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protocolSection identificationModule nctId: NCT06278233, orgStudyIdInfo id: 2023/85-70, briefTitle: Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency, acronym: TDCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition., conditionsModule conditions: Stuttering, Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this study, a double-blind, randomized controlled research design from experimental research methods will be applied., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: One researcher not involved in any aspect of the study will randomize participants to the sham and tDCS study arms using blocked randomization. To ensure blinding, one researcher will record the administration of the tDCS and assessments, while independent speech-language pathologists will monitor the assessment recordings and score the test items., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Disfluent syllables, secondaryOutcomes measure: Stuttering Severity Instrument- Fourth Edition (SSI-IV) score, secondaryOutcomes measure: The Overall Assessment of the Speaker's Experience of Stuttering (OASES) score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Biruni University, status: RECRUITING, city: Istanbul, state: Zeytinburnu, zip: 34015, country: Turkey, contacts name: Feyzanur Ocak, Slp, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06278220, orgStudyIdInfo id: Corneal HOA, briefTitle: Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Aim of work:To assess the agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) regard measuring corneal higher order aberrations before and after LASIK., conditionsModule conditions: Corneal Higher-order Aberrations, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ), outcomesModule primaryOutcomes measure: Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam), secondaryOutcomes measure: Changes in high order aberrations after LASIK., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Naglaa Moustafa, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06278207, orgStudyIdInfo id: 22731, briefTitle: An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions, acronym: FINEROD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study, in which data from people in Japan with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.The data will come from a network of commercial electronic health records (EHRs) and national claims data in Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study., conditionsModule conditions: Chronic Kidney Disease, conditions: Type 2 Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Finerenone (BAY 94-8862), outcomesModule primaryOutcomes measure: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone., primaryOutcomes measure: Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone., primaryOutcomes measure: Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone., secondaryOutcomes measure: Proportion of finerenone initiators with and without UACR measurements at baseline, secondaryOutcomes measure: Mean UACR in the subcohort with UACR measurements, secondaryOutcomes measure: Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone., secondaryOutcomes measure: Number of participants who initiate finerenone at a 10 mg dose daily, secondaryOutcomes measure: Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark, secondaryOutcomes measure: Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark, secondaryOutcomes measure: Number of participants who initiate finerenone at a 20 mg dose daily, secondaryOutcomes measure: Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark, secondaryOutcomes measure: Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, status: RECRUITING, city: Berlin, zip: 13353, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Many Locations, status: COMPLETED, city: Multiple Locations, country: Japan, hasResults: False |
protocolSection identificationModule nctId: NCT06278194, orgStudyIdInfo id: 22.11.2023.589, briefTitle: Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle., conditionsModule conditions: Trigeminal Neuralgia, conditions: Gasserian Ganglion; Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Gasserian Ganglion Radiofrequency Thermocoagulation, outcomesModule primaryOutcomes measure: Masseter muscle thickness, primaryOutcomes measure: Masseter muscle thickness, primaryOutcomes measure: Masseter muscle thickness, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06278181, orgStudyIdInfo id: 2023/08/1545, briefTitle: Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-21, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: University of Dschang, collaborators name: European Foundation for the Study of Diabetes, descriptionModule briefSummary: Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. The investigators will assess the risk of malaria, as well as other parasitic diseases, in a prospectively followed group of adults with diabetes, compared with those without diabetes. Malaria parasites and intestinal worms will be tested using blood and stool collected at four time points during a one-year follow-up. In addition, this project will investigate how natural protection against malaria is affected by diabetes and other risk factors for heart diseases., conditionsModule conditions: Malaria, conditions: Diabetes Mellitus, conditions: Metabolic Syndrome, conditions: Endemic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: asymptomatic malaria, secondaryOutcomes measure: symptomatic malaria, otherOutcomes measure: schistosoma infection, otherOutcomes measure: strongyloides infection, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Limbe Regional Hospital, status: RECRUITING, city: Limbe, country: Cameroon, contacts name: George Awungafac, MD, role: CONTACT, phone: +23779750125, email: [email protected], geoPoint lat: 4.02356, lon: 9.20608, hasResults: False |
protocolSection identificationModule nctId: NCT06278168, orgStudyIdInfo id: CNR-IRIB-PRO-2024-002, briefTitle: Awareness Training in Children With Autism Spectrum Disorder., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-12, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-05-08, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, collaborators name: Messina, Italy, descriptionModule briefSummary: The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Awareness training with using Oculus., interventions name: Awareness training without using Oculus, outcomesModule primaryOutcomes measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV), primaryOutcomes measure: Multidimensional Anxiety Scale for Children-Second Edition (MASC 2), primaryOutcomes measure: Screen for Child Anxiety Related Disorders (SCARED), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: [email protected], contacts name: Maria Valeria Maiorana, role: CONTACT, phone: +393285856656, email: [email protected], contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Gennaro Tartarisco, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False |
protocolSection identificationModule nctId: NCT06278155, orgStudyIdInfo id: CNR-IRIB-PRO-2024-001, briefTitle: Social Relations Training for Children With ASD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-04-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, collaborators name: Messina, Italy, descriptionModule briefSummary: The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Social relation training with social robot, interventions name: Traditional social relations training, outcomesModule primaryOutcomes measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: [email protected], contacts name: Giovanni Pioggia, role: CONTACT, phone: +393203390892, email: [email protected], contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Alfio Puglisi, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False |
protocolSection identificationModule nctId: NCT06278142, orgStudyIdInfo id: ERTELEME_1, briefTitle: Web-Based Cognitive Behavior Therapy for Procrastination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Anadolu University, class: OTHER, descriptionModule briefSummary: The main purpose of this study is to present the development process and project flow of an internet-based self-help intervention programme to reduce the level of procrastination among university students., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Internet Based Intervention - GUIDED, interventions name: Internet Based Intervention - WİTHOUT GUİDANCE, outcomesModule primaryOutcomes measure: Tuckman Procrastination Behaviour Scale, primaryOutcomes measure: Cognitive Distortions Questionnaire, primaryOutcomes measure: Time Management Scale, primaryOutcomes measure: Attitude Scale for Internet-Based Interventions, secondaryOutcomes measure: Depression Anxiety Stress Scale-21 (DASS-21), otherOutcomes measure: Sociodemographic Information Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06278129, orgStudyIdInfo id: 4146, briefTitle: Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease, acronym: MRI_SSHL/MD, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-06-19, primaryCompletionDateStruct date: 2021-04-23, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates., conditionsModule conditions: Sudden Sensorineural Hearing Loss, conditions: Meniere Disease, conditions: Ménière's Vertigo, conditions: Meniere's Disease Aggravated, conditions: Inner Ear Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Vestibular myogenic potentials, outcomesModule primaryOutcomes measure: Evaluation of inner ear structures in MRI images, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Audiology and Neuroradiology - Milan (Italy), status: RECRUITING, city: Milan, zip: 20133, country: Italy, contacts name: Diego Zanetti, MD Prof, role: CONTACT, phone: 00390255033936, email: [email protected], contacts name: Federica Di Berardino, MD Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Giorgio Conte, MD Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06278116, orgStudyIdInfo id: 2024-ALIGNERSCLEANSIGN, briefTitle: Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study., conditionsModule conditions: Dental Malocclusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Aligners cleansing with water, interventions name: Aligners cleansing with dish soap Svelto, interventions name: Aligners cleansing with Polident Antibacterial Denture Cleaner, interventions name: Aligners cleansing with Invisalign Cleaning Crystals, interventions name: Aligners cleansing with Geldis, outcomesModule primaryOutcomes measure: Change in adsorbance (A) value, primaryOutcomes measure: Changes in patient's perception, secondaryOutcomes measure: Changes in Probing Pocket Depth (PPD) values, secondaryOutcomes measure: Changes in Gingival Index (GI) values, secondaryOutcomes measure: Changes in Bleeding on probing (BOP), secondaryOutcomes measure: Change in Schiff Air Index - Dental sensitivity test, secondaryOutcomes measure: Change of the BEWE Index Basic Erosive Wear Examination, secondaryOutcomes measure: Change in plaque index (PI):, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, status: RECRUITING, city: Pavia, state: Lombardy, zip: 27100, country: Italy, contacts name: Andrea Scribante, DDS, PhD, role: CONTACT, phone: +39 0382516223, email: [email protected], geoPoint lat: 45.19205, lon: 9.15917, hasResults: False |
protocolSection identificationModule nctId: NCT06278103, orgStudyIdInfo id: 2023PI113, briefTitle: Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M), acronym: MethylRH-M, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2000-01-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression., conditionsModule conditions: Meningioma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 180, type: ESTIMATED, outcomesModule primaryOutcomes measure: immunohistochemical expression of different hormonal receptors, secondaryOutcomes measure: methylation profile of the promoters of hormonal receptor genes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06278090, orgStudyIdInfo id: AUDC, briefTitle: Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution, acronym: GALPOL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:• Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventionsParticipants will be managed according to the standard practice of the department they are attended:* According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.* According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly., conditionsModule conditions: Gallbladder Polyp, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Ursodeoxycholic Acid Only Product, outcomesModule primaryOutcomes measure: Reducing gallbladder polyp size by 2mm or more, secondaryOutcomes measure: Modification of the expected follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06278077, orgStudyIdInfo id: C2104, secondaryIdInfos id: 2022-003565-38, type: EUDRACT_NUMBER, briefTitle: Neurexan - a Clinical Trial in Short-Term Insomnia Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Biologische Heilmittel Heel GmbH, class: INDUSTRY, descriptionModule briefSummary: This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia., conditionsModule conditions: Insomnia, conditions: Stress Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All involved personnel at the investigational site, the Sponsor (except production unit) and the CRO (except independent biostatistician for performing the randomization) will be blinded during the trial. The Investigator keeps the sealed treatment code envelopes throughout the course of the trial for the individual patients and must not break the code without a valid reason (e.g., in case of emergency)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Neurexan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Sleep Efficiency., secondaryOutcomes measure: Change from baseline in sleep pattern characterized by Number of Awakenings., secondaryOutcomes measure: Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire., secondaryOutcomes measure: Ecological Momentary Assessments - continuous daily stress assessment., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jena University Hospital, Department of Psychiatry & Psychotherapy, status: RECRUITING, city: Jena, state: Thuringia, zip: 07743, country: Germany, contacts name: Martin Walter, MD, role: CONTACT, phone: +49 (0)3641 9390101, email: [email protected], geoPoint lat: 50.92878, lon: 11.5899, hasResults: False |
protocolSection identificationModule nctId: NCT06278064, orgStudyIdInfo id: BFHHZML20240006, briefTitle: Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy., conditionsModule conditions: Gastric Cancer, conditions: Esophagus Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 562, type: ESTIMATED, armsInterventionsModule interventions name: Gastric Cancer, interventions name: Esophagus Cancer, outcomesModule primaryOutcomes measure: Plasma proteins in patients with gastric cancer, primaryOutcomes measure: Plasma proteins in patients with esophagus cancer, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: Lianmei Zhao, Ph.D., role: CONTACT, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, country: China, contacts name: Li Min, Ph.D., role: CONTACT, contacts name: Li Min, Ph.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Chenjie Xu, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, country: China, contacts name: Yibin Xie, Ph.D, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06278051, orgStudyIdInfo id: 21411, briefTitle: An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, collaborators name: Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.), descriptionModule briefSummary: This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting.Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor.In addition, this study will help learn more about the following in children with VTE:* The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin* The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding* The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban* The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors.The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024.Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period.In this study, only available data from routine care are collected. No visits or tests are required as part of this study, conditionsModule conditions: Venous Thromboembolism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban granules for oral suspension, interventions name: Warfarin, outcomesModule primaryOutcomes measure: Incidence of major bleeding in participants treated with rivaroxaban, primaryOutcomes measure: Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban, secondaryOutcomes measure: Incidence of major bleeding in participants treated with warfarin, secondaryOutcomes measure: Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference, secondaryOutcomes measure: Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Many facilities, status: RECRUITING, city: Multiple Locations, country: Japan, locations facility: Bayer, status: RECRUITING, city: Osaka, zip: 530-0001, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, hasResults: False |
