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protocolSection identificationModule nctId: NCT06312046, orgStudyIdInfo id: 2018 374-31, briefTitle: Motor-cognitive Performance in People With Multiple Sclerosis, acronym: HiBalance-MS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: Having a neurological disease such as multiple sclerosis (MS) leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks, hindering activity performance and influencing the possibilities for an independent lifestyle.The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS (HiBalance-MS). This program was recently tested and found feasible in a pilot study. The investigators will now perform a randomized controlled trial in people with MS, in order to determine the effects of the program. The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control, walking, motor-cognitive performance, activity performance and health related quality of life., conditionsModule conditions: Multiple Sclerosis, conditions: Postural Balance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and Outcome assessor will not participate in the provided training program. Care provider will not perform the analyses., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: HiBalance-MS, outcomesModule primaryOutcomes measure: Mini Balance Evaluation Systems test., secondaryOutcomes measure: 10-Meter Walk Test, maximum speed., secondaryOutcomes measure: 10-Meter Walk Test, self-selected speed., secondaryOutcomes measure: 2-Minute Walk Test, self-selected speed., secondaryOutcomes measure: Gait speed during simultaneous dual task performance., secondaryOutcomes measure: Stride length during dual task gait performance., secondaryOutcomes measure: Step time during dual task gait performance., secondaryOutcomes measure: Response errors in dual task cognitive performance, secondaryOutcomes measure: Reaction time in dual task cognitive performance, secondaryOutcomes measure: Six-Spot Step Test., secondaryOutcomes measure: Completion time in the Trail Making Test., secondaryOutcomes measure: Number of errors in the Trail Making Test., secondaryOutcomes measure: Immediate and delayed recall in the Ray Auditory Verbal Learning Test., secondaryOutcomes measure: Cognitive processing speed in the Symbol Digit Modalities Test., secondaryOutcomes measure: Cognitive function - composite measure of three cognitive tests., secondaryOutcomes measure: Physical activity level., secondaryOutcomes measure: Physical activity level, self-reported., secondaryOutcomes measure: Physical exercise habits, self-reported., secondaryOutcomes measure: The generic Walk-12 questionnaire., secondaryOutcomes measure: Falls Efficacy Scale - International., secondaryOutcomes measure: Assesment of anxiety with the Hospital Anxiety and Depression Scale., secondaryOutcomes measure: Assesment of depression with the Hospital Anxiety and Depression Scale., secondaryOutcomes measure: Modified Fatigue Impact Scale., secondaryOutcomes measure: Occupational Gap Questionnaire., secondaryOutcomes measure: Acceptance of Chronic Health Condition scale., secondaryOutcomes measure: Multiple Sclerosis Impact Scale - physical impact., secondaryOutcomes measure: Multiple Sclerosis Impact Scale - psychological impact., secondaryOutcomes measure: Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L)., secondaryOutcomes measure: Euroqol Visual Analogue Scale (EQ VAS)., secondaryOutcomes measure: World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, zip: 17177, country: Sweden, contacts name: Sverker Johansson, Ph.D, role: CONTACT, phone: +46702861260, email: sverker.johansson@ki.se, contacts name: Andreas Wallin, Ph.D, role: CONTACT, phone: +46735137604, email: andreas.wallin@ki.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06312033, orgStudyIdInfo id: MRTG_P01, briefTitle: Estradiol's Effect on Brain Volume and Connectivity, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2019-07-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: International Research Training Group 2804, class: OTHER, collaborators name: University Hospital Tübingen, collaborators name: German Research Foundation, collaborators name: Werner Reichardt Centrum für Integrative Neurowissenschaften (CIN), descriptionModule briefSummary: Ovarian hormones are not only modulators of cognitive function, emotion regulation and mental health, but also seem to affect brain plasticity and functional connectivity, During the menstrual cycle, women experience cyclic fluctuation of the ovarian hormone estradiol, which is closely associated with neuroplasticity/changes in brain structure in regions with high estradiol receptor density, such as the amygdala, hippocampus/parahippocampus, anterior cingulate cortex (ACC), striatum, and prefrontal cortex (PFC). Further functional connectivity between these areas seems to be associated with hormonal changes dependent on the menstrual cycle phase. But next to estradiol, also other hormones like progesterone fluctuate across the menstrual cycle. In the past, effects of ovarian hormone levels were often investigated in combination. However, one way to disentangle the impact of estradiol from that of other hormones on neuroplasticity, emotion regulation and mood states, can be the experimental increase of estradiol via estradiol administration. In this double-blinded within-subject study, women were administered either estradiol valerate or placebo during the early follicular phase (thus when ovarian hormone concentrations are low) before undergoing neuroimaging.Parts of the study are already described in Rehbein et al., 2021 and 2022., conditionsModule conditions: Emotion Regulation, conditions: Estradiol, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The intervention assessed the effect of estradiol administration on stress reactivity using a double blind randomized within -between placebo-controled design with repeated measures., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Neither participant or investigator knew the timepoint of drug or placebo administration. Pills were prepared by independent members of the university hospital., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Estradiol Valerate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Impact of E2 concentration on brain structure, primaryOutcomes measure: Impact of E2 concentration and state emotion regulation on brain structure, primaryOutcomes measure: Impact of E2 concentration and emotion regulation traits on brain structure, primaryOutcomes measure: Impact of E2 concentration on resting state functional connectivity, primaryOutcomes measure: Impact of E2 concentration and state emotion regulation on connectivity, primaryOutcomes measure: Impact of E2 concentration and emotion regulation traits on functional connectivity, primaryOutcomes measure: Impact of E2 concentration and associated structural brain changes on connectivity, secondaryOutcomes measure: Impact of E2 concentration and self-esteem on brain structure, secondaryOutcomes measure: Impact of E2 concentration and self-esteem on functional connectivity, secondaryOutcomes measure: Impact of E2 concentration and subjective mood on brain structure, secondaryOutcomes measure: Impact of E2 concentration and state anxiety on brain structure, secondaryOutcomes measure: Impact of E2 concentration and subjective mood on functional connectivity, secondaryOutcomes measure: Impact of E2 concentration and state anxiety on functional connectivity, secondaryOutcomes measure: Impact of E2 administration on E2 concentrations, secondaryOutcomes measure: Impact of E2 administration on E2-progesterone ratio, secondaryOutcomes measure: Impact of E2 administration on testosterone and progesterone concentration, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Tuebingen; Department of Psychiatry & Psychotherapy, city: Tuebingen, state: BW, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
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protocolSection identificationModule nctId: NCT06312020, orgStudyIdInfo id: HZNP-HZN-1116-201, briefTitle: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-09-03, completionDateStruct date: 2026-11-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Horizon Therapeutics Ireland DAC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS)., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: HZN-1116, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1), primaryOutcomes measure: Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2), secondaryOutcomes measure: Change from baseline in ESSDAI (Population #1), secondaryOutcomes measure: Proportion of Participants achieving ESSDAI [5] response (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI pain domain score (Population #1), secondaryOutcomes measure: Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI fatigue domain score (Population #1), secondaryOutcomes measure: Change from baseline in DASPRI fatigue domain score (Population #1), secondaryOutcomes measure: Change from baseline in ESSPRI dryness domain score (Population #1), secondaryOutcomes measure: Change from baseline in DASSPRI dryness domain score (Population #1), secondaryOutcomes measure: Change from baseline in tender joint count (TJC) (Population #1), secondaryOutcomes measure: Change from baseline in swollen joint count (SJC) (Population #1), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1), secondaryOutcomes measure: Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1), secondaryOutcomes measure: Change from baseline in DASPRI (Population #2), secondaryOutcomes measure: Proportion of Participants achieving ESSPRI [1.5] response (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI pain domain (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI fatigue domain (Population #2), secondaryOutcomes measure: Change from baseline in ESSPRI dryness domain (Population #2), secondaryOutcomes measure: Change from baseline in SF-36 PCS Score (Population #2), secondaryOutcomes measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2), secondaryOutcomes measure: Change from baseline in PROMIS-Fatigue SF-10a (Population #2), secondaryOutcomes measure: Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2), secondaryOutcomes measure: Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06312007, orgStudyIdInfo id: UH23030202, briefTitle: Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hasanuddin University, class: OTHER, descriptionModule briefSummary: This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon, conditionsModule conditions: Semi Seated Position, conditions: Side Lying Position, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention semi seated position Control side lying position, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Semi seated position, interventions name: side lying position, outcomesModule primaryOutcomes measure: Kortisol level, primaryOutcomes measure: Oxytocin level, eligibilityModule sex: ALL, minimumAge: 32 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Hasanuddin University, city: Makassar, state: South Sulawesi, country: Indonesia, geoPoint lat: -5.14861, lon: 119.43194, hasResults: False
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protocolSection identificationModule nctId: NCT06311994, orgStudyIdInfo id: GumushaneUni, briefTitle: Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Gümüşhane Universıty, class: OTHER, descriptionModule briefSummary: The stress experienced by patients in hospital environments can lead to a range of issues, from clinical decision-making to discharge. Although stress levels can contribute to new problems, individual characteristics also play a significant role in clinical recovery. Knee surgery is a commonly performed procedure in our country that provides patients with an effective solution to joint-related issues. However, stress experienced by patients who undergo surgery can have negative consequences, from managing problems during their hospital stay to their overall quality of life. The search for effective stress management methods is ongoing and has gained momentum with the development of new technological products. Virtual reality (VR) applications are a novel approach in the literature for managing various issues. Research is being conducted in different areas of our country using this approach. The aim of this project is to evaluate the feasibility, acceptability, and effectiveness of different environment perceptions using virtual reality glasses on postoperative mobilization and well-being in individuals undergoing knee surgery for the first time. The project sample is a randomized controlled trial consisting of 30 patients who will undergo orthopedic surgery for the first time at the Gümüşhane State Hospital orthopedic clinic and meet the acceptance criteria. In the intervention group, patients will view relaxing virtual environment images with VR glasses after surgery. Following the relaxation session, participants will be presented with content to exercise in the virtual environment. Patients will be instructed to perform breathing exercises set in forest and underwater scenes to aid relaxation. The effectiveness of the intervention will be assessed using the Tampa Kinesiophobia Scale and Patient Mobility Scale. A satisfaction scale with a linear format will be used to evaluate the acceptability of the intervention. In addition, a data collection form, developed by the researcher, will be used to gather information on participant characteristics. The obtained data will be analyzed using t-tests, analysis of variance, correlation, and regression tests. Currently, there is a growing number of studies that explore the relationship between technology and health. This project aims to investigate the impact of virtual reality glasses on symptom management. If the results are positive, this method could be used as a solution for various situations where individuals experience symptoms. The goal is to develop a usable product for postoperative mobilization based on the research findings., conditionsModule conditions: Virtual Reality, conditions: Symptom Management, conditions: Surgery, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality, outcomesModule primaryOutcomes measure: Pain measure, primaryOutcomes measure: Stress, secondaryOutcomes measure: Mobilization, secondaryOutcomes measure: Mobility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gumushane University, status: RECRUITING, city: Gumushane, zip: 28010, country: Turkey, contacts name: Aydanur Aydin, role: CONTACT, phone: 0905321730688, email: aydanuraydin_88@hotmail.com, geoPoint lat: 40.46001, lon: 39.47176, hasResults: False
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protocolSection identificationModule nctId: NCT06311981, orgStudyIdInfo id: SPHIC-TR-THLC2023-08, briefTitle: Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-17, completionDateStruct date: 2026-06-17, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Jian Chen, class: OTHER, descriptionModule briefSummary: To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy., conditionsModule conditions: Non-small Cell Lung Cancer, conditions: Older People, conditions: Carbon Ion Radiotherapy, conditions: Radiotherapy Side Effect, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: carbon ion radiotherapy, interventions name: targeted therapy, interventions name: single regimen chemotherapy in sequence with radiotherapy, outcomesModule primaryOutcomes measure: Disease progression-free survival rate, primaryOutcomes measure: Incidence of Treatment-induced Adverse Events, secondaryOutcomes measure: Local control rate, secondaryOutcomes measure: Cause-specific survival rate, secondaryOutcomes measure: Overall survival rate, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Proton and Heavy Ion Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201513, country: China, contacts name: Jing Li, role: CONTACT, phone: 86-21-38296678, email: jing.li@sphic.org.cn, contacts name: Kun Liu, role: CONTACT, phone: 86-21-38296678, email: kun.liu@sphic.org.cn, contacts name: Jian Chen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jingfang Mao, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kai-liang Wu, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06311968, orgStudyIdInfo id: SPHIC-TR-THLC2023-07, briefTitle: The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Jian Chen, class: OTHER, descriptionModule briefSummary: To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival., conditionsModule conditions: Thymus Epithelial Tumor, conditions: Proton Radiotherapy, conditions: Radiation Toxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Proton radiotherapy, interventions name: combined platinum based chemotherapy, outcomesModule primaryOutcomes measure: Disease progression-free survival rate, primaryOutcomes measure: Incidence of Treatment-induced Adverse Events, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Cause-specific survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Proton and Heavy Ion Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201513, country: China, contacts name: Jing Li, role: CONTACT, phone: 86-21-38296678, email: jing.li@sphic.org.cn, contacts name: Kun Liu, role: CONTACT, phone: 86-21-38296678, email: kun.liu@sphic.org.cn, contacts name: Jian Chen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jingfang Mao, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kai-liang Wu, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06311955, orgStudyIdInfo id: SPHIC-TR-THLC2023-06, briefTitle: Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-02-28, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Jian Chen, class: OTHER, descriptionModule briefSummary: To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival., conditionsModule conditions: Thymic Epithelial Tumor, conditions: Radiotherapy Side Effect, conditions: Carbon Ion Radiotheray, conditions: Heavy Ion Radiotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Carbon ion radiotherapy, interventions name: combined with platinum-based regimen, outcomesModule primaryOutcomes measure: Disease progression-free survival rate, primaryOutcomes measure: Incidence of Treatment-induced Adverse Events, secondaryOutcomes measure: Local-progression free survival rate, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Cause-specific survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Proton and Heavy Ion Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201513, country: China, contacts name: Jing Li, role: CONTACT, phone: 86-21-38296678, email: jing.li@sphic.org.cn, contacts name: Kun Liu, role: CONTACT, phone: 86-21-38296678, email: kun.liu@sphic.org.cn, contacts name: Jian Chen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jingfang Mao, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kai-liang Wu, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06311942, orgStudyIdInfo id: Precision AT-02, briefTitle: Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chen Xiaoping, class: OTHER, descriptionModule briefSummary: Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored., conditionsModule conditions: HCC, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: HAIC plus PD-1 inhibitors plus lenvatinib, interventions name: PD-1 inhibitors plus lenvatinib, outcomesModule primaryOutcomes measure: DFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311929, orgStudyIdInfo id: Precision AT-01, briefTitle: Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chen Xiaoping, class: OTHER, descriptionModule briefSummary: Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed., conditionsModule conditions: HCC, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: PD-1 monoclonal antibody and lenvatinib, interventions name: PD-1 monoclonal antibody, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311916, orgStudyIdInfo id: Neoadj-Net, briefTitle: Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chen Xiaoping, class: OTHER, descriptionModule briefSummary: Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate., conditionsModule conditions: HCC, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: HAIC + Tirelizumab +lenvatinib +liver resection, interventions name: liver resection, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Safety Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311903, orgStudyIdInfo id: 36264PR430/11/23, briefTitle: Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock., conditionsModule conditions: Norepinephrine, conditions: Hemorrhagic Shock, conditions: Hypotensive Resuscitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Low dose of Norepinephrine (NE), interventions name: High dose of Norepinephrine (NE), outcomesModule primaryOutcomes measure: 24 hours mortality, secondaryOutcomes measure: 28 day mortality, secondaryOutcomes measure: Incidence of acute kidney injury, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Length of intensive care unit stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University, status: RECRUITING, city: Tanta, state: El-Gharbia, zip: 31527, country: Egypt, contacts name: Rabab M Mohamed, MD, role: CONTACT, phone: 00201069122935, email: rabmoh_30@outlook.com, contacts name: Atia G Anwar, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed A Eid, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06311890, orgStudyIdInfo id: 2023XLA141-2, briefTitle: Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Xiyuan Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability., conditionsModule conditions: Acne, conditions: Photodynamic Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: N-chlorin e6 triglumine, interventions name: acne removal surgery, outcomesModule primaryOutcomes measure: Change in Global Acne Grading System (GAGS) Relative to Baseline, otherOutcomes measure: Change in Inflammatory&non-inflammatory Lesion Counts Relative to Baseline, otherOutcomes measure: Change in Acne-specific Quality of Life Assessment Instrument（Qol-Acne）Relative to Baseline, otherOutcomes measure: Change in Numerical Rating Scale(NRS) Relative to Baseline, otherOutcomes measure: Number of participants with abnormalities of Hematological Parameters and Urine Parameters Relative to Baseline, otherOutcomes measure: Change in Adverse Reaction Management Form(AR-MF) Relative to Baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization, status: RECRUITING, city: Beijing, zip: 100091, country: China, contacts name: Huiyan Chi, doctor, role: CONTACT, phone: 13811626953, email: chihuiyan@163.com, contacts name: Yisheng Zhang, doctor, role: CONTACT, phone: 15652386117, email: llleera@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06311877, orgStudyIdInfo id: 6795, briefTitle: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-02-14, completionDateStruct date: 2025-02-14, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, descriptionModule briefSummary: Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia., conditionsModule conditions: Dysgeusia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: mBerry, interventions name: No intervention, outcomesModule primaryOutcomes measure: 5-Point Hedonic Rating Scale, primaryOutcomes measure: Chemotherapy-induced Taste Alteration Scale (CITAS), secondaryOutcomes measure: M.D. Anderson Dysphagia Inventory (MDADI), secondaryOutcomes measure: Functional Oral Intake Scale (FOIS), otherOutcomes measure: Patients weight measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311864, orgStudyIdInfo id: PROxy240215, briefTitle: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: PeriPharm, class: OTHER, collaborators name: Idorsia Pharmaceuticals Ltd., descriptionModule briefSummary: The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia., conditionsModule conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Daridorexant 50 mg, outcomesModule primaryOutcomes measure: Change from Baseline in Quality of Life, primaryOutcomes measure: Change from Baseline in Work Productivity Loss, primaryOutcomes measure: Change from Baseline in the Severity of Insomnia Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PROxy Network, an initiative of PeriPharm inc., city: Montreal, state: Quebec, zip: H2Y 2H4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06311851, orgStudyIdInfo id: PNCC140201, briefTitle: Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Pardis Noor Medical Imaging and Cancer Center, class: OTHER, descriptionModule briefSummary: Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study., conditionsModule conditions: Cancer, conditions: Metastatic Cancer, conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Overall Survival Rate, primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311838, orgStudyIdInfo id: 2023H0244, briefTitle: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country., conditionsModule conditions: Opioid Use Disorder, conditions: Dual Diagnosis, conditions: Housing Problems, conditions: Mental Disorder in Adolescence, conditions: Risk Behavior, conditions: Homelessness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Using a dismantling, randomized controlled design, researchers will examine the singular and combined impact of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) on substance use, mental health and other outcomes (e.g., housing stability, education, employment) with Youth Experiencing Homelessness (YEH) recruited from a local drop-in center., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessors will be blind to intervention condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Motivational Interviewing/Community Reinforcement Approach (MI/CRA), interventions name: Strengths-Based Outreach and Advocacy (SBOA ), interventions name: Services as Usual (SAU), outcomesModule primaryOutcomes measure: Form 90 Substance Use interview, primaryOutcomes measure: Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD), primaryOutcomes measure: Presence of drugs of abuse, primaryOutcomes measure: Beck Depression Inventory II (BDI-II), primaryOutcomes measure: Beck Anxiety Inventory (BAI), primaryOutcomes measure: Short Form-12, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Star House, city: Columbus, state: Ohio, zip: 43201, country: United States, contacts name: Natasha Slesnick, PhD, role: CONTACT, phone: 614-247-8469, email: slesnick.5@osu.