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protocolSection identificationModule nctId: NCT06273033, orgStudyIdInfo id: CONCORDE, briefTitle: Implementation of Contemporary Coronary CT Angiography in Clinical Practice, acronym: CONCORDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Humanitas Hospital, Italy, class: OTHER, descriptionModule briefSummary: Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe.The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies., conditionsModule conditions: Coronary Artery Disease of Significant Bypass Graft, conditions: Coronary Syndrome, conditions: Coronary Arteriosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD., secondaryOutcomes measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD., secondaryOutcomes measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD, secondaryOutcomes measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: Milano, zip: 20089, country: Italy, contacts name: Carlo Andrea Pivato, MD, role: CONTACT, phone: +39 02 8224 7235, email: [email protected], geoPoint lat: 45.38193, lon: 9.1559, hasResults: False |
protocolSection identificationModule nctId: NCT06273020, orgStudyIdInfo id: MI22-00013, briefTitle: Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-17, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Dr. Jose E. Gonzalez, class: OTHER, collaborators name: Ever Neuro Pharma GmbH, descriptionModule briefSummary: A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes, conditionsModule conditions: Ischemic Stroke, Acute, conditions: Diabetes Mellitus, Type 2, conditions: Blood Brain Barrier, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are 3 groups in this clinical trialGroup 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cerebrolysin, interventions name: Brain-MRI with contrast after 10-14 days of cerebrolysin, outcomesModule primaryOutcomes measure: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery, secondaryOutcomes measure: Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin, secondaryOutcomes measure: Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin, secondaryOutcomes measure: Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González", status: RECRUITING, city: Nuevo León, state: Monterrey, zip: 64020, country: Mexico, contacts name: Servicio F de Neurología del Hospital Universitario "Dr.José E. González", role: CONTACT, phone: +528183591111, email: [email protected], contacts name: José C Becerra-Cruz, M.D., role: CONTACT, phone: +522324393970, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06273007, orgStudyIdInfo id: EFP_2023_02_19, briefTitle: Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach, acronym: PartoMa-Eth, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Haramaya Unversity, class: OTHER, collaborators name: University of Copenhagen, collaborators name: Leiden University Medical Center, collaborators name: Laerdal Foundation, descriptionModule briefSummary: Overall ObjectiveTo introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.Interventions1. Locally agreed and achievable intrapartum guidelines2. Low dose high frequency trainings (LDHF)3. Partograph Overall DesignA quasi-experimental pre-post study (PartoMa study)SettingDepartment of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.PopulationLaboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.EndpointsThe primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.Study TimeData collection from June 2023 to May 2025.Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.SettingPartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000., conditionsModule conditions: Stillbirth, conditions: Obstetric Complication, conditions: Maternal Death, conditions: Perinatal Death, conditions: Perinatal Morbidity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings, outcomesModule primaryOutcomes measure: stillbirth, primaryOutcomes measure: Birth Asphyxia, secondaryOutcomes measure: Maternal death, secondaryOutcomes measure: Cesarean sections and vacuum extractions, secondaryOutcomes measure: Process indicators of quality of intrapartum care, secondaryOutcomes measure: Birth attendant's perception of their work condition in the labour and delivery rooms, secondaryOutcomes measure: The women's experience of care received during delivery., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Haramaya Hospital, status: RECRUITING, city: Harar, state: Oromia, country: Ethiopia, contacts name: Roba Ararsa, MD, role: CONTACT, geoPoint lat: 9.31387, lon: 42.11815, locations facility: Hiwot Fana University Hospital, status: NOT_YET_RECRUITING, city: Harar, country: Ethiopia, contacts name: Redwan Ahmed, MD, role: CONTACT, geoPoint lat: 9.31387, lon: 42.11815, hasResults: False |
protocolSection identificationModule nctId: NCT06272994, orgStudyIdInfo id: 231724, briefTitle: Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin, acronym: STOP-Vanc, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care., conditionsModule conditions: Community-acquired Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be performed as a single center, pragmatic, randomized clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 212, type: ESTIMATED, armsInterventionsModule interventions name: MRSA Nasal Swab PCR, outcomesModule primaryOutcomes measure: Vancomycin-free hours alive, secondaryOutcomes measure: Time Alive off Vancomycin, secondaryOutcomes measure: 30-day all-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False |
protocolSection identificationModule nctId: NCT06272981, orgStudyIdInfo id: BWI202308, briefTitle: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS, acronym: PulseSmart, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-08-29, completionDateStruct date: 2025-08-29, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Biosense Webster, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation, outcomesModule primaryOutcomes measure: Number of Participants with Primary Adverse Events (PAEs), primaryOutcomes measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure, secondaryOutcomes measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Prince Alfred Hospital, status: NOT_YET_RECRUITING, city: Camperdown, zip: 2050, country: Australia, geoPoint lat: -33.88965, lon: 151.17642, locations facility: Canberra Heart Rhythm, status: RECRUITING, city: Garran, zip: 2605, country: Australia, geoPoint lat: -35.34206, lon: 149.10846, locations facility: John Hunter Hospital, status: WITHDRAWN, city: New Lambton Heights, zip: 2305, country: Australia, geoPoint lat: -32.92466, lon: 151.69364, locations facility: Westmead Hospital, status: RECRUITING, city: Westmead, zip: 2145, country: Australia, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Southlake Regional Health Centre, status: NOT_YET_RECRUITING, city: Newmarket, state: Ontario, zip: L3Y 2P9, country: Canada, geoPoint lat: 44.05011, lon: -79.46631, locations facility: University of Ottawa Heart Institute, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, zip: K1Y 4W7, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Montreal Heart Institute, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H1T 1C8, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: McGill University Health Centre, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H3G 1A4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06272968, orgStudyIdInfo id: EA2/252/23, briefTitle: Predicting Cognition After DBS for Parkinson's Disease 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2030-12-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, descriptionModule briefSummary: The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures., conditionsModule conditions: Cognitive Impairment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological Testing, outcomesModule primaryOutcomes measure: Change in cognitive performance after STN-DBS, primaryOutcomes measure: Incidence of postoperative neurocognitive disorder, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - Universitätsmedizin Berlin, city: Berlin, zip: 13351, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False |
protocolSection identificationModule nctId: NCT06272955, orgStudyIdInfo id: H-54417, briefTitle: LONG TERM EFFECTS OF SPINAL CORD STIMULATION, acronym: SCS for FOG OL, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Nora Vanegas, class: OTHER, descriptionModule briefSummary: Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Cord Stimulator (SCS), outcomesModule primaryOutcomes measure: Safety and Tolerability, secondaryOutcomes measure: New Freezing of Gait Questionnaire (NFOG-Q) score, secondaryOutcomes measure: Gait and Falls Questionnaire (GFQ), secondaryOutcomes measure: MDS-UPDRS score, secondaryOutcomes measure: Timed Up and Go test (TUG), secondaryOutcomes measure: Timed 10-meter walk (T10MW), secondaryOutcomes measure: Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Montreal Cognitive Assessment Scale (MoCA), secondaryOutcomes measure: Beck Depression Inventory (BDI-2), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Parkinson's Disease Questionnaire - 39 (PDQ39), secondaryOutcomes measure: Non-Motor Symptoms Scale (NMSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor College of Medicine, city: Houston, state: Texas, zip: 77005, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06272942, orgStudyIdInfo id: 22722, briefTitle: An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States, acronym: SeeMe Tool, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.In observational studies, only observations are made without participants receiving any advice or any changes to health care.People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay., conditionsModule conditions: Acute Respiratory Distress Syndrome (ARDS), conditions: Post Intensive Care Syndrome (PICS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 140000, type: ESTIMATED, armsInterventionsModule interventions name: An ICU admission and a temporally related ARDS diagnosis, outcomesModule primaryOutcomes measure: Morbidity, primaryOutcomes measure: Post ICU Syndrome-related morbidity, primaryOutcomes measure: Incident morbidity, primaryOutcomes measure: Post ICU Syndrome-related incident morbidity, primaryOutcomes measure: Difference in prevalence rates pre versus post index hospitalization, primaryOutcomes measure: Average total healthcare costs based on healthcare billing data in the one year post index ICU admission, otherOutcomes measure: Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Whippany, state: New Jersey, zip: 07981, country: United States, geoPoint lat: 40.82454, lon: -74.4171, hasResults: False |
protocolSection identificationModule nctId: NCT06272929, orgStudyIdInfo id: behcet and vascular, briefTitle: Serum Elafin and Vascular Affection in Behcet Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.To assess the correlation between serum elafin and vascular affection and their relation with disease activity., conditionsModule conditions: Behcet Disease and Vascular Affection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: doppler ultrasound, outcomesModule primaryOutcomes measure: Measuring the level of serum Elafin in patients with BD in comparison to healthy participants., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272916, orgStudyIdInfo id: Effect drugs on headache inCS, briefTitle: Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH., conditionsModule conditions: Post-Dural Puncture Headache, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 630, type: ESTIMATED, armsInterventionsModule interventions name: Aminophylline, magnesium sulphate and placebo, outcomesModule primaryOutcomes measure: Effect of the study drugs on the incidence and severity of PDPH, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272903, orgStudyIdInfo id: MBRU IRB-2023-228, briefTitle: Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Mohammed Bin Rashid University of Medicine and Health Sciences, class: OTHER, descriptionModule briefSummary: The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE)., conditionsModule conditions: Effect of Benzocaine on Pain, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: 20% benzocaine, topical anesthetic, interventions name: Children's Toothpaste, outcomesModule primaryOutcomes measure: Immediate Pain Levels, secondaryOutcomes measure: Patient Satisfaction During Procedure, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mohammed Bin Rashid University Of Medicine and Health Sciences, city: Dubai, country: United Arab Emirates, contacts name: Iyad Hussein, role: CONTACT, phone: 971564715509, email: [email protected], contacts name: Simran Kaur Sura, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.0657, lon: 55.17128, hasResults: False |
protocolSection identificationModule nctId: NCT06272890, orgStudyIdInfo id: GiresunU, briefTitle: THE EFFECT OF MOTIVATIONAL INTERVIEWING ON NURSING STUDENTS WITH SOCIAL ANXIETY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, descriptionModule briefSummary: Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety., conditionsModule conditions: Motivation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research was planned as a randomized controlled experimental study in a two-center parallel group pretest-posttest design., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: In order to prevent detection bias in the study, all measurements will be made using an online survey form. In order to prevent reporting bias, the data obtained from the research will be coded as A and B by an independent statistician, transferred to the SPSS program and analyzed., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: motivational interviewing, outcomesModule primaryOutcomes measure: Motivational interviewing has an effect on nursing students' social anxiety., secondaryOutcomes measure: Motivational interviewing has an effect on nursing students' dating violence., otherOutcomes measure: Motivational interviewing has an effect on nursing students' self-compassion., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272877, orgStudyIdInfo id: 129944-54, briefTitle: Fluidotherapy in Patients With Distal Radius Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Ahi Evran University Education and Research Hospital, class: OTHER, descriptionModule briefSummary: Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase., conditionsModule conditions: Distal Radius Fractures, conditions: Edema Arm, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The Investigator and the outcomes assesor will be different persons. Statician will be different person., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Fluidotherapy, interventions name: conventional rehabilitation program, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Wrist joint range of motion, primaryOutcomes measure: Wrist joint range of motion, primaryOutcomes measure: Wrist joint range of motion, primaryOutcomes measure: Circumference (mm), primaryOutcomes measure: Circumference (mm), primaryOutcomes measure: Circumference (mm), secondaryOutcomes measure: Gross Grip Strength:, secondaryOutcomes measure: Gross Grip Strength:, secondaryOutcomes measure: Gross Grip Strength:, secondaryOutcomes measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire, secondaryOutcomes measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire, secondaryOutcomes measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kirsehir Research and Training Hospital, status: RECRUITING, city: Kirsehir, state: Kişrsehşr, zip: 40100, country: Turkey, contacts name: Levent Horoz, Asst Prof, role: CONTACT, phone: :+90 386 280 39 00, email: [email protected], geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06272864, orgStudyIdInfo id: BEGIN study, briefTitle: BostonGene and Exigent Genomic INsight Study, acronym: BEGIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2026-01-08, completionDateStruct date: 2028-01-08, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: BostonGene, class: INDUSTRY, collaborators name: Exigent, descriptionModule briefSummary: The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings., conditionsModule conditions: Breast Cancer, conditions: Non-small Cell Lung Cancer, conditions: Melanoma, conditions: Sarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Frequency of actionable findings, primaryOutcomes measure: Test turn-around time, secondaryOutcomes measure: Frequency of patients who receive molecularly matched therapy, secondaryOutcomes measure: Frequency of patients who receive molecularly matched therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwest Medical Specialities, city: Puyallup, state: Washington, zip: 98373, country: United States, contacts name: Sibel Blau, MD, role: CONTACT, geoPoint lat: 47.18538, lon: -122.2929, hasResults: False |
