Jinan, state: Shandong, zip: 250102, country: China, contacts name: linlin song, MD, role: CONTACT, phone: 18853169334, email: qylcsyllwyh@163.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06313684, orgStudyIdInfo id: Fondecyt 1230787, briefTitle: Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure, acronym: COCREATIONHF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Universidad de La Frontera, class: OTHER, collaborators name: University of Chile, descriptionModule briefSummary: CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone., conditionsModule conditions: Heart Failure NYHA Class II, conditions: Heart Failure NYHA Class III, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive Initial Assessment, interventions name: Continuous evaluation, interventions name: Interval Exercise, interventions name: Psychosocial support, interventions name: Diet management, interventions name: Resistance exercise, interventions name: Continuous exercise, interventions name: Initial Assessment, outcomesModule primaryOutcomes measure: Cardiorespiratory fitness, primaryOutcomes measure: Functional capacity, primaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Program adherence and completion, secondaryOutcomes measure: Concentration of Pro-B-type Natriuretic Peptide, secondaryOutcomes measure: Functioning, secondaryOutcomes measure: Mortality and Hospital admission, secondaryOutcomes measure: Upper-body muscle strength, secondaryOutcomes measure: Lower-body muscle strength, secondaryOutcomes measure: Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario San José, city: Santiago, country: Chile, contacts name: Manuel Galvez, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Hospital Clínico Universidad de Chile, city: Santiago, country: Chile, contacts name: Karen Rouliez, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Hospital San Borja Arriarán, city: Santiago, country: Chile, contacts name: Gonzalo Latin, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Universidad de La Frontera, city: Temuco, country: Chile, contacts name: Francisca Contreras, role: CONTACT, geoPoint lat: -38.73965, lon: -72.59842, hasResults: False
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protocolSection identificationModule nctId: NCT06313671, orgStudyIdInfo id: Perfusion Index - FR study, briefTitle: Plethysmographic Perfusion Index and Fluid Responsiveness, acronym: PPI-FR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Avicenna Military Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care., conditionsModule conditions: Fluid Responsiveness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Perfusion index, outcomesModule primaryOutcomes measure: Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Avicenna Military Hospital, status: RECRUITING, city: Marrakesh, state: Marrakesh Tensift El Haouz, zip: 40000, country: Morocco, contacts name: Younes Aissaoui, MD, role: CONTACT, phone: +21266140333, email: younes.aissaoui@live.fr, contacts name: Chaimae Abouelkemhe, MD, role: CONTACT, phone: +212694830675, email: chaimaeabouelkemhe@gmail.com, geoPoint lat: 31.63416, lon: -7.99994, hasResults: False
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protocolSection identificationModule nctId: NCT06313658, orgStudyIdInfo id: Total BPBI, briefTitle: Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes., conditionsModule conditions: Brachial Plexus Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Total brachial plexus exploration and reconstruction, outcomesModule primaryOutcomes measure: Active Movement Scale (AMS), secondaryOutcomes measure: Al-Qattan pronation/Supination score, secondaryOutcomes measure: Raimondi hand score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University Hospitals, status: RECRUITING, city: Assiut, zip: 71526, country: Egypt, contacts name: Yousif T El-Gammal, MD, role: CONTACT, phone: 5023797500, email: yousif.elgammal@med.aun.edu.eg, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06313645, orgStudyIdInfo id: B83C22004880006, briefTitle: Vascular Senescence and Atherosclerotic Plaque Vulnerability, acronym: VICTORIA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Niguarda Hospital, class: OTHER, collaborators name: Istituto di Fisiologia Clinica CNR, descriptionModule briefSummary: Chronological aging significantly contributes to structural and functional alterations in the vasculature, making it a major risk factor for atherosclerotic disease and its acute thrombotic events. DNA damage, including telomeric, non-telomeric, and mitochondrial damage, is recognized as a key initiator of vascular aging and atherogenesis. There is abundant evidence indicating the presence of oxidative DNA lesions, telomere erosion, and mitochondrial DNA damage in both experimental and human plaques, as well as in the peripheral cells of atherosclerotic patients.It is increasingly evident that genomic instability activates signaling pathways that lead to a multitude of pathophysiological cellular and molecular changes. These changes promote inflammation, apoptosis, autophagy, and ultimately, cellular