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protocolSection identificationModule nctId: NCT06328946, orgStudyIdInfo id: IOE intracerebral hemorrhage, briefTitle: The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.Participants will be divided into two groups randomly, with different nutritional support respectively., conditionsModule conditions: Intracerebral Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Basic treatment, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Number of cases of successful extubation, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Concentration of Serum albumin, secondaryOutcomes measure: Concentration of Hemoglobin, secondaryOutcomes measure: Clinical Pulmonary Infection Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328933, orgStudyIdInfo id: IOE feeding amount, briefTitle: Intermittent Oral Tube on Feeding Amount, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Nasogastric Tube Feeding, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Nutritional status-total protein, primaryOutcomes measure: Nutritional status-hemoglobin, primaryOutcomes measure: Nutritional status-albumin, primaryOutcomes measure: Nutritional status-prealbumin, secondaryOutcomes measure: Feeding Amount, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328920, orgStudyIdInfo id: IOE Yicongxing, briefTitle: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Rehabilitation Treatment Compliance Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328907, orgStudyIdInfo id: IOE Social Condition, briefTitle: Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: comprehensive rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Swallowing-Quality of Life questionnaire, secondaryOutcomes measure: The Reintegration to Normal Living Index, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Patient Health Questionnaire-9, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328894, orgStudyIdInfo id: IOE Psychological, briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Nasogastric Tube Feeding, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder 7, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Self-made questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328881, orgStudyIdInfo id: IOE Parkinson, briefTitle: Effect of Intermittent Oral Tube on Dysphagia in Parkinson's Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation training, interventions name: Intermittent Oro-esophageal Tube, interventions name: Nasogastric tube, outcomesModule primaryOutcomes measure: Concentration of Serum albumin, primaryOutcomes measure: Concentration of Hemoglobin, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328868, orgStudyIdInfo id: IOE Nasopharyngeal Carcinoma, briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Concentration of Hemoglobin, primaryOutcomes measure: Concentration of Serum albumin, primaryOutcomes measure: Body Mass Index, primaryOutcomes measure: Concentration of Serum prealbumin, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing-Quality of Life questionnaire, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328855, orgStudyIdInfo id: IOE Dysphagia in Stroke, briefTitle: Intermittent Oro-esophageal Tube Feeding on Dysphagia in Stroke Survivor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: comprehensive rehabilitation therapy, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Nutritional status-total protein, secondaryOutcomes measure: Nutritional status-albumin, secondaryOutcomes measure: Yale pharyngeal residue severity rating scale, secondaryOutcomes measure: Patient health questionnaire-9, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328842, orgStudyIdInfo id: IOE Cerebral Small Vessel, briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Video Fluoroscopic Swallowing Study, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Activities of daily living, secondaryOutcomes measure: World Health Organization Quality of Life Assessment Instrument Brief Version, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328829, orgStudyIdInfo id: IOE Alzheimer, briefTitle: Intermittent Oral Tube in Alzheimer's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Care, interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: Nasogastric tube, outcomesModule primaryOutcomes measure: Concentration of Hemoglobin, primaryOutcomes measure: Concentration of Serum albumin, primaryOutcomes measure: Concentration of Total serum protein, primaryOutcomes measure: Concentration of Serum prealbumin, primaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Pulmonary Infections, secondaryOutcomes measure: Mini Nutritional Assessment, secondaryOutcomes measure: Standardized Swallowing Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328816, orgStudyIdInfo id: Computer-based Training, briefTitle: Computer-based Training on Cognitive Dysphagia in Stroke Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Computer-assisted Cognitive Function Training, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: The coordination of swallowing, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing reflex, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328803, orgStudyIdInfo id: Active Breathing Exercises, briefTitle: Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation training, interventions name: Active Breathing Exercises, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Yale Pharyngeal Residue Severity Rating Scale, secondaryOutcomes measure: Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray Secretion Scale, secondaryOutcomes measure: Swallowing Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328790, orgStudyIdInfo id: PNRR-MAD-2022-12376826, briefTitle: Study of Biomorkers and Rehabilitation Strategies in Functional Motor Disorders (FMD), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-31, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Michele Tinazzi, MD, PhD, class: OTHER, collaborators name: IRCCS Ospedale San Raffaele, collaborators name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, descriptionModule briefSummary: Functional motor disorders (FMD) are prevalent and highly disabling conditions characterized by abnormal movements (functional weakness, tremor, dystonia) significantly altered by distractive manoeuvres and incongruent with movement disorders seen in specific neurological diseases. FMDs are still misunderstood, diagnosed with delay, and not adequately treated, leading to reduced independence and high healthcare costs. Symptoms are physiologically associated with voluntary movement (distractibility, resolution with placebo) but are reported as involuntary. How this happens is yet a matter of debate. Identifying diagnostic and prognostic disease-specific biomarkers is an unmet need. The investigators will investigate motor, exteroceptive and interoceptive domains in a large cohort of FMD patients by a comprehensive set of behavioural, neurophysiological, and MRI tests. Ad-hoc eXplainable Artificial Intelligence (XAI) methods will develop disease-specific diagnostic and prognostic biomarker algorithms., conditionsModule conditions: Functional Motor Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Multidisciplinary Rehabilitation Training, interventions name: Cross-sectional study on patients with FMD and patients with structural/organic diseases, interventions name: Cross-sectional study on patients with FMD and healthy controls (HC), outcomesModule primaryOutcomes measure: Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score, primaryOutcomes measure: Multidimensional Fatigue Inventory Scale (MFI-20) score, primaryOutcomes measure: Brief Pain Inventory (BPI) score, primaryOutcomes measure: Beck Anxiety Inventory (BAI) score, primaryOutcomes measure: Beck Depression Inventory (BDI-II) score, primaryOutcomes measure: 12-item Short-Form Health Survey (SF-12) score, primaryOutcomes measure: Toronto Alexithymia Scale (TAS-20) score, primaryOutcomes measure: Direct adn indirect index of Sensory Attenuation (SA), primaryOutcomes measure: Joint angle at the elbow vibrated and reproduced, primaryOutcomes measure: N2/P2 amplitude, primaryOutcomes measure: Objective/Subjective heart rate ratio, primaryOutcomes measure: Cortical thickness and gray matter volumes, primaryOutcomes measure: Clinical Global Impression (CGI) score, primaryOutcomes measure: Gait speed (cm/sec), primaryOutcomes measure: Swing time (%), primaryOutcomes measure: Stride time (s), primaryOutcomes measure: Stride length (cm), primaryOutcomes measure: Sway area (mm2), primaryOutcomes measure: Stance time (sec), primaryOutcomes measure: Total excursion path (mm), primaryOutcomes measure: Velocity of Cop displacement in the anteroposterior directions (mm/s), primaryOutcomes measure: Velocity of Cop displacement in the mediolateral directions (mm/s), primaryOutcomes measure: Autism spectrum Quotient (AQ), primaryOutcomes measure: Schizotypal Personality Questionnaire (SPQ), otherOutcomes measure: Number of drop-out, otherOutcomes measure: Number of patients who refuse the treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, status: RECRUITING, city: Salerno, state: Campania, zip: 84131, country: Italy, contacts name: Maria Teresa Pellecchia, PhD, role: CONTACT, phoneExt: +39, email: mpellecchia@unisa.it, geoPoint lat: 40.67545, lon: 14.79328, locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milano, state: Lombardia, zip: 20132, country: Italy, contacts name: Federica Agosta, PhD, role: CONTACT, phoneExt: +39, email: agosta.federica@hsr.it, contacts name: Elisabetta Sarasso, PhD, role: CONTACT, email: sarasso.elisabetta@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, status: RECRUITING, city: Verona, zip: 37131, country: Italy, contacts name: Michele Tinazzi, PhD, role: CONTACT, phone: 0458124768, phoneExt: +39, email: michele.tinazzi@univr.it, contacts name: Marialuisa Gandolfi, PhD, role: CONTACT, phone: 3491656108, phoneExt: +39, email: marialuisa.gandolfi@univr.it, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
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protocolSection identificationModule nctId: NCT06328777, orgStudyIdInfo id: CAB-201-003, briefTitle: RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-07, completionDateStruct date: 2029-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cabaletta Bio, class: INDUSTRY, descriptionModule briefSummary: RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis, conditionsModule conditions: Systemic Sclerosis, conditions: Scleroderma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: CABA-201, outcomesModule primaryOutcomes measure: To evaluate incidence of adverse events, secondaryOutcomes measure: To evaluate adverse events and laboratory abnormalities, secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To evaluate efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: James St. Clair, role: CONTACT, phone: 734-936-5615, email: ssc-coordinator@umich.edu, contacts name: Neda Kortam, role: CONTACT, phone: 734-763-4866, email: ssc-coordinator@umich.edu, contacts name: Monalisa Ghosh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06328764, orgStudyIdInfo id: CS-101-11, briefTitle: A Clinical Trial Evaluating the Safety and Efficacy of CS-101 in Treating Subjects With β-thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: CorrectSequence Therapeutics Co., Ltd, class: INDUSTRY, collaborators name: First Affiliated Hospital of Guangxi Medical University, descriptionModule briefSummary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating β-thalassemia., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: CS-101, outcomesModule primaryOutcomes measure: Frequency and severity of adverse events(AEs）as assessed by CTCAE v5.0, primaryOutcomes measure: Time to neutrophil and platelet engraftment, primaryOutcomes measure: Proportion of subjects with engraftment, primaryOutcomes measure: Incidence of transplant-related mortality, primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Proportion of subjects achieving transfusion independence for at least 6 consecutive months, primaryOutcomes measure: Time to last red blood cell(RBC) transfusion, secondaryOutcomes measure: Change in total hemoglobin(Hb) concentration over time, secondaryOutcomes measure: Change in fetal hemoglobin(HbF) concentration over time, secondaryOutcomes measure: Chimerism level in Peripheral blood and bone marrow, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, country: China, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
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protocolSection identificationModule nctId: NCT06328751, orgStudyIdInfo id: 76043823.0.0000.0004, briefTitle: Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Emily Santos Montarroyos, class: NETWORK, collaborators name: AC Camargo Cancer Center, descriptionModule briefSummary: Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients., conditionsModule conditions: Cancer Pain, conditions: Quality of Life, conditions: Palliative Medicine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Randomization will be carried out using a specific application called Randomizer ® for Clinical Trial Lite, which is a secure and validated application that works with encrypted network traffic using Transport Layer Security (TLS), a strong encryption. There will be 3 groups which will be divided into the Case Group, the Active Control Group and the Passive Control Group. Each patient will be seen individually wearing a Samsung® smartwatch and will not know about the other patients' meditation. The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the Oncology Control Center Foundation (FCECON) office, using Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound at the office. The passive control group will perform breathing exercises based on the healthcare professional's instructions for 4 minutes in the office., whoMasked: PARTICIPANT, enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: Case group, interventions name: Active control group, interventions name: Passive control group, outcomesModule primaryOutcomes measure: Brief Pain Inventory (Reduced version), primaryOutcomes measure: McGill Quality of Life Questionnaire, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: The Edmonton Symptom Assessment Scale (ESAS), secondaryOutcomes measure: The National Comprehensive Cancer Network® (NCCN) Distress Thermometer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328738, orgStudyIdInfo id: ELVN-002-003, briefTitle: ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Enliven Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer., conditionsModule conditions: HER2-positive Breast Cancer, conditions: HER2-positive Gastric Cancer, conditions: HER2 Positive Solid Tumors, conditions: HER2 Amplification, conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase 1a will be a dose escalation of ELVN-002 in combination with fixed doses of trastuzumab or trastuzumab + chemotherapy according to the Bayesian Optimal Interval Design model. Phase 1b will be a dose expansion at one or more doses of ELVN-002., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 255, type: ESTIMATED, armsInterventionsModule interventions name: ELVN-002, interventions name: Trastuzumab, interventions name: 5-Fluorouracil, interventions name: Oxaliplatin, interventions name: Capecitabine, interventions name: Eribulin, interventions name: paclitaxel, interventions name: Leucovorin, outcomesModule primaryOutcomes measure: Incidence of dose limiting toxicities (DLTs; Phase 1a only), primaryOutcomes measure: Incidence of adverse events (AEs), primaryOutcomes measure: Incidence of laboratory abnormalities, primaryOutcomes measure: Incidence of electrocardiogram abnormalities, secondaryOutcomes measure: PK parameter of area under the curve of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of maximum concentration of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of minimum concentration of ELVN-002 (Phase 1a only), secondaryOutcomes measure: PK parameter of terminal half life of ELVN-002 (Phase 1a only), secondaryOutcomes measure: Confirmed objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR; Phase 1b only), secondaryOutcomes measure: Brain metastases response (Phase 1b only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alexander Spira, MD, role: CONTACT, phone: 703-636-1473, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False