protocolSection identificationModule nctId: NCT06272851, orgStudyIdInfo id: Choroidal thickness by OCT, briefTitle: Measuring Choroidal Thickness Using Optical Coherence Tomography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2029-03-30, completionDateStruct date: 2029-05-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography., conditionsModule conditions: Choroid Disease, conditions: Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: optical coherence tomography, outcomesModule primaryOutcomes measure: comparison between choroidal thickness, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272838, orgStudyIdInfo id: 2023-19/145, briefTitle: Biodex Balance System in Patients With Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-09-14, completionDateStruct date: 2024-10-14, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises, conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and Outcomes Assessor will be different persons, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Biodex balance system, interventions name: The conventional balance exercise program, outcomesModule primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Biodex dynamic balance score, primaryOutcomes measure: Biodex dynamic balance score, primaryOutcomes measure: Biodex dynamic balance score, primaryOutcomes measure: The fall efficacy scale, primaryOutcomes measure: The fall efficacy scale, primaryOutcomes measure: The fall efficacy scale, primaryOutcomes measure: Time up and go test, primaryOutcomes measure: Time up and go test, primaryOutcomes measure: Time up and go test, secondaryOutcomes measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8), secondaryOutcomes measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8), secondaryOutcomes measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8), secondaryOutcomes measure: The Five Times Sit to Stand Test, secondaryOutcomes measure: The Five Times Sit to Stand Test, secondaryOutcomes measure: The Five Times Sit to Stand Test, secondaryOutcomes measure: Beck Depression Inventory, secondaryOutcomes measure: Beck Depression Inventory, secondaryOutcomes measure: Beck Depression Inventory, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kırşehir Ahi Evran University Faculty of Medicine, status: RECRUITING, city: Kırşehir, state: City Center, zip: 40100, country: Turkey, contacts name: Basak Cigdem Karacay, Asist Prof, role: CONTACT, phone: 0905445094803, email: [email protected], contacts name: Basak Cigdem Karacay, Asist Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06272825, orgStudyIdInfo id: 2023-19/140, briefTitle: Virtual Reality in Patients With Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-08-14, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation., conditionsModule conditions: Knee Osteoarthritis, conditions: Pain, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and Outcomes Assessor will be different persons., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality, interventions name: conventional rehabilitation, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), primaryOutcomes measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), primaryOutcomes measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), primaryOutcomes measure: Biodex Balance System, primaryOutcomes measure: Biodex Balance System, primaryOutcomes measure: Biodex Balance System, secondaryOutcomes measure: Short Form 36 (SF36), secondaryOutcomes measure: Short Form 36 (SF36), secondaryOutcomes measure: Short Form 36 (SF36), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kırşehir Ahi Evran University Faculty of Medicine, status: RECRUITING, city: Kırşehir, state: City Center, zip: 40100, country: Turkey, contacts name: Basak Cigdem Karacay, Asist Prof, role: CONTACT, phone: 0905445094803, email: [email protected], contacts name: Basak Cigdem Karacay, Asist Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06272812, orgStudyIdInfo id: IAVI C113, briefTitle: A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: International AIDS Vaccine Initiative, class: NETWORK, collaborators name: Biofabri, SLU, collaborators name: Universidad de Zaragoza, descriptionModule briefSummary: A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region., conditionsModule conditions: Tuberculosis (TB), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4300, type: ESTIMATED, armsInterventionsModule interventions name: MTBVAC, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo, secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants., secondaryOutcomes measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants., eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272799, orgStudyIdInfo id: RS1480/21, briefTitle: Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study, acronym: ATD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-20, primaryCompletionDateStruct date: 2024-09-20, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, descriptionModule briefSummary: Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: T-DM1 adjuvant, outcomesModule primaryOutcomes measure: Evaluate the tolerability., secondaryOutcomes measure: Evaluate the effectiveness of treatment., eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Patrizia Vici, Doctor, role: CONTACT, phone: 06-5266.5584, phoneExt: +39, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06272786, orgStudyIdInfo id: 2023-18/128, briefTitle: Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications., conditionsModule conditions: Rotator Cuff Tears, conditions: Pain, conditions: Nerve Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator and outcome assessor will be different persons., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: conventional physiotherapy program., interventions name: Suprascapular nerve block, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Shoulder joint range of motion (ROM), primaryOutcomes measure: Shoulder joint range of motion (ROM), primaryOutcomes measure: Shoulder joint range of motion (ROM), secondaryOutcomes measure: Shoulder Pain and Disability İndex (SPADİ), secondaryOutcomes measure: Shoulder Pain and Disability İndex (SPADİ), secondaryOutcomes measure: Shoulder Pain and Disability İndex (SPADİ), secondaryOutcomes measure: Modified Constant-Murley Scoring, secondaryOutcomes measure: Modified Constant-Murley Scoring, secondaryOutcomes measure: Modified Constant-Murley Scoring, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahi Evran University, status: RECRUITING, city: Kirşehir, state: City Centre, zip: 40100, country: Turkey, contacts name: Basak Cigdem Karacay, Assist Prof, role: CONTACT, phone: :+90 386 280 39 00, email: [email protected], contacts name: Basak Cigdem Karacay, Assist Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06272773, orgStudyIdInfo id: IRAS Ref: 333663, briefTitle: Forced Oscillation and Breathing Pattern in Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Karl Sylvester, class: OTHER, descriptionModule briefSummary: Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: Forced Oscillation Test, outcomesModule primaryOutcomes measure: Change in airway resistance at 5 Hertz (Hz) and 19Hz, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06272760, orgStudyIdInfo id: 2024-02-060, briefTitle: Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single blinding, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Home-based hand-arm bimanual intensive training (Tele-HABIT), interventions name: Hand-arm bimanual intensive training (In-clinic-HABIT), outcomesModule primaryOutcomes measure: Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0)., secondaryOutcomes measure: Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0)., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272747, orgStudyIdInfo id: XH-S003-I-101, briefTitle: A Phase I Study of XH-S003 in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: S-Infinity Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S003., conditionsModule conditions: Healthy Adults, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: XH-S003, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs), primaryOutcomes measure: Number of participants with adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital,Capital Medical University, city: Beijing, country: China, contacts name: Ruihua Dong, MD, role: CONTACT, phone: 010-63139033, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06272734, orgStudyIdInfo id: RCV-0007, briefTitle: Reprieve System Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Reprieve Cardiovascular, Inc, class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure., conditionsModule conditions: Acute Decompensated Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Reprieve System, outcomesModule primaryOutcomes measure: Functional Device Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tbilisi Heart and Vascular Clinic, status: RECRUITING, city: Tbilisi, zip: 0159, country: Georgia, contacts name: Tamaz Shaburishvili, MD, role: CONTACT, phone: +995 322 479300, email: [email protected], geoPoint lat: 41.69411, lon: 44.83368, hasResults: False |
protocolSection identificationModule nctId: NCT06272721, orgStudyIdInfo id: 6272, briefTitle: Hypothyroidism in Pregnancy and Neuropsychological Development in Children, acronym: OHPLDO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention., conditionsModule conditions: Thyroid Dysfunction, conditions: Pregnancy Related, conditions: Language Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Griffiths Scale, outcomesModule primaryOutcomes measure: total development quotient measured using the Griffiths scale, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, contacts name: ALFREDO PONTECORVI, role: CONTACT, phone: +390630155701, email: [email protected], contacts name: ALFREDO PONTECORVI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06272708, orgStudyIdInfo id: IIT-2023-0356, briefTitle: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer., conditionsModule conditions: Thromboelastography, conditions: Hemodialysis, conditions: Anticoagulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: thromboelastography parameter R value, secondaryOutcomes measure: thromboelastography parameter K value, secondaryOutcomes measure: thromboelastography parameter Angle, secondaryOutcomes measure: thromboelastography parameter MA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Yunyue Guo, role: CONTACT, phone: 0086-021-68383312, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06272695, orgStudyIdInfo id: R477-203, briefTitle: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: REMD Biotherapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline., conditionsModule conditions: Type 1 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Volagidemab, outcomesModule primaryOutcomes measure: Change in Time to glucagon treatment success at Week 6., secondaryOutcomes measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia., secondaryOutcomes measure: Treatment emergent adverse events (AEs), secondaryOutcomes measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale, secondaryOutcomes measure: Hypoglycemia symptoms - Clarke Survey, secondaryOutcomes measure: Hypoglycemia symptoms - Gold Questionnaire, secondaryOutcomes measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Altman Clinical and Translational Research Institute, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Schafer Boeder, MD, role: CONTACT, contacts name: Schafer Baoder, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Diablo Clinical Research, status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: Mark Christiansen, MD, role: CONTACT, email: [email protected], contacts name: Mark Christiansen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, hasResults: False |
protocolSection identificationModule nctId: NCT06272682, orgStudyIdInfo id: 6669, briefTitle: Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-17, primaryCompletionDateStruct date: 2024-08-11, completionDateStruct date: 2025-10-11, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hospital Italiano de Buenos Aires, class: OTHER, descriptionModule briefSummary: The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.The main questions it aims to answer are:* What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?* What are the adverse effects and application site pain associated with each route of administration?Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.The Redcap randomizer will be used to assign the patient to one of the branches.Researchers will compare* Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound* Branch B: patients treated with intramuscular corticosteroid injection.Researchers will:* Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.* Describe adverse reactions associated with the route of administration.* Compare the pain at the site of application associated with the route of administration., conditionsModule conditions: Carpal Tunnel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomised, controlled, non-inferiority analytical study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Systemic bethametasone injection, interventions name: Local bethametasone injection, outcomesModule primaryOutcomes measure: Compare the Boston Carpal Tunnel Syndrome Questionnaire, secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Pain at the site of application, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Italiano de Buenos Aires, status: RECRUITING, city: Buenos Aires, zip: C1199, country: Argentina, contacts name: Jorge Boretto, MD, role: CONTACT, phone: +541169026969, email: [email protected], contacts name: Rocio Avanzi, MD, role: CONTACT, phone: +541157727055, email: [email protected], geoPoint lat: -34.61315, lon: -58.37723, hasResults: False |
