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protocolSection identificationModule nctId: NCT06354959, orgStudyIdInfo id: 1030020, briefTitle: Prehab for Lung and Esophageal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Nova Scotia Health Authority, class: OTHER, collaborators name: Dalhousie University, descriptionModule briefSummary: Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles., conditionsModule conditions: Neoplasm of Lung, conditions: Neoplasms, conditions: Exercise, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation, outcomesModule primaryOutcomes measure: Feasibility- Recruitment, primaryOutcomes measure: Feasibility- Participant fidelity, primaryOutcomes measure: Feasibility - Safety, primaryOutcomes measure: Feasibility - Retention/Attrition, primaryOutcomes measure: Feasibility - Participant Experience, primaryOutcomes measure: Feasibility- Attendance, secondaryOutcomes measure: Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E), secondaryOutcomes measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), secondaryOutcomes measure: 5x chair stand, secondaryOutcomes measure: Stair climb test, secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Resting Heart rate, secondaryOutcomes measure: Resting blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Victoria General Hospital, city: Halifax, state: Nova Scotia, country: Canada, contacts name: Jodi Langley, role: CONTACT, email: [email protected], geoPoint lat: 44.64533, lon: -63.57239, hasResults: False
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protocolSection identificationModule nctId: NCT06354946, orgStudyIdInfo id: SCORE 4C, briefTitle: External Validation of Simplified 4C Mortality Score by Deleting CRP, acronym: 4Cs, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-11-30, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Monastir, class: OTHER, descriptionModule briefSummary: The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score., conditionsModule conditions: COVID-19 Pandemic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ACTUAL, outcomesModule primaryOutcomes measure: The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate, secondaryOutcomes measure: Number of patients admitted to the ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: EPS Fattouma Bourguiba University hospital, city: Monastir, zip: 5020, country: Tunisia, geoPoint lat: 35.77799, lon: 10.82617, hasResults: False
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protocolSection identificationModule nctId: NCT06354933, orgStudyIdInfo id: DemeNSS (3785), briefTitle: Neurological Soft Signs in Neurodegenerative Dementias, acronym: DemeNSS, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Milano Bicocca, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?* Are NSS associated with neuropsychiatric alterations in dementia patients?* Do NSS correlate with cognitive screening tools?* Do NSS increase over time in patients with neurodegenerative dementias?Participants will undergo assessments including:* Evaluation of NSS using the Heidelberg scale* Neuropsychiatric assessments* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored., conditionsModule conditions: Alzheimer Disease, conditions: Dementia With Lewy Bodies, conditions: Frontotemporal Dementia, conditions: Corticobasal Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 186, type: ACTUAL, armsInterventionsModule interventions name: Neurological Soft Signs, outcomesModule primaryOutcomes measure: Difference in NSS, secondaryOutcomes measure: Association between NSS and Neuropsychiatric Inventory (NPI) scores, secondaryOutcomes measure: Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE), secondaryOutcomes measure: Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB), secondaryOutcomes measure: Longitudinal changes in NSS scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS San Gerardo dei Tintori, city: Monza, state: Lombardia, zip: 20900, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, hasResults: False
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protocolSection identificationModule nctId: NCT06354920, orgStudyIdInfo id: HUM00247781, secondaryIdInfos id: R18HS028963, type: AHRQ, link: https://reporter.nih.gov/quickSearch/R18HS028963, briefTitle: M-Well Bonding Bundle to Improve Patient-Physician Relationships, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are:* Will using the intervention strategies improve doctors' empathy towards their patients?* Will using the intervention strategies lead to improved scores in patient views of doctors' empathy?There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally.Researchers will compare the doctors in the intervention arm to those in the control arm.Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following:1. Allow study staff to observe the interaction between them and their patients.2. Complete a brief survey at the end of their 2-week work rotation.Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital.Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following:1. Allow study staff to observe the interaction between them and their doctors.2. Complete a brief survey after meeting with their doctor., conditionsModule conditions: Physician-Patient Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Quasi-experimental randomized controlled trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 3624, type: ESTIMATED, armsInterventionsModule interventions name: Bonding Bundle, outcomesModule primaryOutcomes measure: Jefferson Scale of Empathy (JSE), primaryOutcomes measure: Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE), primaryOutcomes measure: Communication Assessment Tool, primaryOutcomes measure: Frequency of use of intervention methods, secondaryOutcomes measure: Perceived duration of interaction, secondaryOutcomes measure: Wake Forest Physician Trust Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Sanjay Saint, MD, MPH, role: CONTACT, phone: 734-615-8341, email: [email protected], contacts name: Karen Fowler, MPH, role: CONTACT, phone: 734-845-3611, email: [email protected], contacts name: Sanjay Saint, MD, MPH, role: PRINCIPAL_INVESTIGATOR, contacts name: Christopher Smith, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: VA Ann Arbor Healthcare System, status: NOT_YET_RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Nathan Houchens, MD, role: CONTACT, phone: 734-845-5922, email: [email protected], contacts name: Karen Fowler, MPH, role: CONTACT, phone: 734-845-3611, email: [email protected], contacts name: Nathan Houchens, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Sanjay Saint, MD, MPH, role: SUB_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06354907, orgStudyIdInfo id: HUM00150780, briefTitle: Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP), acronym: KEP, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-03, primaryCompletionDateStruct date: 2024-10-02, completionDateStruct date: 2024-10-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life., conditionsModule conditions: Child Mental Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups of children and their parent will be compared and evaluated twice (twelve weeks apart). The first group (approximately half of the sample) will participate in the Kids' Empowerment Program in their classroom and their parent will complete assessments online. The second group will complete both assessments and then receive the program in their classroom after the 12 week interval., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy., whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: The Kids' Empowerment Program, outcomesModule primaryOutcomes measure: Revised Children's Anxiety and Depression Scale, primaryOutcomes measure: Strengths and Difficulties Questionnaire, secondaryOutcomes measure: Cognitive Emotion Regulation Questionnaire, otherOutcomes measure: EPOCH Questionnaire, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06354894, orgStudyIdInfo id: MACOXS, secondaryIdInfos id: 133/2020/U, type: REGISTRY, domain: MACOXS, briefTitle: Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-11-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws., conditionsModule conditions: Proximal Humeral Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Proximal humeral fracture fixation, outcomesModule primaryOutcomes measure: Oxford Shoulder Score (OSS), primaryOutcomes measure: Quick Disabilities of the arm, shoulder and hand (DASH) score, primaryOutcomes measure: Subjective Shoulder Value (SSV), primaryOutcomes measure: Radiographic outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Luigi Gonzaga Hospital, status: RECRUITING, city: Orbassano, state: Turin, zip: 10043, country: Italy, contacts name: Enrico Bellato, MD, role: CONTACT, phone: +393406429207, email: [email protected], geoPoint lat: 45.00547, lon: 7.53813, hasResults: False
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protocolSection identificationModule nctId: NCT06354881, orgStudyIdInfo id: 0967, secondaryIdInfos id: TM61008S3, type: OTHER_GRANT, domain: British Heart Foundation, briefTitle: The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke, acronym: LACUNAR_CA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Leicester, class: OTHER, collaborators name: British Heart Foundation, collaborators name: University Hospitals, Leicester, descriptionModule briefSummary: The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors., conditionsModule conditions: Lacunar Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres, outcomesModule primaryOutcomes measure: Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes., primaryOutcomes measure: Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes., primaryOutcomes measure: Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes., primaryOutcomes measure: End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes., primaryOutcomes measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA)., primaryOutcomes measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR)., primaryOutcomes measure: Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals of Leicester NHS Trust, city: Leicester, state: Leicestershire, zip: LE1 5WW, country: United Kingdom, contacts name: Amit Mistri, role: CONTACT, email: [email protected], geoPoint lat: 52.6386, lon: -1.13169, hasResults: False
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protocolSection identificationModule nctId: NCT06354868, orgStudyIdInfo id: NNBioEP004, briefTitle: A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy, acronym: ECLIPSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Neuronostics Ltd, class: INDUSTRY, collaborators name: Cornwall Partnership NHS Foundation Trust, descriptionModule briefSummary: This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy, conditionsModule conditions: Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 158, type: ESTIMATED, outcomesModule primaryOutcomes measure: The relationship between BioEP and seizure frequency., secondaryOutcomes measure: Association between the 12-month change from baseline in BioEP result and the patients reported global impression of change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354855, orgStudyIdInfo id: NEU-FTR-FE-04, briefTitle: "Which Type of Exercise is More Effective in Chronic Constipation?, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation., conditionsModule conditions: Chronic Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups with a conventional therapy control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The assignment of people to groups will be done by a statistician, apart from the research using a computer program. Randomization will be determined by entering the total number of cases through the program whose URL address is https://www.randomizer.org., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Group is doing breathing exercises while watching videos, interventions name: Medium pace walking group, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Constipation Severity Scale (CSS), otherOutcomes measure: Chronic Constipation Quality of Life Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University, city: Konya, state: Meram, zip: 42000, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06354842, orgStudyIdInfo id: 12345678, briefTitle: Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-05, primaryCompletionDateStruct date: 2020-12-11, completionDateStruct date: 2020-12-11, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: pilocarpine iontopheresis, outcomesModule primaryOutcomes measure: Sweat sodium concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, city: Vienna, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06354829, orgStudyIdInfo id: MEDICALBUM, briefTitle: Medical Images Collection Research, acronym: MEDICALBUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2049-04, completionDateStruct date: 2049-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, collaborators name: Papa Giovanni XXIII Hospital, descriptionModule briefSummary: This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only., conditionsModule conditions: Kidney Diseases, conditions: Brain Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Medical imaging procedures, outcomesModule primaryOutcomes measure: Creation of a medical images collection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center for Rare Disease Aldo e Cele Daccò, city: Ranica, state: BG, zip: 24020, country: Italy, contacts name: Anna Caroli, PhD, role: CONTACT, phone: +3903545351, email: [email protected], geoPoint lat: 45.72328, lon: 9.71335, hasResults: False
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protocolSection identificationModule nctId: NCT06354816, orgStudyIdInfo id: V 2.0, 07Feb2024, briefTitle: VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults, acronym: VENLID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Krankenhaus Barmherzige Schwestern Linz, class: OTHER, descriptionModule briefSummary: Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: prospective, randomized, double-blind, controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Xylocaine 10% pump spray, interventions name: Saline solution isotonic 0.9% NaCl, outcomesModule primaryOutcomes measure: To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita, secondaryOutcomes measure: To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm, secondaryOutcomes measure: To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus vs. at the forearm/cubita, secondaryOutcomes measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS, secondaryOutcomes measure: To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC, secondaryOutcomes measure: To measure pain rated by NRS depending on success, secondaryOutcomes measure: To describe success rates and compare it, secondaryOutcomes measure: To measure the correlation between PCS and pain caused by PIVC rated by NRS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354803, orgStudyIdInfo id: KafrelsheikhU 30, briefTitle: Effect of Pezzi Ball on Balance in Pregnant Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The effect of kinaesthetic training on performance and postural stability during pregnancy and 2 weeks postpartum, conditionsModule conditions: Postural Stability, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 45 participants with gestational age below 28 weeks, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, maskingDescription: The drawing procedure was conducted by a researcher without disclosure to the participants, ensuring unbiased allocation. Moreover, both the assessor and statistician remained blinded throughout the assessment period, unaware of the group assignments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: proprioceptive training, outcomesModule primaryOutcomes measure: change of postural stability, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy kafrelshiekh university, city: Kafr Ash Shaykh, state: Kafrelshiekh, zip: 6850001, country: Egypt, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06354790, orgStudyIdInfo id: NatHis LAMA2, briefTitle: Natural History Study of Children With LAMA2-related Dystrophies, acronym: LAMA2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2027-06-14, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Institut de Myologie, France, class: OTHER, collaborators name: Association Française contre les Myopathies (AFM), Paris, descriptionModule briefSummary: The goal of this natural history study is to characterize the disease course, characteristics in paediatric population of LAMA2-RD (related dystrophies) patients.The aim of the study is to establish a well-described cohort of patients in France with LAMA2-RD for prospective follow-up and recruitment for future clinical trials.Participants will be follow up during a two years period regarding exhaustive aspects of the pathology:* Muscular function* Respiratory function* Cognitive phenotyping* Quality of life* Growth parameters* Biomarkers, conditionsModule conditions: Merosin Deficient Congenital Muscular Dystrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Motor evaluations, interventions name: Cognitive assessment, interventions name: Pulmonary function test, interventions name: Cardiac evaluation, interventions name: Quality of life, interventions name: Spine X Ray, interventions name: Muscular MRI, interventions name: Biomarkers collection and analysis, outcomesModule primaryOutcomes measure: Change in Motor function Measurement (MFM32) score, primaryOutcomes measure: Change in Motor Milestone Checklist, primaryOutcomes measure: Change in Revised Upper Limb Module (RULM) score, primaryOutcomes measure: Change in grip strength measured by dynamometer tool, primaryOutcomes measure: Change in pinch strength measured by dynamometer tool, primaryOutcomes measure: Change in arm flexion/extension strength measured by dynamometer