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protocolSection identificationModule nctId: NCT06379672, orgStudyIdInfo id: 2023[No.193], briefTitle: Resonance Breathing Training for Long Covid-related Myocardial Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2024-09-05, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Chengdu Sport University, class: OTHER, descriptionModule briefSummary: An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury, conditionsModule conditions: Long COVID, conditions: Myocardial Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Resonance breathing, outcomesModule primaryOutcomes measure: New YorkHeart Association (NYHA), primaryOutcomes measure: left ventricle global longitudinal strain, LVGLS, secondaryOutcomes measure: hypertension, secondaryOutcomes measure: Average heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379659, orgStudyIdInfo id: IR.MUI.MED.REC.1402.449, secondaryIdInfos id: IRCT20110908007513N18, type: REGISTRY, domain: IRAN registry of clinical trials (IRCT), briefTitle: Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Isfahan University of Medical Sciences, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle.The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo., conditionsModule conditions: Thin Endometrium, conditions: Infertility Female, conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was designed as a randomized controlled exploratory clinical trial, controlled with a parallel placebo group and random allocation using an online based system., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In this study, a double-blind methodology will be employed to minimize bias. Patients will be administered medication without knowing the study group and placebo or treatment intervention. To ensure uniformity between growth hormone and placebo, which has a similar appearance to the placebo, will be prepared by an individual informed of the enrolled patients in the study and will be provided to the administering physician. The evaluator assessing outcomes such as clinical pregnancy rate and endometrial thickness will not know which treatment each patient received. Laboratory staff will also be unaware of the treatment groups., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Growh hormone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Endometrial thickness, secondaryOutcomes measure: Clinical Pregnancy Rate, secondaryOutcomes measure: Response to treatment, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: IVF cancellation rate, secondaryOutcomes measure: Early pregnancy complications, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center, status: RECRUITING, city: Isfahan, zip: 8174673461, country: Iran, Islamic Republic of, contacts name: Nastaran Zamani Dehkordi, role: CONTACT, phoneExt: +989133842958, email: nastaran14zd@gmail.com, contacts name: Hatav Ghasemi Dehkordi, role: CONTACT, phoneExt: +989131134081, email: hatav.tehrani2014@gmail.com, contacts name: Hatav Ghasemi Tehrani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.65246, lon: 51.67462, hasResults: False

protocolSection identificationModule nctId: NCT06379646, orgStudyIdInfo id: YTS109-003, briefTitle: An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-21, completionDateStruct date: 2026-04-21, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: China Immunotech (Beijing) Biotechnology Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Changzheng Hospital, descriptionModule briefSummary: An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease, conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Systemic Sclerosis, conditions: Inflammatory Myopathy, conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, conditions: Antiphospholipid Syndrome, conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: YTS109, outcomesModule primaryOutcomes measure: Safety outcomes, primaryOutcomes measure: Efficacy outcomes for SLE, primaryOutcomes measure: Efficacy outcomes for Sjogren's Syndrome, primaryOutcomes measure: Efficacy outcomes for Systemic Sclerosis, primaryOutcomes measure: Efficacy outcomes for Inflammatory Myopathy, primaryOutcomes measure: Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, primaryOutcomes measure: Efficacy outcomes for Antiphospholipid Syndrome, secondaryOutcomes measure: Peak Plasma Concentration (Cmax) of YTS109, secondaryOutcomes measure: Time to Peak (Tmax) of YTS109, secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC) of YTS109, secondaryOutcomes measure: PD parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379633, orgStudyIdInfo id: s67010, briefTitle: Virtual Reality Exposure for Socially Anxious Adolescents, acronym: VIRTUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, collaborators name: Utrecht University, descriptionModule briefSummary: Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition.It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being.Moreover, the study has the following (secondary) objectives:* To elucidate potential working mechanisms of VRE and IVE* To identify predictors of adolescents' response to VRE and IVE* To assess to what extent adolescents accept VRE and IVE and how they experience it, conditionsModule conditions: Social Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: All pre-assessments and post-assessment will be conducted by researchers who will be blind to the participants' allocated condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: In vivo exposure, interventions name: (Virtual reality) exposure, outcomesModule primaryOutcomes measure: Brief version of the Social Phobia and Anxiety Inventory (SPAI-18), primaryOutcomes measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale, primaryOutcomes measure: Behavioral assessment task (BAT) - Peak anxiety, secondaryOutcomes measure: Brief Resilience Scale (BRS), secondaryOutcomes measure: Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales, secondaryOutcomes measure: Revised Children's Anxiety and Depression Scale (RCADS), secondaryOutcomes measure: Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale, secondaryOutcomes measure: Social Phobia Weekly Summary Scale (SPWSS), secondaryOutcomes measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale, secondaryOutcomes measure: Adolescent Social Cognitions Questionnaire (ASCQ), secondaryOutcomes measure: Behavioral assessment task (BAT) - Anticipatory anxiety, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Task duration, secondaryOutcomes measure: Behavioral assessment task (BAT) - Confederate rating, otherOutcomes measure: Behavioral inhibition system / behavioral activation system scale (BIS/BAS), otherOutcomes measure: Experiences in Close Relationship Scale - Relationship Structures (ECR-RS), otherOutcomes measure: Immersive Tendency Questionnaire (ITQ) - Factor Involvement, otherOutcomes measure: Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale, otherOutcomes measure: Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale, otherOutcomes measure: VR experience, motivation, need for connection/relatedness, openness to experiences, otherOutcomes measure: Preference for treatment question, otherOutcomes measure: Credibility and Expectancy Questionnaire (CEQ), otherOutcomes measure: Working Alliance Inventory-Short Form (WAI-S), otherOutcomes measure: Exposure log questions - expectancy violation & expectancy change, otherOutcomes measure: Exposure log open-ended questions - expectancy violation & expectancy change, otherOutcomes measure: Exposure log questions - within- & between- session habituation, otherOutcomes measure: Exposure log question- Self-efficacy, otherOutcomes measure: Exposure log question - Presence, otherOutcomes measure: Exposure log questions - Participant feedback, otherOutcomes measure: Acceptability interview, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Psychological Institute (PSI) of KU Leuven, status: RECRUITING, city: Leuven, zip: 3000 Leuven, country: Belgium, contacts name: Jella De Lee, MSc, role: CONTACT, phone: +3216373075, email: jella.delee@kuleuven.be, contacts name: Elizabeth S. Uduwa-vidanalage, MSc, role: CONTACT, email: s.e.uduwavidanalage@uu.nl, contacts name: Dirk Hermans, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Iris Engelhard, PhD, role: SUB_INVESTIGATOR, contacts name: Katharina Meyerbröker, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Scheveneels, PhD, role: SUB_INVESTIGATOR, contacts name: Jella De Lee, MSc, role: SUB_INVESTIGATOR, contacts name: Elizabeth S Uduwa-vidanalage, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06379620, orgStudyIdInfo id: 22-5544, briefTitle: Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction, acronym: Hi-OXSR, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-29, primaryCompletionDateStruct date: 2024-03-04, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction., conditionsModule conditions: Post COVID-19 Condition, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment.The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator), outcomesModule primaryOutcomes measure: Safety of use of Hi-OX sequential rebreathing device, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06379607, orgStudyIdInfo id: HFNC2024, briefTitle: High Flow Nasal Cannula Rates in Pediatric Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, descriptionModule briefSummary: This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations., conditionsModule conditions: Pediatric Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: "High Flow" High Flow Nasal Cannula, interventions name: "Low Flow" High Flow Nasal Cannula, outcomesModule primaryOutcomes measure: Percent of participants enrolled, secondaryOutcomes measure: Mean Change in Pediatric Asthma Severity Score (PASS), secondaryOutcomes measure: Mean Change in Respiratory Rate, secondaryOutcomes measure: Mean Total Duration of Continuous Albuterol, secondaryOutcomes measure: Percentage of Children with Escalation of Respiratory Support, secondaryOutcomes measure: Mean Total Duration of Respiratory Support, secondaryOutcomes measure: Percentage of Participants placed on Adjunct Asthma Therapies, secondaryOutcomes measure: Percentage of Participants who needed Sedation, secondaryOutcomes measure: Percentage of Participants on Antibiotics, secondaryOutcomes measure: Mean PICU Length of Stay (LOS), secondaryOutcomes measure: Mean Hospital Length of Stay (LOS), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379594, orgStudyIdInfo id: 294633, briefTitle: UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI), acronym: BHC, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-06-20, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: South London and Maudsley NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis., conditionsModule conditions: Mild Cognitive Impairment, conditions: Mild Cognitive Impairment Due to Alzheimer's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI., primaryOutcomes measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI., secondaryOutcomes measure: To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic, secondaryOutcomes measure: 2. To establish the acceptability and feasibility of administering the following cognitive assessments remotely in a brain health clinic, secondaryOutcomes measure: To establish the validity of novel MRI analysis software tools, secondaryOutcomes measure: 5. To investigate the acceptability and feasibility of remote tablet-based cognitive training, secondaryOutcomes measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme, secondaryOutcomes measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme, secondaryOutcomes measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme, secondaryOutcomes measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King's College London, city: London, state: Denmark Hill, zip: SE5 8AF, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06379581, orgStudyIdInfo id: 2022-04900-02, briefTitle: Skin Cancer Diagnostics Using Photoacoustic Imaging, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Region Skane, class: OTHER, collaborators name: Lund University, descriptionModule briefSummary: In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth., conditionsModule conditions: Skin Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Tumor thickness, primaryOutcomes measure: Tumor size, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthamology, Lund, Skåne University Hospital, status: RECRUITING, city: Lund, zip: 22185, country: Sweden, contacts name: Malin Malmsjö, Professor, role: CONTACT, phone: +46722335060, email: malin.malmsjo@med.lu.se, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False

protocolSection identificationModule nctId: NCT06379568, orgStudyIdInfo id: SichuanPPHLC01, briefTitle: Risk of Aspergillus Infection in Patients With Chronic Lung Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Lin Chen, class: OTHER, descriptionModule briefSummary: Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined., conditionsModule conditions: Fungal Infection Lungs, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 209, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Descriptive statistical index, primaryOutcomes measure: Independent risk factor for aspergillus pneumonia, primaryOutcomes measure: The area under ROC curve of risk factors for aspergillus pneumonia, secondaryOutcomes measure: Threshold analysis of aspergillus pneumonia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, city: Chengdu, state: Sichuan, zip: 610072, country: China, geoPoint lat: 30.66667, lon: 104.06667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-31, uploadDate: 2024-04-17T04:01, filename: Prot_SAP_000.pdf, size: 101446, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-31, uploadDate: 2024-04-14T12:03, filename: ICF_001.pdf, size: 105933, hasResults: False

protocolSection identificationModule nctId: NCT06379555, orgStudyIdInfo id: 2023-A02756-39, briefTitle: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study, acronym: WALANPOIGNE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones.For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated.WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages:* Greater precision of the surgical procedure.* A reduction in discomfort, risks and related adverse effects to anesthesia.* Faster recovery.WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery.In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures, conditionsModule conditions: Wrist Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Walanpoigne, outcomesModule primaryOutcomes measure: Failure percentage, secondaryOutcomes measure: Pain assessment, secondaryOutcomes measure: Patient experience, secondaryOutcomes measure: Wrist mobility, secondaryOutcomes measure: Functional characteristics of the wrist, secondaryOutcomes measure: Functional characteristics of the wrist, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379542, orgStudyIdInfo id: XC8-03-05-2023, briefTitle: Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo., conditionsModule conditions: Acute Respiratory Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: XC8, interventions name: Placebo, outcomesModule primaryOutcomes measure: Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1, secondaryOutcomes measure: Number of cough attacks by day 5, day 8, day 11 and day 15, secondaryOutcomes measure: Time (days) from visit 1 until clinical cough cure is achieved, secondaryOutcomes measure: Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1, secondaryOutcomes measure: Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1, secondaryOutcomes measure: Percentage of patients needed acetylcysteine, secondaryOutcomes measure: Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14, secondaryOutcomes measure: Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5, secondaryOutcomes measure: Number of adverse events (AEs), secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Percentage of patients with AEs, secondaryOutcomes measure: Percentage of patients who interrupted treatment, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: City Pediatric Outpatient Clinic number 5, status: RECRUITING, city: Perm, zip: 614066, country: Russian Federation, contacts name: Olga Perminova, MD, PhD, role: CONTACT, phone: +7 (912) 882 0549, email: perminova20062006@yandex.ru, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Professors' Clinic LLC., status: RECRUITING, city: Perm, zip: 614070, country: Russian Federation, contacts name: Svetlana Teplykh, MD, PhD, role: CONTACT, phone: +7 (919) 498 2931, email: profkliniki@mail.ru, geoPoint lat: 58.01046, lon: 56.25017, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44", status: RECRUITING, city: Saint Petersburg, zip: 192071, country: Russian Federation, contacts name: Olga V Trusova, MD,PhD, role: CONTACT, phone: +7 (812) 417-40-02, email: o-tru@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: ArsVite North-West, LLC, status: RECRUITING, city: Saint Petersburg, zip: 194223, country: Russian Federation, contacts name: Svetlana G Lazareva, MD, role: CONTACT, phone: +7-812-335-29-58, email: alexlaz58@rambler.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: PiterKlinika LLC, status: RECRUITING, city: Saint Petersburg, zip: 196158, country: Russian Federation, contacts name: Tatiana Pak, MD,PhD, role: CONTACT, phone: +7 (981) 851 8150, email: pte@list.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35", status: RECRUITING, city: Saint Petersburg, zip: 196191, country: Russian Federation, contacts name: Tatiana I Antonova, MD, PhD, role: CONTACT, phone: +7-812-246-46-45, email: antian@bk.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False

protocolSection identificationModule nctId: NCT06379529, orgStudyIdInfo id: USCOPD2022B, briefTitle: The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: NuvoAir Medical PC, class: INDUSTRY, collaborators name: Optum, Inc., descriptionModule briefSummary: A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only., conditionsModule conditions: COPD Exacerbation, conditions: COPD, conditions: Cardio/Pulm: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: NuvoAir clinical service, outcomesModule primaryOutcomes measure: Moderate & Severe Exacerbations, secondaryOutcomes measure: Severe COPD Exacerbations, secondaryOutcomes measure: Major Adverse Cardiac Event, secondaryOutcomes measure: 30-Day COPD Related Readmissions, secondaryOutcomes measure: All-Cause Hospitalizations, secondaryOutcomes measure: All-Cause Readmissions, secondaryOutcomes measure: Days Hospitalized due to COPD, secondaryOutcomes measure: Cost of Care Related to COPD, secondaryOutcomes measure: Medication Adherence, secondaryOutcomes measure: Quality of Life (QOL), otherOutcomes measure: Short-Acting Beta-Agonists Used, otherOutcomes measure: Courses of Oral Antibiotics/Steroids, otherOutcomes measure: Self-efficacy, otherOutcomes measure: Patient Activation, otherOutcomes measure: Cat Score, otherOutcomes measure: mMRC Dyspnea Scale, otherOutcomes measure: Physical Activity, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379516, orgStudyIdInfo id: NB240004-NB-V, briefTitle: Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-01-26, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: NovoBliss Research Pvt Ltd, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters., conditionsModule conditions: Validation of the Process of Wound Creation and Evaluation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Proof of science/concept, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Moisturising Cream (5%), interventions name: Moisturising Cream (10%), interventions name: Coconut Oil, outcomesModule primaryOutcomes measure: Trans Epidermal Water Loss (TEWL), primaryOutcomes measure: Skin hydration, primaryOutcomes measure: Skin surface topography, secondaryOutcomes measure: Dermatological Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: NovoBliss Research Pvt Ltd, city: Gandhinagar, state: Gujarat, zip: 382421, country: India, geoPoint lat: 23.21667, lon: 72.68333, hasResults: False