senescence, accompanied by the "senescence-associated secretory phenotype" (SASP). However, the precise mechanisms linking the DNA damage response (DDR) to senescence, SASP in vascular cells, and the pathogenesis of atherosclerosis and vulnerable atheroma are yet to be fully understood. Additional research is needed to delineate the underlying mechanisms through which mitochondrial dysfunction influences telomere length and vice versa, and how their interaction contributes to the vascular aging process. Progress in this area has the potential to uncover therapeutic targets and novel, more precise diagnostic, and prognostic indicators.The objectives of the VICTORIA study are to examine the levels of aging-related non-coding RNA deregulation (specifically lncRNA TERRA and mitomiR) and peripheral markers of cell aging (including telomere length and mitochondrial DNA content) across the various spectra of angina pectoris (stable angina, unstable angina, NSTEMI, and STEMI). Additionally, the study aims to determine whether these markers are correlated with vulnerable plaque characteristics and major adverse cardiovascular events., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Several biomarkers, outcomesModule primaryOutcomes measure: Telomere length, secondaryOutcomes measure: Mitochondrial DNA copy number (mtDNAcn), secondaryOutcomes measure: MitomiR, secondaryOutcomes measure: Long non-coding (lnc) RNA TERRA, secondaryOutcomes measure: pro-oxidant cytokines, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST GOM Niguarda, status: RECRUITING, city: Milano, state: Lombardia, zip: 20162, country: Italy, contacts name: Jonica Campolo, MSc, role: CONTACT, phone: +39026444, phoneExt: 5578, email: jonica.campolo@ospedaleniguarda.it, contacts name: Emanuela Piccaluga, MD, role: CONTACT, phone: +39026444, phoneExt: 2308, email: emanuela.piccaluga@ospedaleniguarda.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06313632, orgStudyIdInfo id: STUDY-23-01105, briefTitle: Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone., conditionsModule conditions: Pleural Disease, conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple blind study, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine injection, interventions name: Placebo, interventions name: Monitored Anesthesia Care, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS) for Pain, secondaryOutcomes measure: Change in the Numerical Rating Scale, secondaryOutcomes measure: Type of Analgesic use, secondaryOutcomes measure: Number of Analgesic use, secondaryOutcomes measure: Dosage of Analgesic use, secondaryOutcomes measure: Quality of Recovery-15 (QoR-15) Survey Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai West Hospital, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Udit Chaddha, MBBS, role: CONTACT, phone: 212-824-8546, email: udit.chaddha@mssm.edu, contacts name: Udit Chaddha, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06313619, orgStudyIdInfo id: BSMMU/20236831, briefTitle: Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, class: OTHER, descriptionModule briefSummary: The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).A before-after designed quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted among the same participants with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers. For qualitative part, the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding acceptability, adoption, feasibility, and cost of the intervention.The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs., conditionsModule conditions: Resistance Bacterial, conditions: Increased Drug Resistance, conditions: Drug Resistance, Microbial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: SmartAMR, outcomesModule primaryOutcomes measure: Irrational usage of anti-microbials, primaryOutcomes measure: Acceptance rate, primaryOutcomes measure: Completion rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medicine Shop, status: RECRUITING, city: Dhaka, zip: 1212, country: Bangladesh, contacts name: Abid Hasan Khan, MPH, role: CONTACT, phone: +8801308634347, email: ahkriaz.ju@gmail.com, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
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protocolSection identificationModule nctId: NCT06313606, orgStudyIdInfo id: 2047436, briefTitle: Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool., conditionsModule conditions: Dietary Fat Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dietary fat positive control, interventions name: Dietary fat negative control, outcomesModule primaryOutcomes measure: Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Davis School of Medicine, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Sean H. Adams, PhD, role: CONTACT, phone: 916-734-4868, email: shadams@ucdavis.edu, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False