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protocolSection identificationModule nctId: NCT06328725, orgStudyIdInfo id: EN001_POWER, briefTitle: Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular Dystrophy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: ENCell, class: INDUSTRY, descriptionModule briefSummary: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Duchenne Muscular Dystrophy, conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: \<Phase 1 Clinical Trial\> A total of 6-12 participants (3-6 participants per cohort).\<Phase 2 Clinical Trial\> A total of 76 participants (a minimum of 30 participants per group, considering a dropout rate of 20%, resulting in 38 participants per group)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The investigational drug for the clinical trial of the following cohort or group will be administered intravenously (IV) three times at 6-week intervals.\<Phase 1 Clinical Trial\> Cohort 1: EN001 5.0x10\^5 cells/kg / Cohort 2: EN001 2.5x10\^6 cells/kg\<Phase 2 Clinical Trial\> Experimental Group: Recommended Phase 2 Dose (RP2D) for EN001 / Control Group: Placebo for EN001, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: EN001, outcomesModule primaryOutcomes measure: <Phase 1> Adverse drug reactions related to dose limiting toxicity (DLT), primaryOutcomes measure: <Phase 1> Adverse drug reactions related to discontinuation of clinical trial drug administration, primaryOutcomes measure: <Phase 2> Change in time to stand test (TTSTAND), secondaryOutcomes measure: <Phase 1> Time to stand test (TTSTAND) change amount, secondaryOutcomes measure: <Phase 1> TTSTAND velocity (1/TTSTAND) change amount, secondaryOutcomes measure: <Phase 1> Time to run/walk 10 meters test (TTRW) change amount, secondaryOutcomes measure: <Phase 1> TTRW velocity (1/TTRW) change amount, secondaryOutcomes measure: <Phase 1> North Star Ambulatory Assessment (NSAA) change amount, secondaryOutcomes measure: <Phase 1> Time to climb 4 steps test (TTCLIMB) change amount, secondaryOutcomes measure: <Phase 1> TTCLIMB velocity (1/TTCLIMB) change amount, secondaryOutcomes measure: <Phase 1> 6-minute walk test (6MWT) change amount, secondaryOutcomes measure: <Phase 1> Changes amount in muscle strength by region, secondaryOutcomes measure: <Phase 1> Changes amount in parameters related to pulmonary function, secondaryOutcomes measure: <Phase 1> Changes amount in parameters related to cardiac function, secondaryOutcomes measure: <Phase 1> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2), secondaryOutcomes measure: <Phase 2> Time to stand test (TTSTAND) change amount, secondaryOutcomes measure: <Phase 2> TTSTAND velocity (1/TTSTAND) change amount, secondaryOutcomes measure: <Phase 2> Time to run/walk 10 meters test (TTRW) change amount, secondaryOutcomes measure: <Phase 2> TTRW velocity (1/TTRW) change amount, secondaryOutcomes measure: <Phase 2> North Star Ambulatory Assessment (NSAA) change amount, secondaryOutcomes measure: <Phase 2> Time to climb 4 steps test (TTCLIMB) change, secondaryOutcomes measure: <Phase 2> TTCLIMB velocity (1/TTCLIMB) change amount, secondaryOutcomes measure: <Phase 2> 6-minute walk test (6MWT) change amount, secondaryOutcomes measure: <Phase 2> Changes amount in muscle strength by region, secondaryOutcomes measure: <Phase 2> Changes amount and rate of change in whole thigh muscle volume and index assessed by MRI, secondaryOutcomes measure: <Phase 2> Changes amount in parameters related to pulmonary function, secondaryOutcomes measure: <Phase 2> Changes amount in parameters related to cardiac function, secondaryOutcomes measure: <Phase 2> Change rate of creatine kinase (CK) at each visit after administration of investigational product compared to baseline (Visit 2), secondaryOutcomes measure: <Phase 2> Pediatric Outcomes Data Collection Instrument (PODCI) item score and total score change, secondaryOutcomes measure: <Phase 2> Pediatric Quality of Life inventory™ (PedsQL™) item scores and total score change, secondaryOutcomes measure: <Phase 1> Adverse Event, secondaryOutcomes measure: <Phase 1> Laboratory examination, secondaryOutcomes measure: <Phase 1> Vital sign, secondaryOutcomes measure: <Phase 2> Adverse Event, secondaryOutcomes measure: <Phase 2> Laboratory examination, secondaryOutcomes measure: <Phase 2> Vital sign, eligibilityModule sex: MALE, minimumAge: 6 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, contacts name: Jeehun Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, contacts name: Jong-Hee Chae, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06328712, orgStudyIdInfo id: EN001_MIRACLE1, briefTitle: Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: ENCell, class: INDUSTRY, descriptionModule briefSummary: An Open, Dose-escalation, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A (CMT1A), conditionsModule conditions: Charcot-Marie-Tooth Disease Type 1A, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: EN001, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration, secondaryOutcomes measure: CMTNSv2 score change, secondaryOutcomes measure: CMT examination score change, secondaryOutcomes measure: Rasch-modified CMTNSv2 score change, secondaryOutcomes measure: Rasch-modified CMTES score change, secondaryOutcomes measure: FDS score change, secondaryOutcomes measure: ONLS score change, secondaryOutcomes measure: 10MWT score change, secondaryOutcomes measure: Change in grade of fatty infiltration in the proximal lower extremities (According to Goutallier classification scale), secondaryOutcomes measure: Change in Motor Nerve Conduction Velocity (Unit: m/s), secondaryOutcomes measure: Change in Compound Muscle Action Potential (Unit: ㎷), secondaryOutcomes measure: Change in Sensory Nerve Action Potential (Unit: ㎶), secondaryOutcomes measure: Change in Sensory Nerve Conduction Velocity (Unit: m/s), secondaryOutcomes measure: SF-36v2 score change, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Vital sign, secondaryOutcomes measure: Laboratory examination, secondaryOutcomes measure: electrocardiography, secondaryOutcomes measure: X-ray, secondaryOutcomes measure: Physical Examinations, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Byung-Ok Choi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06328699, orgStudyIdInfo id: STUDY00006456, secondaryIdInfos id: EU6011-23, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: K01AT010488, type: NIH, link: https://reporter.nih.gov/quickSearch/K01AT010488, secondaryIdInfos id: P30CA138292, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA138292, briefTitle: Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation., conditionsModule conditions: Lymphoma, conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spiritual Therapy, interventions name: Best Practice, outcomesModule primaryOutcomes measure: Feasibility - patient enrollment and treatment-specific retention rates, secondaryOutcomes measure: Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey, secondaryOutcomes measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT], secondaryOutcomes measure: Acceptability - Chaplain Satisfaction Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital/Winship Cancer Institute, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Erin Brauer, MPH, role: CONTACT, email: erin.graf.brauer@emory.edu, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06328686, orgStudyIdInfo id: STUDY00005787, secondaryIdInfos id: NCI-2023-10895, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00005787, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: WINSHIP5883-23, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: P30CA138292, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA138292, briefTitle: Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy., conditionsModule conditions: Metastatic Malignant Neoplasm in the Brain, conditions: Metastatic Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Arginine, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Spectroscopy, interventions name: Whole-Brain Radiotherapy, outcomesModule primaryOutcomes measure: Peak plasma L-arginine (arginine) and arginine metabolite concentration, secondaryOutcomes measure: Incidence of adverse events associated with delivering L-arginine with standard fractionation whole brain radiation therapy, secondaryOutcomes measure: Side effect profile of oral and IV arginine, secondaryOutcomes measure: Frontal cortex blood volume/flow changes with L-arginine administration, secondaryOutcomes measure: Describe The Immunological Effects of Oral versus IV Arginine, secondaryOutcomes measure: Describe The Metabolic Effects of Oral versus IV Arginine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital/Winship Cancer Institute, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Lisa Sudmeier, MD, PhD, role: CONTACT, phone: 404-712-9625, email: lsudmei@emory.edu, contacts name: Agnes Harutyunyan, role: CONTACT, email: aharuty@emory.edu, contacts name: Lisa Sudmeier, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06328673, orgStudyIdInfo id: DM919-001, briefTitle: A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: D2M Biotherapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumorsThe main questions it aims to answer are:What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab??Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: DM919, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Number of treatment-emergent events (TEAEs) in Dose Escalation, primaryOutcomes measure: RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, secondaryOutcomes measure: All cohorts, otherOutcomes measure: Dose Expansion, otherOutcomes measure: Dose Expansion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78216, country: United States, contacts name: Shiraj Sen, role: CONTACT, phone: 972-893-8800, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06328660, orgStudyIdInfo id: EX-MKTG-155, briefTitle: Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-18, completionDateStruct date: 2024-06-18, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Coopervision, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market., conditionsModule conditions: Presbyopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Lens 1, interventions name: Lens 2, outcomesModule primaryOutcomes measure: Overall Lens Handling, secondaryOutcomes measure: Overall logMAR Visual Acuity, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ocular Technology Group, city: London, zip: SW1E6AU, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06328647, orgStudyIdInfo id: 24-010, briefTitle: Quantra Point-of-Care Hemostasis Monitoring, acronym: QUANTRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion)., conditionsModule conditions: Bleeding, conditions: Hemostatic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 666, type: ESTIMATED, armsInterventionsModule interventions name: POC Quantra QPlus System, interventions name: Routine care, outcomesModule primaryOutcomes measure: Blood and blood component transfusions, secondaryOutcomes measure: Bleeding, otherOutcomes measure: PT/aPTT, otherOutcomes measure: INR, otherOutcomes measure: Platelet, otherOutcomes measure: Fibrinogen, otherOutcomes measure: hematocrit/hemoglobin, otherOutcomes measure: ICU length of stay, otherOutcomes measure: Hospital length of stay., otherOutcomes measure: In-hospital mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328634, orgStudyIdInfo id: LOCAL/2014/FV-01, briefTitle: Bacillus Cereus Infection of Patients Diagnosed at Nîmes University Hospital, statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-01, primaryCompletionDateStruct date: 2012-12-31, completionDateStruct date: 2012-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: OBJECTIVES:We aimed to study the characteristics of patients presenting with a Bacillus cereus infection in a university hospital.METHODS:We performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between January 1st, 2008 and December 31st, 2012 and diagnosed with a B. cereus infection. We identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients., conditionsModule conditions: Bacillus Cereus Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 76, type: ACTUAL, outcomesModule primaryOutcomes measure: descriptive analysis of patients' characteristics and B. cereus infection or colonization., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328621, orgStudyIdInfo id: 19594, secondaryIdInfos id: NCI-2021-05881, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19594, type: OTHER, domain: City of Hope Medical Center, secondaryIdInfos id: P30CA033572, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA033572, briefTitle: Lung Cancer Risk Assessment and Etiology, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-02, primaryCompletionDateStruct date: 2029-06-15, completionDateStruct date: 2029-06-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer., conditionsModule conditions: Lung Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Electronic Health Record Review, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Frequency of germline alterations, otherOutcomes measure: Frequency of abnormal radiographic findings, otherOutcomes measure: Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes, otherOutcomes measure: Liquid biopsy (LB) test sensitivity, otherOutcomes measure: LB test specificity, otherOutcomes measure: LB test positive predictive value, otherOutcomes measure: LB test negative predictive value, otherOutcomes measure: LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Stacy W. Gray, role: CONTACT, phone: 626-218-6639, email: stagray@coh.org, contacts name: Stacy W. Gray, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False