protocolSection identificationModule nctId: NCT06278038, orgStudyIdInfo id: NO.0057 in 2024 Ethical Review, briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use., conditionsModule conditions: Major Depression Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Toludesvenlafaxine hydrochloride sustained-release tablets, interventions name: Venlafaxine hydrochloride sustained-release tablets, outcomesModule primaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale (DARS) Score, secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score, secondaryOutcomes measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score, secondaryOutcomes measure: Sheehan Disability Scale (SDS) Score, secondaryOutcomes measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score, otherOutcomes measure: Treatment Emergent Symptom Scale (TESS) Score, otherOutcomes measure: Arizona Sexual Experience Scale (ASEX) Score, otherOutcomes measure: Count of red blood cell in blood, otherOutcomes measure: Count of white blood cell in blood, otherOutcomes measure: Count of platelet in blood, otherOutcomes measure: Concentration of hemoglobin in blood, otherOutcomes measure: Concentration of alanine aminotransferase in blood, otherOutcomes measure: Concentration of aspartate aminotransferase in blood, otherOutcomes measure: Concentration of gamma-glutamyltransferase in blood, otherOutcomes measure: Concentration of blood glucose in blood, otherOutcomes measure: Concentration of serum creatinine in blood, otherOutcomes measure: Concentration of urea in blood, otherOutcomes measure: Concentration of total cholesterol in blood, otherOutcomes measure: Concentration of high density lipoprotein in blood, otherOutcomes measure: Concentration of low density lipoprotein in blood, otherOutcomes measure: Concentration of triglyceride in blood, otherOutcomes measure: Concentration of protein in urine, otherOutcomes measure: Concentration of sugar in urine, otherOutcomes measure: Count of white blood cell in urine, otherOutcomes measure: Count of red blood cell in urine, otherOutcomes measure: ECG QT Interval, otherOutcomes measure: Changes in weight, otherOutcomes measure: Changes in pulse, otherOutcomes measure: Changes in both systolic and diastolic blood pressure, otherOutcomes measure: Changes in respiration rate, otherOutcomes measure: Changes in armpit temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06278025, orgStudyIdInfo id: GO 19/833, briefTitle: Dysphagia and Deep Cervical Flexor Muscles, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Atılım University, class: OTHER, descriptionModule briefSummary: Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia., conditionsModule conditions: Dysphagia, conditions: Neurological Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: assessment, outcomesModule primaryOutcomes measure: dcf muscle strenght, primaryOutcomes measure: dcf endurance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atilim University, city: Ankara, state: Incek, zip: 06830, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06278012, orgStudyIdInfo id: E-59394181-604.01.02-32288, briefTitle: Development of Atılım Kinesiophobia Scale, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Atılım University, class: OTHER, descriptionModule briefSummary: Background:Kinesiophobia or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The existing scales measuring kinesiophobia are thought to have some limitations (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition). These questionnaires may not have specific questions enough to assess fear of movement in different patient populations.Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.Material/method:In the first stage of the study, research on kinesiophobia was reviewed and a total of 38 questions were created for the scale. The questions were submitted to the opinion of 11 experts working in the physiotherapy and rehabilitation field. Then A total of 100 patients with acute and chronic musculoskeletal pain completed the Turkish Atılım Kinesiophobia Scale and Tampa Scale of Kinesiophobia., conditionsModule conditions: Kinesiophobia, conditions: Acute Pain, conditions: Chronic Pain, conditions: Fear of Movement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group., primaryOutcomes measure: item analyses and exploratory factor analysis (EFA) analysis will be performed with a sample size of 5 times the number of questions in the item pool with acute and chronic pain patients., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atılım University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Naime Uluğ, PhD., role: CONTACT, phone: +905365434409, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06277999, orgStudyIdInfo id: D8820C00001, briefTitle: C.Difficile Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-10-11, completionDateStruct date: 2024-10-11, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires, conditionsModule conditions: Clostridium Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of participants that completed key study activities according to protocol, secondaryOutcomes measure: Time intervals across stool sample collection logistics, secondaryOutcomes measure: Participant Experience and site staff evaluation questionnaires, secondaryOutcomes measure: Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06277986, orgStudyIdInfo id: KY20212018-F-2, briefTitle: Early Diagnosis of Gastric Cancer Cachexia, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia., conditionsModule conditions: Cachexia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: cachexia, outcomesModule primaryOutcomes measure: BMI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fourth Military Medical University, status: RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Jipeng Li, role: CONTACT, phone: +86-029-84771533, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06277973, orgStudyIdInfo id: 0007551-2, briefTitle: Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Tel Aviv University, class: OTHER, descriptionModule briefSummary: The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD., conditionsModule conditions: Post-traumatic Stress Disorder, conditions: Acute Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly allocated to one of the following groups: the experiment group and the waiting list group. Each group will receive the intervention but in the waiting list group this will occur a week later:Experiment group:Day 1 - questionnaires (T1) Day 4 - intervention Day 7 - questionnaires (T2) Day 97 - follow up questionnaires (T3)Waiting list group:Day 1 - questionnaires (T0) Day 7 - questionnaires (T1) Day 11- intervention Day 14- questionnaires (T2) Day 104- follow up questionnaires (T3) The parallel element of this model lies in the first week of the study: the experiment group goes through 2 measurements with the intervention in the middle of the week, whereas the waiting list group goes through 2 measurements without the intervention., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants will be informed that the intervention will occur between 2 days and 14 days and that they will fill 3-4 surveys. They will not be aware that there are two groups., whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Eye Movement Desensitization and Reprocessing (EMDR), outcomesModule primaryOutcomes measure: PCL-5 (Posttraumatic Stress Disorder Checklist), primaryOutcomes measure: GAD-7 (General Anxiety Disorder-7), primaryOutcomes measure: SSASI (The Short Scale Anxiety Sensitivity Index), primaryOutcomes measure: BSI 18 (Brief Symptom Inventory), primaryOutcomes measure: DES-II (Dissociative Experiences Scale), primaryOutcomes measure: DERS (Difficulties in Emotion Regulation Scale), primaryOutcomes measure: NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale), primaryOutcomes measure: SASRQ (Stanford Acute Stress Reaction Questionnaire), primaryOutcomes measure: Exposure to traumatic event during the current war, primaryOutcomes measure: PDEQ (Peritraumatic Dissociative Experiences Questionnaire), primaryOutcomes measure: TIS (Tonic Immobility Scale), primaryOutcomes measure: PDI (The Peritraumatic Distress Inventory), primaryOutcomes measure: Questionnaires to test user experience of the system, primaryOutcomes measure: Questionnaire for examining the experience of the intervention, primaryOutcomes measure: Qualitative interview, primaryOutcomes measure: Questionnaire regarding receiving emotional treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tel Aviv University, city: Tel Aviv, country: Israel, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False |
protocolSection identificationModule nctId: NCT06277960, orgStudyIdInfo id: CNS2301, briefTitle: Septal Ablation for Obstructive HCM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: SuZhou Sinus Medical Technologies Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy., conditionsModule conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: percutaneous intramyocardial septal radiofrequency ablation system, outcomesModule primaryOutcomes measure: 30-day major adverse clinical events (MACE), secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Short Form 36 (SF-36) health survey questionnaire, secondaryOutcomes measure: Improvement of left ventricular outflow tract gradient (LVOTG), secondaryOutcomes measure: Improvement of NYHA functional classification, secondaryOutcomes measure: 6-min walk distance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Yaxun Sun, MD, role: CONTACT, phone: +86 15057173170, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06277947, orgStudyIdInfo id: SYSKY-2024-096-01, briefTitle: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward, acronym: GARD-HIPEC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, collaborators name: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University, descriptionModule briefSummary: Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion., conditionsModule conditions: Epithelial Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC), outcomesModule primaryOutcomes measure: The incidence of adverse events of grade 3-5, secondaryOutcomes measure: Time to progress (TTP), secondaryOutcomes measure: The Time to the First Subsequent Therapy，TTFST, secondaryOutcomes measure: Quality of life, QLQ-C30, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06277934, orgStudyIdInfo id: RGT001-075-203, briefTitle: A Study of RGT001-075 in Adult Patients With Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Regor Pharmaceuticals Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: RGT001-075, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings, secondaryOutcomes measure: Percent change in body weight, secondaryOutcomes measure: Change in body weight in kilogram, secondaryOutcomes measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction, secondaryOutcomes measure: Change in Body mass index (BMI) in kg/m^2, secondaryOutcomes measure: Change in waist circumference in centimetre, secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research, status: RECRUITING, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: David Guzman, MD, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Velocity Clinical Research, status: RECRUITING, city: Valparaiso, state: Indiana, zip: 46383, country: United States, contacts name: Robert Buynak, MD, role: CONTACT, geoPoint lat: 41.47309, lon: -87.06114, locations facility: Velocity Clinical Research, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, contacts name: Frederick Raiser, MD, role: CONTACT, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Velocity Clinical Research, status: RECRUITING, city: Vestal, state: New York, zip: 13850, country: United States, contacts name: Eric Lorraine, MD, role: CONTACT, geoPoint lat: 42.08507, lon: -76.05381, locations facility: Velocity Clinical Research, status: RECRUITING, city: Durham, state: North Carolina, zip: 27701, country: United States, contacts name: William Cromwell, MD, role: CONTACT, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Velocity Clinical Research, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44122, country: United States, contacts name: Margaret Rhee, MD, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Velocity Clinical Research, status: RECRUITING, city: Medford, state: Oregon, zip: 97504, country: United States, contacts name: Sarah Smiley, MD, role: CONTACT, geoPoint lat: 42.32652, lon: -122.87559, locations facility: Velocity Clinical Research, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, contacts name: David Fried, MD, role: CONTACT, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Velocity Clinical Research, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Dan Lender, MD, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Velocity Clinical Research, status: RECRUITING, city: West Jordan, state: Utah, zip: 84088, country: United States, contacts name: Barbara Rizzardi, MD, role: CONTACT, geoPoint lat: 40.60967, lon: -111.9391, hasResults: False |
protocolSection identificationModule nctId: NCT06277921, orgStudyIdInfo id: 110-2, briefTitle: Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery, acronym: ESOSTAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-09-18, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: P. Herzen Moscow Oncology Research Institute, class: OTHER_GOV, collaborators name: National Medical Research Radiological Centre of the Ministry of Health of Russia, descriptionModule briefSummary: Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation., conditionsModule conditions: Esophageal Cancer, conditions: Oesophageal Cancer, conditions: Siewert Type I Adenocarcinoma of Esophagogastric Junction, conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Elective Surgery for gastric cancer, outcomesModule primaryOutcomes measure: the type of complications and the incidence of it, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A.S. Loginov Moscow Clinical Scientific Center, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: I.M. Sechenov First Moscow State Medical University, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: P.Herzen Moscow Oncological Research Institute, city: Moscow, country: Russian Federation, contacts name: Andrey Ryabov, role: CONTACT, contacts name: Nuriddin Abdulkhakimov, role: CONTACT, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Petrovsky National Research Centre of Surgery, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Vishnevsky National Medical Research Center of Surgery, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Nizhny Novgorod Regional Clinical Oncological Dispensary, city: Nizhny Novgorod, country: Russian Federation, geoPoint lat: 56.32867, lon: 44.00205, locations facility: A.Tsyb Medical Radiological Research Centre, city: Obninsk, country: Russian Federation, geoPoint lat: 55.09681, lon: 36.61006, locations facility: National Medical Research Centre for Oncology, city: Rostov-on-Don, country: Russian Federation, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Petrov National Medical Research Center of Oncology, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False |
protocolSection identificationModule nctId: NCT06277908, orgStudyIdInfo id: 110-1, briefTitle: Postoperative Morbidity and Mortality After Gastric Cancer Surgery, acronym: GASTROSTAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-09-18, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: P. Herzen Moscow Oncology Research Institute, class: OTHER_GOV, collaborators name: National Medical Research Radiological Centre of the Ministry of Health of Russia, descriptionModule briefSummary: Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation., conditionsModule conditions: Gastric Cancer, conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction, conditions: Stomach Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Elective Surgery for gastric cancer, outcomesModule primaryOutcomes measure: the type of complications and the incidence of it, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A.S. Loginov Moscow Clinical Scientific Center, city: Moscow, country: Russian Federation, contacts name: Roman Izrailov, role: CONTACT, contacts name: Nikolay Semenov, role: CONTACT, geoPoint lat: 55.75222, lon: 37.61556, locations facility: A.Tsyb Medical Radiological Research Centre, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: I.M. Sechenov First Moscow State Medical University, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: P.Herzen Moscow Oncological Research Institute, city: Moscow, country: Russian Federation, contacts name: Andrey Ryabov, role: CONTACT, contacts name: Nuriddin Abdulkhakimov, role: CONTACT, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Petrovsky National Research Centre of Surgery, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Vishnevsky National Medical Research Center of Surgery, city: Moscow, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Nizhny Novgorod Regional Clinical Oncological Dispensary, city: Nizhny Novgorod, country: Russian Federation, geoPoint lat: 56.32867, lon: 44.00205, locations facility: National Medical Research Centre for Oncology, city: Rostov-on-Don, country: Russian Federation, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Petrov National Medical Research Center of Oncology, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False |
