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protocolSection identificationModule nctId: NCT06276933, orgStudyIdInfo id: MA-NSCLC-II-039, briefTitle: A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2025-11-22, completionDateStruct date: 2026-11-22, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Tongji University, class: OTHER, collaborators name: Shanghai Pulmonary Hospital, Shanghai, China, descriptionModule briefSummary: To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients, conditionsModule conditions: Lung Cancer, conditions: Camrelizumab, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab + chemotherapy+Thalidomide, interventions name: Camrelizumab + chemotherapy+placebo, outcomesModule primaryOutcomes measure: Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP), secondaryOutcomes measure: Median time to RCCEP, secondaryOutcomes measure: Median time to RCCEP of level 3 or above, secondaryOutcomes measure: Incidence rate of ≥G3 grade RCCEP, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival(OS), secondaryOutcomes measure: Treatment-related Adverse Events (TRAE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276920, orgStudyIdInfo id: 2024/5554(1), briefTitle: Evaluation of Joint Position Sense in Healthy Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain., conditionsModule conditions: Proprioception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 4, type: ESTIMATED, outcomesModule primaryOutcomes measure: Joint position sense measurement with universal goniometer in close kinetic chain, primaryOutcomes measure: Joint position sense measurement with universal goniometer in open kinetic chain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Inonu University, status: RECRUITING, city: Malatya, zip: 12000, country: Turkey, contacts name: DILAN DEMİRTAŞ KARAOBA, role: CONTACT, phone: 0554112779, email: [email protected], geoPoint lat: 38.35018, lon: 38.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06276907, orgStudyIdInfo id: ILBS-ACLF-16, briefTitle: An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy., conditionsModule conditions: Acute on Chronic Liver Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Plasma Exchange, interventions name: Standard Medical Treatment, outcomesModule primaryOutcomes measure: The AARC grading is done by AARC score the values of which vary from 5-15, pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival, secondaryOutcomes measure: Transplant-free survival at 28-days, secondaryOutcomes measure: The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28, secondaryOutcomes measure: the development of infection at day 7 and 14 in patients who had no infection, secondaryOutcomes measure: Duration of ICU and hospital stay, secondaryOutcomes measure: The proportion of patients developing adverse events will be compared between the two groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Liver & Biliary Sciences, city: New Delhi, state: Delhi, zip: 110070, country: India, contacts name: Dr Rakhi Maiwall, DM, role: CONTACT, phone: 01146300000, email: [email protected], geoPoint lat: 28.63576, lon: 77.22445, hasResults: False |
protocolSection identificationModule nctId: NCT06276894, orgStudyIdInfo id: IRB #2064530-1, briefTitle: Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention, acronym: fNIRS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Craig Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Motek C-Mill™ treadmill, interventions name: training session with and without VR wearing the fNIRS cap, outcomesModule primaryOutcomes measure: Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability), primaryOutcomes measure: Acceptability of the intervention, primaryOutcomes measure: fNIRS Data Quality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Craig Hospital, city: Englewood, state: Colorado, zip: 80113, country: United States, geoPoint lat: 39.64777, lon: -104.98776, hasResults: False |
protocolSection identificationModule nctId: NCT06276881, orgStudyIdInfo id: DSC1001, secondaryIdInfos id: 1R43DA054845-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R43DA054845-01, briefTitle: Visual Stimulation for Pain Relief, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2022-12-28, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-02-26, resultsFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Dandelion Science, class: INDUSTRY, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Visual Stimulation, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS) Score, primaryOutcomes measure: Event-related Potential (ERP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dandelion Science, city: Hoboken, state: New Jersey, zip: 07030, country: United States, geoPoint lat: 40.74399, lon: -74.03236, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-12-21, uploadDate: 2024-03-08T12:20, filename: Prot_SAP_000.pdf, size: 689133, hasResults: True |
protocolSection identificationModule nctId: NCT06276868, orgStudyIdInfo id: HELEN-017, briefTitle: Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2029-06-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy., conditionsModule conditions: Breast Cancer, conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single arm clinical study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Dalcilib+letrozole+HP treatment group, outcomesModule primaryOutcomes measure: pathologic complete response, secondaryOutcomes measure: Adverse event occurrence, secondaryOutcomes measure: objective response rate, secondaryOutcomes measure: Residual cancer burden, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Distant disease/recurrence free survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan cacer hospital, city: Henan, state: Henan, zip: 450008, country: China, hasResults: False |
protocolSection identificationModule nctId: NCT06276855, orgStudyIdInfo id: CUtülay, briefTitle: Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-23, primaryCompletionDateStruct date: 2021-07-01, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental group Control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Sleep hygiene education, outcomesModule primaryOutcomes measure: Demographic Information Form (DIF)., primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI)., primaryOutcomes measure: Visual Analog Scale (VAS)., primaryOutcomes measure: Beck Depression Inventory (BDI)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, state: Center, zip: 58140, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False |
protocolSection identificationModule nctId: NCT06276842, orgStudyIdInfo id: 12345678, briefTitle: Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2020-09-30, completionDateStruct date: 2020-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: CIMS Dental College, class: OTHER, descriptionModule briefSummary: OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block., conditionsModule conditions: Pulpitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Inferior Alveolar Nerve Block, interventions name: Buccal Infiltration, interventions name: Inferior Alveolar Nerve Block and Buccal Infiltration, outcomesModule primaryOutcomes measure: Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dr Ayesha Ahmed, city: Multan, country: Pakistan, geoPoint lat: 30.19679, lon: 71.47824, hasResults: False |
protocolSection identificationModule nctId: NCT06276829, orgStudyIdInfo id: 02.05.2023/291, briefTitle: Behçet and LDH/Albumin, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-01, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.Patients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio., conditionsModule conditions: Behcet's Disease, conditions: Albumin, conditions: Lactate Dehydrogenase, conditions: Disease Severity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: LDH/albumin ratio, outcomesModule primaryOutcomes measure: LDH/albumin ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erdal Pala, city: Erzurum, zip: 25240, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False |
protocolSection identificationModule nctId: NCT06276816, orgStudyIdInfo id: 2022-LC14, briefTitle: Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-13, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia., conditionsModule conditions: Sinus Bradycardia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 88, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of patients with postoperative recurrence of bradycardia symptoms, secondaryOutcomes measure: The result of the atropine test, secondaryOutcomes measure: Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36), secondaryOutcomes measure: Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS), secondaryOutcomes measure: Changes in minmum heart rate, secondaryOutcomes measure: Changes in mean heart rate, secondaryOutcomes measure: Changes in deceleration capacity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Beijing, country: China, contacts name: Yao Yan, MD PhD, role: CONTACT, phone: +86-1390-1121-319, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06276803, orgStudyIdInfo id: Adenocyte 104, briefTitle: The LINFU® U.S. Registry for the in the General Population Without Risk Factors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2034-04-15, completionDateStruct date: 2034-06-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Adenocyte, LLC, class: INDUSTRY, descriptionModule briefSummary: Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3)., conditionsModule conditions: Pancreatic Cancer, conditions: Pancreatic Ductal Adenocarcinoma, conditions: Pancreatic Dysplasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: LINFU®, outcomesModule primaryOutcomes measure: The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU®, primaryOutcomes measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term, secondaryOutcomes measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention, otherOutcomes measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU®, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276790, orgStudyIdInfo id: ChengdeCentralHospital, briefTitle: Objective Analysis of Caesarean Scar Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-18, primaryCompletionDateStruct date: 2022-12-23, completionDateStruct date: 2022-12-25, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Chengde Central Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy., conditionsModule conditions: Caesarean Scar Pregnancy, conditions: Ultrasound Scoring System, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 117, type: ACTUAL, armsInterventionsModule interventions name: ultrasound-guided/hysteroscopic curettage, interventions name: Procedure/Surgery: laparoscopic removal of the pregnancy lesion, outcomesModule primaryOutcomes measure: intraoperative blood loss, primaryOutcomes measure: length of hospital stay, primaryOutcomes measure: serum β-HCG levels, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chengde Central Hospital, city: Chengde, zip: 067000, country: China, geoPoint lat: 40.9519, lon: 117.95883, hasResults: False |
protocolSection identificationModule nctId: NCT06276777, orgStudyIdInfo id: SPRG Dentin Hypersensitivity, briefTitle: The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial, acronym: S-PRG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Eman Omar Elfarouk, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups., conditionsModule conditions: Dentin Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants and both assessors will be blind to the type of material used., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Tooth varnish (PRG Barrier Coat from Shofu), interventions name: Tooth varnish (Clinpro white varnish 3M), outcomesModule primaryOutcomes measure: Dentin hypersensitivity reduction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Cairo University, city: Cairo, zip: 11331, country: Egypt, contacts name: Eman Omar, bachelor, role: CONTACT, phone: 01156677558, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06276764, orgStudyIdInfo id: Adenocyte 103, briefTitle: The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2034-03-30, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Adenocyte, LLC, class: INDUSTRY, descriptionModule briefSummary: In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes., conditionsModule conditions: IPMN, Pancreatic, conditions: Pancreas Cancer, conditions: Pancreatic Cyst, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: LINFU®, interventions name: Standard imaging tests, outcomesModule primaryOutcomes measure: The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods, secondaryOutcomes measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period, secondaryOutcomes measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention., otherOutcomes measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU®, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276751, orgStudyIdInfo id: E1-23-3870 ptx endtidalco2, briefTitle: The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2024-02-06, completionDateStruct date: 2024-02-13, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments.End-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2.In this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases., conditionsModule conditions: Pneumothorax, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: End-tidal CO2 monitor, outcomesModule primaryOutcomes measure: ETCO2-0, primaryOutcomes measure: ΔETCO2-1, primaryOutcomes measure: ΔETCO2-2, primaryOutcomes measure: ETCO2-1, primaryOutcomes measure: ETCO2-2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bilkent Şehir Hastanesi, city: Ankara, state: Çankaya, zip: 06170, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06276738, orgStudyIdInfo id: Adenocyte 102, briefTitle: The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2034-03-01, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Adenocyte, LLC, class: INDUSTRY, descriptionModule briefSummary: Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC., conditionsModule conditions: Pancreatic Cancer, conditions: Jaundice, conditions: Abdominal Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas), outcomesModule primaryOutcomes measure: The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods, secondaryOutcomes measure: The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined, secondaryOutcomes measure: Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention, otherOutcomes measure: Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276725, orgStudyIdInfo id: 23-606, briefTitle: Writing Wrongs: Expressive Writing for Microaggressions, acronym: WW, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Auburn University, class: OTHER, collaborators name: Medical University of South Carolina, descriptionModule briefSummary: Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions., conditionsModule conditions: Posttraumatic Stress Disorder, conditions: Discriminatory Stress, conditions: Microaggression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: After consenting to participate in the study, participants will be randomized in a 1:1 manner into either the Writing Wrongs Intervention or the Assessment Control condition. All participants will complete a total of five online study sessions including a pre-intervention assessment, three intervention or assessment only sessions, and a one-week follow-up assessment ., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Writing Wrongs, outcomesModule primaryOutcomes measure: Racial and Discriminatory Trauma, primaryOutcomes measure: Daily Racial and Discrimination Trauma, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Posttraumatic Stress, secondaryOutcomes measure: Daily Depression, secondaryOutcomes measure: Daily Anxiety, secondaryOutcomes measure: Daily Posttraumatic Stress, otherOutcomes measure: Negative Affect, otherOutcomes measure: Positive Affect, otherOutcomes measure: Acceptability of Writing Wrongs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Auburn University, status: RECRUITING, city: Auburn, state: Alabama, zip: 368849, country: United States, contacts name: Cassidy M Brydon, MS, role: CONTACT, phone: 954-591-5261, email: [email protected], contacts name: Tracy K Witte, PhD, role: CONTACT, phone: 334-844-6465, email: [email protected], geoPoint lat: 32.60986, lon: -85.48078, hasResults: False |
protocolSection identificationModule nctId: NCT06276712, orgStudyIdInfo id: UNISS_PHD_Osstem_5, briefTitle: RCT Comparing KS Versus TS for Ovedenture, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2028-01-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Università degli Studi di Sassari, class: OTHER, collaborators name: Dr. Dario Melodia, collaborators name: Dr. Milena Pisano, collaborators name: Dr. Aurea Lumbau, collaborators name: Prof. Silvio Mario Meloni, collaborators name: Prof. Edoardo Baldoni, descriptionModule briefSummary: To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants, conditionsModule conditions: Dental Implant, conditions: Dental Implant-Abutment Design, conditions: Edentulous Jaw, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A multicenters, randomized controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Implant placement with 3.5 mm diameter KS implants., interventions name: Implant placement with 3.5 mm diameter TS implants., outcomesModule primaryOutcomes measure: Number of implant failure, primaryOutcomes measure: Number of prosthesis failure, primaryOutcomes measure: Number of complications, primaryOutcomes measure: Rate of implant stability, secondaryOutcomes measure: Peri-implant marginal bone level changes, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06276699, orgStudyIdInfo id: FAHS, briefTitle: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Peradeniya, class: OTHER, descriptionModule briefSummary: This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly., conditionsModule conditions: Cervical Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: 1.Isometric exercise 2.combined conservative treatment, outcomesModule primaryOutcomes measure: Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline., secondaryOutcomes measure: Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline., secondaryOutcomes measure: Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06276686, orgStudyIdInfo id: RS211 - 332296, briefTitle: Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Hull, class: OTHER, collaborators name: Hull University Teaching Hospitals NHS Trust, descriptionModule briefSummary: This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Supervised Vigorous intensity aerobic interval exercise, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: withdrawal rate, secondaryOutcomes measure: Serum Carcinoembryonic antigen levels, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Physical activity levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276673, orgStudyIdInfo id: 301, briefTitle: The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-11-10, completionDateStruct date: 2024-12-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Salisbury University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception., conditionsModule conditions: Blood Vessel Disease, conditions: Muscle Edema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Unable to blind due to differences in cuff size and appearance., enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Delfi, outcomesModule primaryOutcomes measure: Arterial Stiffness, primaryOutcomes measure: Muscle Morphology, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Salisbury University, city: Salisbury, state: Maryland, zip: 21801, country: United States, geoPoint lat: 38.36067, lon: -75.59937, hasResults: False |
protocolSection identificationModule nctId: NCT06276660, orgStudyIdInfo id: STUDY23070079, briefTitle: Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit., conditionsModule conditions: Mild Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: BCTT, interventions name: Dynamic ExIT, outcomesModule primaryOutcomes measure: Physiological response to dynamic or aerobic test (HEART RATE), secondaryOutcomes measure: Post Concussion Symptom Scale, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), secondaryOutcomes measure: Vestibular Ocular Motor Screening (VOMS), secondaryOutcomes measure: Clinical Profiles Screening (CP-Screen), secondaryOutcomes measure: Blood Pressure, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15203, country: United States, contacts name: Cynthia Holland, MPH, role: CONTACT, phone: 412-904-1298, email: [email protected], geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06276647, orgStudyIdInfo id: 850584, secondaryIdInfos id: R01MD016029, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MD016029, briefTitle: Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk, acronym: HOME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: Columbia University, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\[s\] it aims to answer are:* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?* How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum., conditionsModule conditions: Maternal Behavior, conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 214, type: ESTIMATED, armsInterventionsModule interventions name: HOME, outcomesModule primaryOutcomes measure: Emergency Department (ED) Visits and Readmissions, secondaryOutcomes measure: Ability to Obtain Needed Services, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Depressive Symptoms, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital of the University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Elizabeth Howell, MD MPP, role: CONTACT, email: [email protected], contacts name: Micki Burdick, PhD, role: CONTACT, email: [email protected], contacts name: Elizabeth Howell, MD MPP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06276634, orgStudyIdInfo id: STU00219535, secondaryIdInfos id: R21HD108587, type: NIH, link: https://reporter.nih.gov/quickSearch/R21HD108587, briefTitle: Intermittent Hypoxia in Persons With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shirley Ryan AbilityLab, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Northwestern University, descriptionModule briefSummary: This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS., conditionsModule conditions: Multiple Sclerosis, conditions: Multiple Sclerosis-Relapsing-Remitting, conditions: Multiple Sclerosis, Secondary Progressive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Acute Intermittent Hypoxia, interventions name: Sham-Acute Intermittent Hypoxia, outcomesModule primaryOutcomes measure: Ankle Plantarflexion Strength, secondaryOutcomes measure: Task fMRI, otherOutcomes measure: Timed 25 Feet Walk test, otherOutcomes measure: Six-Minute Walk test, otherOutcomes measure: Stride length, otherOutcomes measure: 12-Item Multiple Sclerosis walk scale (MSWS-12), otherOutcomes measure: Resting-State fMRI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shirley Ryan AbilityLab, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Alexander Barry, MS, CCRC, role: CONTACT, phone: 312-238-1435, email: [email protected], contacts name: Milap Sandhu, PT, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Molly Bright, D.Phil., role: SUB_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06276621, orgStudyIdInfo id: STUDY00003564, briefTitle: Family Bridge Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Children's Hospital of Philadelphia, descriptionModule briefSummary: Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care., conditionsModule conditions: Healthcare Inequities, conditions: General Pediatric Medical Conditions, conditions: Healthcare System Navigation, conditions: Patient-provider Communication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 728, type: ESTIMATED, armsInterventionsModule interventions name: Family Bridge Program, interventions name: Care as usual - resources only, outcomesModule primaryOutcomes measure: System Navigation Ability, primaryOutcomes measure: Pediatric Transition Experience Measure (P-TEM), secondaryOutcomes measure: Diagnosis Comprehension, secondaryOutcomes measure: Perceived Stress Scale, secondaryOutcomes measure: Observed Communication: utterances in which team offers information, secondaryOutcomes measure: Observed Communication: utterances in which team offers supportive talk, secondaryOutcomes measure: Observed Communication: utterances in which parent asks questions, secondaryOutcomes measure: Observed Communication: utterances in which parent responds assertively, secondaryOutcomes measure: Observed Communication: parent talk-time, secondaryOutcomes measure: Observed Communication: global partnership rating, secondaryOutcomes measure: 30-day readmissions, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06276608, orgStudyIdInfo id: PED_Fe_def, briefTitle: Iron Deficiency in Pediatric Heart Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, descriptionModule briefSummary: The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests., conditionsModule conditions: Iron Deficiencies, conditions: Iron Deficiency Anemia, conditions: Cardiac Surgical Procedures, conditions: Congenital Heart Disease in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Iron status, outcomesModule primaryOutcomes measure: Prevalence of preoperative iron deficiency (%), primaryOutcomes measure: Complications, eligibilityModule sex: ALL, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Denis Schmartz, MD, role: CONTACT, phone: +3225553919, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06276595, orgStudyIdInfo id: IRB00009466, briefTitle: Telling Our Daughters Our Story, acronym: TODOS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-03-30, primaryCompletionDateStruct date: 2022-03-22, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins Bloomberg School of Public Health, class: OTHER, collaborators name: White Mountain Apache Tribe, collaborators name: Native American Research Centers for Health, descriptionModule briefSummary: The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use., conditionsModule conditions: Substance Use, conditions: Sexual Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 183, type: ACTUAL, armsInterventionsModule interventions name: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS), interventions name: Control condition - 3 Monthly Group Activities in the Community, outcomesModule primaryOutcomes measure: Change in child cultural knowledge score on knowledge assessment, primaryOutcomes measure: Change in average score on risky behaviors assessment, primaryOutcomes measure: Change in child reproductive health knowledge via a reproductive health knowledge questionnaire, eligibilityModule sex: FEMALE, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: White Mountain Apache Center for Indigenous Health, city: Whiteriver, state: Arizona, zip: 85941, country: United States, geoPoint lat: 33.83699, lon: -109.96427, hasResults: False |
protocolSection identificationModule nctId: NCT06276582, orgStudyIdInfo id: 519379-2, briefTitle: Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-17, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Norwegian University of Science and Technology, class: OTHER, collaborators name: Picterus AS, collaborators name: Instituto Mexicano del Seguro Social, descriptionModule briefSummary: The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared., conditionsModule conditions: Jaundice, Neonatal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Screening for neonatal jaundice with a mobile health device, outcomesModule primaryOutcomes measure: Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP, secondaryOutcomes measure: Correlation between bilirubin measurements with Picterus JP and total serum bilirubin, otherOutcomes measure: Accuracy of Picterus JP to screen for neonatal jaundice, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 14 Days, stdAges: CHILD, contactsLocationsModule locations facility: Hospital General de Zona 1, status: RECRUITING, city: Oaxaca, zip: 68040, country: Mexico, contacts name: Rey Manuel Silva Mendez, role: CONTACT, phone: +529511283520, email: [email protected], geoPoint lat: 17.06542, lon: -96.72365, hasResults: False |