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protocolSection identificationModule nctId: NCT06328608, orgStudyIdInfo id: CLI-06657AA1-01, secondaryIdInfos id: 2022-503128-29, type: REGISTRY, domain: Clinical Trial Information System (CTIS) - EU, briefTitle: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease, acronym: FLY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Chiesi Farmaceutici S.p.A., class: INDUSTRY, collaborators name: ICON plc, descriptionModule briefSummary: A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease., conditionsModule conditions: Fabry Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: PRX-102 1 mg/kg every two weeks, outcomesModule primaryOutcomes measure: Incidence of Treatment Emergent Adverse Events (TEAEs), primaryOutcomes measure: Incidence of Infusion Related Reactions (IRRs), primaryOutcomes measure: Incidence of Injection site reactions (ISRs), primaryOutcomes measure: Change in Tanner stage, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: Mean Heart Rate, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: PR Interval, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: QRS Duration, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: QT Interval, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: QTc Interval, primaryOutcomes measure: Change from baseline of 12-lead ECG quantitative parameters: ST Segment, primaryOutcomes measure: Incidence of treatment-emergent Anti-Drug Antibodies (ADAs), primaryOutcomes measure: Incidence of premedication use at each visit and change of infusion premedications from baseline, primaryOutcomes measure: Pharmacokinetics: Time to maximum plasma concentration (tmax), primaryOutcomes measure: Pharmacokinetic : Area under the plasma concentration-time curve from time 0 to time t (AUC0 t), primaryOutcomes measure: Pharmacokinetics: Area under the curve from time 0 to 2 weeks (AUC0-2wk), primaryOutcomes measure: Pharmacokinetics: Area under the curve from time 0 to infinity (AUC0-∞), primaryOutcomes measure: Pharmacokinetics: Terminal half-life (t1/2), primaryOutcomes measure: Pharmacokinetics: Area under the curve over a dosing interval (AUCτ), primaryOutcomes measure: Pharmacokinetics: Observed drug concentration at the end of the dosing interval (Cτ), primaryOutcomes measure: Pharmacokinetics: Clearance (Cl), primaryOutcomes measure: Pharmacokinetics: Volume of distribution (Vz), primaryOutcomes measure: Change in eGFR, primaryOutcomes measure: Change in annualized eGFR slope, primaryOutcomes measure: Change in urine albumin levels, primaryOutcomes measure: Change in urine protein levels, primaryOutcomes measure: Change from baseline in LVMi as assessed by echocardiogram, primaryOutcomes measure: Change from baseline in LVMi as assessed by echocardiogram, primaryOutcomes measure: Change from baseline in LVMi as assessed by echocardiogram, primaryOutcomes measure: Change from baseline in LVMi as assessed by echocardiogram, primaryOutcomes measure: Change from baseline in LVMi as assessed by echocardiogram, primaryOutcomes measure: Incidence of any cardiac arrythmias as assessed by Holter ECG, primaryOutcomes measure: Change in plasma levels of cardiac biomarkers, primaryOutcomes measure: Change in plasma level of Gb3 concentration (nM), primaryOutcomes measure: Change in plasma level of lyso-Gb3 (nM), primaryOutcomes measure: Change in urine level of lyso-Gb3 (nM), primaryOutcomes measure: Incidence of change from baseline in the number of different pain medications, primaryOutcomes measure: Incidence of Fabry Clinical Events, primaryOutcomes measure: Change from baseline of Mainz Severity Score Index (MSSI) scores, primaryOutcomes measure: Change from baseline of PedsQL-GI (or GSRS for subjects who reaches 18 yrs of age) scores, primaryOutcomes measure: Change from baseline of FPHPQ scores, primaryOutcomes measure: Change from baseline of PedsQL-PPQ (or BPI-SF for subjects who reaches 18 yrs of age) scores, primaryOutcomes measure: Change from baseline of EQ-5D-Y (or EQ-5D-5L for subjects who reaches 18 yrs of age) scores, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328595, orgStudyIdInfo id: Cross sectional, briefTitle: Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-22, primaryCompletionDateStruct date: 2023-05-04, completionDateStruct date: 2023-08-20, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Syrian Private University, class: OTHER, descriptionModule briefSummary: Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue, conditionsModule conditions: Musculoskeletal Pain, conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1039, type: ACTUAL, outcomesModule primaryOutcomes measure: The Demographic characteristics were classified into four groups: Gender, Residual area, education level., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 78 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohamad Zaid Ahmad Abdalla, city: Damascus, country: Syrian Arab Republic, geoPoint lat: 33.5102, lon: 36.29128, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-24, uploadDate: 2024-03-22T04:16, filename: Prot_SAP_000.pdf, size: 235804, hasResults: False
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protocolSection identificationModule nctId: NCT06328582, orgStudyIdInfo id: Zhenjiu Post-stroke dysphagia, briefTitle: Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Routine rehabilitation training, interventions name: Acupuncture Technique for Restoring Consciousness combined with Scalp Acupuncture, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Gugging Swallowing Screen, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328569, orgStudyIdInfo id: VR Wallenberg Syndrome, briefTitle: Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy., conditionsModule conditions: Wallenberg Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Therapy, interventions name: Conventional dysphagia treatment, outcomesModule primaryOutcomes measure: standardized swallowing assessment, secondaryOutcomes measure: Murray secretion scale, secondaryOutcomes measure: penetration-aspiration scale, secondaryOutcomes measure: swallowing-quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328556, orgStudyIdInfo id: Ultrasound-guided Botulinum, briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, the investigators employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations., conditionsModule conditions: Cricopharyngeal Achalasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: botulinum toxin type A, interventions name: Injection, outcomesModule primaryOutcomes measure: functional oral intake scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: The Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray secretion scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328543, orgStudyIdInfo id: N-20210046 4th project, briefTitle: Itch Sensation Induced by Multiple Applications of Pruritogens (Temporal Summation), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Aalborg University, class: OTHER, descriptionModule briefSummary: In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application., conditionsModule conditions: Histamine, conditions: Cowhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The participants will randomly receive applications of cowhage and histamine, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participant will be blinded about application of pruritogens, whoMasked: PARTICIPANT, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Histamine, interventions name: Cowhage, outcomesModule primaryOutcomes measure: Assessment of itch, primaryOutcomes measure: Assessment of pain, secondaryOutcomes measure: Microvascular reactivity, secondaryOutcomes measure: Alloknesis, secondaryOutcomes measure: Mechanically evoked itch, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328530, orgStudyIdInfo id: N-20210046 3rd project, briefTitle: Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Aalborg University, class: OTHER, descriptionModule briefSummary: In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen., conditionsModule conditions: Histamine, conditions: Cowhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The participants will randomly receive applications of cowhage and histamine., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participant will be blinded about application of pruritogens., whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Cowhage, interventions name: Histamine, outcomesModule primaryOutcomes measure: Assessment of itch, primaryOutcomes measure: Assessment of pain, secondaryOutcomes measure: Alloknesis, secondaryOutcomes measure: Mechanically evoked itch, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328517, orgStudyIdInfo id: 2023-305, briefTitle: The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Juan Kang, class: OTHER, descriptionModule briefSummary: Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation.Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis., conditionsModule conditions: Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Death, secondaryOutcomes measure: complication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: juan Kang, role: CONTACT, phone: +8613996112052, email: 68368892@qq.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06328504, orgStudyIdInfo id: Cashew Protocol, briefTitle: Efficacy of Cashew Nut Protein Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-04-21, completionDateStruct date: 2027-04-21, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: It is a randomized, sigle-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy., conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Cashew immunotherapy, outcomesModule primaryOutcomes measure: Cashew full tolerance, secondaryOutcomes measure: Cashew partial tolerance, secondaryOutcomes measure: OIT safety, secondaryOutcomes measure: Wheal diamater in skin prick tests, secondaryOutcomes measure: SIgE and IgG 4 levels, secondaryOutcomes measure: BAT scores, secondaryOutcomes measure: Quality of life- FAQLQ, secondaryOutcomes measure: Air condensate, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Medical University of Warsaw, city: Warsaw, state: Mazowieckie, zip: 02-091, country: Poland, contacts name: Agnieszka Szczukocka-Zych, MD, role: CONTACT, phone: +48 22 3179427, email: agnieszka.szczukocka-zych@wum.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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protocolSection identificationModule nctId: NCT06328491, orgStudyIdInfo id: OZUHN-014, secondaryIdInfos id: 22-5325, type: OTHER, domain: University Health Network, briefTitle: Erdafitinib in Metastatic Steroid-cell Ovarian Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-30, primaryCompletionDateStruct date: 2022-08-22, completionDateStruct date: 2022-08-22, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary., conditionsModule conditions: Ovarian Cancer, conditions: Steroid Cell Tumor, Malignant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: Erdafitinib, outcomesModule primaryOutcomes measure: Tumor response, primaryOutcomes measure: Overall health status, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Margaret Cancer Centre, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06328478, orgStudyIdInfo id: Predictors of AKI in PICU., briefTitle: Predictors of Acute Kidney Injury in Critically Ill Children Admitted to PICU., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Predictors of Acute Kidney Injury in critically ill children admitted to PICU during one year., conditionsModule conditions: Acute Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Observational prospective study., outcomesModule primaryOutcomes measure: Incidence of acute kidney injury and survival to discharge from the PICU., eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328465, orgStudyIdInfo id: IEO 1108, briefTitle: fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases, acronym: fREEDOM, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-11-22, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI., conditionsModule conditions: Invasive Breast Cancer, conditions: HER2-positive Breast Cancer, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 145, type: ESTIMATED, armsInterventionsModule interventions name: Diffusion whole body MRI, outcomesModule primaryOutcomes measure: 5-year overall survival, secondaryOutcomes measure: Overall survival of patients underwent local treatment, secondaryOutcomes measure: Breast cancer specific survival, secondaryOutcomes measure: Safety of local treatment, secondaryOutcomes measure: Anxiety assessment, secondaryOutcomes measure: Health state assessment, secondaryOutcomes measure: Ability to Cope With Trauma assessment, secondaryOutcomes measure: Personality assessment, secondaryOutcomes measure: Acceptability and perception of DWB-MRI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Monica Iorfida, MD, role: CONTACT, phone: +390257489970, email: monica.iorfida@ieo.it, contacts name: Mara Negri, role: CONTACT, phone: +390257489536, email: mara.negri@ieo.it, contacts name: Monica Iorfida, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06328452, orgStudyIdInfo id: MASLD, briefTitle: Risk Factors and Impact MASLD in Patients With IBD, acronym: MASLD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Inflammatory bowel disease (IBD) is a chronic disease characterized by remitting and relapsing inflammation of the gastrointestinal tract. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD and their incidence and prevalence are increasing.In about 5-50% of patients with IBD, there are several extraintestinal manifestations as primary sclerosing cholangitis, autoimmune/granulomatous hepatitis, and non-alcoholic fatty liver disease (NAFLD).Metabolic dysfunction-associated steatotic liver disease "MASLD"(formerly NAFLD) is a spectrum of hepatic diseases associated with metabolic and cardiovascular disorders, such as obesity, insulin resistance (IR), hypertension, dyslipidemia, impaired glucose tolerance and type 2 diabetes mellitus.The risk factors of developing liver steatosis in patients with IBD remain undetermined. Some studies have supported traditional risk factors, such as type 2 Diabetes mellitus (T2DM), weight gain, or obesity, to contribute to MAFLD development in patients with IBD. Other studies have highlighted the involvement of disease activity, duration, drug-induced liver injury and small bowel surgeries in MAFLD progression.Limited data are available on the frequency and risk factors of MASLD in Egyptian patients with IBD, and no published Egyptian study has addressed the clinical utility of serum steatosis markers in MASLD prediction in IBD population. Moreover, the impact of MASLD on IBD course is unclear. Therefore, we will conduct our study to shed some light on this issue., conditionsModule conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: FibroScan, outcomesModule primaryOutcomes measure: Assess the prevalence and risk factors of metabolic dysfunction associated steatotic liver disease among patients attending inflammatory bowel disease outpatient clinic, primaryOutcomes measure: Effect of metabolic dysfunction associated steatotic liver disease on inflammatory bowel disease course, secondaryOutcomes measure: Performance of serum steatosis markers in prediction of steatosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328439, orgStudyIdInfo id: ANS014004-I-CN-01, briefTitle: A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Chest Hospital, collaborators name: Hunan Cancer Hospital, collaborators name: Henan Cancer Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Peking University Cancer Hospital & Institute, descriptionModule briefSummary: Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, and anti-tumor antitumor activity of ANS014004 monotherapy in subjects with locally advanced or metastatic solid tumors.* The study consists of two parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2). For each subject, the study will consist of a screening period (Day -28 to Day -1), a treatment period (until discontinuation of treatment) and a follow-up period (including safety follow-up and survival follow-up).* During the Treatment Period, subjects will receive ANS014004 single-agent oral administration until the subject meets any treatment termination criteria. 