protocolSection identificationModule nctId: NCT06277895, orgStudyIdInfo id: KYLL-202401-047, briefTitle: VOCs in Patients With Acute Cardiogenic Chest Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure., conditionsModule conditions: Acute Coronary Syndrome, conditions: Acute Aortic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1400, type: ESTIMATED, armsInterventionsModule interventions name: VOCs, outcomesModule primaryOutcomes measure: Baseline VOCs (aldehydes) levels in healthy population, secondaryOutcomes measure: MACE in patients with cardiogenic chest pain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: yuan bian, role: CONTACT, phone: 18560084775, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False |
protocolSection identificationModule nctId: NCT06277882, orgStudyIdInfo id: Si 067/2024, briefTitle: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general populationHAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.The main questions it aims to answer are:* Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.* Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis., conditionsModule conditions: Cirrhosis, conditions: Hep A, conditions: Vaccination, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: HAVRIX, outcomesModule primaryOutcomes measure: Post-vaccination serological response rate, secondaryOutcomes measure: Post-vaccination serological response, secondaryOutcomes measure: Post-vaccination serological response, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at month 1, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at month 7, secondaryOutcomes measure: Anti-hepatitis A Virus (HAV) antibody at 1 year, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Siriraj Hospital, status: RECRUITING, city: Bangkok Noi, state: Bangkok, zip: 10700, country: Thailand, contacts name: Watcharasak Chotiyaputta, Asso Prof, role: CONTACT, phone: 6624197281, email: [email protected], geoPoint lat: 13.76266, lon: 100.47798, hasResults: False |
protocolSection identificationModule nctId: NCT06277869, orgStudyIdInfo id: PR-22146, briefTitle: Effectiveness Trial of Thermal Jacket, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-22, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, collaborators name: Directorate General of Health Services (DGHS), Bangladesh, collaborators name: Poeticgem International Ltd, descriptionModule briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation.The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh., conditionsModule conditions: Preterm Neonate, conditions: Low Birthweight Neonate, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Stepped wedge cluster randomised trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Thermal Jacket, interventions name: Kangaroo Mother Care, outcomesModule primaryOutcomes measure: Body temperature of preterm or low birthweight neonates maintain the euthermic range., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lakshmipur District Hospital, status: RECRUITING, city: Lakshmipur, state: Chattogram, zip: 3700, country: Bangladesh, contacts name: Ahmed Kabir, MBBS, role: CONTACT, phone: 01842587456, email: [email protected], geoPoint lat: 22.9443, lon: 90.83005, locations facility: Kushtia 250 Bedded General Hospital, status: RECRUITING, city: Kushtia, state: Khulna, zip: 7000, country: Bangladesh, contacts name: Md. Rafiqul Islam, MBBS, role: CONTACT, phone: 01829699289, email: [email protected], geoPoint lat: 23.9028, lon: 89.11943, locations facility: Jamalpur 250 Beded General Hospital, status: NOT_YET_RECRUITING, city: Jamalpur, state: Mymensingh, zip: 2000, country: Bangladesh, contacts name: Muhammad Mahfuzur Rahman, MBBS, role: CONTACT, phone: 01716267689, email: [email protected], geoPoint lat: 24.91965, lon: 89.94812, hasResults: False |
protocolSection identificationModule nctId: NCT06277856, orgStudyIdInfo id: Aysun Eksioglu, secondaryIdInfos id: Ayse Akyar, type: OTHER, domain: Ege University, briefTitle: Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding., conditionsModule conditions: Mothers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: In order to eliminate selection bias in the study, "block randomisation" method, one of the fixed probability randomisation methods, will be used and women who meet the inclusion criteria will be distributed to the intervention and control groups., whoMasked: INVESTIGATOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Peer interaction/control, outcomesModule primaryOutcomes measure: breastfeeding self-efficacy, primaryOutcomes measure: exclusive breastfeeding rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ege University, status: RECRUITING, city: Izmir, zip: 35100, country: Turkey, contacts name: Ayşe Akyar, Midwife, role: CONTACT, phone: +905538507280, email: [email protected];, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06277843, orgStudyIdInfo id: PR-21131, briefTitle: Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-13, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, collaborators name: Directorate General of Health Services (DGHS), Bangladesh, collaborators name: Poeticgem International Ltd, collaborators name: University of Dhaka, descriptionModule briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours., conditionsModule conditions: Preterm, conditions: Low Birthweight, conditions: Hypothermia Neonatal, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm non-randomized trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Thermal Jacket, outcomesModule primaryOutcomes measure: Body temperature of preterm or low birthweight neonates and duration of time in euthermic range., eligibilityModule sex: ALL, minimumAge: 0 Hours, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Bangabandhu Sheikh Mujib Medical University (BSMMU), city: Dhaka, zip: 1000, country: Bangladesh, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False |
protocolSection identificationModule nctId: NCT06277830, orgStudyIdInfo id: 2023P002788, briefTitle: Physical Activity Monitoring in Myasthenia Gravis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: BioSensics, descriptionModule briefSummary: The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG).The main question\[s\] it aims to answer are:* To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales.* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic., conditionsModule conditions: Myasthenia Gravis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Wearable sensor, outcomesModule primaryOutcomes measure: Primary outcome, secondaryOutcomes measure: Exploratory outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Carina Stafstrom, BS, role: CONTACT, email: [email protected], contacts role: CONTACT, phone: 617-726-5175, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06277817, orgStudyIdInfo id: 2021/1916, briefTitle: The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-19, primaryCompletionDateStruct date: 2021-06-25, completionDateStruct date: 2022-10-24, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support., conditionsModule conditions: Patient Involvement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: expiratory rib cage compression, interventions name: percussion vibration, outcomesModule primaryOutcomes measure: The effect of percussion vibration on the amount of secretion, primaryOutcomes measure: Effect of expiratory rib cage compression on the amount of secretion, primaryOutcomes measure: Effect of percussion vibration on blood gas parameters, primaryOutcomes measure: Effect of expiratory rib cage compression on blood gas parameters, primaryOutcomes measure: Perküsyon vibrasyonun yaşam bulgularına etkisi, primaryOutcomes measure: Effect of expiratory rib cage compression on vital signs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tunceli State Hospital, city: Tunceli, zip: 62000, country: Turkey, geoPoint lat: 39.09921, lon: 39.54351, hasResults: False |
protocolSection identificationModule nctId: NCT06277804, orgStudyIdInfo id: LTC004-102, briefTitle: A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Letolab, class: INDUSTRY, descriptionModule briefSummary: This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors., conditionsModule conditions: Adult Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: LTC004 in Combination With Cyclophosphamide and Fludarabine, outcomesModule primaryOutcomes measure: Safety, tolerability and antitumor efficacy of Combination., secondaryOutcomes measure: PK Characteristics and immunogenicity of Combination, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06277791, orgStudyIdInfo id: HStomatologyWuhan1, briefTitle: The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Hospital of Stomatology, Wuhan University, class: OTHER, descriptionModule briefSummary: The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are:• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\]., conditionsModule conditions: Clinical IVb Stage Oral Squamous Cell Carcinomas Patients, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, outcomesModule primaryOutcomes measure: Effective mitigation rate（EMR）, secondaryOutcomes measure: DFS, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: ORR, secondaryOutcomes measure: mOS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: School of Stomatology Wuhan University, status: RECRUITING, city: Hubei, state: Wuhan, zip: 430079, country: China, contacts name: JJia Associate Professor, role: CONTACT, phone: +8613277924848, email: [email protected], contacts name: zili Yu, role: PRINCIPAL_INVESTIGATOR, hasResults: False |
protocolSection identificationModule nctId: NCT06277778, orgStudyIdInfo id: HSEARS20211117003-03, briefTitle: Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Taekwondo training with music therapy, interventions name: Taekwondo training alone, outcomesModule primaryOutcomes measure: Engagement in the Training Sessions, primaryOutcomes measure: Gross Motor Skills, secondaryOutcomes measure: Physical Activity Level, secondaryOutcomes measure: Enjoyment State, secondaryOutcomes measure: Rate of Perceived Exertion, secondaryOutcomes measure: Taekwondo skills performance, secondaryOutcomes measure: Conners' Continuous Performance Test II, secondaryOutcomes measure: Comprehensive Trail-Making Test (CTMT), secondaryOutcomes measure: Social Responsiveness Scale, second edition (SRS-2), secondaryOutcomes measure: Childhood Autism Spectrum Test, secondaryOutcomes measure: Strength and Difficulties Questionnaires (SDQ), secondaryOutcomes measure: Clinical Global Improvement (CGI) score, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06277765, orgStudyIdInfo id: CM310-101212, briefTitle: Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Keymed Biosciences Co.Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: CM310, interventions name: placebo, outcomesModule primaryOutcomes measure: Proportion of subjects achieving EASI-75 at week 18, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Peking University People's hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06277752, orgStudyIdInfo id: CIBI128A101, briefTitle: A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor), statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-03-16, completionDateStruct date: 2024-03-16, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Innovent Biologics (Suzhou) Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects., conditionsModule conditions: Gout Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: dose-5 group, interventions name: dose-1 group, interventions name: dose-2 group, interventions name: dose-4 group, interventions name: dose-3 group, outcomesModule primaryOutcomes measure: PK parameter: Cmax, primaryOutcomes measure: PK parameter: AUC, primaryOutcomes measure: PK parameter: Tmax, primaryOutcomes measure: PK parameter: T1/2, secondaryOutcomes measure: Safety parameter: AE, secondaryOutcomes measure: PD parameter: serum UA (uric acid）, secondaryOutcomes measure: Tolerability parameter: SAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06277739, orgStudyIdInfo id: 20220117020315695, briefTitle: Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Zhou Xingchen, class: OTHER, descriptionModule briefSummary: The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH., conditionsModule conditions: Lumbar Disc Herniation, 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: Spinal Manipulative Therapy, interventions name: Sham Laser Treatment, outcomesModule primaryOutcomes measure: visual analogue scale (VAS), primaryOutcomes measure: Japanese Orthopaedic Association Scores (JOA), primaryOutcomes measure: Amplitude of Low-Frequency Fluctuation (ALFF), primaryOutcomes measure: Regional Homogeneity (ReHo), primaryOutcomes measure: Functional Connectivity (FC), primaryOutcomes measure: Magnetic Resonance Spectrum （MRS）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, city: Hangzhou, state: Zhejiang, zip: 310053, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06277726, orgStudyIdInfo id: IU-SBE-CGI-01, briefTitle: The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application., conditionsModule conditions: Intrauterine Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled study with pre-test post-test group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: In order to ensure randomization and prevent contamination between groups, data will be collected in a sequence such that emotional freedom technique is collected one week, music is collected one week, and control group data is collected one week. It will be decided by drawing lots which group's data will be collected first., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Emotional freedom technique group, interventions name: Music group, interventions name: Control group, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: State Anxiety Inventory, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Şırnak State Hospital, status: RECRUITING, city: Şırnak, zip: 73000, country: Turkey, contacts name: Ceylan GÜZEL İNAL, Lecturer, role: CONTACT, phone: +095432588644, email: [email protected], geoPoint lat: 37.51393, lon: 42.45432, hasResults: False |
protocolSection identificationModule nctId: NCT06277713, orgStudyIdInfo id: CME2023/069, briefTitle: Preventing Exercise Resistance With Sedentary Interruptions, acronym: PERSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Hasselt University, class: OTHER, descriptionModule briefSummary: The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease.The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day.Participants will be asked to:* Complete three intervention periods for a duration of 2 days at their workplace,* Attend a supervised training session (60min) at the research facility at the end of each intervention period,* Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test., conditionsModule conditions: Sedentary Behavior, conditions: Lipid Metabolism Disorder, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will follow three regimes of 2 days each including a sedentary control, a sedentary with exercise and a standing breaks with exercise regimen. The sequence of the regimens will be randomised. Each regimen will be followed by a minimum wash-out period of 7 days during which subjects will continue their normal lifestyle.We will use a balanced design with 6 randomisation blocks (ABC, ACB, BAC,BCA, CAB, CBA). The randomisation will be computer-generated and allocation will be determined by a member of the research team drawing a sealed, non-translucent envelop with herein written the scheme., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor will be blinded to the allocation of participants as samples will be code labeled., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Standing interruptions, interventions name: Exercise bout, interventions name: Sedentary, outcomesModule primaryOutcomes measure: Total and incremental area under the curve of postprandial response in lipid metabolism, secondaryOutcomes measure: Total and incremental area under the curve of glucose and insulin postprandial responses, secondaryOutcomes measure: Resting metabolic rate, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hasselt University, status: RECRUITING, city: Diepenbeek, state: Limburg, zip: 3590, country: Belgium, contacts name: Bert Op 't Eijnde, Prof. dr., role: CONTACT, phone: +3211292121, email: [email protected], contacts name: Jen Vanherle, Drs., role: CONTACT, email: [email protected], contacts name: Bert Op 't Eijnde, Prof. dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Jen Vanherle, Drs., role: SUB_INVESTIGATOR, geoPoint lat: 50.90769, lon: 5.41875, hasResults: False |