protocolSection identificationModule nctId: NCT06272669, orgStudyIdInfo id: HSEARS20220216004, briefTitle: Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-02, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD., conditionsModule conditions: Transcranial Direct Current Stimulation, conditions: Autistic Spectrum Disorder, conditions: Electroencephalography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study comprises 3 phases: Phase 1 will be a randomized controlled trial in which 90 participants will be randomly assigned to receive either active or sham-tDCS combined with computerized executive function training for 10 consecutive working days over 2 weeks period. The other 2 phases will be an open-label, crossover phase, in which for Phase 2, participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session. Whereas bimonthly booster tDCS sessions will be provided to all tDCS responders for the first 3 months and monthly booster tDCS in the subsequent 3 months (Total 9 sessions in phase 3), and with assessments performed every month in Phase 3., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Active-tDCS, interventions name: Sham-tDCS, outcomesModule primaryOutcomes measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2), secondaryOutcomes measure: Clinical response in tDCS outcome, secondaryOutcomes measure: Change in neuropsychological measures - CANTAB® cognitive tests, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hung Hom, state: Kowloon, zip: Hong Kong, country: Hong Kong, contacts name: Yvonne Han, PhD, role: CONTACT, phone: +852 27667578, email: [email protected], geoPoint lat: 22.30715, lon: 114.18532, hasResults: False |
protocolSection identificationModule nctId: NCT06272656, orgStudyIdInfo id: AKR-TACE-001, briefTitle: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Third Hospital, class: OTHER, descriptionModule briefSummary: Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc., but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE, secondaryOutcomes measure: long-term survival (1-year, 3-year, 5-year), secondaryOutcomes measure: progression- free - time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HebeiMUTH, status: RECRUITING, city: Shijia Zhuang, state: Hebei, zip: 050000, country: China, contacts name: Yuemin Nan, role: CONTACT, phone: +8633188602489, email: [email protected], contacts name: Pei Guo, role: CONTACT, phone: 17835683894, email: [email protected], geoPoint lat: 34.17775, lon: 109.84894, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-12-25, uploadDate: 2024-02-02T21:48, filename: Prot_ICF_000.pdf, size: 258859, hasResults: False |
protocolSection identificationModule nctId: NCT06272643, orgStudyIdInfo id: EPIC36-EMPERATRIZ, briefTitle: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions, acronym: EMPERATRIZ, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-01-20, completionDateStruct date: 2026-01-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fundación EPIC, class: OTHER, descriptionModule briefSummary: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT., conditionsModule conditions: Coronary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography), outcomesModule primaryOutcomes measure: To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions, secondaryOutcomes measure: Cardiac Death, secondaryOutcomes measure: Cardiovascular Death, secondaryOutcomes measure: Acute myocardial infarction of treated/functionally assessed lesion, secondaryOutcomes measure: Acute myocardial infarction of any lesion, secondaryOutcomes measure: Need for revascularisation of lesion treated/functionally assessed, secondaryOutcomes measure: Need for revascularisation of any lesion, secondaryOutcomes measure: Secondary efficacy endpoint: Clear Image Length, secondaryOutcomes measure: Extend of detectable EEL in LM, secondaryOutcomes measure: Correlation between contrast volume used and results, as well as the average contrast volume used in the study., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Juan Ramon Jimenez, status: RECRUITING, city: Huelva, zip: 21005, country: Spain, geoPoint lat: 37.26638, lon: -6.94004, locations facility: Hospital Universitario de Leon, status: RECRUITING, city: León, zip: 24071, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, hasResults: False |
protocolSection identificationModule nctId: NCT06272630, orgStudyIdInfo id: DW_DWJ1464401, briefTitle: Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Daewoong Pharmaceutical Co. LTD., class: INDUSTRY, descriptionModule briefSummary: This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded., conditionsModule conditions: Chronic Liver Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 258, type: ESTIMATED, armsInterventionsModule interventions name: DWJ1464, interventions name: Placebo of DWJ1464, outcomesModule primaryOutcomes measure: At 8 weeks, the change of ALT level compared to baseline, secondaryOutcomes measure: At 4 weeks, the change of ALT level compared to baseline, secondaryOutcomes measure: At 4, 8 weeks, the change of AST level compared to baseline, secondaryOutcomes measure: At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline, secondaryOutcomes measure: At 8 weeks, the change of liver function comparator Fibrotest compared to baseline, secondaryOutcomes measure: At 8 weeks, the change of liver function comparator Fibroscan compared to baseline, secondaryOutcomes measure: At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SoonChunHyang University Seoul Hospital, city: Seoul, zip: 04401, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06272617, orgStudyIdInfo id: 2023-960, briefTitle: Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-25, primaryCompletionDateStruct date: 2024-07-24, completionDateStruct date: 2025-07-24, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, collaborators name: West China Fourth Hospital, Sichuan University, descriptionModule briefSummary: A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors, conditionsModule conditions: Malignant Tumor of Head and/or Neck, conditions: Radiotherapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: verum acupuncture, interventions name: sham acupuncture, outcomesModule primaryOutcomes measure: Xerostomia questionnaire scores, secondaryOutcomes measure: Salivary flow rate, secondaryOutcomes measure: Taste function assessed by patients, secondaryOutcomes measure: Taste function assessed by electrogustometer test, secondaryOutcomes measure: Taste function assessed by taste strips test, secondaryOutcomes measure: Oral mucositis, secondaryOutcomes measure: Dysphagia, secondaryOutcomes measure: Quality of Life assessed by EORTC QLQ-C30, secondaryOutcomes measure: Quality of Life assessed by QLQ-H&N35, secondaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Changes of oral flora, secondaryOutcomes measure: Tongue range of motion, secondaryOutcomes measure: Neck Fibrosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Xingchen Peng, role: CONTACT, phone: 0086-18980606753, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06272604, orgStudyIdInfo id: 2024-IRB-0015-P-01, briefTitle: Exercise Rehabilitation for Children With Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: The Children's Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients., conditionsModule conditions: Asthma in Children, conditions: Rehabilitation, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Exercise Rehabilitation, outcomesModule primaryOutcomes measure: Lung Function, primaryOutcomes measure: Daily Physical Activity Level, secondaryOutcomes measure: Asthma Control Status, secondaryOutcomes measure: Fractional Exhaled Nitric Oxide (FeNO), secondaryOutcomes measure: Body Composition, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: Inflammatory Mediators, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06272591, orgStudyIdInfo id: IRBN1192023/CHUSTE, briefTitle: Comparison of Patient Satisfaction With Home Induction and In-patient Induction., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital., conditionsModule conditions: Induced; Birth, conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Preliminary search in the patient's file, interventions name: A posteriori research in the patient's file, interventions name: First questionnaire : choice of induction method reason for choice, interventions name: Second questionnaire : experience of induction, outcomesModule primaryOutcomes measure: Questionnaire on patients' experience of induction in hospital and at home., primaryOutcomes measure: Questionnaire on patients' satisfaction of induction in hospital and at home., secondaryOutcomes measure: Questionnaire on patients' choice of induction method, secondaryOutcomes measure: Questionnaire on reasons for choosing home induction., secondaryOutcomes measure: Maternal morbidity, secondaryOutcomes measure: Maternal mortality, secondaryOutcomes measure: Neonatal morbidity, secondaryOutcomes measure: Neonatal mortality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Saint Etienne, status: RECRUITING, city: St Etienne, zip: 42100, country: France, contacts name: Tiphaine BARJAT, MD PhD, role: CONTACT, phone: (0)477828609, phoneExt: +33, email: [email protected], contacts name: Clara CHIARADONNA, resident, role: CONTACT, phone: (0)634100341, phoneExt: +33, email: [email protected], contacts name: Tiphaine BARJAT, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Clara CHIARADONNA, resident, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False |
protocolSection identificationModule nctId: NCT06272578, orgStudyIdInfo id: 20021405, briefTitle: Screen CardRen - A Cross-sectional Observational Cohort Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-27, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure., conditionsModule conditions: Heart Failure, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography, outcomesModule primaryOutcomes measure: prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction, primaryOutcomes measure: Proteomic analysis, secondaryOutcomes measure: Duration of echocardiographic examination, secondaryOutcomes measure: Time saved by portable echocardiography and automated image analysis, secondaryOutcomes measure: Image quality of cart-based vs. portable echo images, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272565, orgStudyIdInfo id: 2023KYPJ292, briefTitle: Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage, acronym: DR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group., conditionsModule conditions: Diabetic Retinopathy, conditions: Diabetic Macular Edema, conditions: Anti-vascular Endothelial Growth Factor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Untargeted metabolomics for metabolic profile using UHPLC/MS, secondaryOutcomes measure: Best-corrected visual acuity, secondaryOutcomes measure: Central subfield thickness, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Ophthalmic Center of Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510623, country: China, contacts name: Zhongshan Ophthalmic Center of Sun Yat-sen University, role: CONTACT, phone: 86+13560323773, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06272552, orgStudyIdInfo id: PI21-00026, secondaryIdInfos id: 2021/10182/I, type: OTHER, domain: CEIm Parc de Salut Mar, briefTitle: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact, acronym: PROMs & PREMs, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Parc de Salut Mar, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health., conditionsModule conditions: PROMs, conditions: PREMs, conditions: Implementation Research, conditions: Impact Evaluation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: PROMs and PREMs, interventions name: PREMs, interventions name: Control, interventions name: Healthcare professionals, outcomesModule primaryOutcomes measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals, primaryOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital del Mar Reseach Institute, status: RECRUITING, city: Barcelona, state: Catalonia, zip: 08003, country: Spain, contacts name: Olatz Garin, role: CONTACT, phone: +34 636210255, email: [email protected], contacts name: Olatz Garin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06272539, orgStudyIdInfo id: 2023 101435, briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fundación Universidad Católica de Valencia San Vicente Mártir, class: OTHER, collaborators name: Instituto de Investigación Biomédica de Salamanca, descriptionModule briefSummary: Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception., conditionsModule conditions: Failed Back Surgery Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: By doing so, we will aim to eliminate or reduce potential biases due to the order of patients and any transference effects that might occur if one profile clinical patients will influence the performance in several evaluations. Specifically, each patient will complete a sequence of allocation in the order of A, B, B, A, where 'A' represents SCS treatment isolated and 'B' denotes combined treatment. Subsequently, the average of the two 'A' conditions was calculated, and the same process was applied for the 'B' conditions, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Spinal Cord Stimulation, outcomesModule primaryOutcomes measure: Disability (Oswestry Disability Index), primaryOutcomes measure: Perception Pain (Visual analogue scale), secondaryOutcomes measure: Quality of life (Short Form 36 Health Survey, SF36), secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Strength (Sorensen Test), secondaryOutcomes measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK), secondaryOutcomes measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale), secondaryOutcomes measure: Catastrophic thinking (Pain Catastrophizing Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Juan Vicente-Mampel, city: Torrent, state: Valencia, zip: 46900, country: Spain, geoPoint lat: 39.43705, lon: -0.46546, hasResults: False |
protocolSection identificationModule nctId: NCT06272526, orgStudyIdInfo id: SOCIALANX_1, briefTitle: Internet-Based Self-Help Intervention for Social Anxiety Symptoms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Anadolu University, class: OTHER, descriptionModule briefSummary: This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Internet Based Intervention - GUIDED, outcomesModule primaryOutcomes measure: Liebowitz Social Anxiety Scale (LSAS) Turkish Form, secondaryOutcomes measure: Social Appearance Anxiety Scale (SAAS) Turkish Form, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form, secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form, otherOutcomes measure: Sociodemographic Information Form, otherOutcomes measure: System Usability Scale (SUS-10) Turkish Form, otherOutcomes measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form, otherOutcomes measure: Adherence to Intervention, otherOutcomes measure: Guide Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272513, orgStudyIdInfo id: ProAct-HNC-02, briefTitle: Influencing Factors for Physical Activity in People With Head and Neck Cancer, acronym: ProAct-HNC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Kantonsspital Winterthur KSW, class: OTHER, collaborators name: Eastern Switzerland University of Applied Sciences, collaborators name: University of Applied Sciences of Western Switzerland, collaborators name: UMC Utrecht, collaborators name: University of Lausanne, collaborators name: Zurich University of Applied Sciences, descriptionModule briefSummary: The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?* What motivates people with advanced head and neck cancer to be physically active?* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?The interviews will be transcribed verbatim and analysed with a structuring content analysis approach., conditionsModule conditions: Advanced Head and Neck Squamous Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: interview transcripts, secondaryOutcomes measure: personal information of participants, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-09, uploadDate: 2024-02-15T04:21, filename: Prot_000.pdf, size: 1702659, hasResults: False |