1, The dose-escalation part (Part 1) will consist of a single-dose period and a multiple-dose period (28 days per cycle), participants during dose escalation will receive a single dose of ANS014004 on Day 1 of the single-dose period in order to obtain complete PK parameters for the single dose. There will be a 7-day washout period between the single dosing period and the multiple dosing period at the same dose level. If no dose-limiting toxicity (DLT) occurs during the 7-day washout period, participants will begin Cycle 1 (28 days per cycle) multiple dosing treatment on Day 8, receiving ANS014004 once daily (QD). participants in the backfill cohort will enter the multiple dosing period directly. The specific dose which participant receives will depend on the different cohort assignments. The dose-escalation part (Part 1) will use the initial accelerated titration design (ATD) and the traditional "3 + 3" design to determine the MTD of ANS014004 in subjects with locally advanced or metastatic solid tumors. 2. In the Dose Expansion (Part 2), participants, will receive oral administration of ANS014004 QD at each treatment cycle (28 days per cycle). An end-of-treatment (EOT) visit will be conducted within 7 days of the final dose or investigator decision to discontinue.All subjects will undergo imaging evaluations of their tumors every 8 weeks until disease progression is confirmed by the investigator, the subject begins new antitumor therapy, dies, is lost to follow-up, or withdraws from the study, whichever occurs first., conditionsModule conditions: Locally Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Cohort1: 7.5mg Cohort2: 15mg Cohort3: 30mg Cohort4: 45mg Cohort5: 60mg, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: ANS014004, outcomesModule primaryOutcomes measure: Incidence of Adverse Events (AEs), primaryOutcomes measure: Incidence of Serious Adverse Events (SAEs), primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol, primaryOutcomes measure: Incidence of baseline laboratory finding, ECG and vital signs changes, primaryOutcomes measure: Proportion of patients with radiological response (ORR), secondaryOutcomes measure: Objective Response Rate (ORR), 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: Pharmacokinetics of ANS014004: Plasma PK concentrations, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max), secondaryOutcomes measure: Pharmacokinetics of ANS014004: Clearance, secondaryOutcomes measure: Pharmacokinetics of ANS014004: Half-life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Shun Lu, Ph.D, role: CONTACT, phone: +8618017321551, email: shunlu_shchest@sina.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06328426, orgStudyIdInfo id: Anti-osteoarthritis, briefTitle: Vitamin D With Omega-3 or Metformin in Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To determine the efficacy of vitamin D with omega-3 or metformin for reducing knee symptoms and effusion synovitis in patients with symptomatic knee osteoarthritis., conditionsModule conditions: Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D, interventions name: Omega-3, interventions name: Metformin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Effusion-synovitis volume on musculoskeletal ultrasound., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328413, orgStudyIdInfo id: KAEK-302, briefTitle: L-PRF vs PBM on Extraction Socket Healing, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-20, primaryCompletionDateStruct date: 2021-06-21, completionDateStruct date: 2021-09-21, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets., conditionsModule conditions: Healing Surgical Wounds, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: photobiomodulation, interventions name: Leukocyte and Platelet Rich Fibrin, outcomesModule primaryOutcomes measure: Newly formed bone (Healing at extraction sockets), secondaryOutcomes measure: Soft tissue healing, secondaryOutcomes measure: Probing depth, otherOutcomes measure: Postoperative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Akdeniz University, city: Antalya, state: Merkez, zip: 07058, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
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protocolSection identificationModule nctId: NCT06328400, orgStudyIdInfo id: VV116-RSV-02, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Vigonvita Life Sciences, class: INDUSTRY, descriptionModule briefSummary: This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Deuremidevir Hydrobromide for Suspension, interventions name: Deuremidevir Hydrobromide for Suspension Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: AUC0- t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: t1/2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hushan Hospital Fudan university, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201900, country: China, contacts name: Xiaojie Wu, role: CONTACT, phone: 13524686330, email: maomao_xj@163.com, contacts name: Jufang Wu, role: CONTACT, phone: 13816357099, email: 13816357099@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06328387, orgStudyIdInfo id: SYSKY-2024-064-03, briefTitle: HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group.Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival.To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer., conditionsModule conditions: Advanced Breast Cancer, conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research model consists of four arms：1. arm A: SG.2. arm B: HCQ+SG.3. arm C: T-DXd .4. arm D: HCQ+T-DXd., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine, interventions name: Sacituzumab Govitecan, interventions name: Trastuzumab Deruxtecan, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity, DLT, primaryOutcomes measure: Adverse event, AE, primaryOutcomes measure: Objective Response Rate, ORR, secondaryOutcomes measure: Progression-Free Survival, PFS, secondaryOutcomes measure: Overall Survival, OS, secondaryOutcomes measure: Clinical Benefit Rate, CBR, secondaryOutcomes measure: Disease Control Rate, DCR, secondaryOutcomes measure: The rate of adverse events, secondaryOutcomes measure: Quality of life scale score, QoL, secondaryOutcomes measure: Exploration of biomarkers, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Jianli J Zhao, doctorate, role: CONTACT, phone: 15920589334, email: zhaojli5@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06328374, orgStudyIdInfo id: 240420, briefTitle: Voice and Swallowing Disorders in Adults With and Without Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: This research study is investigating whether people with Alzheimer's disease experience more changes to voice and swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe Alzheimer's Disease is high (85-93%) and voice is also often negatively impacted by Alzheimer's disease. The overall objective of this study is to evaluate the voice and swallowing function of adults with and without Alzheimer's disease. The investigators will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of voice and swallowing impairments on the primary caregivers of those with Alzheimer's Disease.Healthy adults and individuals with Alzheimer's disease will:* undergo tests of cough, voice, and swallow function* undergo tests of grip and tongue strength* complete questionnairesCaregivers of individuals with Alzheimer's disease will also complete questionnaires., conditionsModule conditions: Alzheimer Disease, conditions: Caregiver Burden, conditions: Healthy Aging, conditions: Dysphonia, conditions: Dysphagia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Swallowing safety, primaryOutcomes measure: Voluntary cough peak expiratory flow, primaryOutcomes measure: Vocal fold bowing index, secondaryOutcomes measure: Swallowing and Eating Related Fatigue Questionnaire (SERF), secondaryOutcomes measure: Swallowing Related Quality of Life Questionnaire (SWAL-QOL), secondaryOutcomes measure: Voice Handicap Index (VHI), secondaryOutcomes measure: Aging Voice Index (AVI), secondaryOutcomes measure: Grip Strength, secondaryOutcomes measure: Tongue strength, secondaryOutcomes measure: Clinical frailty scale, secondaryOutcomes measure: Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire, secondaryOutcomes measure: Caregiver Self-Assessment Questionnaire, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328361, orgStudyIdInfo id: R24008, briefTitle: Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer, acronym: NORPPA-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Tampere University Hospital, class: OTHER, collaborators name: Tampere University, collaborators name: Helsinki University Central Hospital, collaborators name: Turku University Hospital, collaborators name: Kuopio University Hospital, collaborators name: Oulu University Hospital, collaborators name: Jyväskylä Central Hospital, collaborators name: Seinajoki Central Hospital, collaborators name: Satakunta Central Hospital, collaborators name: North Karelia Central Hospital, collaborators name: Tartu University Hospital, collaborators name: East Tallinn Central Hospital, collaborators name: West Tallinn Central Hospital, collaborators name: North Estonia Medical Centre, descriptionModule briefSummary: The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are* if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere* what is the organ preservation rate* what is the local regrowth rate, conditionsModule conditions: Rectal Cancer, conditions: Rectal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Nonoperative surveillance, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: TME-free survival, secondaryOutcomes measure: ctDNA-free survival, secondaryOutcomes measure: Post local regrowth disease-free survival, secondaryOutcomes measure: Post local regrowth overall survival, secondaryOutcomes measure: Local regrowth-free survival, secondaryOutcomes measure: Local recurrence-free survival, secondaryOutcomes measure: Distant metastases-free survival, secondaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Salvage rate after local regrowth, secondaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Complication rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: East Tallinn Central Hospital, city: Tallinn, country: Estonia, geoPoint lat: 59.43696, lon: 24.75353, locations facility: North Estonia Medical Centre, city: Tallin, country: Estonia, contacts name: Indrek Seire, MD, PhD, role: CONTACT, email: indrek.seire@ut.ee, geoPoint lat: 59.43696, lon: 24.75353, locations facility: West Tallinn Central Hospital, city: Tallin, country: Estonia, contacts name: Kaur Liivak, MD, PhD, role: CONTACT, email: kaur.liivak@keskhaigla.ee, geoPoint lat: 59.43696, lon: 24.75353, locations facility: Tartu University Hospital, city: Tartu, country: Estonia, contacts name: Jaan Soplepman, MD, PhD, role: CONTACT, email: jaan.soplepmann@kliinikum.ee, geoPoint lat: 58.38062, lon: 26.72509, locations facility: Helsinki University Central Hospital, city: Helsinki, zip: 00290, country: Finland, contacts name: Anna H Lepistö, MD, PhD, role: CONTACT, email: anna.lepisto@hus.fi, geoPoint lat: 60.16952, lon: 24.93545, locations facility: North Karelia Central Hospital, city: Joensuu, country: Finland, contacts name: Markku Matikainen, MD, PhD, role: CONTACT, email: markku.matikainen@siunsote.fi,, geoPoint lat: 62.60118, lon: 29.76316, locations facility: Jyväskylä Central Hospital, city: Jyväskylä, country: Finland, contacts name: Kyösti Tahkola, MD, PhD, role: CONTACT, email: kyosti.tahkola@hyvaks.fi, geoPoint lat: 62.24147, lon: 25.72088, locations facility: Kuopio University Hospital, city: Kuopio, country: Finland, contacts name: Anne Fageström, MD, PhD, role: CONTACT, email: anne.fagerstrom@pshyvinvointialue.fi, geoPoint lat: 62.89238, lon: 27.67703, locations facility: Oulu University Hospital, city: Oulu, country: Finland, contacts name: Karoliina Paarmio, MD, PhD, role: CONTACT, email: karoliina.paarnio@pohde.fi, geoPoint lat: 65.01236, lon: 25.46816, locations facility: Satakunta Central Hospital, city: Pori, country: Finland, contacts name: Jyrki Haikonen, MD, PhD, role: CONTACT, email: jyrki.haikonen@sata.fi, geoPoint lat: 61.48333, lon: 21.78333, locations facility: Seinajoki Central Hospital, city: Seinäjoki, country: Finland, geoPoint lat: 62.79446, lon: 22.82822, locations facility: Tampere University Hospital, city: Tampere, zip: 33400, country: Finland, contacts name: Toni T Seppälä, MD, PhD, role: CONTACT, phone: +358444722846, email: toni.seppala@tuni.fi, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Turku University Hospital, city: Turku, country: Finland, contacts name: Pirita Varpe, MD, PhD, role: CONTACT, email: Pirita.Varpe@tyks.fi, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
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protocolSection identificationModule nctId: NCT06328348, orgStudyIdInfo id: SW010, briefTitle: Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population.The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes.The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power., conditionsModule conditions: Menopause Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: supplementation, interventions name: placebo, outcomesModule primaryOutcomes measure: Change in the Menopause Rating Scale (MRS) score, secondaryOutcomes measure: Follicle-Stimulating Hormone (FSH) change, secondaryOutcomes measure: Estradiol change, secondaryOutcomes measure: Number of any adverse events, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False