protocolSection identificationModule nctId: NCT06379503, orgStudyIdInfo id: 2021/37-04, briefTitle: Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-15, primaryCompletionDateStruct date: 2023-01-18, completionDateStruct date: 2023-06-18, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: This type of study is a randomized controlled trial. The aim is to contribute to the literature by comparing the effects of heart yoga on the depression level, sleep and quality of life of patients who do and do not do heart yoga.The main elements it aims to answer are:* Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.* Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.* Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.Patients who accept the study will practice heart yoga simultaneously with heart yoga videos via an online link every other day for 12 weeks after heart surgery.Researchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life., conditionsModule conditions: Cardiac Disease, conditions: Yoga, conditions: Nursing Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: HEART YOGA, interventions name: routine nursing care, outcomesModule primaryOutcomes measure: sleep quality, primaryOutcomes measure: depression, primaryOutcomes measure: life quality, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dokuz Eylül Üniversitesi Hastanesi, city: İ̇zmi̇r, state: Balçova, zip: 35330, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False

protocolSection identificationModule nctId: NCT06379490, orgStudyIdInfo id: CTA no: 2024-510572-20-00, secondaryIdInfos id: 2024-510572-20-00, type: CTIS, secondaryIdInfos id: P-2023-296, type: OTHER, domain: Privacy - Region Hovedstaden, briefTitle: Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nordsjaellands Hospital, class: OTHER, descriptionModule briefSummary: To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure., conditionsModule conditions: Distal Radius Fractures, conditions: Lidocaine, conditions: Ropivacaine, conditions: Fracture Dislocation, conditions: Closed Reduction of Fracture and Application of Plaster Cast, conditions: Colles' Fracture, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Ropivacaine 0.2% Injectable Solution, interventions name: Lidocaine epinephrine, interventions name: Ropivacaine 0.5% Injectable Solution, outcomesModule primaryOutcomes measure: Block success, otherOutcomes measure: Degree of sensory and motor blockade, otherOutcomes measure: Total duration of sensory blockade, otherOutcomes measure: Total duration of motor blockade, otherOutcomes measure: Pain intensity before block performance, otherOutcomes measure: Time to pain relief/lowest pain intensity, otherOutcomes measure: Pain intensity during closed reduction, otherOutcomes measure: Pain intensity during cast application, otherOutcomes measure: Time to pain breakthrough after the blockade has ended, otherOutcomes measure: Maximum pain intensity after the blockade has ended, otherOutcomes measure: Duration of maximum pain intensity after the blockade has ended, otherOutcomes measure: Amount of strong painkillers consumed by patients within 24 hours after closed reduction, otherOutcomes measure: Grading of closed reduction difficulty, otherOutcomes measure: Quality of closed reduction evaluated by X-ray imaging, otherOutcomes measure: Attempts used for closed reduction, otherOutcomes measure: Grading of casting difficulty, otherOutcomes measure: The patient's experience of the treatment, otherOutcomes measure: Occurence of adverse events (AE) and serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital - North Zealand, status: RECRUITING, city: Hillerød, zip: 3400, country: Denmark, contacts name: Anders K. Nørskov, PhD, role: CONTACT, phone: 48 29 74 59, phoneExt: +45, email: anders.kehlet.noerskov@regionh.dk, contacts name: Kai H. W. Lange, DMSc, role: CONTACT, phone: 48 29 42 52, phoneExt: +45, email: kai.henrik.wiborg.lange@regionh.dk, geoPoint lat: 55.92791, lon: 12.30081, hasResults: False

protocolSection identificationModule nctId: NCT06379477, orgStudyIdInfo id: refractive error surprises, briefTitle: Correction of Refractive Error Surprises After Cataract Surgery in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery., conditionsModule conditions: Refractive Errors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Refractive surgeries, outcomesModule primaryOutcomes measure: Diagnosis and treatment of the resulting refractive error surprises, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379464, orgStudyIdInfo id: CALM2303, briefTitle: Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: Objectives of Study： Through the cross-sectional study of stroke and depression, key biomarkers are targeted by screening disease-associated intestinal bacteria, metabolites and immune factors through multi-omics techniques., conditionsModule conditions: Acute Ischaemic Stroke, conditions: Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The severity of neurological damage in stroke patients, primaryOutcomes measure: The functional recovery outcomes after stroke, primaryOutcomes measure: The severity of symptoms in patients with depression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510145, country: China, contacts name: Hongwei Zhou, Professor, role: CONTACT, phone: 186 8848 9622, email: hzhou@smu.edu.cn, hasResults: False

protocolSection identificationModule nctId: NCT06379451, orgStudyIdInfo id: [2023]YLJSA088, briefTitle: An Clinical Study of NKG2D-CAR-NK Cells for the Treatment of Refractory Recurrent Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Changzhou No.2 People's Hospital, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. However, multiple myeloma remains an incurable disease and requires the exploration of more effective treatment methods to improve the efficacy of relapsed refractory multiple myeloma and prolong survival time.Currently, clinical application of CAR-T is mostly based on autologous T cell preparation, while relapsed/refractory AML patients have undergone multiple chemotherapy treatments, resulting in impaired self-T cell function, which affects the efficacy and prognosis of CAR-T therapy. Therefore, it is necessary to find new alternative treatments. NK cells are important immune cells in the body and are an important component of innate immunity. Compared with CAR-T cell therapy, CAR-NK cells have unique advantages in adoptive cell therapy. NKG2D receptor is an activating receptor expressed on NK cells, which can recognize NKG2D ligands (NKG2DL) expressed on tumor cells, activating NK cell killing activity through NKG2D-NKG2DL interaction. Therefore, the investigators plan to treat relapsed multiple myeloma by infusing NKG2D-CAR-NK cells to evaluate its efficacy and safety., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: NKG2D Chimeric Antigen Receptor NK Cell Injection, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicity (DLTs), primaryOutcomes measure: Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Objective Response Rate of subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changzhou Second People's Hospital, city: Changzhou, state: Jiangsu, zip: 213000, country: China, contacts name: Wei Qin, doctor, role: CONTACT, phone: +8618796912763, email: qinwei19840601@163.com, geoPoint lat: 31.77359, lon: 119.95401, hasResults: False

protocolSection identificationModule nctId: NCT06379438, orgStudyIdInfo id: 06/16022018, briefTitle: Treatment of Aphtous Ulcers With Photodynamic Therapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-03-05, primaryCompletionDateStruct date: 2019-03-01, completionDateStruct date: 2019-03-08, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Yuzuncu Yıl University, class: OTHER, descriptionModule briefSummary: The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers., conditionsModule conditions: Oral Ulcer, conditions: Aphthous Recurrent Ulcers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Photodynamic therapy (indocyanine green+laser), outcomesModule primaryOutcomes measure: Ulcer wound healing with diameter measurement, primaryOutcomes measure: Level of recovery, secondaryOutcomes measure: Pain evaluation with Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yuzuncu Yil University, city: Van, state: Merkez, zip: 65080, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False

protocolSection identificationModule nctId: NCT06379425, orgStudyIdInfo id: 23-0050, briefTitle: Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Northwell Health, class: OTHER, descriptionModule briefSummary: This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures., conditionsModule conditions: Pain, Postoperative, conditions: Postoperative Pain, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Acetaminophen, interventions name: Celecoxib, interventions name: Gabapentin, outcomesModule primaryOutcomes measure: Time to initiation of active trial of void, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwell Health South Shore Surgery Center, status: RECRUITING, city: Bay Shore, state: New York, zip: 11706, country: United States, contacts name: Kathleen R Catalano, MSN, RN-BC, role: CONTACT, phone: 631-647-5550, email: kcatalano@southshoresurg.com, contacts name: Nirmala Pillalamarri, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Steliana Fakas, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.7251, lon: -73.24539, hasResults: False

protocolSection identificationModule nctId: NCT06379412, orgStudyIdInfo id: Zhujianghmy, briefTitle: A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery), conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: observational study, no intervention, outcomesModule primaryOutcomes measure: HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: He Xiaolong, Professor, role: CONTACT, phone: 186 2007 1640, email: 307660349@qq.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06379399, orgStudyIdInfo id: IRB-2023-1072, briefTitle: Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Wangxia LV, class: OTHER, descriptionModule briefSummary: This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Cetuximab, interventions name: Trifluridine/Tipiracil, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate( DCR), secondaryOutcomes measure: Quality of life: EORTC QLQ-C30, secondaryOutcomes measure: Adverse Events(safety), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Wangxia Lv, role: CONTACT, phone: +86-13757141026, email: lvwangxia@163.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06379386, orgStudyIdInfo id: TRACE TAVR Registry, briefTitle: Long-term Prognosis and Valve Durability of TAVR, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner., conditionsModule conditions: Aortic Valve Stenosis and Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Transcatheter aortic valve replacement, outcomesModule primaryOutcomes measure: All-casuse mortality, primaryOutcomes measure: Valve-related long-term clinical efficacy, secondaryOutcomes measure: Combined early safety and clinical efficacy outcomes, secondaryOutcomes measure: Rate of technical success, secondaryOutcomes measure: Rate of device success, secondaryOutcomes measure: Combined clinical efficacy outcomes, secondaryOutcomes measure: Valve-related long-term clinical efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, status: RECRUITING, city: Xi'an, state: Shannxi, zip: 710032, country: China, contacts name: Rutao Wang, M.D., Ph.D., role: CONTACT, phone: +86-15091095796, email: rutaowang@qq.com, contacts name: Ruining Zhang, BSc, role: CONTACT, phone: +86-15802990370, email: ruining-zhang@qq.com, contacts name: Ling Tao, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False

protocolSection identificationModule nctId: NCT06379373, orgStudyIdInfo id: 2023-KLS-190-02, briefTitle: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects., conditionsModule conditions: Tourette Syndrome in Children, conditions: Food Intolerance, conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: According to the order of enrollment, the random number table method was used to divide the massage spinal manipulation+ placebo group (oral placebo, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d), relaxation manipulation+ western medicine group (oral Typride tablets, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d) for 2 consecutive weeks. Both groups were intervened for 2 courses. The observation time points were 2 weeks, 4 weeks, and 3 months before treatment and after treatment., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spine manipulation; westren medicine, outcomesModule primaryOutcomes measure: Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8, primaryOutcomes measure: Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8, secondaryOutcomes measure: Change from Baseline in difference in the spacing of the lantoine side, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, contacts name: xiao Li, Doc., role: CONTACT, phone: 0571-87072953, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06379360, orgStudyIdInfo id: SZAMLLRM01, briefTitle: Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-11-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: Hypomethylating agent, Azacitidine or Decitabine, outcomesModule primaryOutcomes measure: Relapse free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Cumulative incidence of relapse (CIR), eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215006, country: China, contacts name: Sheng-Li Xue, M.D., role: CONTACT, phone: +86 512 6778 1139, email: slxue@suda.edu.cn, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False

protocolSection identificationModule nctId: NCT06379347, orgStudyIdInfo id: FZ 23/41, briefTitle: HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound, acronym: HOCUS-POCUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Flevoziekenhuis, class: OTHER, descriptionModule briefSummary: Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward., conditionsModule conditions: Volume Status, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: POCUS perfomed on clinica indication, outcomesModule primaryOutcomes measure: Volume status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Flevoziekenhuis, status: RECRUITING, city: Almere, country: Netherlands, contacts name: Koen de Heer, MD PhD, role: CONTACT, geoPoint lat: 52.37535, lon: 5.25295, hasResults: False

protocolSection identificationModule nctId: NCT06379334, orgStudyIdInfo id: I-22PJ911, briefTitle: Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-12-06, primaryCompletionDateStruct date: 2024-12-06, completionDateStruct date: 2026-12-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Hepatitis B, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Urine test, outcomesModule primaryOutcomes measure: upregulated proteins, primaryOutcomes measure: downregulated proteins, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06379321, orgStudyIdInfo id: 24-362, briefTitle: A Retrospective/Prospective, Post-market Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System, acronym: Hinge, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2034-05-01, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, collaborators name: Stryker Orthopaedics, descriptionModule briefSummary: This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years., conditionsModule conditions: Knee Arthropathy, conditions: Recurrence, conditions: Knee Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Triathlon Hinge Knee (THK) System, outcomesModule primaryOutcomes measure: Survivorship, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Florida, city: Weston, state: Florida, zip: 33331, country: United States, contacts name: Kaitlin Bernabe, role: CONTACT, phone: 954-610-8016, email: BERNABK@ccf.org, contacts name: Jorge Manrique-Succar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.10037, lon: -80.39977, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Laura Stiegel, role: CONTACT, phone: 216-442-5511, email: stiegel@ccf.org, contacts name: Alison Klika, role: CONTACT, phone: 216 444-4954, email: klikaa@ccf.org, contacts name: Matthew Deren, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False

protocolSection identificationModule nctId: NCT06379308, orgStudyIdInfo id: IRBN552024/CHUSTE., briefTitle: Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates)., conditionsModule conditions: Anterior Cruciate Ligament Rupture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: questionaries, interventions name: datas of medical record, outcomesModule primaryOutcomes measure: Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI), primaryOutcomes measure: Results of Functional score questionary Tegner Activity Scale (TAS), primaryOutcomes measure: Results of Functional score questionary Simple Knee Value (SKV), primaryOutcomes measure: Results of Functional score questionary International Knee Documentation Commitee (IKDC), secondaryOutcomes measure: Surgical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Saint-Etienne, city: Saint-Étienne, country: France, contacts name: Thomas NERI, MD PhD, role: CONTACT, phone: (0)477120784, phoneExt: +33, email: thomas.neri@chu-st-etienne.fr, contacts name: Thomas NERI, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False