tool, primaryOutcomes measure: Change in 6 Minutes Walking Test, primaryOutcomes measure: Change in 4 Stairs Climbing Test (4SCT), primaryOutcomes measure: Change in 10m Walking Test, primaryOutcomes measure: Change in Rise from Floor Test, primaryOutcomes measure: Change in patient's Forced Vital Capacity (FVC) results, primaryOutcomes measure: Change in patient's Peak Cough Flow (PCF) results, primaryOutcomes measure: Change in patient's Maximum Expiratory Pressure (MEP) results, primaryOutcomes measure: Change in patient's Maximal Inspiratory Pressure (MIP) results, primaryOutcomes measure: Change in patient's Sniff Nasal Inspiratory Pressure (SNIP) results, primaryOutcomes measure: Change in patient's muscle fat replacement measured by Magnetic Nuclear Resonance, primaryOutcomes measure: Change in patient's cross-sectional area of the residual muscle measured by MNR, secondaryOutcomes measure: Change in Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV) results, secondaryOutcomes measure: Change in Wechsler Intelligence Scale for Children-V (WISC-V) results, secondaryOutcomes measure: Change in PedsQL questionnaire results, secondaryOutcomes measure: Change in CGI-S questionnaire results, secondaryOutcomes measure: Change in CGI-I questionnaire results, secondaryOutcomes measure: Change in Faces pain rating scale results, secondaryOutcomes measure: Change in Fatigue Severity Scale results, secondaryOutcomes measure: Change in ACTIVLIM questionnaire results, secondaryOutcomes measure: Change in Egen Klassifikation Scale Version 2 (EK2) results, secondaryOutcomes measure: Change in Caregiver burden questionnaire (LMDIS) results, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre de Référence GNMH, Pédiatrie Hôpital Raymond-Poincaré, city: Garches, country: France, contacts name: Isabelle BOSSARD, role: CONTACT, contacts name: Marta GOMEZ, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.84226, lon: 2.18232, locations facility: Service de MPR pédiatrique L'Escale - HCL, city: Lyon, country: France, contacts name: Manel SAIDI, role: CONTACT, contacts name: Carole VUILLEROT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Département de neuropédiatrie Pôle Femme Mère Enfant CHU de Montpellier - Hôpital Gui de Chauliac, city: Montpellier, country: France, contacts name: Léa THEVENET, role: CONTACT, contacts name: Ulrike WALTHER-LOUVIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Plateforme d'essais cliniques pédiatriques iMotion, city: Paris, country: France, contacts name: Dominique DUCHENE, role: CONTACT, contacts name: Andreea SEFERIAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06354777, orgStudyIdInfo id: EVERCOOL AF, briefTitle: REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry, acronym: EVERCOOL AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Heart Rhythm Clinical and Research Solutions, LLC, class: OTHER, collaborators name: Attune Medical, descriptionModule briefSummary: This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: Ablation Procedure, outcomesModule primaryOutcomes measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling., primaryOutcomes measure: To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling., primaryOutcomes measure: To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling., primaryOutcomes measure: Patient reported outcomes in patients treated with active esophageal cooling., primaryOutcomes measure: Physician reported outcome post procedure with active esophageal cooling., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354764, orgStudyIdInfo id: 8780-UC1, briefTitle: Propensity to Hospitalize Patients From the ED in European Centers., acronym: eCREAM-UC1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, collaborators name: Astir S.r.l., collaborators name: Centre Hospitalier Universitaire Vaudois, collaborators name: Orobix Life S.r.l., collaborators name: Fondazione Bruno Kessler, descriptionModule briefSummary: The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated., conditionsModule conditions: Emergency Medicine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 162000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Create two separate databases, primaryOutcomes measure: Multivariable models, primaryOutcomes measure: Adjusted comparison, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354751, orgStudyIdInfo id: 327236, briefTitle: Maternity Care Experiences of Asylum-seeking and Refugee Women in Scotland, acronym: MACAWS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Aberdeen, class: OTHER, descriptionModule briefSummary: The International Organisation of Migration reports that over half (52.4%) of international migrants in Europe are women. Evidence suggests that women with immigrant backgrounds often struggle to access healthcare across the world. Among migrant women, asylum-seeking and refugee women face higher risks of poor pregnancy and birth outcomes, including babies with low birth weight, physical and/or mental health problems or death related to pregnancy and/or childbirth. Previous studies have focused on immigrant women's experiences of care during pregnancy and birth and did not differentiate between asylum seekers, refugees, and economic migrants. This can make it difficult to compare studies accurately. This PhD study focuses on asylum-seeking and refugee women, using the definitions provided by the United Nations. Asylum-seeking women refer to women who seek protection in a country other than their own and are waiting for a decision on their status. Asylum seekers become refugees once their application has been processed and accepted.A scoping review was conducted to understand the experiences of asylum-seeking and refugee women accessing maternity care in the UK, with a focus on Scotland. The review found that all studies that focused on the experiences of asylum-seeking and refugee women accessing maternity care were mainly based in England. The review identified the presence of specialist migrant services in maternity settings in Scotland and across the UK, but there was no information on their implementation or impact on women's outcomes. Additionally, there is limited evidence in the UK on the perceptions of healthcare professionals providing care to asylum-seeking and refugee women.This PhD aims to close this gap in research by exploring this area more deeply in Scotland through mixed-methods studies of surveys with asylum-seeking and refugee women and interviews with maternity care leaders, policymakers, maternity healthcare professionals, and asylum-seeking and refugee women., conditionsModule conditions: Refugee, conditions: Asylum-seeking Women, conditions: Maternity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Exploring and understanding asylum-seeking and refugee women's experiences of maternity care in Scotland., primaryOutcomes measure: Evidence of healthcare professionals' experiences of providing maternity care for asylum-seeking and refugee women in Scotland., secondaryOutcomes measure: Identification of the successful components of specialist migrant maternity services in Scotland., secondaryOutcomes measure: Identification of gaps between care pathways and practice (implementation gap) and how this affects the quality of maternity care and women's experiences of maternity services, secondaryOutcomes measure: Information for policymakers on approaches needed to improve maternity care for refugee and asylum-seeking women at local and national levels., eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354738, orgStudyIdInfo id: S66928, briefTitle: Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment, acronym: EUGENIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-16, primaryCompletionDateStruct date: 2028-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Gasthuisberg, class: OTHER, collaborators name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, collaborators name: University Medical Centre Maribor, descriptionModule briefSummary: EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging, outcomesModule primaryOutcomes measure: Endometrial cancer stage, primaryOutcomes measure: Molecular type of endometrial cancer, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to recurrence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Gasthuisberg, Katholieke Universiteit Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Ayaka Wakatsuki, role: CONTACT, phone: +32 16 34 41 69, email: [email protected], contacts name: Frédéric Amant, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06354725, orgStudyIdInfo id: 2vs4, briefTitle: Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Bruno Figueira, class: OTHER, collaborators name: Vytautas Magnus University, descriptionModule briefSummary: Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split., conditionsModule conditions: Physical Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Plyometric, outcomesModule primaryOutcomes measure: Horizontal jump, secondaryOutcomes measure: CMJ, otherOutcomes measure: Drop Jump, otherOutcomes measure: Drop jump (RSI), otherOutcomes measure: Linear sprint-5m, otherOutcomes measure: Linear sprint-20m, otherOutcomes measure: Change of direction, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Vytutas Magnus University, city: Kaunas, country: Lithuania, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False
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protocolSection identificationModule nctId: NCT06354712, orgStudyIdInfo id: 2024-45, briefTitle: Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients., conditionsModule conditions: Oral Mucositis (Ulcerative) Due to Radiation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: N-Acetyl-Cysteine with Institutional standard care, interventions name: Institutional standard care, outcomesModule primaryOutcomes measure: Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis., secondaryOutcomes measure: Time to develop oral mucositis with grade ≥ 2., secondaryOutcomes measure: Duration of oral mucositis with grade ≥ 2., secondaryOutcomes measure: Pain assessed by Visual Analog Scale (VAS)., secondaryOutcomes measure: Functional oral intake scale, secondaryOutcomes measure: Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, status: RECRUITING, city: Mansoura, country: Egypt, contacts name: Rasha Abd-Ellatif, Professor, role: CONTACT, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06354699, orgStudyIdInfo id: RGS0000003993, briefTitle: A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children, acronym: POPSICLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Telethon Kids Institute, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery., conditionsModule conditions: Chronic Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The prevalence of chronic post-surgical pain after 10- 12 months., secondaryOutcomes measure: Identifying potential risk factors for chronic post-surgical pain, eligibilityModule sex: ALL, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Telethon Kids Institute, status: RECRUITING, city: Perth, state: Western Australia, country: Australia, contacts name: Natalie P Jowett, role: CONTACT, phone: 08 6456 4809, email: [email protected], contacts name: Lliana Slevin, role: CONTACT, phone: 08 64564806, email: [email protected], contacts name: Britta von Ungern-Sternberg, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: David Sommerfield, Associate, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False
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protocolSection identificationModule nctId: NCT06354686, orgStudyIdInfo id: STUDY00004245, briefTitle: Characterizing the Scalp Tolerability of TMS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Florida State University, class: OTHER, descriptionModule briefSummary: The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TMS Tolerability, outcomesModule primaryOutcomes measure: Tolerability of TMS - Scalp Location, primaryOutcomes measure: Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst)., secondaryOutcomes measure: Tolerability of TMS (Knee Location), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida State University, status: RECRUITING, city: Tallahassee, state: Florida, zip: 32306, country: United States, contacts name: Isabelle Taylor, MA, role: CONTACT, phone: 850-645-8882, email: [email protected], geoPoint lat: 30.43826, lon: -84.28073, hasResults: False
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protocolSection identificationModule nctId: NCT06354673, orgStudyIdInfo id: 278/1-April-2024, briefTitle: Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-09-04, completionDateStruct date: 2024-10-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay., conditionsModule conditions: Paroxysmal Sympathetic Hyperactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 205, type: ESTIMATED, armsInterventionsModule interventions name: Stellate ganglion block, interventions name: Dexmedetomidine, interventions name: Ketamine, outcomesModule primaryOutcomes measure: To compare the time of remission of neurostorm symptoms, primaryOutcomes measure: To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score., secondaryOutcomes measure: ▪ To measure the duration of intensive care unit (ICU) stay., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zagazig university, city: Zagazig, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06354660, orgStudyIdInfo id: 18804, secondaryIdInfos id: J1I-MC-GZBY, type: OTHER, domain: Eli Lilly and Company, briefTitle: Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits., conditionsModule conditions: Diabetes Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 7.0%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 5.7%, secondaryOutcomes measure: Change from Baseline in Fasting Serum Glucose, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Change from Baseline in Body Weight, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction, secondaryOutcomes measure: Percent Change from Baseline in Triglycerides, secondaryOutcomes measure: Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol, secondaryOutcomes measure: Change from Baseline in Systolic Blood Pressure (SBP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scottsdale Clinical Trials, city: Scottsdale, state: Arizona, zip: 85260, country: United States, contacts name: Ernest Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Tucson Clinical Research Institute, city: Tucson, state: Arizona, zip: 85712, country: United States, contacts name: Girish Karamchandani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.22174, lon: -110.92648, locations facility: San Fernando Valley Health Institute, city: Canoga Park, state: California, zip: 91304, country: United States, contacts name: Jeffrey London, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Ark Clinical Research, city: Long Beach, state: California, zip: 90815, country: United States, contacts name: Martha Navarro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Northeast Research Institute (NERI), city: Fleming Island, state: Florida, zip: 32003, country: United States, contacts name: Senan Sultan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Ezy Medical Research, city: Miami, state: Florida, zip: 33175, country: United States, contacts name: Manuel Fernandez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Clinical Research of Central Florida, city: Winter Haven, state: Florida, zip: 33880, country: United States, contacts name: Eduardo Torres, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Trinity Research Centers, city: Marietta, state: Georgia, zip: 30064, country: United States, contacts name: Jean Philippe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.9526, lon: -84.54993, locations facility: Cotton O'Neil Clinical Research Center - Central Office, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: Michael Cox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: NECCR PrimaCare Research, city: Fall River, state: Massachusetts, zip: 02721, country: United States, contacts name: Ehab Sorial, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.70149, lon: -71.15505, locations facility: Clinical Research Professionals, city: Chesterfield, state: Missouri, zip: 63005, country: United States, contacts name: Timothy Jennings, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.66311, lon: -90.57707, locations facility: Boeson Research MSO, city: Missoula, state: Montana, zip: 59804, country: United States, contacts name: Aubrey Remmers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87215, lon: -113.994, locations facility: NJ MedCare & NJ Heart, city: Linden, state: New Jersey, zip: 07036, country: United States, contacts name: Preet Randhawa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.62205, lon: -74.24459, locations facility: Accellacare - Wilmington - 1917 Tradd Court, city: Wilmington, state: North Carolina, zip: 28401, country: United States, contacts name: John Parker, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Providence Health Partners-Center for Clinical Research, city: Dayton, state: Ohio, zip: 45439, country: United States, contacts name: Joni Koren, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Clinical Research of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19114, country: United States, contacts name: Donna Gavarone, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians, city: Uniontown, state: Pennsylvania, zip: 15401, country: United States, contacts name: Richard Cook II, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.90008, lon: -79.71643, locations facility: Delricht Research - Tobias Gadson Boulevard - Charleston, city: Charleston, state: South Carolina, zip: 29407, country: United States, contacts name: Edward Newton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Lifedoc Research - Lenox Park Drive, city: Memphis, state: Tennessee, zip: 38115, country: United States, contacts name: Pedro Velasquez-Mieyer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Clinical Research Associates Inc, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: Stephan Sharp, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Dallas Diabetes Research Center, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Dan Lender, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Prime Revival Research Institute, city: Flower Mound, state: Texas, zip: 75028, country: United States, contacts name: WASIM HAQUE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01457, lon: -97.09696, locations facility: Valley Institute of Research - Fort Worth, city: Fort Worth, state: Texas, zip: 76164, country: United States, contacts name: alex guevara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Texas Valley Clinical Research, city: Weslaco, state: Texas, zip: 78596, country: United States, contacts name: Eduardo Luna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.15952, lon: -97.99084, locations facility: Manassas Clinical Research Center, city: Manassas, state: Virginia, zip: 20110, country: United States, contacts name: Nabil Andrawis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.75095, lon: -77.47527, locations facility: MultiCare Rockwood Cheney Clinic, city: Cheney, state: Washington, zip: 99004, country: United States, contacts name: Jonathan Staben, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.48739, lon: -117.57576, locations facility: Eastside Research Associates, city: Redmond, state: Washington, zip: 98052, country: United States, contacts name: Chad Crystal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.67399, lon: -122.12151, locations facility: All India Institute of Medical Sciences, city: Raipur, state: Chhattisgarh, zip: 492099, country: India, contacts name: Amritava Ghosh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.23333, lon: 81.63333, locations facility: Gujarat Endocrin Pvt Ltd, city: Ahmedabad, state: Gujarat, zip: 380052, country: India, contacts name: parag Shah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Nirmal Hospital, city: Surat, state: Gujarat, zip: 395002, country: India, contacts name: Piyush Desai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.19594, lon: 72.83023, locations facility: Victoria Hospital, Bangalore Medical College And Research Institute, city: Bangalore, state: Karnataka, zip: 560002, country: India, contacts name: Sivaranjani Holigi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Government Medical College - Kozhikode, city: Kozhikode, state: Kerala, zip: 673008, country: India, contacts name: Chandni R, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 11.24802, lon: 75.7804, locations facility: S C B Medical College and Hospital, city: Cuttack, state: Odisha, zip: 753001, country: India, contacts name: Jayanta Panda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.46497, lon: 85.87927, locations facility: Eternal Heart Care Center and Research Institute, city: Jaipur, state: Rajasthan, zip: 302020, country: India, contacts name: Jugal Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Brij Medical Centre Private Limited, city: Kanpur, state: Uttar Pradesh, zip: 208020, country: India, contacts name: brij mohan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, city: Mexico City, state: Distrito Federal, zip: 14080, country: Mexico, contacts name: Emma Chávez Manzanera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Grupo Ollin Care, city: Pachuca, state: Hidalgo, zip: 42000, country: Mexico, contacts name: Eduardo Zambrano Ruiz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.11697, lon: -98.73329, locations facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad, city: Guadalajara, state: Jalisco, zip: 04460, country: Mexico, contacts name: Guillermo Gonzalez Galvez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Unidad biomedica avanzada monterrey, city: Monterrey, state: Nuevo León, zip: 64460, country: Mexico, contacts name: Raymundo Garcia Reza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Clínica García Flores SC, city: Monterrey, state: Nuevo León, zip: 64610, country: Mexico, contacts name: Pedro Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Centro de investigación y control metabólico, city: Monterrey, state: Nuevo León, zip: 66465, country: Mexico, contacts name: Ramiro Banda Elizondo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Medical Care and Research SA de CV, city: Merida, state: Yucatán, zip: 97070, country: Mexico, contacts name: Carlos Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: EME RED Hospitalaria, city: Mérida, state: Yucatán, zip: 97000, country: Mexico, contacts name: Hugo Laviada Molina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.97537, lon: -89.61696, locations facility: Arké SMO S.A de C.V, city: Veracruz, zip: 91910, country: Mexico, contacts name: Luis Aguilar Espinoza, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Dorado Medical Complex, city: Dorado, zip: 00646, country: Puerto Rico, contacts name: Luis Pagan-Cardona, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.45883, lon: -66.26767, locations facility: Ponce Medical School Foundation Inc., city: Ponce, zip: 00716, country: Puerto Rico, contacts name: Elizabeth Barranco Santana, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.01108, lon: -66.61406, hasResults: False
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protocolSection identificationModule nctId: NCT06354647, orgStudyIdInfo id: HM20028419, briefTitle: Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection., conditionsModule conditions: Dental Caries, conditions: Tooth Decay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Zirconia-based primary anterior crowns with retention grooves, interventions name: Zirconia-based primary anterior crowns without retention grooves, outcomesModule primaryOutcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes, primaryOutcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes, secondaryOutcomes measure: Parental satisfaction, secondaryOutcomes measure: Child satisfaction, secondaryOutcomes measure: Oral health impact during early childhood, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD, role: CONTACT, phone: (804) 828-9095, email: [email protected], contacts name: Alpna Khatri, role: CONTACT, phone: (571) 302-6719, email: [email protected], geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06354634, orgStudyIdInfo id: HM20028439, briefTitle: Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection., conditionsModule conditions: Dental Caries, conditions: Tooth Decay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Each participant will receive both interventions., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Resin polymer (NuSmile Bioflx) crown, interventions name: Stainless steel crown, outcomesModule primaryOutcomes measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments, primaryOutcomes measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments, secondaryOutcomes measure: Parental satisfaction, secondaryOutcomes measure: Child satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Jayakumar Jayaraman, role: CONTACT, phone: 804-828-2362, email: [email protected], geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06354621, orgStudyIdInfo id: D/185/FIMS, briefTitle: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of the Punjab, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infectionThe main question\[s\] it aims to answer are:If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes., conditionsModule conditions: Maternal and Child Health, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ACTUAL, armsInterventionsModule interventions name: Vitamin-D supplementation, outcomesModule primaryOutcomes measure: Pre-Eclampsia (Maternal Outcome), primaryOutcomes measure: Gestational Diabetes Mellitus (Maternal Outcome), primaryOutcomes measure: C/Section delivery (Maternal Outcomes), primaryOutcomes measure: Low Birth Weight (Foetal Outcome), primaryOutcomes measure: Pre-Term delivery (Foetal Outcome), primaryOutcomes measure: Apgar Score (Foetal Outcome), secondaryOutcomes measure: Improvement in maternal vitamin-D levels, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of the Punjab, city: Lahore, state: Punjab, zip: 54600, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06354608, orgStudyIdInfo id: duygudemirr, briefTitle: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Yalova, class: OTHER, descriptionModule briefSummary: The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear., conditionsModule conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is an experimental, parallel-group (intervention-control), randomized controlled design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Audio Book Group, interventions name: Local Vibration Group, outcomesModule primaryOutcomes measure: Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES, primaryOutcomes measure: Comparison of the fear score values of the groups, primaryOutcomes measure: Comparison of the fear score values of the groups, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Yalova, status: RECRUITING, city: Yalova, country: Turkey, contacts name: Duygu Demir, PhD, role: CONTACT, phone: +905053662358, email: [email protected], geoPoint lat: 40.65501, lon: 29.27693, hasResults: False
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protocolSection identificationModule nctId: NCT06354595, orgStudyIdInfo id: XiamenU1, briefTitle: Feasibility Study of Multidimensional Rehabilitation in the Metaverse, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Qu Shen, class: OTHER, collaborators name: The First Affiliated Hospital of Xiamen University, descriptionModule briefSummary: The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform., conditionsModule conditions: Colorectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Multidimensional Rehabilitation in the Metaverse, outcomesModule primaryOutcomes measure: Post-Study System Usability Questionnaire (PSSUQ) Third Edition, primaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Semi-structured interview, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yuru Hu, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361005, country: China, contacts name: Yuru HU, role: CONTACT, phone: 18189530895, email: [email protected], geoPoint lat: 24.47979, lon: 118.08187, hasResults: False
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protocolSection identificationModule nctId: NCT06354582, orgStudyIdInfo id: 2024-085-01, briefTitle: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia, acronym: EIVCIMFAELA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Kunyue Li, class: OTHER, collaborators name: Third Affiliated Hospital of Zhengzhou University, descriptionModule briefSummary: This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication., conditionsModule conditions: Obstetric Labor Complications, conditions: Fever, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin C Injection, interventions name: Normal saline, outcomesModule primaryOutcomes measure: Intrapartum fever or not, primaryOutcomes measure: The temperature of parturients, primaryOutcomes measure: The duration of intrapartum fever, primaryOutcomes measure: Complete blood count indicators, secondaryOutcomes measure: Visual analogue scale(VAS), secondaryOutcomes measure: Amount of total analgesics, secondaryOutcomes measure: Side effects on mothers, secondaryOutcomes measure: the duration of total labor, secondaryOutcomes measure: Incidence of rupture of membranes, secondaryOutcomes measure: Delivery characteristics 2, secondaryOutcomes measure: Record the weight of the baby., secondaryOutcomes measure: Record the gender of the baby., secondaryOutcomes measure: Apgar score, secondaryOutcomes measure: the incidence of fetal distress, secondaryOutcomes measure: Record the infant ward administration., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354569, orgStudyIdInfo id: 2022.232, briefTitle: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sichuan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children, conditionsModule conditions: Perioperative Respiratory Adverse Events, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: The occurrence of perioperative respiratory adverse events, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sichuan provincial Peopel'Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Yanyu Liu, role: CONTACT, phone: +8613438348895, email: [email protected], contacts name: Ting Xu, role: CONTACT, phone: +8317708130267, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06354556, orgStudyIdInfo id: HRS-1893-102, briefTitle: Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shandong Suncadia Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects., conditionsModule conditions: Obstructive Hypertrophic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single center, open, single arm, fixed sequence, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: HRS-1893 tablet, interventions name: Verapamil tablet, outcomesModule primaryOutcomes measure: Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose, primaryOutcomes measure: Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose, primaryOutcomes measure: Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose, secondaryOutcomes measure: Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose, secondaryOutcomes measure: Elimination half-life (T1/2) for HRS-1893 after single dose, secondaryOutcomes measure: Apparent oral clearance (CL/F) for HRS-1893 after single dose, secondaryOutcomes measure: Apparent volume of distribution (Vz/F) for HRS-1893 after single dose, secondaryOutcomes measure: Accumulated amount of excretion (Ae) for HRS-1893 after single dose, secondaryOutcomes measure: Urinary excretion fraction（fe）for HRS-1893 after single dose, secondaryOutcomes measure: Renal clearance（CLr）for HRS-1893 after single dose, secondaryOutcomes measure: Number of subjects with adverse events and the severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354543, orgStudyIdInfo id: CA01-TK-ARTHRO, briefTitle: Arthroplasty Cements Outcomes - A Post-market Follow-up, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-16, primaryCompletionDateStruct date: 2035-12, completionDateStruct date: 2045-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Teknimed, class: INDUSTRY, descriptionModule briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site., conditionsModule conditions: Arthroplasty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Cemented joint arthroplasty, outcomesModule primaryOutcomes measure: Survival rate, primaryOutcomes measure: Superficial and/or deep postoperative infection rate., secondaryOutcomes measure: Pain Level, secondaryOutcomes measure: Patients' satisfaction, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Evaluation of function and radiological outcomes, secondaryOutcomes measure: Complications rate, secondaryOutcomes measure: Antalgic consumption, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Restoration of function, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique du Vivarais, status: RECRUITING, city: Aubenas, state: Auvergne-rhône-alpes, zip: 07200, country: France, contacts name: Michel MILAIRE, MD, role: CONTACT, email: [email protected], contacts name: Michel MILAIRE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.62006, lon: 4.38994, locations facility: Clinique du Val d'Ouest, status: RECRUITING, city: Ecully, state: Auvergne-rhône-alpes, zip: 69130, country: France, contacts name: Benoît GIRAUD, MD, role: CONTACT, email: [email protected], contacts name: Benoît GIRAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77726, lon: 4.77481, locations facility: Cabinet de consultation, status: RECRUITING, city: Evreux, state: Eure, zip: 27000, country: France, contacts name: Edouard DECRETTE, MD, role: CONTACT, email: [email protected], contacts name: Edouard DECRETTE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.02414, lon: 1.15082, locations facility: Clinique du Dr Henri Guillard, status: RECRUITING, city: Coutances, state: Normandie, zip: 50200, country: France, contacts name: Olivier COSSART, MD, role: CONTACT, email: [email protected], contacts name: Olivier COSSART, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.05, lon: -1.43333, locations facility: Clinique de l'Atlantique, status: RECRUITING, city: Puilboreau, state: Nouvelle-aquitaine, zip: 17138, country: France, contacts name: Cédric BOUQUET, MD, role: CONTACT, email: [email protected], contacts name: Cédric BOUQUET, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.1862, lon: -1.11797, locations facility: Hôpital Européen Marseille, status: RECRUITING, city: Marseille, state: Provence-alpes-cote D'azur, zip: 13003, country: France, contacts name: Maxime MUNIER, MD, role: CONTACT, email: [email protected], contacts name: Maxime MUNIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Ospedale Santissima Annunziata, status: RECRUITING, city: Cento, state: Emilie-Romagne, zip: 44042, country: Italy, contacts name: Luca CASTAGNINI, MD, role: CONTACT, email: [email protected], contacts name: Luca CASTAGNINI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.73099, lon: 11.28716, locations facility: Instituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: Émilie-Romagne, zip: 40136, country: Italy, contacts name: Stefano ZAFFAGNINI, MD, role: CONTACT, email: [email protected], contacts name: Stefano ZAFFAGNINI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06354530, orgStudyIdInfo id: 2023 (315), briefTitle: A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Army Medical Center of PLA, class: OTHER_GOV, descriptionModule briefSummary: The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma., conditionsModule conditions: Neoadjuvant Therapy, conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 266, type: ESTIMATED, armsInterventionsModule interventions name: anlotinib, interventions name: Thoracic radiotherapy, outcomesModule primaryOutcomes measure: Pathological complete response (pCR), Major pathological response (MPR), primaryOutcomes measure: Major pathological response (MPR), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: 3-year disease free survival, secondaryOutcomes measure: R0 excision rate, secondaryOutcomes measure: 3-year overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Army Medical Center of PLA, status: RECRUITING, city: Chongqing, state: None Selected, country: China, contacts name: Mengxia Li, role: CONTACT, phone: +86-18580408265, email: [email protected], contacts name: Xiao Yang, role: CONTACT, phone: +86-19923257675, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06354517, orgStudyIdInfo id: YIU-M-CI-003, briefTitle: The Impact of the SENSE Program on NICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yuksek Ihtisas University, class: OTHER, descriptionModule briefSummary: The SENSE program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined., conditionsModule conditions: Pre-Term, conditions: Individualized Developmental Care, conditions: Sensory Experiences, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: SENSE group, outcomesModule primaryOutcomes measure: Hammersmıth Neonatal Neurologıcal Examınatıon, primaryOutcomes measure: Parental Stress Scale: Neonatal Intensive Care Unit, primaryOutcomes measure: State-trait Anxiety Inventory, primaryOutcomes measure: Edinburgh Postnatal Depression Scale, eligibilityModule sex: ALL, minimumAge: 24 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Yuksek Ihtisas University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06354504, orgStudyIdInfo id: 20.02.2019/177, briefTitle: Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-19, primaryCompletionDateStruct date: 2020-09-20, completionDateStruct date: 2020-09-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Akdeniz University, class: OTHER, descriptionModule briefSummary: The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß)., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Non-surgical periodontal treatment, outcomesModule primaryOutcomes measure: Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels, secondaryOutcomes measure: Gingival crevicular fluid interleukin-1Beta levels, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Akdeniz Üniversity, city: Antalya, zip: 07070, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi, city: Antalya, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