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protocolSection identificationModule nctId: NCT06328335, orgStudyIdInfo id: Orthostatic Hypotension, briefTitle: The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom, conditionsModule conditions: Orthostatic Hypotension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation training, interventions name: Rise-bed Training, outcomesModule primaryOutcomes measure: Composite Autonomic Symptom Scale 31, secondaryOutcomes measure: Orthostatic Hypotension Questionnaire, secondaryOutcomes measure: Orthostatic Grading Scale, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328322, orgStudyIdInfo id: Soh-Med-24-03-02MD, briefTitle: Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomesThe left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategiesAmong the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral wallsThe selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process, conditionsModule conditions: Left Main Coronary Artery Disease With Acute Coronary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous Coronary Intervention in Left Main Artery Disease, outcomesModule primaryOutcomes measure: major adverse cardiac events (MACE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06328309, orgStudyIdInfo id: Myofascial Traumatic Brain, briefTitle: Impact of v Release on Dysphagia in Patients With Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation treatment, interventions name: Myofascial Release Therapy, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, secondaryOutcomes measure: Patient health questionnaire-9, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328296, orgStudyIdInfo id: Myofascial Parkinson's Dysphag, briefTitle: Impact of Myofascial Release on Dysphagia in Parkinson's Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Parkinson's Patients. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Parkinson's Patients? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation treatment, interventions name: Myofascial Release Therapy, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, secondaryOutcomes measure: patient health questionnaire-9, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328283, orgStudyIdInfo id: Soh-Med-24-02-01MD, briefTitle: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015)., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: measure of Glutamine synthetase and BCLFAF1, outcomesModule primaryOutcomes measure: glutamine synthetase, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, city: Sohag, state: Sohagm, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06328270, orgStudyIdInfo id: 03.09.2019 / 2505, briefTitle: Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-01-30, completionDateStruct date: 2022-03-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sisli Hamidiye Etfal Training and Research Hospital, class: OTHER, descriptionModule briefSummary: This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC)., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Ozone - oxygen Therapy, interventions name: Corticosteroid, outcomesModule primaryOutcomes measure: Visual Pain Score, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, secondaryOutcomes measure: Visual Pain Score, secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06328257, orgStudyIdInfo id: Elderly Community Myofascial, briefTitle: Impact of Myofascial Release on Preventing Dysphagia in the Elderly Community, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Myofascial Release Training, outcomesModule primaryOutcomes measure: Swallowing-Related Quality of Life Questionnaire, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328244, orgStudyIdInfo id: Community-Based Swallowing, briefTitle: Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Simple swallowing training, outcomesModule primaryOutcomes measure: Eating Assessment Tool-10, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Swallowing-Related Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328231, orgStudyIdInfo id: Community elderly dysphagia, briefTitle: The Impact of Swallowing Intervention for Elderly Community Dwellers, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-14, completionDateStruct date: 2024-04-14, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 248, type: ACTUAL, armsInterventionsModule interventions name: Systematic simple swallowing training, outcomesModule primaryOutcomes measure: Gugging Swallowing Screen, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Swallowing-Related Quality of Life Questionnaire, secondaryOutcomes measure: Eating Assessment Tool-10, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Railway Commu., city: Zhenzhou, country: China, geoPoint lat: 32.28034, lon: 119.16999, hasResults: False
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protocolSection identificationModule nctId: NCT06328218, orgStudyIdInfo id: Gymnastics ParkinsonCommunity, briefTitle: The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Simple Gymnastics Training, outcomesModule primaryOutcomes measure: Unified Parkinson's Disease Rating Scale, secondaryOutcomes measure: The Berg Balance Scale, secondaryOutcomes measure: Patient Health Questionnaire-9, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328205, orgStudyIdInfo id: Glossopharyngeal Nerve Block, briefTitle: Impact of Glossopharyngeal Nerve Block on Swallowing Difficulties Caused by Gastroesophageal Reflux Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Glossopharyngeal Nerve Block, interventions name: Lidocaine Hydrochloride, interventions name: placebo injection, outcomesModule primaryOutcomes measure: penetration-aspiration scale, secondaryOutcomes measure: Gastroesophageal Reflux Disease Questionnaire, secondaryOutcomes measure: Pressure pain threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328192, orgStudyIdInfo id: active breathing elderly, briefTitle: The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Active Breathing Exercises, outcomesModule primaryOutcomes measure: Standardized Swallowing Assessment Scale, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Swallowing-Related Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328179, orgStudyIdInfo id: KY-2023-058-01, briefTitle: Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-24, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Huai'an First People's Hospital, class: OTHER, collaborators name: Zhenjiang First People's Hospital, collaborators name: The First People's Hospital of Changzhou, collaborators name: The Affiliated Hospital of Xuzhou Medical University, descriptionModule briefSummary: This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities.This study includes the induction and consolidation phases of AML treatment., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Venetoclax 100 mg d1，200 mg d2，400 mg d3-14；, outcomesModule primaryOutcomes measure: Overall response rate，ORR, secondaryOutcomes measure: Overall survival, OS, secondaryOutcomes measure: Event free survival, EFS, secondaryOutcomes measure: Duration of remission, DOR, otherOutcomes measure: Adverse event, AE, otherOutcomes measure: Treatment-related mortality, TRM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital）, status: RECRUITING, city: Huai'an, state: Jiangsu, zip: 210000, country: China, contacts name: Shandong Tao, role: CONTACT, phone: 15252393900, email: TSD8884@126.com, geoPoint lat: 33.50389, lon: 119.14417, hasResults: False
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protocolSection identificationModule nctId: NCT06328166, orgStudyIdInfo id: rFGF-1 for CTS, briefTitle: The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Tri-Service General Hospital, class: OTHER, collaborators name: Eusol Biotech Co., Ltd., descriptionModule briefSummary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein, which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Sono-guided injection with ES135, interventions name: Sono-guided injection with placebo, outcomesModule primaryOutcomes measure: Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection., secondaryOutcomes measure: Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection., secondaryOutcomes measure: Change from baseline of cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection., secondaryOutcomes measure: Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328153, orgStudyIdInfo id: BF2022-101, briefTitle: Efficacy and Mechanism of FSN Treatment for Senile Knee Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare FSN with oral Nonsteroidal Antiinflammatory Drugs (NSAIDs) in pain relief and improvement in knee function among elder people, the main questions it aims to answer are:Q1: Compared with the positive drug (celecoxib), whether FSN is more or at least as effective for pain relief and improvement in knee function in elder people with knee arthritis.Q2: From the biomechanical point of view, what is the mechanism by which FSN plays a therapeutic role in knee osteoarthritis (KOA)?Participants will:1. Will be randomly assigned to 2 groups. There will be 30 participants in each group.2. A group of patients will receive FSN monotherapy, while the other group will receive oral celecoxib and pantoprazole. Each patient will receive a 2-week course of treatment.3. Visual analogue scale (VAS), WOMAC, knee range of motion (ROM), gait analysis, and musculoskeletal ultrasonography (US) of lower extremity muscles will be assessed during treatment and in the follow-up.Researchers will compare FSN and celecoxib to see if FSN has better, or at least equivalent, efficacy than celecoxib, which is commonly used in clinical practice., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Fu's Subcutaneous Needling, interventions name: Celecoxib, outcomesModule primaryOutcomes measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 14th day after receiving treatment., secondaryOutcomes measure: Change from Baseline in the visual analogue scale (VAS) (0-100 mm) at the 7th day, the 28th day and 42th day after the start of treatment., secondaryOutcomes measure: Change from Baseline in The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the 7th day, the 14th day, the 28th day and 42th day after the start of treatment., secondaryOutcomes measure: Change from Baseline in the active range of motion (ROM) of the knee at the 7th day,the 14th day,the 28th day and 42th day after the start of treatment., otherOutcomes measure: Change from Baseline in the data of the Three-dimensional gait analysis at the 7th day and 14th day after the start of treatment., otherOutcomes measure: Change from Baseline in the data of the shear wave elastic imaging technology analysis at the 7th day and 14th day after the start of treatment., otherOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328140, orgStudyIdInfo id: Skyland 001, briefTitle: Sleep Quality, Cognitive Performance, and Computerized Cognitive Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-14, completionDateStruct date: 2026-04-14, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: George West Mental Health Foundation d/b/a Skyland Trail, class: OTHER, collaborators name: Sumitomo Pharmaceuticals America, descriptionModule briefSummary: Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as wellIn previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy., conditionsModule conditions: Bipolar Disorder, conditions: Major Depressive Disorder, conditions: Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Lurasidone, interventions name: FDA Approved antidepressant treatment, outcomesModule primaryOutcomes measure: Improvement in Cognitive Performance, secondaryOutcomes measure: Training Engagement in Cognitive training, secondaryOutcomes measure: Nighttime sleep measured with actigraphy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: George West Mental Health Foundation, DBA Skyland Trail, city: Atlanta, state: Georgia, zip: 30329, country: United States, contacts name: Ben W Hunter, MD, role: CONTACT, phone: 866-504-4966, email: bhunter@skylandtrail.org, contacts name: Ben W Hunter, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alex O Rothbaum, PhD, MPH, role: SUB_INVESTIGATOR, contacts name: Philip D Harvey, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06328127, orgStudyIdInfo id: 23-691, briefTitle: Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors, acronym: PATH-4, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Dana-Farber Cancer Institute, collaborators name: Duke University, collaborators name: H. Lee Moffitt Cancer Center and Research Institute, descriptionModule briefSummary: This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care., conditionsModule conditions: Hematopoietic Stem Cell Transplant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: PATH, outcomesModule primaryOutcomes measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale, secondaryOutcomes measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale, secondaryOutcomes measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale, secondaryOutcomes measure: Gratitude based on the Gratitude Questionnaire, secondaryOutcomes measure: Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale, secondaryOutcomes measure: Physical function based on the Patient-Reported Outcomes Measurement Information System-Physical Function-20, secondaryOutcomes measure: Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), otherOutcomes measure: Flourishing based on the Flourishing Scale, otherOutcomes measure: Optimism based on the Life Orientation Test-Revised (LOT-R), otherOutcomes measure: Coping based on the Brief-COPE questionnaire, otherOutcomes measure: Post-traumatic stress based on the Post-traumatic Stress Checklist-Civilian Version, otherOutcomes measure: Steps per day based on the ActiGraph accelerometer, otherOutcomes measure: Sedentary leisure time based on the ActiGraph accelerometer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Heather Jim, PhD, role: CONTACT, email: heather.jim@moffitt.org, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Dana Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Duke Cancer Institute, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Thomas LeBlanc, MD, role: CONTACT, email: thomas.leblanc@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06328114, orgStudyIdInfo id: Pro00114549, briefTitle: Accelerating TMS for Cervical Dystonia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-07-01, completionDateStruct date: 2029-07-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: American Academy of Neurology, descriptionModule briefSummary: This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition., conditionsModule conditions: Isolated Cervical Dystonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single-arm crossover study design with subjects receiving TMS at two different intensities, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The TMS intensity delivered at each TMS visit will be masked, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation (TMS), outcomesModule primaryOutcomes measure: Change in Neck Angles as Measured by Neck Sensor Device, secondaryOutcomes measure: Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI), secondaryOutcomes measure: Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University Health System, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Noreen Bukhari-Parlakturk, MD PhD, role: CONTACT, phone: 919-668-8248, email: movdisres@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06328101, orgStudyIdInfo id: 2023-02558, briefTitle: Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR), acronym: AiPPEAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University Medical Center Goettingen, class: OTHER, collaborators name: University Medical Centre Maribor, collaborators name: Aalborg University Hospital, collaborators name: University Hospital Munich, collaborators name: Tartu University Hospital, collaborators name: University Hospital in Halle, descriptionModule briefSummary: The goal of this observational, retrospective study is to learn about cancer risk in autoimmune pancreatitis (AIP) patients. The main questions it aims to answer are:* Do patients with AIP have higher incidence of cancer in comparison to general population?* What is the overall prevalence of cancer in AIP patients?* What are the characteristics of AIP patients associated with the incidence of cancer?, conditionsModule conditions: Autoimmune Pancreatitis Type 1, conditions: Autoimmune Pancreatitis Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Standardized incidence ratio (SIR) of first invasive cancer, secondaryOutcomes measure: The prevalence of cancer diagnoses 12 months prior to AIP diagnosis, secondaryOutcomes measure: Risk factor associated with cancer diagnosis., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328088, orgStudyIdInfo id: EC/12/23/2400, briefTitle: Vegetarian Versus Non Vegetarian Based Diet in the Recurrence of Hepatic Encephalopathy in Patients With Cirrhosis: An Open Label Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-04-16, completionDateStruct date: 2024-10-16, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sir Ganga Ram Hospital, class: OTHER, descriptionModule briefSummary: Earlier protein restriction was advocated in the treatment of HE but later this concept was refuted and increase protein intake was advocated in patients with HE. Diet in patients during an episode HE is also not known. It is advisable based on many case reports or case series that vegetable-based diet during the episode of HE is better than animal-based diet as it reduces ammonia level and other false neurotransmitters in brain and helps in early recovery of, HE . However, diet in patients who had recovered from an episode of, HE is not known and what type of protein (vegetarian or non-vegetarian) should be taken to prevent another episode of HE has never been evaluated. In India majority of the patients are vegetarian and patients with cirrhosis are malnourished and lack protein in their diet as per our previous published study, conditionsModule conditions: Hepatic Encephalopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Non vegetarian, outcomesModule primaryOutcomes measure: Recurrence of overt hepatic encephalopathy, secondaryOutcomes measure: Hospitalization due to any cause, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Ganga Ram Hospital, status: RECRUITING, city: Delhi, zip: 110060, country: India, contacts name: Praveen Sharma, MD,DM, role: CONTACT, phone: 9810365151, geoPoint lat: 28.65195, lon: 77.23149, hasResults: False