protocolSection identificationModule nctId: NCT06379295, orgStudyIdInfo id: CHUO-2024-05, briefTitle: Coronary Artery Calcification Assessed on PET/CT, acronym: CALCOTEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-21, primaryCompletionDateStruct date: 2025-05-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Régional d'Orléans, class: OTHER, descriptionModule briefSummary: Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non ECG-gated, contrast-enhanced or non-enhanced CT scans performed in association of PET acquisition, with a good agreement with standard scans.The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing 18F-FDG PET/CT imaging to improve primary prevention of cardiovascular diseases.A visual CAC assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy CAC. When possible, a CAC score will be computed.Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Artery Calcification, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Prevalence of moderate CAC in participants without history of cardiac disease, secondaryOutcomes measure: Prevalence of coronary heart disease among participants, secondaryOutcomes measure: Correlation of CAC with the medical indication for PET imaging, secondaryOutcomes measure: Prevalence of CAC in young participants (< 45 years old), secondaryOutcomes measure: Prevalence of moderate CAC in participants not taking low-cholesterol drug, secondaryOutcomes measure: Prevalence of no CAC in participants taking statins, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06379282, orgStudyIdInfo id: FHMS 21-22 263 EGA, briefTitle: Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia, acronym: HIT-CLL, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-14, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Surrey, class: OTHER, collaborators name: American Society of Hematology, descriptionModule briefSummary: This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Frailty, conditions: Muscle Function, conditions: Immune Function, conditions: Lipid Cell; Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: HIT, interventions name: EXE+ Nutritional Guidance, outcomesModule primaryOutcomes measure: Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12, primaryOutcomes measure: Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Muscle Strength and Endurance, secondaryOutcomes measure: Muscle Health, secondaryOutcomes measure: Change in Quality of Life using the EORCT-QLQ-C30, secondaryOutcomes measure: Change in muscle oxygen metabolism during a single bout of exercise, secondaryOutcomes measure: Change in B-CLL Cell Function, secondaryOutcomes measure: Change in systemic and cellular bioenergetics, otherOutcomes measure: Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test, otherOutcomes measure: Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Surrey, status: RECRUITING, city: Guildford, zip: GU2 7WG, country: United Kingdom, contacts name: David Bartlett, PhD, role: CONTACT, phone: 01483 683 45, email: d.bartlett@surrey.ac.uk, geoPoint lat: 51.23536, lon: -0.57427, hasResults: False

protocolSection identificationModule nctId: NCT06379269, orgStudyIdInfo id: CMUH112-REC3-160, briefTitle: Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, collaborators name: National Cheng Kung University, collaborators name: National Science and Technology Council, descriptionModule briefSummary: Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention., conditionsModule conditions: Myofascial Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: App healthcare, interventions name: Control, outcomesModule primaryOutcomes measure: current pain visual analogue scale, secondaryOutcomes measure: functional questionnaire, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379256, orgStudyIdInfo id: 202400364B0, briefTitle: Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2029-03-17, completionDateStruct date: 2032-03-17, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: Radiation therapy (RT) is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma (HCC). Our previous preclinical investigation (Hsieh et al., Science Immunology 2022) revealed that RT can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving HCC patients. Given that RT represents a standard therapeutic approach for unresectable HCC, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive RT for HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Photon or proton radiotherapy, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Local control (LC), secondaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence and severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung Memorial Hospital at Linkou, city: Taoyuan City, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06379243, orgStudyIdInfo id: KY-2023-008-02, briefTitle: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The Seventh Affiliated Hospital of Sun Yat-sen University, class: OTHER, collaborators name: The Fourth Affiliated Hospital of Guangzhou Medical University, collaborators name: Huizhou Municipal Central Hospital, collaborators name: Dongguan Hospital of Traditional Chinese Medicine, descriptionModule briefSummary: In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year)., conditionsModule conditions: Osteoporosis Fracture, conditions: Osteoporosis Vertebral, conditions: Compression Fracture, conditions: Perform PVP / PKP Treatment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: PVP/PKP, outcomesModule primaryOutcomes measure: Non-operative vertebral re-fracture within 1 year after PVP / PKP, secondaryOutcomes measure: Visual Analog Score (VAS) at 1 year after PVP/ PKP, secondaryOutcomes measure: Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Seventh Affiliated Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Kuiqing Lu, role: CONTACT, phone: 0755-81207263, email: lukq@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06379230, orgStudyIdInfo id: SH9H-2023-T378-1, briefTitle: A Retrospective Study on Epidemiological Characteristics of Chinese NF1 Patients in Real World (PROMISE), statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: Background/Rationale: Neurofibromatosis type 1 (NF1) affects about 1 in every 3000 people worldwide. Globally, 30\~50% NF1 patients will develop plexiform neurofibromas (PNs), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. This systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. In NF1 patients, the lifetime risk of MPNST developed from PN is 8% to 13%. The mean age for NF1-associated death was approximately 20 years lower than that for the general population. Limited epidemiological and clinical data of Chinese NF1 patients is available to date. And the treatment pattern of Chinese NF1-PN patients is also unknown.Objectives and Hypotheses: It is a descriptive study without formal hypothesis. The primary objective of this study is determining the percentage of NF1 patients who develop PN. The secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of NF1-PN. The exploratory objective is exploring the epidemiological characteristics of other NF1 manifestations.Methods:Study design: The study is a retrospective multi-center chart review study. Data Source(s): All the data will be collected by CRF from inpatient and outpatient electronic medical records in every study site from January 1, 2019 to December 31, 2022.Study Population: Patients who attended the study sites between January 1, 2019 - December 31, 2022 and were diagnosed with NF1 were included in this study. Statistical Analysis: This study is purely descriptive without any formal hypotheses.Missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. All reported measures will be summarized in the study tables. Point estimates and their 95% CIs will be presented in the final analyses., conditionsModule conditions: Neurofibromatosis 1, conditions: Plexiform Neurofibroma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: This study is purely descriptive study., outcomesModule primaryOutcomes measure: Determine the percentage of NF1 patients developed PN at the baseline., secondaryOutcomes measure: Clinical characteristics of NF1-PN:, secondaryOutcomes measure: Tumor progression of NF1-PN, secondaryOutcomes measure: Treatment pattern of NF1-PN:, otherOutcomes measure: The exploratory endpoints:, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Lei Zhang, role: CONTACT, phone: +86 13683139858, email: zhanglei@xwhosp.org, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Affiliated Hospital of Guangxi Medical University, status: RECRUITING, city: Nanning, state: Guangxi, country: China, contacts name: Jiping Shi, role: CONTACT, phone: +86 17758670856, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The First Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Minjing Chen, role: CONTACT, phone: +86 13673665337, email: 1916833431@qq.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, status: ACTIVE_NOT_RECRUITING, city: Shanghai, state: Shanghai, zip: 200011, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Yang Xiao, role: CONTACT, phone: +86 18884266797, email: xiaoyang_angela@163.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False

protocolSection identificationModule nctId: NCT06379217, orgStudyIdInfo id: CAAA617H12101, secondaryIdInfos id: 2023-505655-43, type: EUDRACT_NUMBER, briefTitle: NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-18, primaryCompletionDateStruct date: 2027-06-04, completionDateStruct date: 2027-06-04, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gonadotropin Releasing Hormone Receptor (GRPR)) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC)., conditionsModule conditions: Metastatic Neuroendocrine Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to a treatment arm based on their predominantly expressed target per PET images (based on central read):* \[177Lu\]Lu-PSMA-617 will be assigned to those with predominant PSMA expression* \[177Lu\]Lu-DOTA-TATE will be assigned to those with predominant SSTR2 expression* \[177Lu\]Lu-NeoB will be assigned to those with predominant GRPR expression, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: [68Ga]Ga-PSMA-11, interventions name: [68Ga]GA-DOTA-TATE, interventions name: [68Ga]Ga-NeoB, interventions name: [177Lu]Lu-PSMA-617, interventions name: [177Lu]Lu-DOTA-TATE, interventions name: [177Lu]Lu-NeoB, interventions name: L-Lysine HCl-L-Arginine HCl, 2.5 %,, interventions name: Gonadotropin-releasing hormone (GnRH) analogues, interventions name: GnRH antagonists, interventions name: Antiemetics & antinauseants, interventions name: Metoclopramide, outcomesModule primaryOutcomes measure: Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI), primaryOutcomes measure: Percentage changes in qualitative PET parameters., secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Radiographic Progression-free Survival (rPFS), secondaryOutcomes measure: Proportion of participants with a decline in PSA level, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Therapy (RLT), secondaryOutcomes measure: Dose modifications for [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Imaging (RLI), secondaryOutcomes measure: Blood radioactivity concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB), secondaryOutcomes measure: Blood mass concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB), secondaryOutcomes measure: Observed maximum blood concentrations (Cmax) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Time of maximum blood concentration (Tmax) occurence of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Area under the blood concentration time curve (AUC) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Total systemic clerance (CL) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Terminal half-life (T^1/2) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Absorbed radiation doses of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Time Activity Curves (TACs) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379204, orgStudyIdInfo id: No.2022026, briefTitle: A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-04, primaryCompletionDateStruct date: 2023-08-30, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Taiyuan Central Hospital of Shanxi Medical University, class: OTHER, descriptionModule briefSummary: Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients., conditionsModule conditions: Metabolic Syndrome X, 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: 52, type: ACTUAL, armsInterventionsModule interventions name: the maximum physiological value standardized group, interventions name: the ventilatory threshold individualized group, outcomesModule primaryOutcomes measure: Peak oxygen uptake, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taiyuan Cardiac Rehabilitation Center, city: Taiyuan, state: Shanxi, zip: 030009, country: China, geoPoint lat: 37.86944, lon: 112.56028, hasResults: False

protocolSection identificationModule nctId: NCT06379191, orgStudyIdInfo id: ZS-3411, briefTitle: The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted., conditionsModule conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Nutrition intervention model based on WeChat applets, outcomesModule primaryOutcomes measure: patient-generated subjective global assessment (PG-SGA), secondaryOutcomes measure: nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L), secondaryOutcomes measure: inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L), secondaryOutcomes measure: nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06379178, orgStudyIdInfo id: 6462e56fe8177, briefTitle: Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-19, primaryCompletionDateStruct date: 2023-08-15, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Gadjah Mada University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question it aims to answer is the optimal frequency of colostrum application that can be applied Participants will be divided by randomization using permutation blocks after meeting the inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using computer software such as Microsoft Excel, determining the sequence for allocation to the control and intervention groups based on the randomization order from the permutation code, every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding in preterm infants \<34 weeks gestational age., conditionsModule conditions: Trophic Feeding, conditions: Very Low Birth Weight Baby, conditions: Preterm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Oral colostrum application 2 hours, interventions name: Oral colostrum application 4 hours, outcomesModule primaryOutcomes measure: Days to Achieve Trophic Feeding, eligibilityModule sex: ALL, maximumAge: 2 Days, stdAges: CHILD, contactsLocationsModule locations facility: Neonatal Intensive Care Unit RSUP Dr. Sardjito, city: Sleman, state: Daerah Istimewa Yogyakarta, zip: 55281, country: Indonesia, geoPoint lat: -7.71556, lon: 110.35556, hasResults: False

protocolSection identificationModule nctId: NCT06379165, orgStudyIdInfo id: SYH9015-002, briefTitle: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-17, primaryCompletionDateStruct date: 2023-07-11, completionDateStruct date: 2023-07-13, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 192, type: ACTUAL, armsInterventionsModule interventions name: Meloxicam Nanocrystal Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose), secondaryOutcomes measure: TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48., secondaryOutcomes measure: SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48, secondaryOutcomes measure: Time to the first dose of the remedial analgesia, secondaryOutcomes measure: Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose, secondaryOutcomes measure: Proportion of subjects requiring remedial analgesia, secondaryOutcomes measure: The total amount of remedial analgesia used 24 h and 48 h after the first dose, secondaryOutcomes measure: The subject's analgesic treatment satisfaction score (0-4 point categorical scale score), secondaryOutcomes measure: The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, city: Wuhan, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False

protocolSection identificationModule nctId: NCT06379152, orgStudyIdInfo id: 2024-04-16, briefTitle: Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-20, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, conditions: Prognathism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The level of direct bilirubin, primaryOutcomes measure: a composite of heart failure rehospitalization or all-cause mortality, secondaryOutcomes measure: heart failure rehospitalization, secondaryOutcomes measure: all-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Chongqing Medical University, status: RECRUITING, city: Chongqing, country: China, contacts name: Dongying Zhang, doctor, role: CONTACT, phone: +8613608398395, email: zdy.chris@qq.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False

protocolSection identificationModule nctId: NCT06379139, orgStudyIdInfo id: MALDINEY J'InvEst-I 2022, briefTitle: Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients, acronym: BIOPAVIR2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP), the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP, conditionsModule conditions: Healthcare Associated Infection, conditions: Critically Ill, conditions: Endotracheal Tube, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube, outcomesModule primaryOutcomes measure: Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type, primaryOutcomes measure: type of microbiological associated with each shape, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH William Morey, status: RECRUITING, city: Chalon-sur-Saône, country: France, contacts name: Thomas MALDINEY, role: CONTACT, email: thomas.maldiney@ch-chalon71.fr, geoPoint lat: 46.78333, lon: 4.85, locations facility: CHU Dijon Bourgogne, status: RECRUITING, city: Dijon, country: France, contacts name: Jean Pierre QUENOT, role: CONTACT, email: jean-pierre.quenot@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False

protocolSection identificationModule nctId: NCT06379126, orgStudyIdInfo id: Yuting Li05, briefTitle: The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-04-20, completionDateStruct date: 2026-04-20, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results., conditionsModule conditions: Sepsis-induced Coagulopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM）, outcomesModule primaryOutcomes measure: Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379113, orgStudyIdInfo id: 53211030-2, briefTitle: GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-13, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Xiaojun Chen, class: OTHER, descriptionModule briefSummary: To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients., conditionsModule conditions: Endometrial Neoplasms, conditions: Atypical Endometrial Hyperplasia, conditions: Progesterone Resistance, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: GnRH antagonist, interventions name: Letrozole 2.5mg, outcomesModule primaryOutcomes measure: Complete response rates within 28 weeks of treatment, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Time to achieve complete response, secondaryOutcomes measure: Relapse rates, secondaryOutcomes measure: Rates of fertility outcomes, secondaryOutcomes measure: Compliance, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Obstetrics and Gynecology Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Xiaojun Chen, role: CONTACT, phone: 862133189900, email: cxjlhjj@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06379100, orgStudyIdInfo id: KY20232388, briefTitle: Cerebellar iTBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2024-09-25, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG., conditionsModule conditions: Transcranial Magnetic Stimulation, conditions: Alzheimer Disease, conditions: Magnetic Resonance Imaging, conditions: Electroencephalogram, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Alzheimer's disease patients were enrolled by expert neurol ogists who were blinded to treatment allocation. rTMS sessions were performed by dedicated technicians. The Cognitive evaluations and analysis of neuro physiological data were performed by expert neurophysiologists blinded to treatment allocation., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: The changes in CDR（Clinical Dementia Rating）, secondaryOutcomes measure: The changes in MMSE(Mini Mental State Examination), secondaryOutcomes measure: NPI (Neuropsychiatric Inventory), secondaryOutcomes measure: ADL( Lawton-Brody Activities of Daily Living), secondaryOutcomes measure: DST (Digital Span Test; Forward and Backward), secondaryOutcomes measure: ADAS-cog（Alzheimer's disease assessment scale), secondaryOutcomes measure: DMS(Delayed matching-to-sample task), secondaryOutcomes measure: MEP（Motor evoked potential）, secondaryOutcomes measure: MRI measures, secondaryOutcomes measure: EEG（electroencephalogram）, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital of Air Force Military Medical University, city: Xi'an, state: Shaanxi, zip: 710032, country: China, contacts name: Wen Jiang, role: CONTACT, phone: 13991905538, email: jiangwen@fmmu.edu.cn, contacts name: Xin Zhang, role: CONTACT, phone: 13154378732, email: zx312316@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False