protocolSection identificationModule nctId: NCT06276569, orgStudyIdInfo id: 2023-LCYJ-MS-26, briefTitle: Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application., conditionsModule conditions: Cardiac Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: Sivelestat, interventions name: placebo, outcomesModule primaryOutcomes measure: Oxygenation index, primaryOutcomes measure: Inflammatory index, primaryOutcomes measure: Myocardial injury marker, primaryOutcomes measure: Acute physiology and chronic health evaluation(APACHE II) socre, primaryOutcomes measure: Murray socre, primaryOutcomes measure: ICU time, primaryOutcomes measure: In-hospital time, primaryOutcomes measure: 30-day all-cause mortality, primaryOutcomes measure: 90-day all-cause mortality, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06276556, orgStudyIdInfo id: ABP-671-302, briefTitle: Extension Study of ABP-671 in Participants With Gout, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-07-02, completionDateStruct date: 2025-07-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3)., conditionsModule conditions: Gout, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 580, type: ESTIMATED, armsInterventionsModule interventions name: ABP-671, interventions name: Allopurinol, outcomesModule primaryOutcomes measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L), primaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety and Tolerability), secondaryOutcomes measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alliance for Multispecialty Research, city: Tempe, state: Arizona, zip: 85281, country: United States, geoPoint lat: 33.41477, lon: -111.90931, locations facility: Tucson Neuroscience Research, LLC, city: Tucson, state: Arizona, zip: 85710, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Anaheim Clinical Trials (Cenexel ACT), city: Anaheim, state: California, zip: 92801, country: United States, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Center for Clinical Trials of Sacramento, city: Sacramento, state: California, zip: 95823, country: United States, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Access Research Institute, city: Brooksville, state: Florida, zip: 34613, country: United States, geoPoint lat: 28.55554, lon: -82.38991, locations facility: Nature Coast Clinical Reasearch, city: Crystal River, state: Florida, zip: 34429, country: United States, geoPoint lat: 28.90248, lon: -82.5926, locations facility: JY Research Institute Inc., city: Cutler Bay, state: Florida, zip: 33189, country: United States, geoPoint lat: 25.5783, lon: -80.3377, locations facility: Accel Clinical Research Site, city: DeLand, state: Florida, zip: 32720, country: United States, geoPoint lat: 29.02832, lon: -81.30312, locations facility: Jacksonville Center for Clinical Research, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: A & D Doctor Center, city: Miami, state: Florida, zip: 33135, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Bioclinical Research Alliance, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Cordova Research Institute, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Century Research LLC, city: Miami, state: Florida, zip: 33173, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: ITB Research, city: Miami, state: Florida, zip: 33173, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Combined Research Orlando Phase I-IV, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: New Horizons Research, city: Palmetto Bay, state: Florida, zip: 33158, country: United States, geoPoint lat: 25.62177, lon: -80.32477, locations facility: Advanced Clinical Research of Atlanta, city: Atlanta, state: Georgia, zip: 30309, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Centricity Research, city: Columbus, state: Georgia, zip: 31904, country: United States, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Alliance for Multispecialty Research, LLC., city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: DelRicht Research, city: New Orleans, state: Louisiana, zip: 70115, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: AMR, city: New Orleans, state: Louisiana, zip: 70119, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Annapolis Internal Medicine/CCT Research, city: Annapolis, state: Maryland, zip: 21401, country: United States, geoPoint lat: 38.97845, lon: -76.49218, locations facility: DelRicht Research of Gulfport, city: Gulfport, state: Mississippi, zip: 39501, country: United States, geoPoint lat: 30.36742, lon: -89.09282, locations facility: Quality Clinical Research, Inc, city: Omaha, state: Nebraska, zip: 68114, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Santa Rosa Medical Center, city: Las Vegas, state: Nevada, zip: 89119, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Inspire Santa Fe Medical Group, city: Santa Fe, state: New Mexico, zip: 87505, country: United States, geoPoint lat: 35.68698, lon: -105.9378, locations facility: OnSite Clinical Solutions, city: Salisbury, state: North Carolina, zip: 28144, country: United States, geoPoint lat: 35.67097, lon: -80.47423, locations facility: Altoona Center for Clinical Research, city: Duncansville, state: Pennsylvania, zip: 16635, country: United States, geoPoint lat: 40.42341, lon: -78.4339, locations facility: ClinSearch, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, geoPoint lat: 35.04563, lon: -85.30968, locations facility: Medical Care/CCT, city: Elizabethton, state: Tennessee, zip: 37643, country: United States, geoPoint lat: 36.34872, lon: -82.21069, locations facility: PanAmerican Clinical Research, LLC, city: Brownsville, state: Texas, zip: 78520, country: United States, geoPoint lat: 25.90175, lon: -97.49748, locations facility: Quality Research Inc., city: San Antonio, state: Texas, zip: 78209, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Worldwide Clinical Trials, city: San Antonio, state: Texas, zip: 78217, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Paratus Clinical Research Western Sydney, city: Blacktown, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Emeritus Research Sydney, city: Botany, state: New South Wales, zip: 2019, country: Australia, geoPoint lat: -33.94599, lon: 151.19591, locations facility: Paratus Clinical Research Central Coast, city: Kanwal, state: New South Wales, zip: 2259, country: Australia, geoPoint lat: -33.253, lon: 151.4911, locations facility: A R Houston Medical Pty Ltd, city: Kippa-Ring, state: Queensland, zip: 4021, country: Australia, geoPoint lat: -27.22586, lon: 153.0835, locations facility: Emeritus Research Melbourne, city: Camberwell, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.84205, lon: 145.0694, locations facility: Austin Health - Repatriation Hospital, city: Heidelberg, state: Victoria, zip: 3084, country: Australia, geoPoint lat: -37.75, lon: 145.06667, locations facility: New Hospitals, city: Tbilisi, zip: 0114, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Evex Hospitals Caraps Medline, city: Tbilisi, zip: 0159, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Aversi Clini, city: Tbilisi, zip: 0160, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: The First Medical Center, city: Tbilisi, zip: 0180, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Academician Vakhtang Bochorishvili Clinic, city: Tbilisi, zip: 0186, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Innova, city: Tbilisi, zip: 0186, country: Georgia, geoPoint lat: 41.69411, lon: 44.83368, locations facility: Clinical Research Center (CRC), city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER), city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna y Reumatología, city: C.p., zip: 01010, country: Guatemala, locations facility: Clínica Médica Especializada en Medicina Interna, city: C.p., zip: 01010, country: Guatemala, locations facility: Buddhist Dalin Tzu Chi General Hospital, city: Chiayi City, zip: 62247, country: Taiwan, geoPoint lat: 23.47917, lon: 120.44889, locations facility: Chang Gung Memorial Hospital CGMH, city: Kaohsiung City, zip: 833, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Chung Shan Medical Univ. Hospital, city: Taichung, zip: 402367, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Cheng-Shin General Hospital, city: Taipei City, zip: 112401, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Chang Gung Memorial Hospital LinKou, city: Taoyuan, zip: 333423, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False |
protocolSection identificationModule nctId: NCT06276543, orgStudyIdInfo id: C-BSEAL-002, briefTitle: Bactiseal Catheter Safety Registry Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Integra LifeSciences Corporation, class: INDUSTRY, descriptionModule briefSummary: Research Purpose:This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.Research Design:This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.The following information will be collected from subjects' medical records or hospitals' databases (if any):1. General condition of the subjects (including previous shunting and external drainage operation)2. Intraoperative condition and catheter implantation3. Information on the shunt catheters4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done), conditionsModule conditions: Hydrocephalus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: antibiotic-impregnated catheter, outcomesModule primaryOutcomes measure: Infection outcome, primaryOutcomes measure: Safety outcome, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Children's Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Hailang Sun, MD, role: CONTACT, phone: 0086-10-59616408, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Ning Wang, MD, role: CONTACT, phone: 010-83198899, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Cheng Sha, MD, role: CONTACT, phone: 0086-10-85132266, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Guangzhou Women and Children Medical Center, city: Guangzhou, state: Guangdong, zip: 510623, country: China, contacts name: Fangcheng Li, MD, role: CONTACT, phone: 020-81886332, geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangdong Province People Hospital, city: Guangzhou, state: Guangdong, zip: 519041, country: China, contacts name: Feng Wang, MD, role: CONTACT, phone: 0086 20 83827812, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Ting Lei, MD, role: CONTACT, phone: 0086 27 83662688, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Nan Bao, MD, role: CONTACT, phone: 0086-21-38626161, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Jianguo Xu, MD, role: CONTACT, phone: 0086 28 85422114, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06276530, orgStudyIdInfo id: APHP231036, briefTitle: Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling, acronym: VaPosVent, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy., conditionsModule conditions: Resectable Lung Non-Small Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EOS imaging for musculoskeletal disorder, interventions name: Movement analysis by an optoelectronic camera., interventions name: Stabilometric measurement by strength platform, outcomesModule primaryOutcomes measure: Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS), secondaryOutcomes measure: Width of rib cage (EOS), secondaryOutcomes measure: Rib cage volume (EOS), secondaryOutcomes measure: " Umbrella "angle (EOS), secondaryOutcomes measure: Center of Pressure displacement (Optoelectronic system), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Thoracic and Vascular Surgery Tenon University Hospital, city: Paris, zip: 75020, country: France, contacts name: Harry ETIENNE, M.D., PhD, role: CONTACT, phone: +33 6 67 96 82 89, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06276517, orgStudyIdInfo id: APHP220918, secondaryIdInfos id: 2022-A01739-34, type: OTHER, domain: IDRCB, briefTitle: Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom, acronym: HIDDEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire, conditionsModule conditions: Intracranial Hemorrhages, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, interventions name: SS-QoL, interventions name: SF-36, interventions name: CIQ-R, interventions name: BREFF, interventions name: MoCA, interventions name: IADL, interventions name: mMRS, interventions name: PCL-5, interventions name: Brief-Cope, outcomesModule primaryOutcomes measure: Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome., secondaryOutcomes measure: - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year, secondaryOutcomes measure: To study the prevalence of post-traumatic stress in this population, secondaryOutcomes measure: Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276504, orgStudyIdInfo id: APHP211001, secondaryIdInfos id: 2023-503520-31-00, type: OTHER, domain: EU CT number, briefTitle: Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection, acronym: PENALTY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period., conditionsModule conditions: Progressive Multifocal Leukoencephalopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection, outcomesModule primaryOutcomes measure: Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period, secondaryOutcomes measure: Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event, secondaryOutcomes measure: Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF), secondaryOutcomes measure: Repositivation of JCV PCR: at least a positive result following at least a negative result, secondaryOutcomes measure: Evolution of National Institutes of Health Stroke Scale (NIHSS) score, secondaryOutcomes measure: Evolution of 6-item Modified Rankin Scale score (includes death as most severe state), secondaryOutcomes measure: Evolution of Glasgow Outcome Scale Extended (GOS-E) score, secondaryOutcomes measure: Relapse or progression, secondaryOutcomes measure: Death (and date of death), secondaryOutcomes measure: Cause specific death: death related to PML, secondaryOutcomes measure: Any adverse event classified by using US NCI CTCAE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation, city: Paris, zip: 75013, country: France, contacts name: Nicolas WEISS, Pr, role: CONTACT, phone: +33 (0)1 42 16 27 70, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Pitié-Salpêtrière - Service d'hématologie clinique, city: Paris, zip: 75013, country: France, contacts name: Damien ROOS-WEIL, Dr, role: CONTACT, phone: +33 (0)1 42 16 15 96, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales, city: Paris, zip: 75013, country: France, contacts name: Valérie POURCHER, Pr, role: CONTACT, phone: +33 (0)1 42 16 02 62, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06276491, orgStudyIdInfo id: XmAb541-01, briefTitle: Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Xencor, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes., conditionsModule conditions: Ovarian Cancer, conditions: Endometrial Cancer, conditions: Germ Cell Tumor, conditions: Testicular Germ Cell Tumor, conditions: Ovarian Germ Cell Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Dose escalation and expansion study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 212, type: ESTIMATED, armsInterventionsModule interventions name: XmAb541, outcomesModule primaryOutcomes measure: Incidence of Adverse Events, primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs), primaryOutcomes measure: Incidence of cytokine release syndrome (CRS), secondaryOutcomes measure: Measurement of Cmax, secondaryOutcomes measure: Measurement of area under curve (AUC), secondaryOutcomes measure: Measurement of Ctrough, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Changes in Circulating Tumor DNA (ctDNA), eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Einstein Comprehensive Cancer Center, status: RECRUITING, city: Bronx, state: New York, zip: 10461, country: United States, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False |