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protocolSection identificationModule nctId: NCT06328075, orgStudyIdInfo id: AI-ATTR-ECHO, secondaryIdInfos id: 20211029191554, type: OTHER, domain: registre général des traitements de l'APHP, briefTitle: Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis, acronym: AI-ATTR-ECHO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Algalarrondo Vincent, class: OTHER, collaborators name: Bichat Hospital, collaborators name: Bioquantis, descriptionModule briefSummary: The goal of this study is to develop an algorithm using artificial intelligence (AI) to assist identification of potential ATTR-CM cases using routine transthoracic echocardiography.The main questions it aims to answer are:* is the algorithm able to diagnose ATTR-CM* is the algorithm able to diagnose different types of ATTR-CM (ATTRv, ATTRwt)This is a non interventional study. Participant' echocardiographies will be, after deidentification, used to train, valid and test the algorithm., conditionsModule conditions: Amyloid Cardiomyopathy, conditions: Transthyretin Amyloid Cardiomyopathy, conditions: Transthyretin Cardiac Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 15000, type: ESTIMATED, armsInterventionsModule interventions name: non interventional study, outcomesModule primaryOutcomes measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTR-CM :, primaryOutcomes measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTR-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRwt-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-V122I-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics of the AI algorithm to diagnose ATTRv-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRwt-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-V122I-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to diagnose ATTRv-CM :, secondaryOutcomes measure: Building and validating the diagnostic performance metrics curves of the AI algorithm to differentiate ATTR-CM from LV hypertrophy (LVH) :, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bichat, status: RECRUITING, city: Paris, zip: 75018, country: France, contacts name: Vincent Algalarrondo, MD, PhD, role: CONTACT, phone: +33140257785, email: vincent.algalarrondo@aphp.fr, contacts name: Gregory Ducrocq, PD, PhD, role: CONTACT, email: gregory.ducrocq@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06328062, orgStudyIdInfo id: TUH Mirogabalin TKA, briefTitle: Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.The main question\[s\] it aims to answer are:• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.Participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA., conditionsModule conditions: Pain Postoperative, conditions: Osteoarthritis, conditions: Total Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Mirogabalin, interventions name: Pregabalin, outcomesModule primaryOutcomes measure: Pain score, secondaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Knee society score, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: Sedation score, secondaryOutcomes measure: Incidence of Somnolence and dizziness, secondaryOutcomes measure: Total hospital stay, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University Hospital, status: RECRUITING, city: Khlong Luang, state: Pathum Thani, zip: 12120, country: Thailand, contacts name: Yot Tanariyakul, M.D., role: CONTACT, phone: 6683930257, email: y.tanariyakul@gmail.com, contacts name: Yot Tanariyakul, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Krit Boontanapibul, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False
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protocolSection identificationModule nctId: NCT06328049, orgStudyIdInfo id: HSKY-033, briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-10, primaryCompletionDateStruct date: 2025-02-10, completionDateStruct date: 2025-08-10, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Taixing People's Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Trilaciclib Injection, outcomesModule primaryOutcomes measure: Incidence of febrile neutropenia (FN), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Antibiotic Use rate, secondaryOutcomes measure: Number of medication delays, secondaryOutcomes measure: Number of chemotherapy dose reductions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taixing People's Hospital, status: RECRUITING, city: Taixing, state: Jiangsu, zip: 225400, country: China, contacts name: liu C yang, M.D., role: CONTACT, phone: 87656001, phoneExt: 0523, email: liuyctx@163.com, geoPoint lat: 32.16667, lon: 120.01361, hasResults: False
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protocolSection identificationModule nctId: NCT06328036, orgStudyIdInfo id: NCI-2024-02185, secondaryIdInfos id: NCI-2024-02185, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10640, type: OTHER, domain: University of Pittsburgh Cancer Institute LAO, secondaryIdInfos id: 10640, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186690, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186690, briefTitle: Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-21, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma., conditionsModule conditions: Recurrent Glioblastoma, IDH-Wildtype, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Atezolizumab, interventions name: Biospecimen Collection, interventions name: Magnetic Resonance Imaging, interventions name: Surgical Procedure, interventions name: Tiragolumab, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Tumor infiltrating T lymphocyte density, secondaryOutcomes measure: Dose limiting toxicity, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: PFS6, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Tumor mutational burden (TMB), secondaryOutcomes measure: Expression of immune checkpoint receptors and ligands, otherOutcomes measure: Tumor response signatures including for T-cells, interferon and cell cycle, otherOutcomes measure: T cell receptor (TCR) clonality and diversity, otherOutcomes measure: Tumor infiltrating T-cell, T-regs, and myeloid cells, otherOutcomes measure: TCR overlap and clonal expression, otherOutcomes measure: Peripheral blood mononuclear cell (PBMC) response signatures including for T-cells, interferon and cell cycle, otherOutcomes measure: TCR clonality by PBMC, otherOutcomes measure: TCR clonality, otherOutcomes measure: Trough concentrations in serum and concentrations in cerebrospinal fluid, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328023, orgStudyIdInfo id: REC/MS-PT/01831, briefTitle: Impact of Concussion History on Sleep and Physical Performance in Contact Sports Athletes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-06-02, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study investigates the correlation between a history of concussions and its effects on both sleep patterns and physical performance among athletes engaged in contact sports. By examining the relationship between concussion history, sleep quality, and athletic performance, this research aims to provide insights into the potential long-term implications of concussions on the well-being and performance of athletes in contact sports, conditionsModule conditions: Concussion, Mild, conditions: Sleep, conditions: Physical Performance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 115, type: ESTIMATED, armsInterventionsModule interventions name: SCOAT 6 to find association, outcomesModule primaryOutcomes measure: Cantu Scale, secondaryOutcomes measure: Sport Concussion Office Assessment Tool 6, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 36 Years, stdAges: ADULT, contactsLocationsModule locations facility: HAYATABAD Sports complex, status: RECRUITING, city: Peshawar, state: Khyber Pakhtun Khawan, zip: 24730, country: Pakistan, contacts name: Nadia Ishtiaq, MSOMPT, role: CONTACT, phone: 03486977541, email: Nadia.Ishtiaq@riphah.edu.pk, contacts name: Muhammad haroon, MSSPT*, role: CONTACT, phone: 03484644733, email: muhammad-haroon6528@zu.edu.pk, contacts name: Muhammad Haroon, MS*SPT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.008, lon: 71.57849, hasResults: False
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protocolSection identificationModule nctId: NCT06328010, orgStudyIdInfo id: SIDDXAC02, briefTitle: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers, acronym: SIDDX, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2030-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Siddhey LLC, class: INDUSTRY, descriptionModule briefSummary: Collect data on various wound treatments and their related wound healing process, in real life settings.Analyze the safety and efficacy of wound treatments, including: advanced biological/synthetic grafts and standard of wound care treatments., conditionsModule conditions: Wounds and Injuries, conditions: Burns, conditions: Mohs Surgery, conditions: Diabetic Foot Ulcer Mixed, conditions: Venous Leg Ulcer, conditions: Non-healing Wound, conditions: Trauma Injury, conditions: Injury and Wounds, conditions: Degloving Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Advanced Treatment Modalities for wound and injuries, outcomesModule primaryOutcomes measure: Data collection of 5000 patients, secondaryOutcomes measure: Different types of wounds/injuries heal rate, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Comprehensive Medicine, city: Alpine, state: California, zip: 91901, country: United States, geoPoint lat: 32.83505, lon: -116.76641, locations facility: West Hills Hospital and Medical Centers Doctors Suites, city: West Hills, state: California, zip: 91307, country: United States, geoPoint lat: 34.19731, lon: -118.64398, hasResults: False
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protocolSection identificationModule nctId: NCT06327997, orgStudyIdInfo id: BZE2203-A-01, briefTitle: An Exploratory Study by Fast CAR T Cells, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2027-03-06, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Shanghai Cell Therapy Group Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fast CAR T cells, outcomesModule primaryOutcomes measure: Dose-limiting toxicity(DLT), secondaryOutcomes measure: Maximum tolerated dose (MTD), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: AUC, secondaryOutcomes measure: Pharmacodynamics (PD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Mengchao Cancer Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Lou jinxing, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06327984, orgStudyIdInfo id: 157354, briefTitle: Barts Sex-CAD Database, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes').Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area.Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. We think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood.In this study we wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. We will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. We will combine this data with the data that is routinely collected during hospital admission. In this way we hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research we will address an under researched area and find new ways of treating women and men with coronary artery disease., conditionsModule conditions: Coronary Artery Disease, conditions: Myocardial Infarction, conditions: Acute Coronary Syndrome, conditions: Atherosclerosis, conditions: Inflammation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality, primaryOutcomes measure: Re-admission, primaryOutcomes measure: MACE, secondaryOutcomes measure: Relationship with specific MI types, secondaryOutcomes measure: Relationship with inflammation, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327971, orgStudyIdInfo id: 0000, briefTitle: Enhanced Outcome Prediction in Cutaneous Squamous Cell Carcinoma Using Deep-learning and Computational Histopathology, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: Evaluate a deep-learning model trained on computational histopathology for predicting outcomes in cutaneous squamous cell carcinoma, conditionsModule conditions: Squamous Cell Carcinoma of the Skin, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Metastasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts Health NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06327958, orgStudyIdInfo id: protocol Number: 2021/21, briefTitle: THE EFFECTS OF DIRECT AND INDIRECT LARYNGOSCOPY ON CORMACK-LEHANE AND POGO SCORES, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-15, primaryCompletionDateStruct date: 2022-06-15, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Zonguldak Bulent Ecevit University, class: OTHER, descriptionModule briefSummary: Direct laryngoscopy (DL) is a conventional and highly difficult method that is used in endotracheal intubation (ETI) training. Today, the usage of video-laryngoscopes (VLs) to teach airway management to inexperienced healthcare personnel is a prevalent practice. In ETI training, it is recommended to train students on simulators before allowing them direct access to patients., conditionsModule conditions: Being a 5th Year Student at the Faculty of Medicine, conditions: No Previous Laryngoscopy Experience, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Cormack-Lehane (C&L), interventions name: POGO score, outcomesModule primaryOutcomes measure: The percentage of glottic opening (POGO) scores in the airway management training of medical students., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zonguldak Bülent Ecevit University, city: Zonguldak, state: Kozlu, zip: 67600, country: Turkey, geoPoint lat: 41.45139, lon: 31.79305, hasResults: False