protocolSection identificationModule nctId: NCT06272500, orgStudyIdInfo id: 2024-KY-0146-001, briefTitle: Exploring Methods for Treating Hypergastrinemia in Patients With Autoimmune Gastritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Jianning Yao, class: OTHER, descriptionModule briefSummary: Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+/K+-ATPase. CD4+ T lymphocytes target the parietal cells' H+/K+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).Gastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.Due to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of oral apple cider vinegar on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients., conditionsModule conditions: Autoimmune Gastritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: oral administration of a compound digestive enzyme capsule, interventions name: oral administration of apple cider vinegar, interventions name: oral administration of both the compound digestive enzyme capsule and apple cider vinegar, outcomesModule primaryOutcomes measure: serum gastrin levels, primaryOutcomes measure: serum gastrin levels, secondaryOutcomes measure: the adverse reaction rates, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-30, uploadDate: 2024-02-15T10:32, filename: Prot_SAP_000.pdf, size: 152941, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-30, uploadDate: 2024-02-15T10:32, filename: ICF_001.pdf, size: 156619, hasResults: False |
protocolSection identificationModule nctId: NCT06272487, orgStudyIdInfo id: ALN-AGT01-007, briefTitle: Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3), acronym: KARDIA-3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-12-19, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Alnylam Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications., conditionsModule conditions: High Cardiovascular Risk, conditions: Hypertension, 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: 390, type: ESTIMATED, armsInterventionsModule interventions name: Zilebesiran, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP), secondaryOutcomes measure: Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM), secondaryOutcomes measure: Change from Baseline at Month 6 in Mean Seated Office SBP, secondaryOutcomes measure: Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM, secondaryOutcomes measure: Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6, secondaryOutcomes measure: Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6, secondaryOutcomes measure: Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM, secondaryOutcomes measure: Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP, secondaryOutcomes measure: Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM, secondaryOutcomes measure: Change from Baseline Over Time in Serum Angiotensinogen (AGT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trial Site, status: RECRUITING, city: Flint, state: Michigan, zip: 48504, country: United States, geoPoint lat: 43.01253, lon: -83.68746, hasResults: False |
protocolSection identificationModule nctId: NCT06272474, orgStudyIdInfo id: 0266-07/2021 - 18/07/2021, briefTitle: Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-11, primaryCompletionDateStruct date: 2023-12-09, completionDateStruct date: 2023-12-09, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hams Hamed Abdelrahman, class: OTHER, descriptionModule briefSummary: Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained., conditionsModule conditions: Dental Occlusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group is receiving the two interventional arms, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: CAD-CAM zirconia crowns using buccal interocclusal record., interventions name: CAD-CAM zirconia crowns using lateral interocclusal records., outcomesModule primaryOutcomes measure: Static occlusal interference, primaryOutcomes measure: Dynamic occlusal interference, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alexandria Faculty of Dentistry, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False |
protocolSection identificationModule nctId: NCT06272461, orgStudyIdInfo id: UTEM ELKI, briefTitle: Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively., conditionsModule conditions: Colorectal (Colon or Rectal) Cancer, conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intravenous Lidocaine vs intravenous ketamine, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Lidocaine IV, interventions name: Ketamine Injectable Solution, outcomesModule primaryOutcomes measure: The variation of Interleukin-6 levels, secondaryOutcomes measure: Pain assessed by Numerical Rating Scale (NRS), secondaryOutcomes measure: Post-operative nausea and vomiting, secondaryOutcomes measure: Bowel function., secondaryOutcomes measure: Hospital length of stay., secondaryOutcomes measure: Post-operative complications., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tunisia, status: RECRUITING, city: Nabeul, zip: 8000, country: Tunisia, contacts name: BEN ALI MECHAAL, role: CONTACT, phone: 53890987, phoneExt: 00216, email: [email protected], geoPoint lat: 36.45606, lon: 10.73763, hasResults: False |
protocolSection identificationModule nctId: NCT06272448, orgStudyIdInfo id: CERM2022-27 21042022, briefTitle: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment, acronym: RAPIDO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-15, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Università Politecnica delle Marche, class: OTHER, collaborators name: Universita di Verona, descriptionModule briefSummary: The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Before-after study with one follow-up at 3 months of treatment end, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation, outcomesModule primaryOutcomes measure: Compliance with the telerehabilitation system, primaryOutcomes measure: Perceived usability of system, primaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: User satisfaction, secondaryOutcomes measure: Compliance with the monitoring system, secondaryOutcomes measure: Feasibility of telemonitoring approach, secondaryOutcomes measure: Motor symptom and disability progression, secondaryOutcomes measure: Non motor symptom progression, secondaryOutcomes measure: Patients' Quality of life, secondaryOutcomes measure: Caregiver's burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurorehabilitation Clinic, status: RECRUITING, city: Ancona, zip: 60126, country: Italy, contacts name: Elisa Andrenelli, Dr, role: CONTACT, phone: 0715965794, email: [email protected], geoPoint lat: 43.5942, lon: 13.50337, locations facility: Università di Verona, status: RECRUITING, city: Verona, zip: 37100, country: Italy, contacts name: Marialuisa Gandolfi, Prof, role: CONTACT, phone: +39 045 812 4943, email: [email protected], geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06272435, orgStudyIdInfo id: PRO-FY2024-64, briefTitle: Beverage Hydration Index: Assessment of Four Rehydration Solutions, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-23, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Memphis, class: OTHER, descriptionModule briefSummary: No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine., conditionsModule conditions: Hydration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Semi-blinded, placebo controlled, crossover design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup., whoMasked: PARTICIPANT, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Multiplier, interventions name: Sugar Free, interventions name: Sugar Free with Amino Acids, interventions name: Water, outcomesModule primaryOutcomes measure: Beverage Hydration Index, primaryOutcomes measure: Beverage Hydration Index, primaryOutcomes measure: Beverage Hydration Index, primaryOutcomes measure: Beverage Hydration Index, primaryOutcomes measure: Beverage Hydration Index, secondaryOutcomes measure: Net Fluid Balance, secondaryOutcomes measure: Net Fluid Balance, secondaryOutcomes measure: Net Fluid Balance, secondaryOutcomes measure: Net Fluid Balance, secondaryOutcomes measure: Net Fluid Balance, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Osmolality, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Sodium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Potassium, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Urine Specific Gravity, secondaryOutcomes measure: Sodium balance, secondaryOutcomes measure: Sodium balance, secondaryOutcomes measure: Sodium balance, secondaryOutcomes measure: Sodium balance, secondaryOutcomes measure: Sodium balance, secondaryOutcomes measure: Potassium balance, secondaryOutcomes measure: Potassium balance, secondaryOutcomes measure: Potassium balance, secondaryOutcomes measure: Potassium balance, secondaryOutcomes measure: Potassium balance, secondaryOutcomes measure: Body Mass, secondaryOutcomes measure: Body Mass, secondaryOutcomes measure: Mood and Digestive Questionnaire, secondaryOutcomes measure: Mood and Digestive Questionnaire, secondaryOutcomes measure: Mood and Digestive Questionnaire, secondaryOutcomes measure: Mood and Digestive Questionnaire, secondaryOutcomes measure: Mood and Digestive Questionnaire, secondaryOutcomes measure: Mood and Digestive Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Nutraceutical and Dietary Supplement Research, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38152, country: United States, contacts name: Jackie Pence, Ph.D., role: CONTACT, phone: 901-678-1547, email: [email protected], contacts name: Richard J Bloomer, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False |
protocolSection identificationModule nctId: NCT06272422, orgStudyIdInfo id: 2022/0472, secondaryIdInfos id: 2023-A00358-37, type: OTHER, domain: IDRCB - ANSM ID, briefTitle: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning, acronym: HIP3D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Lille, class: OTHER, descriptionModule briefSummary: The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.To this end, two types of examination are carried out, both of which are used in current practice:* Pre-operatively: EOS radiography* Post-operatively: EOS radiograph and CT scanInclusion (m-3; m-1) :* Patient information at pre-operative visit* Non-opposition of patient, family member or legal guardian, if applicable* Questionnaires and clinical examination (standard management)* EOS during anesthetic consultationFollow-up visit (m+3):- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examinationFollow-up visit (m+12):- Post-operative check-up, questionnaire and clinical examination, conditionsModule conditions: Coxarthrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: hip arthroplasty, outcomesModule primaryOutcomes measure: Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty., secondaryOutcomes measure: Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA)., secondaryOutcomes measure: Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA)., secondaryOutcomes measure: Correlate restoration of hip femoral offset and patient functional outcome at 3 months., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272409, orgStudyIdInfo id: DEP114-III-0123, briefTitle: Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children., acronym: SIERRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-02-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: EMS, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years., conditionsModule conditions: Allergic Rhinitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 318, type: ESTIMATED, armsInterventionsModule interventions name: DEP114, interventions name: Desloratadine 0.5 MG/ML, outcomesModule primaryOutcomes measure: To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment., secondaryOutcomes measure: To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant., secondaryOutcomes measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 11 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06272396, orgStudyIdInfo id: CHUBX 2023/64, briefTitle: Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch, acronym: ECG-MC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single or six derivations can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an ICD may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children., conditionsModule conditions: Arrhythmias, Cardiac, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Smart watch, outcomesModule primaryOutcomes measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude, primaryOutcomes measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration, primaryOutcomes measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude, primaryOutcomes measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS duration, primaryOutcomes measure: Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc, secondaryOutcomes measure: Creation of bank of anormal ECG trace, secondaryOutcomes measure: Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG, secondaryOutcomes measure: Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home, secondaryOutcomes measure: Validate the feasibility of recording an ECG trace with a connected watch for a child, secondaryOutcomes measure: Validate the sensibility of an ECG trace with a connected watch for a child, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Haut-Lévèque, city: Pessac, zip: 33604, country: France, contacts name: Pierre BORDACHAR, role: CONTACT, geoPoint lat: 44.81011, lon: -0.64129, hasResults: False |