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protocolSection identificationModule nctId: NCT06354491, orgStudyIdInfo id: 2023-1494, briefTitle: An Imaging-based Quantitative Biomarker Assay for NAFLD in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI)., conditionsModule conditions: NAFLD, conditions: NASH, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic Resonance Imaging (MRI), interventions name: Ultrasound (US), outcomesModule primaryOutcomes measure: MRI, primaryOutcomes measure: Quantitative US, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Wisconsin, Madison, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Gemma Gliori, MS, role: CONTACT, phone: 608-262-7269, email: [email protected], contacts name: Suzanne Hanson, BS, role: CONTACT, phone: 608-262-7269, email: [email protected], geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
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protocolSection identificationModule nctId: NCT06354478, orgStudyIdInfo id: ms-103-2021, briefTitle: IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2022-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Egypt, class: OTHER, descriptionModule briefSummary: Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM.This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications., conditionsModule conditions: Breast Cancer, conditions: Pain, Postoperative, conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Both patients and Investigator for postoperative pain will be blinded:* Group 1(D): (n=30) Patients will receive oral placebo starch capsules 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.* Group 2(G): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous saline infusion with general anaesthesia.* Group 3(DG): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine Hydrochloride 0.5 MG/ML, interventions name: Gabapentin, outcomesModule primaryOutcomes measure: The time to first rescue analgesia during the first 24 hour Postoperatively., secondaryOutcomes measure: Total postoperative morphine consumption till the first 24 hours, secondaryOutcomes measure: The degree of postoperative sedation according to Ramsay scores, secondaryOutcomes measure: VAS scores both at rest and during shoulder movement, secondaryOutcomes measure: Postoperative nausea and vomiting (PONV) as side effects of morphine., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Institute, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06354465, orgStudyIdInfo id: IRB1967355, secondaryIdInfos id: K23DA055695, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DA055695, briefTitle: Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Lifespan, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders., conditionsModule conditions: Opioid Use Disorder, conditions: Criminal Justice, conditions: Treatment Adherence and Compliance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Qualitative Transcripts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rhode Island Department of Corrections, status: RECRUITING, city: Cranston, state: Rhode Island, zip: 02920, country: United States, contacts name: Jessica Migliaccio, role: CONTACT, phone: 401-462-3921, email: [email protected], geoPoint lat: 41.77982, lon: -71.43728, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-09, uploadDate: 2024-03-31T17:37, filename: Prot_000.pdf, size: 125769, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-01-07, uploadDate: 2024-04-04T09:46, filename: ICF_001.pdf, size: 488632, hasResults: False
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protocolSection identificationModule nctId: NCT06354452, orgStudyIdInfo id: HGG2024_01, briefTitle: Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients, acronym: HGG_UCI1, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2019-12-31, completionDateStruct date: 2020-01-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospital de Granollers, class: OTHER, collaborators name: Department of Health, Generalitat de Catalunya, descriptionModule briefSummary: The average age of patients with sepsis has increased in recent years in parallel with the incidence of sepsis. Many of these patients are frail and require various medications for the treatment of their chronic diseases. Common treatments, including e.g. sarcopenic drugs (statins, sulphonylureas, methyglinides), antioxidants that prevent sarcopenia (allopurinol) or immunoregulators (corticosteroids) may influence the survival and functional prognosis of these patients. Knowing which drugs influence sepsis survival and to what degree patients who survive sepsis have functional deterioration and increased comorbidity and which modifiable factors limit this may be essential., conditionsModule conditions: Sepsis, conditions: Septic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 59578, type: ACTUAL, armsInterventionsModule interventions name: Person-level linkage of the database looking for relationship with sepsis survival and previous intake of certain drug families and previous dependence on health services., outcomesModule primaryOutcomes measure: Death due to sepsis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital General de Granollers, city: Granollers, state: Barcelona, zip: 08402, country: Spain, geoPoint lat: 41.60797, lon: 2.28773, hasResults: False
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protocolSection identificationModule nctId: NCT06354439, orgStudyIdInfo id: 77015224.6.1001.5327, briefTitle: Use of Letrozole for Ectopic Pregnancy, acronym: EcZOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospital de Clinicas de Porto Alegre, class: OTHER, descriptionModule briefSummary: A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate, conditionsModule conditions: Ectopic Pregnancy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Due to the nature of the outcome and the interventions, blinding was not considered an issue., enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Letrozole tablets, interventions name: Methotrexate Sodium, outcomesModule primaryOutcomes measure: levels of beta fraction of human chorionic gonadotropin (beta-hCG), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de Clínicas de Porto Alegre, status: RECRUITING, city: Porto Alegre, state: RS, zip: 90035-903, country: Brazil, contacts name: RICARDO F SAVARIS, MD,PHD, role: CONTACT, phone: 55 51 33598117, email: [email protected], contacts name: Michele S Savaris, BBA, role: CONTACT, phone: 555133598624, email: [email protected], geoPoint lat: -30.03306, lon: -51.23, hasResults: False
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protocolSection identificationModule nctId: NCT06354426, orgStudyIdInfo id: BVT2022/01, briefTitle: Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hanoi Heart Hospital, class: OTHER, descriptionModule briefSummary: Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate., conditionsModule conditions: Acute Decompensated Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 216, type: ACTUAL, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Re-admission rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hanoi Heart Hospital, city: Hanoi, state: Hoan Kiem, zip: 110000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
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protocolSection identificationModule nctId: NCT06354413, orgStudyIdInfo id: 2023-2261, briefTitle: Outcomes of Concomitant Bypass Surgery in Septal Myectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2009-01, primaryCompletionDateStruct date: 2020-12, completionDateStruct date: 2023-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Chinese Academy of Medical Sciences, Fuwai Hospital, class: OTHER, descriptionModule briefSummary: To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy., conditionsModule conditions: Hypertrophic Cardiomyopathy, conditions: Coronary Artery Disease, conditions: Myocardial Bridging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 320, type: ACTUAL, armsInterventionsModule interventions name: CABG during myectomy, outcomesModule primaryOutcomes measure: all-cause mortality, secondaryOutcomes measure: cardiac-related deaths and readmission, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354400, orgStudyIdInfo id: 2022/001-002, briefTitle: Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, collaborators name: Nuh Naci Yazgan University, descriptionModule briefSummary: Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions.Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined., conditionsModule conditions: Core Stabilization, conditions: Respiration, conditions: Functional Capacity, conditions: Endurance, conditions: Hearing Impaired Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Core stabilization training, outcomesModule primaryOutcomes measure: Chest expansion, secondaryOutcomes measure: Functional capacity, secondaryOutcomes measure: Trunk muscle endurance, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Nuh Naci Yazgan University, status: RECRUITING, city: Kayseri, country: Turkey, contacts name: Busra Kepenek-Varol, PhD, PT, role: CONTACT, phone: +905449106628, email: [email protected], contacts name: Busra Kepenek Varol, PhD, PT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06354387, orgStudyIdInfo id: CMUH110-REC3-246, briefTitle: Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-16, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan. Despite decades' intensive studies, surgery and local-regional chemo-embolization, radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Alectinib (Alecensa), Nivolumab (Opdivo), outcomesModule primaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: PFS, otherOutcomes measure: TTP, otherOutcomes measure: DOR, otherOutcomes measure: DCR, otherOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMUH, status: RECRUITING, city: Taichung, country: Taiwan, contacts name: Chang-Fang Chiu, PhD, role: CONTACT, phone: 8864-22052121, email: [email protected], geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
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protocolSection identificationModule nctId: NCT06354374, orgStudyIdInfo id: 24-026, briefTitle: Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, collaborators name: British University In Egypt, descriptionModule briefSummary: Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system., conditionsModule conditions: Soft Tissue Volume, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: volume survey, outcomesModule primaryOutcomes measure: the relationship between soft tissue volume & tomographic alveolar ridge classes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahmed Hamdy, status: RECRUITING, city: Al Shorouk City, state: Cairo, zip: 11837, country: Egypt, contacts name: Ahmed Hamdy, role: CONTACT, phone: +201061112512, email: [email protected], hasResults: False
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protocolSection identificationModule nctId: NCT06354361, orgStudyIdInfo id: 17440, briefTitle: Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Workplace Safety and Insurance Board, descriptionModule briefSummary: Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD).The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.The main questions it aims to answer are:1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?Participants will:* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires* participate in a nine-week group treatment program (one day a week for two hours)* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires, conditionsModule conditions: Post-Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomised into two groups.One group will receive nine sessions of Trauma-Informed Goal Management Training, and the other group will receive nine sessions of standard Goal Management Training.Each group session will be 2 hours long, and offered virtually (using Zoom for Healthcare)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Trauma-Informed Goal Management Training (TI-GMT), interventions name: Goal Management Training (GMT), outcomesModule primaryOutcomes measure: Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up, primaryOutcomes measure: Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up, secondaryOutcomes measure: Demographic Information, secondaryOutcomes measure: Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline, secondaryOutcomes measure: Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline, secondaryOutcomes measure: Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354348, orgStudyIdInfo id: GastrectomyUSG, briefTitle: Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-06, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, class: OTHER, descriptionModule briefSummary: The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method., conditionsModule conditions: Sarcopenia, conditions: Gastrectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: USG, Grip strength, Chair stand test (CST), outcomesModule primaryOutcomes measure: Sarcopenia (Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI ), eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06354335, orgStudyIdInfo id: 1-16-02-62-20, briefTitle: Impact of a Major Organizational Change on Employee Productivity and Mental Health, acronym: PRO-MENTA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Aarhus University Hospital, class: OTHER, collaborators name: University of Aarhus, collaborators name: Herning Hospital, collaborators name: Bispebjerg Hospital, descriptionModule briefSummary: The study investigates the short- and long-term impact of a major organizational change on employee health and productivity. Changes in organizations is a common aspect of modern work life in all sectors and public healthcare is no exception. However, emerging evidence suggests that organizational changes may be a potential stressor which can impact on employee well-being and contribute to stress-related health problems. Using a large-scale natural experiment, the overall aim of the study is to investigate the impact of a major organizational change that took place during 2016-19 on employee health and productivity. In addition, we aim to identify groups that may be at increased risk of experiencing negative consequences of the reorganization. These at-risk groups can in turn be candidates for extended preventive measures when planning future major organizational changes., conditionsModule conditions: Work Related Stress, conditions: Mental Health Issue, conditions: Work-related Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 31555, type: ACTUAL, armsInterventionsModule interventions name: Employees exposed to a major hospital reorganisation, outcomesModule primaryOutcomes measure: Employee health measured by rate of absenteeism, use of health care services and redeemed drug prescriptions, secondaryOutcomes measure: Workplace productivity measured by number of patient contacts and medical procedures, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus University Hospital, city: Aarhus, state: Central Denmark Region, zip: 8200, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06354322, orgStudyIdInfo id: APHP230630, briefTitle: Unclassified GENotypes of Autoinflammatory Diseases and AA Amyloidosis, acronym: IPHYGENI MAI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2034-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Patients with autoinflammatory diseases (AID) have recurrent episodes of systemic inflammation accompanied by nonspecific elevation of blood inflammation markers typically absent between attacks. A complication of autoinflammatory diseases is AA amyloidosis, which can lead to renal failure and dialysis. Advances in genetic analysis have led to the identification of new autoinflammatory diseases and thus new pathophysiological pathways.However, genetic analyses are sometimes confronted with results that are difficult to interpret. These are the Variants of Unknown Significance, for which genetic analysis alone does not allow to determine if the genetic mutation is responsible for the symptoms.genetic analysis sometimes has limitations in the diagnosis of AID which can only be overcome by pathophysiological studies of the variants found., conditionsModule conditions: AA Amyloidosis, conditions: Autoinflammatory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Exploration of VUS in AutoInflammatory Diseases, secondaryOutcomes measure: Pathophysiology of Autoinflammatory Diseases, secondaryOutcomes measure: Role of other innate immune cells in AutoInflammatory Diseases, secondaryOutcomes measure: Improve knowledge of AA amyloidosis, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354309, orgStudyIdInfo id: vr_study, briefTitle: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2023-10-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: He Eye Hospital, class: OTHER, descriptionModule briefSummary: The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score., conditionsModule conditions: Amblyopia, conditions: Motion Sickness, conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Virtual reality game, outcomesModule primaryOutcomes measure: Simulator Sickness Questionnaire Score, secondaryOutcomes measure: Postural stability, secondaryOutcomes measure: Non-invasive tear breakup time, secondaryOutcomes measure: Tear meniscus height, secondaryOutcomes measure: Lipid layer classification, secondaryOutcomes measure: Eye blink frequency, secondaryOutcomes measure: Eye surface temperature, secondaryOutcomes measure: Ocular surface disease index dry eye questionnaire score, secondaryOutcomes measure: Visual quality questionnaire score, secondaryOutcomes measure: Visual fatigue questionnaire score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: He Eye Hospital, city: Shenyang, state: Liaoning, zip: 110034, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