protocolSection identificationModule nctId: NCT06277700, orgStudyIdInfo id: CMT001, briefTitle: Effects Of Dynamic Stabilizatıon Exercises And HVLA Manipulatıon in Low Back Paın, acronym: DNSHVLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: SEFA HAKTAN HATIK, class: OTHER, descriptionModule briefSummary: Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain., conditionsModule conditions: Low Back Pain, conditions: Neuromuscular Subluxation of Joint, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 60 people will participate in the study and the participants will be divided into four groups. The groups will be formed as chiropractic manipulation (CM) group (n=15), dynamic neuromuscular stabilization (DNS) group (n=15), CM + DNS group (n=15) and control group (CG) (n=15). Chiropractic manipulation will be performed once in the side-lying position. An individualized exercise program will be applied to the DNS group under the supervision of a physiotherapist. Kruskal Wallis test for comparisons of quantitative variables between 4 independent groups; Mann Whitney U test with Bonferonni correction will be used in double subgroup comparisons of significant variables. Friedman test was used for comparisons of quantitative variables in 3 dependent groups. Wilcoxon test with Bonferonni correction will be used for two-way subgroup comparisons for significant variables. In all statistical analyzes in the study, results with a p value below 0.05 will be considered statistically significant., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chiropractic Manipulation (HVLA - high velocity low amplitude), interventions name: Dynamic Neuromuscular Stabilization, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Physical Adequacy Level, primaryOutcomes measure: Disability Level, primaryOutcomes measure: Dynamic Stabilization and Adaptibility, primaryOutcomes measure: Posture, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sefa Haktan Haktik, city: Sinop, country: Turkey, geoPoint lat: 42.02683, lon: 35.16253, hasResults: False |
protocolSection identificationModule nctId: NCT06277687, orgStudyIdInfo id: SYSKY-2024-023-02, briefTitle: Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap, and explore its effectiveness and accuracy through sensitivity and specificity.In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups., conditionsModule conditions: Blood Vessel Perforation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: After performing CTA examination, input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the Finder and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Augmented Reality Combined With Finder, outcomesModule primaryOutcomes measure: Sensitivity, primaryOutcomes measure: Specificity, secondaryOutcomes measure: positive predictive value, secondaryOutcomes measure: negative predictive value, secondaryOutcomes measure: Youden Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510000, country: China, contacts name: Song Fan, Doctor degree, role: CONTACT, phone: 020-81332477, email: [email protected], contacts name: Song Fan, Doctor degree, role: PRINCIPAL_INVESTIGATOR, hasResults: False |
protocolSection identificationModule nctId: NCT06277674, orgStudyIdInfo id: ZF2023-252, briefTitle: Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Guangzhou University of Traditional Chinese Medicine, class: OTHER, collaborators name: Akeso Pharmaceuticals, Inc., descriptionModule briefSummary: This study was designed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in combination with pemetrexed and anlotinib for treatment of elderly patients with T790M-negative advanced non-squamous non-small cell lung cancer following resistance to EGFR-TKI., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab plus Pemetrexed and Anlotinib, outcomesModule primaryOutcomes measure: ORR(Objective response rate), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: (Disease control rate assessed by investigators) DCR (CR+PR+SD), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Haibo Zhang, Prof, role: CONTACT, phone: 86-020-81887233, phoneExt: 34830, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06277661, orgStudyIdInfo id: 2023H0305, briefTitle: The Mom and Infant Outcomes (MOMI) Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-05-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites., conditionsModule conditions: Postpartum Depression, conditions: Postpartum Anxiety, conditions: Cardiometabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: MOMI PODS, interventions name: Enhanced Usual Care (EUC), outcomesModule primaryOutcomes measure: Change in Life's Essential 8 (LE8) Composite Score, primaryOutcomes measure: Change in Life's Essential 8 (LE8) Composite Score, primaryOutcomes measure: Change in Life's Essential 8 (LE8) Composite Score, primaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score, primaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score, primaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score, primaryOutcomes measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score, primaryOutcomes measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score, primaryOutcomes measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Shannon L. Gillespie, PhD, RN, role: CONTACT, phone: 614-292-4589, email: [email protected], contacts name: Sandra Solove, MA, role: CONTACT, phone: 6142478366, email: [email protected], geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06277648, orgStudyIdInfo id: 18-2021, briefTitle: the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Haseki Training and Research Hospital, class: OTHER, descriptionModule briefSummary: This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures.The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively., conditionsModule conditions: Collum Femoris Fracture, conditions: Pericapsular Nerve Group Block, conditions: Suprainguinal Fascia Iliaca Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a double-blind, prospective, randomized, controlled study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: PENG block, interventions name: SIFIB, outcomesModule primaryOutcomes measure: pain scores, secondaryOutcomes measure: rescue analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haseki Training and Research Hospital, status: RECRUITING, city: Istanbul, state: Sultangazi, country: Turkey, contacts name: Berna Caliskan, role: CONTACT, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06277635, orgStudyIdInfo id: TAPAC001, briefTitle: Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Phramongkutklao College of Medicine and Hospital, class: OTHER, descriptionModule briefSummary: To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis, conditionsModule conditions: Rheumatoid Arthritis, conditions: Psoriatic Arthritis, conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Silymarin, interventions name: Placebo, outcomesModule primaryOutcomes measure: AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L), secondaryOutcomes measure: AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN, secondaryOutcomes measure: AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L), secondaryOutcomes measure: AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice, secondaryOutcomes measure: Discontinuation rate of methotrexate, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Change of DAS-28 ESR or CRP Score, secondaryOutcomes measure: Change of BASDAI Score, secondaryOutcomes measure: Change of ASDAS ESR or CRP Score, secondaryOutcomes measure: Change of BSA for psoriasis, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, status: RECRUITING, city: Bangkok, Thailand, 10400, state: Bangkok, zip: 10400, country: Thailand, contacts name: Rattapol Pakchotanon, M.D., role: CONTACT, phone: 66+23547980, email: [email protected], contacts name: Rattapol Pakchotanon, M.D., role: SUB_INVESTIGATOR, contacts name: Supasa Niyompanichakarn, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06277622, orgStudyIdInfo id: PekingUTH ZFCY PFUN, briefTitle: A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, collaborators name: Beijing Yanqing Hospital, descriptionModule briefSummary: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture., conditionsModule conditions: Femoral Intertrochanteric Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: PFUN, interventions name: PFNA, outcomesModule primaryOutcomes measure: Internal fixation failure rate, secondaryOutcomes measure: Number of Participants with Bone nonunion, secondaryOutcomes measure: Harris hip score, secondaryOutcomes measure: operation time, secondaryOutcomes measure: The times of intraoperative fluoroscopy, secondaryOutcomes measure: Number of Participants with Postoperative adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Yuan Cao, MD, role: CONTACT, phone: +86-01082266699, email: [email protected], contacts name: Fang Zhou, MD, role: CONTACT, phone: +86010-82267010, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06277609, orgStudyIdInfo id: 20508A, briefTitle: A Trial Investigating Lu AF28996 in Healthy Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-05-18, completionDateStruct date: 2024-05-18, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: H. Lundbeck A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lu AF28996, interventions name: Acetylsalicylic Acid, interventions name: Mefenamic Acid, interventions name: Amoxicillin/clavulanic acid, outcomesModule primaryOutcomes measure: Maximum Observed Concentration (Cmax) of Lu AF28996, primaryOutcomes measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996, secondaryOutcomes measure: Nominal Time Corresponding to the Occurrence of Cmax, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Covance Dallas CRU, status: RECRUITING, city: Dallas, state: Texas, zip: 75247, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06277596, orgStudyIdInfo id: ETK00-2023-0101, briefTitle: The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Eastern Mediterranean University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Visual Analog Scale ( VAS ), secondaryOutcomes measure: Sociodemographic information (age), secondaryOutcomes measure: Sociodemographic information (height), secondaryOutcomes measure: Sociodemographic information (weight), secondaryOutcomes measure: Trunk Muscle Endurance (McGill Endurance Test and Plank Test), secondaryOutcomes measure: Chair Sit to stand test, secondaryOutcomes measure: 6 minute walk test, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Revised Fibromyalgia Impact Questionnaire, secondaryOutcomes measure: Fear-Avoidance Beliefs Questionnaire, secondaryOutcomes measure: Pain Self-Efficacy Questionnaire, secondaryOutcomes measure: Body Awareness Questionnaire, secondaryOutcomes measure: Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ), secondaryOutcomes measure: Short form-36 (SF-36), secondaryOutcomes measure: Treatment Satisfaction Evaluation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Eastern Mediterranean University, status: RECRUITING, city: Famagusta, zip: 99628, country: Cyprus, contacts name: Sevim Oksüz, Asst.Prof.Dr, role: CONTACT, phone: 5488351465, phoneExt: +90, email: [email protected], geoPoint lat: 35.12054, lon: 33.93894, hasResults: False |
protocolSection identificationModule nctId: NCT06277583, orgStudyIdInfo id: NUS-IRB-2023-191, briefTitle: Urban Care Farming on Living Well and Productive Engagement of Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: National University of Singapore, class: OTHER, collaborators name: National Medical Research Council (NMRC), Singapore, descriptionModule briefSummary: The goal of the randomized controlled trials is to learn about the effects of urban farming interventions on older adults' physical, mental, and social well-being of older adults aged 50 and above. The main questions the study aims to answer are Q1. Would participants who have undergone the urban care farming intervention have lower stress levels compared to those who did not undergo the intervention? Q2. Would the quality of life and biopsychosocial factors of older adults who participate in the urban farming interventions be better before the intervention and compared to those who did not participate? Q3. Would running intervention programs as such demonstrate cost-effectiveness? Participants will be enrolled in 24 weekly lessons providing hands-on urban farming techniques, including physical activity, planting, and social interactions. Researchers will compare older participants with similar demographic profile to determine if the biological, psychological, and social factors are better for the intervention group., conditionsModule conditions: Stress, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Waitlist controlled trials: Participants from both the intervention and waitlist control groups will undergo the intervention 6 months apart., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Urban care farming, outcomesModule primaryOutcomes measure: WHO Quality of Life Scale (WHOQOL-BREF), secondaryOutcomes measure: Immuno-biomarkers: IL-1RA, IL-6, IL-8 (CXCL8), IL-10, IL-13, IL-17A (CTLA-8), MIP-3 beta (CCL19), SDF-1 alpha, MMP-3, MMP-9, MCP-1 (CCL2), and TNF alpha, secondaryOutcomes measure: Brief sense of community scale (BSCS), secondaryOutcomes measure: Fried phenotype of frailty, secondaryOutcomes measure: Lubben social network scale (LSNS-6), secondaryOutcomes measure: Functional near-infrared spectroscopy, secondaryOutcomes measure: EQ5D, secondaryOutcomes measure: Geriatric anxiety scale (GAS-10), secondaryOutcomes measure: MOCA, secondaryOutcomes measure: Brief resilience scale, secondaryOutcomes measure: De jong Gierveld loneliness scale, secondaryOutcomes measure: Fitbit, secondaryOutcomes measure: Body weight and height, secondaryOutcomes measure: Fasting plasma glucose, HbA1c, secondaryOutcomes measure: Serum Creatinine, secondaryOutcomes measure: Attitude towards eating healthy food, secondaryOutcomes measure: Waist and hip circumference, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Lipid panel, secondaryOutcomes measure: Eating fruits and vegetables behavior, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NUS, status: RECRUITING, city: Singapore, zip: 117549, country: Singapore, contacts name: Ezra Chiam, role: CONTACT, phone: +6566016036, email: [email protected], contacts name: Cynthia Chen, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Choon Nam Ong, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Schwarz Herbert, PhD, role: SUB_INVESTIGATOR, contacts name: Mary Chong, PhD, role: SUB_INVESTIGATOR, contacts name: Roger Ho, PhD, role: SUB_INVESTIGATOR, contacts name: Leng Leng Theng, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Jurong Lake Garden, status: RECRUITING, city: Singapore, zip: 618661, country: Singapore, contacts name: Joan Hung, role: CONTACT, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06277570, orgStudyIdInfo id: 2023-487, briefTitle: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Gulhane School of Medicine, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: conventional physiotherapy, interventions name: NMES, interventions name: Superimposed NMES, outcomesModule primaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Joint position sense, secondaryOutcomes measure: Muscle structure and knee joint cartilage thickness, secondaryOutcomes measure: Joint range of motion, secondaryOutcomes measure: Short Form-36, secondaryOutcomes measure: Western Ontario and McMaster Universities Osteoarthritis Index Scale, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Balance assessment, secondaryOutcomes measure: Functional capacity, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physiotherapy and Rehabilitation, University of Health Sciences, status: RECRUITING, city: Ankara, state: Etlik, zip: 06018, country: Turkey, contacts name: Oğuzhan METE, role: CONTACT, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06277557, orgStudyIdInfo id: HSEARS20211229002, briefTitle: Evaluation of the Effects of Virtual Reality Learning Environment on Nursing Student Non-technical Skills Development, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The goal of this waitlist control study is to evaluate the benefits of virtual reality teaching pedagogy to developing non-technical skills in nursing students.The main question\[s\] it aims to answer are:1. What is the relationship between VR training programs and students' situation awareness skills development?2. What is the relationship between VR training programs and students' communication skills development?3. What is the relationship between VR training programs and students' satisfaction/self-confidence in learning?4. What is the relationship between the sense of presence and satisfaction/ self-confidence in learning?5. How does the student's learning experience after VR training programs?Participants will attend the Virtual Reality training program. Researchers will compare the use of high-fidelity simulation to see if the non-technical skills were developed., conditionsModule conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Waitlist-control study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Situation awareness and communication skills, primaryOutcomes measure: Student's self-confidence in learning, primaryOutcomes measure: Participants' sense of presence in this virtual clinical environment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, contactsLocationsModule locations facility: Timothy LAI, city: Kowloon, country: Hong Kong, geoPoint lat: 22.31667, lon: 114.18333, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-01-01, uploadDate: 2024-02-18T20:16, filename: Prot_SAP_000.pdf, size: 840053, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-01-01, uploadDate: 2024-02-18T20:16, filename: ICF_001.pdf, size: 720367, hasResults: False |