protocolSection identificationModule nctId: NCT06272383, orgStudyIdInfo id: HS26166 (B2023:092), briefTitle: Croup Dosing Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup., conditionsModule conditions: Croup, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an internal double-blinded vanguard randomized controlled trial (RCT), which will be conducted at the Winnipeg Children's Hospital (WCH). Computerized randomization will be performed by a statistician at the George and Fay Yee Centre for HealthCare Innovation to generate the randomization list. Investigators will perform a computerized randomization stratified by age. Investigators will do a block randomization with random blocks of undisclosed block sizes over the seasons to ensure temporal distribution of croup cases is captured. Investigators will randomly assign patients to either the intervention or control in ratio 1:1. While croup is common between 6 months and 5 years, a typical croup affects children between 6 months and 3 years. Based on this, we will randomize such that this age category (6 months-3years) has almost similar distribution in each arm., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 0.15 mg/kg dexamethasone, outcomesModule primaryOutcomes measure: Return visits or readmissions to the hospital, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272370, orgStudyIdInfo id: PLACER-2021C3-24737-IC, briefTitle: Individualizing Treatment for Asthma in Primary Care, acronym: iTREAT-PC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: DARTNet Institute, class: OTHER_GOV, collaborators name: Penn State University, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: University of Colorado, Denver, collaborators name: RAND, collaborators name: University of Washington, collaborators name: Rutgers University, collaborators name: University of North Carolina, collaborators name: Brigham and Women's Hospital, collaborators name: Reliant Medical Group, collaborators name: Kelsey Research Foundation, collaborators name: Wake Forest University Health Sciences, descriptionModule briefSummary: This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system., conditionsModule conditions: Asthma, conditions: Bronchial Diseases, conditions: Respiratory Tract Infections, conditions: Lung Diseases, Obstructive, conditions: Lung Diseases, conditions: Respiratory Hypersensitivity, conditions: Immune System Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: patient randomized trial of three different drug combinations, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Asthma Symptom Monitoring online tools, interventions name: Inhaled Steroids, interventions name: Azithromycin Pill, outcomesModule primaryOutcomes measure: The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids)., secondaryOutcomes measure: Asthma control as measured by the Asthma Control Test, secondaryOutcomes measure: Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire, secondaryOutcomes measure: Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DARTNet Insitute, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Brian K Manning, MPH, role: CONTACT, phone: 800-434-0278, phoneExt: 82, email: [email protected], contacts name: Joel Shields, MA, role: CONTACT, phone: 80004340278, phoneExt: 84, email: [email protected], contacts name: Michelle Hernandez, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kari Stephens, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: John Valenta, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Wisniveski, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lipika Samal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06272357, orgStudyIdInfo id: Antiarrhythmic drugs, briefTitle: The Use of Antiarrhythmic Drugs in Pediatrics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit, conditionsModule conditions: Antiarrhythmic Drug Adverse Reaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Antiarrhythmic drugs, outcomesModule primaryOutcomes measure: Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia., eligibilityModule sex: ALL, minimumAge: 30 Days, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272344, orgStudyIdInfo id: CHUBX 2022/38, briefTitle: Remote Programming of Cardiac Implantable Electronic Devices 2, acronym: REACT 2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-24, primaryCompletionDateStruct date: 2024-10-24, completionDateStruct date: 2024-10-24, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert., conditionsModule conditions: Pacemaker, conditions: Defibrillator, conditions: Telemedecine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single-center, single-arm, pairwise comparison trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Teleconsultation, outcomesModule primaryOutcomes measure: assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital, secondaryOutcomes measure: Time saving for patient, secondaryOutcomes measure: Savings on medical transport, secondaryOutcomes measure: Costs associated with teleconsultation, secondaryOutcomes measure: safety of teleconsultation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bordeaux University Hospital, status: RECRUITING, city: Pessac, zip: 33604, country: France, contacts name: Sylvain MD Ploux, role: CONTACT, phone: (0)5 57 65 64 71, phoneExt: +33, email: [email protected], contacts name: Estel HUGOT, role: CONTACT, phone: (0)5 57 62 32 26, phoneExt: +33, email: [email protected], contacts name: Sylvain MD Ploux, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.81011, lon: -0.64129, hasResults: False |
protocolSection identificationModule nctId: NCT06272331, orgStudyIdInfo id: NL83162.091.22, briefTitle: Milk and Plant Protein Digestion, acronym: MAPP-D, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Wageningen University, class: OTHER, collaborators name: FrieslandCampina, descriptionModule briefSummary: The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior., conditionsModule conditions: Food Digestion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Low-protein plant-based drink, interventions name: High-protein plant-based drink, interventions name: Cow's milk, outcomesModule primaryOutcomes measure: Postprandial plasma amino acid profile as characterized by the peak height and iAUC, secondaryOutcomes measure: Gastric behavior, secondaryOutcomes measure: Postprandial plasma response, otherOutcomes measure: Verbal ratings of wellbeing, otherOutcomes measure: MRI markers of digestion, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Human Research Unit - Division of Human Nutrition and Health, status: RECRUITING, city: Wageningen, zip: 6708WE, country: Netherlands, contacts name: Paul Smeets, PhD, role: CONTACT, phone: + 31317484681, email: [email protected], contacts name: Paul Smeets, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.97, lon: 5.66667, hasResults: False |
protocolSection identificationModule nctId: NCT06272318, orgStudyIdInfo id: 74131, briefTitle: Vital Signs Blood Pressure Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device., conditionsModule conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Blood Pressure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Blood Pressure Cuff, EKG, PPG, outcomesModule primaryOutcomes measure: Collection of Subject Name (optional), primaryOutcomes measure: Collection of Subject Height, primaryOutcomes measure: Collection of Subject Weight, primaryOutcomes measure: Collection of Subject Age, primaryOutcomes measure: Collection of Subject Medical Comorbidities, primaryOutcomes measure: Blood Pressure Measurement, primaryOutcomes measure: Collection of ECG Waveforms, primaryOutcomes measure: Collection of PPG Waveforms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272305, orgStudyIdInfo id: 49RC21_0301, briefTitle: TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis, acronym: TREC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis., conditionsModule conditions: Hyperplasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: This research does not require any specific investigation and does not imply any modification of treatment., outcomesModule primaryOutcomes measure: Rate of restenosis, secondaryOutcomes measure: Morbidity and mortality rate, secondaryOutcomes measure: Major cardiological event, secondaryOutcomes measure: Minor neurological events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272292, orgStudyIdInfo id: S66441, briefTitle: Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls, acronym: CAM-FAI adult, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-28, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Femoroacetabular impingement (FAI) is an orthopaedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms.This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology., conditionsModule conditions: Femoroacetabular Impingement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cross-sectional, case-control prospective clinical study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: 3 study groups, based on clinical examination and medical imaging:* symptomatic CAM-FAI patients* asymptomatic CAM controls* healthy controls, whoMasked: PARTICIPANT, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: EOS, interventions name: 3D motion lab analysis, outcomesModule primaryOutcomes measure: The presence of CAM morphology in combination with symptoms, secondaryOutcomes measure: The Copenhagen Hip and Groin Outcome Score (HAGOS), secondaryOutcomes measure: Radiographic spinopelvic parameters, secondaryOutcomes measure: 3D motion analysis parameters, eligibilityModule sex: MALE, minimumAge: 21 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospitals of Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Stijn Ghijselings, MD, role: CONTACT, phone: +32 16 33 88 18, email: [email protected], contacts name: Orthopedic Research, role: CONTACT, phone: +32 16 33 88 18, email: [email protected], geoPoint lat: 50.87959, lon: 4.70093, hasResults: False |
protocolSection identificationModule nctId: NCT06272279, orgStudyIdInfo id: HS23666(B2020:015), briefTitle: Neuromodulation With Spinal Stimulation Methods, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed., conditionsModule conditions: Spinal Cord Injuries, conditions: Spinal Cord Injury at C5-C7 Level, conditions: Paraplegia, Spinal, conditions: Paraplegia, Incomplete, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Semi-blinded, randomized block entry design, crossover intervention study., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: spinal stimulation-DCS, interventions name: spinal stimulation-sham DCS, interventions name: spinal stimulation-EPS, interventions name: sham spinal stimulation-EPS, outcomesModule primaryOutcomes measure: Motor response, primaryOutcomes measure: Motor evoked potentials, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Manitoba, status: ENROLLING_BY_INVITATION, city: Winnipeg, state: Manitoba, zip: R3E 0J9, country: Canada, geoPoint lat: 49.8844, lon: -97.14704, locations facility: University of Manitoba, status: RECRUITING, city: Winnipeg, state: Manitoba, zip: R3E 0J9, country: Canada, contacts name: Katinka Stecina, Ph.D., role: CONTACT, phone: 2047893761, email: [email protected], contacts name: Kristine Cowley, Ph.D., role: CONTACT, phone: 2047893305, email: [email protected], geoPoint lat: 49.8844, lon: -97.14704, hasResults: False |
protocolSection identificationModule nctId: NCT06272266, orgStudyIdInfo id: 2021/03-26, briefTitle: The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-20, primaryCompletionDateStruct date: 2022-05-30, completionDateStruct date: 2023-02-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Selda Sarıkaya, class: OTHER, collaborators name: Zonguldak Bulent Ecevit University, descriptionModule briefSummary: The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment., conditionsModule conditions: COVID-19 Pneumonia, conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ACTUAL, armsInterventionsModule interventions name: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system), interventions name: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)., interventions name: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.), interventions name: Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.), outcomesModule primaryOutcomes measure: Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device, primaryOutcomes measure: Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., primaryOutcomes measure: Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., primaryOutcomes measure: Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., primaryOutcomes measure: Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., primaryOutcomes measure: Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook)., primaryOutcomes measure: Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system,, primaryOutcomes measure: Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device, secondaryOutcomes measure: Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ), secondaryOutcomes measure: Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., secondaryOutcomes measure: Assessment of Perceived Difficulty by using the Borg Scale, secondaryOutcomes measure: Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI., secondaryOutcomes measure: Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor, secondaryOutcomes measure: Assessment of resting heart rate (beats/min) by using a a pulse oximeter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zonguldak Bülent Ecevit University, city: Zonguldak, zip: 67100, country: Turkey, geoPoint lat: 41.45139, lon: 31.79305, hasResults: False |
protocolSection identificationModule nctId: NCT06272253, orgStudyIdInfo id: UNAIR-MP-INAKTIF-R-010, briefTitle: UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-19, primaryCompletionDateStruct date: 2024-03-19, completionDateStruct date: 2024-07-19, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Dr. Soetomo General Hospital, class: OTHER_GOV, collaborators name: Indonesia-MoH, collaborators name: Universitas Airlangga, collaborators name: PT Biotis Pharmaceuticals, Indonesia, descriptionModule briefSummary: This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports., conditionsModule conditions: COVID-19 Pandemic, conditions: COVID-19 Vaccines, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ACTUAL, armsInterventionsModule interventions name: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg, outcomesModule primaryOutcomes measure: Humoral Immune Response (Neutralizing antibody), secondaryOutcomes measure: Incidence of Adverse Events, secondaryOutcomes measure: Humoral Immune Response - The neutralizing antibody, secondaryOutcomes measure: Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA, otherOutcomes measure: Exploratory Endpoints-Whole Genome Sequencing, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Dr. Soetomo General Hospital, city: Surabaya, state: Jawa Timur, zip: 67161, country: Indonesia, geoPoint lat: -7.24917, lon: 112.75083, hasResults: False |
protocolSection identificationModule nctId: NCT06272240, orgStudyIdInfo id: 17380, briefTitle: Tumor Microenvironment in Ovarian Cancer, acronym: MICO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Udine, class: OTHER, descriptionModule briefSummary: A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules)., conditionsModule conditions: Ovarian Cancer Stage III, conditions: Ovarian Cancer Stage IV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ovarian Cancer Organoids, outcomesModule primaryOutcomes measure: • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università degli Studi di Udine, status: RECRUITING, city: Udine, state: UD, zip: 33100, country: Italy, geoPoint lat: 46.0693, lon: 13.23715, hasResults: False |
protocolSection identificationModule nctId: NCT06272227, orgStudyIdInfo id: 4-2023-0986, briefTitle: Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: alfacalcidol, interventions name: placebo, interventions name: Denosumab, outcomesModule primaryOutcomes measure: Improvement in SPPB score of 0.5 or more compared to the control group, eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06272214, orgStudyIdInfo id: ZJCCRT005, briefTitle: Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0.Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients., conditionsModule conditions: Adjuvant Radiotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Adjuvant radiotherapy, interventions name: Observation, outcomesModule primaryOutcomes measure: 2-year DFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: LRFS, secondaryOutcomes measure: DMFS, secondaryOutcomes measure: HRQoL, secondaryOutcomes measure: Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period, secondaryOutcomes measure: Incidence of Recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, city: Hangzhou, state: Zhejiang, country: China, contacts name: YANG YANG, M.D., role: CONTACT, phone: +8657188128182, email: [email protected], contacts name: Youhua Jiang, role: PRINCIPAL_INVESTIGATOR, contacts name: Yongling Ji, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06272201, orgStudyIdInfo id: 50620 TPR, briefTitle: Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study, acronym: INSPIRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: USGI Medical, class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP)., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors, outcomesModule primaryOutcomes measure: Percentage of total body weight loss (%TBWL) following randomization, primaryOutcomes measure: Responder rate of at least 50% in the POSE2.0 treatment group, primaryOutcomes measure: Safety- Incidence of device and procedure related adverse events through 12 months, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272188, orgStudyIdInfo id: 09.2023.1435, briefTitle: Preconception Care for Couples Planning Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2025-08-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Yuzuncu Yıl University, class: OTHER, collaborators name: Marmara University, collaborators name: Kocaeli University, collaborators name: Kastamonu University, collaborators name: Maltepe University, collaborators name: Izmir Katip Celebi University, descriptionModule briefSummary: Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.The aim of this project is to examine the effect of online preconception counseling on information and care practices for couples planning pregnancy for healthy starts.Materials and Methods:The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data., conditionsModule conditions: Preconception Care, Preconception Risk, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: We do not use a model, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: web-based online preconceptional counselling, outcomesModule primaryOutcomes measure: Identifying Information Form, secondaryOutcomes measure: Preconceptional Period Risk Assessment Form, otherOutcomes measure: Preconceptional Care Health Literacy Scale, otherOutcomes measure: Preconceptional Period Health Behavior Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Van Yuzuncu Yil University, city: Van, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False |