protocolSection identificationModule nctId: NCT06379087, orgStudyIdInfo id: NEO-PIONEER, briefTitle: Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ji Yongling, class: OTHER, descriptionModule briefSummary: This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer., conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Anlotinib Hydrochloride Capsule, interventions name: Tislelizumab Injection, interventions name: Hypofractionated Radiotherapy, outcomesModule primaryOutcomes measure: 1-year EFS Rate, secondaryOutcomes measure: pCR Rate, secondaryOutcomes measure: MPR Rate, secondaryOutcomes measure: Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379074, orgStudyIdInfo id: 2022PMFMSE, secondaryIdInfos id: C53D23004250008, type: OTHER_GRANT, domain: Italian Ministry of University and Research (MUR), briefTitle: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health, acronym: MOTHERS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-08-06, completionDateStruct date: 2025-10-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Rome G. Marconi, class: OTHER, collaborators name: University of Bologna, collaborators name: University of the Italian Switzerland, descriptionModule briefSummary: Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes., conditionsModule conditions: Postpartum Depression, conditions: Insomnia, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will receive a personal e-mail address to access their reserved area of the study's website. Each e-mail address is created using the pre-defined pseudonymized code, which will be assigned to each participant after screening (participants with sleep difficulties will be randomly assigned a code for condition B1 or B2).This procedure is designed to increase privacy protection, allow for matching of responses throughout study's phases, and blind outcome assessors to participants allocation.The personal website areas include contents based on their group allocation:* A: online questionnaire and sleep diaries;* B1: online questionnaire and sleep diaries; placebo intervention's contents (videos and pdf);* B2: online questionnaire and sleep diaries; intervention's contents (videos and pdf); weekly optional private chat with a clinician (a psychotherapist expert in CBT-I and insomnia during pregnancy)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The codes associated to participants in Group B will be randomly assigned to intervention (Group B2) or placebo (Group B1). E-mail addresses will be created for each participant using the ID-code to access the private area of the study website. The code will be associated with responses to online questionnaires, actigraphy recording, saliva samples and sleep diaries., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Improving sleep health and resilience during pregnancy, interventions name: Information on pregnancy-related issues, outcomesModule primaryOutcomes measure: Stress reactivity, primaryOutcomes measure: Sleep efficiency, primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: Insomnia symptoms, primaryOutcomes measure: Anxiety symptoms, primaryOutcomes measure: Valence of affective states, primaryOutcomes measure: Arousal of affective states, primaryOutcomes measure: Emotion regulation, secondaryOutcomes measure: Mothers' parenting stress, secondaryOutcomes measure: Partners' insomnia symptoms, secondaryOutcomes measure: Children sleep difficulties, otherOutcomes measure: Partners' sleep efficiency, otherOutcomes measure: Fathers' parenting stress, otherOutcomes measure: Daytime sleepiness, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy, city: Bologna, zip: 40126, country: Italy, contacts name: Viviana Lo Martire, role: CONTACT, email: viviana.lomartire2@unibo.it, contacts name: Debora Meneo, M.Sc, role: CONTACT, phone: 06377251, email: d.meneo@unimarconi.it, contacts name: Debora Meneo, M.Sc, role: PRINCIPAL_INVESTIGATOR, contacts name: Elisabetta Baldi, M.Sc, role: SUB_INVESTIGATOR, contacts name: Silvia Cerolini, PhD, role: SUB_INVESTIGATOR, contacts name: Viviana Lo Martire, PhD, role: SUB_INVESTIGATOR, contacts name: Giuliana Simonazzi, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Curati, B.Sc, role: SUB_INVESTIGATOR, contacts name: Stefano Bastianini, PhD, role: SUB_INVESTIGATOR, contacts name: Chiara Berteotti, PhD, role: SUB_INVESTIGATOR, contacts name: Mauro Manconi, PhD, role: SUB_INVESTIGATOR, contacts name: Giovanna Zoccoli, PhD, role: SUB_INVESTIGATOR, contacts name: Francesca Gelfo, PhD, role: SUB_INVESTIGATOR, contacts name: Chiara Baglioni, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Paola De Bartolo, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False

protocolSection identificationModule nctId: NCT06379061, orgStudyIdInfo id: MM-01-24, briefTitle: Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Beckman Coulter, Inc., class: INDUSTRY, collaborators name: MeMed Diagnostics Ltd., descriptionModule briefSummary: The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance., conditionsModule conditions: Infection, Bacterial, conditions: Infection Viral, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Blood Specimen Collection, eligibilityModule sex: ALL, minimumAge: 90 Days, maximumAge: 89 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379048, orgStudyIdInfo id: 2021.12.282, briefTitle: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-08-31, completionDateStruct date: 2022-09-20, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair., conditionsModule conditions: Labor; Prolonged, Second Stage, conditions: Episiotomy Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 132, type: ACTUAL, armsInterventionsModule interventions name: Matress Suturing, interventions name: Primary Suturing, interventions name: Continuous Subcutaneous Suturing, outcomesModule primaryOutcomes measure: Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score, primaryOutcomes measure: Pain by Visual Analog Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cam and Sakura City Hospital, city: Istanbul, state: Basaksehir, zip: 34494, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06379035, orgStudyIdInfo id: Protozoa in CRC patients, briefTitle: Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression., conditionsModule conditions: Blastocystis Infection, conditions: Cryptosporidium Infection, conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: ELISA / PCR, outcomesModule primaryOutcomes measure: Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University., secondaryOutcomes measure: Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379022, orgStudyIdInfo id: AUTh-29/21-11-2018, briefTitle: Proteomic Analysis of Newly Restored Single Implants, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-03, primaryCompletionDateStruct date: 2019-11-29, completionDateStruct date: 2019-11-29, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, collaborators name: Karolinska Institutet, descriptionModule briefSummary: In 10 systemically healthy non-smokers, free of periodontitis, one newly restored implant (baseline-T0) and one corresponding tooth were followed over 12 months (T1). All implants were screw-retained, and platform-switched. Oral hygiene was closely monitored during the study. Probing pocket depth (PPD), attachment levels (CAL), bleeding and plaque indices and crevicular fluid were collected from an implant-site (PICF) and a tooth-site (GCF). Total proteomic profiles in PICF and GCF were investigated using label-free quantitative proteomics., conditionsModule conditions: Peri-Implantitis, conditions: Peri-implant Mucositis, conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Plaque control, outcomesModule primaryOutcomes measure: Probing pocket depth, primaryOutcomes measure: Protein expression, secondaryOutcomes measure: Recession, secondaryOutcomes measure: Bleeding upon probing, secondaryOutcomes measure: Inflammation index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dental School, Aristotle University, city: Thessaloniki, zip: 54124, country: Greece, geoPoint lat: 40.64361, lon: 22.93086, hasResults: False

protocolSection identificationModule nctId: NCT06379009, orgStudyIdInfo id: 473076, briefTitle: Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: South-Eastern Norway Regional Health Authority, descriptionModule briefSummary: Does home-based training work in kidney transplant recipients with reduced physical function?The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is* Does home-based training improves physical function in kidney transplant recipients.* All the participants are assessed to have reduced physical function before the transplantationParticipants will:* follow either a home-based training program or todays standard of physical activity after kidney transplantation* the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning.* the program consists of both cardio-training, strength-straining and optional activity* the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor.* the effect of the training will be evaluated one year after the transplantation, conditionsModule conditions: Kidney Transplant; Complications, conditions: Frailty, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 arms randomized control study. The intervention arm is exposed of a 12 week home-based training program. The control arm follow standard of care., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Both participants and investigators will know which arm the participants are randomized to. Training is not easy to mask, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Training, outcomesModule primaryOutcomes measure: 6-minute walking distance test, primaryOutcomes measure: Clinical Frailty Scale, secondaryOutcomes measure: Hand-grip strength, secondaryOutcomes measure: 30 seconds Sit-to-stand test, secondaryOutcomes measure: Bone density test, secondaryOutcomes measure: Bioelectrical impedance phase angle to measure muscle mass and strength., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, zip: 0372, country: Norway, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False

protocolSection identificationModule nctId: NCT06378996, orgStudyIdInfo id: S68535, briefTitle: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring, acronym: ALARM-PILOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry., conditionsModule conditions: Mitral Valve Prolapse, conditions: Ventricular Arrythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single arm, interventional cohort study including 3 different patient cohorts:* Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation* Patients with AMVP and mild to moderate mitral valve regurgitation* Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 14-day rhythm monitoring, outcomesModule primaryOutcomes measure: Time to arrhythmic mitral valve prolapse detection, primaryOutcomes measure: Number of days with high PVC-burden ≥5%, primaryOutcomes measure: Number of days with complex ventricular arrhythmia (nsVT, VT, or VF), primaryOutcomes measure: Day-to-day variation in percentage PVC burden, secondaryOutcomes measure: Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI, secondaryOutcomes measure: Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI, secondaryOutcomes measure: Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography, secondaryOutcomes measure: Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Bert Vandenberk, MD, PhD, role: CONTACT, email: bert.vandenberk@uzleuven.be, contacts name: Bert Vandenberk, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06378983, orgStudyIdInfo id: SYSKY-2023-1149-02, briefTitle: Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study plans to select 100 AV patients and randomly divide them into two groups in a 1:1 ratio: the experimental group will be treated with MRF combined with oral isotretinoic acid for 8 consecutive weeks, with a total of 3 MRF treatments at weeks 1, 4, and 8. The control group received oral administration of isotretinoic acid alone for 8 weeks. The main observation indicators are the percentage of effective skin injury clearance achieved by subjects at week 20, as well as the change in ECCA acne scar score compared to baseline at week 20. I hope this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation., conditionsModule conditions: Moderate to Severe Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Oral isotretinoin, interventions name: Oral isotretinoin combined with microneedle radiofrequency therapy, outcomesModule primaryOutcomes measure: Changes in ECCA acne scar score from baseline at week 20, primaryOutcomes measure: The percentage of effective skin lesion clearance rate in the 20th week, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University., status: RECRUITING, city: Guangzhou, zip: 510030, country: China, contacts name: Sha Lu, role: CONTACT, phone: 13632383399, email: lush7@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06378970, orgStudyIdInfo id: 22-1T/49, briefTitle: Audio Books Effects on Anxiety and Vital Sings, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-15, primaryCompletionDateStruct date: 2022-07-15, completionDateStruct date: 2022-07-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support.Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group.Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group., conditionsModule conditions: Non-invasive Mechanical Ventilation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Audio Book Application, outcomesModule primaryOutcomes measure: Facial Anxiety Scale, primaryOutcomes measure: Patient Follow-up Form, primaryOutcomes measure: Audio Book Application Preference Form, primaryOutcomes measure: Patient Information Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University, city: Bornova, state: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, hasResults: False

protocolSection identificationModule nctId: NCT06378957, orgStudyIdInfo id: IRB00436545, briefTitle: Behavioral Pharmacology of Orally Administered THC and D-limonene, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers., conditionsModule conditions: Subjective Drug Effects, conditions: THC, conditions: D-limonene, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Within-subjects design where participants are randomly assigned to dose conditions, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: place controlled, double-blind, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: D-Limonene, interventions name: Delta-9-THC, interventions name: Placebo, outcomesModule primaryOutcomes measure: Subjective Drug Effect as assessed by Visual Analog Scale, secondaryOutcomes measure: Subjective Drug Liking as assessed by Visual Analog Scale, secondaryOutcomes measure: Subjective anxiety as assessed by Visual Analog Scale, secondaryOutcomes measure: Subjective hunger as assessed by Visual Analog Scale, secondaryOutcomes measure: Subjective paranoia as assessed by Visual Analog Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Johns Hopkins Behavioral Pharmacology Research Unit, city: Baltimore, state: Maryland, zip: 21224, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06378944, orgStudyIdInfo id: 61/23, briefTitle: Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer, acronym: INSEAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Omphis Foundation, class: OTHER, descriptionModule briefSummary: The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15000, type: ESTIMATED, armsInterventionsModule interventions name: Application of green indocyanine colorant, interventions name: Technetium99, outcomesModule primaryOutcomes measure: Number of Sentinel lymph node detected. Scale of numbers, secondaryOutcomes measure: Number of possitive lymph nodes, secondaryOutcomes measure: surgery time in minutes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sandra Lopez Gordo, status: RECRUITING, city: Cerdanyola Del Valles, state: Barcelona, zip: 08290, country: Spain, contacts name: Sandra Lopez gordo, role: CONTACT, phone: 660284047, email: sandra.lopezgordo@gmail.com, geoPoint lat: 41.49109, lon: 2.14079, hasResults: False