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Jodi Ford, PhD, role: CONTACT, phone: 614-292-6862, email: ford.553@osu.edu, contacts name: Natasha Slesnick, PhD, role: CONTACT, phone: (614) 247-8469, email: slesnick.5@osu.edu, contacts name: Jodi Ford, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Natasha Slesnick, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06311825, orgStudyIdInfo id: IstanbulUCDH, briefTitle: The Effect of Horticultural Therapy on Loneliness and Life Satisfaction in Elderly Adults Living in Nursing Home, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Loneliness in elderly individuals increases with age and negatively affects individuals by decreasing life satisfaction. In recent years, horticultural therapy is a type of therapy that has developed and is added routine care of elderly individuals living in nursing homes. Social interaction, life satisfaction, feelings of success and responsibility and increase while loneliness and depression levels decrease through human-nature interaction in horticultural therapy.In our country, no study has been found on the effects of horticultural therapy on physical or mental health in elderly individuals. This research will be conducted as a randomized control group study to examine the effects of horticultural therapy on loneliness and life satisfaction in elderly individuals living in nursing homes., conditionsModule conditions: Horticultural Therapy, conditions: Loneliness, conditions: Satisfaction, Personal, conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two parallel groups randomized control study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Horticultural Therapy, outcomesModule primaryOutcomes measure: Loneliness Scale for Elderly, primaryOutcomes measure: Life Satisfaction Scale, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa (IUC), city: Istanbul, state: Şişli, country: Turkey, contacts name: Hülya Bilgin, PhD, role: CONTACT, phone: 2122244986, phoneExt: 90, email: hulya.bilgin@iuc.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06311812, orgStudyIdInfo id: CREC 2023.683, briefTitle: Retrospective Review on Uterovaginal Anomalies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-02-14, completionDateStruct date: 2025-02-14, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis., conditionsModule conditions: Abnormalities Uterine, conditions: Vaginal Abnormality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of re-stenosis, primaryOutcomes measure: Incidence of re-operation, primaryOutcomes measure: Number of patients with normal menstruation after operation, primaryOutcomes measure: Number of patients with sexual intercourse after operation, primaryOutcomes measure: Number of patients with post-operative infection, primaryOutcomes measure: Number of patients with pregnancy after operation, secondaryOutcomes measure: Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies, secondaryOutcomes measure: Number of participants with Pre-operative factors affecting post-operative outcomes, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06311799, orgStudyIdInfo id: 2024-0102, briefTitle: Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy, acronym: FIMPreg, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Geisinger Clinic, class: OTHER, collaborators name: Family Health Council of Central Pennsylvania (FHCCP), collaborators name: American Heart Association, descriptionModule briefSummary: This study is being done to find out if online references to a food management program for Women, Infants, and Children (WIC) made by doctors will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and have one or more heart-related health risks (high blood pressure, diabetes, or obesity) will be asked to join this study. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their doctor. Group 2 will be sent to WIC by their doctor. Group 3 will get details about WIC from their doctor and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their doctor and a dietitian will talk to them about heart-healthy diets and food management. This study will last about 18 months and will have 200 total subjects joining at about 50 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study team after they are done., conditionsModule conditions: Cardiovascular Diseases, conditions: Obesity, Maternal, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: WIC Referral, interventions name: RDN Referral, outcomesModule primaryOutcomes measure: Difference in WIC enrollment, secondaryOutcomes measure: WIC retention, secondaryOutcomes measure: WIC adherence, secondaryOutcomes measure: Prenatal clinic visit adherence., secondaryOutcomes measure: RDN visit adherence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311786, orgStudyIdInfo id: 257HV107, briefTitle: A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants, acronym: Mass Balance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-05-13, completionDateStruct date: 2024-05-13, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Biogen, class: INDUSTRY, descriptionModule briefSummary: The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-BIIB091, outcomesModule primaryOutcomes measure: Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu), primaryOutcomes measure: Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef), primaryOutcomes measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu), primaryOutcomes measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef), primaryOutcomes measure: Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu), primaryOutcomes measure: Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef), primaryOutcomes measure: Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu), primaryOutcomes measure: Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef), primaryOutcomes measure: Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Apparent Clearance (CL/F) of BIIB091 in Plasma, primaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Urine, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Feces, secondaryOutcomes measure: Cmax of Plasma Metabolite 23 (M23), secondaryOutcomes measure: Tmax of Plasma M23, secondaryOutcomes measure: AUClast of Plasma M23, secondaryOutcomes measure: AUCinf of Plasma M23, secondaryOutcomes measure: t1/2 of Plasma M23, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters, secondaryOutcomes measure: Number of Participants With Clinically Significant Vital Sign Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Physical Examination Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements, secondaryOutcomes measure: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311773, orgStudyIdInfo id: Protocol # 24-01, briefTitle: Pivotal Trial of the Boomerang Catheter for pDVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2029-01-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Aveera Medical, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia., conditionsModule conditions: Chronic Limb-Threatening Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Boomerang Catheter, outcomesModule primaryOutcomes measure: Amputation Free Survival (AFS), secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Limb salvage, secondaryOutcomes measure: Primary patency, secondaryOutcomes measure: Primary assisted patency, secondaryOutcomes measure: Secondary patency, secondaryOutcomes measure: Target wound healing, secondaryOutcomes measure: Complete wound healing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311760, orgStudyIdInfo id: D7700C00001, briefTitle: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-09-24, completionDateStruct date: 2024-09-24, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants., conditionsModule conditions: Healthy Participants Study, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: AZD0292, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events, primaryOutcomes measure: Number of Participants with Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Maximum Observed Drug Concentration (Cmax), secondaryOutcomes measure: Area Under Concentration-Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Area Under Concentration-Time Curve from Time Zero to Infinity (AUCinfinity), secondaryOutcomes measure: Number of Participants with Positive Anti-drug Antibodies (ADAs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21225, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06311747, orgStudyIdInfo id: 24-1T/45, briefTitle: The Effect of Oculomotor Exercises in the Warm-up on Forehand and Backhand Stroke Performance in Tennis Players, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: 30 tennis players aged 12-18, will be included in the study. After their normal warm-up, the participants will make 30 forehand and 30 backhand strokes. Forehand and backhand stroke accuracy rate will be calculated. After a week, additional oculo-motor exercises will be included in the warm-up and the forehand and backhand stroke accuracy rate will be calculated again. The hypothesis that there will be an improvement in forehand and backhand stroke accuracy after oculo-motor exercises will be tested., conditionsModule conditions: Supportive Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Oculo-motor exercises, outcomesModule primaryOutcomes measure: Forehand and backhand stroke accuracy, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ege University Sports Medicine Clinic, status: RECRUITING, city: İzmir, state: Bornova, zip: 35100, country: Turkey, contacts name: Cim CINAR, role: CONTACT, phone: 905375213611, email: cimcinar95@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06311734, orgStudyIdInfo id: LW231-I-01, briefTitle: A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Longwood Biopharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects ., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: LW231 tablets, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants With Adverse Events (AEs), secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of LW231, secondaryOutcomes measure: Time to Cmax (Tmax) of LW231, secondaryOutcomes measure: Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231, secondaryOutcomes measure: Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231, secondaryOutcomes measure: Half-life (t1/2) of LW231, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06311721, orgStudyIdInfo id: 20210033, secondaryIdInfos id: 2023-508336-57, type: EUDRACT_NUMBER, briefTitle: A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2027-10-22, completionDateStruct date: 2027-10-22, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®)., conditionsModule conditions: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 927, type: ESTIMATED, armsInterventionsModule interventions name: ABP 234, interventions name: Pembrolizumab (US), interventions name: Pembrolizumab (EU), outcomesModule primaryOutcomes measure: Objective response (OR), primaryOutcomes measure: Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234, primaryOutcomes measure: AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234, secondaryOutcomes measure: OR, secondaryOutcomes measure: OR, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234, secondaryOutcomes measure: Cmax_dose1 of pembrolizumab (US), secondaryOutcomes measure: Cmax_dose1 of pembrolizumab (EU), secondaryOutcomes measure: Time to maximum concentration following the first dose (tmax_dose1) of ABP 234, secondaryOutcomes measure: Tmax_dose1 of pembrolizumab (US), secondaryOutcomes measure: Tmax_dose1 of pembrolizumab (EU), secondaryOutcomes measure: Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234, secondaryOutcomes measure: Cmax_ss of pembrolizumab (US), secondaryOutcomes measure: Cmax_ss of of pembrolizumab (EU), secondaryOutcomes measure: Time to maximum concentration at steady state (tmax_ss) of ABP 234, secondaryOutcomes measure: Tmax_ss of pembrolizumab (US), secondaryOutcomes measure: Tmax_ss of pembrolizumab (EU), secondaryOutcomes measure: Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234, secondaryOutcomes measure: Ctrough_w4 of pembrolizumab (US), secondaryOutcomes measure: Ctrough_w4 of pembrolizumab (EU), secondaryOutcomes measure: Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234, secondaryOutcomes measure: Ctrough_ss at pre-dose of pembrolizumab (US), secondaryOutcomes measure: Ctrough_ss at pre-dose of pembrolizumab (EU), secondaryOutcomes measure: AUC21d of pembrolizumab (US), secondaryOutcomes measure: AUC21d of pembrolizumab (EU), secondaryOutcomes measure: AUCtau_ss of pembrolizumab (US), secondaryOutcomes measure: AUCtau_ss pembrolizumab (EU), secondaryOutcomes measure: Number of participants who experience a Treatment-emergent adverse event, secondaryOutcomes measure: Number of participants who experience a Treatment-emergent serious adverse event, secondaryOutcomes measure: Number of participants who experience a Treatment-emergent adverse event of interest, secondaryOutcomes measure: Number of participants who experience anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311708, orgStudyIdInfo id: TN-401-0011, briefTitle: Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), acronym: RIDGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-31, primaryCompletionDateStruct date: 2030-03-29, completionDateStruct date: 2030-07-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tenaya Therapeutics, class: INDUSTRY, collaborators name: University of California, San Francisco, collaborators name: Brigham and Women's Hospital, collaborators name: New York University, collaborators name: University of Colorado, Denver, collaborators name: Johns Hopkins University, collaborators name: The Cleveland Clinic, collaborators name: Mayo Clinic, collaborators name: Medical University of South Carolina, collaborators name: Hopital Louis Pradel, collaborators name: Istituti Clinici Scientifici Maugeri SpA, collaborators name: The Queen Elizabeth Hospital, collaborators name: St George's University Hospitals NHS Foundation Trust, collaborators name: Royal Brompton & Harefield NHS Foundation Trust, collaborators name: Barts & The London NHS Trust, descriptionModule briefSummary: This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy., conditionsModule conditions: Arrhythmogenic Right Ventricular Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Investigate the seroprevalence of pre-existing antibodies to AAV9 in patients with PKP2-associated ARVC, secondaryOutcomes measure: To characterize the burden of illness in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To characterize arrhythmic risk in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To evaluate functional status and Quality of Life (QoL) in patients with pathogenic or likely pathogenic PKP2 mutations, secondaryOutcomes measure: To evaluate heart function as assessed by imaging in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: • To monitor biomarkers associated with disease progression and inflammation in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: To evaluate genetics associated with PKP2-associated ARVC, otherOutcomes measure: To evaluate the effect of other cardiac mutations or other genetic variants that might affect the penetrance and/or expressivity of PKP2 mutations in patients with pathogenic or likely pathogenic PKP2 mutations, otherOutcomes measure: To evaluate health care utilization in patients with pathogenic or likely pathogenic PKP2 mutations, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Vasanth Vedantham, MD, PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of Colorado, Denver, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Matthew Taylor, MD, PhD, role: CONTACT, geoPoint lat: 39.72943, lon: -104.83192, locations facility: John Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Hugh G Calkins, MD, role: CONTACT, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Neal Lakdawala, MD, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: John Giudicessi, MD PhD, role: CONTACT, geoPoint lat: 44.02163, lon: -92.4699, locations facility: New York University, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Larry Chinitz, MD, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Wai Hong Wilson Tang, MD, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Medical University of South Carolina, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Daniel Judge, MD, role: CONTACT, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Hopital Louis Pradel, status: RECRUITING, city: Bron, country: France, contacts name: Philippe Chevalier, MD, PhD, role: CONTACT, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Istituti Clinici Scientifici Maugeri SpA, status: RECRUITING, city: Pavia, country: Italy, contacts name: Silvia Priori, MD, PhD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: The Queen Elizabeth Hospital, status: RECRUITING, city: Glasgow, zip: G514TF, country: United Kingdom, contacts name: Caroline Coats, MD, role: CONTACT, geoPoint lat: 55.86515, lon: -4.25763, locations facility: Barts & The London Health NHS Trust, status: RECRUITING, city: London, zip: E1 1BB, country: United Kingdom, contacts name: Perry Elliott, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St. George's University Hospitals NHS Foundation Trust, status: RECRUITING, city: London, zip: SW17 0QT, country: United Kingdom, contacts name: Elijah Behr, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Brompton & Harefield NHS Foundation Trust, status: RECRUITING, city: London, zip: SW3 6NP, country: United Kingdom, contacts name: Antonio Pantazis, MD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06311695, orgStudyIdInfo id: IEO 960, briefTitle: Contrast-Enhanced Spectral Mammography (CESM), acronym: CESM, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-02-28, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM), considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB)., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 325, type: ACTUAL, armsInterventionsModule interventions name: Contrast Enhanced Mammography, outcomesModule primaryOutcomes measure: Evaluation of negative predictive value (NPV) of the CEM, secondaryOutcomes measure: Evaluation of sensitivity of CEM, secondaryOutcomes measure: Evaluation of specificity of CEM, secondaryOutcomes measure: Positive Predictive Value (PPV) of CEM, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS, city: Milan, zip: 20141, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06311682, orgStudyIdInfo id: LP0162-1336, secondaryIdInfos id: U1111-1285-6559, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-503630-44, type: OTHER, domain: European Medicines Agency (EMA), briefTitle: A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis, acronym: TRAPEDS 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-24, primaryCompletionDateStruct date: 2026-03-26, completionDateStruct date: 2028-04-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: LEO Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design is parallel for children and a single group for infants., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: For subjects aged 2 to \<12 years at screening, the trial is double-blind to ensure an objective evaluation of efficacy and safety of the Investigational Medicinal Product (IMP). The subject, the subject's caregiver(s), and the investigator involved in the clinical evaluation and monitoring of the subjects will not be aware of the treatment from baseline to Week 16. However, the site staff that responsible for administering tralokinumab will be aware of the treatment allocation as tralokinumab is visibly different from placebo and has a higher viscosity, requiring more pressure to depress the plunger during injections., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: Tralokinumab + TCS, interventions name: Placebo + TCS, outcomesModule primaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening., primaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in affected BSA in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in affected BSA in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening., secondaryOutcomes measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening., secondaryOutcomes measure: Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening., secondaryOutcomes measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of TCS free days in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Number of TCS free days in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311669, orgStudyIdInfo id: 29409010104798, briefTitle: Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions, conditionsModule conditions: Nonthrombotic Iliac Vein Lesions, conditions: Pelvic Congestive Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: iliac vein stenting, interventions name: pelvic vein embolization, outcomesModule primaryOutcomes measure: Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ainshams University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06311656, orgStudyIdInfo id: 18840, secondaryIdInfos id: J5C-MC-FOAA, type: OTHER, domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, briefTitle: A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, class: INDUSTRY, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: LY4100511 (DC-853), interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs), secondaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853), secondaryOutcomes measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Altasciences Clinical Los Angeles, Inc, city: Cypress, state: California, zip: 90630, country: United States, geoPoint lat: 33.81696, lon: -118.03729, hasResults: False