protocolSection identificationModule nctId: NCT06276478, orgStudyIdInfo id: 2024-PEDOAI, briefTitle: Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.A cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.Children will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;* in the Control group, only the "tell-show-do" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.At the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement., conditionsModule conditions: Dental Anxiety, conditions: Dental Phobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: AI-video, interventions name: Verbal instructions, outcomesModule primaryOutcomes measure: Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995), secondaryOutcomes measure: Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997), secondaryOutcomes measure: Change in Bleeding on Probing - BoP (Löe H. et al.,1967), secondaryOutcomes measure: Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964), secondaryOutcomes measure: International Caries Detection and Assessment System - ICDAS, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False |
protocolSection identificationModule nctId: NCT06276465, orgStudyIdInfo id: UC-GTG-2306, secondaryIdInfos id: 2023-507482-26-00, type: OTHER, domain: EU-CT, briefTitle: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging, acronym: PEACE8, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2032-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: UNICANCER, class: OTHER, collaborators name: Bayer, descriptionModule briefSummary: In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide., conditionsModule conditions: Prostatic Cancer, Castration-Resistant, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible patients will be randomly allocated in a 1:1 ratio to either the:* Control arm: ADT + darolutamide.* Experimental arm: ADT + darolutamide + SBRT., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: Darolutamide 300 mg, interventions name: Stereotactic body radiation therapy, interventions name: Androgen deprivation therapy, outcomesModule primaryOutcomes measure: Radiographic Progression-free survival (rPFS), secondaryOutcomes measure: Time to treatment failure (TTF), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Prostate cancer-specific survival, secondaryOutcomes measure: Time to PSA progression, secondaryOutcomes measure: Biochemical response rate, secondaryOutcomes measure: Time to next symptomatic skeletal event (SSE), secondaryOutcomes measure: Time to pain progression, secondaryOutcomes measure: Safety/tolerance, secondaryOutcomes measure: Functional Assessment of CAncer Therapy - Prostate (FACT-P), secondaryOutcomes measure: Brief Pain Inventory - Short Form (BP-SFI) questionnaire, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276452, orgStudyIdInfo id: 23.0434, secondaryIdInfos id: U2CDA050097, type: NIH, link: https://reporter.nih.gov/quickSearch/U2CDA050097, briefTitle: Supporting Resilience Among Re-entered Seniors, acronym: SRRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-09, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.Aim 1 participants will:* complete a baseline survey* participate in a focus groupAim 2 participants will:* complete a baseline survey* participate in an 8-week once weekly intervention* complete three follow up surveys, conditionsModule conditions: Chronic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Chronic disease self managment, eligibilityModule sex: MALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New Legacy Reentry, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40203, country: United States, contacts name: Stephanie Grace Prost, PhD, role: CONTACT, email: [email protected], geoPoint lat: 38.25424, lon: -85.75941, hasResults: False |
protocolSection identificationModule nctId: NCT06276439, orgStudyIdInfo id: IRB23-0314, briefTitle: Intraoperative Imaging of Lymph Nodes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-02-19, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, collaborators name: U.S. National Science Foundation, collaborators name: Ss. Cyril and Methodius University of Skopje, Macedonia, descriptionModule briefSummary: One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Surgical removal of breast cancer and lymph nodes, outcomesModule primaryOutcomes measure: Positive lymph node detection with custom sensors, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Clinic Hospital, status: RECRUITING, city: Skopje, zip: 1000, country: North Macedonia, contacts name: Viktor Gruev, PhD, role: CONTACT, phone: +1.267.847.4020, email: [email protected], contacts name: Goran Kondov, MD, PHD, role: CONTACT, phone: +389 70 252010, email: [email protected], geoPoint lat: 41.99646, lon: 21.43141, hasResults: False |
protocolSection identificationModule nctId: NCT06276426, orgStudyIdInfo id: 24468, briefTitle: Plants Optimizing Development Study (PODS), acronym: PODS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Urbana-Champaign, class: OTHER, collaborators name: Soy Nutrition Institute, descriptionModule briefSummary: This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children., conditionsModule conditions: Healthy Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Soy foods, interventions name: Non-Soy Plant-Based Foods, outcomesModule primaryOutcomes measure: Sex steroid excretion, secondaryOutcomes measure: Gut microbiota, secondaryOutcomes measure: Attentional Accuracy, secondaryOutcomes measure: Attentional Reaction Time, secondaryOutcomes measure: Hippocampal-dependent Relational memory, secondaryOutcomes measure: Body Composition, secondaryOutcomes measure: Metabolic Markers, secondaryOutcomes measure: Pubertal Staging, secondaryOutcomes measure: Cognitive Abilities and Academic Achievement, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Illinois, status: RECRUITING, city: Urbana, state: Illinois, zip: 61801, country: United States, contacts name: Naiman Khan, PhD, RD, role: CONTACT, phone: 217-300-2197, email: [email protected], contacts name: Naiman Khan, PhD, RD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.11059, lon: -88.20727, hasResults: False |
protocolSection identificationModule nctId: NCT06276413, orgStudyIdInfo id: REBRA, secondaryIdInfos id: REBRA, type: REGISTRY, domain: REBRA, briefTitle: REgistRy BRAnch goRE EndopRosthEsis, acronym: REBRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Padova, class: OTHER, descriptionModule briefSummary: Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis, conditionsModule conditions: Aortic Aneurysm, Thoracic, conditions: Aortic Dissection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: GORE TAG Thoracic Branch Endoprosthesis, outcomesModule primaryOutcomes measure: early mortality, primaryOutcomes measure: device stability, primaryOutcomes measure: technical success, secondaryOutcomes measure: early major adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vascular and Endovascular Clinic - Padova University, city: Padova, zip: 35020, country: Italy, contacts name: Michele Piazza, Pr, role: CONTACT, phone: 3498644688, email: [email protected], geoPoint lat: 45.40797, lon: 11.88586, hasResults: False |
protocolSection identificationModule nctId: NCT06276400, orgStudyIdInfo id: 4-24-0023:1, briefTitle: LPFC Organization in Emotion-Duration Difference Estimation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of California, Santa Barbara, class: OTHER, descriptionModule briefSummary: To support optimal behavior in daily life, goals and responses following emotional events should ideally incorporate not only the valence and intensity of prior emotional episodes but also their temporal features, such as the relative duration of positive vs. negative attributes. However, how specific brain regions contribute to the integration of temporal and emotional information and promote goal-directed response remains unknown.The goal of this study is to examine how specific brain regions track both emotional and temporal information of dynamic emotional events to inform other related brain regions to guide goal-oriented and context-appropriate actions. The investigators will scan healthy human participants using functional MRI (fMRI) while they view emotional image sequences and track the associated emotional and temporal (duration) information, and act accordingly. The investigators will employ multivariate patterns analysis and pattern similarity analysis to identify brain regions that represent (can decode) emotion, time, and their combined signals, as well as brain regions that represent the associated action goal. In addition, to infer the causal contributions of these brain regions in forming task-relevant representations (emotion, time, and action goal), the same participants will be recruited to receive transcranial magnetic stimulation (TMS) in these regions., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns)., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Emotion valence, interventions name: Time, interventions name: TMS Stimulation, outcomesModule primaryOutcomes measure: Multivariate BOLD metrics, primaryOutcomes measure: Behavioral response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Santa Barbara, status: RECRUITING, city: Santa Barbara, state: California, zip: 93106, country: United States, geoPoint lat: 34.42083, lon: -119.69819, hasResults: False |
protocolSection identificationModule nctId: NCT06276387, orgStudyIdInfo id: K23AT011768-01, type: NIH, link: https://reporter.nih.gov/quickSearch/K23AT011768-01, secondaryIdInfos id: K23AT011768, type: NIH, link: https://reporter.nih.gov/quickSearch/K23AT011768, briefTitle: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis, acronym: DREAMER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:* Assess patient satisfaction with a mindfulness course* Identify barriers to participation in, or completion of, a mindfulness course* Gather initial information to understand how a mindfulness course impacts RA symptomsParticipants will:* Complete online questionnaires* Attend two in-person study visits, involving a brief joint exam and blood draw* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness courseResearchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA., conditionsModule conditions: Arthritis, Rheumatoid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness Program, outcomesModule primaryOutcomes measure: Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study, secondaryOutcomes measure: MBSR Course Attendance (Intervention Adherence), secondaryOutcomes measure: Percent of Study Completers (Study Retention), otherOutcomes measure: Clinical Disease Activity Index (CDAI), otherOutcomes measure: Disease Activity Score in 28 Joints (DAS-28), otherOutcomes measure: Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5), otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale, otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale, otherOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale, otherOutcomes measure: Perceived Stress Scale, 10-item, otherOutcomes measure: Brief Resilience Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Osher Center for Integrative Health, status: RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False |
protocolSection identificationModule nctId: NCT06276374, orgStudyIdInfo id: SMC 2023-12-107, briefTitle: Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Woo-Keun Seo, class: OTHER, descriptionModule briefSummary: To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk., conditionsModule conditions: Carotid Artery Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1556, type: ESTIMATED, armsInterventionsModule interventions name: Patients who are scheduled to undergo carotid artery stenting, outcomesModule primaryOutcomes measure: Clinically significant bleeding, secondaryOutcomes measure: Combined cardiovascular and cerebrovascular accidents, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276361, orgStudyIdInfo id: ROV-QUAR-2023-01, briefTitle: Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia, acronym: QUARTZ, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rovi Pharmaceuticals Laboratories, class: INDUSTRY, descriptionModule briefSummary: This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal, interventions name: Oral risperidone; QUAR F1/2, Dose 2 - Gluteal, interventions name: Oral risperidone; QUAR F1/2, Dose 3 - Gluteal, interventions name: Oral risperidone; QUAR F1/2, Dose 3 - Deltoids, outcomesModule primaryOutcomes measure: λz, primaryOutcomes measure: t1/2, primaryOutcomes measure: Tmax, primaryOutcomes measure: Cmax, primaryOutcomes measure: Cmin, primaryOutcomes measure: Clast, primaryOutcomes measure: AUC0-t, primaryOutcomes measure: AUCinf, primaryOutcomes measure: AUCextrap, primaryOutcomes measure: Vd/F, primaryOutcomes measure: Cl/F, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Investigational Site, status: RECRUITING, city: Amman, country: Jordan, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False |