protocolSection identificationModule nctId: NCT06277544, orgStudyIdInfo id: M2024087, briefTitle: Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-27, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome., conditionsModule conditions: Avulsion Fracture of Lateral Ankle Ligament, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: lateral ankle ligament repair or reconstruction, outcomesModule primaryOutcomes measure: Karlsson score, secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: American Orthopaedic Foot and Ankle Society (AOFAS), secondaryOutcomes measure: Tegner Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06277531, orgStudyIdInfo id: IRB00006761-M2024086, briefTitle: Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE), acronym: ECCBILE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, collaborators name: Beijing Tsinghua Changgeng Hospital, descriptionModule briefSummary: Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy., conditionsModule conditions: Biliary Stricture, conditions: Bile Duct Cancer, conditions: Pancreas Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 99, type: ESTIMATED, outcomesModule primaryOutcomes measure: Patient is diagnosed with malignant disease from biliary system, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 1000191, country: China, contacts name: Zhuo Cheng, M.D., role: CONTACT, phone: +86-18701012781, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tsinghua Changgung Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102218, country: China, contacts name: Xiue Yan, M.D., role: CONTACT, phone: +86-15811117418, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06277518, orgStudyIdInfo id: Liqin Deng, briefTitle: System for Postoperative Admission to ICU for Patients With Digestive System Malignancy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: General Hospital of Ningxia Medical University, class: OTHER, descriptionModule briefSummary: Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor., conditionsModule conditions: Intensive Care Unit Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ACTUAL, armsInterventionsModule interventions name: Surgery for malignant tumors of the digestive system, outcomesModule primaryOutcomes measure: admitted to ICU after surgery, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Hospital of Ningxia Medical University, city: Yinchuan, state: Ningxia, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, hasResults: False |
protocolSection identificationModule nctId: NCT06277505, orgStudyIdInfo id: 2023(164), briefTitle: Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation., conditionsModule conditions: Effect of Prebiotics and Probiotics on Functional Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Take prebiotics and probiotics, interventions name: lifestyle guidance, outcomesModule primaryOutcomes measure: Change in the number of fully autonomous bowel movements per week at the end of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Xiamen Univisity, city: Xiamen, state: Fujian, zip: 350000, country: China, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False |
protocolSection identificationModule nctId: NCT06277492, orgStudyIdInfo id: GN-001, briefTitle: A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-08-09, completionDateStruct date: 2025-11-08, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: GEN İlaç ve Sağlık Ürünleri A.Ş., class: INDUSTRY, collaborators name: Sulfateq B.V., descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years)., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Single ascending doses SUL-238, interventions name: Single dose Placebo, interventions name: Single dose SUL-238, interventions name: Multiple ascending doses SUL-238, interventions name: Multiple doses Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by ECG, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination., secondaryOutcomes measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after a single ascending dose (Part 1 and Part 2)., secondaryOutcomes measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after multiple ascending doses (Part 3)., secondaryOutcomes measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after single ascending dose (Part 1 and Part 2)., secondaryOutcomes measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after multiple ascending doses (Part 3)., secondaryOutcomes measure: Renal clearance and percentage of drug excreted in urine after single and multiple ascending doses of SUL-238., secondaryOutcomes measure: Percentage of drug excreted in feces after multiple ascending doses of SUL-238., secondaryOutcomes measure: The cerebrospinal fluid (CSF) levels of SUL-238, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University IKUM Center, status: RECRUITING, city: Kayseri, zip: 38030, country: Turkey, contacts name: Zafer Sezer, MD, role: CONTACT, phone: +903522076666, phoneExt: 24405, email: [email protected], geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06277479, orgStudyIdInfo id: Rigshospitalet. Hematology, briefTitle: Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Danish Cancer Society, descriptionModule briefSummary: The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life., conditionsModule conditions: Hematological Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100), secondaryOutcomes measure: Health literacy Questionnaire (HLQ), secondaryOutcomes measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mette Schaufuss Engedal, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06277466, orgStudyIdInfo id: XYFY2023-KL478-01, briefTitle: Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2028-01-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Xuzhou Medical University, class: OTHER, descriptionModule briefSummary: In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Gene Polymorphisms, conditions: Genetic Mutations, conditions: Susceptibility, Genetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs, interventions name: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs, outcomesModule primaryOutcomes measure: Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients, primaryOutcomes measure: Detection of T2DM susceptibility gene expression in controls, primaryOutcomes measure: Correlation between T2DM susceptibility gene expression and clinicopathological features, secondaryOutcomes measure: Baseline BMI of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline TC of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline TG of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes, secondaryOutcomes measure: Baseline BMI of controls with different genotypes, secondaryOutcomes measure: Baseline WHR of controls with different genotypes, secondaryOutcomes measure: Baseline FPG of controls with different genotypes, secondaryOutcomes measure: Baseline HbA1c of controls with different genotypes, secondaryOutcomes measure: Baseline TC of controls with different genotypes, secondaryOutcomes measure: Baseline TG of controls with different genotypes, secondaryOutcomes measure: Baseline HDL-C of controls with different genotypes, secondaryOutcomes measure: Baseline LDL-C of controls with different genotypes, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China, Jiangsu, Department of Endocrinology, status: RECRUITING, city: Xuzhou, zip: 221006, country: China, contacts name: Hongwei Ling, MD, role: CONTACT, phone: 18052268607, email: [email protected], contacts name: Renguo Chen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Yuhan Huang, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.18045, lon: 117.15707, hasResults: False |
protocolSection identificationModule nctId: NCT06277453, orgStudyIdInfo id: 2024KY010, briefTitle: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-25, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy., conditionsModule conditions: Locally Advanced Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 219, type: ACTUAL, armsInterventionsModule interventions name: surgery, outcomesModule primaryOutcomes measure: 3-year overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Gastric Surgery， Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06277440, orgStudyIdInfo id: NSTC 112-2314-B-341-001, briefTitle: Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University, class: OTHER, descriptionModule briefSummary: To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated., conditionsModule conditions: Attention Deficit Hyperactivity Disorders, conditions: Developmental Delays, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome measurements will be performed by a researcher who is blind to the groups' allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: cognitive training, interventions name: active control, outcomesModule primaryOutcomes measure: Changes of executive function, secondaryOutcomes measure: changes of symptoms of attention deficit hyperactivity disorder, secondaryOutcomes measure: changes of attention, secondaryOutcomes measure: Changes of sensory integration, secondaryOutcomes measure: changes of intelligence, secondaryOutcomes measure: changes of functional performance, secondaryOutcomes measure: Changes of family impact, secondaryOutcomes measure: Changes of quality of life, secondaryOutcomes measure: Changes in performance activity in kindergarten, otherOutcomes measure: changes of brain network connectivity, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Shin Kong Wu Ho-Su Memorial Hospital, city: Taipei, zip: 111-01, country: Taiwan, contacts name: Ru-Lan Hsieh, MD, role: CONTACT, phone: 886-2-28332211, phoneExt: 2538, email: [email protected], contacts name: Ru-Lan Hsieh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06277427, orgStudyIdInfo id: [2023]S208, briefTitle: Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Lingli Dong, class: OTHER, collaborators name: Shenzhen Pregene Biopharma Co., Ltd., descriptionModule briefSummary: Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis., conditionsModule conditions: Lupus Nephritis, conditions: ANCA Associated Vasculitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: PRG-1801 （CAR-T against BCMA）, outcomesModule primaryOutcomes measure: AE Incidence of PRG-1801 Single Infusion, primaryOutcomes measure: Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN., secondaryOutcomes measure: Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion), secondaryOutcomes measure: Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion), secondaryOutcomes measure: Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.), secondaryOutcomes measure: Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion), secondaryOutcomes measure: Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion ), secondaryOutcomes measure: Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion), secondaryOutcomes measure: Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion), secondaryOutcomes measure: Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion）, secondaryOutcomes measure: Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.）, secondaryOutcomes measure: Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.）, secondaryOutcomes measure: PK feature evaluation (PK parameters related to CAR copy number）, secondaryOutcomes measure: Serum sBCMA level, secondaryOutcomes measure: Serum ANCA titer level (AAV), secondaryOutcomes measure: Serum dsDNA level (LN), secondaryOutcomes measure: Serum ANA titer level (LN), secondaryOutcomes measure: Serum complement C3 levels, secondaryOutcomes measure: Serum complement C4 levels, secondaryOutcomes measure: Serum immunoglobulin quantification, secondaryOutcomes measure: Levels of CRP levels, secondaryOutcomes measure: Levels of ferritin levels, secondaryOutcomes measure: Levels of cytokine levels, secondaryOutcomes measure: Changes of peripheral blood lymphocyte subsets, secondaryOutcomes measure: Expression levels of BCMA on peripheral blood B cell subsets surface, secondaryOutcomes measure: The level of anti drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Lingli Dong, MD, role: CONTACT, phone: 86-27-83665519, email: [email protected], contacts name: Cong Ye, MD, role: CONTACT, phone: 86-27-83665518, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06277414, orgStudyIdInfo id: 2024ll0204001, briefTitle: a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of University of South China, class: OTHER, descriptionModule briefSummary: To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP, conditionsModule conditions: Endoscopic Retrograde Cholangiopancreatography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: collection of laboratory test results, imaging results and symptoms, outcomesModule primaryOutcomes measure: Number of Participants with Pancreatitis, secondaryOutcomes measure: Number of Acute PEC(post-ERCP-cholecystitis ), secondaryOutcomes measure: Number of Participants with Cholangitis, secondaryOutcomes measure: Number of Participants with Perforation, secondaryOutcomes measure: Number of Participants with bile duct stents, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of University of South China, status: RECRUITING, city: Hengyang, state: Hunan, country: China, contacts name: Chen Guodong, PhD, role: CONTACT, phone: 15211450345, email: [email protected], geoPoint lat: 26.88946, lon: 112.61888, hasResults: False |
protocolSection identificationModule nctId: NCT06277401, orgStudyIdInfo id: RCT_hypermobile_knee, briefTitle: Exercise in Patients With Hypermobile Joints and Knee Pain, acronym: HIPEr-Knee, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: Independent Research Fund Denmark, collaborators name: Odense Patient Data Explorative Network, descriptionModule briefSummary: Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain., conditionsModule conditions: Hypermobility, Joint, conditions: Hypermobility Syndrome, conditions: Knee Discomfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Neuromuscular training for the knee, interventions name: High-load strength training for the knee, outcomesModule primaryOutcomes measure: Visual Analogue Scale Nominated Activity, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Dynamic knee strength, secondaryOutcomes measure: Knee reposition sense, secondaryOutcomes measure: Single-Leg-Hop for Distance, otherOutcomes measure: Knee pain past week, otherOutcomes measure: Tampa scale of Kinesiophobia (TSK) 11 item, otherOutcomes measure: EQ-5D-5L, otherOutcomes measure: EQ VAS, otherOutcomes measure: Global perceived effect (GPE), otherOutcomes measure: PASS, otherOutcomes measure: TF, otherOutcomes measure: Clinical important difference, otherOutcomes measure: Knee instability questions, otherOutcomes measure: Tendon stiffness, otherOutcomes measure: Quadriceps rate of torque development (RTD), otherOutcomes measure: Patella instability, otherOutcomes measure: Quadriceps maximal voluntary isometric contraction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Physiotherapy Clinics Region of Southern Denmark, city: Odense, state: Fyn, zip: 5000, country: Denmark, contacts name: Behnam Liaghat, PhD, role: CONTACT, phone: +4526826801, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, locations facility: University of Southern Denmark, city: Odense, state: Fyn, zip: 5230, country: Denmark, contacts name: Behnam Liaghat, PhD, role: CONTACT, phone: +4526826801, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, hasResults: False |