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protocolSection identificationModule nctId: NCT06311643, orgStudyIdInfo id: 35, briefTitle: Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: Effect of massage on hormone levels in puerperal women, conditionsModule conditions: Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, maskingDescription: the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Postpartum back massage in study group, outcomesModule primaryOutcomes measure: Leptin and prolactin levels increase, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kafrelshiekh university, city: Kafrelshiekh, zip: 6850001, country: Egypt, hasResults: False
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protocolSection identificationModule nctId: NCT06311630, orgStudyIdInfo id: 65/23/IEC/JMMC&RI, briefTitle: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block vs FEMORAL BLOCK in Hip Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-20, primaryCompletionDateStruct date: 2025-01-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Jubilee Mission Medical College and Research Institute, class: OTHER, descriptionModule briefSummary: To study the analgesic effect of ultrasound guided PENG Block vs Femoral nerve block in patients with Hip fracture presenting to Emergency department, conditionsModule conditions: Hip Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, outcomesModule primaryOutcomes measure: Comparative Study of Analgesic Effect of Ultrasound Guided PENG Block With FEMORAL NERVE BLOCK in Patients With Hip Fracture as assessed by NRS pain scoring scale by patient, secondaryOutcomes measure: Time taken for each technique, secondaryOutcomes measure: Time taken for adequate analgesia, secondaryOutcomes measure: Incidence of complications, secondaryOutcomes measure: To note if rescue analgesic is required, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jubilee mission medical College and research centre, status: RECRUITING, city: Thrissur, state: Kerala, zip: 680005, country: India, contacts name: Jogi Varghese, MBBS, role: CONTACT, phone: 9947004222, email: jogi1907@gmail.com, geoPoint lat: 10.51667, lon: 76.21667, hasResults: False
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protocolSection identificationModule nctId: NCT06311617, orgStudyIdInfo id: 231592, briefTitle: Retinal Vascular Changes During Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes., conditionsModule conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Fundus photography and optical coherence tomography, outcomesModule primaryOutcomes measure: Imaging Biomarkers: Choroid, primaryOutcomes measure: Imaging Biomarkers: Vessel density, primaryOutcomes measure: Imaging Biomarkers: Foveal avascular zone (FAZ), secondaryOutcomes measure: Fetal Health: delivery, secondaryOutcomes measure: Fetal Health, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Avni Finn, MD, MBA, role: CONTACT, phone: 615-936-1639, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
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protocolSection identificationModule nctId: NCT06311604, orgStudyIdInfo id: 38RC22.0272, briefTitle: Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients, acronym: IsoSAFE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (\> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label, single-centre, interventional dose escalation study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Isoflurane, outcomesModule primaryOutcomes measure: To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients, secondaryOutcomes measure: To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma, secondaryOutcomes measure: To assess the neurological outcome at D28 after inhaled sedation in head trauma patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Grenoble, city: Grenoble, state: Choisir Une Région, zip: 38043, country: France, contacts name: barthélémy H Grenoble, MD, role: CONTACT, phone: +33476766879, email: bbertrand4@chu-grenoble.fr, contacts name: Anais ADOLLE, role: CONTACT, phone: +33476766879, email: aadolle@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False
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protocolSection identificationModule nctId: NCT06311591, orgStudyIdInfo id: STUDY00000716 Part B, secondaryIdInfos id: 1P50MH129701, type: NIH, link: https://reporter.nih.gov/quickSearch/1P50MH129701, briefTitle: Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B, acronym: Jaspr-PartB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: Ohio State University, collaborators name: University of Colorado, Denver, collaborators name: Evidence-Based Practice Institute, Seattle, WA, collaborators name: National Institute of Mental Health (NIMH), collaborators name: Worcester Polytechnic Institute, descriptionModule briefSummary: This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used, conditionsModule conditions: Suicidal Ideation, conditions: Suicide Attempt, conditions: Self Harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 27908, type: ESTIMATED, armsInterventionsModule interventions name: Jaspr App, outcomesModule primaryOutcomes measure: Suicide composite, binary, otherOutcomes measure: Evidence-Based Practice (EBP) delivery, otherOutcomes measure: Patient reach, otherOutcomes measure: Fidelity, otherOutcomes measure: Exposure, Time, otherOutcomes measure: Costs, otherOutcomes measure: Clinician acceptability, otherOutcomes measure: Patient acceptability, otherOutcomes measure: Feasibility of Jaspr in ED, otherOutcomes measure: Usability (clinician), otherOutcomes measure: System workflow impact, door to behavioral health evaluation, otherOutcomes measure: System workflow impact, total length of stay, otherOutcomes measure: System workflow impact, 28 day revisit, otherOutcomes measure: System workflow impact, clinician perception, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCHealth University of Colorado Hospital, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Marian Betz, MD, role: CONTACT, email: marian.betz@cuanschutz.edu, geoPoint lat: 39.72943, lon: -104.83192, locations facility: UCHealth Memorial Hospital Central, city: Colorado Springs, state: Colorado, zip: 80909, country: United States, contacts name: Marian Betz, MD, role: CONTACT, email: marian.betz@cuanschutz.edu, geoPoint lat: 38.83388, lon: -104.82136, locations facility: Ohio State East Hospital, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Michael S Lyons, MD, role: CONTACT, email: michael.lyons@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: The Ohio State University Wexner Medical Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Michael S Lyons, MD, role: CONTACT, email: michael.lyons@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06311578, orgStudyIdInfo id: 87704916LUC1001, secondaryIdInfos id: 2023-506495-27-00, type: REGISTRY, domain: EUCT number, briefTitle: A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2028-11-08, completionDateStruct date: 2033-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Johnson & Johnson Enterprise Innovation Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: JNJ-87704916, interventions name: Cetrelimab, outcomesModule primaryOutcomes measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT), primaryOutcomes measure: Number of Participants with Adverse Events (AEs) by Severity, secondaryOutcomes measure: Parts 1 and 2: Percentage of Participants With Objective Response (OR), secondaryOutcomes measure: Parts 1 and 2: Percentage of Participants With Disease Control (DC), secondaryOutcomes measure: Parts 1 and 2: Duration of Response (DOR), secondaryOutcomes measure: Part 2: Progression Free Survival (PFS), secondaryOutcomes measure: Part 2: Overall Survival (OS), secondaryOutcomes measure: Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter, secondaryOutcomes measure: Parts 1 and 2: Payload Concentrations of JNJ-87704916, secondaryOutcomes measure: Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06311565, orgStudyIdInfo id: SBU-ISTANBUL-0001, briefTitle: Effects of Education After Colorectal Cancer Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istanbul Saglik Bilimleri University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group., conditionsModule conditions: Healthy Lifestyle, conditions: Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled ( experimental and control group), primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Colorectal cancer screening attitude belief scale, primaryOutcomes measure: Healthy lifestyle behaviors scale II, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hilal KARTAL, city: Istanbul, state: Beylikdüzü, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06311552, orgStudyIdInfo id: 0856, briefTitle: Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations., acronym: OPTMISE-HFpEF, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-31, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Leicester, class: OTHER, descriptionModule briefSummary: The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner, outcomesModule primaryOutcomes measure: To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper)., secondaryOutcomes measure: To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study, secondaryOutcomes measure: To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group., secondaryOutcomes measure: To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Glenfield Hospital, city: Leicester, country: United Kingdom, geoPoint lat: 52.6386, lon: -1.13169, hasResults: False
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protocolSection identificationModule nctId: NCT06311539, orgStudyIdInfo id: IstanbulBUFC4, briefTitle: The Effect of Circadian Rhythm on Physical Performance in Healthy Male Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals., conditionsModule conditions: Chronotype, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Study, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, maskingDescription: The evaluator who will perform isokinetic assessments and vertical jump measurements will be blinded to the participants' chronotype., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Theraband Strengthening Exercise Program, outcomesModule primaryOutcomes measure: Isokinetic strength test, primaryOutcomes measure: Vertical jump test, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311526, orgStudyIdInfo id: 24C303, briefTitle: Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study, acronym: SASHA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking.There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure.Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session.When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed.On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity).On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity.To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity.Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits?Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke.Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits.Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity).This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity).Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones).Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment.If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds.On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment., conditionsModule conditions: Stroke, conditions: Hemiparesis, conditions: Hemiplegia, conditions: Spasticity as Sequela of Stroke, conditions: Upper Limb Hypertonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal Shockwave Therapy, outcomesModule primaryOutcomes measure: M wave and H reflex recruitment curve, primaryOutcomes measure: H reflex post-activation depression, primaryOutcomes measure: F waves, primaryOutcomes measure: T reflex, secondaryOutcomes measure: Upper limb dexterity measures, secondaryOutcomes measure: Ultrasound arm and forearm assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milano, state: MI, zip: 20122, country: Italy, contacts name: Antonio Caronni, MD, PhD, role: CONTACT, phone: 02 619111, email: a.caronni@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06311513, orgStudyIdInfo id: 2023-1017, secondaryIdInfos id: 1177535, type: OTHER_GRANT, domain: Arthritis Foundation, briefTitle: Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hospital for Special Surgery, New York, class: OTHER, collaborators name: Emory University, collaborators name: Arthritis Foundation, descriptionModule briefSummary: The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects., conditionsModule conditions: Anterior Cruciate Ligament Injuries, conditions: Post-Traumatic Osteoarthritis of Knee, conditions: Bone Marrow Aspirate Concentrate, conditions: ACL Injury, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a single-blinded randomized controlled trial. Participants will be allocated to either:1. Investigational arm (Revision ACLR + cBMA)2. Control arm (Revision ACLR + Sham Incision), primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Concentrated Bone Marrow Aspirate Injection, interventions name: Sham Incision, interventions name: Revision Anterior Cruciate Ligament Reconstruction, outcomesModule primaryOutcomes measure: Change from baseline in patient reported knee pain, secondaryOutcomes measure: Expression of local inflammatory biomarkers, secondaryOutcomes measure: Concentration of circulating inflammatory biomarkers, secondaryOutcomes measure: Change from baseline in cartilage morphology, secondaryOutcomes measure: Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Emory Orthopaedics & Spine Center, city: Atlanta, state: Georgia, zip: 30097, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Hospital for Special Surgery, city: New York, state: New York, zip: 10021, country: United States, contacts name: Daniel de la Huerta, MD, role: CONTACT, phone: 212-606-1000, phoneExt: 2603159, email: delahuertamezad@hss.edu, contacts name: Miguel Otero, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06311500, orgStudyIdInfo id: STUDY00151143, briefTitle: Sleep Health Enhancement in Midlife Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: Despite the strong links between sleep and AD, a sleep health enhancement has yet to be targeted in mid-life adults (45-64 years old) to delay or prevent AD. An intervention aimed at enhancing sleep health is a critical opportunity for primary prevention to potentially delay the onset of AD. The objective of the proposed study is to develop and assess the feasibility, acceptability, and treatment effect of a comprehensive sleep health intervention (SHI) on improving sleep health in mid-life adults, conditionsModule conditions: Sleep Health, conditions: Midlife Adults, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Sleep health enhancement intervention, outcomesModule primaryOutcomes measure: 6-item Acceptability Scale, primaryOutcomes measure: Qualitative interview, primaryOutcomes measure: Ru-SATED Composite score, primaryOutcomes measure: Sleep Self-Efficacy Scale, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Epworth Sleepiness Scale, primaryOutcomes measure: Dysfunctional Beliefs About Sleep (DBAS-10) consists of 10 statements reflecting beliefs and attitudes about sleep. Each statement is rated from 1 = strongly disagree to 10 = strongly agree, primaryOutcomes measure: Positive Affect and Negative Affect Schedule, primaryOutcomes measure: Continuous Performance Test, primaryOutcomes measure: Stroop Test, primaryOutcomes measure: Cognitive Failures Questionnaire, primaryOutcomes measure: Actigraphy, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, status: RECRUITING, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
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protocolSection identificationModule nctId: NCT06311487, orgStudyIdInfo id: 23-1388, secondaryIdInfos id: 1R56DK136601-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R56DK136601-01, briefTitle: Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study), acronym: TANDEM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: This study plans to learn more about metabolic responses to aerobic exercise at different times of the day (morning or evening) under fasting versus fed conditions., conditionsModule conditions: Overweight and Obesity, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fasted-AM, interventions name: Fed-AM, interventions name: Fasted-PM, interventions name: Fed-PM, outcomesModule primaryOutcomes measure: Exercise Energy Expenditure (kcals), primaryOutcomes measure: Substrate Oxidation (Respiratory Quotient), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Justin Lorentzen, BHS, role: CONTACT, phone: 303-724-3685, email: justin.lorentzen@cuanschutz.edu, contacts name: Shelby Panter, MS, role: CONTACT, phone: 303-724-3202, email: shelby.panter@cuanschutz.edu, contacts name: Seth Creasy, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
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protocolSection identificationModule nctId: NCT06311474, orgStudyIdInfo id: W81XWH-22-1-0250, briefTitle: Remote Assessment and Intervention for Behavior Problems in Kids With TSC, acronym: RAINBOW, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems., conditionsModule conditions: Tuberous Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The clinical trial portion of this study uses a waitlist control design with random assignment to group. Randomization is stratified by age (3-4 years old, 5-6 years old)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessments will be performed by assessors who are blind to group status. Investigators will be kept blind to study outcomes until data collection for the primary outcome is complete., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Parent-Child Interaction Therapy (PCIT), outcomesModule primaryOutcomes measure: Eyberg Child Behavior Inventory (ECBI), secondaryOutcomes measure: Behavior Assessment Scale for Children-3rd Edition (BASC-3), secondaryOutcomes measure: Vineland Adaptive Behavior Scales-3rd Edition (Vineland-3), secondaryOutcomes measure: Parenting Stress Index-4th Edition-Short Form (PSI-4-SF), secondaryOutcomes measure: Dyadic Parent-Child Interaction Coding System (DPICS), secondaryOutcomes measure: Therapy Attitude Index (TAI), secondaryOutcomes measure: Telehealth Usability Questionnaire (TUQ), secondaryOutcomes measure: Aberrant Behavior Checklist (ABC), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California, Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Viviana Rodriguez, role: CONTACT, phone: 424-326-3118, email: vivianarodriguez@mednet.ucla.edu, contacts name: Nicole McDonald, role: CONTACT, phone: 310-825-3251, email: nmcdonald@mednet.ucla.edu, contacts name: Nicole McDonald, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06311461, orgStudyIdInfo id: 22-001111, briefTitle: Effects of Acupuncture on Symptoms of Stable Angina, acronym: EASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, collaborators name: University of Illinois at Chicago, descriptionModule briefSummary: The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina.This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantageParticipants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (\~7.5-10 hrs.).The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes., conditionsModule conditions: Angina, Stable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, interventions name: Attention control, outcomesModule primaryOutcomes measure: Pain Now, primaryOutcomes measure: Worst Pain, primaryOutcomes measure: Least Pain, primaryOutcomes measure: Acute Coronary Syndrome like symptoms (ACS Symptom Checklist), primaryOutcomes measure: Anginal Pain (Seattle Angina Questionnaire-7), primaryOutcomes measure: Number of Angina Attacks (From American Heart Association Angina Log), primaryOutcomes measure: Symptom Triggers (From American Heart Association Angina Log), primaryOutcomes measure: Pain from Angina Attack (From American Heart Association Angina Log), primaryOutcomes measure: Length of Angina Attack (American Heart Association Angina Log), primaryOutcomes measure: Self-treatment for Symptoms (From American Heart Association Angina Log), secondaryOutcomes measure: Functional Status Related to Angina (Seattle Angina Questionnaire-7), secondaryOutcomes measure: General Functional Status (PROMIS 29v.2), secondaryOutcomes measure: Quality of Life (Seattle Angina Questionnaire-7), secondaryOutcomes measure: Use of Nitrates and Analgesics (AHA Angina log), secondaryOutcomes measure: Patient Reported Outcomes (Patient Reported Outcomes Measurement Information System-29v.2, secondaryOutcomes measure: Healthcare Utilization, secondaryOutcomes measure: Ischemia on Electrocardiogram (ECG), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311448, orgStudyIdInfo id: 10094, briefTitle: Personalized Targeted Immunomodulation in COVID-19 ARDS, acronym: COMODULATE, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-02, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2022-02-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Amsterdam UMC, collaborators name: Leiden University Medical Center, collaborators name: St. Antonius Hospital, descriptionModule briefSummary: Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.* Identify immunological pathways which are associated with outcome in C-ARDS.* Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).* Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.Study type: Retrospective observational multicenter study in the Netherlands.Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.Intervention (if applicable): Not applicable (retrospective study design).Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19., conditionsModule conditions: COVID-19 Acute Respiratory Distress Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 164, type: ACTUAL, armsInterventionsModule interventions name: Single target immunomodulation, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Mortality up to day 90, primaryOutcomes measure: Change in SOFA score, primaryOutcomes measure: Ventilator free days, primaryOutcomes measure: Change in biomarker values, primaryOutcomes measure: Costs of immmunomodulation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Centre, city: Rotterdam, state: Zuid-Holland, zip: 3015 GD, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06311435, orgStudyIdInfo id: FBB-RNA-004, briefTitle: Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: MaxWell Clinic, PLC, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to determine, in unblinded samples, whether artificial intelligence can classify specific blood RNA from patients with long COVID together and separately from apparently healthy normals and other medical conditions which share signs and symptoms of long COVID., conditionsModule conditions: Long COVID, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be placed into one of eleven possible cohorts based on their presenting complaints., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Patients will be assigned a random number from the electronic health record. The only information shared with the sponsor will be Pt ID number, age, gender and state of residence., whoMasked: PARTICIPANT, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: RNA Biomarker Blood Test, outcomesModule primaryOutcomes measure: Artificial Intelligence Identified number of RNA Biomarkers for Long COVID, secondaryOutcomes measure: Artificial Intelligence Identified number of RNA Biomarkers for specific Long COVID subgroups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The MaxWell Clinic, status: RECRUITING, city: Brentwood, state: Tennessee, zip: 37027, country: United States, contacts name: Justin Davis, role: CONTACT, phone: 615-370-0091, email: Justin@maxwellclinic.com, contacts name: Cale T Queen, PhD, role: CONTACT, phone: 16153700091, email: cale@maxwellclinic.com, contacts name: David H Haase, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.03312, lon: -86.78278, locations facility: The MaxWell Clinic, status: RECRUITING, city: Brentwood, state: Tennessee, zip: 37027, country: United States, contacts name: Justin Davis, role: CONTACT, phone: 615-370-0091, email: justin@maxwellclinic.com, contacts name: Cale T Queen, PhD., role: CONTACT, phone: 6153700091, email: cale@maxwellclinic.com, contacts name: David H Haase, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.03312, lon: -86.78278, hasResults: False