protocolSection identificationModule nctId: NCT06276348, orgStudyIdInfo id: 20226892, briefTitle: Newborn Genomic Sequencing Pilot Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Rady Pediatric Genomics & Systems Medicine Institute, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?* What are the potential issues related to implementing DWGS in this population?Enrolled newborns will have a blood sample taken and will receive three tests:* DWGS* BeginNGS* WES, conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, multiple interventions. All enrollees receive all interventions., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Whole genome sequencing, interventions name: BeginNGS test, interventions name: WES, outcomesModule primaryOutcomes measure: Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS., secondaryOutcomes measure: Proportion of enrolled infants who are identified with a genetic disease by BeginNGS., secondaryOutcomes measure: Proportion of enrolled infants who are identified with a genetic disease by WES., secondaryOutcomes measure: Proportion of enrolled infants who have a positive standard NBS test., secondaryOutcomes measure: Proportion of parents approached who agree to participate in the study., secondaryOutcomes measure: Parental reasons for refusal., secondaryOutcomes measure: Time from sample arriving in lab to return of DWGS results., secondaryOutcomes measure: Time from birth to return of DWGS results., secondaryOutcomes measure: Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 10 Days, stdAges: CHILD, contactsLocationsModule locations facility: Rady Children's Hospital San Diego, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False |
protocolSection identificationModule nctId: NCT06276335, orgStudyIdInfo id: IRAS:322440, briefTitle: Influence of Timing of Implant Placement on Early Healing Molecular Events, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, collaborators name: University of Zurich, descriptionModule briefSummary: Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP)., conditionsModule conditions: Dental Implant, conditions: Healing Wound, conditions: Biomarkers, conditions: Saliva, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Immediate implant placement and guided bone regeneration (Test), interventions name: Late implant placement and guided bone regeneration (Control), outcomesModule primaryOutcomes measure: Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva, secondaryOutcomes measure: Blood flow changes, secondaryOutcomes measure: Soft tissue volume changes, secondaryOutcomes measure: Peri-implant bone level, secondaryOutcomes measure: Full mouth plaque score (FMPS), secondaryOutcomes measure: Full mouth bleeding score (FMBS), secondaryOutcomes measure: Probing pocket depth (PPD), secondaryOutcomes measure: Gingival recession (REC), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Suppuration, secondaryOutcomes measure: Patient satisfaction at 6 months after loading, secondaryOutcomes measure: Changes in the pink esthetic score (PES), secondaryOutcomes measure: Changes in the white esthetic score (WES), secondaryOutcomes measure: Changes in the papilla fill index (PFI), secondaryOutcomes measure: Implant survival, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Oral Clinical Research, city: London, zip: E1 2AD, country: United Kingdom, contacts name: Nikolaos Donos, DDS MS PhD, role: CONTACT, phone: +44(0)2078823063, email: [email protected], contacts name: Vandana Luthra, Dr, role: CONTACT, phone: +44(0)2078826348, email: [email protected], contacts name: Nikolaos Donos, DDS MS PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06276322, orgStudyIdInfo id: HU-FTR-SZK-01, briefTitle: Assessment of All Spine Segments ın Individuals With Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Low back pain group and healthy group, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Low back pain group, interventions name: Healthy group, outcomesModule primaryOutcomes measure: Evaluation of the kinematics of the all spine during walking, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Standing from Sitting, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Climbing Step, secondaryOutcomes measure: Spine Normal Joint Movement evaluation, secondaryOutcomes measure: Pain intensity: Visual Analog Scale, secondaryOutcomes measure: Oswestry Disability Index, secondaryOutcomes measure: Fear of movement: Tampa Kinesiophobia Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe university, status: RECRUITING, city: Ankara, state: Altındağ, zip: 06050, country: Turkey, contacts name: Sümeyye Zehra Güler, MSc, role: CONTACT, phone: 5079320390, phoneExt: +90, email: [email protected], geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06276309, orgStudyIdInfo id: NECC2401, briefTitle: Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Fujian Maternity and Child Health Hospital, class: OTHER, descriptionModule briefSummary: The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value., conditionsModule conditions: Neuroendocrine Neoplasm, conditions: China, conditions: Women, conditions: Cervical Cancer, conditions: Cervical Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: mortality rate, primaryOutcomes measure: Disease-free survival, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Maternity and Child Health Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350001, country: China, contacts name: Binhua Dong, role: CONTACT, phone: +8687558732, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, locations facility: Fujian Provincial Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, contacts name: Dongjie Chen, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Ningde Mindong Hospital, status: RECRUITING, city: Ningde, state: Fujian, country: China, contacts name: Fang Xie, role: CONTACT, geoPoint lat: 26.66167, lon: 119.52278, locations facility: Putian City first Hospital, status: RECRUITING, city: Putian, state: Fujian, country: China, contacts name: Yi Chen, role: CONTACT, geoPoint lat: 25.43944, lon: 119.01028, locations facility: The Second Affiliated Hospital of Fujian Medical University, status: RECRUITING, city: Quanzhou, state: Fujian, country: China, contacts name: Luhong Li, role: CONTACT, geoPoint lat: 24.91389, lon: 118.58583, locations facility: Zhangzhou affiliated Hospital of Fujian Medical University, status: RECRUITING, city: Zhangzhou, state: Fujian, zip: 363000, country: China, contacts name: Feifeng Shi, M.D, role: CONTACT, geoPoint lat: 24.51333, lon: 117.65556, locations facility: Maternal and Child Health Hospital of Hubei Province, status: RECRUITING, city: Wuhan, state: Hubei, country: China, contacts name: Hongning Cai, M.D, role: CONTACT, phone: +8615926224867, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Xiangya Hospital, Central South University, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yu Zhang, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Jiangxi maternal and Child Health Hospital, status: RECRUITING, city: Nanchang, state: Jiangxi, country: China, contacts name: Ling Li, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False |
protocolSection identificationModule nctId: NCT06276296, orgStudyIdInfo id: 0001, briefTitle: Heart Rate Variability After Ablation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Vascular surgery, University hospital Královské Vinohrady, Prague, descriptionModule briefSummary: Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Holter EKG - 1 day before ablation, interventions name: Radiofrequency ablation, interventions name: Pulsed field ablation, interventions name: Holter EKG - 1 month after ablation, outcomesModule primaryOutcomes measure: Mean RR interval (ms), primaryOutcomes measure: SDNN (ms), primaryOutcomes measure: RMSSD (ms), primaryOutcomes measure: pNN50 (%), primaryOutcomes measure: peak frequency (Hz), primaryOutcomes measure: power (ms2), primaryOutcomes measure: LF/HF ratio, primaryOutcomes measure: SD1 (ms), primaryOutcomes measure: SD2 (ms), primaryOutcomes measure: SD2/SD1, primaryOutcomes measure: ApEn, primaryOutcomes measure: Correlation dimension, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady, status: RECRUITING, city: Prague, zip: 10034, country: Czechia, contacts name: Jana Vesela, Ing.,Ph.D., role: CONTACT, phone: +420267162714, email: [email protected], contacts name: Pavel Osmancik, MD,Ph.D., role: CONTACT, phone: +420267162714, email: [email protected], geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06276283, orgStudyIdInfo id: DZ2022E0006, briefTitle: DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Dizal Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: DZD9008 plus Bevacizumab, outcomesModule primaryOutcomes measure: Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs., secondaryOutcomes measure: Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Lu, Dr, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06276270, orgStudyIdInfo id: PT-MUC-1_05-21, briefTitle: Multi-centre, Open-label, First-in-man Study With Mucopad HA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Contipro Pharma a.s., class: OTHER, descriptionModule briefSummary: The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results., conditionsModule conditions: Oral Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mucopad HA, outcomesModule primaryOutcomes measure: Resolution of mucositis symptoms since completion of radiotherapy, secondaryOutcomes measure: - Pain management (VAS scale), secondaryOutcomes measure: Development of xerostomy, secondaryOutcomes measure: Subjective evaluation on scale 1-5 of the treatment by investigator/ patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Masarykův onkologický ústav, Klinika radiační onkologie, status: RECRUITING, city: Brno, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Tomáš Novotný, role: CONTACT, phone: +420543131103, email: [email protected], geoPoint lat: 49.19522, lon: 16.60796, locations facility: FN Hradec Králové Klinika onkologie a radioterapie, status: RECRUITING, city: Hradec Králové, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Milan Vošmik, role: CONTACT, phone: +420495832316, email: [email protected], geoPoint lat: 50.20923, lon: 15.83277, locations facility: Fakultní nemocnice Ostrava, Klinika onkologická, status: RECRUITING, city: Ostrava, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Jana Jackaninová, role: CONTACT, phone: +420597371111, email: [email protected], geoPoint lat: 49.83465, lon: 18.28204, locations facility: Etická komise FN Bulovka, status: RECRUITING, city: Praha, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Petra Holečková, role: CONTACT, phone: +420266084516, email: [email protected], geoPoint lat: 50.08804, lon: 14.42076, locations facility: Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN, status: RECRUITING, city: Praha, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Radka Lohynská, role: CONTACT, phone: +420261083890, email: [email protected], geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06276257, orgStudyIdInfo id: 2024-7301, briefTitle: Paravertebral Block for Mastectomy With Immediate Reconstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: CHU de Quebec-Universite Laval, class: OTHER, descriptionModule briefSummary: Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Paravertebral block, interventions name: Usual analgesia, outcomesModule primaryOutcomes measure: Evaluation of postoperative pain using the BPI, secondaryOutcomes measure: Total use of opioids received intraoperatively., secondaryOutcomes measure: Use of non-opioid analgesia intraoperatively, secondaryOutcomes measure: Total dose of opioids received in the PACU, secondaryOutcomes measure: Time before first opioid, secondaryOutcomes measure: Total opioids consumed in the 48 hours following surgery, secondaryOutcomes measure: Chronic pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06276244, orgStudyIdInfo id: NM040-GUP19002, briefTitle: Trial Readiness and Endpoint Assessment in Congenital and Childhood Myotonic Dystrophy, acronym: GUP19002, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-07-08, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Fondazione Serena Onlus - Centro Clinico NeMO Milano, class: OTHER, collaborators name: Bambino Gesù Hospital and Research Institute, collaborators name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, collaborators name: IRCCS Istituto delle Scienze Neurologiche di Bologna, collaborators name: IRCCS Fondazione Stella Maris, collaborators name: IRCCS Istituto Neurologico Mondino, Pavia, Italy, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, collaborators name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, collaborators name: Istituto Giannina Gaslini, descriptionModule briefSummary: Children with congenital myotonic dystrophy (CDM) present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. There is a 30% mortality rate in the first year of life. Children with childhood onset myotonic dystrophy present with symptoms later on but soon develop behavioural difficulties and learning difficulties and are at risk for autistic features and gastrointestinal symptoms. The ability to conduct a therapeutic trial in children with CDM or ChDM is directly limited by the lack of available data regarding appropriate clinical endpoints and biomarkers. Whereas there is an active Italian collaboration recruiting adults with DM1 to study muscle and multisystem aspects in this population, there is no active network in Italy involved in the pediatric population with DM1. Though the underlying mechanism is the same in adult DM1, in CDM and ChDM there are specific challenges to the pediatric population. The aim of this project is to coordinate the Italian Child Neurologist actively involved with CDM and ChDM in a common effort of standardizing protocols and procedures to be applied in the care of these patients. Specific aims are to collect functional measures and