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protocolSection identificationModule nctId: NCT06327945, orgStudyIdInfo id: 22-00009, briefTitle: Transplanting Lungs From Uncontrolled Donation After Circulatory Death, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation., conditionsModule conditions: Lung Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Lung uDCD Protocol, outcomesModule primaryOutcomes measure: Incidence of Primary Graft Dysfunction (PDG) Grade III, secondaryOutcomes measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO), secondaryOutcomes measure: Number of Participants who Required Normothermic Extracorporeal Membrane Oxygenation (nECMO), secondaryOutcomes measure: Incidence of Re-Transplantation, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06327932, orgStudyIdInfo id: HIVEC(PRG), briefTitle: HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC)., conditionsModule conditions: Non-Muscle-Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: TURBT, interventions name: HIVEC, interventions name: Intravesical Chemotherapy, interventions name: Gemcitabine, outcomesModule primaryOutcomes measure: Recurrence rate, secondaryOutcomes measure: 1-year recurrence rate, secondaryOutcomes measure: Recurrence-free survival (RFS) rate, secondaryOutcomes measure: Time to treatment failure, secondaryOutcomes measure: Success rate of therapeutic operation, secondaryOutcomes measure: Quality of international prostate symptom score, secondaryOutcomes measure: Quality of bother of score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327919, orgStudyIdInfo id: 62885, briefTitle: Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-05-25, completionDateStruct date: 2023-09-23, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: National Nutrition and Food Technology Institute, class: OTHER, descriptionModule briefSummary: To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups., conditionsModule conditions: Weight Regain After Bariatric Surgery and Food Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Probiotic supplement, interventions name: Placebo supplement, outcomesModule primaryOutcomes measure: Weight, primaryOutcomes measure: BMI, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Fat mass, primaryOutcomes measure: Food addiction, secondaryOutcomes measure: Eating behavior, secondaryOutcomes measure: Leptin, secondaryOutcomes measure: Serotonin, secondaryOutcomes measure: Oxytocin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Azita Hekmatdoost, city: Tehran, state: Middle East, zip: 19835, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, locations facility: National Nutrition and Food Technology Research Institute, city: Tehran, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
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protocolSection identificationModule nctId: NCT06327906, orgStudyIdInfo id: qilu000002, briefTitle: A Prospective Birth Cohort of Infants With Allergy and Neurodevelopmental Disorders in China, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2026-11-15, completionDateStruct date: 2029-11-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: In this study, a birth cohort was established to demonstrate the causal relationship between allergies and neurodevelopment disorders in infants and young children, and to find out the influencing factors of neurodevelopment disorders in early life., conditionsModule conditions: Child Allergy, conditions: Neurodevelopmental Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, outcomesModule primaryOutcomes measure: ASD, primaryOutcomes measure: ADHD, eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 42 Days, stdAges: CHILD, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, country: China, contacts name: zhu mengna, role: CONTACT, phone: 15211482407, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06327893, orgStudyIdInfo id: AQUATIC_RESCUE, briefTitle: Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023, acronym: RESCUE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues., conditionsModule conditions: Drowning, conditions: Drowning, Near, conditions: Submersion, conditions: Submersion - Accidental, conditions: Submersion or Drowning Due to Being Washed Overboard, conditions: Submersion or Drowning Due to Being Thrown Overboard, conditions: Submersion or Drowning Due to Ship Sinking, Water Skier Injured, conditions: Submersion or Drowning Due to Boat Submerging, Swimmer Injured, conditions: Submersion or Drowning Due to Boat Overturning, Swimmer Injured, conditions: Submersion or Drowning Due to Boat Submerging, Water Skier Injured, conditions: Submersion or Drowning Due to Fall From Gangplank, Swimmer Injured, conditions: Submersion or Drowning Due to Ship Sinking, Docker or Stevedore Injured, conditions: Submersion or Drowning Due to Fall Overboard, Docker or Stevedore Injured, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Submersion or immersion in liquid, outcomesModule primaryOutcomes measure: The annual incidence., primaryOutcomes measure: The annual incidence rate., secondaryOutcomes measure: The spatial distribution of aquatic rescues on a map of Denmark., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06327880, orgStudyIdInfo id: C4151006, secondaryIdInfos id: 2023-509339-17-00, type: REGISTRY, domain: CTIS (EU), briefTitle: A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2024-07-02, completionDateStruct date: 2024-07-02, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.The study is seeking the following participants:* Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.* Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).* Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: PF-07054894 or placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AE) or serious adverse events (SAE), primaryOutcomes measure: Number of participants with clinically meaningful change from baseline in laboratory tests results, primaryOutcomes measure: Number of participants with clinically meaningful change from baseline in vital signs, primaryOutcomes measure: Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters, primaryOutcomes measure: Maximal plasma concentration (Cmax), primaryOutcomes measure: Time to Maximum Plasma Concentration (Tmax), primaryOutcomes measure: Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt), primaryOutcomes measure: Half-life of PF-07054894, secondaryOutcomes measure: Observed Accumulation Ratio (Rac), secondaryOutcomes measure: Observed Accumulation Ratio Based on Cmax (Rac,Cmax), secondaryOutcomes measure: Trough plasma concentrations (Ctrough), secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) as data permits, secondaryOutcomes measure: Apparent Oral Clearance (CL/F), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pfizer Clinical Research Unit - Brussels, city: Brussels, state: Bruxelles-capitale, Région DE, zip: B-1070, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
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protocolSection identificationModule nctId: NCT06327867, orgStudyIdInfo id: drs2402021836, briefTitle: Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Patan Academy of Health Sciences, class: OTHER, descriptionModule briefSummary: This is an open-label, single center, prospective, randomized, comparative, intervention study.The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:1. To assess the adverse events during video laryngoscopy2. To assess the adverse events during direct Laryngoscopy3. To compare the first pass success rate of DL vs VL according to demographic profile (age and sex), conditionsModule conditions: To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An open-label, single center, prospective, randomized, comparative, intervention study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Oro Tracheal Intubation by DL, interventions name: Oro Tracheal Intubation by VL, outcomesModule primaryOutcomes measure: First pass success of direct laryngoscopy in oro tracheal intubation, primaryOutcomes measure: First pass success of video laryngoscopy in oro tracheal intubation, secondaryOutcomes measure: Complications rates between two methods., secondaryOutcomes measure: Use of alternative methods for ventilation or oxygenation between two methods, secondaryOutcomes measure: Better visualization of Cormack-Lehane grading between two methods, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327854, orgStudyIdInfo id: NUOROS (PI: M Briguglio), secondaryIdInfos id: L4175, type: OTHER_GRANT, domain: Italian Ministry of Health, briefTitle: NUtrition and ORal Health in Orthopaedic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-03-22, completionDateStruct date: 2024-12-10, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery)., conditionsModule conditions: Orthopedic Disorder, conditions: Metabolism and Nutrition Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, outcomesModule primaryOutcomes measure: Association between pre-operative oral health and diet, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milan, country: Italy, contacts name: Elena Cittera, role: CONTACT, phone: 00390283502224, email: elena.cittera@grupposandonato.it, contacts name: Matteo Briguglio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06327841, orgStudyIdInfo id: EK 1117/2022, briefTitle: Plaque Reduction Sesame Oil, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-21, primaryCompletionDateStruct date: 2022-08-18, completionDateStruct date: 2022-08-18, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Medical University Innsbruck, class: OTHER, descriptionModule briefSummary: The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect., conditionsModule conditions: Dental Plaque, conditions: Gingivitis, conditions: Oral Microbial Colonization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: sesame oil, interventions name: distilled water, outcomesModule primaryOutcomes measure: Rustogi Modified Navy Plaque Index (RMNPI), secondaryOutcomes measure: Gingival Index (GI), secondaryOutcomes measure: microbial analysis, secondaryOutcomes measure: Oral Health Impact Profile (OHIP), secondaryOutcomes measure: Interview halitosis, xerostomia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University, city: Innsbruck, state: Tyrol, zip: 6020, country: Austria, geoPoint lat: 47.26266, lon: 11.39454, hasResults: False
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protocolSection identificationModule nctId: NCT06327828, orgStudyIdInfo id: 32-663, briefTitle: Methimazole in Graves' Disease - a Randomised Controlled Trial Comparing the Computer-aided Treatment DigiThy Versus Usual Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, collaborators name: Graz University of Technology, descriptionModule briefSummary: The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required., conditionsModule conditions: Graves Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy), interventions name: Usual care, outcomesModule primaryOutcomes measure: The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices, secondaryOutcomes measure: Comparison in terms of dosing and penalties, secondaryOutcomes measure: Comparison based on free thyroxine (fT4) target range, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, city: Graz, zip: 8044, country: Austria, contacts name: Verena Theiler-Schwetz, MD, PhD, role: CONTACT, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
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protocolSection identificationModule nctId: NCT06327815, orgStudyIdInfo id: D1690L00149, briefTitle: Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM., conditionsModule conditions: Type 2 Diabetes Mellitus (T2DM), designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 632, type: ESTIMATED, armsInterventionsModule interventions name: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, interventions name: Dapagliflozin tablets and Metformin HCl extended-release tablets, outcomesModule primaryOutcomes measure: Change in HbA1c from baseline, secondaryOutcomes measure: Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24., secondaryOutcomes measure: Absolute change in FPG from baseline to week 24., secondaryOutcomes measure: Absolute change in PPG from baseline to week 24., secondaryOutcomes measure: The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24., secondaryOutcomes measure: The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24., secondaryOutcomes measure: To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM., otherOutcomes measure: AEs, otherOutcomes measure: SAE, otherOutcomes measure: ADRs, otherOutcomes measure: Temperature, otherOutcomes measure: Systolic and diastolic BP, otherOutcomes measure: Pulse rate, otherOutcomes measure: Respiratory rate, otherOutcomes measure: Weight, otherOutcomes measure: Height, otherOutcomes measure: BMI, otherOutcomes measure: Number of participants with abnormal ECG readings, otherOutcomes measure: Proportion of TITR (Time in Tight Target Range), otherOutcomes measure: TIR (Time In Range), otherOutcomes measure: TBR (Time Below Range), otherOutcomes measure: TAR (Time Above Range), otherOutcomes measure: MAGE (Mean Amplitude of Glycemic Excursion), otherOutcomes measure: SDBG (Standard Deviation of Blood Glucose), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Beijing, zip: 100020, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wei Fang, zip: 261035, country: China, hasResults: False
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protocolSection identificationModule nctId: NCT06327802, orgStudyIdInfo id: 20240104, briefTitle: Improving the Well-being of Caregivers of Cystic Fibrosis Patients During Physiotherapy Treatment, acronym: MucoZar, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Pole Sante Grace de Dieu, class: OTHER, descriptionModule briefSummary: The main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Zarit Burden Interview, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PSLA GDD, city: Caen, zip: 14000, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False
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protocolSection identificationModule nctId: NCT06327789, orgStudyIdInfo id: ZBEU-MS, briefTitle: Trunk Control and Disability in Persons With Multiple Sclerosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-21, primaryCompletionDateStruct date: 2021-12-25, completionDateStruct date: 2022-02-21, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Zonguldak Bulent Ecevit University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Expanded Disability Status Scale (EDSS), primaryOutcomes measure: Trunk Impairment Scale (TIS), primaryOutcomes measure: Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA), primaryOutcomes measure: Step Length (cm), primaryOutcomes measure: Stride Length (cm), primaryOutcomes measure: Step Width (cm), primaryOutcomes measure: Cadence (steps/min), primaryOutcomes measure: Velocity (m/s), primaryOutcomes measure: Step time (s), primaryOutcomes measure: Stride time (s), primaryOutcomes measure: Timed 25-Foot Walk Test (T25FW), primaryOutcomes measure: Nine-Hole Peg Test (9HPT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zonguldak Bülent Ecevit University, city: Zonguldak, country: Turkey, geoPoint lat: 41.45139, lon: 31.79305, hasResults: False