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protocolSection identificationModule nctId: NCT06311422, orgStudyIdInfo id: CAD/CAM-endocrown, briefTitle: A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-03-15, primaryCompletionDateStruct date: 2023-03-15, completionDateStruct date: 2028-09-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test., conditionsModule conditions: Endodontically Treated Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: resin nanoceramic block, interventions name: zirconia-reinforced lithium silicate, outcomesModule primaryOutcomes measure: Clinical performance of two materials, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University Faculty of Dentistry, city: Ankara, zip: 06060, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06311409, orgStudyIdInfo id: SMFS2019, briefTitle: Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-29, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage. From October 2014 to date, a study has been conducted for the linguistic-cultural validation of the Humpty Dumpty Fall Scale (HDFS) in the Italian context, through a multicentre survey with the help of the Clinical Risk Management Group of the Region of Tuscany.The objective of this study is the validation of the new Humpty Dumpty Fall Scale defined as Speedy Meyer-Fall Scale (SMFS) by assessing the comprehension and validity of the scale and items via Content Validity Index (SCVI and ICVI) estimation of inter-item reliability (Crombach's alpha), inter-rater reliability (Cohen's K), sensitivity, specificity, PPV, NPV and ROC curve., conditionsModule conditions: Fall Prevention, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 332, type: ESTIMATED, outcomesModule primaryOutcomes measure: validation of the SMFS t, secondaryOutcomes measure: identification of patients high risk of falls, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: AUSL Toscana Sud Est, status: NOT_YET_RECRUITING, city: Arezzo, zip: 51100, country: Italy, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Daniele Ciofi, role: CONTACT, email: daniele.ciofi@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Fondazione Gabriele monasterio - Ospedale Pediatrico Apuano Massa, status: NOT_YET_RECRUITING, city: Massa, country: Italy, geoPoint lat: 44.03541, lon: 10.13927, hasResults: False
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protocolSection identificationModule nctId: NCT06311396, orgStudyIdInfo id: REVEAL, briefTitle: Development of a Neuronal Microscope, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes mellitus., conditionsModule conditions: Hepatic Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: genetic model, outcomesModule primaryOutcomes measure: Isolation of epithelial cells, primaryOutcomes measure: Omics studies and functional morphological studies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, status: RECRUITING, city: Milan, state: Milano, zip: 20122, country: Italy, contacts name: Luca Vittorio Carlo Valenti, role: CONTACT, phone: 02 5503 6595, phoneExt: 56595, email: luca.valenti@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-12-09, uploadDate: 2024-03-08T10:03, filename: Prot_SAP_000.pdf, size: 2182994, hasResults: False
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protocolSection identificationModule nctId: NCT06311383, orgStudyIdInfo id: CLEE011ADE03, briefTitle: A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment, acronym: RIBANNA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2017-10-09, primaryCompletionDateStruct date: 2025-02-16, completionDateStruct date: 2025-02-16, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer treated with one of the following 1st line treatments: Ribociclib + AI/FUL, or endocrine monotherapy, or chemotherapy, conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2610, type: ACTUAL, armsInterventionsModule interventions name: First-line Ribociclib + endocrine therapy, interventions name: First-line endocrine therapy, interventions name: First-line chemtherapy, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Cox proportional hazard regression for progression free survival in 1st line therapy, secondaryOutcomes measure: Propensity Score matching for progression free survival in 1st line therapy, secondaryOutcomes measure: Sequential progression-free survival (PFS_S), secondaryOutcomes measure: Conditional progression-free survival, secondaryOutcomes measure: Time to treatment failure (TTF), secondaryOutcomes measure: Time to first chemotherapy, secondaryOutcomes measure: Time to next treatment / therapy (TTNT) after 1st line treatment, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Dose reduction, secondaryOutcomes measure: Dose interruption, secondaryOutcomes measure: Discontinuations, secondaryOutcomes measure: Adherence - MMAS-8 questionnaire, secondaryOutcomes measure: Number of participants with mutations, secondaryOutcomes measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-C30, secondaryOutcomes measure: Quality of life for specific cohorts and treatment lines - EORTC QLQ-B23, secondaryOutcomes measure: Quality of life for specific cohorts and treatment lines - HADS-D, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis Investigative Site, city: Freudenstadt, state: Baden Wuerttemberg, zip: 72250, country: Germany, geoPoint lat: 48.46695, lon: 8.41371, locations facility: Novartis Investigative Site, city: Karlsruhe, state: Baden Wuerttemberg, zip: 76199, country: Germany, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Novartis Investigative Site, city: Mannheim, state: Baden Wuerttemberg, zip: 68165, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Novartis Investigative Site, city: Nuertingen, state: Baden Wuerttemberg, zip: 72622, country: Germany, locations facility: Novartis Investigative Site, city: Reutlingen, state: Baden Wuerttemberg, zip: 72764, country: Germany, geoPoint lat: 48.49144, lon: 9.20427, locations facility: Novartis Investigative Site, city: Winnenden, state: Baden Wuerttemberg, zip: 71364, country: Germany, geoPoint lat: 48.87563, lon: 9.39819, locations facility: Novartis Investigative Site, city: Ostfildern, state: Baden Württemberg, zip: 73760, country: Germany, geoPoint lat: 48.72704, lon: 9.24954, locations facility: Novartis Investigative Site, city: Baden-Baden, state: Baden-Wuerttemberg, zip: 76532, country: Germany, geoPoint lat: 48.7606, lon: 8.23975, locations facility: Novartis Investigative Site, city: Mutlangen, state: Baden-Wuerttemberg, zip: 73557, country: Germany, geoPoint lat: 48.82588, lon: 9.79714, locations facility: Novartis Investigative Site, city: Rottweil, state: Baden-Wuerttemberg, zip: 78628, country: Germany, geoPoint lat: 48.16783, lon: 8.62719, locations facility: Novartis Investigative Site, city: Schwaebisch, state: Baden-Wuerttemberg, zip: 74523, country: Germany, locations facility: Novartis Investigative Site, city: Sigmaringen, state: Baden-Wuerttemberg, zip: 72488, country: Germany, geoPoint lat: 48.08829, lon: 9.23033, locations facility: Novartis Investigative Site, city: Augsburg, state: Bavaria, zip: 86152, country: Germany, geoPoint lat: 48.37154, lon: 10.89851, locations facility: Novartis Investigative Site, city: Bamberg, state: Bavaria, zip: 96052, country: Germany, geoPoint lat: 49.89873, lon: 10.90067, locations facility: Novartis Investigative Site, city: Muenchen, state: Bavaria, zip: 80639, country: Germany, geoPoint lat: 51.60698, lon: 13.31243, locations facility: Novartis Investigative Site, city: Altoetting, state: Bayern, zip: 84503, country: Germany, locations facility: Novartis Investigative Site, city: Amberg, state: Bayern, zip: 92224, country: Germany, geoPoint lat: 49.44287, lon: 11.86267, locations facility: Novartis Investigative Site, city: Ansbach, state: Bayern, zip: 91522, country: Germany, geoPoint lat: 49.30481, lon: 10.5931, locations facility: Novartis Investigative Site, city: Aschaffenburg, state: Bayern, zip: 63739, country: Germany, geoPoint lat: 49.97704, lon: 9.15214, locations facility: Novartis Investigative Site, city: Bayreuth, state: Bayern, zip: 95445, country: Germany, geoPoint lat: 49.94782, lon: 11.57893, locations facility: Novartis Investigative Site, city: Ebersberg, state: Bayern, zip: 85560, country: Germany, geoPoint lat: 48.0771, lon: 11.97063, locations facility: Novartis Investigative Site, city: Landshut, state: Bayern, zip: 84036, country: Germany, geoPoint lat: 48.52961, lon: 12.16179, locations facility: Novartis Investigative Site, city: Muenchen, state: Bayern, zip: 81241, country: Germany, geoPoint lat: 51.60698, lon: 13.31243, locations facility: Novartis Investigative Site, city: Muenchen, state: Bayern, zip: 81925, country: Germany, geoPoint lat: 51.60698, lon: 13.31243, locations facility: Novartis Investigative Site, city: Nuernberg, state: Bayern, zip: 90409, country: Germany, geoPoint lat: 49.45421, lon: 11.07752, locations facility: Novartis Investigative Site, city: Regensburg, state: Bayern, zip: 93053, country: Germany, geoPoint lat: 49.01513, lon: 12.10161, locations facility: Novartis Investigative Site, city: Rosenheim, state: Bayern, zip: 83022, country: Germany, geoPoint lat: 47.85637, lon: 12.12247, locations facility: Novartis Investigative Site, city: Straubing, state: Bayern, zip: 94315, country: Germany, geoPoint lat: 48.88126, lon: 12.57385, locations facility: Novartis Investigative Site, city: Wuerzburg, state: Bayern, zip: 97070, country: Germany, geoPoint lat: 49.79391, lon: 9.95121, locations facility: Novartis Investigative Site, city: Mannheim, state: Beden Wuerttenberg, zip: 68167, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Novartis Investigative Site, city: Brandenburg A D Havel, state: Brandenburg, zip: 14770, country: Germany, locations facility: Novartis Investigative Site, city: Doberlug Kirchhain, state: Brandenburg, zip: 03253, country: Germany, geoPoint lat: 51.62578, lon: 13.56232, locations facility: Novartis Investigative Site, city: Fuerstenwalde, state: Brandenburg, zip: 15517, country: Germany, locations facility: Novartis Investigative Site, city: Ludwigsfelde, state: Brandenburg, zip: 14974, country: Germany, geoPoint lat: 52.30322, lon: 13.25405, locations facility: Novartis Investigative Site, city: Neu-Brandenburg, state: Brandenburg, zip: 17036, country: Germany, locations facility: Novartis Investigative Site, city: Spremberg, state: Brandenburg, zip: 03130, country: Germany, geoPoint lat: 51.56971, lon: 14.37355, locations facility: Novartis Investigative Site, city: Bremerhaven, state: Bremen, zip: 27576, country: Germany, geoPoint lat: 53.55021, lon: 8.57673, locations facility: Novartis Investigative Site, city: Bayern, state: Donauworth, zip: 86609, country: Germany, geoPoint lat: 47.795, lon: 12.53381, locations facility: Novartis Investigative Site, city: Baden-Württemberg, state: Heidenheim a.d.B, zip: 89522, country: Germany, locations facility: Novartis Investigative Site, city: Bad Homburg, state: Hessen, zip: 61352, country: Germany, geoPoint lat: 50.22683, lon: 8.61816, locations facility: Novartis Investigative Site, city: Bad Nauheim, state: Hessen, zip: 61231, country: Germany, geoPoint lat: 50.36463, lon: 8.73859, locations facility: Novartis Investigative Site, city: Darmstadt, state: Hessen, zip: 64283, country: Germany, geoPoint lat: 49.87167, lon: 8.65027, locations facility: Novartis Investigative Site, city: Erbach, state: Hessen, zip: 64711, country: Germany, geoPoint lat: 49.66148, lon: 8.99402, locations facility: Novartis Investigative Site, city: Langen, state: Hessen, zip: 63225, country: Germany, geoPoint lat: 49.98955, lon: 8.66852, locations facility: Novartis Investigative Site, city: Lich, state: Hessen, zip: 35423, country: Germany, geoPoint lat: 50.52085, lon: 8.81567, locations facility: Novartis Investigative Site, city: Marburg, state: Hessen, zip: 35043, country: Germany, geoPoint lat: 50.80904, lon: 8.77069, locations facility: Novartis Investigative Site, city: Arnsberg Huesten, state: Hochsauerland, zip: 59759, country: Germany, locations facility: Novartis Investigative Site, city: Twistringen, state: Lower Saxony, zip: 27239, country: Germany, geoPoint lat: 52.79926, lon: 8.64163, locations facility: Novartis Investigative Site, city: Rostock, state: Mecklenburg Vorpommern, zip: 18057, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, locations facility: Novartis Investigative Site, city: Schwerin, state: Mecklenburg Vorpommern, zip: 19059, country: Germany, geoPoint lat: 53.62937, lon: 11.41316, locations facility: Novartis Investigative Site, city: Stralsund, state: Mecklenburg Vorpommern, zip: 18435, country: Germany, geoPoint lat: 54.30911, lon: 13.0818, locations facility: Novartis Investigative Site, city: Braunschweig, state: Niedersachsen, zip: 38100, country: Germany, geoPoint lat: 52.26594, lon: 10.52673, locations facility: Novartis Investigative Site, city: Buchholz, state: Niedersachsen, zip: 21244, country: Germany, geoPoint lat: 53.00884, lon: 9.56287, locations facility: Novartis Investigative Site, city: Damme, state: Niedersachsen, zip: 49401, country: Germany, geoPoint lat: 52.52157, lon: 8.19793, locations facility: Novartis Investigative Site, city: Georgsmarienhuette, state: Niedersachsen, zip: 49124, country: Germany, locations facility: Novartis Investigative Site, city: Hameln, state: Niedersachsen, zip: 31785, country: Germany, geoPoint lat: 52.10397, lon: 9.35623, locations facility: Novartis Investigative Site, city: Hannover, state: Niedersachsen, zip: 30171, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Novartis Investigative Site, city: Lingen, state: Niedersachsen, zip: 49808, country: Germany, geoPoint lat: 52.52143, lon: 7.31845, locations facility: Novartis Investigative Site, city: Osnabrueck, state: Niedersachsen, zip: 49076, country: Germany, locations facility: Novartis Investigative Site, city: Quedlinburg, state: Niedersachsen, zip: 06484, country: Germany, geoPoint lat: 51.78843, lon: 11.15006, locations facility: Novartis Investigative Site, city: Westerstede, state: Niedersachsen, zip: 26655, country: Germany, geoPoint lat: 53.25682, lon: 7.92737, locations facility: Novartis Investigative Site, city: Wolfenbuettel, state: Niedersachsen, zip: 38304, country: Germany, locations facility: Novartis Investigative Site, city: Bergisch Gladbach, state: Nordrhein Westfalen, zip: 51465, country: Germany, geoPoint lat: 50.9856, lon: 7.13298, locations facility: Novartis Investigative Site, city: Bielefeld, state: Nordrhein Westfalen, zip: 33611, country: Germany, geoPoint lat: 52.03333, lon: 8.53333, locations facility: Novartis Investigative Site, city: Bielefeld, state: Nordrhein Westfalen, zip: 33615, country: Germany, geoPoint lat: 52.03333, lon: 8.53333, locations facility: Novartis Investigative Site, city: Bonn, state: Nordrhein Westfalen, zip: 53113, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Novartis Investigative Site, city: Bonn, state: Nordrhein Westfalen, zip: 53177, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Novartis Investigative Site, city: Dortmund, state: Nordrhein Westfalen, zip: 44137, country: Germany, geoPoint lat: 51.51494, lon: 7.466, locations facility: Novartis Investigative Site, city: Duesseldorf, state: Nordrhein Westfalen, zip: 40325, country: Germany, geoPoint lat: 51.22172, lon: 6.77616, locations facility: Novartis Investigative Site, city: Duesseldorf, state: Nordrhein Westfalen, zip: 40625, country: Germany, geoPoint lat: 51.22172, lon: 6.77616, locations facility: Novartis Investigative Site, city: Gelsenkirchen, state: Nordrhein Westfalen, zip: 45879, country: Germany, geoPoint lat: 51.50508, lon: 7.09655, locations facility: Novartis Investigative Site, city: Herdecke, state: Nordrhein Westfalen, zip: 58313, country: Germany, geoPoint lat: 51.39999, lon: 7.43584, locations facility: Novartis Investigative Site, city: Hilden, state: Nordrhein Westfalen, zip: 40724, country: Germany, geoPoint lat: 51.16818, lon: 6.93093, locations facility: Novartis Investigative Site, city: Krefeld, state: Nordrhein Westfalen, zip: 47805, country: Germany, geoPoint lat: 51.33645, lon: 6.55382, locations facility: Novartis Investigative Site, city: Lemgo, state: Nordrhein Westfalen, zip: 32657, country: Germany, geoPoint lat: 52.02786, lon: 8.89901, locations facility: Novartis Investigative Site, city: Neuss, state: Nordrhein Westfalen, zip: 41464, country: Germany, geoPoint lat: 51.19807, lon: 6.68504, locations facility: Novartis Investigative Site, city: Olpe, state: Nordrhein Westfalen, zip: 57462, country: Germany, geoPoint lat: 51.02899, lon: 7.85139, locations facility: Novartis Investigative Site, city: Paderborn, state: Nordrhein Westfalen, zip: 33098, country: Germany, geoPoint lat: 51.71905, lon: 8.75439, locations facility: Novartis Investigative Site, city: Siegen, state: Nordrhein Westfalen, zip: 57072, country: Germany, geoPoint lat: 50.87481, lon: 8.02431, locations facility: Novartis Investigative Site, city: Wesel, state: Nordrhein Westfalen, zip: 46483, country: Germany, geoPoint lat: 51.6669, lon: 6.62037, locations facility: Novartis Investigative Site, city: Wesel, state: Nordrhein Westfalen, zip: 46485, country: Germany, geoPoint lat: 51.6669, lon: 6.62037, locations facility: Novartis Investigative Site, city: Witten, state: Nordrhein Westfalen, zip: 58455, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: Novartis Investigative Site, city: Koeln, state: Nordrhein Westphalen, zip: 50179, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Novartis Investigative Site, city: Bochum, state: Nordrhein-Westfalen, zip: 44787, country: Germany, geoPoint lat: 51.48165, lon: 7.21648, locations facility: Novartis Investigative Site, city: Dortmund, state: Nordrhein-Westfalen, zip: 44309, country: Germany, geoPoint lat: 51.51494, lon: 7.466, locations facility: Novartis Investigative Site, city: Herne, state: Nordrhein-Westfalen, zip: 44649, country: Germany, geoPoint lat: 51.5388, lon: 7.22572, locations facility: Novartis Investigative Site, city: Remscheid, state: Nordrhein-Westfalen, zip: 42853, country: Germany, geoPoint lat: 51.17983, lon: 7.1925, locations facility: Novartis Investigative Site, city: Troisdorf, state: Nordrhein-Westfalen, zip: 53840, country: Germany, geoPoint lat: 50.80901, lon: 7.14968, locations facility: Novartis Investigative Site, city: Velbert, state: North Rhine-Westphalia, zip: 42551, country: Germany, geoPoint lat: 51.33537, lon: 7.04348, locations facility: Novartis Investigative Site, city: Hagen, state: Northrhine Westfalia, zip: 58095, country: Germany, geoPoint lat: 51.36081, lon: 7.47168, locations facility: Novartis Investigative Site, city: Remscheid Innen, state: Northrhine Westfalia, zip: 42859, country: Germany, locations facility: Novartis Investigative Site, city: Eggenfelde, state: Passau, zip: 84307, country: Germany, locations facility: Novartis Investigative Site, city: Mayen, state: Rheinland Pfalz, zip: 56727, country: Germany, geoPoint lat: 50.32797, lon: 7.22277, locations facility: Novartis Investigative Site, city: Simmern, state: Rheinland Pfalz, zip: 55469, country: Germany, geoPoint lat: 49.98198, lon: 7.52351, locations facility: Novartis Investigative Site, city: Neustadt, state: Rheinland-Pfalz, zip: 67434, country: Germany, geoPoint lat: 49.35009, lon: 8.13886, locations facility: Novartis Investigative Site, city: Magdeburg, state: Sachsen Anhalt, zip: 39108, country: Germany, geoPoint lat: 52.12773, lon: 11.62916, locations facility: Novartis Investigative Site, city: Magdeburg, state: Sachsen Anhalt, zip: 39130, country: Germany, geoPoint lat: 52.12773, lon: 11.62916, locations facility: Novartis Investigative Site, city: Dresden, state: Sachsen, zip: 01127, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Novartis Investigative Site, city: Dresden, state: Sachsen, zip: 01307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Novartis Investigative Site, city: Leipzig, state: Sachsen, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Novartis Investigative Site, city: Pirna, state: Sachsen, zip: 01796, country: Germany, geoPoint lat: 50.95843, lon: 13.93702, locations facility: Novartis Investigative Site, city: Rodewisch, state: Sachsen, zip: 08228, country: Germany, geoPoint lat: 50.53083, lon: 12.41329, locations facility: Novartis Investigative Site, city: Scheibenberg, state: Sachsen, zip: 09481, country: Germany, geoPoint lat: 50.54023, lon: 12.91215, locations facility: Novartis Investigative Site, city: Schkeuditz, state: Sachsen, zip: 04435, country: Germany, geoPoint lat: 51.39678, lon: 12.22141, locations facility: Novartis Investigative Site, city: Zittau, state: Sachsen, zip: 02763, country: Germany, geoPoint lat: 50.89772, lon: 14.80764, locations facility: Novartis Investigative Site, city: Zxickau, state: Sachsen, zip: 08060, country: Germany, locations facility: Novartis Investigative Site, city: Flensburg, state: Schleswig Flensburg, zip: 24939, country: Germany, geoPoint lat: 54.78431, lon: 9.43961, locations facility: Novartis Investigative Site, city: Luebeck, state: Schleswig-Holstein, zip: 23563, country: Germany, geoPoint lat: 53.86893, lon: 10.68729, locations facility: Novartis Investigative Site, city: Apolda, state: Thueringen, zip: 99510, country: Germany, geoPoint lat: 51.02624, lon: 11.51638, locations facility: Novartis Investigative Site, city: Eisenach, state: Thueringen, zip: 99817, country: Germany, geoPoint lat: 50.9807, lon: 10.31522, locations facility: Novartis Investigative Site, city: Erfurt, state: Thueringen, zip: 99084, country: Germany, geoPoint lat: 50.9787, lon: 11.03283, locations facility: Novartis Investigative Site, city: Meinigen, state: Thueringen, zip: 98617, country: Germany, locations facility: Novartis Investigative Site, city: Suhl, state: Thueringen, zip: 98527, country: Germany, geoPoint lat: 50.60911, lon: 10.69401, locations facility: Novartis Investigative Site, city: Altoetting, zip: 84503, country: Germany, locations facility: Novartis Investigative Site, city: Augsburg, zip: 86150, country: Germany, geoPoint lat: 48.37154, lon: 10.89851, locations facility: Novartis Investigative Site, city: Augsburg, zip: 86179, country: Germany, geoPoint lat: 48.37154, lon: 10.89851, locations facility: Novartis Investigative Site, city: Bad Liebenwerda, zip: 04924, country: Germany, geoPoint lat: 51.51826, lon: 13.39459, locations facility: Novartis Investigative Site, city: Bamberg, zip: 96049, country: Germany, geoPoint