clinical information over time to define clinically meaningful endpoints and outcome measures in preparation for international therapeutic clinical trials. This project will contribute to the ongoing international study in CDM by recruiting additional patients from all over Italy and will extend the investigations to the childhood onset forms as an additional add-on pilot study in view of potential treatment options. The investigators expect that the Italian network, with Telethon support, will provide the necessary backbone for trial readiness in the pediatric population both at the national and international levels., conditionsModule conditions: CDM, conditions: ChDM, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Physical function, primaryOutcomes measure: Physical function, primaryOutcomes measure: Cognitive-behavioral and Quality of Life, primaryOutcomes measure: Cognitive-behavioral and Quality of Life, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Biomarkers, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Fondazione Serena Onlus - Centro Clinico NeMO Milano, city: Milan, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06276231, orgStudyIdInfo id: SalbuEase, briefTitle: Nebulized Salbutamol in Acute Renal Colic, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, descriptionModule briefSummary: A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.Research Summary:INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colicINTERVENTION: Single dose of Nebulized Salbutamol 10mg.CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation., conditionsModule conditions: Renal Colic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 214, type: ESTIMATED, armsInterventionsModule interventions name: Salbutamol, interventions name: 0.9% Normal Saline, interventions name: Diclofenac Injection, outcomesModule primaryOutcomes measure: Pain reduction at 60 minutes, secondaryOutcomes measure: Adverse Event/Side Effects, secondaryOutcomes measure: Need of Rescue medications, secondaryOutcomes measure: Pain reduction rate., secondaryOutcomes measure: ED revisits, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276218, orgStudyIdInfo id: PSU, briefTitle: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace., conditionsModule conditions: Clavicle Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Clavicular brace, outcomesModule primaryOutcomes measure: DASH, secondaryOutcomes measure: Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla University, status: RECRUITING, city: Songkla, state: Hatyai, zip: 90110, country: Thailand, contacts name: Thanachai Klongsangsorn, role: CONTACT, phone: +66991964733, email: [email protected], geoPoint lat: 7.19882, lon: 100.5951, hasResults: False |
protocolSection identificationModule nctId: NCT06276205, orgStudyIdInfo id: 1037/RC/KEMU, briefTitle: Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism, acronym: ViDaLLiT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.The main question it aims to answer is:• whether adding Vitamin D to standard therapy has any additional benefitsParticipants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them, conditionsModule conditions: Hypothyroidism Primary, conditions: Lipid Disorder, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D, interventions name: Levothyroxin, outcomesModule primaryOutcomes measure: Decline in Total Cholesterol, primaryOutcomes measure: Decline in LDL, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Edward Medical University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: AP Endocrinology, role: CONTACT, phone: +923004683473, email: [email protected], geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06276192, orgStudyIdInfo id: 2023-01882-01, briefTitle: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care, acronym: diSAID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-03-26, completionDateStruct date: 2028-03-26, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Region Östergötland, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.The main question this clinical trial aims to answer are:- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?, conditionsModule conditions: Subacromial Pain Syndrome, conditions: Shoulder Pain, conditions: Rotator Cuff Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Non-Inferiority Randomised Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Digital Physiotherapy (diSAID), interventions name: Traditional Physiotherapy, outcomesModule primaryOutcomes measure: Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI), secondaryOutcomes measure: Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS), secondaryOutcomes measure: Mean change in pain Self-Efficacy, secondaryOutcomes measure: Mean change of self-reported rating of improvement, secondaryOutcomes measure: Mean change of health-related quality of life, otherOutcomes measure: Patients treatment expectancies, otherOutcomes measure: Patients self-reported rating of pain sensitivity, otherOutcomes measure: Costs and cost-effectiveness direct and indirect, otherOutcomes measure: Impact on the environment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Petersson, city: Linköping, zip: SE 58191, country: Sweden, contacts name: Anna Petersson, PhD student, role: CONTACT, phone: +46101031053, email: [email protected], contacts name: Teresa Holmgren, PhD, role: CONTACT, phone: +46101034158, email: [email protected], contacts name: Hanna Björnsson Hallgren, Associate Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Jenny Samuelsson, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False |
protocolSection identificationModule nctId: NCT06276179, orgStudyIdInfo id: KFSIRB200-97, briefTitle: Epidural Oxycodone for Pain Management for Lower Limb Amputation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation., conditionsModule conditions: Epidural, conditions: Oxycodone, conditions: Pain, conditions: Lower Limb Amputation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Oxycodone, interventions name: Bupivacaine, outcomesModule primaryOutcomes measure: Acute postoperative pain scores, secondaryOutcomes measure: Time to the first request for the rescue analgesia, secondaryOutcomes measure: Postoperative morphine consumption, secondaryOutcomes measure: Incidence of phantom limb pain, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafrelsheikh University, status: RECRUITING, city: Kafr Ash Shaykh, state: Kafrelsheikh, zip: 33516, country: Egypt, contacts name: Gamal H Shams, MD, role: CONTACT, phone: 00201095927971, email: [email protected], contacts name: Ahmed A Ghareeb, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mohamed H Osman, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Heba F Dawood, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mohamed M Kotb, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False |
protocolSection identificationModule nctId: NCT06276166, orgStudyIdInfo id: 72374215, briefTitle: Trajectory of Frailty and Cognitive Dysfunction in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Zheng Li, class: OTHER, descriptionModule briefSummary: To explore the heterogeneity of the development trend of frailty and cognitive function of older adults., conditionsModule conditions: Frailty, conditions: Cognitive Dysfunction, conditions: Community-dwelling Older Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 934, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Frailty, primaryOutcomes measure: Cognitive function, otherOutcomes measure: Health status and life style, otherOutcomes measure: Activities of daily life (ADLs), otherOutcomes measure: Anxiety, otherOutcomes measure: Apathy, otherOutcomes measure: Perceived social support, otherOutcomes measure: Social network, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276153, orgStudyIdInfo id: CRGGCext, briefTitle: Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer, acronym: CRGGCext, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy., conditionsModule conditions: Biliary Tract Diseases, conditions: Gallbladder Cancer, conditions: Gallbladder Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: no interventions, outcomesModule primaryOutcomes measure: overall survival, secondaryOutcomes measure: progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276140, orgStudyIdInfo id: 4/23/2-4661/2-9, briefTitle: Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery, acronym: ID-COLO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Oncology Institute of Vojvodina, class: OTHER_GOV, collaborators name: University of Bern, descriptionModule briefSummary: The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices., conditionsModule conditions: Iron Deficiencies, conditions: Iron Deficiency Anaemia, conditions: Postoperative Complications, conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Laboratory analyses for the detection of iron deficiency anaemia, outcomesModule primaryOutcomes measure: Overall morbidity, secondaryOutcomes measure: Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population, secondaryOutcomes measure: Red blood cell transfusion rate, secondaryOutcomes measure: All-cause infection rate, secondaryOutcomes measure: Days of antibiotic use, secondaryOutcomes measure: Number of different antibiotics administered, secondaryOutcomes measure: Length of Intensive care unit-stay, secondaryOutcomes measure: Length of hospital-stay, secondaryOutcomes measure: Intraoperative complications, secondaryOutcomes measure: Quality of postoperative recovery, secondaryOutcomes measure: Reoperation, secondaryOutcomes measure: Estimated total iron-deficit, secondaryOutcomes measure: Serum ferritin level, secondaryOutcomes measure: Values of different erythrocyte indices, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06276127, orgStudyIdInfo id: MERC301123, briefTitle: Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate., acronym: BisoAF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, descriptionModule briefSummary: INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes., conditionsModule conditions: Atrial Fibrillation With Rapid Ventricular Response, conditions: Atrial Flutter With Rapid Ventricular Response, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: * Study Design: Double-blind, randomized controlled trial.* Participants: Patients with atrial fibrillation/flutter and rapid ventricular rate.* Treatment Arms: Oral Bisoprolol vs. Intravenous Diltiazem.* Randomization: Subjects randomly assigned to either treatment group.* Primary Endpoint: Reduction of heart rate to a target level within a specific timeframe.* Secondary Outcomes: Adverse effects, hospital admission rates, additional rate control needs.* Objective: Compare effectiveness and safety of oral Bisoprolol to intravenous Diltiazem.* Monitoring: Continuous observation of vital signs and electrocardiograms for safety., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: While the treating physician, nurse, and the patient will not be blinded to the treatment, the investigator collecting data and the statistician analysing it will remain blinded to treatment allocations. This ensures unbiased data collection and analysis., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Oral Bisoprolol, interventions name: Intravenous Diltiazem, outcomesModule primaryOutcomes measure: Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction, primaryOutcomes measure: Safety Outcome Evaluated by the Presence of serious adverse event, secondaryOutcomes measure: The use of Rescue medication, secondaryOutcomes measure: Proportion of patients who required hospitalization, secondaryOutcomes measure: ED revisit, secondaryOutcomes measure: Number of Participants Experiencing Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sultan Qaboos University Hospital, city: Muscat, state: Al-khod, zip: 38, country: Oman, contacts name: Fatin k Al omairi, MD, role: CONTACT, phone: 71308058, phoneExt: +968, email: [email protected], contacts name: Awatif Al-Alalawi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Usama Alkhalasi, MD, role: SUB_INVESTIGATOR, contacts name: Mohamed Al Rawahi, MD, role: SUB_INVESTIGATOR, contacts name: Adil Al Riyami, MD, role: SUB_INVESTIGATOR, contacts name: Said Al Hadhrami, MD, role: SUB_INVESTIGATOR, contacts name: Hatim Al Lawati, MD, role: SUB_INVESTIGATOR, geoPoint lat: 23.58413, lon: 58.40778, hasResults: False |
protocolSection identificationModule nctId: NCT06276114, orgStudyIdInfo id: 07, briefTitle: IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON), acronym: DRAGON, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of Silesia, class: OTHER, descriptionModule briefSummary: The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint., conditionsModule conditions: Coronary Artery Calcification, conditions: Intravascular Lithotripsy, conditions: Excimer Laser-coronary Atherectomy, conditions: Stent Restenosis, conditions: Stent Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 121, type: ACTUAL, armsInterventionsModule interventions name: Stent Underexpansion, outcomesModule primaryOutcomes measure: The primary efficacy endpoint was device success, secondaryOutcomes measure: Device-oriented composite endpoint (DOCE), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital, city: Florence, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Fabrizio D'Ascenzo, city: Turin, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital, city: Białystok, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland, city: Gdańsk, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland, city: Katowice, zip: 40-635, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Jacek Legutko, city: Kraków, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland, city: Kraków, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: 1st Military Hospital in Lublin, Lublin, Poland, city: Lubin, country: Poland, geoPoint lat: 51.40089, lon: 16.20149, locations facility: Department of Cardiology, Copper Health Centre (MCZ), city: Lubin, country: Poland, geoPoint lat: 51.40089, lon: 16.20149, locations facility: Clinical Department of Interventional Cardiology, Medical University of Lublin, city: Lublin, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Department of Cardiology, University Hospital, Institute of Medical Sciences, city: Opole, country: Poland, geoPoint lat: 50.67211, lon: 17.92533, locations facility: Department of Cardiology, Poznan University of Medical Sciences, city: Poznań, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow, city: Rzeszów, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: 1st Department of Cardiology, Medical University of Warsaw, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland, city: Warszawa, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, city: Warszawa, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Department of Invasive Cardiology, Wejherowo, city: Wejherowo, country: Poland, geoPoint lat: 54.60568, lon: 18.23559, locations facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, city: Wrocław, country: Poland, geoPoint lat: 51.1, lon: 17.03333, locations facility: Third Department of Cardiology, Medical University of Katowice, city: Zabrze, country: Poland, geoPoint lat: 50.32492, lon: 18.78576, hasResults: False |