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protocolSection identificationModule nctId: NCT06354296, orgStudyIdInfo id: CAF2024, briefTitle: Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: He Eye Hospital, class: OTHER, descriptionModule briefSummary: The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) \[Holladay 1 (D-K)\] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula., conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Accuracy of the IOL formula, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06354283, orgStudyIdInfo id: Progresif, briefTitle: Progressive Muscle Relaxation Exercises Women With Low Sexual Satisfaction Sexual Satisfaction and Functioning of Women and Their Partners, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: This study was conducted to investigate the effect of progressive muscle relaxation exercises on sexual satisfaction and functioning of women and their partners in women with low sexual satisfaction.Method: The single-blind, randomized controlled study was conducted between April 2023 and January 2024. The sample of the study was women with low sexual satisfaction and their partners were randomized into two groups as intervention and control. Each group consisted of 120 couples, n=60. The women in the intervention group were given progressive muscle relaxation techniques three times a week for four weeks. The results of the study focused on the effect on sexual satisfaction and functioning of men and women., conditionsModule conditions: Women With Low Sexual Satisfaction, conditions: Partners of Women With Low Sexual Satisfaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention Group and Control Group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The progressive relaxation intervention and follow-up was conducted by the researcher who was not blinded to the interventions (PSI). Randomization was performed by another academic who was not an investigator in the study. In order to avoid bias, the researcher who conducted the intervention did not participate in any step of the pre-test, post-test and statistical evaluation process. Group information was not shared with the statistician who performed the analysis., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Progressive Muscle Relaxation Exercises, outcomesModule primaryOutcomes measure: Sexual Satisfaction, secondaryOutcomes measure: Sexual Function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fatma Şule Bilgiç, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06354270, orgStudyIdInfo id: 300104, briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste., conditionsModule conditions: Dentin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 115, type: ACTUAL, armsInterventionsModule interventions name: Stannous fluoride toothpaste, interventions name: Regular fluoride toothpaste (Crest Cavity Protection), outcomesModule primaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Day 56, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 56, secondaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Day 28, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 28, secondaryOutcomes measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Family and Cosmetic Dentistry, All Sums Research Center Ltd., city: Melbourne, state: Florida, zip: 32940, country: United States, geoPoint lat: 28.08363, lon: -80.60811, hasResults: False
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protocolSection identificationModule nctId: NCT06354257, orgStudyIdInfo id: 220104, briefTitle: A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Fixed sequence, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Open-label, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: EE/LNG, interventions name: GSK3036656 Dose Level 1, interventions name: GSK3036656 Dose Level 2, outcomesModule primaryOutcomes measure: Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2, secondaryOutcomes measure: AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Cmax of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Tmax of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG, secondaryOutcomes measure: AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2, secondaryOutcomes measure: Tmax of EE/LNG after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2, secondaryOutcomes measure: Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG, secondaryOutcomes measure: t1/2 of EE and LNG after a single dose of EE/LNG in combination with 14 days of treatment with GSK3036656 at DL 2, secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with Grade 3 or higher severity adverse events (AEs), secondaryOutcomes measure: Number of participants with drug-related AEs, secondaryOutcomes measure: Number of participants with drug-related AEs following the administration of GSK3036656, secondaryOutcomes measure: Number of participants withdrawn from the treatment/study due to AEs, secondaryOutcomes measure: Percentage of participants with ECG values of Potential Clinical Importance (PCI), secondaryOutcomes measure: Percentage of participants with clinical chemistry laboratory values of PCI, secondaryOutcomes measure: Percentage of participants with haematology laboratory values of PCI, secondaryOutcomes measure: Percentage of participants with vital signs parameters of PCI, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Madrid, zip: 28046, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: [email protected], contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: [email protected], contacts name: Alberto Borobia Perez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06354244, orgStudyIdInfo id: 2023-183-KY-02, briefTitle: Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions, conditionsModule conditions: Urinary Retention, conditions: Lower Motor Neurone Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Electroacupuncture of 2 sessions per week, interventions name: Electroacupuncture of 3 sessions per week, interventions name: Electroacupuncture of 4 sessions per week, outcomesModule primaryOutcomes measure: The response rate., secondaryOutcomes measure: The response rate., secondaryOutcomes measure: The change in post void residuals (PVR) from baseline., secondaryOutcomes measure: The change in the proportion of patients reporting severe urinating difficulty from baseline., secondaryOutcomes measure: The change in the proportion of patients having stool retention from baseline., secondaryOutcomes measure: The change in the proportion of patients requiring catheterization from baseline., secondaryOutcomes measure: The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I)., secondaryOutcomes measure: The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, status: RECRUITING, city: Beijing, country: China, contacts name: Zhishun Liu, PhD, role: CONTACT, phone: +861088002331, email: [email protected], contacts name: Min Yang, role: CONTACT, phone: +8618810268077, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06354231, orgStudyIdInfo id: RC48-C012, briefTitle: DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment., conditionsModule conditions: Renal Insufficiency, conditions: Upper Urinary Tract Urothelial Carcinoma, conditions: Solitary Kidney, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: DV, interventions name: Toripalimab, interventions name: Laser surgery, outcomesModule primaryOutcomes measure: Kidney-intact disease-free survival, KI-DFS, secondaryOutcomes measure: Time to progression, TTP, secondaryOutcomes measure: Time to RNU, secondaryOutcomes measure: Disease-specific survival time, DSS, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: 3m complete remission, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, country: China, contacts name: dingwei ye, role: CONTACT, phone: 64175590-82800, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06354218, orgStudyIdInfo id: GXL-005, briefTitle: Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria., conditionsModule conditions: Esophageal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab, outcomesModule primaryOutcomes measure: mPFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: DOR, secondaryOutcomes measure: Toxic side reactions, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Xiaolin MM Ge, PHD, role: CONTACT, phone: 13951818797, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06354205, orgStudyIdInfo id: 24-3.1T/98, briefTitle: Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, collaborators name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE, descriptionModule briefSummary: Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT., conditionsModule conditions: Bacterial Infections, conditions: Children, Only, conditions: Procalcitonin, conditions: Saliva, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Sliva Procalcitonin, outcomesModule primaryOutcomes measure: Correlation, secondaryOutcomes measure: Diagnose, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Ege University School of Medicine, status: RECRUITING, city: İzmir, zip: 35100, country: Turkey, contacts name: Caner Turan, role: CONTACT, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06354192, orgStudyIdInfo id: 0450, briefTitle: Precision Nudging for Hypertension Management: Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-10-11, completionDateStruct date: 2026-10-11, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Lirio, class: INDUSTRY, collaborators name: Cone Health, descriptionModule briefSummary: The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP)., conditionsModule conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Precision Nudging for Hypertension Management, outcomesModule primaryOutcomes measure: Clinical encounter behavioral outcome, primaryOutcomes measure: Blood pressure reading clinical outcome, secondaryOutcomes measure: Engagement, secondaryOutcomes measure: Medication adherence behavioral outcome, secondaryOutcomes measure: Self-monitoring of blood pressure behavioral outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06354179, orgStudyIdInfo id: 87RI23_0031 (EASY), briefTitle: Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY), acronym: EASY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Limoges, class: OTHER, descriptionModule briefSummary: World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®., conditionsModule conditions: Liver Transplantation, conditions: Immunosuppression, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: XR-tacrolimus QD + MMF BID, interventions name: LCP-tacrolimus QD + MMF BID, interventions name: LCP-tacrolimus QD + MMF QD, outcomesModule primaryOutcomes measure: Treatment failure, secondaryOutcomes measure: Adherence to treatment, secondaryOutcomes measure: measuring of quality of life, secondaryOutcomes measure: Adherence to treatment, secondaryOutcomes measure: measuring of quality of life, secondaryOutcomes measure: Appearance Adverse events, secondaryOutcomes measure: Appearance Adverse events, secondaryOutcomes measure: Comparison tacrolimus daily exposure, secondaryOutcomes measure: Comparison of MPA daily exposure, secondaryOutcomes measure: Comparison of Tacrolimus dose, secondaryOutcomes measure: Comparison of Tacrolimus AUC 0-24h, secondaryOutcomes measure: Comparison of MPA AUC 0-24h, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon hospital - APHP, city: Clichy, zip: 92110, country: France, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Lille university hospital, city: Lille, zip: 59000, country: France, contacts name: Sébastien DHARANCY, MD, role: CONTACT, email: [email protected], contacts name: Sébastien DHARANCY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Limoges university hospital, city: Limoges, zip: 87042, country: France, contacts name: Marilyne DEBETTE-GRATIEN, MD, role: CONTACT, email: [email protected], contacts name: Marilyne DEBETTE-GRATIEN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Lyon university hospital, city: Lyon, zip: 69000, country: France, contacts name: Teresa ANTONINI, MD, role: CONTACT, email: [email protected], contacts name: Teresa ANTONINI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Montpellier university hospital, city: Montpellier, zip: 34000, country: France, contacts name: Georges-Philippe PAGEAUX, MD, role: CONTACT, email: [email protected], contacts name: Georges-Philippe PAGEAUX, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Nice university hospital, city: Nice, zip: 06202, country: France, contacts name: Rodolphe ANTY, MD, role: CONTACT, email: [email protected], contacts name: Rodolphe ANTY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Pitie Salpetriere hospital - APHP, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bordeaux university hospital, city: Pessac, zip: 33604, country: France, contacts name: Jean-Baptiste HIRIART, MD, role: CONTACT, email: [email protected], contacts name: Jean-Baptiste HIRIART, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Poitiers university hospital, city: Poitiers, zip: 86000, country: France, contacts name: Christine SILVAIN, MD, role: CONTACT, email: [email protected], contacts name: Christine SILVAIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Rennes university hospital, city: Rennes, zip: 35033, country: France, contacts name: Pauline HOUSSEL-DEBRY, MD, role: CONTACT, email: [email protected], contacts name: Pauline HOUSSEL-DEBRY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Strasbourg university hospital, city: Strasbourg, zip: 67000, country: France, contacts name: Camille BESCH, MD, role: CONTACT, email: [email protected], contacts name: Camille BESCH, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Tours university Hospital, city: Tours, zip: 37000, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Paul Brousse Hospital - APHP, city: Villejuif, zip: 94800, country: France, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False
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protocolSection identificationModule nctId: NCT06354166, orgStudyIdInfo id: 2023-A02745-40, briefTitle: Study Human Digital Support Transitional Care, acronym: SUNH-ST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Divoluci, class: OTHER, descriptionModule briefSummary: The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Interventional, randomised (1:1 ratio), single-centre study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: open-label study, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Unscheduled hospital admissions, outcomesModule primaryOutcomes measure: length of stay, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU de Tours - Hôpital Bretonneau, city: Tours, zip: 37044, country: France, contacts name: Wassim GANA, MD, role: CONTACT, email: [email protected], geoPoint lat: 47.38333, lon: 0.68333, hasResults: False