protocolSection identificationModule nctId: NCT06378931, orgStudyIdInfo id: 2024HX161, briefTitle: Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Chunling Jiang, class: OTHER, descriptionModule briefSummary: The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure., conditionsModule conditions: Secondary Hyperparathyroidism, conditions: End Stage Renal Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Quality of life progression after parathyroidectomy, outcomesModule primaryOutcomes measure: Measure quality of life scores change with respect to time, secondaryOutcomes measure: Measure anxiety and depression score change with respect to time, secondaryOutcomes measure: Measure bone pain scores change with respect to time, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378918, orgStudyIdInfo id: 2023-A02791-44, briefTitle: Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus, acronym: PILO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence.An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov.The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage., conditionsModule conditions: Pilonidal Cyst, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: puncture, interventions name: incision of the abscess, outcomesModule primaryOutcomes measure: healing time, secondaryOutcomes measure: Effectiveness of the 2 procedures, secondaryOutcomes measure: Cost-utility analysis, secondaryOutcomes measure: Duration of nursing care, secondaryOutcomes measure: Duration of work stoppage, secondaryOutcomes measure: Returning to work, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Healing after definitive resection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378905, orgStudyIdInfo id: 141/57, briefTitle: Cukurova Score Validation Study, acronym: CUKUROVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Cukurova University, class: OTHER, collaborators name: Muğla Sıtkı Koçman University, collaborators name: Sakarya University, collaborators name: Gazi University, collaborators name: Ankara Etlik City Hospital, collaborators name: Kayseri City Hospital, collaborators name: Mersin University, collaborators name: Selçuk University, collaborators name: Bezmialem Vakif University, collaborators name: Uludag University, collaborators name: Mersin City Hospital, collaborators name: Marmara University, collaborators name: Prof. Dr. Cemil Tascıoglu City Hospital, collaborators name: Ankara University, collaborators name: Ege University, collaborators name: Hacettepe University, collaborators name: Akdeniz University, collaborators name: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital, collaborators name: Mustafa Kemal University, collaborators name: Trakya University, descriptionModule briefSummary: Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery.The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery., conditionsModule conditions: Epithelial Ovarian Cancer, conditions: Primary Cytoreduction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of complete cytoreduction, secondaryOutcomes measure: Rate of postoperative 90-days mortality, otherOutcomes measure: Rate of postoperative morbidity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cukurova University, city: Adana, zip: 01330, country: Turkey, contacts name: Ghanim Khatib, MD, role: CONTACT, phone: 03223386060, email: ghanim.khatib@gmail.com, contacts name: Ghanim Khatib, MD, role: CONTACT, phone: +903223386060, phoneExt: Khatib, email: ghanim.khatib@gmail.com, contacts name: Ghanim Khatib, MD,Ass.Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.00167, lon: 35.32889, hasResults: False

protocolSection identificationModule nctId: NCT06378892, orgStudyIdInfo id: CRO-2023-78, briefTitle: A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib, acronym: ALK-PPL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Centro di Riferimento Oncologico - Aviano, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent., conditionsModule conditions: Non Small Cell Lung Cancer Metastatic, conditions: ALK Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Lorlatinib, outcomesModule primaryOutcomes measure: Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib., secondaryOutcomes measure: Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib., secondaryOutcomes measure: Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression, secondaryOutcomes measure: Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro di Riferimento Oncologico (CRO) IRCCS, status: RECRUITING, city: Aviano, zip: 33081, country: Italy, contacts name: Alessandra Bearz, role: CONTACT, phone: 0434659294, email: abearz@cro.it, geoPoint lat: 46.07056, lon: 12.59472, locations facility: Azienda Ospedaliero-Universitaria Careggi Oncologia Medica, status: NOT_YET_RECRUITING, city: Firenze, zip: 50134, country: Italy, contacts name: Lorenzo Antonuzzo, role: CONTACT, phone: 0557947298, email: antonuzzol@aou-careggi.toscana.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia, status: NOT_YET_RECRUITING, city: Lido Di Camaiore, zip: 55049, country: Italy, contacts name: Camerini Andrea, role: CONTACT, phone: 05846057282, email: andrea.camerini@uslnordovest.toscana.it, geoPoint lat: 43.90012, lon: 10.2269, locations facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori", status: NOT_YET_RECRUITING, city: Meldola, zip: 47014, country: Italy, contacts name: Delmonte Angelo, role: CONTACT, phone: 0543739100, email: angelo.delmonte@irst.emr.it, geoPoint lat: 44.12775, lon: 12.0626, locations facility: Fondazione IRCCS San Gerardo dei Tintori, status: NOT_YET_RECRUITING, city: Monza, zip: 20900, country: Italy, contacts name: Cortinovis Diego Luigi, role: CONTACT, phone: 0392336040, email: diegoluigi.cortinovis@irccs-sangerardo.it, geoPoint lat: 45.58005, lon: 9.27246, locations facility: IOV Istituto Oncologico Veneto IRCCS, status: NOT_YET_RECRUITING, city: Padova, zip: 35128, country: Italy, contacts name: Pasello Giulia, role: CONTACT, phone: 0498215608, email: giulia.pasello@iov.veneto.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Ospedaliero-Universitaria di Parma, status: NOT_YET_RECRUITING, city: Parma, zip: 43126, country: Italy, contacts name: Tiseo Marcello, role: CONTACT, phone: 0521702316, email: mtiseo@ao.pr.it, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Azienda Ospedaliera di Perugia, status: NOT_YET_RECRUITING, city: Perugia, zip: 06129, country: Italy, contacts name: Metro Giulio, role: CONTACT, phone: 0755783695, email: giulio.metro@ospedale.perugia.it, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), status: NOT_YET_RECRUITING, city: Udine, zip: 33010, country: Italy, contacts name: Giacomo Pellizzari, role: CONTACT, phone: 0432552754, email: giacomo.pelizzari@asufc.sanita.fvg.it, geoPoint lat: 46.0693, lon: 13.23715, hasResults: False

protocolSection identificationModule nctId: NCT06378879, orgStudyIdInfo id: 1073/1/3/26, briefTitle: Intermittent Boluses Versus Infusion of Propofol During Gastroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Al-Balqa Applied University, class: OTHER, collaborators name: Luzmila Hospital, descriptionModule briefSummary: It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Propofol 100 MG in 10 ML Injection, outcomesModule primaryOutcomes measure: Sedation induction time (minutes), primaryOutcomes measure: Total dose of propofol (mg), primaryOutcomes measure: Recovery time (minutes), secondaryOutcomes measure: Involuntary movement, secondaryOutcomes measure: Quality of sedation, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378866, orgStudyIdInfo id: MC230502, secondaryIdInfos id: NCI-2024-02978, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-012176, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230502, type: OTHER, domain: Mayo Clinic in Rochester, briefTitle: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial, acronym: DIVINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT., conditionsModule conditions: Recurrent Castration-Sensitive Prostate Carcinoma, conditions: Stage IVB Prostate Cancer AJCC v8, conditions: Recurrent Prostate Cancer, conditions: Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Abiraterone, interventions name: Apalutamide, interventions name: Biospecimen Collection, interventions name: Bone Scan, interventions name: Computed Tomography, interventions name: Darolutamide, interventions name: Degarelix, interventions name: Enzalutamide, interventions name: Goserelin, interventions name: Histrelin, interventions name: Leuprolide, interventions name: Magnetic Resonance Imaging, interventions name: Patient Observation, interventions name: Positron Emission Tomography, interventions name: Prednisone, interventions name: Questionnaire Administration, interventions name: Relugolix, interventions name: Stereotactic Body Radiation Therapy, interventions name: Triptorelin, outcomesModule primaryOutcomes measure: Modified radiographic progression-free survival (mrPFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Biologic progression-free survival (bPFS), secondaryOutcomes measure: Time to local progression (TLP), secondaryOutcomes measure: Time to distant progression (TDP), secondaryOutcomes measure: Adverse event (AE) rate, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Jacob J. Orme, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False

protocolSection identificationModule nctId: NCT06378853, orgStudyIdInfo id: 2023DZKY-049-01, briefTitle: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Jinling Hospital, China, class: OTHER, descriptionModule briefSummary: By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients., conditionsModule conditions: Pancreatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 548, type: ACTUAL, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: complications, primaryOutcomes measure: overall survival, primaryOutcomes measure: risk factors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinling Hospital, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06378840, orgStudyIdInfo id: KY2021-268-B, briefTitle: the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor, conditionsModule conditions: Locally Advanced Cervical Carcinoma, conditions: Concurrent Chemoradiotherapy, conditions: Immunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Nab-paclitaxel/Platinum, Sintilimab, outcomesModule primaryOutcomes measure: the change of immune cells in the blood after chemoradiotherapy and immunotherapy, primaryOutcomes measure: the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy, primaryOutcomes measure: the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy, secondaryOutcomes measure: the change of immune cells in the tissue after chemoradiotherapy, secondaryOutcomes measure: the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy, secondaryOutcomes measure: the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RenJi hospital, status: RECRUITING, city: Shanghai, zip: 200127, country: China, contacts name: Haiyan Chen, Dr, role: CONTACT, phone: +862168383624, email: chenhaiyan@renji.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06378827, orgStudyIdInfo id: 418-1/2, briefTitle: Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Novi Sad, class: OTHER, descriptionModule briefSummary: This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery., conditionsModule conditions: Acute Kidney Injury, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: Indicator of renal function, primaryOutcomes measure: An early biomarker of kidney injury, primaryOutcomes measure: The change of inflammatory markers, secondaryOutcomes measure: Length of postoperative mechanical ventilation, secondaryOutcomes measure: Length of stay in the intensive care unit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Novi Sad, Faculty of Medicine, status: RECRUITING, city: Novi Sad, zip: 21000, country: Serbia, contacts name: Ranko Zdravkovic, role: CONTACT, phone: +381654674620, email: ranko.zdravkovic@mf.uns.ac.rs, geoPoint lat: 45.25167, lon: 19.83694, hasResults: False

protocolSection identificationModule nctId: NCT06378814, orgStudyIdInfo id: IRAS N335444, briefTitle: Outcome of Selective & Nonselective Caries Removal in Permanent Teeth, acronym: RCT-SNCR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: Guy's and St Thomas' NHS Foundation Trust, descriptionModule briefSummary: Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice.This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality).The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital.Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients.In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches., conditionsModule conditions: Deep Caries, conditions: Carious Exposure of Pulp, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two arms parallel randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Selective Caries Removal (No Pulp Exposure), interventions name: Non-Selective Caries Removal (No Pulp exposure), interventions name: Partial Pulpotomy (Pulp Exposed), outcomesModule primaryOutcomes measure: To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention., secondaryOutcomes measure: Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment, secondaryOutcomes measure: Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378801, orgStudyIdInfo id: RADX-P-2408, briefTitle: Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Radicle Science, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes, conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified based on gender at birth, then randomized to one of the study arms, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: Placebo Control Form 1, interventions name: Relaxation Active Study Product 1.1, outcomesModule primaryOutcomes measure: Change in stress, secondaryOutcomes measure: Change in feelings of anxiety, secondaryOutcomes measure: Change in cognitive function, secondaryOutcomes measure: Change in mood (emotional distress-depression), secondaryOutcomes measure: Minimal clinically important difference (MCID) in stress, secondaryOutcomes measure: Minimal clinically important difference (MCID) in feelings of anxiety, secondaryOutcomes measure: Minimal clinically important difference (MCID) in cognitive function, secondaryOutcomes measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression), otherOutcomes measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radicle Science, Inc, city: Del Mar, state: California, zip: 92014, country: United States, geoPoint lat: 32.95949, lon: -117.26531, hasResults: False

protocolSection identificationModule nctId: NCT06378788, orgStudyIdInfo id: 2023/211, briefTitle: Muscle Architecture and Muscle Strength in Fibromyalgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:* Is there a significant difference in muscle morphology between FMS and controls?* Is there a significant difference in muscle strength between FMS and controls?* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality?, conditionsModule conditions: Fibromyalgia, conditions: Sarcopenia, conditions: Muscle Weakness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Demographic information form, interventions name: widespread pain index (WPI), interventions name: symptom severity scale (SSS), interventions name: Fibromyalgia Impact Questionnaire (FIQ), interventions name: Tender Point examination, interventions name: Muscle Architecture visualized with ultrasound, interventions name: Sarcopenia assessed by measuring isometric strengths of different parts of the body, interventions name: Timed Up & Go (TUG), outcomesModule primaryOutcomes measure: Quadriceps Femoris Vastus Lateralis Muscle Thickness, primaryOutcomes measure: Quadriceps Femoris Vastus Lateralis Fascicle Length, primaryOutcomes measure: Quadriceps Femoris Vastus Medialis Muscle Thickness, primaryOutcomes measure: Quadriceps Femoris Vastus Medialis Fascicle Length, primaryOutcomes measure: Quadriceps Femoris Rectus Femoris Muscle Thickness, primaryOutcomes measure: Quadriceps Femoris Rectus Femoris Fascicle Length, primaryOutcomes measure: Tibialis Anterior Muscle Thickness, primaryOutcomes measure: Tibialis Anterior Muscle Fascicle Length, primaryOutcomes measure: Gastrocnemius Muscle Vastus Medialis Muscle Thickness, primaryOutcomes measure: Gastrocnemius Muscle Vastus Medialis Fascicle Length, primaryOutcomes measure: Gastrocnemius Muscle Vastus Lateralis Muscle Thickness, primaryOutcomes measure: Gastrocnemius Muscle Vastus Lateralis Fascicle Length, primaryOutcomes measure: Cervical Muscle strength, primaryOutcomes measure: Truncal Muscle strength, primaryOutcomes measure: Shoulder Muscle strength, primaryOutcomes measure: Hip Muscle strength, primaryOutcomes measure: Knee Muscle strength, primaryOutcomes measure: Ankle Muscle strength, primaryOutcomes measure: Timed Up & Go (TUG), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem Vakif University, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34093, country: Turkey, contacts name: Mehmet Serkan Kılıçoğlu, Ass.Prof., role: CONTACT, phone: +902124530453, email: drserkankilicoglu@yahoo.com, contacts name: Delal Ozturk, Res.Ass., role: CONTACT, phone: +902124530453, email: drdelalozturk@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06378775, orgStudyIdInfo id: H23-03334, briefTitle: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery, acronym: ROBOT RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Cardiology Research UBC, class: OTHER, descriptionModule briefSummary: The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications., conditionsModule conditions: Coronary Artery Disease, conditions: Multivessel Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Coronary Artery Bypass Graft, interventions name: Robotically-assisted minimally-invasive direct coronary artery bypass, interventions name: Percutaneous Coronary Intervention, outcomesModule primaryOutcomes measure: Post-operative Length of Stay, secondaryOutcomes measure: Conversion to sternotomy / CABG, otherOutcomes measure: Intubation duration, otherOutcomes measure: ICU length of stay, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06378762, orgStudyIdInfo id: 6/2021, briefTitle: Interference of Endurance Training on Strength Development and Neuromuscular Adaptations, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Lisbon, class: OTHER, collaborators name: Fundação para a Ciência e a Tecnologia, descriptionModule briefSummary: This study aims to find out if performing combined strength and endurance exercise in the same program (called concurrent training-CT) leads to similar long-term improvements in neuromuscular function as doing each type of exercise separately. The main questions it seeks to answer are:Does performing CT result in similar improvements in strength and power as doing just strength training? Does performing CT result in similar improvements in cardiorespiratory fitness as doing just endurance training? Are neuromuscular adaptations similar between CT and just strength training? Researchers will compare the results between three groups: the CT group, the endurance training group (E), and the strength training group (S) to answer these questions., conditionsModule conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Endurance Exercise, interventions name: Strength Exercise, interventions name: Concurrent Exercise, outcomesModule primaryOutcomes measure: Maximal Isometric Strength, primaryOutcomes measure: Maximal Dynamic Strength, primaryOutcomes measure: Surface EMG, primaryOutcomes measure: H-reflex excitability, primaryOutcomes measure: V-wave, primaryOutcomes measure: Lower Body Muscle Power, primaryOutcomes measure: Muscle architecture of the quadriceps femoris, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculdade de Motricidade Humana - Universidade de Lisboa, city: Lisboa, state: Cruz Quebrada - Dafundo, zip: 1499-002, country: Portugal, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False