protocolSection identificationModule nctId: NCT06276101, orgStudyIdInfo id: NEWISH-HPV-101, briefTitle: NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Newish Technology (Beijing) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL., conditionsModule conditions: High-grade Squamous Intraepithelial Lesion (HSIL), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: NWRD08 administered by electroporation, outcomesModule primaryOutcomes measure: Safety, primaryOutcomes measure: Dose-limiting toxicity (DLT), secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Histopathology outcome and HPV Viral clearance, secondaryOutcomes measure: The recommended phase II dose (RP2D), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Fang Jiang, M.D., role: CONTACT, phone: 86-010-69155635, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06276088, orgStudyIdInfo id: NFEC-2024-067, briefTitle: Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients., conditionsModule conditions: Immunotherapy, conditions: Hyperprogression, conditions: Biomarker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 374, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of hyperprogression, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, M.D., role: CONTACT, phone: 86+13632102247, email: [email protected], contacts name: Jian Guan, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Fujian Provinical Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, country: China, contacts name: Yongmei Dai, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Huizhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Huizhou, country: China, contacts name: Yunming Tian, role: CONTACT, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Jieyang people's hospital, status: NOT_YET_RECRUITING, city: Jieyang, country: China, contacts name: Peibao Lai, role: CONTACT, geoPoint lat: 23.5418, lon: 116.36581, locations facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, status: NOT_YET_RECRUITING, city: Meizhou, country: China, contacts name: Jianda Sun, role: CONTACT, geoPoint lat: 24.2886, lon: 116.11767, hasResults: False |
protocolSection identificationModule nctId: NCT06276075, orgStudyIdInfo id: 10/KRN/2020, briefTitle: The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2023-05-10, completionDateStruct date: 2023-09-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Anna Olczak, class: OTHER, descriptionModule briefSummary: The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Conventional rehabilitation, the Erigo®Pro table, motor imagery, outcomesModule primaryOutcomes measure: Trunk Control Test, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: RiabloTM device, primaryOutcomes measure: RiabloTM device, primaryOutcomes measure: Luna EMG, primaryOutcomes measure: Luna EMG, eligibilityModule sex: ALL, minimumAge: 38 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military Institute of Medicine, city: Warsaw, state: Masovian District, zip: 04-141, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06276062, orgStudyIdInfo id: Titanium nail usage, briefTitle: Uses of Titanium Nail in Pediatric Fractures, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures., conditionsModule conditions: Trauma Injury of Upper Extremity Forearm Multiple, conditions: Fracture of Distal End of Radius, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Distal radius fracture fixation in pediatrics., outcomesModule primaryOutcomes measure: Comparison between usage of titanium nail and old methods, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sohag university, status: RECRUITING, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06276049, orgStudyIdInfo id: DGETRRP2023-54, briefTitle: ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement, acronym: CHAT-MS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-25, primaryCompletionDateStruct date: 2024-01-06, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Wang Shalong, class: OTHER, collaborators name: Central South University, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:How does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?Participants will:Undergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\&#39;s support.If there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences., conditionsModule conditions: Self-Directed Learning, conditions: Artificial Intelligence, conditions: Medical Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ACTUAL, armsInterventionsModule interventions name: custom GPT supported self-directed learning, outcomesModule primaryOutcomes measure: Self-Directed Learning Scale, secondaryOutcomes measure: Cornell Critical Thinking Test (CCTT) Level Z, secondaryOutcomes measure: Flow Short Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Geriatirc Surgery, city: Changsha, state: Hunan, zip: 410011, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False |
protocolSection identificationModule nctId: NCT06276036, orgStudyIdInfo id: CAPID, briefTitle: Autoimmune Cytopenias as a Sign of Primary Immunodeficiency., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-07-23, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies, conditionsModule conditions: Cytopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: Identification of specific markers, outcomesModule primaryOutcomes measure: Identification of specific markers, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of South Florida, city: Tampa, state: Florida, zip: 33620, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Ghent University Hospital, city: Ghent, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: Clinica Pediatrica - Università di Catania, city: Catania, country: Italy, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Meyer Children's Hospital IRCCS, city: Florence, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Istituto Giannina Gaslini, city: Genova, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Azienda Ospedaliero Universitaria Pisana, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06276023, orgStudyIdInfo id: 2023P003638, secondaryIdInfos id: 1R01AG078204-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AG078204-01, briefTitle: Supporting Our Caregivers In ADRD Learning (SOCIAL), acronym: SOCIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: University of California, San Francisco, descriptionModule briefSummary: Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention., conditionsModule conditions: Alzheimer's Disease and Related Dementias, conditions: Quality of Life, conditions: Caregiver Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: MASC is an intervention that includes evidence-based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC comprises 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Mindful and Self-Compassionate Care Program (MASC), interventions name: Health Education Program (HEP), outcomesModule primaryOutcomes measure: Feasibility of Recruitment, primaryOutcomes measure: Feasibility of Randomization, primaryOutcomes measure: Feasibility of Assessment Measures, primaryOutcomes measure: Feasibility of Quantitative Measures, primaryOutcomes measure: Adherence to treatment, primaryOutcomes measure: Patient's Global Impression of Change (PGIC), primaryOutcomes measure: Perceptions of Questionnaire Battery, primaryOutcomes measure: Adherence to Home Practice, primaryOutcomes measure: Perceptions of Email and Text Reminders, primaryOutcomes measure: Credibility and Expectancy, primaryOutcomes measure: Modified Perception of Global Improvement, primaryOutcomes measure: Satisfaction with the Intervention, primaryOutcomes measure: Therapist Fidelity, otherOutcomes measure: Symptoms of Depression, otherOutcomes measure: Mindfulness, otherOutcomes measure: Perceived Stress Scale, otherOutcomes measure: Symptoms of Anxiety, otherOutcomes measure: The Self-Compassion Scale, otherOutcomes measure: Compassion, otherOutcomes measure: Caregiver self-efficacy, otherOutcomes measure: Loneliness, otherOutcomes measure: Social Support, otherOutcomes measure: Well-being, otherOutcomes measure: Distress Due to Patient Challenges Behaviors, otherOutcomes measure: Dyadic Relationship Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114-2524, country: United States, contacts name: Michelle StPaul, MS, role: CONTACT, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06276010, orgStudyIdInfo id: 2023-102, briefTitle: Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Xiaotong Hou, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery., conditionsModule conditions: Extracorporeal Membrane Oxygenation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: nafamostat mesilate, interventions name: unfractionated heparin group, outcomesModule primaryOutcomes measure: Incidence of thrombotic complications, secondaryOutcomes measure: Incidence of severe bleeding complications, secondaryOutcomes measure: Infusion volume of blood products, secondaryOutcomes measure: ACT qualified rate, secondaryOutcomes measure: Hospitalization mortality, secondaryOutcomes measure: The incidence of oxygenator dysfunction, secondaryOutcomes measure: Heparin-induced thrombocytopenia, secondaryOutcomes measure: Time to reach the target anticoagulant level for the first time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06275997, orgStudyIdInfo id: GAIN, briefTitle: GAIN Project: Gastric Cancer and Artificial Intelligence, acronym: GAIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4)., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel/Crossover Study Model; Patients will be randomized 1:1:1:1, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 6600, type: ESTIMATED, armsInterventionsModule interventions name: Integration of Artificial Intelligence (AI) assistance to screening gastroscopy, outcomesModule primaryOutcomes measure: Miss rate reduction, secondaryOutcomes measure: Change number of Detections, secondaryOutcomes measure: patient satisfaction, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06275984, orgStudyIdInfo id: PI23/00288, secondaryIdInfos id: 4R23/440, type: OTHER, domain: IDIAP Jordi Gol, briefTitle: Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers., acronym: EFORCP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, class: OTHER, collaborators name: Hospital Universitari Joan XXIII de Tarragona., descriptionModule briefSummary: Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventionsHypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrestsObjectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodologyVariables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into accountExpected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population., conditionsModule conditions: Cardiorespiratory Arrest, conditions: Cardiopulmonary Arrest With Successful Resuscitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: online CPR-AED training, outcomesModule primaryOutcomes measure: Difference between pre and post training scores in ad hoc designed scale, primaryOutcomes measure: Percentage of participants that reach or exceed 10 out of 12 on the checklist, secondaryOutcomes measure: Odds ratios (with 95% CI) for adjustment variables, secondaryOutcomes measure: Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IDIAP Jordi Gol, city: Barcelona, zip: 08007, country: Spain, contacts name: Ester Granado_Font, PhD, role: CONTACT, phone: 977778715, phoneExt: 405, email: [email protected], contacts name: Ester Granado-Font, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06275971, orgStudyIdInfo id: KBSMC 2022-07-006, briefTitle: Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-24, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Kangbuk Samsung Hospital, class: OTHER, collaborators name: DexCom, Inc., descriptionModule briefSummary: The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring., conditionsModule conditions: Cardiac Disease, conditions: PreDiabetes, conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G6, interventions name: SMBG or venous/arterial blood glucose, outcomesModule primaryOutcomes measure: Time within the target range of 100-180 mg/dL, secondaryOutcomes measure: Time within the target range of 100-140 mg/dL, secondaryOutcomes measure: Time within the target range of 70-180 mg/dL, secondaryOutcomes measure: Time to reach <70 mg/dL, secondaryOutcomes measure: Time to reach <54 mg/dL, secondaryOutcomes measure: Time to reach >180 mg/dL, secondaryOutcomes measure: Time to reach >250 mg/dL, secondaryOutcomes measure: Standard Deviation (SD), secondaryOutcomes measure: Coefficient of variation (CV), secondaryOutcomes measure: Mean glucose, secondaryOutcomes measure: Glucose management indicator (GMI), secondaryOutcomes measure: Number of days of ICU hospitalization, secondaryOutcomes measure: Number of days hospitalized after surgery, secondaryOutcomes measure: Number of participants with pneumonia occurrence after surgery, secondaryOutcomes measure: Number of participants with wound infection occurrence after surgery, secondaryOutcomes measure: Number of participants who underwent CRRT implementation after surgery, secondaryOutcomes measure: Number of participants with Atrial fibrillation