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protocolSection identificationModule nctId: NCT06354153, orgStudyIdInfo id: 0305898, briefTitle: Polarity Management Training Program for First Line Nurse Manager, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Polarities are vital issues in healthcare systems. Nursing is a profession riddled with polarities. If first-line nurse managers are well trained to manage polarities in the workplace, this could lead to positive outcomes for nurses, nurse managers and organization performance., conditionsModule conditions: Intervention, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Polarity Management Training Program, outcomesModule primaryOutcomes measure: Questionnaire to measure nurse managers' knowledge, primaryOutcomes measure: Nursing polarity case study situations to assess first-line nurse manager's ability to differentiate between problems to solve and polarities to manage, primaryOutcomes measure: Questionnaire to measure creativity behavior of first-line nurse managers, primaryOutcomes measure: questionnaire to measure intrinsic work motivation among first-line nurse managers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Marsa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
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protocolSection identificationModule nctId: NCT06354140, orgStudyIdInfo id: WeGuo, briefTitle: PPIO-008S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-07, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, class: OTHER, descriptionModule briefSummary: To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy, conditionsModule conditions: Postoperative Assistance for Esophageal Squamous Cell Carcinoma With Negative Lymph Nodes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: The study was a one-arm open study, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Tegafur, outcomesModule primaryOutcomes measure: 1-year DFS rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Army Medical Center of the People's Liberation Army, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400042, country: China, contacts name: Guo, role: CONTACT, phone: +8613527323568, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06354127, orgStudyIdInfo id: DW_DWP450009, briefTitle: DWP450 for Treating Moderate to Severe Glabellar Lines, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-12, primaryCompletionDateStruct date: 2020-11-24, completionDateStruct date: 2021-01-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Daewoong Pharmaceutical Co. LTD., class: INDUSTRY, descriptionModule briefSummary: A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines, conditionsModule conditions: Moderate to Severe Glabellar Lines, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 473, type: ACTUAL, armsInterventionsModule interventions name: DWP450, interventions name: Botox®, outcomesModule primaryOutcomes measure: Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06354114, orgStudyIdInfo id: SYHX2011-003, briefTitle: A Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: CSPC Ouyi Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the efficacy and safety in subjects with advanced breast cancer treated with SYHX2011, conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: SYHX2011, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) by Investigator, secondaryOutcomes measure: Progression-Free-Survival (PFS), secondaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Harbin Medical University Cancer Hospital, city: Harbin, state: Heilongjiang, country: China, contacts name: Qingyuan Zhang, role: CONTACT, phone: 86-13313612989, email: [email protected], geoPoint lat: 45.75, lon: 126.65, hasResults: False
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protocolSection identificationModule nctId: NCT06354101, orgStudyIdInfo id: CorEvitas-VITALITY, briefTitle: The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study., statusModule overallStatus: WITHDRAWN, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: CorEvitas, class: NETWORK, collaborators name: Eli Lilly and Company, descriptionModule briefSummary: The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study., conditionsModule conditions: Metabolic Health, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Tirzepatide, interventions name: Semaglutide, outcomesModule primaryOutcomes measure: Main Objective of Registry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06354088, orgStudyIdInfo id: AAAU9636, briefTitle: Human Models of Selective Insulin Resistance: Alpelisib, Part I, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, collaborators name: University of California, Berkeley, descriptionModule briefSummary: The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels., conditionsModule conditions: Insulin Resistance, conditions: Prediabetic State, conditions: Overweight and Obesity, conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Alpelisib 300 mg, interventions name: Placebo, interventions name: [1-13C] sodium acetate, interventions name: [6,6-2H2] D-glucose, interventions name: Nestlé BOOST Plus, outcomesModule primaryOutcomes measure: Hepatic de novo lipogenesis (DNL) (absolute value), primaryOutcomes measure: Hepatic de novo lipogenesis (DNL) (relative value), primaryOutcomes measure: Endogenous glucose production (EGP) (absolute value), primaryOutcomes measure: Endogenous glucose production (EGP) (relative value), primaryOutcomes measure: Serum insulin level, primaryOutcomes measure: Plasma glucose level, secondaryOutcomes measure: Triglycerides level, secondaryOutcomes measure: Free fatty acids level, secondaryOutcomes measure: Glucose kinetics: rate of appearance (absolute value), secondaryOutcomes measure: Glucose kinetics: rate of appearance (relative value), secondaryOutcomes measure: Glucose kinetics: rate of disappearance (absolute value), secondaryOutcomes measure: Glucose kinetics: rate of disappearance (relative value), otherOutcomes measure: Apolipoprotein B level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Columbia University Irving Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Joshua R Cook, MD, PhD, role: CONTACT, phone: 212-305-6289, email: [email protected], contacts name: Zachary D Sone, role: CONTACT, phone: 2123059336, email: [email protected], contacts name: Joshua R Cook, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Blandine Laferrère, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Henry N Ginsberg, MD, role: SUB_INVESTIGATOR, contacts name: Julia J Wattacheril, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06354075, orgStudyIdInfo id: IRBN302024/CHUSTE, briefTitle: Evaluation of Patient Information in Interventional Radiology, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos., conditionsModule conditions: Patient Satisfaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Questionary, outcomesModule primaryOutcomes measure: to evaluate satisfaction of patient of explanatory videos in interventional radiology, primaryOutcomes measure: To evaluate satisfaction of patient of comic book in interventional radiology, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Saint-Etienne, status: RECRUITING, city: Saint-Étienne, zip: 42055, country: France, contacts name: Sylvain GRANGE, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rémi GRANGE, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06354062, orgStudyIdInfo id: 0305896, briefTitle: Talent Management Intervention Program for First-Line Nurse Managers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Matrouh University, class: OTHER, descriptionModule briefSummary: Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems., conditionsModule conditions: Intervention, conditions: Behavior, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: A quasi-experimental design, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: First Line Nurse Managers received talent Management intervention program, whoMasked: PARTICIPANT, enrollmentInfo count: 125, type: ACTUAL, armsInterventionsModule interventions name: Talent management intervention program, outcomesModule primaryOutcomes measure: Questionnaire to measure nurse managers' knowledge, primaryOutcomes measure: Questionnaire to measure talent management practice among first line nurse managers., primaryOutcomes measure: Questionnaire to measure first-line nurse manager job performance, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Matrouh University, city: Mersa Matruh, zip: 002, country: Egypt, geoPoint lat: 31.3529, lon: 27.23725, hasResults: False
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protocolSection identificationModule nctId: NCT06354049, orgStudyIdInfo id: CASE3Z24, briefTitle: Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population., conditionsModule conditions: Cancer Pain, conditions: Oncology Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Reiki, outcomesModule primaryOutcomes measure: Recruitment rate as measured by the percentage of participants enrolled, primaryOutcomes measure: Retention rate as measured by the number of participants retained until the final survey point, primaryOutcomes measure: Attendance rate as measured by number of sessions attended per 6 sessions, primaryOutcomes measure: Protocol adherence rate as measured by the number of participants treated in manner consistent with the intervention, primaryOutcomes measure: Acceptability as measured by the patient mean of participant satisfaction survey, primaryOutcomes measure: Data completeness rate, secondaryOutcomes measure: Patient-reported outcomes as measured by PROMIS-29(Patient-Reported Outcomes Measurement Information System) score, secondaryOutcomes measure: Patient-reported outcomes as measured by ESAS(Edmonton Symptom Assessment System) scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44106, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06354036, orgStudyIdInfo id: NCC4465, briefTitle: Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: the Transhiatal Tunnel Valvuloplasty technique, outcomesModule primaryOutcomes measure: The incidence of postoperative reflux esophagitis, secondaryOutcomes measure: the incidence of postoperative anastomotic fistula, secondaryOutcomes measure: the incidence of anastomotic stenosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Beijing, zip: 100021, country: China, contacts name: Dongbing R Zhao, M.D., role: CONTACT, phone: +86-13901331816, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06354023, orgStudyIdInfo id: IAGH for Osteoarthritis, briefTitle: Human Growth Hormone Injections in the Knee Joint to Treat Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2025-05-08, completionDateStruct date: 2025-05-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: John Sledge, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if growth hormone injections can be used to treat osteoarthritis (OA) in the knee. Human studies have shown that repeated injections of human growth hormone leads to the production of articular chondrocytes, which are the cells that make up the cartilage in the knee joint. Restoring cartilage in the knee can alleviate pain, improve function, and postpone the need for a joint replacement procedure. The main questions the study aims to answer are:* Do growth hormone injections in the knee joint stimulate cartilage growth?* Do the injections lower pain and stiffness in the participant's treated knee?* Does the participant have more mobility after the injections?The physician will monitor the participant's progress through X-ray images, questionnaires, and physical evaluation of the treated knee.For the trial, participants will:* Receive a growth hormone injection in their knee once per week for six weeks, for a total of 6 injections.* Complete at-home exercises during the treatment period.* Use crutches as needed during the trial.* Have X-rays taken at 8 weeks, 6 months, and 12 months after the first injection.* Go to follow-up visits at 8 weeks, 6 months, and 12 months after the first injection.* Complete treatment surveys before treatment starts and after it is finished., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The proposed clinical trial is a single-arm intervention model. Once per week for six weeks, each participant will receive an intra-articular injection of recombinant human growth hormone (rGH) 15 IU in their affected knee. During the treatment course, the participants will use the same knee brace and crutches (as needed) and be given the same exercises to complete at home. They will all be evaluated 8 weeks, 6 months, and 12 months after their initial injection., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None, each participant will receive the same treatment, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human growth hormone, outcomesModule primaryOutcomes measure: Knee Society Score, primaryOutcomes measure: Kellgren-Lawrence Grading Scale, secondaryOutcomes measure: Serum IGF-1 Levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BioShift Life Sciences, city: Santa Monica, state: California, zip: 90404, country: United States, contacts name: Maggie Phillips, role: CONTACT, phone: 301-655-4651, email: [email protected], geoPoint lat: 34.01945, lon: -118.49119, hasResults: False
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protocolSection identificationModule nctId: NCT06354010, orgStudyIdInfo id: SENS-NH02, briefTitle: Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis, acronym: SONG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sensorion, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene., conditionsModule conditions: Sensorineural Hearing Loss, Bilateral, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Genotyping, interventions name: Audiological assessments, outcomesModule primaryOutcomes measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene., primaryOutcomes measure: Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene, secondaryOutcomes measure: Genetic characteristics of adult patients with early-onset presbycusis, secondaryOutcomes measure: Audiological characteristics of adult patients with early-onset presbycusis, secondaryOutcomes measure: Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: CHU Gui de Chauliac, city: Montpellier, zip: 34295, country: France, contacts name: Frederic Venail, Pr, role: CONTACT, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False
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protocolSection identificationModule nctId: NCT06353997, orgStudyIdInfo id: 2024000099, briefTitle: Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Providence Health & Services, class: OTHER, collaborators name: Inhibrx, Inc., descriptionModule briefSummary: This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule., conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: INBRX-106, outcomesModule primaryOutcomes measure: Pathological response (post-IO), secondaryOutcomes measure: Pathological response (post-chemotherapy), secondaryOutcomes measure: IO-path response assessed prior to Cycle 2, secondaryOutcomes measure: Volumetric response, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Toxicity profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ellison Institute of Technology (EITM), city: Los Angeles, state: California, zip: 90064, country: United States, contacts name: Reva Basho, MD, role: CONTACT, phone: 310-272-7640, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Providence Portland Cancer Institute - Franz Clinic, city: Portland, state: Oregon, zip: 97213, country: United States, contacts name: Nicole Moxon, RN, role: CONTACT, email: [email protected], contacts name: Alison Conlin, MD, role: SUB_INVESTIGATOR, contacts name: Evelyn Brosnan, MD, role: SUB_INVESTIGATOR, contacts name: Evie Hobbs, MD, role: SUB_INVESTIGATOR, contacts name: Rui Li, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Sasha Stanton, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Zheng Topp, MD, role: SUB_INVESTIGATOR, contacts name: Amy Hartman, NP, role: SUB_INVESTIGATOR, contacts name: Kathleen Dronkowski, NP, role: SUB_INVESTIGATOR, contacts name: Kimberlie Dame, NP, role: SUB_INVESTIGATOR, contacts name: Molly Davis, NP, role: SUB_INVESTIGATOR, contacts name: RaYoung Chung, NP, role: SUB_INVESTIGATOR, contacts name: Roxanne Griswold, NP, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Providence St. Vincent Medical Center, city: Portland, state: Oregon, zip: 97225, country: United States, contacts name: Nicole Moxon, RN, role: CONTACT, email: [email protected], contacts name: David Page, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Swedish Cancer Institute, city: Seattle, state: Washington, zip: 98104, country: United States, contacts name: Danielle File, MD, role: CONTACT, phone: 206-386-3900, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06353984, orgStudyIdInfo id: Minimeal 1.0, briefTitle: Effects of In-between Meal Products on Cognitive Function in Older Adults, acronym: Minimeal, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: The overall aim of the present 9-week intervention study is to determine how a healthy drinkable in between meal affects cognitive function and brain activity in healthy adults 70 years and older. Secondary, the study also investigates the impact of the intervention on low grade inflammation, immune function, gut health, body composition, physical function, and well-being as secondary or exploratory outcomes. The present study has as the potential to prevent or slow down the onset of cognitive decline as it targets healthy older adults and gives additional insight regarding secondary and exploratory outcomes., conditionsModule conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three-arm randomized controlled trial that includes a double-blinded, two-armed intervention and a non-blinded control arm without any intervention, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Investigators and participants are partly blinded as the control group receives no placebo product, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Minimeal product, interventions name: Reference product, outcomesModule primaryOutcomes measure: Functional brain activity, secondaryOutcomes measure: Fasting blood glucose/insulin, secondaryOutcomes measure: Blood fats/lipid status, secondaryOutcomes measure: Interleukin-6, secondaryOutcomes measure: High-sensitivity C-reactive protein, secondaryOutcomes measure: Tumor necrosis factor, secondaryOutcomes measure: Interferon-gamma, secondaryOutcomes measure: Zonulin, secondaryOutcomes measure: Intestinal fatty-acid binding protein, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Magnetic resonance imaging (MRI), secondaryOutcomes measure: The Perceived Stress Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: SF 36, secondaryOutcomes measure: Western Ontario and McMaster Osteoarthritis Index, secondaryOutcomes measure: Clinical Outcomes in Routine Evaluation, secondaryOutcomes measure: Gastrointestinal Symptoms Rating Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: International Physical Activity Questionnaire for the Elderly short form, secondaryOutcomes measure: Historical Physical Activity Questionnaire, secondaryOutcomes measure: Food frequency questionnaire, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Balance, secondaryOutcomes measure: 30-sec repeated chair raise, secondaryOutcomes measure: Maximal leg strength, secondaryOutcomes measure: Maximal handgrip strength, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353971, orgStudyIdInfo id: JSP-CP-010, secondaryIdInfos id: 2023-507534-24, type: EUDRACT_NUMBER, briefTitle: A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines, acronym: SPOTLIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-04-21, completionDateStruct date: 2025-08-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Jasper Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts., conditionsModule conditions: Chronic Inducible Urticaria, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This is an open-label, single ascending dose, Phase 1b/2a trial.Cohort 1 follows a 3+3 design and will be treated with a single 40mg dose. Cohort 2 will be treated with a single 120mg dose., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Briquilimab, outcomesModule primaryOutcomes measure: Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines., secondaryOutcomes measure: Preliminary efficacy of briquilimab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - University Clinic Berlin, status: RECRUITING, city: Berlin, zip: 12203, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Hospital Dresden, status: RECRUITING, city: Dresden, zip: 01307, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Medical University Hannover, status: NOT_YET_RECRUITING, city: Hannover, zip: 30625, country: Germany, geoPoint lat: 52.37052, lon: 9.73322, locations facility: University Clinic Schleswig-Holstein, status: RECRUITING, city: Lübeck, zip: 23538, country: Germany, geoPoint lat: 53.86893, lon: 10.68729, hasResults: False