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protocolSection identificationModule nctId: NCT06313593, orgStudyIdInfo id: INCB160058-101, briefTitle: A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-14, primaryCompletionDateStruct date: 2027-06-06, completionDateStruct date: 2027-09-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms., conditionsModule conditions: Myeloproliferative Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: INCB160058, outcomesModule primaryOutcomes measure: Number of participants with Dose Limiting Toxicities (DLTs), primaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), primaryOutcomes measure: Number of participants with TEAEs leading to dose modification or discontinuation, secondaryOutcomes measure: INCB160058 pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Response using the revised IWG-MRT and ELN response criteria for MF, secondaryOutcomes measure: Percentage of participants achieving spleen volume reduction as defined in the protocol, secondaryOutcomes measure: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS), secondaryOutcomes measure: Participants with MF with symptomatic anemia: Anemia Response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313580, orgStudyIdInfo id: 22-1055, briefTitle: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Alabama, Tuscaloosa, class: OTHER, collaborators name: McCormick Science Institute, descriptionModule briefSummary: Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites., conditionsModule conditions: Cardiometabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded., whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Yogurt with added Spices, interventions name: Yogurt without added Spices, outcomesModule primaryOutcomes measure: Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate, primaryOutcomes measure: Concentration of serum leptin, primaryOutcomes measure: Concentration of serum ghrelin (pg/mL), primaryOutcomes measure: Concentration of serum peptide tyrosine tyrosine (PYY), eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Alabama, status: RECRUITING, city: Tuscaloosa, state: Alabama, zip: 35487, country: United States, contacts name: Kristi M. Crowe-White, PhD, RD, role: CONTACT, phone: 205-348-6173, email: kcrowe@ches.ua.edu, geoPoint lat: 33.20984, lon: -87.56917, hasResults: False
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protocolSection identificationModule nctId: NCT06313567, orgStudyIdInfo id: Meca-GC, briefTitle: Metronomic Capecitabine in Stage III Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2029-03-10, completionDateStruct date: 2029-03-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 722, type: ESTIMATED, armsInterventionsModule interventions name: Metronomic capecitabine, interventions name: Observation, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Dazhi Xu, MD,PHD, role: CONTACT, phone: 021-64175590, email: xudzh@shca.org.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06313554, orgStudyIdInfo id: HMPL-012-SH-ICC101, briefTitle: Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2027-05-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin, outcomesModule primaryOutcomes measure: ORR objective response rate, secondaryOutcomes measure: Progression-Free Survival(PFS), secondaryOutcomes measure: OS overall survival, secondaryOutcomes measure: DCR disease control rate, secondaryOutcomes measure: Adverse events as assessed by NCI CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313541, orgStudyIdInfo id: 2024-Lung-LDRT/SBRT, briefTitle: Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC, conditionsModule conditions: NSCLC Stage IV, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: SBRT or LDRT, interventions name: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy, outcomesModule primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression free survival 2, secondaryOutcomes measure: Treatment-related adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06313528, orgStudyIdInfo id: 18726, secondaryIdInfos id: J1I-MC-GZBW, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Sponsor-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: LY3437943, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined), secondaryOutcomes measure: Change from Baseline in Sleep Metabolic Rate (SMR), secondaryOutcomes measure: Change from Baseline in SMR, secondaryOutcomes measure: Change from Baseline in 24-hour Energy Expenditure (EE), secondaryOutcomes measure: Change from Baseline in 24-hour EE, secondaryOutcomes measure: Change from Baseline in Total Calorie Intake at Lunch, secondaryOutcomes measure: Change from Baseline in Total Calorie Intake at Dinner, secondaryOutcomes measure: Change from Baseline in Fasting Appetite Visual Analog Score (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: AdventHealth Orlando, status: RECRUITING, city: Orlando, state: Florida, zip: 32804, country: United States, contacts role: CONTACT, phone: 407-303-7100, contacts name: Steven Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Pennington Biomedical Research Center, status: RECRUITING, city: Baton Rouge, state: Louisiana, zip: 70808, country: United States, contacts role: CONTACT, phone: 225-763-3000, contacts name: Eric Ravussin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.45075, lon: -91.15455, locations facility: Columbia University Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts role: CONTACT, phone: 212-305-9949, contacts name: Michael Rosenbaum, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06313515, orgStudyIdInfo id: STUDY00019529, briefTitle: Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, descriptionModule briefSummary: Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).The main questions the study aims to answer are:* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.* Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.* Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.* Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.Participants will:* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.* Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.* During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning.Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Spinal Cord Stimulation, interventions name: Arm-crank bike exercise, interventions name: Sham Stimulation, outcomesModule primaryOutcomes measure: Change in systolic Blood Pressure (BP) from baseline., primaryOutcomes measure: Change in systolic Blood Pressure during a sit-up test or head-up tilt test., primaryOutcomes measure: Heart rate variability recorded by electrocardiogram (ECG)., secondaryOutcomes measure: Peak oxygen uptake (VO2peak), secondaryOutcomes measure: Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure, secondaryOutcomes measure: International Standards for Neurological Classification of Spinal Cord Injury, secondaryOutcomes measure: International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI), secondaryOutcomes measure: Blood Pressure variability, secondaryOutcomes measure: Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2, secondaryOutcomes measure: Change from baseline- Capabilities of Upper Extremity Test, secondaryOutcomes measure: International Spinal Cord Injury Pain Basic Dataset version 2.0, secondaryOutcomes measure: International Spinal Cord Injury Lower Urinary Tract Function Dataset, secondaryOutcomes measure: International Spinal Cord Injury Bowel Function Dataset, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98195, country: United States, contacts name: Soshi Samejima, DPT, PhD, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06313502, orgStudyIdInfo id: 274271, briefTitle: High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Arkansas, class: OTHER, collaborators name: University of Iowa, descriptionModule briefSummary: The purpose of this research is to evaluate whether HDAA in combination with a single dose of 100 mg/m2 IV melphalan followed by autologous stem cell transplantation (ASCT) is safe and effective for subjects with relapsed refractory multiple myeloma. The proposed melphalan dose is 50% of the current standard myeloablative dose (200 mg/m2). Based on our preclinical data, the investigator hypothesize that the combination of reduced dose melphalan with IV HDAA will have high efficacy and tolerabilityPrimary Objective To determine tumor response using International Myeloma Working Group (IMWG) criteria (see Appendix B).Secondary ObjectivesObjectives:1. Determine the safety and tolerability of HDAA in combination with reduced dose melphalan conditioning and autologous stem cell transplantation (ASCT) in relapsed refractory multiple myeloma subjects.2. Determine the rate of Minimal Residual Disease (MRD) negativity at time point of response assessment using 8 color flow cytometry on BM sample. Functional imaging, such as positron emission tomography (PET) scan and magnetic resonance imaging (MRI), will also be performed to assess the disease status.3. Categorize and quantify adverse events compared to historical control.4. Determine quality of life parameters using standardized health-related quality of life measures5. Determine oxidative stress parameters in plasma during treatment., conditionsModule conditions: Plasma Cell Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: 75gm HDAA, interventions name: 100gm HDAA, interventions name: 125gm HDAA, outcomesModule primaryOutcomes measure: Tumor Response measured by IMWG criteria, secondaryOutcomes measure: Safety and Tolerability of HDAA with reduced dose melphalan measured using number and severity of AEs, secondaryOutcomes measure: Rate of Minimal Residual Disease (MRD) negativity using 8 color flow cytometry, secondaryOutcomes measure: Determine quality of life parameter using QLQ-C30, secondaryOutcomes measure: Determine quality of life parameter using EQ-5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313489, orgStudyIdInfo id: 282151, briefTitle: Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, descriptionModule briefSummary: Fractures of the wrist (fractures of the distal radius) are one of the most common fractures with almost 60 000 injuries per year in Sweden. One known complication following these fractures is that the long extensor tendon of the thumb ruptures (extensor pollicis longus tendon, EPL tendon). This leads to disability to stretch the thumb in order to grip bigger objects. Earlier