protocolSection identificationModule nctId: NCT06272175, orgStudyIdInfo id: 10102023, briefTitle: Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istinye University, class: OTHER, descriptionModule briefSummary: Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Open Kinetic Chain Activity, interventions name: Closed Kinetic Chain Activity, outcomesModule primaryOutcomes measure: MyotonPRO digital palpation device, primaryOutcomes measure: Box and Block Test, secondaryOutcomes measure: Modified Ashworth Scale, secondaryOutcomes measure: Goniometer, secondaryOutcomes measure: PhysioMaster, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istinye University Hospital Medical Park Gaziosmanpasa, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Mehmet Salih Baran, Assist. Prof., role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06272162, orgStudyIdInfo id: NL85622.041.24, secondaryIdInfos id: 15030, type: OTHER_GRANT, domain: KWF, secondaryIdInfos id: 23U-0725, type: OTHER, domain: NedMec, briefTitle: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy, acronym: LAPSTAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2030-01, completionDateStruct date: 2030-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Amsterdam UMC, location VUmc, collaborators name: Radboud University Medical Center, collaborators name: Catharina Ziekenhuis Eindhoven, collaborators name: Centre for Human Drug Research, Netherlands, collaborators name: Dutch Pancreatic Cancer Group (DPCG), descriptionModule briefSummary: A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC)., conditionsModule conditions: Locally Advanced Pancreatic Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: MR guided radiotherapy, outcomesModule primaryOutcomes measure: HRQoL deterioration-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Patient reported Quality of Life EORTC QLQ-PAN26, secondaryOutcomes measure: Patient reported Quality of Life EORTC QLQ-C30, secondaryOutcomes measure: Patient reported Quality of Life EQ5D-5L, secondaryOutcomes measure: The need of subsequent treatments, secondaryOutcomes measure: Treatment response assessed on CT-imaging (graded according to RECIST guidelines), secondaryOutcomes measure: CA 19.9 response, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Body+ scale, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility Whitings Sleep, secondaryOutcomes measure: Trial@home monitoring related outcome: feasibility ePRO application, secondaryOutcomes measure: Trial@home monitoring related outcome: digital biomarkers, secondaryOutcomes measure: Intervention arm related outcome toxicity, secondaryOutcomes measure: Intervention arm related outcome, completion of therapy, secondaryOutcomes measure: Intervention arm related outcome diffusion weighted images, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catharina Hospital, city: Eindhoven, state: Noord- Brabant, zip: 5623 EJ, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: [email protected], contacts name: H. M.U. Peulen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Amsterdam University Medical Center, VUmc, city: Amsterdam, state: Noord-Holland, zip: 1081 HV, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: [email protected], contacts name: A. M.E. Bruynzeel, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Radboud University Medical Center, city: Nijmegen, zip: 6525 GA, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: [email protected], contacts name: H. D. Heerkens, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, locations facility: University Medical Center Utrecht, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: J. C.M. Scheepens, MD, role: CONTACT, email: [email protected], contacts name: L. A. Daamen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: M. P.W. Intven, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False |
protocolSection identificationModule nctId: NCT06272149, orgStudyIdInfo id: VGN-R08b-001, briefTitle: An Exploratory Clinical Trial of VGN-R08b in Patients With Type II Gaucher Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, collaborators name: Shanghai Vitalgen BioPharma Co., Ltd., descriptionModule briefSummary: This exploratory trial is to prove the tolerability and safety of VGN-R08b to treat infants with type II Gaucher disease., conditionsModule conditions: Type II Gaucher Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: VGN-R08b, outcomesModule primaryOutcomes measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs), secondaryOutcomes measure: Long-term safety follow-up, secondaryOutcomes measure: Survival ratio at age of 24 months, secondaryOutcomes measure: Changes in the activity of glucose cerebroside lipase (GCase), secondaryOutcomes measure: Changes in the activity of glucose cerebroside (GC) levels, secondaryOutcomes measure: Changes in the activity of glucose sphingosine (Lyso GL1) levels in peripheral blood and CSF after medication, secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Changes in the genomic level of VGN-R08b vector in peripheral blood after medication, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200097, country: China, contacts name: Zhang Huiwen, Dr., role: CONTACT, phone: 18117165075, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06272136, orgStudyIdInfo id: SPN-007, briefTitle: Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Spiden AG, class: INDUSTRY, collaborators name: Profil Institut für Stoffwechselforschung GmbH, descriptionModule briefSummary: This is a single-centre, multiple sequential-cohort, open study., conditionsModule conditions: Type 1 Diabetes, conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Demo 2.0, outcomesModule primaryOutcomes measure: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Profil for Stoffwechselforschung GmbH, status: RECRUITING, city: Neuss, state: Nordrhein-Westfallen, zip: 41460, country: Germany, contacts name: Marc Stoffel, MD, role: CONTACT, phone: 0049213140180, geoPoint lat: 51.19807, lon: 6.68504, hasResults: False |
protocolSection identificationModule nctId: NCT06272123, orgStudyIdInfo id: 20D.776, briefTitle: Endotypic Stability in CRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Thomas Jefferson University, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients, conditionsModule conditions: Chronic Sinusitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Endotypic markers, secondaryOutcomes measure: SF-36, secondaryOutcomes measure: SNOT-22, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thomas Jefferson University Department of Otolaryngology, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Elizabeth Kangas, RN, BSN, role: CONTACT, phone: 215-955-6784, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06272110, orgStudyIdInfo id: 22-01303, briefTitle: Promoting Equitable Access to Language Services in Health and Human Services, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: Department of Health and Human Services, descriptionModule briefSummary: This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase)., conditionsModule conditions: Appropriate Use of Language Across Services, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 17500, type: ESTIMATED, armsInterventionsModule interventions name: System level Language Access (LA) intervention, outcomesModule primaryOutcomes measure: Percentage of appropriate interpreter use, primaryOutcomes measure: Percentage of appropriate interpreter use, secondaryOutcomes measure: Percentage of patients up to date with preventive screenings and vaccinations, secondaryOutcomes measure: Percentage of patients up to date with preventive screenings and vaccinations, secondaryOutcomes measure: Percentage of patients with knowledge of federal rights related to LA services, secondaryOutcomes measure: Percentage of patients with knowledge of federal rights related to LA services, secondaryOutcomes measure: Percentage using untrained interpreters, secondaryOutcomes measure: Percentage using untrained interpreters, secondaryOutcomes measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back), secondaryOutcomes measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back), secondaryOutcomes measure: Percentage of patients with satisfaction with LA services preventive health services utilization, secondaryOutcomes measure: Percentage of patients with satisfaction with LA services preventive health services utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health + Hospitals Diagnostic/Treatment Centers, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NYC Health + Hospitals/Bellevue, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NYC Health + Hospitals/Woodhull, city: New York, state: New York, zip: 11206, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06272097, orgStudyIdInfo id: 201328, briefTitle: Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Danni Feng, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life., conditionsModule conditions: Wound Heal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Intervention program based on TIME-CDST tool led by wound specialist nurses, interventions name: A routine wound care program, outcomesModule primaryOutcomes measure: Wound healing time, secondaryOutcomes measure: The wound healing rate, secondaryOutcomes measure: The rate of wound area reduction, secondaryOutcomes measure: The Pressure Ulcer Scale for Healing (PUSH), secondaryOutcomes measure: The positive rate of bacterial culture, secondaryOutcomes measure: The pain intensity, secondaryOutcomes measure: Patient comfort score, secondaryOutcomes measure: Patient satisfaction score, secondaryOutcomes measure: The levels of albumin, secondaryOutcomes measure: The number of dressing changes, secondaryOutcomes measure: Medical costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272084, orgStudyIdInfo id: CRRT-TPE-01-DE, briefTitle: Analysis of TPE Treatments With multiFiltratePRO, acronym: TPEopt, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Fresenius Medical Care Deutschland GmbH, class: INDUSTRY, collaborators name: X-act Cologne Clinical Research GmbH, descriptionModule briefSummary: Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments., conditionsModule conditions: Autoimmune Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO, outcomesModule primaryOutcomes measure: Total amount of exchange plasma (prescribed vs achieved exchange volume), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinikum Aschaffenburg-Alzenau, city: Aschaffenburg, state: Bavaria, zip: 63739, country: Germany, contacts name: Stefan Büttner, Dr. med., role: CONTACT, email: [email protected], geoPoint lat: 49.97704, lon: 9.15214, hasResults: False |
protocolSection identificationModule nctId: NCT06272071, orgStudyIdInfo id: 2023YFC2308802-01, briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Beijing Ditan Hospital, collaborators name: Beijing YouAn Hospital, collaborators name: Huashan Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:* Mapping of infectious agents in patients with severe hepatitis (liver failure)* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function., conditionsModule conditions: Liver Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection., primaryOutcomes measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks, secondaryOutcomes measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection., secondaryOutcomes measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection., secondaryOutcomes measure: qSOFA score at 8 weeks, secondaryOutcomes measure: qSOFA score at 12 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06272058, orgStudyIdInfo id: 1366-0034, briefTitle: A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet.Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Healthy, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Avenciguat (BI 685509), outcomesModule primaryOutcomes measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), primaryOutcomes measure: Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Orlando Clinical Research Center, status: RECRUITING, city: Orlando, state: Florida, zip: 32809, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: [email protected], geoPoint lat: 28.53834, lon: -81.37924, hasResults: False |
protocolSection identificationModule nctId: NCT06272045, orgStudyIdInfo id: IRB00398712, secondaryIdInfos id: 5U24HL163114-02, type: NIH, link: https://reporter.nih.gov/quickSearch/5U24HL163114-02, briefTitle: Early Intervention to Promote Cardiovascular Health of Mothers and Children, acronym: ENRICH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: JHSPH Center for Clinical Trials, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors., conditionsModule conditions: Cardiovascular Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: cluster randomized at the home visiting supervisor level, stratified within home visiting agencies, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6400, type: ESTIMATED, armsInterventionsModule interventions name: Enriched home visiting, interventions name: Routine home visiting, outcomesModule primaryOutcomes measure: Parent physical activity, primaryOutcomes measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale, primaryOutcomes measure: Parent body mass index, primaryOutcomes measure: Parent blood pressure, secondaryOutcomes measure: Child body mass index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: California Polytechnic Institute, city: San Luis Obispo, state: California, zip: 93407, country: United States, contacts name: Noemi Alarcon, role: CONTACT, phone: 805-756-5694, email: [email protected], contacts name: Suzanne Phelan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.28275, lon: -120.65962, locations facility: Colorado University, city: Aurora, state: Colorado, zip: 80045-7464, country: United States, contacts name: Katharine Gamalski, role: CONTACT, phone: 720-499-4501, email: [email protected], contacts name: Mandy Allison, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60208, country: United States, contacts name: Danielle Lorch, role: CONTACT, phone: 630-222-2194, email: [email protected], contacts name: Darius Tandon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Washington University, city: Saint Louis, state: Missouri, zip: 63130, country: United States, contacts name: Cindy Schwartz, role: CONTACT, phone: 314-346-7101, email: [email protected], contacts name: Debra Haire-Joshu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Wake Forest University, city: Winston-Salem, state: North Carolina, zip: 27109, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15260, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Pennsylvania State University, city: State College, state: Pennsylvania, zip: 16801, country: United States, geoPoint lat: 40.79339, lon: -77.86, locations facility: Lifespan, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Angelica McHugh, role: CONTACT, phone: 401-793-8978, email: [email protected], contacts name: Rena Wing, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False |