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protocolSection identificationModule nctId: NCT06353958, orgStudyIdInfo id: MiSaver PIIa, briefTitle: MiSaver® Stem Cell Treatment for Acute Myocardial Infarction, acronym: MiSaver®, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Honya Medical Inc, class: INDUSTRY, collaborators name: Chung Shan Medical University, descriptionModule briefSummary: Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.Primary Endpoint:The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.Secondary Outcomes:Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups., conditionsModule conditions: Acute Myocardial Infarction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: MiSaver, outcomesModule primaryOutcomes measure: Safety and adverse events events, secondaryOutcomes measure: Efficacy on ventricular ejection fraction (LVEF) improvement, eligibilityModule sex: ALL, minimumAge: 41 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung Shan Medical University Hospital, city: Taichung, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
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protocolSection identificationModule nctId: NCT06353945, orgStudyIdInfo id: HB062-24, briefTitle: Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Herbarium Laboratorio Botanico Ltda, class: INDUSTRY, descriptionModule briefSummary: The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone.", conditionsModule conditions: Vaginal Atrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: vaginal moisturizer, outcomesModule primaryOutcomes measure: evaluate the perceived effectiveness of the investigational product, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06353932, orgStudyIdInfo id: KA-23026, briefTitle: The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2024-02-25, completionDateStruct date: 2024-02-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups., conditionsModule conditions: Endotracheal Tube, conditions: Cuff Pressure, conditions: Sore Throat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 263, type: ACTUAL, armsInterventionsModule interventions name: keeping the endotracheal tube cuff pressure within a certain range, outcomesModule primaryOutcomes measure: Sore throat, primaryOutcomes measure: cough, primaryOutcomes measure: hoarseness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University Hospital, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06353919, orgStudyIdInfo id: NUNM, briefTitle: Remote Yoga Nidra for Deprescribing BZRAs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National University of Natural Medicine, class: OTHER, collaborators name: US Department of Veterans Affairs, descriptionModule briefSummary: The overall goal of this application is to assess feasibility and impact of a remotely delivered guided meditation practice called Yoga Nidra, for reducing or stopping use of Benzodiazepine Receptor Agonists (BZRAs) for insomnia and anxiety in a population of older adults recruited from within the Birmingham VA medical system., conditionsModule conditions: Anxiety, conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Yoga Nidra, interventions name: Sleep Hygiene, Anxiety, and Benzodiazepine Receptor Agonist Education, outcomesModule primaryOutcomes measure: Demand, primaryOutcomes measure: Recruitment Success, primaryOutcomes measure: Implementation practicality, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Retention, primaryOutcomes measure: Adherence to Protocol, secondaryOutcomes measure: Use of Benzodiazepine Receptor Agonist medications, secondaryOutcomes measure: Cessation of Benzodiazepine Receptor Agonist medication, secondaryOutcomes measure: Baseline Urine Benzodiazepine Receptor Agonist Concentration, secondaryOutcomes measure: Close-out Urine Benzodiazepine Receptor Agonist Concentration, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Insomnia Severity Index, otherOutcomes measure: Patient reported outcomes measurement information system 29, otherOutcomes measure: Patient reported outcomes measurement information system 29, otherOutcomes measure: Generalized Anxiety Disorder 7 Questionnaire, otherOutcomes measure: Generalized Anxiety Disorder 7 Questionnaire, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353906, orgStudyIdInfo id: N22APC, briefTitle: Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer, acronym: PRIAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-14, primaryCompletionDateStruct date: 2026-10-14, completionDateStruct date: 2028-01-14, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis, conditionsModule conditions: Urologic Neoplasms, conditions: Urogenital Neoplasms, conditions: Male Urogenital Diseases, conditions: Penile Cancer, conditions: Penile Squamous Cell Carcinoma, conditions: Locally Advanced Penile Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin/Paclitaxel, interventions name: Pembrolizumab, interventions name: Partial or total penectomy with inguinal and/or pelvic lymph node dissection, outcomesModule primaryOutcomes measure: Pathological complete response (pCR), secondaryOutcomes measure: Drug toxicity, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Assessment of correlation between clinical endpoints and tumor characteristics, secondaryOutcomes measure: Tumor tissue HPV status in relation to treatment response, secondaryOutcomes measure: Tumor tissue PD-L1 expression in relation to treatment response, secondaryOutcomes measure: Evaluation of changes in patient reported outcome regarding Quality of Life (QoL), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353893, orgStudyIdInfo id: Integrity-001, briefTitle: MRI Evaluation of Integrity Bio-Inductive Implant for Rotator Cuff Tears, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Foundation for Orthopaedic Research and Education, class: OTHER, collaborators name: Anika Therapeutics, Inc., descriptionModule briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are:* How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS?* What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant?Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair., conditionsModule conditions: Rotator Cuff Tears, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Anika Integrity Implant System, outcomesModule primaryOutcomes measure: MRI Assessment of Adverse Events and Structural Integrity, secondaryOutcomes measure: Effectiveness Evaluation with PROMIS outcome tool, secondaryOutcomes measure: Effectiveness Evaluation with PROMIS tool, secondaryOutcomes measure: Effectiveness Evaluation with SANE score, secondaryOutcomes measure: Effectiveness Evaluation with SANE score, secondaryOutcomes measure: Effectiveness Evaluation with ASES rating scale, secondaryOutcomes measure: Effectiveness Evaluation with ASES rating scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation for Orthopaedic Research and Education, city: Tampa, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06353880, orgStudyIdInfo id: 24K08-001, briefTitle: Obesity With Sperm Quality in Men With Fertility Need, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yu xiaowei, class: OTHER, descriptionModule briefSummary: This study aims to investigate the impact of different types of obesity on sperm quality. Participants will be divided into three groups: a normal BMI group, an obese group without pudendal fat wrapping the testicles, and an obese group with pudendal fat wrapping the testicles. Sperm quality parameters will be compared among these groups to assess potential differences associated with different types of obesity., conditionsModule conditions: Sperm Quality, conditions: Obesity, conditions: Sex Hormones, conditions: Visceral Fat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Participants will be categorized into three groups based on BMI and the presence of pudendal fat deposition., outcomesModule primaryOutcomes measure: Investigation of Testicular Fat-Wrapped Testes Incidence and Associated Risk Factors, secondaryOutcomes measure: Comparison of Sperm Quality Across BMI Categories and Testicular Fat-Wrapped Subgroups, secondaryOutcomes measure: Comparison of Sex Hormone Levels Across BMI Categories and Testicular Fat-Wrapped Subgroups, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06353867, orgStudyIdInfo id: 56365223-050.01.04-2023.13754, briefTitle: The Effect of Group Exercise in Children With Special Needs, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-27, primaryCompletionDateStruct date: 2023-04-15, completionDateStruct date: 2023-04-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Istanbul Gedik University, class: OTHER, descriptionModule briefSummary: Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention., conditionsModule conditions: Developmental Disability, conditions: Child Autism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Group Exercise, outcomesModule primaryOutcomes measure: Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF), primaryOutcomes measure: Paediatric Balance Scale, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Timed Up and Go Test, primaryOutcomes measure: Stroop Test, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Marmara University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06353854, orgStudyIdInfo id: FFCD 2112-CORESIM, briefTitle: Prospective Cohort Study of Immunotherapy Resistance in Metastatic Colorectal Cancer Patients With MSI, acronym: CORESIM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2029-02-12, completionDateStruct date: 2030-02-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Federation Francophone de Cancerologie Digestive, class: OTHER, descriptionModule briefSummary: Over the last ten years, the discovery of the mechanisms by which tumours escape the control of the immune system, and in particular the T lymphocyte response, has led to the emergence of new therapeutic strategies against cancer, such as the use of "immune checkpoint inhibitors" (ICI). The immune system plays a crucial role in controlling tumour proliferation, and involves several players.Schematically, after recognition of the MHC-peptide complex by the TCR, the T lymphocyte response is modulated by several activating or inhibiting co-stimulatory signals (or "checkpoints"). The balance of these different signals determines whether the T lymphocyte (LT) is activated, resulting in the destruction of the target cell, or whether the T lymphocyte is inhibited (anergy), inducing immune tolerance. By hijacking this system through the expression of inhibitory checkpoints on its surface, the tumour cell is able to evade the effector immune response (1). Monoclonal antibodies (mAbs) directed against inhibitory co-stimulatory molecules such as Programmed-cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) or their ligand Programmed-cell death ligand 1 (PD-L1) have been developed to restore effective anti-tumour immunity. These ICIs have led to a major improvement in the prognosis of certain cancers, notably melanoma and non-small cell lung cancer.However, the efficacy of ICIs varies from one cancer to another. In addition to the expression of PDL1 by the tumour and/or immune cells, and the mutational load, one of the primary factors predicting response to immunotherapy mentioned in several studies is microsatellite instability (MSI)., conditionsModule conditions: Colorectal Cancer Metastatic, conditions: Microsatellite Instability-High Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identification of predictive factors of resistance to pembrolizumab immunotherapy in first-line treatment of unresectable mRCC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ch - Centre Hospitalier de La Côte Basque, status: NOT_YET_RECRUITING, city: Bayonne CEDEX, zip: 64100, country: France, contacts name: Franck AUDEMAR, Dr, role: CONTACT, phone: +33 5 59 44 37 22, email: [email protected], contacts name: Anne GUILNGAR, Dr, role: CONTACT, phone: +33 5 59 44 37 22, email: [email protected], contacts name: Franck AUDEMAR, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Ch - Ch Beauvais, status: NOT_YET_RECRUITING, city: Beauvais, country: France, contacts name: Fayçal HOCINE, role: CONTACT, phone: 03 44 11 23 09, email: [email protected] ; [email protected], geoPoint lat: 49.43333, lon: 2.08333, locations facility: CH Jean Minjoz, status: NOT_YET_RECRUITING, city: Besançon, zip: 25030, country: France, contacts name: Stéfano KIM, Dr, role: CONTACT, email: [email protected], geoPoint lat: 47.24878, lon: 6.01815, locations facility: Polyclinique Saint Privat, status: RECRUITING, city: Boujan-sur-Libron, zip: 34760, country: France, contacts name: Michaël HUMMELSBERGER, Dr, role: CONTACT, email: [email protected], geoPoint lat: 43.36996, lon: 3.24759, locations facility: Ch - Duchenne, status: NOT_YET_RECRUITING, city: Boulogne-sur-Mer, country: France, contacts name: Vincent BOURGEOIS, role: CONTACT, phone: 06 84 88 43 37, email: [email protected], contacts name: Vincent BOURGEOIS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.71667, lon: 1.61667, locations facility: Ch - Centre Hospitalier Metropole Savoie, status: NOT_YET_RECRUITING, city: Chambéry CEDEX, zip: 73011, country: France, contacts name: Olivier BERTHELET, Dr, role: CONTACT, phone: 0479965087, email: [email protected], contacts name: Tarik HABET, Arc Étude, role: CONTACT, phone: 0479965910, email: [email protected], contacts name: Olivier BERTHELET, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.56667, lon: 5.93333, locations facility: Ch - Centre Hospitalier de Cholet, status: NOT_YET_RECRUITING, city: Cholet, zip: 49300, country: France, contacts name: You-Heng LAM, Dr, role: CONTACT, phone: 02 41 49 66 79, email: [email protected], contacts name: Laura VALLEE, Arc Étude, role: CONTACT, phone: 02 41 49 69 91, email: [email protected], contacts name: You-Heng LAM, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.06667, lon: -0.88333, locations facility: CH - Compiegne, status: NOT_YET_RECRUITING, city: Compiègne, country: France, contacts name: Virginie SEBBAGH, role: CONTACT, phone: 0344236278, email: [email protected], contacts name: Virginie SEBBAGH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.41794, lon: 2.82606, locations facility: Ch - Chd Vendée, status: NOT_YET_RECRUITING, city: La Roche-sur-Yon, zip: 85925, country: France, contacts name: Margot LALY, Dr, role: CONTACT, phone: +33 2 51 44 61 68, email: [email protected], contacts name: Paul GIROT, Dr, role: CONTACT, phone: +33 2 51 44 61 68, email: [email protected], contacts name: Margot LALY, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.66667, lon: -1.43333, locations facility: CH - Louis Pasteur, status: NOT_YET_RECRUITING, city: Le Coudray, country: France, contacts name: Sylvie APRELON, role: CONTACT, phone: 0237303030, email: [email protected], geoPoint lat: 48.42115, lon: 1.50057, locations facility: Centre Hospitalier Regional et Universitaire de Lille, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: ANTONY TURPIN, MD, role: CONTACT, phone: 0320445461, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CH Saint Joseph - Saint Luc, status: NOT_YET_RECRUITING, city: Lyon, zip: 69365, country: France, contacts name: Denis PERE VERGE, Dr, role: CONTACT, email: [email protected]; [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: Caluire et Cuire - Infirmerie Protestante de Lyon, status: NOT_YET_RECRUITING, city: Lyon, country: France, contacts name: Johannes HARTWIG, role: CONTACT, email: [email protected], contacts name: Johannes HARTWIG, role: PRINCIPAL_INVESTIGATOR, contacts name: David TAVAN, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Ch - Hôpital Saint Joseph, status: NOT_YET_RECRUITING, city: Marseille, zip: 13285, country: France, contacts name: Hervé PERRIER, Dr, role: CONTACT, phone: 0491808211, email: [email protected], contacts name: Christelle BASTHISTE-PELE, Dr, role: CONTACT, phone: 0491808203, email: [email protected], contacts name: Hervé PERRIER, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Christelle BASTHISTE-PELE, Dr, role: SUB_INVESTIGATOR, contacts name: Patrick BEAURAIN, Dr, role: SUB_INVESTIGATOR, contacts name: Hélène BRUNETEAU, Dr, role: SUB_INVESTIGATOR, contacts name: Aurélie CAMOIN, Dr, role: SUB_INVESTIGATOR, contacts name: Annick CHICOUENE-BRUNELLE, Dr, role: SUB_INVESTIGATOR, contacts name: Christophe LAPLACE, Dr, role: SUB_INVESTIGATOR, contacts name: Nadjet SAADALLAH-BOUCHEMOT, Dr, role: SUB_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CH Saint Joseph, status: NOT_YET_RECRUITING, city: Marseille, country: France, contacts name: Hervé PERRIER, role: CONTACT, email: [email protected]; [email protected], contacts name: Hervé PERRIER, role: PRINCIPAL_INVESTIGATOR, contacts name: Xavier ADHOUTE, role: SUB_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Centre Hospitalier, status: NOT_YET_RECRUITING, city: Mulhouse, zip: 68070, country: France, contacts name: D. B. Vedrenne, MD, role: CONTACT, phone: 33-3-8964-7049, geoPoint lat: 47.75, lon: 7.33333, locations facility: CHR D'Orleans - Hopital de la Source, status: NOT_YET_RECRUITING, city: Orleans, zip: 45100, country: France, contacts name: Jean-Paul Lagasse, role: CONTACT, phone: 33-02-3651-4704, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Prive - Institut Montsouris, status: RECRUITING, city: Paris, country: France, contacts name: Raphael COLLE, role: CONTACT, phone: 0156616035, email: [email protected], contacts name: Emilie SOULARUE, role: CONTACT, phone: 0633312811, email: [email protected], contacts name: Christophe LOUVET, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Ch - Centre Hospitalier de Soisson, status: NOT_YET_RECRUITING, city: Soissons CEDEX, zip: 02209, country: France, contacts name: Sarah MONTEMBAULT, Dr, role: CONTACT, phone: 0326966859, email: [email protected], contacts name: Valérie PANIS, Arc Étude, role: CONTACT, phone: 0322824002, email: [email protected], contacts name: Sarah MONTEMBAULT, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.38167, lon: 3.32361, locations facility: CH - Gustave Dron, status: NOT_YET_RECRUITING, city: Tourcoing, country: France, contacts name: Loïc LEBELLEC, role: CONTACT, phone: 0320694488, email: [email protected], contacts name: Floriane RICHA, role: CONTACT, phone: 0320694949, email: [email protected], contacts name: Loïc LEBELLEC, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.72391, lon: 3.16117, hasResults: False
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protocolSection identificationModule nctId: NCT06353841, orgStudyIdInfo id: 2023/435, briefTitle: Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children., conditionsModule conditions: Functional Constipation, conditions: Therapeutic Touch, conditions: Infants, conditions: Children, conditions: Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic Touch, outcomesModule primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, primaryOutcomes measure: Primary Results Follow-up Form, secondaryOutcomes measure: Bristol Stool Scale, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Bucak State Hospital, status: RECRUITING, city: Burdur, state: Bucak, zip: 15030, country: Turkey, contacts name: Selda Ateş Beşirik, PhD., role: CONTACT, phone: +905076228189, email: [email protected], contacts name: Selda Ateş Beşirik, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Emine Geçkil, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False
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protocolSection identificationModule nctId: NCT06353828, orgStudyIdInfo id: ICBD-UC-01, briefTitle: Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: CannaMore Biotechs, class: INDUSTRY, descriptionModule briefSummary: Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis., conditionsModule conditions: Ulcerative Colitis, 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: 45, type: ESTIMATED, armsInterventionsModule interventions name: CBD, synthetic form, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Full Mayo Score, secondaryOutcomes measure: Change in Partial Mayo Score, secondaryOutcomes measure: Change in patient reported outcome (PRO-UC), secondaryOutcomes measure: Change in endoscopic Mayo subscore in distal 15 cm of anus, secondaryOutcomes measure: Change in the length of the inflamed colon, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meir Medical Center, city: Kfar Saba, country: Israel, geoPoint lat: 32.175, lon: 34.90694, hasResults: False
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protocolSection identificationModule nctId: NCT06353815, orgStudyIdInfo id: anaesthetic efficacy, briefTitle: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars, conditionsModule conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: 4% articaine infiltration, outcomesModule primaryOutcomes measure: Success of local anesthesia, secondaryOutcomes measure: Child behavior during treatment, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353802, orgStudyIdInfo id: P.T.REC/012/004963, briefTitle: Relationship Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: to investigate the correlation between chronic non-specific neck pain and lumbar reposition sense., conditionsModule conditions: Chronic Non-specific Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 67, type: ACTUAL, armsInterventionsModule interventions name: Chronic non-specific neck pain and lumbar reposition sense, outcomesModule primaryOutcomes measure: Correlation Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense Using iPhone inclinometer app, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Physical Therapy College Cairo University, city: Giza, zip: 12613, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06353789, orgStudyIdInfo id: RoADPain Clinical Study, briefTitle: Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study, acronym: RoADPain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: University of Exeter, collaborators name: University of York, collaborators name: Endometriosis UK, descriptionModule briefSummary: This study aims to understand whether changes in a variety of body systems which are seen in adult women with period pain are also seen in adolescents in the first few years of having periods. This information will help us to understand 1) how quickly any changes occur, informing clinical practice, and 2) how period pain might lead to other types of chronic pain, potentially allowing development of preventative strategies., conditionsModule conditions: Dysmenorrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Quantitative Sensory Testing (QST), primaryOutcomes measure: Heart rate (HR), primaryOutcomes measure: Change in heart rate, primaryOutcomes measure: Bladder sensitivity to filling, primaryOutcomes measure: Volume voided at maximum tolerance, primaryOutcomes measure: Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan), primaryOutcomes measure: Area under the curve (AUC) of single day salivary cortisol profile, secondaryOutcomes measure: Change of pressure pain threshold (PPT), secondaryOutcomes measure: fMRI scan, eligibilityModule sex: FEMALE, minimumAge: 11 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353776, orgStudyIdInfo id: 02052023, briefTitle: MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface., conditionsModule conditions: Conjunctiva, conditions: Cornea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: conjunctival biopsy after micropulse transscleral laser therapy, outcomesModule primaryOutcomes measure: conjunctival inflammation or fibrosis, primaryOutcomes measure: intraocular pression, primaryOutcomes measure: ocular surface disease index score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohamed Taher Maamouri Hospital, city: Nabeul, zip: 8000, country: Tunisia, geoPoint lat: 36.45606, lon: 10.73763, hasResults: False
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protocolSection identificationModule nctId: NCT06353763, orgStudyIdInfo id: CV, briefTitle: Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-24, primaryCompletionDateStruct date: 2022-05-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire)., conditionsModule conditions: Pressure Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants were blinded in their group assignment., whoMasked: PARTICIPANT, enrollmentInfo count: 127, type: ACTUAL, armsInterventionsModule interventions name: Immersive virtual reality learning program, outcomesModule primaryOutcomes measure: Knowledge, primaryOutcomes measure: Skill performance, primaryOutcomes measure: Usefulness, Satisfaction, and Ease of Use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Navarra, city: Pamplona, state: Navarra, country: Spain, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False
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protocolSection identificationModule nctId: NCT06353750, orgStudyIdInfo id: 331039, briefTitle: Intracellular Magnesium and Heart Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-04-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: British Heart Foundation, collaborators name: Oxford University Hospitals NHS Trust, descriptionModule briefSummary: Low magnesium levels are surprisingly common in those with a heart condition known as HFpEF, where the heart pumps well but is too rigid to fill properly with blood. While routine blood tests can check magnesium levels, they don't tell us how much magnesium is actually inside the heart and muscle cells, where it's vital for energy and overall function. Our research aims to get a clearer picture by looking directly at the magnesium inside these cells and understanding its role in the body's energy production and usage. We're also interested in how magnesium levels affect symptoms and the body's handling of sugar. We're using advanced medical imaging techniques, like heart magnetic resonance imaging (MRI) and other heart and muscle function tests, at rest and when the heart is working hard to help answer these questions. We'll compare the magnesium levels inside the cells before and after giving a supplement of magnesium to see if this can make a difference in how the heart and muscles work., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, conditions: Hypomagnesemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Magnesium supplement, outcomesModule primaryOutcomes measure: Myocardial/ skeletal muscle metabolism and energetics at rest and stress., secondaryOutcomes measure: Serum versus intracellular magnesium concentration, secondaryOutcomes measure: Cardiac function, secondaryOutcomes measure: Skeletal muscle performance, secondaryOutcomes measure: Symptoms, secondaryOutcomes measure: Insulin sensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oxford Centre for Magnetic Resonance (OCMR), city: Oxford, zip: OX3 9DU, country: United Kingdom, contacts name: Jennifer L Holland, BMBS, role: CONTACT, email: [email protected], contacts name: Oliver Rider, BM BCh, role: CONTACT, email: [email protected], geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06353737, orgStudyIdInfo id: CTO 4489, briefTitle: Looking for Asymptomatic Mpox in a Population at High Risk, acronym: LAMP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, descriptionModule briefSummary: Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature., conditionsModule conditions: Mpox (Monkeypox), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, outcomesModule primaryOutcomes measure: Asymptomatic prevalence, secondaryOutcomes measure: Symptomatic prevalence, secondaryOutcomes measure: Mpox seropositivity, secondaryOutcomes measure: Characteristics, secondaryOutcomes measure: Characteristics of seropositivity, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unity Health Toronto, status: RECRUITING, city: Toronto, state: Ontario, zip: M5B 1T8, country: Canada, contacts name: Reva Persaud, role: CONTACT, phone: 416-360-4000, phoneExt: 77105, email: [email protected], contacts name: Darrell HS Tan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06353724, orgStudyIdInfo id: RP2218, briefTitle: Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent, acronym: stent, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-14, primaryCompletionDateStruct date: 2020-10-01, completionDateStruct date: 2021-01-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues, salivary PH. The main question it aims to answer are: Does the difference in manufacturing method affect on Healthy tissues, salivary PH.Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared* Group A: OPRS was constructed according to the conventional technique.* Group B: OPRS was constructed digitally using CAD /CAM technology. to evaluate Dosimetric analysis to quantify the radiation dose in OARs, PH of saliva measurement and Mucositis assessment., conditionsModule conditions: Radiotherapy Side Effect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning, interventions name: Digital positioning stent, outcomesModule primaryOutcomes measure: Dosimetric analysis, primaryOutcomes measure: PH of saliva measurement:, primaryOutcomes measure: Mucositis assessment:, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Tanta, state: Gharbia, zip: 31527, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06353711, orgStudyIdInfo id: IRB-23-0746, secondaryIdInfos id: R34MH129782, type: NIH, link: https://reporter.nih.gov/quickSearch/R34MH129782, briefTitle: CA-LINC Black Youth Suicide Detection and Intervention Study, acronym: CA-LINC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Charlotte, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34).CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards.CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study., conditionsModule conditions: Suicide, conditions: Suicide Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: CA-LINC Intervention, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Change in Suicide Ideation, primaryOutcomes measure: Change in Suicide Behaviors, otherOutcomes measure: Treatment Acceptability, otherOutcomes measure: Change in Therapeutic Alliance, otherOutcomes measure: Change in Cultural Humility, otherOutcomes measure: Change in Family Relationships, otherOutcomes measure: Change in Engagement Behaviors, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The University of North Carolina at Charlotte, city: Charlotte, state: North Carolina, zip: 28223, country: United States, contacts name: Sonyia Richardson, PhD, role: CONTACT, phone: 704-687-7935, email: [email protected], contacts name: Sonyia C Richardson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, hasResults: False
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protocolSection identificationModule nctId: NCT06353698, orgStudyIdInfo id: Nnftri, briefTitle: Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-02, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Nutrition and Food Technology Institute, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia., conditionsModule conditions: Fasting Mimicking Diet, conditions: Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: fasting mimicking diet, outcomesModule primaryOutcomes measure: Blast cell count, primaryOutcomes measure: Quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azita Hekmatdoost, status: RECRUITING, city: Tehran, state: Middle East, zip: 19835, country: Iran, Islamic Republic of, contacts name: Azita Hekmatdoost, MD, PhD, role: CONTACT, phone: +989123065084, email: [email protected], geoPoint lat: 35.69439, lon: 51.42151, locations facility: Ehsan Hejazi, status: RECRUITING, city: Tehran, zip: 19839-63113, country: Iran, Islamic Republic of, contacts name: Ehsan Hejazi, PhD, role: CONTACT, phone: 00989121530775, email: [email protected], geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
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protocolSection identificationModule nctId: NCT06353685, orgStudyIdInfo id: neo-CHART-HNC, briefTitle: De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation.Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total, fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks., conditionsModule conditions: De-escalated Radiotherapy; Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: Continuous, hyperfractionated, accelerated radiotherapy(CHART), outcomesModule primaryOutcomes measure: 2-year PFS, secondaryOutcomes measure: 2-year OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353672, orgStudyIdInfo id: RLR-01, briefTitle: A Study to Evaluate Safety and Feasibility of Robotic Liver Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR., conditionsModule conditions: Liver Diseases, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Robotic liver resection, outcomesModule primaryOutcomes measure: Postoperative complications, primaryOutcomes measure: Postoperative hospital stay, primaryOutcomes measure: Postoperative unplanned reoperation, primaryOutcomes measure: Unplanned readmission, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Medical College of Zhejiang University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Tingbo Liang, MD,PHD, role: CONTACT, phone: 086-571-87236688, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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