studies show that the tendon ruptures in about 3-5% of all wrist fractures. These ruptures occur some weeks to months after the fracture.There are different theories about the cause of the rupture. One theory is that the fracture creates a bleeding in the tight area that the tendon lies, leading to high pressure and therefore low blood supply to the tendon. Another theory is that the tendon comes in contact with some sharp bonny fragments in this area that injures the tendon when it moves.Such tendon ruptures need almost always some type of surgical intervention in order to reconstruct the function of the thumb. A common problem is that the quality of the tendon is insufficient for just suturing it. Another problem is that the muscle becomes stiff after the rupture. However, there is no objective method to determine how stiff the muscle is.The most common treatment option is the transfer of one of the two extensor tendons of the index finger to the thumb, a so-called extensor indicis proprius to extensor pollicis longus transfer. The motivation behind this operation is that the muscle of EPL is so stiff that cannot be used to lift the thumb. However, there is no consensus about the time period after which the EPL muscle can be used to reconstruct the function of thumb.The study aims to investigate the microscopical changes in the muscle and tendon of EPL after such a rupture. Better knowledge of these factors could lead to better understanding of the treatment options.The investigators plan to include in the study all patients that would get operated for an EPL tendon rupture after a fracture of the distal radius at the institution the study is conducted. After oral and written information to the patient and written consent the investigators will take some samples from the ruptured tendon and muscle for microscopical analysis., conditionsModule conditions: Distal Radius Fractures, conditions: Tendon Injury - Hand, conditions: Pathology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: Biopsy of EPL tendon and muscle during the operation, outcomesModule primaryOutcomes measure: Histopathological analysis of the EPL muscle, secondaryOutcomes measure: Histopathological analysis of the EPL tendon, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahlgrenska University Hospital, city: Gothenburg, state: Västra Götaland, zip: 43180, country: Sweden, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06313476, orgStudyIdInfo id: SYSKY-2024-030-01, briefTitle: AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause, conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Anti-Mullerian Hormone, secondaryOutcomes measure: Estradiol, secondaryOutcomes measure: Follicle Stimulating Hormone, secondaryOutcomes measure: Menstruation, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 59 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06313463, orgStudyIdInfo id: SYSKY-2023-1282-02, briefTitle: Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2031-09, completionDateStruct date: 2035-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients.The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy., conditionsModule conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Carrellizumab + Capecitabine, interventions name: Placebo + Capecitabine, outcomesModule primaryOutcomes measure: Disease-Free Survival, secondaryOutcomes measure: Invasive Disease-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Distant Recurrence-Free Interval, secondaryOutcomes measure: Patient-reported outcomes-Proportion of patients in each group experiencing clinically meaningful deterioration, secondaryOutcomes measure: Patient-reported outcomes-EORTC QLQ-C30 scores after treatment, secondaryOutcomes measure: Patient-reported outcomes-EORTC QLQ-C30 scores changes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Shicheng Su, M.D., Ph.D., role: CONTACT, phone: +86 13632394954, email: lnl_trial@126.com, contacts name: Erwei Song, M.D., Ph.D., role: CONTACT, phone: +86 13719237746, email: lnl_trial@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06313450, orgStudyIdInfo id: B2023-110-X02, briefTitle: De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Radiotherapy; Complications, conditions: IMMUNOTHERAPY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: de-escalated radiotherapy, interventions name: conventional radiotherapy, outcomesModule primaryOutcomes measure: local recurrence rate(LRR), secondaryOutcomes measure: primary tumor volume regression≥75% rate, secondaryOutcomes measure: 3-year overall survival, secondaryOutcomes measure: acute and late radiation-induced toxicities, secondaryOutcomes measure: complete response rate of primary tumor, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Puyun Ouyang, role: CONTACT, phone: +8602087342926, email: ouyangpy@sysucc.org.cn, contacts name: Fangyun Xie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06313437, orgStudyIdInfo id: 24-021, briefTitle: Revumenib in Combination With 7+3 + Midostaurin in AML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-03-02, completionDateStruct date: 