protocolSection identificationModule nctId: NCT06272032, orgStudyIdInfo id: 2023KFKT001, briefTitle: Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients., conditionsModule conditions: Allergic Rhinitis, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity focused ultrasound (HIFU), interventions name: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines, outcomesModule primaryOutcomes measure: Nasal Symptom Score, primaryOutcomes measure: daily medication score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, country: China, contacts name: Shen Yang, Doctoral, role: CONTACT, phone: 15111953398, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06272019, orgStudyIdInfo id: HREC-DCU 2023-074, briefTitle: Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: To compare the iodine remaining in saliva between gargle method and swab method, conditionsModule conditions: The Retention of Iodine in Saliva Over the Time, conditions: The Comparison of Iodine in Saliva Between Gargle and Swab, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: the participant will use iodine gargle in 2 method, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Iodine gargle, outcomesModule primaryOutcomes measure: The rate of retention of iodine in saliva, primaryOutcomes measure: The comparison of the retention of iodine between gargle and swab, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Chulalongkorn University, city: Bangkok, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06272006, orgStudyIdInfo id: Anatomical recession, briefTitle: The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2025-03-04, completionDateStruct date: 2025-04-05, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate., conditionsModule conditions: Gingival Recession, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This study implements single-blind masking where outcomes assessors are unaware of participants' group assignments to minimize bias. While blinding participants and care providers is not feasible due to the nature of surgical interventions, strict protocols ensure assessors remain blinded to treatment allocation throughout the study, enhancing outcome evaluation objectivity., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Coronally Positioned Flap with Connective Tissue Graft, interventions name: Modified Coronally Advanced Tunnel with Connective Tissue Graft, outcomesModule primaryOutcomes measure: Anatomical Recession Rate (ARR), secondaryOutcomes measure: Clinical Attachment Level (CAL), secondaryOutcomes measure: Gingival Thickness (GT), secondaryOutcomes measure: Keratinized Tissue Thickness (KTT), secondaryOutcomes measure: Wound healing index (WHI), secondaryOutcomes measure: Tissue appearance, secondaryOutcomes measure: Aesthetic evaluation, secondaryOutcomes measure: Dentin hypersensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, zip: 06100, country: Turkey, contacts name: Abdullah Akman, PHD, role: CONTACT, phone: +905327609139, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06271993, orgStudyIdInfo id: 23-233, briefTitle: SPT for Sensitization of Collagen Dressing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-02-16, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Covalon Technologies Inc., class: INDUSTRY, collaborators name: ALS Beauty and Personal Care, descriptionModule briefSummary: The goal of this clinical trial is to determine the sensitization (contact allergy) potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects. The main question it aims to answer is:• Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs., conditionsModule conditions: Allergy Skin, conditions: Allergic Skin Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 20 healthy adult subjects, age 18-70 years. Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: ColActivePlus Collagen Matrix Dressing, outcomesModule primaryOutcomes measure: Wheal measurement, primaryOutcomes measure: Wheal measurement, primaryOutcomes measure: Wheal measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ALS Beauty and Personal Care, status: RECRUITING, city: Torrance, state: California, zip: 90501, country: United States, contacts name: Ashley Glavis, BS, role: CONTACT, phone: 424-307-5900, email: [email protected], contacts name: Jordan DeSantis, MHI, BS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False |
protocolSection identificationModule nctId: NCT06271980, orgStudyIdInfo id: 23228/ENCORE, briefTitle: Early-Onset Colorectal Cancer Recurrence, acronym: ENCORE, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, collaborators name: IRCCS San Raffaele Hospital, Milan, Italy, collaborators name: Institute of Biomedical Research of Salamanca, Salamanca, Spain, descriptionModule briefSummary: Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid), conditionsModule conditions: Colorectal Cancer Recurrent, conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, conditions: Colorectal Adenocarcinoma, conditions: Colorectal Cancer Stage I, conditions: Colorectal Cancer Stage II, conditions: Colorectal Cancer Stage III, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 177, type: ACTUAL, armsInterventionsModule interventions name: ENCORE, outcomesModule primaryOutcomes measure: Recurrence Free Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False |
protocolSection identificationModule nctId: NCT06271967, orgStudyIdInfo id: ABT-CIP-10518, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False |
protocolSection identificationModule nctId: NCT06271954, orgStudyIdInfo id: 202300096A3, briefTitle: The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-27, primaryCompletionDateStruct date: 2025-03-26, completionDateStruct date: 2025-03-26, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: National Taiwan University Hospital, descriptionModule briefSummary: According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important.Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction".Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context., conditionsModule conditions: Major Depressive Disorder, conditions: Anxiety Disorder, conditions: Attention Deficit Hyperactivity Disorder (ADHD), conditions: Adjustment Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The Difference and Similarity in Emotional Regulation Strategy Patterns between Western and Eastern Countries., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Chang-Geng Medical Foundation Chang-Geng Memorial Hospital, status: RECRUITING, city: Keelung, zip: 204, country: Taiwan, contacts name: Tzuyu Liu, role: CONTACT, phone: (02)24329292, phoneExt: 2720, email: [email protected], geoPoint lat: 25.12825, lon: 121.7419, hasResults: False |
protocolSection identificationModule nctId: NCT06271941, orgStudyIdInfo id: HAPC-RCT, briefTitle: Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de l'Université de Montréal (CHUM), class: OTHER, descriptionModule briefSummary: Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding.We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. We also hypothesize that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed., conditionsModule conditions: Colorectal Cancer, conditions: Polyp of Colon, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 892, type: ESTIMATED, armsInterventionsModule interventions name: Hybrid Argon Plasma Coagulation (h-APC), interventions name: Snare tip soft coagulation (STSC), outcomesModule primaryOutcomes measure: To compare the recurrence rates after EMR colorectal between the h-APC and SSTC methods, secondaryOutcomes measure: To assess the potential advantages associated with a complete defect closure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de l'Université de Montréal, city: Montréal, state: Quebec, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False |
protocolSection identificationModule nctId: NCT06271928, orgStudyIdInfo id: TJ-IRB20220634-yijingkeli, briefTitle: A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA., conditionsModule conditions: Ovarian Aging, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Yijing Keli, outcomesModule primaryOutcomes measure: the recovery rate of ovarian function, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, country: China, contacts name: jinjin zhang, professor, role: CONTACT, phone: +8683663078, email: [email protected], contacts name: yan zhang, MD, role: CONTACT, phone: +8683663078, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06271915, orgStudyIdInfo id: cervical spine mobilization, briefTitle: Role of Cervical Spine Mobilization on Lateral Epicondylitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis., conditionsModule conditions: Lateral Epicondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: SNAGs - eccentric exercise, outcomesModule primaryOutcomes measure: Leeds assessment of neuropathic symptoms and sign (LANSS) scale, primaryOutcomes measure: Pain-free hand grip test, secondaryOutcomes measure: The Numeric Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Outpatient physical therapy, Faculty of physical therapy, status: RECRUITING, city: Giza, zip: 2334, country: Egypt, contacts name: Ahmed ElMelhat, role: CONTACT, phone: 01112595022, email: [email protected], geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06271902, orgStudyIdInfo id: IRB-2023-531, briefTitle: Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Nanyang Technological University, class: OTHER, descriptionModule briefSummary: The Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) includes an exercise segment and an education segment. This study will (1) assess the effects of the exercise segment, and (2) assess the effects of the education segment among youth volleyball athletes using a randomized controlled trial over 12 weeks. Performance outcome measures of shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion will be used to assess the effects of the exercise segment. Knowledge scores via an online questionnaire will be used to assess the effects of the education segment.Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores., conditionsModule conditions: Sport Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized controlled trial with an intervention group and a control group to evaluate the effects of the YoSO-IPP. The intervention group will perform the exercises and attend the online educational workshop. The control group will only perform lower body stretching exercises which is considered as a sham program., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Singapore Youth Shoulder Overuse Injury Prevention Program, interventions name: Lower body stretching program, outcomesModule primaryOutcomes measure: Shoulder external rotation strength, primaryOutcomes measure: Internal rotation range of motion, primaryOutcomes measure: Thoracic rotation range of motion, primaryOutcomes measure: Knowledge of overuse injuries, secondaryOutcomes measure: Shoulder overuse injury prevalence, secondaryOutcomes measure: Elbow overuse injury prevalence, secondaryOutcomes measure: Shoulder overuse injury severity, secondaryOutcomes measure: Elbow overuse injury severity, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nanyang Technological University, city: Singapore, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06271889, orgStudyIdInfo id: B.10.1.TKH.4.34.H.GP.0.01/330, briefTitle: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-24, primaryCompletionDateStruct date: 2024-02-24, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women., conditionsModule conditions: Delivery Fear, conditions: Labor Pain, conditions: Maternal-Fetal Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized parallel controlled experimental design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Which of the participants is the control or intervention group will be selected by randomization., whoMasked: PARTICIPANT, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Non-stress test, outcomesModule primaryOutcomes measure: VİSUAL ANALOG SCALE, primaryOutcomes measure: STATUS AND CONTINUOUS ANXIETY SCALE, otherOutcomes measure: Postpartum Attachment Scale (PASAS):, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saglık Bilimleri Universitesi, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: YASEMİN AYDIN KARTAL, role: CONTACT, phone: +90 5432870029, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06271876, orgStudyIdInfo id: 0011, briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-03-09, completionDateStruct date: 2024-03-19, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Sierra Varona SL, class: OTHER, collaborators name: Universidad Europea de Madrid, descriptionModule briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and muscular strength in lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure and muscle tissue oxygen levels.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation.In this study, subjects will be divided into three groups: experimental group, activation group and control group.Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory muscle training, outcomesModule primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: Diaphragmatic thickness and thickening fraction, primaryOutcomes measure: Diaphragm movement curve, primaryOutcomes measure: Vertical jump performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271863, orgStudyIdInfo id: Soh-Med-23-11-08MS, briefTitle: Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Prospective observational study, conditionsModule conditions: PROM, Preterm (Pregnancy), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Conservation vs termination in cases of PROM 20 to 28 weeks of pregnancy, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag university hospital, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06271850, orgStudyIdInfo id: P.T.REC/012/004949, briefTitle: Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women., conditionsModule conditions: Breastfeeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ergonomics breastfeeding training, interventions name: Pilates exercises, outcomesModule primaryOutcomes measure: Measurement of craniovertebral angle (CVA), primaryOutcomes measure: Assessment of neck pain intensity, primaryOutcomes measure: Measurement of cervical range of motion, secondaryOutcomes measure: Evaluation of disability due to neck pain, secondaryOutcomes measure: Assessment of neck muscle fatigue, secondaryOutcomes measure: Assessment of breastfeeding self-efficacy, secondaryOutcomes measure: Measurement of weight and height of baby, secondaryOutcomes measure: Assessment of Health-Related Quality of Life, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271837, orgStudyIdInfo id: D781AC00001, briefTitle: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-04-17, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo Co., Ltd., descriptionModule briefSummary: This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy., conditionsModule conditions: Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study is Open-Label Study., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab deruxtecan, outcomesModule primaryOutcomes measure: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR), secondaryOutcomes measure: Confirmed Objective Response Rate (ORR) by investigator assessment, secondaryOutcomes measure: Duration of Response (DoR) by Independent Central Review (ICR), secondaryOutcomes measure: Duration of Response (DoR) by investigator assessment, secondaryOutcomes measure: Disease control rate (DCR) by Independent Central Review (ICR), secondaryOutcomes measure: Disease control rate (DCR) by investigator assessment, secondaryOutcomes measure: Confirmed best objective response (BOR) by Independent Central Review (ICR), secondaryOutcomes measure: Confirmed best objective response (BOR) by investigator assessment, secondaryOutcomes measure: Progression-free survival (PFS) by Independent Central Review (ICR), secondaryOutcomes measure: Progression-free survival (PFS) by investigator assessment, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Pharmacokinetics (PK) of T-DXd, secondaryOutcomes measure: Immunogenicity of T-DXd, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100142, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changchun, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changzhou, zip: 213004, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dongyang, zip: 322100, country: China, geoPoint lat: 29.26778, lon: 120.22528, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510145, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510630, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: WITHDRAWN, city: Haikou, zip: 570311, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310022, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: RECRUITING, city: Harbin, zip: 150081, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hefei, zip: 230031, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kunming, zip: 650118, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lishui, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanchang, zip: 330029, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200011, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xuzhou, zip: 221009, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, zip: 450008, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False |
protocolSection identificationModule nctId: NCT06271824, orgStudyIdInfo id: 23-1519, briefTitle: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session., conditionsModule conditions: Stress, conditions: Caregiver Burden, conditions: Anxiety, conditions: Depressive Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Self-Compassion Based Resilient Caregiving Course, outcomesModule primaryOutcomes measure: Percentage of participants who withdraw from course, primaryOutcomes measure: Percentage of participants who attend at least 4 of 6 intervention sessions, primaryOutcomes measure: Percentage of participants who rate the course as "acceptable" or "completely acceptable", primaryOutcomes measure: Percentage of intervention topics covered, secondaryOutcomes measure: Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks, secondaryOutcomes measure: Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks, secondaryOutcomes measure: Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks, secondaryOutcomes measure: Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks, secondaryOutcomes measure: Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks, secondaryOutcomes measure: Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks, secondaryOutcomes measure: Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks, secondaryOutcomes measure: Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Monica Coudurier, role: CONTACT, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False |
protocolSection identificationModule nctId: NCT06271811, orgStudyIdInfo id: UJAPFPS, briefTitle: Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome, acronym: flossing, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-09, primaryCompletionDateStruct date: 2023-11-14, completionDateStruct date: 2023-11-20, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Jaén, class: OTHER, collaborators name: University of Jaen, descriptionModule briefSummary: The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:* Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?* What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS., conditionsModule conditions: Anterior Knee Pain Syndrome, conditions: Patellofemoral Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Flossing band, interventions name: Conventional physiotherapy, outcomesModule primaryOutcomes measure: Disability related to patellofemoral pain, primaryOutcomes measure: Knee extensor muscle strength, primaryOutcomes measure: Pain report, secondaryOutcomes measure: Self-reported function, secondaryOutcomes measure: Short Form-36 (SF-36), secondaryOutcomes measure: Berg Balance Scale (BBS), secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Brief Pain Questionnaire, secondaryOutcomes measure: Perceived Stress Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Jaen, city: Jaen, zip: 23009, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False |
protocolSection identificationModule nctId: NCT06271798, orgStudyIdInfo id: P.T.REC/012/004867, briefTitle: Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women., conditionsModule conditions: Varicose Veins, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Life style modification advice, interventions name: Resistive exercise, interventions name: Aerobic exercises, outcomesModule primaryOutcomes measure: Peak popliteal vein velocity, secondaryOutcomes measure: Visual analogue scale, secondaryOutcomes measure: Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20), secondaryOutcomes measure: 6-minute. walk test, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University, status: RECRUITING, city: Giza, country: Egypt, contacts name: Mai Saif Elnasr Ghietah, M.Sc. Stud, role: CONTACT, contacts name: Mai Mohamed Ali, PhD, role: CONTACT, contacts name: Soheir Mahmoud Elkosery, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Hossam Aldin H. Kamel, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06271785, orgStudyIdInfo id: 49RC22_0354, briefTitle: Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery, acronym: ISEPEE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.Electrical sources are then fused on structural magnetic resonance imaging (MRI).Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure., conditionsModule conditions: Epilepsy in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HR-EEG recording, outcomesModule primaryOutcomes measure: Prediction accuracy index, secondaryOutcomes measure: Localization of the epileptogenic zone (Baseline), secondaryOutcomes measure: Localization of the epileptogenic zone (After Surgery), secondaryOutcomes measure: preoperative accuracy of epileptogenic source localization, secondaryOutcomes measure: prognostic value of HFO, secondaryOutcomes measure: Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate, secondaryOutcomes measure: health-economic modeling, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Angers university hospital, Pédiatric department, city: Angers, zip: 49000, country: France, contacts name: Patrick Van Bogaert, Professor, role: CONTACT, phone: 02 41 35 48 46, email: [email protected], geoPoint lat: 47.46667, lon: -0.55, locations facility: Lille University Hospital, Clinical Neurophysiology Department, city: Lille, zip: 59000, country: France, contacts name: Philippe DERAMBURE, Professor, role: CONTACT, phone: 03 20 44 63 62, email: [email protected], geoPoint lat: 50.63297, lon: 3.05858, locations facility: Civil Hospices of Lyon, Functional Neurology Department, city: Lyon, zip: 69677, country: France, contacts name: Julien Jung, Doctor, role: CONTACT, phone: 04 72 35 79 00, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department, city: Marseille, zip: 13000, country: France, contacts name: Fabrice BARTOLOMEI, Professor, role: CONTACT, phone: 04 91 38 46 84, email: [email protected], geoPoint lat: 43.29551, lon: 5.38958, locations facility: Nancy University Hospital, Neurology Department, city: Nancy, zip: 54000, country: France, contacts name: Louis Maillard, Professor, role: CONTACT, phone: 03 83 85 16 09, email: [email protected], geoPoint lat: 48.68439, lon: 6.18496, locations facility: Paris Neck University Hospital, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations, city: Paris, zip: 75019, country: France, contacts name: François-Xavier MAUVAIS, Doctor, role: CONTACT, phone: 01 40 03 20 00, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department, city: Paris, zip: 75019, country: France, contacts name: Emmanuel Raffo, Professor, role: CONTACT, phone: 01 48 03 68 17, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Rennes University Hospital, Pediatric department, city: Rennes, zip: 35000, country: France, contacts name: Silvia Adriana NAPURI PEIRANO, Doctor, role: CONTACT, phone: 02 99 26 58 34, email: [email protected], geoPoint lat: 48.11198, lon: -1.67429, hasResults: False |
protocolSection identificationModule nctId: NCT06271772, orgStudyIdInfo id: 18-26045-RII, briefTitle: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II, acronym: REAGIR II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Stanford University, collaborators name: Aravind Eye Care System, collaborators name: Federal University of São Paulo, descriptionModule briefSummary: Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT, conditionsModule conditions: Bacterial Keratitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Difluprednate Ophthalmic, interventions name: Rose Bengal, interventions name: Moxifloxacin Ophthalmic, outcomesModule primaryOutcomes measure: Best Spectacle-Corrected Visual Acuity, secondaryOutcomes measure: Best Spectacle-Corrected Visual Acuity, secondaryOutcomes measure: Scar size, secondaryOutcomes measure: Scar depth, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal University of São Paulo, city: São Paulo, country: Brazil, contacts name: Ana Luisa Hofling Lima, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: -23.5475, lon: -46.63611, locations facility: Aravind Eye Care System, city: Madurai, state: Tamil Nadu, country: India, contacts name: N V Prajna, role: CONTACT, email: [email protected], geoPoint lat: 9.91769, lon: 78.11898, hasResults: False |
protocolSection identificationModule nctId: NCT06271759, orgStudyIdInfo id: PSYFRAG, briefTitle: Psychological Effects of a Set of Functional Fragrances, acronym: PSYFRAG, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Bucharest, class: OTHER, collaborators name: IFF (International Flavors & Fragrances), descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart., conditionsModule conditions: Stress, conditions: Anxiety, conditions: Well-Being, Psychological, conditions: Mood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Fragrance inhalation, outcomesModule primaryOutcomes measure: Affective states - relaxation, primaryOutcomes measure: Affective states - contentment, primaryOutcomes measure: Affective states - happiness, primaryOutcomes measure: Affective states - stress, primaryOutcomes measure: Affective states - motivation, primaryOutcomes measure: Affective states - tension, primaryOutcomes measure: Emotional changes, secondaryOutcomes measure: General mental health - Depression, secondaryOutcomes measure: General mental health - Anxiety, secondaryOutcomes measure: General mental health - Stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bucharest, status: RECRUITING, city: Bucharest, zip: 050663, country: Romania, contacts name: Cezar Giosan, PhD, role: CONTACT, phone: +40730908050, email: [email protected], geoPoint lat: 44.43225, lon: 26.10626, hasResults: False |
protocolSection identificationModule nctId: NCT06271746, orgStudyIdInfo id: TCH101, briefTitle: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Theranica, class: INDUSTRY, descriptionModule briefSummary: Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment. Randomized, double-blind, sham-controlled, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: FibroNova (Active mode), interventions name: FibroNova (Sham mode), outcomesModule primaryOutcomes measure: Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4), primaryOutcomes measure: Device safety (rate of adverse events and device related adverse events), secondaryOutcomes measure: Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score, secondaryOutcomes measure: Mean change in FIQR functionality sub-scale score, secondaryOutcomes measure: Mean change in FIQR pain item score, secondaryOutcomes measure: Mean change in Brief Pain Inventory (BPI) score, secondaryOutcomes measure: Improvement in patient global impression according to PGIC score, secondaryOutcomes measure: Mean reduction in functional disability during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4), otherOutcomes measure: Improvement in quality of life, otherOutcomes measure: Improvement in sleep quality, otherOutcomes measure: Mean change in level of depression, otherOutcomes measure: Mean change in level of anxiety, otherOutcomes measure: Mean change in level of cognitive impairment, otherOutcomes measure: Mean change in level of cognitive presenteeism, otherOutcomes measure: Mean reduction of at least 30% in pain level, otherOutcomes measure: Rate of treatment tolerability, otherOutcomes measure: User experience, otherOutcomes measure: Patient Global Impression- change (PGI-C, otherOutcomes measure: Patient Global Impression- change (PGI-C)- mid study:, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Professionals, status: RECRUITING, city: Chesterfield, state: Missouri, zip: 63005, country: United States, contacts name: Shahmir Kahn, role: CONTACT, phone: 636-220-1200, email: [email protected], contacts name: Daniel Mattson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.66311, lon: -90.57707, locations facility: ClinVest Headlands Research, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Brittni kendrick, role: CONTACT, phone: 417-883-7889, email: [email protected], contacts name: David True, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Gershon Pain Specialists, status: RECRUITING, city: Virginia Beach, state: Virginia, zip: 23454, country: United States, contacts name: Erika Dorman, role: CONTACT, phone: 757-496-2050, email: [email protected], contacts name: Steven Gershon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.85293, lon: -75.97799, locations facility: Tel Aviv Sourasky Medical Center, status: NOT_YET_RECRUITING, city: Tel Aviv, zip: 6423906, country: Israel, contacts name: Sara Pel, role: CONTACT, phone: +972-52-4266605, email: [email protected], contacts name: Ori Elkayam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False |
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