lat: 49.89873, lon: 10.90067, locations facility: Novartis Investigative Site, city: Bayreuth, zip: 95445, country: Germany, geoPoint lat: 49.94782, lon: 11.57893, locations facility: Novartis Investigative Site, city: Berlin, zip: 10117, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 10317, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 10715, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 12487, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 13187, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 13353, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 13581, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 14169, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Berlin, zip: 14197, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Novartis Investigative Site, city: Bochum, zip: 44791, country: Germany, geoPoint lat: 51.48165, lon: 7.21648, locations facility: Novartis Investigative Site, city: Boeblingen, zip: 71032, country: Germany, locations facility: Novartis Investigative Site, city: Bonn, zip: 53111, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Novartis Investigative Site, city: Bonn, zip: 53113, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Novartis Investigative Site, city: Bottrop, zip: 46236, country: Germany, geoPoint lat: 51.52392, lon: 6.9285, locations facility: Novartis Investigative Site, city: Brandenburg, zip: 14770, country: Germany, geoPoint lat: 52.41667, lon: 12.55, locations facility: Novartis Investigative Site, city: Bremen, zip: 28205, country: Germany, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Novartis Investigative Site, city: Bremen, zip: 28209, country: Germany, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Novartis Investigative Site, city: Bremen, zip: 28239, country: Germany, geoPoint lat: 53.07516, lon: 8.80777, locations facility: Novartis Investigative Site, city: Bremerhaven, zip: 27574, country: Germany, geoPoint lat: 53.55021, lon: 8.57673, locations facility: Novartis Investigative Site, city: Celle, zip: 29223, country: Germany, geoPoint lat: 52.62264, lon: 10.08047, locations facility: Novartis Investigative Site, city: Chemnitz, zip: 09113, country: Germany, geoPoint lat: 50.8357, lon: 12.92922, locations facility: Novartis Investigative Site, city: Chemnitz, zip: 09117, country: Germany, geoPoint lat: 50.8357, lon: 12.92922, locations facility: Novartis Investigative Site, city: Cottbus, zip: 03048, country: Germany, geoPoint lat: 51.75769, lon: 14.32888, locations facility: Novartis Investigative Site, city: Dessau Rosslau, zip: 06847, country: Germany, locations facility: Novartis Investigative Site, city: Dresden, zip: 01307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Novartis Investigative Site, city: Erfurt, zip: 99084, country: Germany, geoPoint lat: 50.9787, lon: 11.03283, locations facility: Novartis Investigative Site, city: Erlangen, zip: 91054, country: Germany, geoPoint lat: 49.59099, lon: 11.00783, locations facility: Novartis Investigative Site, city: Essen, zip: 45147, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Novartis Investigative Site, city: Esslingen, zip: 73730, country: Germany, geoPoint lat: 48.73961, lon: 9.30473, locations facility: Novartis Investigative Site, city: Eutin, zip: 23701, country: Germany, geoPoint lat: 54.14054, lon: 10.60751, locations facility: Novartis Investigative Site, city: Frankfurt, zip: 60398, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Novartis Investigative Site, city: Frankfurt, zip: 60431, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Novartis Investigative Site, city: Frankfurt, zip: 65929, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Novartis Investigative Site, city: Freiburg, zip: 79106, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, locations facility: Novartis Investigative Site, city: Friedberg, zip: 86316, country: Germany, geoPoint lat: 48.35693, lon: 10.98461, locations facility: Novartis Investigative Site, city: Friedrichshafen, zip: 88045, country: Germany, geoPoint lat: 47.65689, lon: 9.47554, locations facility: Novartis Investigative Site, city: Gera, zip: 07548, country: Germany, geoPoint lat: 50.88029, lon: 12.08187, locations facility: Novartis Investigative Site, city: Goch, zip: 47574, country: Germany, geoPoint lat: 51.67873, lon: 6.15895, locations facility: Novartis Investigative Site, city: Goettingen, zip: 37073, country: Germany, locations facility: Novartis Investigative Site, city: Goettingen, zip: 37075, country: Germany, locations facility: Novartis Investigative Site, city: Goslar, zip: 38642, country: Germany, geoPoint lat: 51.90425, lon: 10.42766, locations facility: Novartis Investigative Site, city: Greifswald, zip: 17475, country: Germany, geoPoint lat: 54.09311, lon: 13.38786, locations facility: Novartis Investigative Site, city: Gummersbach, zip: 51643, country: Germany, geoPoint lat: 51.02608, lon: 7.56473, locations facility: Novartis Investigative Site, city: Halberstadt, zip: 38820, country: Germany, geoPoint lat: 51.89562, lon: 11.05622, locations facility: Novartis Investigative Site, city: Halle, zip: 06110, country: Germany, geoPoint lat: 51.48159, lon: 11.97948, locations facility: Novartis Investigative Site, city: Hamburg, zip: 20259, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hamburg, zip: 20357, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hamburg, zip: 22081, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hamburg, zip: 22087, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hamburg, zip: 22291, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hamburg, zip: 22457, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Novartis Investigative Site, city: Hameln, zip: 31785, country: Germany, geoPoint lat: 52.10397, lon: 9.35623, locations facility: Novartis Investigative Site, city: Hanau, zip: 63450, country: Germany, geoPoint lat: 50.13423, lon: 8.91418, locations facility: Novartis Investigative Site, city: Hannover, zip: 30161, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Novartis Investigative Site, city: Hannover, zip: 30177, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Novartis Investigative Site, city: Hannover, zip: 30625, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Novartis Investigative Site, city: Hildesheim, zip: 31134, country: Germany, geoPoint lat: 52.15077, lon: 9.95112, locations facility: Novartis Investigative Site, city: Hof, zip: 95028, country: Germany, geoPoint lat: 50.31297, lon: 11.91261, locations facility: Novartis Investigative Site, city: Homburg, zip: 66421, country: Germany, geoPoint lat: 49.32637, lon: 7.33867, locations facility: Novartis Investigative Site, city: Ilsede, zip: 31241, country: Germany, geoPoint lat: 52.2634, lon: 10.19922, locations facility: Novartis Investigative Site, city: Jena, zip: 07740, country: Germany, geoPoint lat: 50.92878, lon: 11.5899, locations facility: Novartis Investigative Site, city: Kaiserslautern, zip: 67655, country: Germany, geoPoint lat: 49.443, lon: 7.77161, locations facility: Novartis Investigative Site, city: Karlsruhe, zip: 76133, country: Germany, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Novartis Investigative Site, city: Karlsruhe, zip: 76135, country: Germany, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Novartis Investigative Site, city: Kassel, zip: 34119, country: Germany, geoPoint lat: 51.31667, lon: 9.5, locations facility: Novartis Investigative Site, city: Kempten, zip: 87439, country: Germany, geoPoint lat: 47.72674, lon: 10.31389, locations facility: Novartis Investigative Site, city: Kiel, zip: 24105, country: Germany, geoPoint lat: 54.32133, lon: 10.13489, locations facility: Novartis Investigative Site, city: Koblenz, zip: 56068, country: Germany, geoPoint lat: 50.35357, lon: 7.57883, locations facility: Novartis Investigative Site, city: Koeln, zip: 50671, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Novartis Investigative Site, city: Koeln, zip: 50935, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Novartis Investigative Site, city: Koeln, zip: 50937, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Novartis Investigative Site, city: Koeln, zip: 51067, country: Germany, geoPoint lat: 50.93333, lon: 6.95, locations facility: Novartis Investigative Site, city: Kronach, zip: 96317, country: Germany, geoPoint lat: 50.23963, lon: 11.33308, locations facility: Novartis Investigative Site, city: Krumbach, zip: 86381, country: Germany, geoPoint lat: 48.24182, lon: 10.3632, locations facility: Novartis Investigative Site, city: Kulmbach, zip: 95326, country: Germany, geoPoint lat: 50.10068, lon: 11.45032, locations facility: Novartis Investigative Site, city: Lebach, zip: 66822, country: Germany, geoPoint lat: 49.41122, lon: 6.90988, locations facility: Novartis Investigative Site, city: Leipzig, zip: 04129, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Novartis Investigative Site, city: Leipzig, zip: 04277, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Novartis Investigative Site, city: Loerrach, zip: 79539, country: Germany, geoPoint lat: 47.61497, lon: 7.66457, locations facility: Novartis Investigative Site, city: Lohsa/Weißkollm, zip: 02999, country: Germany, locations facility: Novartis Investigative Site, city: Luebeck, zip: 23538, country: Germany, geoPoint lat: 53.86893, lon: 10.68729, locations facility: Novartis Investigative Site, city: Mainz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Novartis Investigative Site, city: Mannheim, zip: 68161, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Novartis Investigative Site, city: Mannheim, zip: 68165, country: Germany, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Novartis Investigative Site, city: Marburg, zip: 35037, country: Germany, geoPoint lat: 50.80904, lon: 8.77069, locations facility: Novartis Investigative Site, city: Marktredwitz, zip: 95615, country: Germany, geoPoint lat: 50.00443, lon: 12.08593, locations facility: Novartis Investigative Site, city: Memmingen, zip: 87700, country: Germany, geoPoint lat: 47.98372, lon: 10.18527, locations facility: Novartis Investigative Site, city: Minden, zip: 32429, country: Germany, geoPoint lat: 52.28953, lon: 8.91455, locations facility: Novartis Investigative Site, city: Moenchengladbach, zip: 41061, country: Germany, geoPoint lat: 51.18539, lon: 6.44172, locations facility: Novartis Investigative Site, city: Moers, zip: 47441, country: Germany, geoPoint lat: 51.45342, lon: 6.6326, locations facility: Novartis Investigative Site, city: Muehlhausen, zip: 99974, country: Germany, locations facility: Novartis Investigative Site, city: Muenster, zip: 48145, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Novartis Investigative Site, city: Naunhof, zip: 04683, country: Germany, geoPoint lat: 51.2777, lon: 12.58827, locations facility: Novartis Investigative Site, city: Neuruppin, zip: 16816, country: Germany, geoPoint lat: 52.92815, lon: 12.80311, locations facility: Novartis Investigative Site, city: Neuss, zip: 41462, country: Germany, geoPoint lat: 51.19807, lon: 6.68504, locations facility: Novartis Investigative Site, city: Neustadt/Sachsen, zip: 01844, country: Germany, locations facility: Novartis Investigative Site, city: Nordhausen, zip: 99734, country: Germany, geoPoint lat: 51.5018, lon: 10.7957, locations facility: Novartis Investigative Site, city: Nuernberg, zip: 90419, country: Germany, geoPoint lat: 49.45421, lon: 11.07752, locations facility: Novartis Investigative Site, city: Nuernberg, zip: 90449, country: Germany, geoPoint lat: 49.45421, lon: 11.07752, locations facility: Novartis Investigative Site, city: Offenbach, zip: 63069, country: Germany, geoPoint lat: 50.10061, lon: 8.76647, locations facility: Novartis Investigative Site, city: Offenburg, zip: 77654, country: Germany, geoPoint lat: 48.47377, lon: 7.94495, locations facility: Novartis Investigative Site, city: Oldenburg, zip: 26121, country: Germany, geoPoint lat: 53.14118, lon: 8.21467, locations facility: Novartis Investigative Site, city: Osnabrueck, zip: 49076, country: Germany, locations facility: Novartis Investigative Site, city: Passau, zip: 94036, country: Germany, geoPoint lat: 48.5665, lon: 13.43122, locations facility: Novartis Investigative Site, city: Pforzheim, zip: 75175, country: Germany, geoPoint lat: 48.88436, lon: 8.69892, locations facility: Novartis Investigative Site, city: Plauen-Kauschwitz, zip: 08525, country: Germany, locations facility: Novartis Investigative Site, city: Potsdam, zip: 14467, country: Germany, geoPoint lat: 52.39886, lon: 13.06566, locations facility: Novartis Investigative Site, city: Ravensburg, zip: 88214, country: Germany, geoPoint lat: 47.78198, lon: 9.61062, locations facility: Novartis Investigative Site, city: Regensburg, zip: 93053, country: Germany, geoPoint lat: 49.01513, lon: 12.10161, locations facility: Novartis Investigative Site, city: Rheine, zip: 48431, country: Germany, geoPoint lat: 52.28509, lon: 7.44055, locations facility: Novartis Investigative Site, city: Rodgau, zip: 63110, country: Germany, geoPoint lat: 50.02627, lon: 8.88588, locations facility: Novartis Investigative Site, city: Rostock, zip: 18057, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, locations facility: Novartis Investigative Site, city: Rostock, zip: 18059, country: Germany, geoPoint lat: 54.0887, lon: 12.14049, locations facility: Novartis Investigative Site, city: Rotenburg, zip: 27356, country: Germany, geoPoint lat: 53.11125, lon: 9.41082, locations facility: Novartis Investigative Site, city: Ruesselsheim, zip: 65428, country: Germany, locations facility: Novartis Investigative Site, city: Saarbruecken, zip: 66113, country: Germany, geoPoint lat: 49.23262, lon: 7.0098, locations facility: Novartis Investigative Site, city: Saarlouis, zip: 66740, country: Germany, geoPoint lat: 49.31366, lon: 6.75154, locations facility: Novartis Investigative Site, city: Salzgitter, zip: 38226, country: Germany, geoPoint lat: 52.15256, lon: 10.33144, locations facility: Novartis Investigative Site, city: Schorndorf, zip: 73614, country: Germany, geoPoint lat: 48.80537, lon: 9.52721, locations facility: Novartis Investigative Site, city: Schweinfurt, zip: 97422, country: Germany, geoPoint lat: 50.04937, lon: 10.22175, locations facility: Novartis Investigative Site, city: Schwerte, zip: 58239, country: Germany, geoPoint lat: 51.44387, lon: 7.5675, locations facility: Novartis Investigative Site, city: Schwäbisch-Hall, zip: 74523, country: Germany, geoPoint lat: 49.11127, lon: 9.73908, locations facility: Novartis Investigative Site, city: Soest, zip: 59494, country: Germany, geoPoint lat: 51.57558, lon: 8.10619, locations facility: Novartis Investigative Site, city: Stade, zip: 21680, country: Germany, geoPoint lat: 53.59337, lon: 9.47629, locations facility: Novartis Investigative Site, city: Stendal, zip: 39576, country: Germany, geoPoint lat: 52.6069, lon: 11.85867, locations facility: Novartis Investigative Site, city: Stolberg, zip: 52222, country: Germany, geoPoint lat: 50.77368, lon: 6.22595, locations facility: Novartis Investigative Site, city: Stuttgart, zip: 70174, country: Germany, geoPoint lat: 48.78232, lon: 9.17702, locations facility: Novartis Investigative Site, city: Stuttgart, zip: 70199, country: Germany, geoPoint lat: 48.78232, lon: 9.17702, locations facility: Novartis Investigative Site, city: Suhl, zip: 98527, country: Germany, geoPoint lat: 50.60911, lon: 10.69401, locations facility: Novartis Investigative Site, city: Torgau, zip: 04860, country: Germany, geoPoint lat: 51.56016, lon: 12.99617, locations facility: Novartis Investigative Site, city: Trier, zip: 54290, country: Germany, geoPoint lat: 49.75565, lon: 6.63935, locations facility: Novartis Investigative Site, city: Tuebingen, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, locations facility: Novartis Investigative Site, city: Ulm, zip: 89073, country: Germany, geoPoint lat: 48.39841, lon: 9.99155, locations facility: Novartis Investigative Site, city: Ulm, zip: 89081, country: Germany, geoPoint lat: 48.39841, lon: 9.99155, locations facility: Novartis Investigative Site, city: Vechta, zip: 49377, country: Germany, geoPoint lat: 52.72632, lon: 8.28598, locations facility: Novartis Investigative Site, city: Voelklingen, zip: 66333, country: Germany, locations facility: Novartis Investigative Site, city: Weiden, zip: 92637, country: Germany, geoPoint lat: 49.67682, lon: 12.15613, locations facility: Novartis Investigative Site, city: Weinheim, zip: 69469, country: Germany, geoPoint lat: 49.54887, lon: 8.66697, locations facility: Novartis Investigative Site, city: Wetzlar, zip: 35578, country: Germany, geoPoint lat: 50.56109, lon: 8.50495, locations facility: Novartis Investigative Site, city: Wiesbaden, zip: 65189, country: Germany, geoPoint lat: 50.08258, lon: 8.24932, locations facility: Novartis Investigative Site, city: Wiesbaden, zip: 65191, country: Germany, geoPoint lat: 50.08258, lon: 8.24932, locations facility: Novartis Investigative Site, city: Wilhelmshaven, zip: 26389, country: Germany, geoPoint lat: 53.52998, lon: 8.11253, locations facility: Novartis Investigative Site, city: Wolfsburg, zip: 38440, country: Germany, geoPoint lat: 52.42452, lon: 10.7815, locations facility: Novartis Investigative Site, city: Worms, zip: 67550, country: Germany, geoPoint lat: 49.63278, lon: 8.35916, locations facility: Novartis Investigative Site, city: Wuerselen, zip: 52146, country: Germany, locations facility: Novartis Investigative Site, city: Wuerzburg, zip: 97080, country: Germany, geoPoint lat: 49.79391, lon: 9.95121, hasResults: False
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protocolSection identificationModule nctId: NCT06311370, orgStudyIdInfo id: 2023-0100, briefTitle: Acceptability, Feasibility, and Development of an AI Driven, Multi-sensor, Non-invasive Digital Mental Health Platform in Children With ADHD and Emotional Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2024-02-05, completionDateStruct date: 2024-02-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: MaxisHealth, class: INDUSTRY, descriptionModule briefSummary: This is an observational study collecting data using a wearable to measure the biometric features in youth with Attention deficit hyperactivity disorder(ADHD) and Autism., conditionsModule conditions: ADHD, conditions: Autism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: Emotion dysregulation, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: The League School, city: Brooklyn, state: New York, zip: 11203, country: United States, geoPoint lat: 40.6501, lon: -73.94958, hasResults: False
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protocolSection identificationModule nctId: NCT06311357, orgStudyIdInfo id: 100/2566, briefTitle: Percent Weight Change in the Medical Supplement Group of Early Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-12, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Rajavithi Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).The main question is• the change of weight (%) before and after complete treatment of breast cancer therapy.Participants will be randomized into 2 group* intervention group - receive medical supplement daily during chemotherapy treatment.* control group - Nutritional advise during chemotherapy treatment., conditionsModule conditions: Early Stage Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ensure, outcomesModule primaryOutcomes measure: Percent weight change, secondaryOutcomes measure: EORTC QLQ-C30, secondaryOutcomes measure: Patient interpretation of the Patient-Generated Subjective Global Assessment, secondaryOutcomes measure: EORTC QLQ-BR23, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rajavithi hospital, status: RECRUITING, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, contacts name: Meitinarth Juntong, role: CONTACT, phone: +66654415447, email: juntong.mei@gmail.com, geoPoint lat: 13.759, lon: 100.53358, hasResults: False
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protocolSection identificationModule nctId: NCT06311344, orgStudyIdInfo id: 2021-06, briefTitle: Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-14, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis., conditionsModule conditions: Schistosoma Mansoni, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Molecular biology analyses, outcomesModule primaryOutcomes measure: Number of M. perstans microfilariae, primaryOutcomes measure: Percentage of M. perstans microfilariae, primaryOutcomes measure: Number of Schistosoma eggs, primaryOutcomes measure: Percentage of Schistosoma eggs, secondaryOutcomes measure: Number of samples positive for Wolbachia, secondaryOutcomes measure: Percentage of samples positive for Wolbachia, secondaryOutcomes measure: Number of samples positive for Schistosoma hybrid species, secondaryOutcomes measure: Percentage of samples positive for Schistosoma hybrid species, secondaryOutcomes measure: Identification of hybrid species of Schistosoma spp., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Tamarozzi, role: SUB_INVESTIGATOR, contacts name: Bonnie Webster, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06311331, orgStudyIdInfo id: restor3d-007, briefTitle: Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2031-05, completionDateStruct date: 2031-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Restor3D, class: INDUSTRY, descriptionModule briefSummary: This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use., conditionsModule conditions: Avascular Necrosis of the Talus, conditions: Talar Osteochondral Defect of Ankle, conditions: Talar Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Total Talus Replacement (TTR), outcomesModule primaryOutcomes measure: Proportion of participants who pass a composite of safety and probable benefit outcomes, secondaryOutcomes measure: Change in perceived pain from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline, secondaryOutcomes measure: Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline, secondaryOutcomes measure: Change in ankle range of motion (ROM) from baseline, secondaryOutcomes measure: Proportion of procedure-related Serious Adverse Events, secondaryOutcomes measure: Proportion of Adverse Events, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06311318, orgStudyIdInfo id: Department of surgery MED CMU, briefTitle: Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-11-01, primaryCompletionDateStruct date: 2019-11-30, completionDateStruct date: 2020-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chiang Mai University, class: OTHER, descriptionModule briefSummary: Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up., conditionsModule conditions: Zygomatic and Lefort II Fractures, conditions: Infraorbital Rim Fixation, conditions: Subciliary Approach Repair, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled trial enrolled patients with traumatic facial fractures slated for subciliary approach repair. Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Patients were randomly assigned, using concealed block of four randomization, to either the experimental group receiving lower eyelid massage or the control group receiving standard care. While the authors, acting as massage trainers, were unblinded, an independent plastic surgeon, serving as the assessor, remained blinded to the study interventions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: lower eyelid massage, outcomesModule primaryOutcomes measure: Grading of Lower Eyelid Scar Contracture (GLESCO), primaryOutcomes measure: Grading of lower eyelid malpositioning, primaryOutcomes measure: Comfort scores, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06311305, orgStudyIdInfo id: Soh-med-24-03-07MS, briefTitle: Does Early Laparoscopic Cholecystectomy After ERCP Reduce the Risk of Complications, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Gallstones have been recognised since antiquity and have been found during autopsies of Egyptian mummies. Following the first successful open cholecystectomy in 1882, it was Eric Muhe, a German surgeon, who performed the first laparoscopic cholecystectomy (Lapara, the flank; and skopein, to examine) in 1985.The common mechanism of gallstone formation includes cholesterol hypersecretion, alteration in intestinal bile salt, cholesterol absorption and gall bladder hypokinesia, which leads to bile cholesterol supersaturation and nucleation.Incidence of CBD stones in cases of cholelithiasis is around 3.4%-15%.2 Choledocholithiasis can either be primary or secondary. Secondary Choledocholithiasis being more common occurs due to stones originating in gallbladder and then migrating through cystic duct to CBD. Primary bile duct stones originate from within bile ducts and are more common in Asian populations. These stones are associated with biliary stasis and bacteria., conditionsModule conditions: Cholelithiases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: we aim to assess if the early laparoscopic cholecystectomy after ERCP can reduce the risks or complications, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: NONE (open label single group), enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Early Laparoscopic cholecystectomy, outcomesModule primaryOutcomes measure: bile leakage, primaryOutcomes measure: operative time, primaryOutcomes measure: intraoperative bleeding, primaryOutcomes measure: sepsis, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Abdulla M Ahmed, master, role: CONTACT, phone: 01006546957, phoneExt: 002, email: abdallah_mohamed_ex@med.sohag.edu.eg, contacts name: Abdulla M Ahmed, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06311292, orgStudyIdInfo id: STUDY22090138, briefTitle: Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Daniel J. Weiner, class: OTHER, descriptionModule briefSummary: This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.Participants will use the Volara System during clinic visit in an attempt to produce sputum., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: No parties will be prevented from having knowledge of the Volara System use., enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Volara System, outcomesModule primaryOutcomes measure: Sufficient sputum quantity for a pellet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Presbyterian Hospital, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Elizabeth Hartigan, MPH, RN, role: CONTACT, phone: 412-692-7060, email: elizabeth.hartigan@chp.edu, contacts name: Jamie Adams, BS, RRT, role: CONTACT, email: adamsjm2@upmc.edu, contacts name: Daniel Weiner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