protocolSection identificationModule nctId: NCT06378749, orgStudyIdInfo id: 1R43CA275673, type: NIH, link: https://reporter.nih.gov/quickSearch/1R43CA275673, briefTitle: Previvors Recharge: A Resilience Program for Cancer Previvors, acronym: PreCharge, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Pro-Change Behavior Systems, class: OTHER, descriptionModule briefSummary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale., conditionsModule conditions: Hereditary Cancer, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: PreCharge, outcomesModule primaryOutcomes measure: Connor Davidson Resilience Scale (CDRISC), secondaryOutcomes measure: Cantril/Gallup Life Evaluation Index, secondaryOutcomes measure: Acceptance and Action Questionnaire (AAQII), otherOutcomes measure: Patient Health Questionnaire-2 (PHQ-2), otherOutcomes measure: Generalized Anxiety Disorder-2 (GAD-2), otherOutcomes measure: Cancer Behavior Inventory (CBI-B V2.0-12), otherOutcomes measure: Net Promoter Score (NPS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pro-Change Behavior Systems, status: RECRUITING, city: Narragansett, state: Rhode Island, zip: 02882, country: United States, contacts name: Kerry E Evers, PhD, role: CONTACT, phone: 401-360-2985, email: kevers@prochange.com, contacts name: Madison Gilmore, role: CONTACT, phone: 401-360-2988, email: mgilmore@prochange.com, contacts name: Kerry E Evers, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4501, lon: -71.4495, hasResults: False

protocolSection identificationModule nctId: NCT06378736, orgStudyIdInfo id: 21-1027, briefTitle: Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2026-03-23, completionDateStruct date: 2026-03-23, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Northwell Health, class: OTHER, descriptionModule briefSummary: Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest., outcomesModule primaryOutcomes measure: A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwell Health-Feinstein Insitute, status: RECRUITING, city: Manhasset, state: New York, zip: 11030, country: United States, contacts name: Bruce T Volpe, MD, role: CONTACT, phone: 516-562-3384, email: bvolpe1@northwell.edu, contacts name: Celina B. Fernandez, MS, role: CONTACT, phone: 5165623646, email: cfernandez14@northwell.edu, geoPoint lat: 40.79788, lon: -73.69957, hasResults: False

protocolSection identificationModule nctId: NCT06378723, orgStudyIdInfo id: 2024/01/24, briefTitle: The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-16, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Eastern Mediterranean University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit., conditionsModule conditions: Cerebral Palsy, conditions: Diplegic Cerebral Palsy, conditions: Balance; Distorted, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: Balance Tests, outcomesModule primaryOutcomes measure: trunk control, primaryOutcomes measure: upper extremity functionality, primaryOutcomes measure: balance, primaryOutcomes measure: Weight and Height, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Eastern Mediterranean University, city: Famagusta, zip: 99628, country: Cyprus, geoPoint lat: 35.12054, lon: 33.93894, locations facility: Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi, city: Adana, state: Çukurova, zip: 01170, country: Turkey, geoPoint lat: 37.00167, lon: 35.32889, hasResults: False

protocolSection identificationModule nctId: NCT06378710, orgStudyIdInfo id: 22-0219, briefTitle: Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position, acronym: OPTIPEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-20, primaryCompletionDateStruct date: 2025-01-20, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus, pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position., conditionsModule conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Optimized PEEP, outcomesModule primaryOutcomes measure: Number of occurrences of a MAP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CAEN University Hospital, status: RECRUITING, city: Caen, country: France, contacts name: Mariam BOUTROS, MD, role: CONTACT, phone: 02.31.06.31.06, email: boutros-m@chu-caen.fr, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False

protocolSection identificationModule nctId: NCT06378697, orgStudyIdInfo id: AK111-303, briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis., conditionsModule conditions: Ankylosing Spondylitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: AK111, interventions name: Placebo+AK111, outcomesModule primaryOutcomes measure: the response rate of ASAS20, secondaryOutcomes measure: The response rate of ASAS40, secondaryOutcomes measure: The response rate of ASAS20, secondaryOutcomes measure: The response rate of ASAS40, secondaryOutcomes measure: The response rate of ASAS5/6, secondaryOutcomes measure: Change from baseline on the ASDAS-CRP, secondaryOutcomes measure: Change from baseline on the SF-36 PCS, secondaryOutcomes measure: Change from baseline on the ASQoL scores, secondaryOutcomes measure: Treatment-emergent adverse events, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Clinically significant examination results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 1006-The First Affiliated Hospital of Bengbu Medical University, status: RECRUITING, city: Bengbu, state: Anhui, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: 1038-Anhui Provincial Hospital, status: RECRUITING, city: Hefei, state: Anhui, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: 1001-Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: 1002-Xuanwu Hospital Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: 1042-Peking University Shougang Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: 1049-The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, country: China, geoPoint lat: 24.47979, lon: 118.08187, locations facility: 1027-Lanzhou University Second Hospital, status: RECRUITING, city: Lanzhou, state: Gansu, country: China, geoPoint lat: 36.05701, lon: 103.83987, locations facility: 1005-Nanfang Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: 1025-Guangzhou First People's Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: 1030-Jieyang People's Hospital, status: RECRUITING, city: Jieyang, state: Guangdong, country: China, geoPoint lat: 23.5418, lon: 116.36581, locations facility: 1008-The Seventh Affiliated Hospital, Sun Yat-sen University, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: 1026-Shenzhen People's Hospital, status: RECRUITING, city: Shenzhen, state: Guangdong, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: 1056-Zhongshan Traditional Chinese Medicine Hospital, status: RECRUITING, city: Zhongshan, state: Guangdong, country: China, geoPoint lat: 21.31992, lon: 110.5723, locations facility: 1024-Liuzhou People's Hospital, status: RECRUITING, city: Liuzhou, state: Guangxi, country: China, locations facility: 1021-The People's Hospital of Guangxi Zhuang Autonomous Region, status: RECRUITING, city: Nanning, state: Guangxi, country: China, geoPoint lat: 22.81667, lon: 108.31667, locations facility: 1022-The First Affiliated Hospital of Hainan Medical University, status: RECRUITING, city: Haikou, state: Hainan, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: 1034-Affiliated Hospital of Hebei University, status: RECRUITING, city: Baoding, state: Hebei, country: China, geoPoint lat: 38.85111, lon: 115.49028, locations facility: 1012-Hebei Petro China Central Hospital, status: RECRUITING, city: Langfang, state: Hebei, country: China, geoPoint lat: 39.50972, lon: 116.69472, locations facility: 1029-Hebei General Hospital, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: 1033-The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, state: Heilongjiang, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: 1045-The First Affiliated Hospital of Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: 1053-Nanyang Central Hospital, status: RECRUITING, city: Nanyang, state: Henan, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: 1051-Shiyan People's Hospital, status: RECRUITING, city: Shiyan, state: Hubei, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: 1031-The First Affiliated Hospital of University of South China, status: RECRUITING, city: Hengyang, state: Hunan, country: China, geoPoint lat: 26.88946, lon: 112.61888, locations facility: 1032-Yueyang Central Hospital, status: RECRUITING, city: Yueyang, state: Hunan, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: 1011-Zhuzhou Central Hospital, status: RECRUITING, city: Zhuzhou, state: Hunan, country: China, geoPoint lat: 27.83333, lon: 113.15, locations facility: 1017-Changzhou NO.2 People's Hospital, status: RECRUITING, city: Changzhou, state: Jiangsu, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: 1037-The Second People's Hospital of Lianyungang, status: RECRUITING, city: Lianyungang, state: Jiangsu, country: China, geoPoint lat: 34.59845, lon: 119.21556, locations facility: 1004-Zhongda Hospital Southeast University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: 1007-Nanjing Drum Tower Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: 1036-Jiangsu Province Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: 1018-Affiliated Hospital of Nantong University, status: RECRUITING, city: Nantong, state: Jiangsu, country: China, geoPoint lat: 32.03028, lon: 120.87472, locations facility: 1035-Wuxi People's Hospital, status: RECRUITING, city: Wuxi, state: Jiangsu, country: China, geoPoint lat: 31.56887, lon: 120.28857, locations facility: 1013-Xuzhou Central Hospital, status: RECRUITING, city: Xuzhou, state: Jiangsu, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: 1014-Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: 1047-The First Affiliated Hospital of Gannan Medical College, status: RECRUITING, city: Ganzhou, state: Jiangxi, country: China, locations facility: 1020-The Second Affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: 1039-The First Affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: 1046-Pingxiang People's Hospital, status: RECRUITING, city: Pingxiang, state: Jiangxi, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: 1044-Jilin Provincial People's Hospital, status: RECRUITING, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: 1028- Jining First People's Hospital, status: RECRUITING, city: Jining, state: Shandong, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: 1019-Linyi City People Hospital, status: RECRUITING, city: Linyi, state: Shandong, country: China, geoPoint lat: 35.06306, lon: 118.34278, locations facility: 1055-Weifang People's Hospital, status: RECRUITING, city: Weifang, state: Shandong, country: China, geoPoint lat: 36.71, lon: 119.10194, locations facility: 1016-Zaozhuang Municipal Hospital, status: RECRUITING, city: Zaozhuang, state: Shandong, country: China, geoPoint lat: 34.86472, lon: 117.55417, locations facility: 1054-Linfen Central Hospital, status: RECRUITING, city: Linfen, state: Shanxi, country: China, geoPoint lat: 36.08889, lon: 111.51889, locations facility: 1009-Second Hospital of Shanxi Medical University, status: RECRUITING, city: Taiyuan, state: Shanxi, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: 1043-Yuncheng Central Hospital, status: RECRUITING, city: Yuncheng, state: Shanxi, country: China, geoPoint lat: 35.02306, lon: 110.99278, locations facility: 1010-West China Hospital,Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: 1048-Mianyang Central Hospital, status: RECRUITING, city: Mianyang, state: Sichuan, country: China, geoPoint lat: 31.46784, lon: 104.68168, locations facility: 1041-Affiliated Hospital of North Sichuan Medical College, status: RECRUITING, city: Nanchong, state: Sichuan, country: China, geoPoint lat: 30.79508, lon: 106.08473, locations facility: 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region, status: RECRUITING, city: Urumqi, state: Xinjiang, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: 1040- Huzhou Third People's Hospital, status: RECRUITING, city: Huzhou, state: Zhejiang, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: 1015-Taizhou Hospital of Zhejiang Province, status: RECRUITING, city: Taizhou, state: Zhejiang, country: China, geoPoint lat: 32.49069, lon: 119.90812, locations facility: 1050-The First Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False

protocolSection identificationModule nctId: NCT06378684, orgStudyIdInfo id: JW22105, briefTitle: To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-10, primaryCompletionDateStruct date: 2023-12-23, completionDateStruct date: 2024-01-13, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: JW Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3), interventions name: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3), interventions name: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3), interventions name: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3), interventions name: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3), interventions name: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3), outcomesModule primaryOutcomes measure: Cmax,ss, primaryOutcomes measure: AUCτ,ss, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Center, Severance Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06378671, orgStudyIdInfo id: ColdCough, briefTitle: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough, acronym: ColdCough, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, collaborators name: Ningbo SensCure Biotechnology Co., Ltd., descriptionModule briefSummary: Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough.The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are:* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life?* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough.Participants will:* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina)* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter.* Monitor vital signs and clinical manifestations., conditionsModule conditions: Chronic Cough, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective, single-center, double-blind ,randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: General treatment, interventions name: Cryotherapy Treatment, outcomesModule primaryOutcomes measure: Device/Surgery-Related Serious Adverse Events, primaryOutcomes measure: Device/Surgery Adverse Event Rate, primaryOutcomes measure: Serious Adverse Event Rate, primaryOutcomes measure: Device Defect Rate, primaryOutcomes measure: Cough Visual Analogue Scale (VAS), primaryOutcomes measure: Cough frequency within 2 hours, primaryOutcomes measure: Modified Cough Evaluation Tool (CET), primaryOutcomes measure: Leicester Cough Questionnaire (LCQ), primaryOutcomes measure: Tracheal Vibratory Cough Stimulation Test, primaryOutcomes measure: Capsaicin Cough Stimulation Test, primaryOutcomes measure: Performance evaluation of Cryotherapy Ablation Equipment, primaryOutcomes measure: Performance evaluation of Cryotherapy Ablation Catheter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510163, country: China, contacts name: Shiyue Li, role: CONTACT, phone: +86 13902233925, email: lishiyue@gird.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06378658, orgStudyIdInfo id: 22253, briefTitle: A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' bloodThe study will have 4 treatment periods:- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.On Day 9, participants will take esomeprazole on an empty stomach.- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.On Day 13, participants will take esomeprazole on an empty stomach.Participants will be in this study for about 8 weeks with 3 visits to the study clinic.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment* once, 7 to 10 days after last dose of BAY2927088, for a health check-upDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the levels of BAY2927088* check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment., conditionsModule conditions: Advanced Non-small Cell Lung Cancer, conditions: EGFR Mutation, conditions: HER2 Mutation, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: BAY2927088, interventions name: Esomeprazole, interventions name: Food, outcomesModule primaryOutcomes measure: Cmax for BAY2927088 in plasma, primaryOutcomes measure: AUC for BAY2927088 in plasma, secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: PAREXEL International, Baltimore, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21225, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06378645, orgStudyIdInfo id: 2023-01682, briefTitle: Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery, acronym: PENIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Etienne Xavier Keller, class: OTHER, descriptionModule briefSummary: Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis.To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery.This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations., conditionsModule conditions: Erection; Incomplete, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: General Anesthesia: Propofol, interventions name: General Anesthesia: Sevoflurane, outcomesModule primaryOutcomes measure: Intraoperative Penile Erection, secondaryOutcomes measure: Prolongation of the surgery, secondaryOutcomes measure: Change in operative strategy, secondaryOutcomes measure: Adaptions of instruments or approaches, secondaryOutcomes measure: Altered operative outcome, secondaryOutcomes measure: Necessity for a drug application to decrease penile tumescence, secondaryOutcomes measure: Complications arisen, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, status: RECRUITING, city: Zürich, zip: 8091, country: Switzerland, contacts name: Etienne X Keller, Ass Prof, MD, role: CONTACT, phone: +41 44 255 54 40, email: etiennexavier.keller@usz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False