protocolSection identificationModule nctId: NCT06277388, orgStudyIdInfo id: GASTO-10108, briefTitle: Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-05, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis., conditionsModule conditions: Non-small Cell Lung Cancer, conditions: Cardiac Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 237, type: ESTIMATED, armsInterventionsModule interventions name: Impedance cardiography, outcomesModule primaryOutcomes measure: Stroke volume（SV）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hui Liu, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Hui Liu, MD, role: CONTACT, phone: +86-020-87343031, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06277375, orgStudyIdInfo id: 813/793, briefTitle: The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-14, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas., conditionsModule conditions: Massage Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Massage, outcomesModule primaryOutcomes measure: VAS, primaryOutcomes measure: Fatigue, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dilek Efe Arslan, city: Kayseri, state: Melikgazi, zip: 38280, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06277362, orgStudyIdInfo id: CLTI012023, briefTitle: Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia, acronym: PiPER, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-31, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: EndoCore Lab s.r.l., class: OTHER, descriptionModule briefSummary: The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI., conditionsModule conditions: Peripheral Arterial Disease, conditions: Critical Limb-Threatening Ischemia, conditions: Diabetic Foot, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Safety Composite, secondaryOutcomes measure: Procedural Success, secondaryOutcomes measure: Primary Patency, secondaryOutcomes measure: Secondary Patency, secondaryOutcomes measure: A-V fistula flow rate, secondaryOutcomes measure: Minor amputation rates, secondaryOutcomes measure: Major amputation rates, secondaryOutcomes measure: Re-Treatment rate, secondaryOutcomes measure: Wound Size, secondaryOutcomes measure: TpcO2, secondaryOutcomes measure: WIFi class, secondaryOutcomes measure: Freedom from all cause death, secondaryOutcomes measure: Freedom from procedure-related death, secondaryOutcomes measure: Rutherford class, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Pederzoli, status: RECRUITING, city: Peschiera Del Garda, state: Veneto, zip: 37019, country: Italy, contacts name: Bruno Migliara, MD, role: CONTACT, email: [email protected], geoPoint lat: 45.43912, lon: 10.68614, locations facility: Ospedale San Martino, status: NOT_YET_RECRUITING, city: Belluno, zip: 32100, country: Italy, contacts name: Luca Ferretto, MD, role: CONTACT, contacts name: Luca Ferretto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.14262, lon: 12.2156, locations facility: Ospedale Bufalini, status: NOT_YET_RECRUITING, city: Cesena, zip: 47521, country: Italy, contacts name: Gabriele Testi, MD, role: CONTACT, contacts name: Gabriele Testi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.1391, lon: 12.24315, locations facility: Ospedale di Conegliano - USLL2, status: NOT_YET_RECRUITING, city: Conegliano, zip: 31015, country: Italy, contacts name: Massimo Corato, MD, role: CONTACT, contacts name: Massimo Corato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.88805, lon: 12.30201, locations facility: Ospedale Cardarelli, status: NOT_YET_RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Gianluca Cangiano, MD, role: CONTACT, contacts name: Gianluca Cangiano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Arcispedale Santa Maria Nuova, status: NOT_YET_RECRUITING, city: Reggio Emilia, zip: 42122, country: Italy, contacts name: Antonio Fontana, MD, role: CONTACT, contacts name: Antonio Fontana, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale Santa Chiara, status: NOT_YET_RECRUITING, city: Trento, zip: 38123, country: Italy, contacts name: Stefano Bonvini, MD, role: CONTACT, contacts name: Stenano Bonvini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.06787, lon: 11.12108, hasResults: False |
protocolSection identificationModule nctId: NCT06277349, orgStudyIdInfo id: MAUV1005, briefTitle: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2009-03-04, primaryCompletionDateStruct date: 2011-01-04, completionDateStruct date: 2011-01-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Moorfields Eye Hospital NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery., conditionsModule conditions: Cornea, conditions: Astigmatism, conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Toric multifocal IOL, interventions name: Non-toric multifocal IOL, outcomesModule primaryOutcomes measure: Composite scoring of unaided distance and near vision (monocularly), primaryOutcomes measure: Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2009-02-06, uploadDate: 2024-02-23T13:05, filename: Prot_000.pdf, size: 169392, hasResults: False |
protocolSection identificationModule nctId: NCT06277336, orgStudyIdInfo id: 2023-01716; kt23ChristCrain3, briefTitle: Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD, acronym: ESCAPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia., conditionsModule conditions: SIAD - Syndrome of Inappropriate Antidiuresis, conditions: Hyponatremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Apelin Low Dose, interventions name: Apelin High Dose, interventions name: Selected Apelin Dose, outcomesModule primaryOutcomes measure: Total urinary excretion (ml), secondaryOutcomes measure: Hourly and total urinary excretion (ml), secondaryOutcomes measure: Change in electrolyte free water clearance (ml/min), secondaryOutcomes measure: Change in free water clearance (ml/min), secondaryOutcomes measure: Change in plasma osmolality (mOsm/kg), secondaryOutcomes measure: Change in plasma sodium (mmol/l), secondaryOutcomes measure: Change in body weight (kg), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Mirjam Christ-Crain, Prof. Dr., role: CONTACT, phone: +41 61 328 70 80, email: [email protected], contacts name: Mirjam Christ-Crain, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Sophie Monnerat, Dr. Med., role: SUB_INVESTIGATOR, contacts name: Julie Refardt, PD. Dr. Med., role: SUB_INVESTIGATOR, contacts name: Neeraj Dhaun, Dr., role: SUB_INVESTIGATOR, contacts name: Fiona A. Chapman, PhD, role: SUB_INVESTIGATOR, contacts name: Anthony P. Davenport, Prof., role: SUB_INVESTIGATOR, contacts name: Janet Maguire, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06277323, orgStudyIdInfo id: Cardio, briefTitle: UCLA Health Patient Cardiology Care Gaps, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: UCLA Health Department of Medicine, descriptionModule briefSummary: This is a prospective randomized clinical trial evaluating how two behaviorally-informed interventions (i.e., monthly report card and storyboard interventions) impact physician behavior, with the goal of closing care gaps in preventive care and disease management.In particular, the monthly report card intervention seeks to elevate physicians' intentions to close their patients' care gaps, while the storyboard intervention seeks to prompt action by making patients' care gaps salient. The trial investigates the separate and joint impacts of the proposed behaviorally-informed interventions on encouraging physicians to close their patients' care gaps., conditionsModule conditions: Health Maintenance, conditions: Cardiology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel randomized trial at the physician level., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: Monthly report card intervention, interventions name: Storyboard intervention, outcomesModule primaryOutcomes measure: Care gap closure (patients seen), secondaryOutcomes measure: Care gap closure (all patients in panel), secondaryOutcomes measure: Number of care gaps closed (patients seen), secondaryOutcomes measure: Number of care gaps closed (all patients in panel), secondaryOutcomes measure: HCC/RAF care gap closure (all patients in panel), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA Health Department of Medicine, Quality Office, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06277310, orgStudyIdInfo id: 3WP in SNH, briefTitle: Implementation of the 3 Wishes Project in Safety-Net Hospitals, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: Olive View-UCLA Education & Research Institute, collaborators name: LAC+USC Medical Center, descriptionModule briefSummary: Dignified and compassionate end-of-life (EOL) care is a cornerstone of high-quality, patient-centered care, but in safety-net hospitals EOL care is often overlooked, considered too late, or not at all. By eliciting and implementing final wishes for dying patients, the 3 Wishes Project (3WP) has demonstrated, in tertiary academic centers, that acts of compassion can improve the EOL experience and help families cope with loss. The investigators propose to implement the 3WP in safety-net hospitals where there are less resources and more diverse, disadvantaged patient populations, and hypothesize that there will be similar positive effects on the EOL experience for patients, families, and clinicians., conditionsModule conditions: End of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a before and after stepped wedge study design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: 3 Wishes Project, outcomesModule primaryOutcomes measure: Families' assessment of the quality of end-of-life, particularly in emotional and spiritual support., secondaryOutcomes measure: Family anxiety and depression, secondaryOutcomes measure: Nurse Burnout, secondaryOutcomes measure: Family PTSD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LA General Hospital, city: Los Angeles, state: California, zip: 90033, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Ronald Reagan UCLA Medical Center, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Olive View Medical Center, city: Sylmar, state: California, zip: 91342, country: United States, geoPoint lat: 34.30778, lon: -118.44925, locations facility: Harbor-UCLA, city: Torrance, state: California, zip: 90502, country: United States, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False |
protocolSection identificationModule nctId: NCT06277297, orgStudyIdInfo id: NP/2022/4583, briefTitle: Prognotic Role of CMR in Takotsubo Syndrome, acronym: EVOLUTION, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-09, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2032-11, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Cagliari, class: OTHER, descriptionModule briefSummary: The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.The secondary objectives of this registry are as follows:Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.The design and rationale of this registry are available at 10.1097/RTI.0000000000000709, conditionsModule conditions: Takotsubo Cardiomyopathy, conditions: Machine Learning, conditions: Magnetic Resonance Imaging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, outcomesModule primaryOutcomes measure: All-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Cagliari, status: RECRUITING, city: Cagliari, zip: 09100, country: Italy, contacts name: Riccardo Cau, role: CONTACT, phone: +393393493317, email: [email protected], contacts name: Luca Saba, role: PRINCIPAL_INVESTIGATOR, contacts name: Riccardo Cau, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.23054, lon: 9.11917, hasResults: False |
protocolSection identificationModule nctId: NCT06277284, orgStudyIdInfo id: MG-K10-I-002, briefTitle: Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-01-26, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Mabgeek Biotech.Co.Ltd, class: OTHER_GOV, collaborators name: The Second Hospital of Anhui Medical University, descriptionModule briefSummary: Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults, conditionsModule conditions: Pharmacokinetics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: MG-K10 humanized monoclonal antibody injection (prefilled syringe), interventions name: MG-K10 humanized monoclonal antibody injection（Penicillin bottle）, outcomesModule primaryOutcomes measure: Pharmacokinetic: the maximum concentration (Cmax), primaryOutcomes measure: Pharmacokinetic: area under the curve of o~t, primaryOutcomes measure: Pharmacokinetic: area under the curve of o~∞, secondaryOutcomes measure: Safety evaluation index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Anhui Medical University, city: Hefei, state: Anhui, zip: 230061, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06277271, orgStudyIdInfo id: 1901611-9, briefTitle: E-cigarettes as a Harm Reduction Strategy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Prisma Health-Upstate, class: OTHER, collaborators name: Clemson University, descriptionModule briefSummary: E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics., conditionsModule conditions: Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: E-cigarette, outcomesModule primaryOutcomes measure: Percentage of people who are eligible, primaryOutcomes measure: Percentage of consented participants, primaryOutcomes measure: Percentage of participants who report using the e-cigarette at least once a day, primaryOutcomes measure: Percentage of participants with at least one puff of study e-cigarette, primaryOutcomes measure: Percentage of daily diary completed, secondaryOutcomes measure: Cigarette dependence measured via the Fagerstrom test for nicotine dependence, secondaryOutcomes measure: Cigarette demand measured via the cigarette purchase task, secondaryOutcomes measure: Combustible cigarette smoking, secondaryOutcomes measure: Switching to e-cigarettes, secondaryOutcomes measure: Smoking reduction, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prisma Health, status: RECRUITING, city: Greenville, state: South Carolina, zip: 29609, country: United States, contacts name: Alain Litwin, MD, role: CONTACT, phone: 864-455-5648, email: [email protected], geoPoint lat: 34.85262, lon: -82.39401, hasResults: False |
protocolSection identificationModule nctId: NCT06277258, orgStudyIdInfo id: BSMMU/2022/9656, briefTitle: Patient Empowerment in the Management of Gestational Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-31, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Public Health Foundation of Bangladesh, class: OTHER, descriptionModule briefSummary: This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person., conditionsModule conditions: Diabetes Mellitus in Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: At the end of the study, the outcome will be assessed by blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 388, type: ESTIMATED, armsInterventionsModule interventions name: Patient Empowerment model, outcomesModule primaryOutcomes measure: Number of Participants with adverse maternal pregnancy outcome, primaryOutcomes measure: Number of Participants with adverse foetal outcome, primaryOutcomes measure: Number of Participants with adequate glycaemic control, secondaryOutcomes measure: Maternal satisfaction, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Azimpur Maternity hospital ( MCHTI), status: RECRUITING, city: Dhaka, zip: 1205, country: Bangladesh, contacts name: Rukhsana Parvin, MSc, role: CONTACT, phone: +8801303701545, email: [email protected], geoPoint lat: 23.7104, lon: 90.40744, locations facility: Shaheed Suhrawardy Medical College (ShSMC), status: RECRUITING, city: Dhaka, zip: 1207, country: Bangladesh, contacts name: Farhana Akter, MSc, role: CONTACT, phone: +8801819138421, email: [email protected], contacts name: Fatema Ashraf, MBBS, FCPS, MS,MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, locations facility: Bangabandhu Sheikh Mujib Medical University (BSMMU), status: RECRUITING, city: Dhaka, zip: 1217, country: Bangladesh, contacts name: Naznin Akter, MSc, role: CONTACT, phone: +8801739867303, email: [email protected], contacts name: Tabassum Parvin, MBBS, FCPS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False |