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protocolSection identificationModule nctId: NCT06327776, orgStudyIdInfo id: 21/709, briefTitle: New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-04, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario 12 de Octubre, class: OTHER, descriptionModule briefSummary: Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities., conditionsModule conditions: Mild Traumatic Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Serum and saliva biomarkers, outcomesModule primaryOutcomes measure: Biomarkers diagnostic performance, secondaryOutcomes measure: Determination of the potential of the biomarkers in predicting neurological symptoms after TBI, secondaryOutcomes measure: Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI, secondaryOutcomes measure: Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI, secondaryOutcomes measure: Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI, secondaryOutcomes measure: Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario 12 de Octubre, status: RECRUITING, city: Madrid, zip: 28041, country: Spain, contacts name: Alfonso Lagares, MD, PhD, role: CONTACT, phone: +34917792389, email: alfonso.lagares@salud.madrid.org, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06327763, orgStudyIdInfo id: Ilioinguinal Neurectomy, briefTitle: Prophylactic Ilioinguinal Neurectomy During Open Tension-Free Inguinal Hernia Repair, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: postoperative chronic inguinal pain is a common postoperative complication after open inguinal hernia repair.Chronic inguinal pain is a common complication following open inguinal hernia repair. Ilioinguinal nerve entrapment is a common cause of this chronic pain which may adversely affect the patients' life. Ilioinguinal neurectomy seems to be beneficial in preventing such pain, but it carries the risk for numbness and hypoesthesia., conditionsModule conditions: Ilioinguinal Nerve Section, conditions: Pain Prevention, conditions: Hernioplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 196, type: ACTUAL, armsInterventionsModule interventions name: ilioinguinal nerve section, outcomesModule primaryOutcomes measure: detect postoperative pain using short form inguinal pain questionnaire, eligibilityModule sex: MALE, minimumAge: 16 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: yasmine Hegab, city: Zagazig, zip: 7120730, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06327750, orgStudyIdInfo id: NL83566.018.24, briefTitle: The Microcirculation, Dialysis Modality and Sequestered Salt, acronym: MIMOSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, collaborators name: Dutch Kidney Foundation, collaborators name: Niercentrum aan de Amstel, collaborators name: B.Braun Avitum AG, descriptionModule briefSummary: The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:1. What are the effects on the sequestered sodium content and microcirculation after 4 weeks of treatment with the following dialysis modes? * HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to * HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * HD with an expected zero diffusive sodium balance (DNa = PNa) compared to * HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to * Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)2. Are the SSC and MC interrelated in this patient group?This study is a randomized cross-over trial. Participants will be subjected to the abovementioned dialysis treatment modes in random order., conditionsModule conditions: End-stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized cross-over trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Hemodialysis (DNa = PNa), interventions name: Hemodialysis (DNa<PNa), interventions name: Hemodialysis after isolated ultrafiltration (DNa=PNa), interventions name: High volume hemodiafiltration (DNa=PNa), interventions name: High volume hemodiafiltration (DNa<PNa), outcomesModule primaryOutcomes measure: Skin microcirculation, primaryOutcomes measure: Sequestered salt content (SSC), secondaryOutcomes measure: Intradialytic hypotension, secondaryOutcomes measure: Change in intradialytic blood pressure, secondaryOutcomes measure: Peridialytic blood pressure, secondaryOutcomes measure: Change in CK-MB, secondaryOutcomes measure: Change in high sensitivity C-reactive protein (hs-CRP), secondaryOutcomes measure: Change in interleukin-6 receptor (IL-6R), secondaryOutcomes measure: Change in soluble CD163 (sCD163), secondaryOutcomes measure: Change in soluble intercellular adhesion molecule-1 (s-ICAM-1), secondaryOutcomes measure: Change in serum glycosaminoglycans, secondaryOutcomes measure: Change in syndecan-1, secondaryOutcomes measure: Change in vascular endothelial growth factor C (VEGF-C), secondaryOutcomes measure: Change in extracellular vesicles (EVs), secondaryOutcomes measure: Change in skin microcirculation, secondaryOutcomes measure: Change in sequestered salt content (SSC), secondaryOutcomes measure: modified Dialysis symptom index (mDSI), secondaryOutcomes measure: Thirst distress scale (TDS), secondaryOutcomes measure: EQ Visual analogue scale (EQ VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327737, orgStudyIdInfo id: AKDENIZ-KAEK-916, briefTitle: Diabetic Ketoacidosis Diagnosis and Management, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-12-15, primaryCompletionDateStruct date: 2022-11-15, completionDateStruct date: 2023-03-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, collaborators name: Ceren Kahraman, descriptionModule briefSummary: This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema., conditionsModule conditions: Metabolic Acidosis, conditions: Diabetic Ketoacidosis, conditions: Brain Edema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: Capnography, outcomesModule primaryOutcomes measure: Correlation between PCO2 and EtCO2, primaryOutcomes measure: Correlation between Integrated Pulmonary Index and degree of acidosis, primaryOutcomes measure: Prediction of cerebral edema with Integrated Pulmonary Index, eligibilityModule sex: ALL, minimumAge: 15 Days, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Akdeniz University, city: Antalya, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
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protocolSection identificationModule nctId: NCT06327724, orgStudyIdInfo id: 12434, briefTitle: Belimumab in SLE Synovial Inflammation and Lymph Nodes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported.In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Belimumab, outcomesModule primaryOutcomes measure: Differences in lymph node cellular composition as assessed by advanced flow cytometry, secondaryOutcomes measure: Differences in peripheral blood cellular composition as assessed by advanced flow cytometry, secondaryOutcomes measure: Differences in synovial tissue cellular composition as assessed by advanced flow cytometry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC; location Academic Medical Center, status: RECRUITING, city: Amsterdam, zip: 1100DD, country: Netherlands, contacts name: Sander W Tas, Prof. dr., role: CONTACT, phone: +31 20 56 67765, email: secr-reumatologie@amsterdamumc.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06327711, orgStudyIdInfo id: BL77, briefTitle: Benefits of Nutritional Ingredients for Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Abbott Nutrition, class: INDUSTRY, descriptionModule briefSummary: This is a prospective randomized, double-blinded, parallel design study to evaluate the benefits of long-term consumption of two experimental blends of liquid supplements., conditionsModule conditions: Diabetes type2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 groups, non-crossover, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Control: CHO Blend, interventions name: Experimental: CHO Blend plus AN100, outcomesModule primaryOutcomes measure: Matsuda Index, primaryOutcomes measure: Fasted Glucose, primaryOutcomes measure: Fasted Insulin, secondaryOutcomes measure: Body Weight, secondaryOutcomes measure: Body Composition Measurements, secondaryOutcomes measure: Continuous Glucose Monitoring, secondaryOutcomes measure: Glycated Hemoglobin, secondaryOutcomes measure: Resting Energy Expenditure (REE), secondaryOutcomes measure: Microbiome - Fecal, secondaryOutcomes measure: Microbiome - Saliva, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Hip Circumference, secondaryOutcomes measure: Conicity Index, otherOutcomes measure: Blood Pressure, otherOutcomes measure: Accelerometry Data, otherOutcomes measure: Diabetes Distress Scale, otherOutcomes measure: Dietary Intake, otherOutcomes measure: Blood biomarkers - inflammation, otherOutcomes measure: Urine biomarkers - inflammation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327698, orgStudyIdInfo id: AK104-IIT-C-S-0010, briefTitle: Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Hunan Cancer Hospital, class: OTHER, descriptionModule briefSummary: This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma., conditionsModule conditions: Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: anlotinib, outcomesModule primaryOutcomes measure: Response Rate, secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Safety and tolerability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327685, orgStudyIdInfo id: MCC-22318, briefTitle: Avapritinib With Decitabine in Patients With SM-AHN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: Blueprint Medicines Corporation, descriptionModule briefSummary: Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN., conditionsModule conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Avapritinib, interventions name: Decitabine, interventions name: Decitabine/Cedazuridine, outcomesModule primaryOutcomes measure: Recommended phase 2 dose (RP2D), secondaryOutcomes measure: Systemic mastocytosis overall response rate (ORR), secondaryOutcomes measure: Overall Responsive Rate, secondaryOutcomes measure: Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic - Arizona, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85054, country: United States, contacts name: Cecilia Arana Yi, MD, role: CONTACT, contacts name: Cecilia Arana Yi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Stanford University Medical Center, status: NOT_YET_RECRUITING, city: Palo Alto, state: California, zip: 94305, country: United States, contacts name: Jason Gotlib, MD, role: CONTACT, contacts name: Jason Gotlib, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Caroline Wagstaff, role: CONTACT, phone: 813-745-5197, email: Caroline.Wagstaff@moffitt.org, contacts name: Andrew Kuykendall, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Onyee Chan, role: SUB_INVESTIGATOR, contacts name: Rami Komrokji, role: SUB_INVESTIGATOR, contacts name: Timothy Kubal, role: SUB_INVESTIGATOR, contacts name: Jeffrey Lancet, role: SUB_INVESTIGATOR, contacts name: Eric Padron, role: SUB_INVESTIGATOR, contacts name: David Sallman, role: SUB_INVESTIGATOR, contacts name: Alison Walker, role: SUB_INVESTIGATOR, contacts name: Seongseok Yun, role: SUB_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Dana-Farber Cancer Institute, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Daniel DeAngelo, MD, PhD, role: CONTACT, contacts name: Daniel DeAngelo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, status: NOT_YET_RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Kristen Pettit, MD, role: CONTACT, contacts name: Kristen Pettit, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Memorial Sloan Kettering Cancer Center, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Raajit Rampal, MD, PhD, role: CONTACT, contacts name: Raajit Rampal, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Utah Health, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Tsewang Tashi, MD, role: CONTACT, contacts name: Tsewang Tashi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06327672, orgStudyIdInfo id: 162023, briefTitle: INOCA Spanish National Registry, acronym: ESP-INOCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-24, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Eva Rumiz González, class: OTHER, collaborators name: Hospital San Carlos, Madrid, collaborators name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, collaborators name: Hospital Universitario Virgen de la Arrixaca, collaborators name: University Hospital Gregorio Marañón, collaborators name: Hospital Clínico Universitario de Valladolid, collaborators name: Hospital Universitario Puerta del Mar, collaborators name: Hospital Universitari de Bellvitge, collaborators name: Hospital Universitario La Fe, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital Universitario La Paz, collaborators name: Hospital General Universitario de Alicante, collaborators name: Complejo Hospitalario Universitario de Huelva, collaborators name: Hospital General Universitario de Castellón, collaborators name: Hospital de Manises, collaborators name: Hospital Clinic of Barcelona, collaborators name: Hospital Miguel Servet, collaborators name: Hospital Clínico Universitario Lozano Blesa, collaborators name: Hospital Universitario Donostia, collaborators name: Hospital General Universitario Elche, collaborators name: Hospital Universitario Virgen del Rocio, collaborators name: Hospital de la Ribera, collaborators name: Hospital de la Santa creu i Sant Pau - Barcelona, collaborators name: Hospital Virgen de la Salud, collaborators name: Hospital Universitario San Juan de Alicante, collaborators name: Hospital Universitario de Torrevieja, collaborators name: University Hospital of the Nuestra Señora de Candelaria, collaborators name: Hospital de Basurto, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital Universitario Fundación Jiménez Díaz, collaborators name: Puerta de Hierro University Hospital, collaborators name: Hospital Universitario 12 de Octubre, collaborators name: University of Salamanca, collaborators name: Hospital Universitario Marqués de Valdecilla, collaborators name: Hospital Clinico Universitario de Santiago, collaborators name: Complexo Hospitalario Universitario de A Coruña, descriptionModule briefSummary: Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting., conditionsModule conditions: Non-Obstructive Coronary Atherosclerosis, conditions: Ischemia, conditions: Coronary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of INOCA endotypes., secondaryOutcomes measure: Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department., secondaryOutcomes measure: Targeted pharmacological treatment, secondaryOutcomes measure: Prognostic markers., secondaryOutcomes measure: INOCA and risk of heart failure with preserved ejection fraction., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de la Princesa, status: RECRUITING, city: Madrid, country: Spain, contacts name: Fernando Rivero Crespo, MD, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Virgen de Arrixaca, status: RECRUITING, city: Murcia, country: Spain, contacts name: Ramón Lopez Palop, MD, role: CONTACT, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Hospital General Universitario de Valencia, status: RECRUITING, city: Valencia, country: Spain, contacts name: Eva Rumiz Gonzalez, MD, PhD, role: CONTACT, phone: +34 626068935, email: evarumizgonzalez@gmail.com, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06327659, orgStudyIdInfo id: Thrombectomy by 50 ml syringe, briefTitle: Efficacy of Using 50 ml Syringe Manual Thrombectomy Catheter in Primary PCI With Heavy Thrombus Burden, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: In high thrombus burden subgroup of Acute STEMI, manual aspiration thrombectomy was associated with reduced cardiovascular death but increased stroke or transient ischemic attack. The role of aspiration thrombectomy is still a matter of active debate. Manual aspiration suffers from decreasing aspiration force as the syringe fills with fluid and requires the operator to exchange syringes during the procedure to maintain suction., conditionsModule conditions: STEMI - ST Elevation Myocardial Infarction, conditions: Thrombosis Cardiac, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: 30 mL syringe manual thrombectomy catheter, interventions name: 50 mL syringe manual thrombectomy catheter, outcomesModule primaryOutcomes measure: TIMI flow grade after PCI, primaryOutcomes measure: MBG after PCI, secondaryOutcomes measure: Composite rate of occurrence of MACE, secondaryOutcomes measure: Rate of cardiovascular death, secondaryOutcomes measure: Rate of recurrent myocardial infarction, secondaryOutcomes measure: Rate of stroke, secondaryOutcomes measure: Rate of cardiogenic shock, secondaryOutcomes measure: Rate of NYHA IV heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Badr University Hospital, city: Badr, state: Cairo, country: Egypt, contacts name: Arafa Gomaa, MD, role: CONTACT, contacts name: Arafa Gomaa, MD, role: PRINCIPAL_INVESTIGATOR, hasResults: False
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