protocolSection identificationModule nctId: NCT06378632, orgStudyIdInfo id: CLN0011 DETECT-HF, briefTitle: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM, acronym: DETECT-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-11, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Cordio Medical, class: INDUSTRY, descriptionModule briefSummary: Study Design:This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Hearo App, outcomesModule primaryOutcomes measure: Heart Failure Events (HFEs), eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eastern Shore Research Institute, status: RECRUITING, city: Fairhope, state: Alabama, zip: 36532, country: United States, contacts name: Jessica Huckleberry, SC, role: CONTACT, phone: 251-990-1920, email: jessicahuckleberry@yahoo.com, contacts name: Michael Pursley, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.52297, lon: -87.90333, locations facility: UC San Diego Health, status: RECRUITING, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Joshua Gillman, SC, role: CONTACT, phone: 858-246-2511, email: j1gillman@health.ucsd.edu, contacts name: Nicholas Wettersten, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: VA Loma Linda Healthcare System, status: RECRUITING, city: Loma Linda, state: California, zip: 92357, country: United States, contacts name: Vicki Simpson, SC, role: CONTACT, phone: 909-593-6361, email: vicki.simpson@va.gov, contacts name: Jay Patel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, locations facility: VA San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92161, country: United States, contacts name: Jonathan Narita, SC, role: CONTACT, phone: 858-642-3512, email: jonathan.narita@va.gov, contacts name: Nancy Gardetto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94117, country: United States, contacts name: Priscilla Zhang, SC, role: CONTACT, phone: 415-514-7903, email: priscilla.zhang@ucsf.edu, contacts name: Liviu Klein, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Kaiser Permanente San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94118, country: United States, contacts name: Priscilla Chung, SC, role: CONTACT, phone: 415-833-3480, email: priscilla.s.chung@kp.org, contacts name: Jana Svetlichanaya, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Nature Coast Clinical Research, status: RECRUITING, city: Crystal River, state: Florida, zip: 34429, country: United States, contacts name: Nina Smith, SC, role: CONTACT, phone: 352-563-1865, email: nsmith@encoredocs.com, contacts name: Susan Pasupuleti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.90248, lon: -82.5926, locations facility: Jacksonville Center for Clinical Research, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, contacts name: Taylor Johnson, SC, role: CONTACT, phone: 904-730-0101, email: tjohnson@encoredocs.com, contacts name: Michael Koren, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Amavita Clinical Research, status: RECRUITING, city: Miami, state: Florida, zip: 33137, country: United States, contacts name: Nereisy Alonso, SC, role: CONTACT, phone: 786-703-5941, email: researchadmin@amavita.health, contacts name: Pedro Martinez Clark, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Advance Medical Research Services Corp (AMRS), status: RECRUITING, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: Adam Rachid, SC, role: CONTACT, phone: 305-928-8845, email: arachid.amrs@gmail.com, contacts name: Yordan Orive Gomez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Baptist Health (Miami Cardiac & Vascular Institute), status: RECRUITING, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: Margie Mckercher, SC, role: CONTACT, phone: 786-595-8075, email: margie.mchercher@baptisthealth.net, contacts name: Sandra Chaparro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Comprehensive Medical & Research Center, status: RECRUITING, city: Plantation, state: Florida, zip: 33317, country: United States, contacts name: Wilmer Santiesteban Garcia, SC, role: CONTACT, phone: 954-368-3529, email: wsantiesteban@compmedical.net, contacts name: William Korey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.13421, lon: -80.23184, locations facility: St. Johns Center for Clinical Research, status: RECRUITING, city: Saint Augustine, state: Florida, zip: 32086, country: United States, contacts name: Valerie Hayes, SC, role: CONTACT, phone: 904-209-0043, email: vhayes@encoredocs.com, contacts name: Ameeth Vedre, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.89469, lon: -81.31452, locations facility: Tampa General Hospital, status: RECRUITING, city: Tampa, state: Florida, zip: 33606, country: United States, contacts name: Kiria Almeida-Tamayo, SC, role: CONTACT, phone: 813-844-8058, email: kalmeidatamayo@tgh.org, contacts name: Debbie Hoffman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: West Georgia Cardiology, status: RECRUITING, city: Carrollton, state: Georgia, zip: 30117, country: United States, contacts name: Justina Okeke, SC, role: CONTACT, phone: 678-839-7285, email: justina.okeke@westgacardiology.com, contacts name: Charlie Rouse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.58011, lon: -85.07661, locations facility: University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Veronica Herzog, SC, role: CONTACT, phone: 773-834-9794, email: vherzog@bsd.uchicago.edu, contacts name: Gene Kim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Advocate Illinois Masonic Medical Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60657, country: United States, contacts name: Maci Eiber, SC, role: CONTACT, phone: 773-296-0969, email: maci.eiber@aah.org, contacts name: Sorin Danciu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Advocate Illinois Masonic Health Center, status: RECRUITING, city: Downers Grove, state: Illinois, zip: 60515, country: United States, contacts name: Debra Heidenreich, SC, role: CONTACT, phone: 630-352-2338, email: debra.heidenreich@aah.org, contacts name: Sorin Danciu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.80892, lon: -88.01117, locations facility: Midwest Cardiovascular Center, status: RECRUITING, city: Naperville, state: Illinois, zip: 60540, country: United States, contacts name: Josilyn Klimek, SC, role: CONTACT, phone: 630-600-0730, email: josilyn.klimek@cardio.com, contacts name: Maria Rosa Costanzo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.78586, lon: -88.14729, locations facility: Robert J. Dole VA Medical Center, status: RECRUITING, city: Wichita, state: Kansas, zip: 67218, country: United States, contacts name: Deborah Garner, sc, role: CONTACT, phone: 316-685-2221, phoneExt: 53352, email: deborah.garner@va.gov, contacts name: Freidy Eid, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.69224, lon: -97.33754, locations facility: St. Elizabeth Healthcare, status: RECRUITING, city: Edgewood, state: Kentucky, zip: 41017, country: United States, contacts name: Cynthia Mulcahy, SC, role: CONTACT, phone: 859-301-4046, email: cynthia.mulcahy@stelizabeth.com, contacts name: Haree Vongooru, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Cardiovascular Institute of the South, status: RECRUITING, city: Houma, state: Louisiana, zip: 70360, country: United States, contacts name: Kimberly Lirette, SC, role: CONTACT, phone: 985-873-5619, email: kimberly.lirette@cardio.com, contacts name: Peter Fail, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.59577, lon: -90.71953, locations facility: Cardiovascular Institute of the South, status: RECRUITING, city: Lafayette, state: Louisiana, zip: 70503, country: United States, contacts name: June Jones, SC, role: CONTACT, phone: 337-289-8429, email: june.jones@cardio.com, contacts name: Wade May, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.22409, lon: -92.01984, locations facility: University Medical Center New Orleans, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70112, country: United States, contacts name: Katasha Washington, SC, role: CONTACT, phone: 504-702-4704, email: katasha.washington@lcmchealth.org, contacts name: Frank Smart, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Nebraska Heart Center, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68526, country: United States, contacts name: Julie Potter, SC, role: CONTACT, phone: 402-328-3950, email: julie.potter@commonspirit.org, contacts name: Steven Krueger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.8, lon: -96.66696, locations facility: VA Southern Nevada Healthcare System, status: RECRUITING, city: North Las Vegas, state: Nevada, zip: 89086, country: United States, contacts name: Rosalinda Cruz, SC, role: CONTACT, phone: 702-791-9000, phoneExt: 15575, email: Rosalinda.cruz@va.gov, contacts name: Marriyam Moten, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.19886, lon: -115.1175, locations facility: Mount Sinai Morningside, status: RECRUITING, city: New York, state: New York, zip: 10025, country: United States, contacts name: Kathy Idrissi, SC, role: CONTACT, phone: 646-561-1170, email: katharine.idrissi2@mountsinai.org, contacts name: Kiran Mahmood, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: The Mount Sinai Hospital, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Lovelyne Julien, SC, role: CONTACT, phone: 212-241-1537, email: lovelyne.julien@mountsinai.org, contacts name: Anuradha Lala - Trindade, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: St. Francis Hospital, status: RECRUITING, city: Roslyn, state: New York, zip: 11576, country: United States, contacts name: Lyn Santiago, SC, role: CONTACT, phone: 516-562-6763, email: lyn.santiago@chsli.org, contacts name: Rita Jermyn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79982, lon: -73.65096, locations facility: Mission Hospital, status: RECRUITING, city: Asheville, state: North Carolina, zip: 28803, country: United States, contacts name: Josephine Purbrick, SC, role: CONTACT, phone: 828-412-9149, email: josephine.purbrick@sarahcannon.com, contacts name: Vinay Thohan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: Moses H. Cone Memorial Hospital, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27401, country: United States, contacts name: Michelle McCart, SC, role: CONTACT, phone: 336-832-3799, email: michelle.mccart@conehealth.com, contacts name: Daniel Bensimhon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: The Lindner Research Center at The Christ Hospital, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45219, country: United States, contacts name: Kathryn Gloria, SC, role: CONTACT, email: katherineaubre.glori@thechristhospital.com, contacts name: Eugene Chung, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Savi Radesic, role: CONTACT, phone: 216-445-6916, email: radesis@ccf.org, contacts name: W.H. Wilson Tang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: The Ohio State University, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Carina Pannelle, role: CONTACT, phone: 614-366-8650, email: carina.panelle@osumc.edu, contacts name: Rami Kahwash, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Terry Weyand, SC, role: CONTACT, phone: 615-322-9349, email: terry.l.weyand@vumc.org, contacts name: JoAnn Lindenfeld, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Rio Grande Regional Hospital, status: RECRUITING, city: McAllen, state: Texas, zip: 78503, country: United States, contacts name: Dina Garcia, SC, role: CONTACT, phone: 956-632-6054, email: dina.garcia2@hcahealthcare.com, contacts name: Norman Ramirez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.20341, lon: -98.23001, locations facility: Methodist Hospital of San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Maurene Cantu, role: CONTACT, phone: 210-218-4950, email: maurene.cantu@hcahealthcare.com, contacts name: Sachin Gupta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: University Hospital Samson Assuta Ashdod, status: RECRUITING, city: Ashdod, country: Israel, contacts name: Sapir Swisa, SC, role: CONTACT, contacts name: Alexander Goldman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.79211, lon: 34.64967, locations facility: Assuta Be'er Sheva Medical Center, status: RECRUITING, city: Be'er Sheva, country: Israel, contacts name: Alex Demitriev, SC, role: CONTACT, contacts name: Amos Katz, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.25181, lon: 34.7913, locations facility: Rambam Medical Center, status: RECRUITING, city: Haifa, country: Israel, contacts name: Ludmila Helmer, SC, role: CONTACT, phone: 972-4-7773475, contacts name: Oren Caspi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Shaare Zedek Medical Center, status: RECRUITING, city: Jerusalem, country: Israel, contacts name: Hadas Barda, SC, role: CONTACT, phone: 972-2-6666769, contacts name: Tal Hasin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Galiee Medical Center, status: RECRUITING, city: Nahariya, country: Israel, contacts name: Etti Lasri Kadosh, SC, role: CONTACT, phone: 972-4-9107747, contacts name: Shaul Atar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.00892, lon: 35.09814, locations facility: Tel Aviv Sourasky (Ichilov) Medical Center, status: RECRUITING, city: Tel Aviv, country: Israel, contacts name: Tal Fux, SC, role: CONTACT, phone: 972-3-6972420, contacts name: Michal Laufer Perl, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, locations facility: Poriya Medical Center, status: RECRUITING, city: Tiberias, country: Israel, contacts name: Jannat Mukari, SC, role: CONTACT, phone: 972-4-6652201, contacts name: Wadi Kinany, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.79221, lon: 35.53124, hasResults: False

protocolSection identificationModule nctId: NCT06378619, orgStudyIdInfo id: CSAPG-50, briefTitle: Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach, acronym: MATSEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques., conditionsModule conditions: Tremor, conditions: Essential Tremor, conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Tapping Test, interventions name: Archimedes Spiral, outcomesModule primaryOutcomes measure: Sensitivity, primaryOutcomes measure: Specificity, secondaryOutcomes measure: Reliability, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf, city: Barcelona, state: Cataluña, zip: 08810, country: Spain, contacts name: José Luis Camacho, MD, role: CONTACT, phone: +34 938960025, email: jlcamacho@csapg.cat, contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960025, phoneExt: 43197, email: recerca@csapg.cat, contacts name: José Luis Camacho, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False

protocolSection identificationModule nctId: NCT06378606, orgStudyIdInfo id: P.T.REC/012/004907, briefTitle: Effect of Technology on Cognitive Function in Elderly, acronym: cogntion, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Nourhan Hesham Ali, class: OTHER, collaborators name: Cairo University, descriptionModule briefSummary: Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly ., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly ., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: cognitive therapy, outcomesModule primaryOutcomes measure: Cognitive functions assessment, secondaryOutcomes measure: Quality of life survey, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nour Ali, status: RECRUITING, city: Cairo, state: Giza, zip: 12511, country: Egypt, contacts name: Nour Ali, master, role: CONTACT, phone: 01156860154, email: nourheshame854@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06378593, orgStudyIdInfo id: 3HP-2827-102, briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: 3H (Suzhou) Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations., conditionsModule conditions: Solid Tumors With FGFR2 Alterations, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: 3HP-2827, outcomesModule primaryOutcomes measure: Dose Escalation Stage- incidence of adverse events (AEs), primaryOutcomes measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs), primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, primaryOutcomes measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827, primaryOutcomes measure: Expansion stage -Objective response rate（ORR）, secondaryOutcomes measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy., secondaryOutcomes measure: Duration of Response (DOR) as assessed by RECIST v1.1, secondaryOutcomes measure: Disease control rate (DCR) as assessed by RECIST v1.1, secondaryOutcomes measure: Progression-free survival (PFS) as assessed by RECIST v1.1, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Dose escalation stage - Objective Response Rate (ORR), secondaryOutcomes measure: Expansion Stage- incidence of adverse events (AEs), secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, secondaryOutcomes measure: Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Lin Shen, MD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: ZhongShan Hospital, city: Shanghai, state: Shanghai, zip: 200123, country: China, contacts name: Jia Fan, MD, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06378580, orgStudyIdInfo id: LGF22H160084, secondaryIdInfos id: LGF22H160084, type: OTHER_GRANT, domain: Zhejiang Provincial Basic Public Welfare Research Program, briefTitle: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Luo Cong, class: OTHER, descriptionModule briefSummary: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital., conditionsModule conditions: Pancreatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Surufatinib combine immune checkpoint inhibitor, interventions name: AG/FOLFIRINOX, outcomesModule primaryOutcomes measure: Median progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Province Cancer Hospital, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06378567, orgStudyIdInfo id: HCD J8923, briefTitle: A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: The Water Street Collective, class: INDUSTRY, collaborators name: British American Tobacco (Investments) Limited, collaborators name: HCD Research, descriptionModule briefSummary: A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress., conditionsModule conditions: Sleep, conditions: Mood, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Dietary supplement liquid shot beverage products, outcomesModule primaryOutcomes measure: Sleep Disturbance, secondaryOutcomes measure: Sleep Impairment, secondaryOutcomes measure: Insomnia Severity, secondaryOutcomes measure: Restorative Sleep, secondaryOutcomes measure: Contentedness/Anxiety, secondaryOutcomes measure: Profile of Mood States (POMS), secondaryOutcomes measure: Daily Sleep diary, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sago Atlanta - The Palisades Complex, city: Atlanta, state: Georgia, zip: 30328, country: United States, contacts name: Melissa Hall, role: CONTACT, phone: 770-396-8700, email: connect@sago.com, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06378554, orgStudyIdInfo id: IRB00111227, briefTitle: Cereset Research for Performance Improvement in a Hospital Nursing Unit, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Susanne Marcus Collins Foundation, Inc., descriptionModule briefSummary: The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation., conditionsModule conditions: Health Personnel, conditions: Stress, conditions: Anxiety, conditions: Job Performance, conditions: Insomnia, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cereset Research, outcomesModule primaryOutcomes measure: Percent of ortho trauma unit staff who complete Cereset intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Dawn C Higgins, role: CONTACT, phone: 336-716-9447, email: dkellar@wakehealth.edu, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False