protocolSection identificationModule nctId: NCT06277245, orgStudyIdInfo id: LK001303, briefTitle: A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Lynk Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 354, type: ESTIMATED, armsInterventionsModule interventions name: LNK01001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Eczema Area and Severity Index (EASI-75) at Week 16, primaryOutcomes measure: Investigator's Global Assessment (IGA) score of 0/1 at Week 16, secondaryOutcomes measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16, secondaryOutcomes measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16., secondaryOutcomes measure: Change from Baseline in Eczema Area and Severity Index at all visits., secondaryOutcomes measure: Eczema Area and Severity Index (EASI 75) at all visits other than Week 16, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dermatological Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, country: China, contacts name: Bing Yang, Doctor, role: CONTACT, phone: 020-87257353, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06277232, orgStudyIdInfo id: HMV-2023-00504, secondaryIdInfos id: 2022-05364-02, type: OTHER, domain: The Swedish Ethical Review Authority, briefTitle: Nutrition Care in Patients Living With Chronic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, collaborators name: Ostergotland County Council, Sweden, collaborators name: Fibromyalgia foundation, descriptionModule briefSummary: The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes., conditionsModule conditions: Nutrition Poor, conditions: Overweight and Obesity, conditions: Mobile Phone Use, conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Repeated measures, single-subject withdrawal design. All subjects who enroll in the study will receive the intervention and there is no randomization., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition care, interventions name: Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program), interventions name: activity training (part of Interdisciplinary Pain Rehabilitation Program), interventions name: meetings (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program), interventions name: Physical exercise (part of Interdisciplinary Pain Rehabilitation Program), outcomesModule primaryOutcomes measure: Pain intensity (numeric rating scale), primaryOutcomes measure: Pain interference (one aspect in Multidimensional Pain inventory), primaryOutcomes measure: Dietary habits (a lifestyle questionnaire), primaryOutcomes measure: Perceived Usability (System Usability Scale), primaryOutcomes measure: Perceived benefit (numeric rating scale), primaryOutcomes measure: Adherences/ compliances of nutritional care (numeric rating scale), secondaryOutcomes measure: Difficulty sleeping (Insomnia Severity Index), secondaryOutcomes measure: Emotional distress (The Hospital Anxiety and Depression Scale, HAD), secondaryOutcomes measure: Impact of chronic pain (Multidimensional Pain inventory), secondaryOutcomes measure: Health- related quality of life 1 (EQ-5D), secondaryOutcomes measure: Health- related quality of life 2 (RAND-36), secondaryOutcomes measure: Pain coping (Chronic Pain Acceptance Questionnaire, CPAQ), secondaryOutcomes measure: Fear of movement (Tampa scale for Kinesiophobia), secondaryOutcomes measure: Physical activity and sedentary behavior (self-estimated time, questionnaire), secondaryOutcomes measure: Body fatness (physiological parameter), secondaryOutcomes measure: Body weight (physiological parameter), secondaryOutcomes measure: Biomarkers explored from blood samples (physiological parameters such as proteins, lipids, metabolites and micro-RNA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06277219, orgStudyIdInfo id: LAT010-01, briefTitle: A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1), acronym: LIGHTSPEED-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Latticon Antibody Therapeutics, Inc, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: LAT010, interventions name: LAT010 + ICI, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1), primaryOutcomes measure: Incidence of changes in clinical laboratory values (Phase 1), primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) (Phase 1), primaryOutcomes measure: Objective response rate (ORR) per RECIST 1.1 (Phase 2), secondaryOutcomes measure: Maximum plasma concentration (Cmax) of LAT010, secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC) of LAT010, secondaryOutcomes measure: Terminal phase half-life (t1/2) of LAT010, secondaryOutcomes measure: Time to maximum concentration of LAT010, secondaryOutcomes measure: Trough concentration of LAT010, secondaryOutcomes measure: Volume of distribution of LAT010, secondaryOutcomes measure: Clearance of LAT010, secondaryOutcomes measure: ADA occurrence and titer in serum, secondaryOutcomes measure: Objective response rate (ORR) per RECIST 1.1 (Phase 1 ), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of AEs and SAEs, otherOutcomes measure: Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells., otherOutcomes measure: Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntsman Cancer Institute, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Jeana McKenney, role: CONTACT, phone: 801-213-8414, email: [email protected], contacts name: Benjamin L Maughan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False |
protocolSection identificationModule nctId: NCT06277206, orgStudyIdInfo id: FAPIPDAC02, briefTitle: A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-04, primaryCompletionDateStruct date: 2023-11-19, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC, conditionsModule conditions: 18F-FAPI, conditions: Pancreas Adenocarcinoma, conditions: Systemic Treatment, conditions: Pathologic Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: 18F-FAPI PET/CT, outcomesModule primaryOutcomes measure: Change of Maximum standardized uptake value, primaryOutcomes measure: Change of Mean standardized uptake value, secondaryOutcomes measure: Maximum standardized uptake value, secondaryOutcomes measure: Mean standardized uptake value, secondaryOutcomes measure: Metabolic Tumor Volume, secondaryOutcomes measure: Total Lesion FAP expression, secondaryOutcomes measure: Change of Metabolic Tumor Volume, secondaryOutcomes measure: Change of Total Lesion FAP expression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Medical College of Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06277193, orgStudyIdInfo id: KonyaBeyhekimTRH, briefTitle: Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-03, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2023-09-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Konya Beyhekim Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling)., conditionsModule conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 166, type: ACTUAL, armsInterventionsModule interventions name: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia., interventions name: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia., interventions name: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia., interventions name: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia., outcomesModule primaryOutcomes measure: Sociodemographic data, primaryOutcomes measure: Berg Balance Scale(BBS), primaryOutcomes measure: Falls Efficacy Scale (FES), primaryOutcomes measure: Balance and Gait Assessment Scale, secondaryOutcomes measure: Biochemical data, secondaryOutcomes measure: Co-morbidities, secondaryOutcomes measure: Number of drugs, secondaryOutcomes measure: Basic activities of daily living (Katz), secondaryOutcomes measure: Instrumental activities of living (Lawton-Brody; IADL), secondaryOutcomes measure: Mini-nutritional evaluation (MNA-Short form), secondaryOutcomes measure: Mini-mental state assessment (MMSE), secondaryOutcomes measure: Yesavage Geriatric Depression Scale Short Form (GDS-SF), secondaryOutcomes measure: FRAIL fragility index, secondaryOutcomes measure: Short physical performance battery (SPPB), secondaryOutcomes measure: Timed up and go test (TUG), secondaryOutcomes measure: The Tampa Scale for Kinesiophobia (TSK), eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic, city: Selçuklu, state: Konya, country: Turkey, geoPoint lat: 37.8842, lon: 32.49222, hasResults: False |
protocolSection identificationModule nctId: NCT06277180, orgStudyIdInfo id: TCR-FAPI for MTC Surgery, briefTitle: 68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, collaborators name: Peking University, collaborators name: Peking University Cancer Hospital & Institute, descriptionModule briefSummary: This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level., conditionsModule conditions: Medullary Thyroid Cancer, conditions: Prositron Emission Tomography, conditions: Fibroblast Activation Protein Inhibitor, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Surgery, outcomesModule primaryOutcomes measure: 1-month post-surgery calcitonin level, secondaryOutcomes measure: 2-year event free survival, secondaryOutcomes measure: Ratio of patient that change surgical plan, secondaryOutcomes measure: Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Beijing, zip: 100021, country: China, contacts name: Shaoyan Liu, M.D., role: CONTACT, phone: 0086-010-87787190, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06277167, orgStudyIdInfo id: KXZY-GB05-101, briefTitle: A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-07, primaryCompletionDateStruct date: 2024-05-21, completionDateStruct date: 2024-05-21, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Kexing Biopharm Co., Ltd., class: INDUSTRY, collaborators name: Guoxin Pharmaceutical Technology (Beijing) Co., Ltd., collaborators name: The Third Hospital of Changsha, collaborators name: Beijing SSYP Data Technology Development Co.,Ltd., collaborators name: United-Power Pharma Tech（Shanghai）Co., Ltd., descriptionModule briefSummary: A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses, conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Human interferon alfa 1b inhalation solution, interventions name: Human interferon alfa 1b inhalation solution placebo, interventions name: Human interferon alfa 1b inhalation solution, interventions name: Human interferon alfa 1b inhalation solution placebo, outcomesModule primaryOutcomes measure: TEAEs, primaryOutcomes measure: (ADRs), primaryOutcomes measure: (SAE), primaryOutcomes measure: TEAEs that lead to subject discontinuation from the study, secondaryOutcomes measure: Cmax After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Tmax After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: t1/2 After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Ke After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Vd After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: MRT After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: CL After a Single Dose of GB05 Drug Product, secondaryOutcomes measure: Cmax,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: Cmin,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: Css_av After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: DF After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: (Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product, secondaryOutcomes measure: ADA, secondaryOutcomes measure: NAb, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Third Hospital of Changsha, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False |
protocolSection identificationModule nctId: NCT06277154, orgStudyIdInfo id: MASCT-I-2004, briefTitle: MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: HRYZ Biotech Co., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma., conditionsModule conditions: Leiomyosarcoma, conditions: Liposarcoma, conditions: Synovial Sarcoma, conditions: Angiosarcoma, conditions: Undifferentiated Pleomorphic Sarcoma, conditions: Epithelioid Sarcoma, conditions: Malignant Peripheral Nerve Sheath Tumors, conditions: Fibrosarcoma, conditions: Pleomorphic Rhabdomyosarcoma, conditions: Endometrial Stromal Sarcoma, conditions: Desmoplastic Small Round Cell Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: MASCT-I, interventions name: Doxorubicin, interventions name: Ifosfamide, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Adverse events and serious adverse events, secondaryOutcomes measure: Adverse events and serious adverse events related to MASCT-I, secondaryOutcomes measure: Rate and severity of clinically-significant abnormalities in laboratory testings, otherOutcomes measure: Immune response to tumor-associated antigens, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, country: China, contacts name: Xing Zhang, role: CONTACT, email: [email protected], contacts name: Xing Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06277141, orgStudyIdInfo id: M230742, briefTitle: The Vitality Mammography Messaging Study, acronym: VMS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Wits Health Consortium (Pty) Ltd, class: OTHER, collaborators name: Discovery Vitality, descriptionModule briefSummary: The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages., conditionsModule conditions: Breast Cancer Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 6665, type: ESTIMATED, armsInterventionsModule interventions name: Standard message, interventions name: Radiology booking site link., interventions name: Radiology practice telephone numbers, interventions name: Radiology site link and telephone numbers, outcomesModule primaryOutcomes measure: Comparison of mammography screening rates using WhatsApp, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Witwatersrand, city: Johannesburg, state: Gauteng, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, hasResults: False |
protocolSection identificationModule nctId: NCT06277128, orgStudyIdInfo id: WS016-Ⅱ-01, briefTitle: A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-08-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Waterstone Pharmaceutical (Wuhan) Co., LTD., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase., conditionsModule conditions: Hyperkalemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: WS016 3g, interventions name: WS016 6g, interventions name: WS016 12g, interventions name: Matching Placebo, outcomesModule primaryOutcomes measure: Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase, primaryOutcomes measure: Exponential rate of change in S-K levels during the maintenance treatment phase, secondaryOutcomes measure: Mean change in S-K levels during the acute treatment phase, secondaryOutcomes measure: Proportion of participants recover from hyperkalemia, secondaryOutcomes measure: Time to normalization in S-K levels, secondaryOutcomes measure: Proportion of patients remaining normokalemic, secondaryOutcomes measure: Mean change in S-K levels during the maintenance treatment phase, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Li Zuo, role: CONTACT, phone: 86+ 13910028495, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Shougang Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Zhenzhong Zhu, role: CONTACT, phone: 86+ 13811830871, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Zhongshan Hospital, Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361000, country: China, contacts name: Tianjun Guan, role: CONTACT, phone: 86+ 13950199068, email: [email protected], geoPoint lat: 24.47979, lon: 118.08187, locations facility: The Affiliated Hospital of Hebei University, status: RECRUITING, city: Baoding, state: Hebei, zip: 071000, country: China, contacts name: Yan Gao, role: CONTACT, phone: 86+ 13613125826, email: [email protected], geoPoint lat: 38.85111, lon: 115.49028, locations facility: Hebei Traditional Chinese Medicine Hospital, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Jinchuan Tan, role: CONTACT, phone: 86+ 13831187910, email: [email protected], geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Second Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Shaomei Li, role: CONTACT, phone: 86+ 15803210955, email: [email protected], geoPoint lat: 38.04139, lon: 114.47861, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, state: Heilongjiang, zip: 161000, country: China, contacts name: Yanjun Zhao, role: CONTACT, phone: 86+ 13945277125, email: [email protected], geoPoint lat: 47.34088, lon: 123.96045, locations facility: The First People's Hospital of Nanyang City, status: RECRUITING, city: Nanyang, state: Henan, zip: 473000, country: China, contacts name: Mingai Song, role: CONTACT, phone: 86+ 18937765862, email: [email protected], geoPoint lat: 32.99472, lon: 112.53278, locations facility: Puyang Oilfield General Hospital, status: RECRUITING, city: Puyang, state: Henan, zip: 457000, country: China, contacts name: Xianjun Xue, role: CONTACT, phone: 86+ 13839288161, email: [email protected], geoPoint lat: 29.45679, lon: 119.88872, locations facility: Shiyan Taihe Hospital, status: RECRUITING, city: Shiyan, state: Hubei, zip: 442000, country: China, contacts name: Qinghong Zhang, role: CONTACT, phone: 86+ 13971930628, email: [email protected], geoPoint lat: 32.6475, lon: 110.77806, locations facility: Wuhan No.4 Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Chuanwen Xu, role: CONTACT, phone: 86+ 18607171819, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhuzhou Central Hospital, status: RECRUITING, city: Zhuzhou, state: Hunan, zip: 412000, country: China, contacts name: Qingfeng Peng, role: CONTACT, phone: 86+ 13973319588, email: [email protected], geoPoint lat: 27.83333, lon: 113.15, locations facility: Affiliated Hospital of Inner Mongolia Medical University, status: RECRUITING, city: Hohhot, state: Inner Mongolia, zip: 010000, country: China, contacts name: Jianrong Zhao, role: CONTACT, phone: 86+ 13848129952, email: [email protected], geoPoint lat: 40.81056, lon: 111.65222, locations facility: Sir Run Run Hospital, Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Wenwen Li, role: CONTACT, phone: 86+ 13951644706, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Junwei Yang, role: CONTACT, phone: 86+ 18951767513, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Nantong University, status: RECRUITING, city: Nantong, state: Jiangsu, zip: 226000, country: China, contacts name: Xinzhong Huang, role: CONTACT, phone: 86+ 13912288751, email: [email protected], geoPoint lat: 32.03028, lon: 120.87472, locations facility: Shenyang Central Hospital, affiliated to Shenyang Medical College, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110000, country: China, contacts name: Zhenhua Ji, role: CONTACT, phone: 86+ 18002477058, email: [email protected], geoPoint lat: 41.79222, lon: 123.43278, locations facility: General Hospital of Ningxia Medical University, status: RECRUITING, city: Yinchuan, state: Ningxia, zip: 750000, country: China, contacts name: Na Tian, role: CONTACT, phone: 86+ 13995216063, email: [email protected], geoPoint lat: 38.46806, lon: 106.27306, locations facility: The First People's Hospital of Tancheng County, status: RECRUITING, city: Linyi, state: Shandong, zip: 276100, country: China, contacts name: Changyou Sun, role: CONTACT, phone: 86+ 15168960721, email: [email protected], geoPoint lat: 35.06306, lon: 118.34278, locations facility: Qilu Hospital of Shandong University (Qingdao), status: RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Lanjie He, role: CONTACT, phone: 86+ 18561812668, email: [email protected], geoPoint lat: 36.06488, lon: 120.38042, locations facility: Minhang District Central Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xudong Xu, role: CONTACT, phone: 86+ 18918169003, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai First People's Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Qiuling Fan, role: CONTACT, phone: 86+ 13904012680, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai No.5 Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Jianying Niu, role: CONTACT, phone: 86+ 18918168518, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Tongji Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Chen Yu, role: CONTACT, phone: 86+ 13311996821, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Affiliated Hospital of Tianjin Medical University, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Rong Li, role: CONTACT, phone: 86+ 18698061623, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tianjin People's Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Gang Long, role: CONTACT, phone: 86+ 13602121007, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06277115, orgStudyIdInfo id: BASEC Nr. 2020-02002, briefTitle: Acute and Long-term Effects of CPAP in OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence)., conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Continuous positive airway pressure (CPAP), outcomesModule primaryOutcomes measure: Nocturnal systolic blood pressure, primaryOutcomes measure: Epworth Sleepines Scale Score (ESS), secondaryOutcomes measure: 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure, secondaryOutcomes measure: Office systolic and diastolic blood pressure, secondaryOutcomes measure: 48h, 24h, diurnal, nocturnal and office heart rate, secondaryOutcomes measure: Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF), secondaryOutcomes measure: Blood pressure variability (BPV, systolic and diastolic), secondaryOutcomes measure: Baroreflex sensitivity (BRS), secondaryOutcomes measure: Arterial stiffness, secondaryOutcomes measure: Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2), secondaryOutcomes measure: Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2), secondaryOutcomes measure: Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90), secondaryOutcomes measure: Measures of nocturnal hypoxaemia (hypoxic burden), secondaryOutcomes measure: Measures of OSA severity (apnoea-hypopnoea-index), secondaryOutcomes measure: Measures of OSA severity (oxygen-desaturation index), secondaryOutcomes measure: Sleepiness (Stanford Sleepiness Scale (SSS)), secondaryOutcomes measure: Fatigue (fatigue severity scale (FSS)), secondaryOutcomes measure: Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)), secondaryOutcomes measure: Superoxide dismutase, secondaryOutcomes measure: Urinary catecholamines, secondaryOutcomes measure: Pulse rise index (>6 beats per minute), secondaryOutcomes measure: Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, status: RECRUITING, city: Zurich, zip: 8091, country: Switzerland, contacts name: Esther I Schwarz, MD, role: CONTACT, phone: 0041442553828, email: [email protected], contacts name: Joël J Herzig, role: CONTACT, email: [email protected], geoPoint lat: 47.36667, lon: 8.54999, hasResults: False |
protocolSection identificationModule nctId: NCT06277102, orgStudyIdInfo id: Music pain FHF, briefTitle: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Hospital Authority, Hong Kong, class: OTHER_GOV, descriptionModule briefSummary: Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital., conditionsModule conditions: Hip Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: music listening, outcomesModule primaryOutcomes measure: Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture, secondaryOutcomes measure: Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture, secondaryOutcomes measure: New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ward G9, Queen Elizabeth Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Kwan Yiu Jeffrey Lau, role: CONTACT, phone: 62017014, email: [email protected], contacts name: Kwan Yiu Jeffrey Lau, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06277089, orgStudyIdInfo id: Correction of EOS by casts, briefTitle: Curve Correction of Early Onset Scoliosis by Mehta Serial Casts, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis, conditionsModule conditions: Scoliosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Casts, outcomesModule primaryOutcomes measure: Difference of the scoliotic cobb angle at last cast, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06277076, orgStudyIdInfo id: FMD1234, briefTitle: Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-28, primaryCompletionDateStruct date: 2023-05-02, completionDateStruct date: 2023-08-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Saint-Joseph University, class: OTHER, descriptionModule briefSummary: The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures., conditionsModule conditions: Dental Implant, conditions: Computer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: Computer Implant guided Surgery, outcomesModule primaryOutcomes measure: Assess Accuracy of Implant Placement in Vertical Displacement (VD)., primaryOutcomes measure: Assess Accuracy of Implant Placement in Horizontal Displacement (HD), primaryOutcomes measure: Assess Accuracy of Implant Placement in Error Depth (ED), primaryOutcomes measure: Assess Accuracy of Implant Placement in Error Angle (EA), secondaryOutcomes measure: Evaluate Precision of the Printed Guide, secondaryOutcomes measure: Study Complications and Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Joseph University of Beirut/Dental school, city: Beirut, zip: 1107 2180, country: Lebanon, geoPoint lat: 33.88894, lon: 35.49442, hasResults: False |
protocolSection identificationModule nctId: NCT06277063, orgStudyIdInfo id: NFEC-2024-057, briefTitle: nVNS for the Prevention and Treatment of Primary Headache, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, collaborators name: BrainClos Co., LTD., collaborators name: Zhuhai Fudan Innovation Institute, descriptionModule briefSummary: This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters., conditionsModule conditions: Primary Headache, conditions: Migraine in Adolescence, conditions: Migraine in Children, conditions: Cluster Headache, conditions: Tension Headache, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous auricular vagus nerve stimulation, interventions name: Sham transcutaneous auricular vagus nerve stimulation, outcomesModule primaryOutcomes measure: Visual analogue scales(VAS)-actue period, primaryOutcomes measure: Visual analogue scales(VAS)-prevention period, secondaryOutcomes measure: Heart rate variability(HRV), secondaryOutcomes measure: Electromyography(EMG), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Ji Ya-Bin, post-doc, role: CONTACT, phone: +8615913186246, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol, date: 2024-02-03, uploadDate: 2024-03-06T22:03, filename: Prot_SAP_ICF_002.pdf, size: 158671, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: Informed Consent Form, date: 2024-02-03, uploadDate: 2024-03-06T22:01, filename: ICF_003.pdf, size: 139248, hasResults: False |
protocolSection identificationModule nctId: NCT06277050, orgStudyIdInfo id: NPC-ICMB, briefTitle: Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2029-02-20, completionDateStruct date: 2030-02-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy)., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: High-Risk Cancer, conditions: Maintenance Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Maintenance Therapy with Toripalimab and Capecitabine, interventions name: Maintenance Therapy with Capecitabine, outcomesModule primaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Distant Metastasis-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Loco-Regional Recurrence-Free Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06277037, orgStudyIdInfo id: AB-729-204, briefTitle: Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-15, primaryCompletionDateStruct date: 2029-08-30, completionDateStruct date: 2029-10-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Arbutus Biopharma Corporation, class: INDUSTRY, descriptionModule briefSummary: This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation)., conditionsModule conditions: Long Term Follow-up, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Non-interventional, outcomesModule primaryOutcomes measure: To evaluate the durability of effect of imdusiran on HBV parameters, primaryOutcomes measure: To evaluate the durability of effect of imdusiran on HBV parameters, primaryOutcomes measure: To evaluate the durability of effect of imdusiran on HBV parameters, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Alfred Hospital, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Stuart Roberts, role: CONTACT, contacts role: CONTACT, email: [email protected], geoPoint lat: -37.814, lon: 144.96332, locations facility: Fiona Stanley Hospital, city: Murdoch, zip: 6150, country: Australia, contacts name: Sam Galhenage, role: CONTACT, geoPoint lat: -32.06987, lon: 115.83757, locations facility: Queen Mary Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Prince of Wales Hospital, city: Shatin, country: Hong Kong, contacts name: Grace Wong, role: CONTACT, geoPoint lat: 22.38333, lon: 114.18333, locations facility: Changhua Christian Hospital, city: Changhua city, zip: 600566, country: Taiwan, geoPoint lat: 24.07327, lon: 120.56276, locations facility: Chia-Yi Christian Hospital, city: Chiayi City, zip: 60002, country: Taiwan, contacts name: Chi-Yi Chen, role: CONTACT, geoPoint lat: 23.47917, lon: 120.44889, locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, city: Kaohsiung, zip: 80756, country: Taiwan, contacts name: Wan-Long Chuang, role: CONTACT, geoPoint lat: 22.61626, lon: 120.31333, locations facility: E-Da Hospital, city: Kaohsiung, zip: 82445, country: Taiwan, contacts name: Gin-Ho Lo, role: CONTACT, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 40705, country: Taiwan, contacts name: Sheng-Shun Yang, role: CONTACT, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Chang Gung Medical Foundation Linkou, city: Taoyuan, zip: 33305, country: Taiwan, contacts name: Chao-Wei Hsu, role: CONTACT, geoPoint lat: 24.95233, lon: 121.20193, locations facility: University Hospital of Wales, Cardiff, city: Cardiff, zip: CF144XW, country: United Kingdom, contacts name: Jonathan Underwood, role: CONTACT, geoPoint lat: 51.48, lon: -3.18, locations facility: Royal London Hospital, city: London, zip: E11FR, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: King's College Hospital, city: London, zip: SE59RS, country: United Kingdom, contacts name: Kosh Agarwal, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06277024, orgStudyIdInfo id: FUGES-32, briefTitle: A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients, conditionsModule conditions: Overall Response Rate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Combination of Cardonizumab with Lenvatinib and SOX regimen, outcomesModule primaryOutcomes measure: ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Gastric Surgery， Fujian Medical University Union Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, contacts name: Changming Huang, MD, role: CONTACT, phone: +8613805069676, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06277011, orgStudyIdInfo id: Meta10-19-004, briefTitle: Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-10, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, collaborators name: Leman Biotech Co., Ltd, descriptionModule briefSummary: A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies, conditionsModule conditions: Acute Lymphoblastic Leukemia, conditions: Non-hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Metabolically Armed CD19 CAR-T cells, outcomesModule primaryOutcomes measure: MTD, primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Concentration of CAR-T cells, secondaryOutcomes measure: Pharmacodynamics of CAR-T cells, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, state: Anhui, zip: 518000, country: China, contacts name: Xingbing Wang, PhD, role: CONTACT, phone: +8613856007984, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06276998, orgStudyIdInfo id: LK001304, briefTitle: A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2025-08-04, completionDateStruct date: 2026-11-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Lynk Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 430, type: ESTIMATED, armsInterventionsModule interventions name: LNK01001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24, secondaryOutcomes measure: Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24, secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24, secondaryOutcomes measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits., secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits., secondaryOutcomes measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits., secondaryOutcomes measure: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits, secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24)., secondaryOutcomes measure: Change from Baseline in the Severity of Morning Stiffness at all visits., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Xiaofeng Zeng, role: CONTACT, phone: 0086-010-69158793, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06276985, orgStudyIdInfo id: 977/91, briefTitle: Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-07-25, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy., conditionsModule conditions: Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: low intensity pulsed ultrasound and iPRF, outcomesModule primaryOutcomes measure: Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 22 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: AlAzhar university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06276972, orgStudyIdInfo id: P.T.REC/012/005000, briefTitle: Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-12, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents, conditionsModule conditions: Scoliosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 89, type: ACTUAL, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Cobb's angle, primaryOutcomes measure: Coronal balance, primaryOutcomes measure: length of the the tibia and femur, primaryOutcomes measure: tibiofemoral angle, primaryOutcomes measure: knee joint line convergence angle, primaryOutcomes measure: lower limb mechanical axis; and mechanical axis deviation, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Delta university for science and technology, city: Gamasa, state: Dakahleya, zip: 7731168, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False |
protocolSection identificationModule nctId: NCT06276959, orgStudyIdInfo id: WCHSIRB-D-2022-430, briefTitle: The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: West China College of Stomatology, class: OTHER, descriptionModule briefSummary: As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies., conditionsModule conditions: Dental Caries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: intraoral scanning, interventions name: clinical oral examination, interventions name: cone-beam computed tomography, outcomesModule primaryOutcomes measure: positive percent agreement, primaryOutcomes measure: negative percent agreement, primaryOutcomes measure: overall percent agreement, secondaryOutcomes measure: Proximal caries positive site diagnosed by CBCT, secondaryOutcomes measure: Proximal caries positive site diagnosed by near-infrared imaging (NIRI), secondaryOutcomes measure: Proximal caries positive site diagnosed by unaided visual examination (UVE), eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital of Stomatology, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Zhihe Zhao, Doctor, role: CONTACT, phone: +86 139 8188 1666, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06276946, orgStudyIdInfo id: LCCC2244, briefTitle: Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2028-07, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering., conditionsModule conditions: Oropharynx Cancer, conditions: Head and Neck Cancer, conditions: Xerostomia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: standard radiotherapy, interventions name: experimental radiotherapy, outcomesModule primaryOutcomes measure: The difference in patient-reported xerostomia 6 months, secondaryOutcomes measure: Saliva mass, secondaryOutcomes measure: Parotid duct dose constraint, secondaryOutcomes measure: The difference in patient-reported xerostomia 12 months, secondaryOutcomes measure: Xerostomia by NCI-CTCAE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
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