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protocolSection identificationModule nctId: NCT06311279, orgStudyIdInfo id: Soh-Med-24-03-01MD, briefTitle: End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality., conditionsModule conditions: Rectum Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: randomized comparative clinical trial, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Anterior resection of Rectal cancer, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: Anastomotic leakage, primaryOutcomes measure: hospital stay, primaryOutcomes measure: Mortality, primaryOutcomes measure: Anastomotic leak amount, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Nabil A Al-Ameer, MD, role: CONTACT, phone: 1118416290, email: Nabil.abdelnaser@med.sohag.edu.eg, contacts name: Ahmed G Hassanein, MD, role: CONTACT, phone: 1552538300, phoneExt: 0020, email: ethics@med.sohag.edu.eg, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06311266, orgStudyIdInfo id: 34-424 ex 21/22, briefTitle: Robotic Endoscopic Neurosurgical Interventions, acronym: RENI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Endoscopic operations have become increasingly important in the field of neurosurgery over the past decade and require a high degree of precision. Current methods for setting the planned trajectory only offer limited precision due to the manual control, which can lead to complications.The EndoGuide robot is a modular positioning device for controlling endoscopic instruments, which can use radiological data from neuronavigation to align the trajectory in real time with an accuracy of \<0.1mm.The previous model of the robot is currently approved for interventional radiology and positioning of electrodes and catheters in the field of neurosurgery and is now to be tested in endoscopic neurosurgery.The investigators therefore expect not only an increase in the accuracy of endoscopic interventions, but also a reduction in morbidity., conditionsModule conditions: Robot for Endoscopic Neurosurgical Interventions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, randomized, single center cohort trial, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: SINGLE, maskingDescription: Due to the surgical workflow (using the robotic guided device or not) the performing surgical team will not be blinded to the allocated group. However, investigators will be blinded to the allocation of the patients., whoMasked: PARTICIPANT, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: Robotic endoscopic neurosurgical intervention, outcomesModule primaryOutcomes measure: Target Error (TE), secondaryOutcomes measure: Adverse Effect, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06311253, orgStudyIdInfo id: 2024-LACTOFERRINPREGNANT, briefTitle: Non-surgical Periodontal Treatment With Adjunctive Use of Lactoferrin Contained in Toothpaste and Mouthwash, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess the effect of lactoferrin in LBC complex can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Emoform Glic Toothpaste, interventions name: Emoform Glic Mouthwash, outcomesModule primaryOutcomes measure: Change in Recession (R), primaryOutcomes measure: Change in Plaque Index (Silness and Loe, 1964), primaryOutcomes measure: Change in Bleeding on Probing (BoP), primaryOutcomes measure: Change in Probing Pocket Depth (PPD), primaryOutcomes measure: Change in modified Marginal Gingival Index (mMGI), primaryOutcomes measure: Change in Papillary Marginal Gingival Index (PMGI), primaryOutcomes measure: Change in Plaque Control Record (PCR%), primaryOutcomes measure: Change in Clinical Attachment Loss (CAL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06311240, orgStudyIdInfo id: 02-24-108-003, briefTitle: Chronic Pain in Patients in Hemodialysis, acronym: DolERC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Cardenal Herrera University, class: OTHER, collaborators name: Consorci Sanitari de Terrassa, descriptionModule briefSummary: Pain is one of the most common symptoms among patients with End Stage Renal Disease (ESRD), and often goes unrecognized or inadequately managed in hemodialysis patients. More than 50% of patients undergoing hemodialysis suffer from pain, with 75% of them being treated ineffectively due to healthcare professionals\&#39; lack of awareness of this symptom. Therefore, pain management in this population is a complex and challenging task for healthcare providers. The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders, metabolic neuropathies, in addition to typical intradialytic pain.The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment (physical activity, nutrition, and psychological support) already being implemented in various studies for these patients., conditionsModule conditions: Chronic Pain, conditions: Chronic Kidney Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Stress level assessed by the salivary cortisol test, primaryOutcomes measure: Stress level assessed by the perceived stress scale (PSS), secondaryOutcomes measure: Self- efficacy assessed by questionnaire, secondaryOutcomes measure: Quality of sleep assessed by Pittsburgh Sleep Quality Index, secondaryOutcomes measure: The impact of headaches on life assessed by Headache Impact Test-6, secondaryOutcomes measure: Anxiety and depression assessed by Hospital anxiety and depression scale (HADS), secondaryOutcomes measure: Aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness assessed by The Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Chronic pain assessd by Chronic Pain Grade Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Consorci Sanitari de Terrassa, city: Terrassa, state: Barcelona, zip: 08227, country: Spain, contacts name: Vicent Esteve-Simó, PhD, role: CONTACT, phone: 00 34 937310007, email: vesteve@cst.cat, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Universidad Cardenal Herrera-CEU, CEU Universities, city: Alfara del Patriarca, state: Valencia, zip: 46115, country: Spain, contacts name: Eva Segura Orti, PhD, role: CONTACT, phone: 0034961369000, phoneExt: 64439, email: ESEGURA@UCHCEU.ES, geoPoint lat: 39.55, lon: -0.38333, hasResults: False
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protocolSection identificationModule nctId: NCT06311227, orgStudyIdInfo id: NCI-2024-01904, secondaryIdInfos id: NCI-2024-01904, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10637, type: OTHER, domain: National Cancer Institute LAO, secondaryIdInfos id: 10637, type: OTHER, domain: CTEP, briefTitle: Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival., conditionsModule conditions: Recurrent Hairy Cell Leukemia, conditions: Recurrent Hairy Cell Leukemia Variant, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Complete remission (CR) rate, secondaryOutcomes measure: Minimal residual disease (MRD)-negative CR rate, secondaryOutcomes measure: MRD negativilty, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Complete response duration, secondaryOutcomes measure: MRD-negative survival, otherOutcomes measure: TP53 mutations and other mutations, otherOutcomes measure: Whole exome sequencing of relapsed HCL/HCLv samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311214, orgStudyIdInfo id: NCI-2024-01903, secondaryIdInfos id: NCI-2024-01903, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10397, type: OTHER, domain: University of Texas MD Anderson Cancer Center LAO, secondaryIdInfos id: 10397, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186688, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186688, briefTitle: Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-21, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient. ADCs such as sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan are monoclonal antibodies attached to biologically active drugs and are a form of targeted therapy. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab attaches to a protein called Trop-2 on the surface of tumor cells and delivers govitecan to kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. Trastuzumab deruxtecan is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Personalized treatment with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan may be an effective treatment option for patients with advanced or metastatic solid tumors that screen positive for high expression of Trop-2, nectin-4, or HER2, respectively., conditionsModule conditions: Advanced Malignant Solid Neoplasm, conditions: Metastatic Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: Electronic Health Record Review, interventions name: Enfortumab Vedotin, interventions name: Immunohistochemistry Staining Method, interventions name: Magnetic Resonance Imaging, interventions name: Multigated Acquisition Scan, interventions name: Sacituzumab Govitecan, interventions name: Trastuzumab Deruxtecan, outcomesModule primaryOutcomes measure: Frequency of high protein expression in patients with high ribonucleic acid (RNA) expression of each antibody-drug conjugate target (screening protocol), primaryOutcomes measure: Objective response rate (treatment cohorts), secondaryOutcomes measure: Frequency that patients with high RNA and immunohistochemistry target expression receive cohort treatment on study (screening protocol), secondaryOutcomes measure: Progression free survival (treatment cohorts), secondaryOutcomes measure: Overall survival (treatment cohorts), secondaryOutcomes measure: Time to progression (treatment cohorts), secondaryOutcomes measure: Incidence of adverse events (treatment cohorts), secondaryOutcomes measure: RNA expression of targets of interest (TOIs) (treatment cohorts), secondaryOutcomes measure: Temporal tumor heterogeneity (treatment cohorts), secondaryOutcomes measure: Potential predictive biomarkers and other molecular features (treatment cohorts), secondaryOutcomes measure: Pharmacodynamic changes in the tumor and microenvironment (treatment cohorts), otherOutcomes measure: Mechanisms of acquired resistance (treatment cohorts), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311201, orgStudyIdInfo id: P.T.REC/012/004256, briefTitle: Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2024-01-26, completionDateStruct date: 2024-01-26, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women., conditionsModule conditions: Diastasis Recti, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Abdominal belt, interventions name: Pilates exercises, outcomesModule primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest, primaryOutcomes measure: Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction, primaryOutcomes measure: Assessment of trunk flexion strength, primaryOutcomes measure: Assessment of static trunk flexion endurance, secondaryOutcomes measure: Assessment of functional status, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06311188, orgStudyIdInfo id: HUM00240243, secondaryIdInfos id: 1R21MD016940-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21MD016940-01A1, briefTitle: Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention., conditionsModule conditions: Stress, conditions: Trauma, conditions: PTSD, conditions: HPA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: ITR Healing intervention, outcomesModule primaryOutcomes measure: PTSD Screen, primaryOutcomes measure: PTSD Checklist, secondaryOutcomes measure: Stress Psychosocial, secondaryOutcomes measure: Stress Physiological, secondaryOutcomes measure: Parent/Caregiver-Child Relationship, secondaryOutcomes measure: Five Facet Mindfulness Questionnaire (FFMQ), secondaryOutcomes measure: Recidivism, secondaryOutcomes measure: Personal Agency, secondaryOutcomes measure: Racial Identity, secondaryOutcomes measure: Parenting Stress, otherOutcomes measure: MoCA screen, otherOutcomes measure: CESD - Depression screen, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06311175, orgStudyIdInfo id: H20-0114, briefTitle: Diet Tracking Prescriptions for Weight Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, descriptionModule briefSummary: Lifestyle interventions are effective at producing modest weight loss. One of the strongest predictors of weight loss is food tracking, which involves logging all food and beverage consumed each day in an effort to stay within a daily calorie goal. Standard lifestyle interventions prescribe daily food tracking for the length of the program which can range from 3-24 months. This can be a taxing prescription that is not feasible to do long term for many people. The purpose of this pilot feasibility randomized trial is to test the feasibility of 3 tracking prescriptions during an 8 week digital weight loss intervention: 1) tracking daily, 2) tracking two weeks on and one week off, 3) tracking every other week. Feasibility is defined as tracking prescription compliance, burden, acceptability, and perceived efficacy, and tracking self-efficacy. Diet tracking will be evaluated one month after the intervention ends so that groups can be compared on diet tracking maintenance., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of three intervention groups in parallel for the duration of the study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Tracking Prescription, outcomesModule primaryOutcomes measure: Compliance with diet tracking prescription, primaryOutcomes measure: Persistence with diet tracking prescription, primaryOutcomes measure: Burden of tracking prescription, primaryOutcomes measure: Acceptability of tracking prescription, primaryOutcomes measure: Perceived efficacy of tracking prescription, primaryOutcomes measure: Self-efficacy of diet tracking, secondaryOutcomes measure: Diet Tracking One Month Post-Intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Connecticut, status: RECRUITING, city: Storrs, state: Connecticut, zip: 06269, country: United States, contacts name: Sherry Pagoto, PhD, role: CONTACT, phone: 860-486-2313, email: sherry.pagoto@uconn.edu, contacts name: Sherry Pagoto, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.80843, lon: -72.24952, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-09-14, uploadDate: 2024-01-03T11:42, filename: Prot_000.pdf, size: 518051, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-09-14, uploadDate: 2024-03-12T13:35, filename: ICF_001.pdf, size: 296855, hasResults: False
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protocolSection identificationModule nctId: NCT06311162, orgStudyIdInfo id: 2023-01615, briefTitle: Early Life Intervention in Pediatrics Supported by E-health - SMOKE, acronym: ELIPSE-II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: University of Bern, descriptionModule briefSummary: Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children ., conditionsModule conditions: Smoking Reduction, conditions: Asthma in Children, conditions: Wheezing, conditions: Non-Communicable Disease, conditions: Life Style, conditions: Behavior, Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-blind randomized controlled parallel-group clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: The study team members who are conducting assessments on the participants remain blinded to the treatment allocation., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Life-Style app, interventions name: Sham Comparator, outcomesModule primaryOutcomes measure: Change from baseline in urinary levels of cotinine in children, primaryOutcomes measure: Change from baseline in urinary levels of cotinine in children, secondaryOutcomes measure: Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure, otherOutcomes measure: Acceptance and usability of the app (parent reported outcome), otherOutcomes measure: Acceptance of the app, otherOutcomes measure: Usability of the app, otherOutcomes measure: Number of episodes of airway disease in children, otherOutcomes measure: Frequency of inhalant medications or antibiotics required for airway disease in children, otherOutcomes measure: Amount of inhalant medications or antibiotics required for airway disease in children, otherOutcomes measure: Number of episodes of severe airway disease in children requiring hospitalization, otherOutcomes measure: Change from baseline in parental smoking intensity (number of cigarettes smoked per day), eligibilityModule sex: ALL, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Paediatrics, Inselspital, Bern University Hospital, city: Bern, zip: 3010, country: Switzerland, contacts name: Julian Jakob, MD, role: CONTACT, phone: +41 31 632 12 93, email: julian.jakob@insel.ch, contacts name: Matthias V. Kopp, Prof, MD, role: CONTACT, phone: +41 31 66 4 13 51, email: matthias.kopp@insel.ch, contacts name: Julian Jakob, MD, role: SUB_INVESTIGATOR, contacts name: Andrea Wyssen, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False
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protocolSection identificationModule nctId: NCT06311149, orgStudyIdInfo id: 479/2023/Oss/AOUFe, briefTitle: Multicenter Evaluation of Patients Using LATITUDE Monitoring System, acronym: Multitude, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2043-12-31, completionDateStruct date: 2043-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle., conditionsModule conditions: Cardiovascular Diseases, conditions: Arrhythmias, Cardiac, conditions: Heart Failure, conditions: Sudden Cardiac Death, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Device therapy, secondaryOutcomes measure: Device-related complications, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria di Ferrara, status: RECRUITING, city: Ferrara, zip: 44124, country: Italy, contacts name: Matteo Bertini, MD, PhD, role: CONTACT, email: brtmtt2@unife.it, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Policlinico Federico II, status: RECRUITING, city: Napoli, country: Italy, contacts name: Antonio Rapacciuolo, role: CONTACT, email: antonio.rapacciuolo@unina.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
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protocolSection identificationModule nctId: NCT06311136, orgStudyIdInfo id: PEAK, briefTitle: Effectiveness of an Ecological Momentary Emotion Regulation Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Heidelberg University, class: OTHER, descriptionModule briefSummary: This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice., conditionsModule conditions: Depressive Disorder, Major, conditions: Persistent Depressive Disorder, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: During the treatment phase, both the intervention and monitoring-only control groups use a diary called "Positive Everyday Affect Knowledge". Participants are informed that the diary entries may include instructions for implementing specific emotion regulation strategies in their daily activities. However, this component of the procedure is not characterized explicitly as an intervention. This methodological consideration ensures that differences observed between the groups can be attributed to the intervention itself, rather than to differences in participants' expectations.Clinical interviews will be conducted blindly., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Valence-Specific Ecological Momentary Intervention, outcomesModule primaryOutcomes measure: Emotion Regulation Ability (Positive, Negative Emotions), primaryOutcomes measure: Emotion Regulation Self-Efficacy for Positive and Negative Emotions, secondaryOutcomes measure: Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Positive and Negative Affect, secondaryOutcomes measure: Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions, otherOutcomes measure: Well-being, otherOutcomes measure: Life Satisfaction, otherOutcomes measure: Emotion Beliefs about Positive Emotions (Delay Happiness, Living in the Moment), otherOutcomes measure: Emotion Beliefs about Positive Emotions (Fear of Happiness), otherOutcomes measure: Negative Emotional Contrast Avoidance, otherOutcomes measure: Emotion Regulation Strategy Use, otherOutcomes measure: Self-Esteem, otherOutcomes measure: Locus of Control, otherOutcomes measure: Controllability Beliefs about Emotions, otherOutcomes measure: Anxiety Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University, status: RECRUITING, city: Heidelberg, zip: 69117, country: Germany, contacts name: Ilka Mueller, M.Sc., role: CONTACT, phone: +496221/547362, email: ilka.mueller@psychologie.uni-heidelberg.de, contacts name: Luise Pruessner, M.Sc., role: CONTACT, phone: +496221/547282, email: luise.pruessner@psychologie.uni-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, hasResults: False
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protocolSection identificationModule nctId: NCT06311123, orgStudyIdInfo id: ISR IM047-059, briefTitle: Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration., conditionsModule conditions: Ulcerative Colitis, conditions: Ulcerative Colitis Chronic Moderate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: difference in leukocyte subsets, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92093-006, country: United States, contacts name: Jesus Rivera-Nieves, MD, role: CONTACT, phone: 858-534-5495, email: jriveran@ucsd.edu, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