2027-03-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Maximilian Stahl, MD, class: OTHER, collaborators name: Syndax Pharmaceuticals, descriptionModule briefSummary: This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).The names of the study drugs involved in this study are:* Revumenib (SNDX-5613) (a type of menin inhibitor)* Midostaurin (a type of multi-kinase including FLT3 inhibitor)* Cytarabine (a type of antineoplastic agent)* Daunorubicin (a type of antineoplastic agent), conditionsModule conditions: Acute Myeloid Leukemia, conditions: AML, Adult, conditions: AML With Gene Mutations, conditions: AML, conditions: Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Revumenib, interventions name: Midostaurin, interventions name: Cytarabine, interventions name: Daunorubicin, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Recommended phase II dose (RP2D), secondaryOutcomes measure: Complete Remission (CR) rate with induction chemotherapy, secondaryOutcomes measure: Complete Remission (CR) rate with consolidation chemotherapy, secondaryOutcomes measure: Flow Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy, secondaryOutcomes measure: Flow Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy, secondaryOutcomes measure: Molecular Measurable Residual Disease Negative (MRD-) rate with induction chemotherapy, secondaryOutcomes measure: Molecular Measurable Residual Disease Negative (MRD-) rate with consolidation chemotherapy, secondaryOutcomes measure: Relapse-Free Survival at 1 year (RFS1), secondaryOutcomes measure: Overall Survival at 1 year (OS1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06313424, orgStudyIdInfo id: 9029, briefTitle: Arthroscopic Treatment of Meniscal Lesions on Healthy Meniscus in Children and Adolescents, acronym: ATML, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-29, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: Meniscal lesions are common in pediatrics and mainly affect adolescents. These lesions can jeopardize the functional prognosis of the knee in the short, medium or long term if they are not well managed.More precisely, it is a question of determining whether arthroscopic repair of isolated meniscal lesions in children gives good results and what factors influence them, with the aim of improving the care of children suffering from meniscal lesions.The treatment of meniscal lesions comes down to either conservative or restorative treatment or non-conservative treatment by meniscectomy. For most authors, the treatment of meniscal lesions must remain restorative through meniscal suture, leaving no room for meniscectomy. The open approach has given way to the arthroscopic approach which, according to the literature, is the gold standard. Meniscal lesions are varied and therefore there are numerous therapeutic procedures. Therapeutic indications are precise but the results of the treatments remain differently assessed depending on the studies; studies evaluating the results of treatment in the pediatric population are few in number.Based on this observation, the present study aims to describe the results of repairs of meniscal lesions in pediatric traumatology., conditionsModule conditions: Knee Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: description of the results of repairs of meniscal lesions in pediatric traumatology, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Service de Chirurgie Pédiatrique - CHU de Strasbourg - France, status: RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Philippe GICQUEL, MD, PhD, role: CONTACT, phone: 33 3 88 12 82 65, email: Philippe.Gicquel@chru-strasbourg.fr, contacts name: Philippe GICQUEL, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Saïd Nahl Oumar GANAME, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
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protocolSection identificationModule nctId: NCT06313411, orgStudyIdInfo id: 8778, briefTitle: How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma, acronym: PRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-23, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care., conditionsModule conditions: Endometriosis Pelvic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ESTIMATED, outcomesModule primaryOutcomes measure: laparoscopic removal of a retroperitoneal pelvic schwannoma, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France, status: RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Emilie FALLER, MD, role: CONTACT, phone: 33 3 88 12 63 87, email: emilie.faller@chru-strasbourg.fr, contacts name: Alexandre PIFFER, MD, role: CONTACT, phone: 33 6 71 47 38 61, email: Alexandre.piffer@yahoo.fr, contacts name: Emilie FALLER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexandre PIFFER, MD, role: SUB_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