protocolSection identificationModule nctId: NCT06378541, orgStudyIdInfo id: SDR 21-267, briefTitle: Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE), acronym: Project HOPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2028-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: This study will test whether a new intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings., conditionsModule conditions: Suicide Prevention, conditions: Suicide Attempt, conditions: Suicidal Ideation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 928, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Hope Box Enhanced Facilitation, interventions name: Enhanced Usual Care, outcomesModule primaryOutcomes measure: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review), secondaryOutcomes measure: Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]), otherOutcomes measure: Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale), otherOutcomes measure: Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale), otherOutcomes measure: Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]), otherOutcomes measure: Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]), otherOutcomes measure: Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]), otherOutcomes measure: Demographics, otherOutcomes measure: Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]), otherOutcomes measure: Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]), otherOutcomes measure: Drug use (measured by the Drug Abuse Screening Test [DAST-10]), otherOutcomes measure: Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]), otherOutcomes measure: Coping strategies (measured by the Brief-COPE scale), otherOutcomes measure: Virtual Hope Box (VHB) frequency, otherOutcomes measure: VHB app beliefs, usage, and treatment satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Ann Arbor Healthcare System, Ann Arbor, MI, city: Ann Arbor, state: Michigan, zip: 48105-2303, country: United States, contacts name: Fatima Makki, MPH MSW, role: CONTACT, phone: 734-845-3623, email: fatima.makki@va.gov, contacts name: Courtney L Bagge, PhD MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA, city: Seattle, state: Washington, zip: 98108-1532, country: United States, contacts name: Mark Reger, PhD, role: CONTACT, phone: 253-583-3295, email: Mark.Reger@va.gov, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06378528, orgStudyIdInfo id: 2023-1706, secondaryIdInfos id: Protocol Version Jan 2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: A538900, type: OTHER, domain: UW Madison, briefTitle: Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up., conditionsModule conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single group, open label, pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: SmartSleep EEG recording headband, outcomesModule primaryOutcomes measure: Summary of Adverse Events Attributable to Ketamine Administration, secondaryOutcomes measure: Number of Participants Adhering to the Study Protocol, secondaryOutcomes measure: Number of Visits Completed Throughout the Study Duration, otherOutcomes measure: Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA), otherOutcomes measure: Exploratory Measurements: Change waveform recorded with Philips SmartSleep headband, measured in Hz, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Sara Heyn, JD, PhD, role: SUB_INVESTIGATOR, contacts name: Stephanie Jones, PhD, role: SUB_INVESTIGATOR, contacts name: Steven Garlow, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Paul Hutson, PharmD, role: SUB_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06378515, orgStudyIdInfo id: Glymphactive, briefTitle: Physical Activity, Sleep and Brain Health Based on the Glymphatic System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: University of Oulu, descriptionModule briefSummary: This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer., conditionsModule conditions: Brain Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity, postural changes and cognitive tasks, outcomesModule primaryOutcomes measure: Brain health, secondaryOutcomes measure: Physical activity (habitual), secondaryOutcomes measure: Sleep duration, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Chronotype, secondaryOutcomes measure: Self-reported health status, secondaryOutcomes measure: Other variables, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378502, orgStudyIdInfo id: antibiotic-resistence, briefTitle: The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universita degli Studi di Genova, class: OTHER, descriptionModule briefSummary: The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients., conditionsModule conditions: Antibiotic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Amoxicillin Short, interventions name: Amoxicillin Long, outcomesModule primaryOutcomes measure: Mean peri-implant bone loss, secondaryOutcomes measure: Incidence of biological and technical complications at the implant site, secondaryOutcomes measure: implant survival rate, secondaryOutcomes measure: Antibiotic sensitivity, secondaryOutcomes measure: Peri-implant myco-, microbiome and resistome, secondaryOutcomes measure: Salivary miRNomics, secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Development of a 3D bone model, secondaryOutcomes measure: Plaque index (PI), secondaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Peri-implant pocket probing depth (PPD), eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378489, orgStudyIdInfo id: 2022-0346-01, briefTitle: The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of the Philippines, class: OTHER, collaborators name: Organon, descriptionModule briefSummary: Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant., conditionsModule conditions: Endometrial Hyperplasia Without Atypia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Etonogestrel implant, outcomesModule primaryOutcomes measure: Rate of (resolution) regression to normal endometrium, primaryOutcomes measure: Endometrial thickness (by ultrasound), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378476, orgStudyIdInfo id: 855188, briefTitle: Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment, acronym: SUPPORT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences., conditionsModule conditions: Chronic Kidney Diseases, conditions: Racism, Systemic, conditions: Trauma, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Research coordinators collecting baseline and outcomes data from participants will be blinded to arm., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: IMPaCT Community Health Worker Program, interventions name: Trauma-Informed Care Training, outcomesModule primaryOutcomes measure: Kidney Disease Quality of Life Instrument (KDQOL), secondaryOutcomes measure: Patient Activation Measure, secondaryOutcomes measure: All-Cause Hospitalizations, secondaryOutcomes measure: Patient preferences for end-stage renal disease treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06378463, orgStudyIdInfo id: PSY-2324-S-0362, briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI), acronym: HEADDSET+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Groningen, class: OTHER, collaborators name: Stichting Cosis, collaborators name: Lentis Psychiatric Institute, collaborators name: GGZ Friesland, descriptionModule briefSummary: Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training., conditionsModule conditions: Severe Mental Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pragmatic triple-blinded, randomized, sham-controlled trial, following a non-concurrent multiple baseline design, with the participants serving as their own control. Participants will be randomized over two groups: CIRCuiTS +sham tDCS (group 1), or CIRCuiTS + active tDCS (group 2). The trial will start with a first measurement (T0), followed by a waiting period of 16 weeks and a second measurement (T1). The waiting period serves as the control condition (service users are their own control). Next, the participants will be allocated to 16-20 weeks of either CIRCuiTS + sham tDCS or CIRCuiTS + active tDCS. This period of 16-20 weeks is not fixed as it depends upon how fast participants go through the program. This is followed by a third measurement after treatment (T2). There will be a fourth measurement six months after the end of the intervention (T3)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive remediation + active tDCS, interventions name: Cognitive remediation + sham tDCS, outcomesModule primaryOutcomes measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS), primaryOutcomes measure: Goal Attainment Scale (GAS), secondaryOutcomes measure: Controlled Oral World Association Task (COWAT), secondaryOutcomes measure: Trail Making Test (TMT), secondaryOutcomes measure: Digit span (forward & backward), secondaryOutcomes measure: Wechsler Memory Scale - Visual Reproduction I and II, secondaryOutcomes measure: Stroop Color and Word Task (SCWT), secondaryOutcomes measure: 15 Word Test (15-WT), secondaryOutcomes measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task, secondaryOutcomes measure: Cognitive Failure Questionnaire (CFQ), secondaryOutcomes measure: Self-Evaluation of Negative Symptoms (SNS), secondaryOutcomes measure: DEX self/informant, secondaryOutcomes measure: General Self-Efficacy Scale (GSES), secondaryOutcomes measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cosis, city: Assen, state: Drenthe, zip: 9400 AE, country: Netherlands, contacts name: Liesbeth Brand, MSc, role: CONTACT, phone: +31682079633, email: l.brand@cosis.nu, geoPoint lat: 52.99667, lon: 6.5625, locations facility: Lentis, city: Zuidlaren, state: Drenthe, zip: 9470 AC, country: Netherlands, contacts name: Lisette van der meer, PhD, role: CONTACT, phone: +31628259303, email: l.vandermeer@lentis.nl, geoPoint lat: 53.09417, lon: 6.68194, locations facility: GGZ Friesland, city: Leeuwarden, state: Friesland, zip: 8932 PA, country: Netherlands, contacts name: Sander De Vos, PhD, role: CONTACT, phone: +31 6 47368400, email: sander.de.vos@ggzfriesland.nl, geoPoint lat: 53.20139, lon: 5.80859, hasResults: False

protocolSection identificationModule nctId: NCT06378450, orgStudyIdInfo id: 2022-23892-31512-2, briefTitle: Dose-Response Effects of Mindfulness Meditation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Melbourne, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation.The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses.Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses.Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min.Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention., conditionsModule conditions: Well-Being, Psychological, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 860, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness meditation guided practice, outcomesModule primaryOutcomes measure: Psychological wellbeing, secondaryOutcomes measure: Psychological Distress, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Nonattachment, secondaryOutcomes measure: Trait Mindfulness, secondaryOutcomes measure: Decentering, secondaryOutcomes measure: Equanimity, secondaryOutcomes measure: Repetitive Negative Thoughts, secondaryOutcomes measure: Emotional Regulation, secondaryOutcomes measure: Attentional Control, secondaryOutcomes measure: Emotional Reactivity, secondaryOutcomes measure: Social Anxiety, secondaryOutcomes measure: Sleep Quality, otherOutcomes measure: Momentary Mood, otherOutcomes measure: State Mindfulness, otherOutcomes measure: Attention, otherOutcomes measure: Decentering, otherOutcomes measure: Mindful Attitudes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06378437, orgStudyIdInfo id: GLB-001-02, briefTitle: A Study of GLB-001 in Patients With Myeloid Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Hangzhou GluBio Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study., conditionsModule conditions: Polycythemia Vera, conditions: Essential Thrombocythemia, conditions: Myelofibrosis, conditions: Myelodysplastic Syndromes, conditions: Acute Myeloid Leukemia, conditions: Myeloid Malignancy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: GLB-001, outcomesModule primaryOutcomes measure: Dose-limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Recommended Expansion Doses (RED), primaryOutcomes measure: Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs), primaryOutcomes measure: Recommended Phase 2 Dose (RP2D), primaryOutcomes measure: Response Assessment in Study Participants With PV, primaryOutcomes measure: Response Assessment in Study Participants With ET, primaryOutcomes measure: Response Assessment in Study Participants With MF, primaryOutcomes measure: Response Assessment in Study Participants With LR-MDS, primaryOutcomes measure: Response Assessment in Study Participants With HR-MDS, primaryOutcomes measure: Response Assessment in Study Participants With AML, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2, secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC], secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax], secondaryOutcomes measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: Hu Zhou, MD, role: CONTACT, phone: 86-0371-65587320, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lei Zhang, MD, role: CONTACT, phone: 86-022-23909240, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affilicated Hospital, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Hongyan Tong, MD, role: CONTACT, phone: 86-0571-87236114, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06378424, orgStudyIdInfo id: 2023-6/6, briefTitle: The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-22, primaryCompletionDateStruct date: 2023-03-22, completionDateStruct date: 2023-08-23, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Uludag University, class: OTHER, descriptionModule briefSummary: Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale., conditionsModule conditions: Pain Management, conditions: Emergency Unit, conditions: Diarrhea, conditions: Nausea, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Cold Application, interventions name: Heat Application, interventions name: Vibration Application, outcomesModule primaryOutcomes measure: pain intensity in mm, primaryOutcomes measure: venous dilation in score, primaryOutcomes measure: procedure duration in sec, secondaryOutcomes measure: weight, secondaryOutcomes measure: height, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bursa Uludag University Hospital, city: Bursa, state: Nilüfer, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False

protocolSection identificationModule nctId: NCT06378411, orgStudyIdInfo id: P109, briefTitle: Development and Application of a Musical Game for Motor Rehabilitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universidade da Madeira, class: OTHER, descriptionModule briefSummary: The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time., conditionsModule conditions: Health People, conditions: Survivors of Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Music Game Intervention, outcomesModule primaryOutcomes measure: Motor Coordination, primaryOutcomes measure: Usability, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidade da Madeira, status: RECRUITING, city: Funchal, country: Portugal, contacts name: Yasmim Moniz, Master, role: CONTACT, phone: +351 968412551, email: yasmimfernandes08@hotmail.com, contacts role: CONTACT, email: yasmimfernandes08@hotmail.com, geoPoint lat: 32.66568, lon: -16.92547, hasResults: False

protocolSection identificationModule nctId: NCT06378398, orgStudyIdInfo id: UMCC 2023.037, secondaryIdInfos id: HUM00247729, type: OTHER, domain: University of Michigan, secondaryIdInfos id: UMI23-13-01, type: OTHER, domain: DCP Protocol Number, secondaryIdInfos id: 1UG1CA242632-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG1CA242632-01A1, briefTitle: A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Michigan Rogel Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days.The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected., conditionsModule conditions: Colorectal Neoplasia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Omeprazole, interventions name: Aspirin, outcomesModule primaryOutcomes measure: Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum, secondaryOutcomes measure: Evaluation of gene expression changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Michigan Rogel Cancer Center, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Kirsten Tuck, role: CONTACT, phone: 734-763-1141, email: KLtuck@med.umich.edu, contacts name: Elena Stoffel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Kebire Gofar, role: CONTACT, email: Kebire.Gofar@osumc.edu, contacts name: Peter Stanich, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06378385, orgStudyIdInfo id: DevelopmentCEOAS, briefTitle: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Nove de Julho, class: OTHER, descriptionModule briefSummary: Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population., conditionsModule conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Childhood Early Oral Aging Syndrome index, outcomesModule primaryOutcomes measure: Development of CEOAS index, secondaryOutcomes measure: Validation of CEOAS index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidade Metropolitana de Santos - UNIMES, city: Santos, state: São Paulo, zip: 11045-002, country: Brazil, geoPoint lat: -23.96083, lon: -46.33361, hasResults: False