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protocolSection identificationModule nctId: NCT06311110, orgStudyIdInfo id: #BC-11326 AM04, briefTitle: Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-02-08, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC)., conditionsModule conditions: Developmental Coordination Disorder, conditions: Lower Urinary Tract Symptoms, conditions: Bowel Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, interventions name: Developmental Coordination Disorder Questionnaire, interventions name: Questionnaire concerning impaired toilettraining and comorbities, outcomesModule primaryOutcomes measure: Impaired toilet training, primaryOutcomes measure: Daytime incontinence, primaryOutcomes measure: Enuresis, primaryOutcomes measure: Fecal incontinence, secondaryOutcomes measure: Toilet training difficulties, secondaryOutcomes measure: General bladder and bowel dysfunction, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ghent University Hospital/Ghent University, city: Ghent, state: East Flanders, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
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protocolSection identificationModule nctId: NCT06311097, orgStudyIdInfo id: M402, briefTitle: Dairy Products to Your Gut and Brain, acronym: YourGutBrain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, collaborators name: University of Aarhus, collaborators name: APC Microbiome Ireland, descriptionModule briefSummary: The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function., conditionsModule conditions: Healthy, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Two 4-week intervention periods separated by a washout period of at least 4 weeks.The crossover intervention will include 60 participants. Another 40 participants will only complete the first (baseline) visit., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Fermented dairy, interventions name: Non-fermented dairy, outcomesModule primaryOutcomes measure: Difference in change from baseline in defecation frequency between the interventions, secondaryOutcomes measure: Difference in change from baseline in cognitive performance between the interventions, secondaryOutcomes measure: Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions, secondaryOutcomes measure: Difference in change from baseline in whole gut transit time between the interventions, secondaryOutcomes measure: Difference in change from baseline in stool consistency between the interventions, secondaryOutcomes measure: Difference in change from baseline in stool moisture between the interventions, secondaryOutcomes measure: Difference in change from baseline in fecal abundance of Lactobacillus acidophilus between the interventions, secondaryOutcomes measure: Difference in change from baseline in self-reported gastrointestinal symptoms between the interventions, otherOutcomes measure: Difference in change from baseline in gut microbiota between the interventions, otherOutcomes measure: Difference in change from baseline in fecal pH between the interventions, otherOutcomes measure: Difference in change from baseline in breath hydrogen and methane levels between the interventions, otherOutcomes measure: Difference in change from baseline in biomarkers of colonic fermentation between the interventions, otherOutcomes measure: Difference in change from baseline in fecal short-chain fatty acids (SCFAs) between the interventions, otherOutcomes measure: Difference in change from baseline in fecal zonulin levels between the interventions, otherOutcomes measure: Difference in change from baseline in plasma levels of lipopolysaccharide-binding protein (LBP) between the interventions, otherOutcomes measure: Difference in change from baseline in gut metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in urine metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in plasma metabolome between the interventions, otherOutcomes measure: Difference in change from baseline in inflammatory biomarkers between the interventions, otherOutcomes measure: Difference in change from baseline in plasma levels of cortisol between the interventions, otherOutcomes measure: Difference in change from baseline in biomarkers of glucose and lipid metabolism between the interventions, otherOutcomes measure: Difference in change from baseline in appetite hormones between the interventions, otherOutcomes measure: Difference in change from baseline in plasma level of Brain Derived Neurotrophic Factor (BDNF) between the interventions, otherOutcomes measure: Difference in change from baseline in self-reported stress and mood between the interventions, otherOutcomes measure: Difference in change from baseline in self-reported sleeping patterns between the interventions, otherOutcomes measure: Difference in change from baseline in resting-state cortical connectivity between the interventions, otherOutcomes measure: Difference in change from baseline in event-related potentials evoked by a cognitive task between the interventions, otherOutcomes measure: Difference in change from baseline in quality of life between the interventions, otherOutcomes measure: Difference in change from baseline in habitual diet between the interventions, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Copenhagen, Department of Nutrition, Exercise and Sports, status: RECRUITING, city: Copenhagen, country: Denmark, contacts name: Henrik M Roager, PhD, role: CONTACT, email: hero@nexs.ku.dk, contacts name: Anke Karabanov, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06311084, orgStudyIdInfo id: 310211, briefTitle: IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People, acronym: IMAG2, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-25, primaryCompletionDateStruct date: 2023-11-09, completionDateStruct date: 2024-01-23, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK.Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol to be extended to younger adolescents.Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions., conditionsModule conditions: Self Injurious Behavior, conditions: Adolescent Behavior Problem, conditions: Child Behavior Problem, conditions: Mental Health Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open ended feasibility and acceptability of novel blended digital psychological intervention, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Imaginator 2.0, outcomesModule primaryOutcomes measure: Attrition, primaryOutcomes measure: Treatment adherence, primaryOutcomes measure: Scores on User Experience Questionnaire, secondaryOutcomes measure: Number of self harm episodes over 3 months, otherOutcomes measure: Craving Experiences Questionnaire, otherOutcomes measure: Difficulties in Emotion Regulation Scale, otherOutcomes measure: Depression, Anxiety, Stress Scale, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West London NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-04-04, uploadDate: 2024-02-16T12:11, filename: Prot_000.pdf, size: 1958833, hasResults: False
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protocolSection identificationModule nctId: NCT06311071, orgStudyIdInfo id: IR.SUMS.MED.REC.1401.200, briefTitle: The Predictive Value of Coronary Artery Calcium Score, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shiraz University of Medical Sciences, class: OTHER, descriptionModule briefSummary: In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients, conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 498, type: ACTUAL, armsInterventionsModule interventions name: calcium score, interventions name: Invasive coronary angiography, outcomesModule primaryOutcomes measure: coronary artery disease, primaryOutcomes measure: coronary calcium score, secondaryOutcomes measure: cardiovascular risk score, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Javad Kojuri, city: Shiraz, state: Fars, zip: 7134814336, country: Iran, Islamic Republic of, geoPoint lat: 29.61031, lon: 52.53113, hasResults: False
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protocolSection identificationModule nctId: NCT06311058, orgStudyIdInfo id: PRO00032531, briefTitle: Protein Supplementation After ACL Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy., conditionsModule conditions: ACL Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects are randomized to 1 of 3 intervention groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: This is a double-blinded randomized controlled trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Whey protein isolate, interventions name: Protein + BAA, interventions name: Placebo, outcomesModule primaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Patient Reported Outcomes, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Houston Methodist, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Haley Goble, MHA, role: CONTACT, phone: 713-441-3930, email: hmgoble@houstonmethodist.org, contacts name: Robert A Jack, MD, role: SUB_INVESTIGATOR, contacts name: Patrick C McCulloch, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: David M Lintner, MD, role: SUB_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06311045, orgStudyIdInfo id: 23-01469, briefTitle: Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 206, type: ESTIMATED, armsInterventionsModule interventions name: N-acetylcysteine (NAC), interventions name: Placebo, interventions name: Positive Airway Pressure (PAP) Therapy, outcomesModule primaryOutcomes measure: Percent Change in Overnight Levels of Glutathione (GSH), primaryOutcomes measure: Mean Change in Pre- to Post-Sleep GSH Levels, primaryOutcomes measure: Mean Change in Pre- to Post-Sleep GSH Levels, secondaryOutcomes measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG), secondaryOutcomes measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG), secondaryOutcomes measure: 8-Isoprostane Level, secondaryOutcomes measure: 8-Isoprostane Level, secondaryOutcomes measure: Plasma Nitrate Level, secondaryOutcomes measure: Plasma Nitrate Level, secondaryOutcomes measure: Plasma Nitrite Level, secondaryOutcomes measure: Plasma Nitrite Level, secondaryOutcomes measure: Organic Nitrite Level, secondaryOutcomes measure: Organic Nitrite Level, secondaryOutcomes measure: Interleukin 6 (IL-6) Level, secondaryOutcomes measure: Interleukin 6 (IL-6) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level, secondaryOutcomes measure: Reactive Hyperemia Index (RHI) Score, secondaryOutcomes measure: Reactive Hyperemia Index (RHI) Score, secondaryOutcomes measure: Epworth Sleepiness Scale (ESS) Score, secondaryOutcomes measure: Epworth Sleepiness Scale (ESS) Score, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score, secondaryOutcomes measure: Fatigue Severity Scale (FSS) Score, secondaryOutcomes measure: Fatigue Severity Scale (FSS) Score, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI) Score, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI) Score, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06311032, orgStudyIdInfo id: 22-01227, briefTitle: Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2023-06-28, completionDateStruct date: 2023-07-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas., conditionsModule conditions: Surgery Risk Assessment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of Decisions to Stop Surveillance Imaging, primaryOutcomes measure: Number of Decisions to Continue Surveillance Imaging, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06311019, orgStudyIdInfo id: 791572, briefTitle: The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections, acronym: Dia2tech, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Klavs Würgler Hansen, class: OTHER, collaborators name: Steno Diabetes Center Aarhus, Denmark, descriptionModule briefSummary: The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c \>53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care., conditionsModule conditions: Type 2 Diabetes Treated With Insulin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitoring and use of connected insulinpen for bolus insulin, outcomesModule primaryOutcomes measure: Change in Haemoglobin A1c, secondaryOutcomes measure: Change Time in range, secondaryOutcomes measure: Change in Time above range, secondaryOutcomes measure: Change in Time below range, secondaryOutcomes measure: Mean glucose, secondaryOutcomes measure: Standard deviation, secondaryOutcomes measure: Change in CV, secondaryOutcomes measure: Change in Time with rapid glucose change, secondaryOutcomes measure: Change in ARRC, secondaryOutcomes measure: Fraction of patients with increased number of bolus insulin per day, otherOutcomes measure: Fingerprick glucose measurement, otherOutcomes measure: Glucose views on mobile phone, otherOutcomes measure: Use of Novopen 6 memory function, otherOutcomes measure: WHO-5, otherOutcomes measure: Diabetes Distress Scale, otherOutcomes measure: Revised short form of hypoglycaemia Fear Survey, otherOutcomes measure: eHealth literacy questionnaire (eHLQ),, otherOutcomes measure: The Glucose Monitoring Satisfaction Questionnaire, otherOutcomes measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Aarhus, status: NOT_YET_RECRUITING, city: Aarhus, zip: 8000, country: Denmark, contacts name: Katrine B Gørlitz, MD, role: CONTACT, phone: +45 24210787, email: KAGOER@rm.dk, contacts name: Søren Gregersen, Professor, role: CONTACT, phone: +45 30134245, email: soeren.gregersen@aarhus.rm.dk, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Regional Hospital Silkeborg, Central Jutland Hospital, status: RECRUITING, city: Silkeborg, zip: 8600, country: Denmark, contacts name: Katrine B Gørlitz, MD, role: CONTACT, phone: +45 24210787, email: KAGOER@rm.dk, contacts name: Klavs W Hansen, Professor, role: CONTACT, phone: +45 78417847, email: klavhans@rm.dk, geoPoint lat: 56.1697, lon: 9.54508, hasResults: False
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protocolSection identificationModule nctId: NCT06311006, orgStudyIdInfo id: K170103J, secondaryIdInfos id: 2019-A02579-48, type: OTHER, domain: ANSM, briefTitle: Safety Registry of a Fecal Microbiota Transplant Cohort, acronym: COSMIC-FMT, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-04, primaryCompletionDateStruct date: 2029-01-04, completionDateStruct date: 2029-01-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations.There is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT., conditionsModule conditions: Clostridium Difficile Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 305, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Proportion of hospitalizations attributable to FMT, secondaryOutcomes measure: Proportion of Clostridium difficile relapses, secondaryOutcomes measure: Proportion of relapse, secondaryOutcomes measure: Proportion of reinfections, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of patients, secondaryOutcomes measure: Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to the method of preparation and administration of fecal preparation, secondaryOutcomes measure: Evolution of transit (i.e. number of stools per day and their consistency) and mean BMI in patients Correlation between the evolution of transit and the BMI of the donor and the patient., secondaryOutcomes measure: Patient status (absence of recurrence or relapse or re-infection) according to the composition of the microbiota (by sequencing or metabolomic method or culture) of the donors., secondaryOutcomes measure: Composition of the patient's microbiota before FMT and at week 10 and composition of the donor's microbiota (by sequencing or metabolomic method or culture) of the raw stool and the preparation to be administered to the patient., secondaryOutcomes measure: adverse event rate, secondaryOutcomes measure: Metabolomic, immunological analysis (phenotype of peripheral blood immune cells) of the donor and the patient before and after FMT (at W10)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gastroenterology Department of Saint Antoine Hospital, status: RECRUITING, city: Paris, zip: 75012, country: France, contacts name: Harry SOKOL, MD, PhD, role: CONTACT, phone: 0033 1 49 28 31 62, phoneExt: +33, email: harry.sokol@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06310993, orgStudyIdInfo id: STH22549, briefTitle: Exercise to Boost Immunity in Advanced Cancer, acronym: BICEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sheffield Teaching Hospitals NHS Foundation Trust, class: OTHER, collaborators name: University of Sheffield, collaborators name: Sheffield Hallam University, descriptionModule briefSummary: The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression, conditionsModule conditions: Mesothelioma; Lung, conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Primary Outcome Measure, secondaryOutcomes measure: Secondary outcome 1, secondaryOutcomes measure: Secondary Outcome 2, secondaryOutcomes measure: Secondary Outcome 3, secondaryOutcomes measure: Secondary Outcome 4, secondaryOutcomes measure: Secondary Outcome 5, secondaryOutcomes measure: Secondary Outcome 6, secondaryOutcomes measure: Secondary Outcome 7, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Research Centre at Weston Park Hospital, city: Sheffield, state: England, zip: S1O 2SJ, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, locations facility: Sheffield Hallam University, city: Sheffield, state: South Yorkshire, zip: S10 2BP, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False
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protocolSection identificationModule nctId: NCT06310980, orgStudyIdInfo id: SMARTPEN, briefTitle: Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor., acronym: SMARTPEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Giulio Frontino, class: OTHER, descriptionModule briefSummary: The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: smartpen, outcomesModule primaryOutcomes measure: Time in range, secondaryOutcomes measure: time below range, secondaryOutcomes measure: time above range, secondaryOutcomes measure: coefficient of variation (CV), secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: ITSRQ, secondaryOutcomes measure: DIDS, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310967, orgStudyIdInfo id: IG3018-23-02-01, briefTitle: A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Intelligem Therapeutics Australia Pty Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD., conditionsModule conditions: Hyperuricemia, conditions: Hypouricemia, Renal, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Part 1 is a randomized, double-blind, placebo-controlled study where the doses of the study drug are escalated in a predesigned manner in 3 cohorts.Initiation Dose shall be at 0.25 g tablets (Cohort A) and doses are escalated to 0.5 g (Cohort B) and then to 1.0 g (Cohort C) in a planned manner. Each cohort will have 10 eligible patients. Randomization will be performed in Part 1 and as per the randomization code, 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort. A total of 30 subjects are planned to be enrolled.Part 2 is an open-label proof of concept study involving hyperuricemia subjects with advanced predialysis CKD (Stage 3A, Stage 3B and Stage 4), and treated with two doses \[0.5 g BID IG3018 (Cohort D) and 1.0 g BID IG3018 (Cohort E)\] . At least 5 to 8 hyperuricemia subjects with advanced CKD will be enrolled in each dose and will receive the determined study dose of IG3018 twice daily (BID) for 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Part 1 is a randomized, double-blind, placebo-controlled study. For each dose cohort in Part 1, the Sponsor, subjects and other personnel involved with the conduct of the study will be blinded to the study products.Part 2 is an open-label proof of concept study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: IG3018, interventions name: Placebo matching IG3018, outcomesModule primaryOutcomes measure: Safety Assessments (Part 1 and Part 2), primaryOutcomes measure: The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2), secondaryOutcomes measure: The proportions of change from baseline in serum uric acid to ≤ 0.30 mmol/L and ≤ 0.24 mmol/L respectively (Part 1 and Part 2), secondaryOutcomes measure: The actual change of serum uric acid (Part 1 and Part 2), secondaryOutcomes measure: The percentage change of serum uric acid (Part 1 and Part 2), secondaryOutcomes measure: Gouty Attacks (Part 1 and Part 2), secondaryOutcomes measure: Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only), secondaryOutcomes measure: Ae of IG3018 (Part 1 only), secondaryOutcomes measure: Cmax of IG3018 (Part 1 only), secondaryOutcomes measure: Tmax of IG3018 (Part 1 only), secondaryOutcomes measure: T1/2 of IG3018 (Part 1 only), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310954, orgStudyIdInfo id: 2022-KY-012, briefTitle: Ketogenic Diet in Pediatric Intractable Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-11, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies., conditionsModule conditions: Epilepsy in Children, conditions: Epilepsy Intractable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 59, type: ESTIMATED, armsInterventionsModule interventions name: Early ketogenic diet combined with conventional pharmacotherapy., interventions name: Common diet combined with conventional pharmacotherapy, outcomesModule primaryOutcomes measure: Epilepsy Control Response Rate, secondaryOutcomes measure: Inflammatory Marker Levels, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sun Yat Sen Memorial Hospital， Sun Yat Sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Dongfang Li, role: CONTACT, phone: +8615521284993, email: ldf201310@163.com, contacts name: Dongfang Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06310941, orgStudyIdInfo id: ABSENTA, secondaryIdInfos id: Pending, type: OTHER, domain: Ceim HCSC (ERB of Hospital Clinico San Carlos)), briefTitle: Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection, acronym: ABSENTA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2026-10-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hospital San Carlos, Madrid, class: OTHER, descriptionModule briefSummary: Randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like eradicating bacteria or reducing inflammation., conditionsModule conditions: Nosocomial Infection, conditions: Nosocomial Pneumonia, conditions: Tracheobronchitis, conditions: Mechanical Ventilation Complication, conditions: Endotracheal Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mechanical insufflation-exsufflation, interventions name: Standard of Care, interventions name: Hypertonic saline with hyaluronic acid, outcomesModule primaryOutcomes measure: Median SOFA score increase >2 points on day 4, primaryOutcomes measure: Median respiratory support-free days increase at day 28, primaryOutcomes measure: Percentage of subjects surviving/dying day 28, secondaryOutcomes measure: Subjects with bacterial eradication in respiratory samples at day 4 after randomization, secondaryOutcomes measure: Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy, secondaryOutcomes measure: Median Length of ICU stay, secondaryOutcomes measure: Median antibiotic-free days at 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310928, orgStudyIdInfo id: SBU-201001077-2022, briefTitle: The Effect of Thermal Blanket After Peripheral Artery Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-20, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Peripheral arterial disease is one of the most common clinical conditions associated with cardiovascular morbidity and increased mortality, requiring exercise, antiaggregant and surgical revascularization therapy. As in peripheral arterial surgery, postoperative hypothermia is common in patients who have undergone surgical intervention and the duration of surgery is longer than 30 minutes due to the low temperature of the surgical environment or the suppression of the thermoregulation center by anesthetics and sedatives. With hypothermia, heat loss increases,peripheral vasoconstriction with activation of the sympathetic system, impaired perfusion at the surgical wound site, hypoxemia, coagulopathy, bleeding, postoperative pain, deterioration of thermal comfort, deterioration of patient comfort and prolonged hospital stay are reported. Many heating methods are used to achieve and maintain normal body temperature in the postoperative period, to prevent complications caused by hypothermia.Aluminum-coated thermal blankets are especially preferred. In this way, heat preservation, peripheral vasodilation and perfusion with the effect of temperature, reduction of muscle spasm with increased endorphin release, less pain, and increased comfort of the patient are provided. The thermal blanket is an easy-to-apply material that does not require any tools or electricity for its effectiveness and can come into direct contact with the patient's skin. It provides thermal insulation with its ability to reflect thermal radiation. Peripheral vasodilation and decreased peripheral vascular resistance have been observed with thermal therapy provided by thermal blankets. It is known that thermal blanket methods are used to warm patients in practice. However, the lack of a literature study on the regional effect of these applications on the patient has been noticed. For this purpose, in this study, the regional efficacy of thermal blankets on the patient was evaluated in order to reduce the narrowed arterial lumen and increased peripheral vascular resistance in peripheral arterial diseases and to prevent the vasoconstrictive effect of hypothermia on peripheral vessels. It was predicted that these blankets would maintain heat, increase tissue perfusion with peripheral vasodilation effect, facilitate circulation, reduce pain and facilitate mobilization.In line with this aim, the objectives are;* To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery.* To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery.* To increase the patient's postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming.* To contribute to the control of pain, neurovascular follow-up and reduction of damage and mobilization, which are the main nursing goals after surgery.* To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets, thus providing an easy-to-apply, effective care in terms of nursing and increasing the quality of health care service.Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patient's circulation, pain and mobilization., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a single center randomized controlled clinical trial.The sample consisted of a total of 60 patients who would undergo interventional peripheral arterial surgery, met the study criteria and agreed to participate in this study. They will be divided into two groups as 30 experimental group and 30 control group by randomization method., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Thermal Blanket, outcomesModule primaryOutcomes measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation, secondaryOutcomes measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain, otherOutcomes measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Mobilization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sağlık Bilimleri University, status: RECRUITING, city: Istanbul, state: Uskudar, zip: 34674, country: Turkey, contacts name: BIRGUL AYDOGAN, RN, role: CONTACT, phone: +905336337651, email: 201001077@ogrenci.sbu.edu.tr, contacts name: SONAY GÖKTAŞ, PROF.DR., role: CONTACT, phone: +905324567776, email: sonay.goktas@sbu.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06310915, orgStudyIdInfo id: CROC202310, briefTitle: Oral Chemotherapeutic Drugs Were Analyzed in Patients With Driver Gene Negative Locally Advanced/Advanced Non-small Cell Lung Cancer With PS Score 2 A Prospective, Single-arm, Multicenter, Observational Study on the Efficacy and Safety of Radiochemotherapy Combined With PD-1 Inhibitor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-17, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Guangzhou Institute of Respiratory Disease, class: OTHER, descriptionModule briefSummary: Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor., conditionsModule conditions: Non-small Cell Lung Cancer Stage IIIB/IV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Navelbine oral,Pembrolizumab, outcomesModule primaryOutcomes measure: Progression-free survival time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangdong, state: Guangzhou, zip: 510000, country: China, contacts name: zhou chegnzhi, doctor, role: CONTACT, phone: 13560351186, email: doctorzcz@163.com, hasResults: False
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protocolSection identificationModule nctId: NCT06310902, orgStudyIdInfo id: 2024KY022, briefTitle: Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University Union Hospital, class: OTHER, descriptionModule briefSummary: Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group., conditionsModule conditions: Pancreatic Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Single-cell Sequencing Analysis, outcomesModule primaryOutcomes measure: Bioinformatics analysis of single-cell sequencing results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Yu Pan, M.D, role: CONTACT, phone: +86 18900316399, email: yupan199002@163.com, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06310889, orgStudyIdInfo id: EPIC-Baseline-Survey, briefTitle: Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project, acronym: EPIC-BS, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: European Commission, collaborators name: National and Kapodistrian University of Athens, collaborators name: King's College Hospital NHS Trust, descriptionModule briefSummary: The subject of the study is an online survey of doctors and nurses who provide (intensive) medical care to patients., conditionsModule conditions: Palliative Medicine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, outcomesModule primaryOutcomes measure: Barriers 1, primaryOutcomes measure: Barriers 2, secondaryOutcomes measure: Measures 1, secondaryOutcomes measure: Measures 2, secondaryOutcomes measure: Resources 1, secondaryOutcomes measure: Resources 2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 67 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310876, orgStudyIdInfo id: M24-852, briefTitle: A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Calico Life Sciences LLC, class: INDUSTRY, collaborators name: AbbVie, descriptionModule briefSummary: This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: ABBV-CLS-7262, interventions name: ABBV-CLS-7262, interventions name: Placebo, interventions name: Moxifloxacin 400mg, outcomesModule primaryOutcomes measure: To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects, secondaryOutcomes measure: To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters, secondaryOutcomes measure: To evaluate the sensitivity of QTc measurement using moxifloxacin, secondaryOutcomes measure: To evaluate the effect of ABBV-CLS-7262 on T-wave morphology, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: AbbVie Clinical Pharmacology Research Unit (ACPRU), status: RECRUITING, city: Grayslake, state: Illinois, zip: 60030, country: United States, geoPoint lat: 42.34447, lon: -88.04175, hasResults: False
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protocolSection identificationModule nctId: NCT06310863, orgStudyIdInfo id: EXOCOBIO-NASAL-01, briefTitle: Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-07, primaryCompletionDateStruct date: 2020-11-24, completionDateStruct date: 2020-11-24, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds.Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds.Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety., conditionsModule conditions: Dermal Fillers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Matched pairs, Active controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers, outcomesModule primaryOutcomes measure: Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group, secondaryOutcomes measure: The mean value differences in the WSRS scores between the test group and the control group, secondaryOutcomes measure: Differences in GAIS mean values between test and control groups, secondaryOutcomes measure: Percentage of subjects with WSRS score improvement of at least 1 point, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan mediccal center, city: Seoul, state: Songpa-gu, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06310850, orgStudyIdInfo id: KEAH-238, briefTitle: The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-06-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ankara Ataturk Sanatorium Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure., conditionsModule conditions: Epidural Catheterization, conditions: Thoracic, conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was designed as a randomized, prospective study, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Ketamine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visual analog scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Atatürk Sanatorium Training and Research Hospital, city: Ankara, state: Keçiören, zip: 06290, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06310837, orgStudyIdInfo id: 2023KYPJ300, briefTitle: Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-08-27, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, collaborators name: The Eye Hospital of Wenzhou Medical University, collaborators name: The First Affiliated Hospital of Soochow University, collaborators name: Shandong Eye Hospital, descriptionModule briefSummary: This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues., conditionsModule conditions: Uveitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Adalimumab Biosimilars Injection, interventions name: Corticosteroid, interventions name: Immunosuppressive Agents, outcomesModule primaryOutcomes measure: Change of ETDRS letter count for BCVA at week 24 from baseline, secondaryOutcomes measure: Proportion of patients with weight gain at week 24 from baseline, secondaryOutcomes measure: Time of treatment failures, secondaryOutcomes measure: Number of treatment failures, secondaryOutcomes measure: Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline, secondaryOutcomes measure: Change of anterior chamber inflammation at week 24 from baseline, secondaryOutcomes measure: Change of vitreous opacity at week 24 from baseline, secondaryOutcomes measure: Change of the retinal and choroidal inflammation at week 24 from baseline, secondaryOutcomes measure: Change of the thickness of retina and choroid in macular area at week 24 from baseline, secondaryOutcomes measure: Occurrence of skin abnormalities at the end of study, secondaryOutcomes measure: Occurrence of hypertension at the end of study, secondaryOutcomes measure: Occurrence of hyperglycemia at the end of study, secondaryOutcomes measure: Occurrence of active tuberculosis infection at the end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Ophthalmic Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Wei Chi, role: CONTACT, phone: 13710616456, email: chiwei@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06310824, orgStudyIdInfo id: MAB-22-101, briefTitle: Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Xentria, Inc., class: INDUSTRY, descriptionModule briefSummary: A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®, conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: MAB-22, interventions name: EU-Prolia®, interventions name: US-Prolia®, outcomesModule primaryOutcomes measure: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), primaryOutcomes measure: Maximum observed serum concentration (Cmax), secondaryOutcomes measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last), secondaryOutcomes measure: Area under the concentration-time curve, secondaryOutcomes measure: Area under the concentration-time curve, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06310811, orgStudyIdInfo id: BHCT-RD06-04-01, briefTitle: Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE.This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12.This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2.Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group.1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time.2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD.3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation.4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances.Case expansion:After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT)., conditionsModule conditions: Safety, conditions: Effective, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All patients will be treated with RD06-04 cell injections in a single group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: RD06-04 Cells injection, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity (DLT), primaryOutcomes measure: The incidence of treatment-based adverse events (TEAEs) and the incidence of serious adverse events (SAEs)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wuhan Union, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Heng Mei, Chief physician, role: CONTACT, phone: 13886160811, email: hmei@hust.edu.cn, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06310798, orgStudyIdInfo id: Dnr. 2020-04603, briefTitle: Inter-organizational Health Planning for Older Adults: Public Dental Care and Municipal Care, acronym: GAPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03-01, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, collaborators name: Göteborg University, collaborators name: Gothia Forum - Center for Clinical Trial, collaborators name: Chalmers University of Technology, descriptionModule briefSummary: Patient participation is key for healthy ageing and essential in health planning and decision-making. Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults, dental and nursing staff participate. It has been concluded that shared tools, such as common documentation, and working in teams enables person-centered care in ordinary home settings. Therefore, this protocol outlines the design of a randomized controlled trial (RCT) measuring and comparing effect of two models of team based oral health planning with a common tool (digital platform) in ordinary home care settings in Sweden. The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing.Following ethics approval, a study design was developed guided by the seven action-steps of the knowledge to action framework. In the sixth action-step, older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT. From there older adults,dental hygienists (DH) and nursing assistants (NA) will be randomized into test and control groups. The test group (n= 12 DH and 12 NA) will participate in a two-day course, where a three-step person-centered oral health model will be taught. Control group will be 12 DH within dental care remuneration program conducting business as usual (with unknown number of NA, due to present guidelines). In total 360 older adults/patients will be asked to participate. Test group and control group will respectively have 180 patients each, as such, each team (DH + NA) have 15 patients. Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index. Secondary outcomes include a retrospective record review, a health economic evaluation, Person Centered care Assessment Tool and Oral Hygiene Ability Index. Additionally, qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group., conditionsModule conditions: Oral Health, conditions: Oral Health Related Quality of Life, conditions: Participation, conditions: Participation, Patient, conditions: Health Planning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In pairs, DHs within public dental care organization in the West of Sweden will be randomized into test and control groups. Due to geographical concerns, NAs within the same municipal as the test control DHs will be asked to participate. As such, the test-group will consist of 12 DHs and 12 NAs. They will form teams in pairs, and each team will collaborate with 15 older adults each in home settings, who participate in the oral assessments and health planning. The control group will consist of 12 DHs which will perform oral assessments according to dental care remuneration programme - business as usual. It is not mandatory but recommended for NAs to participate in the oral assessments, therefore the number of participating NAs within control group is unknown. In total 360 oral assessments and health planning will be performed within the RCT., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Inter-professional team test, outcomesModule primaryOutcomes measure: Revised oral assessment guide, primaryOutcomes measure: Revised oral assessment guide, primaryOutcomes measure: Revised oral assessment guide, primaryOutcomes measure: Geriatric oral health assessment index, primaryOutcomes measure: Geriatric oral health assessment index, primaryOutcomes measure: Geriatric oral health assessment index, secondaryOutcomes measure: Sure of myself; understanding information; risk-benefit ration; encouragement-test, secondaryOutcomes measure: Person centered care assessment tool, secondaryOutcomes measure: Person centered care assessment tool, otherOutcomes measure: Retrospective review of records within municipal health care, otherOutcomes measure: Participants experiences of oral health planning in ordinary home settings, otherOutcomes measure: Oral hygiene ability index (OHAI), otherOutcomes measure: Oral hygiene ability index (OHAI), otherOutcomes measure: Health related quality of life instrument, otherOutcomes measure: Health related quality of life instrument, otherOutcomes measure: Health related quality of life instrument, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Folktandvården Västra Götaland, city: Göteborg, state: Västra Götalandsregionen, zip: 42139, country: Sweden, contacts name: Jessica Persson Kylén, PhD, role: CONTACT, phone: +46769472654, email: jessica.persson-kylen@hv.se, contacts name: Eva-Karin Bergström, PhD, role: CONTACT, phone: +46733261110, email: eva-karin.bergstrom@vgregion.se, contacts name: Åsa Leonhardt, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06310785, orgStudyIdInfo id: TJ-IRB20231191, briefTitle: Esketamine Anesthesia in Thoracic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hui Xu, class: OTHER, descriptionModule briefSummary: Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h., conditionsModule conditions: General Anesthesia, conditions: Thoracic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Neither the patients who participated in the trial nor the analysis of the results of the study were aware of the experimental group, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine, interventions name: Sufentanil, outcomesModule primaryOutcomes measure: Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation, secondaryOutcomes measure: Lung compliance during double lung ventilation during operation, secondaryOutcomes measure: Compliance of the ventilator-side lung during one-lung ventilation during operation, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood gas analysis results, secondaryOutcomes measure: Serum inflammatory factor levels, secondaryOutcomes measure: cognitive function, secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Depression and anxiety, secondaryOutcomes measure: Postoperative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310772, orgStudyIdInfo id: NSF 2304297, briefTitle: Assessing Comorbidities in Epilepsy Using Eye Movement Recordings, acronym: ACER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Eysz, Inc., class: INDUSTRY, collaborators name: Wake Forest University Health Sciences, collaborators name: Children's Hospital of Orange County, collaborators name: University of Colorado, Denver, descriptionModule briefSummary: This study wants to make it easier to find kids with a type of epilepsy called childhood absence epilepsy (CAE) who might have problems with ongoing seizures and thinking. Right now, doctors use tests that can be expensive and take a long time. Eysz is developing a system that looks at how kids move their eyes which might help find CAE more quickly and accurately. This study will compare Eysz with the usual tests to see if it can predict seizures and thinking problems in kids with CAE. The goal is to find these problems earlier and help kids do better in school and life., conditionsModule conditions: Childhood Absence Epilepsy, conditions: Absence Seizures, conditions: Epilepsy Comorbidities, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Eye Movements to Diagnose CAE, secondaryOutcomes measure: Eye Movements to Diagnose Attention challenges, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Orange County, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Wake Forest Baptist Health, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06310759, orgStudyIdInfo id: R21088B, briefTitle: Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer, acronym: UROSCOUT-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tampere University Hospital, class: OTHER, collaborators name: Tampere University, descriptionModule briefSummary: Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients., conditionsModule conditions: Urothelial Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection, secondaryOutcomes measure: Sensitivity and specificity of cystoscopy for urothelial cancer detection, secondaryOutcomes measure: Sensitivity and specificity of urine cytology for urothelial cancer detection, secondaryOutcomes measure: Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy, secondaryOutcomes measure: Adverse event rate for cystoscopy, secondaryOutcomes measure: Technical success rate of utDNA test, secondaryOutcomes measure: Estimate of diagnostic cystoscopies avoided, secondaryOutcomes measure: Specificity of high-stringency utDNA threshold, otherOutcomes measure: Characteristics of urothelial cancers that were not detected by the utDNA test, otherOutcomes measure: Concordance between utDNA and urine cytology results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vancouver Prostate Centre, status: NOT_YET_RECRUITING, city: Vancouver, state: British Columbia, country: Canada, contacts name: Peter Black, role: CONTACT, contacts name: Peter Black, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, locations facility: Helsinki University Hospital, status: NOT_YET_RECRUITING, city: Helsinki, country: Finland, contacts name: Riikka Järvinen, role: CONTACT, contacts name: Tuomas Jalanko, role: CONTACT, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Tampere University Hospital and Tampere University, status: RECRUITING, city: Tampere, country: Finland, contacts name: Jussi Nikkola, role: CONTACT, contacts name: Thea Veitonmäki, role: CONTACT, contacts name: Jussi Nikkola, role: PRINCIPAL_INVESTIGATOR, contacts name: Matti Annala, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Turku University Hospital, status: NOT_YET_RECRUITING, city: Turku, country: Finland, contacts name: Peter Boström, role: CONTACT, contacts name: Otto Ettala, role: CONTACT, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
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