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protocolSection identificationModule nctId: NCT06313398, orgStudyIdInfo id: 10001883, secondaryIdInfos id: 001883-H, briefTitle: Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-06-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Heart, Lung, and Blood Institute (NHLBI), class: NIH, collaborators name: Children's National Research Institute, descriptionModule briefSummary: Background:Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant.Objective:To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant.Eligibility:People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed.Design:Participants will be screened. They will have a physical exam with blood and urine tests.Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream.Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected...., conditionsModule conditions: Sickle Cell Disease, conditions: Thalassemia, conditions: Hemoglobinopathy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biotin-labeled red blood cells, outcomesModule primaryOutcomes measure: To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies., secondaryOutcomes measure: Validate the association of RBC survival with known markers of increased survival., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06313385, orgStudyIdInfo id: 22-10-1180, briefTitle: Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses., conditionsModule conditions: Free Flap, conditions: Indocyanine Green, conditions: Microsurgery, conditions: Temperature Change, Body, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The population were divided into three equal groups of indocyanine green concentration : 5 milligram per milliliter (mg/mL), 2,5 mg/mL, and 0,5 mg/mL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: QUADRUPLE, maskingDescription: The participants didn't know about indocyanine green (ICG) drug groups as well as the concentration that they received. The ICG was added into the syringe by research assistant without any label near the end of operation time. The ICG injection to the patient was performed by anesthesiologist who didn't know about the concentration at all. Outcome assessor didn't know about the given concentration., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Indocyanine Green Fluorescence (ICG), interventions name: Temperature, interventions name: Transcutaneous oxygen and carbon dioxide pressure, interventions name: Histopathology, interventions name: Hypoxia inducible factor-1 (HIF-1) alpha, outcomesModule primaryOutcomes measure: The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion, secondaryOutcomes measure: The ICG fluorescence intensity in different titration dose with flap surface Temperature, secondaryOutcomes measure: Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume, secondaryOutcomes measure: Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue, secondaryOutcomes measure: Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, city: Jakarta Pusat, state: Jakarta, zip: 10430, country: Indonesia, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False
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protocolSection identificationModule nctId: NCT06313372, orgStudyIdInfo id: CA2085, briefTitle: Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Scius Healthcare Solutions Pty Ltd, class: INDUSTRY, collaborators name: Chiesi Australia, descriptionModule briefSummary: This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:* Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.* What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds., conditionsModule conditions: Asthma, conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Respiratory oscillometry, outcomesModule primaryOutcomes measure: Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale., primaryOutcomes measure: Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly), secondaryOutcomes measure: Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly), secondaryOutcomes measure: Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06313359, orgStudyIdInfo id: FY2024-125, briefTitle: Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Texas Woman's University, class: OTHER, descriptionModule briefSummary: The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer. Specifically, we are interested to find out if you have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. We are also interested to see if you have any difficulty with doing two activities at the same time, such as walking and texting., conditionsModule conditions: Peripheral Neuropathy Due to Chemotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Fall risk, primaryOutcomes measure: Quality of life- in cancer patients, secondaryOutcomes measure: Trail Making Test (TMT) Parts A & B, secondaryOutcomes measure: Single Task- Working Memory, secondaryOutcomes measure: Single Task- Visual Attention Cognitive Task, secondaryOutcomes measure: Protective Sensation, secondaryOutcomes measure: Grip Strength, secondaryOutcomes measure: LE strength assessment- HHD, secondaryOutcomes measure: Dynamic Balance, secondaryOutcomes measure: Single Task- Gait Speed, secondaryOutcomes measure: Dual Task- Working Memory & Gait Speed - Composite measure, secondaryOutcomes measure: Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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