occurrence after surgery, secondaryOutcomes measure: Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery, secondaryOutcomes measure: Changes in concentration of serum CRP level after surgery, secondaryOutcomes measure: Mortality within 30 days of surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kangbuk Samsung Hospital, status: RECRUITING, city: Seoul, zip: 03181, country: Korea, Republic of, contacts name: Sun Joon Moon, MD, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06275958, orgStudyIdInfo id: 2023-506115-17, secondaryIdInfos id: 2023-506115-17, type: EUDRACT_NUMBER, briefTitle: DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer, acronym: DOSAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Dutch Colorectal Cancer Group, collaborators name: Stichting Darmkanker, descriptionModule briefSummary: The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness., conditionsModule conditions: Older Patients, conditions: Colorectal Cancer, conditions: Metastatic Cancer, conditions: Candidates for Palliative Chemotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A phase III, open-label, non-inferiority, randomized controlled clinical trial comparing dose-reduced chemotherapy versus standard dose chemotherapy in older adults with metastasized colorectal cancer, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 587, type: ESTIMATED, armsInterventionsModule interventions name: Doublet Chemotherapy, Standard Dose (100%), interventions name: Doublet Chemotherapy, Dose-reduced (75%), interventions name: Monotherapy, Standard Dose (100%), interventions name: Monotherapy, Dose-reduced (75%), outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Quality of Life Questionnaire, secondaryOutcomes measure: Quality of Life Questionnaire, secondaryOutcomes measure: Physical functioning Questionnaire, secondaryOutcomes measure: Physical functioning Questionnaire, secondaryOutcomes measure: Grade 3-5 chemotherapy-related toxicity, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of completed treatment cycles, secondaryOutcomes measure: Dose reductions during treatment, secondaryOutcomes measure: Dose delay during treatment, secondaryOutcomes measure: Unplanned hospitalizations, secondaryOutcomes measure: Cumulative received dosage, secondaryOutcomes measure: Cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jeroen Bosch Ziekenhuis, city: 's-Hertogenbosch, country: Netherlands, geoPoint lat: 51.69917, lon: 5.30417, locations facility: Noordwest Ziekenhuisgroep, city: Alkmaar, country: Netherlands, geoPoint lat: 52.63167, lon: 4.74861, locations facility: Ziekenhuis Amstelland, city: Amstelveen, country: Netherlands, geoPoint lat: 52.30083, lon: 4.86389, locations facility: Amsterdam UMC, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Rijnstate, city: Arnhem, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, locations facility: Wilhelmina Ziekenhuis, city: Assen, country: Netherlands, geoPoint lat: 52.99667, lon: 6.5625, locations facility: Rode Kruis Ziekenhuis, city: Beverwijk, country: Netherlands, geoPoint lat: 52.48333, lon: 4.65694, locations facility: Haaglanden Medisch Centrum, city: Den Haag, country: Netherlands, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Hagaziekenhuis, city: Den Haag, country: Netherlands, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Slingeland Ziekenhuis, city: Doetinchem, country: Netherlands, geoPoint lat: 51.965, lon: 6.28889, locations facility: Ziekenhuis Gelderse Vallei, city: Ede, country: Netherlands, geoPoint lat: 52.03333, lon: 5.65833, locations facility: Catharina Ziekenhuis, city: Eindhoven, country: Netherlands, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Treant, city: Emmen, country: Netherlands, geoPoint lat: 52.77917, lon: 6.90694, locations facility: Admiraal de Ruyter Ziekenhuis, city: Goes, country: Netherlands, geoPoint lat: 51.50417, lon: 3.88889, locations facility: Beatrixziekenhuis, city: Gorinchem, country: Netherlands, geoPoint lat: 51.83652, lon: 4.97243, locations facility: Groene Hart Ziekenhuis, city: Gouda, country: Netherlands, geoPoint lat: 52.01667, lon: 4.70833, locations facility: Saxenburgh, city: Hardenberg, country: Netherlands, geoPoint lat: 52.57583, lon: 6.61944, locations facility: St. Jansdal Ziekenhuis, city: Harderwijk, country: Netherlands, geoPoint lat: 52.34167, lon: 5.62083, locations facility: Elkerliek Ziekenhuis, city: Helmond, country: Netherlands, geoPoint lat: 51.48167, lon: 5.66111, locations facility: Tergooi MC, city: Hilversum, country: Netherlands, geoPoint lat: 52.22333, lon: 5.17639, locations facility: Medisch Centrum Leeuwarden, city: Leeuwarden, country: Netherlands, geoPoint lat: 53.20139, lon: 5.80859, locations facility: Leiden University Medical Center, city: Leiden, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Alrijne Ziekenhuis, city: Leiderdorp, country: Netherlands, geoPoint lat: 52.15833, lon: 4.52917, locations facility: Canisius Wilhelmina Ziekenhuis, city: Nijmegen, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Laurentius Ziekenhuis, city: Roermond, country: Netherlands, geoPoint lat: 51.19417, lon: 5.9875, locations facility: Bravis ziekenhuis, city: Roosendaal, country: Netherlands, geoPoint lat: 51.53083, lon: 4.46528, locations facility: Ikazia Ziekenhuis, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Maasstad Ziekenhuis, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Ommelander Ziekenhuis, city: Scheemda, country: Netherlands, geoPoint lat: 53.17333, lon: 6.97222, locations facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen, city: Terneuzen, country: Netherlands, geoPoint lat: 51.33583, lon: 3.82778, locations facility: Bernhoven, city: Uden, country: Netherlands, geoPoint lat: 51.66083, lon: 5.61944, locations facility: Diakonessenhuis, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: St Antonius, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: VieCuri Medisch Centrum, city: Venlo, country: Netherlands, geoPoint lat: 51.37, lon: 6.16806, locations facility: Streekziekenhuis Koninging Beatrix, city: Winterswijk, country: Netherlands, geoPoint lat: 51.9725, lon: 6.71944, locations facility: Zaans Medisch Centrum, city: Zaandam, country: Netherlands, geoPoint lat: 52.43854, lon: 4.82643, hasResults: False |
protocolSection identificationModule nctId: NCT06275945, orgStudyIdInfo id: 1010073, briefTitle: Feasibility Study of A VoRo UrologIc ScaffolD (ARID), acronym: ARID, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-03, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Levee Medical, Inc., class: INDUSTRY, collaborators name: RQMplus, descriptionModule briefSummary: The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years., conditionsModule conditions: Stress Urinary Incontinence, conditions: Radical Prostatectomy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, non-randomized first-in-man study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Voro Urologic Scaffold, outcomesModule primaryOutcomes measure: The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups., secondaryOutcomes measure: The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups., secondaryOutcomes measure: The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups., eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Hospital, status: RECRUITING, city: Panama City, state: Punta Pacifica, country: Panama, contacts name: Natalia Vega, role: CONTACT, email: [email protected], contacts name: Margelis Munoz, role: CONTACT, phone: 507-6499-9304, email: [email protected], contacts name: Gustavo Espino, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.9936, lon: -79.51973, hasResults: False |
protocolSection identificationModule nctId: NCT06275932, orgStudyIdInfo id: TermoNeo/2023, briefTitle: Management of Healthy Newborn's Body Temperature at Birth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth., conditionsModule conditions: Newborn, Infant, conditions: Body Temperature, conditions: Delivery Room, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 776, type: ESTIMATED, armsInterventionsModule interventions name: Interventional group, interventions name: Standard of care group, outcomesModule primaryOutcomes measure: Newborn's body temperature at the end of skin-to-skin contact, secondaryOutcomes measure: Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery, secondaryOutcomes measure: Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery, secondaryOutcomes measure: Newborns' average temperature one hour after arriving at the nursery, secondaryOutcomes measure: Duration of nursery stay, secondaryOutcomes measure: Duration of skin-to-skin contact, secondaryOutcomes measure: Newborns' proportion exclusively breastfed at discharge, secondaryOutcomes measure: Type of breastfeeding at discharge, secondaryOutcomes measure: Newborns' proportion with hypoglycemia during hospitalization, secondaryOutcomes measure: Newborns' proportion affected by respiratory distress syndrome, secondaryOutcomes measure: Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU), secondaryOutcomes measure: Newborns' weight loss at discharge, secondaryOutcomes measure: Mortality before discharge from hospital, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, contacts name: Gabriele Sorrentino, pedRN, role: CONTACT, phone: +393496060149, email: [email protected], contacts name: Gabriele Sorrentino, pedRN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06275919, orgStudyIdInfo id: IOV-BT-1-2023 MIRAGE, briefTitle: Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial), acronym: MIRAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto Oncologico Veneto IRCCS, class: OTHER, collaborators name: Bayer, descriptionModule briefSummary: The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas.Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas.Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice.Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial), maintainingmaintaining a good quality of life., conditionsModule conditions: Meningioma, Malignant, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Regorafenib 40 MG Oral Tablet, interventions name: Local Standard of Care, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Patient Reported Outcomes (PROs), secondaryOutcomes measure: Patient Reported Outcomes (PROs), secondaryOutcomes measure: Toxicity during treatment, secondaryOutcomes measure: Disease control rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", city: Meldola, state: Forlì-Cesena, country: Italy, contacts name: Lorena Gurrieri, MD, role: CONTACT, email: [email protected], contacts name: Lorena Gurrieri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.12775, lon: 12.0626, locations facility: Humanitas Cancer Center, city: Rozzano, state: Milano, country: Italy, contacts name: Matteo Simonelli, MD, role: CONTACT, email: [email protected], contacts name: Matteo Simonelli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Ospedale San Paolo, city: Bari, country: Italy, contacts name: Valeria Internò, MD, role: CONTACT, email: [email protected], contacts name: Valeria Internò, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Bellaria - AUSL Bologna, city: Bologna, country: Italy, contacts name: Enrico Franceschi, MD, role: CONTACT, email: [email protected], contacts name: Enrico Franceschi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Azienda Ospedaliero Universitaria Careggi, city: Firenze, country: Italy, contacts name: Isacco Desideri, MD, role: CONTACT, email: [email protected], contacts name: Isacco Desideri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Policlinico San Martino, city: Genova, country: Italy, contacts name: Elisa Bennicelli, MD, role: CONTACT, email: [email protected], contacts name: Elisa Bennicelli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Spedali Riuniti, city: Livorno, country: Italy, contacts name: Anna Luisa Di Stefano, MD, role: CONTACT, email: [email protected], contacts name: Anna Luisa Di Stefano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Azienda Ospedaliero Universitaria G. Martino, city: Messina, country: Italy, contacts name: Nicola Silvestris, MD, role: CONTACT, email: [email protected], contacts name: Nicola Silvestris, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, city: Milano, country: Italy, contacts name: Paola Gaviani, MD, role: CONTACT, email: [email protected], contacts name: Paola Gaviani, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale San Raffaele, city: Milano, country: Italy, contacts name: Giulia Berzero, MD, role: CONTACT, email: [email protected], contacts name: Giulia Berzero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale del Mare, city: Napoli, country: Italy, contacts name: Bruno Daniele, MD, role: CONTACT, email: [email protected], contacts name: Bruno Daniele, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, city: Roma, country: Italy, contacts name: Silvia Chiesa, MD, role: CONTACT, email: [email protected], contacts name: Silvia Chiesa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: IRCCS Istituto Tumori Regina Elena, city: Roma, country: Italy, contacts name: Veronica Villani, MD, role: CONTACT, email: [email protected], contacts name: Veronica Villani, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Umberto I - Università Sapienza Roma, city: Roma, country: Italy, contacts name: Giuseppe Minniti, MD, role: CONTACT, email: [email protected], contacts name: Giuseppe Minniti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: A.O.U. Città della Salute e della Scienza di Torino, city: Torino, country: Italy, contacts name: Roberta Rudà, MD, role: CONTACT, email: [email protected], contacts name: Roberta Rudà, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False |
protocolSection identificationModule nctId: NCT06275906, orgStudyIdInfo id: NAFLD-POS5, briefTitle: Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters., acronym: NAFLD-POS5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-04-08, completionDateStruct date: 2026-04-08, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, class: OTHER, collaborators name: Russo Francesco, collaborators name: Cozzolongo Raffaele, collaborators name: Shahini Endrit, collaborators name: Zappimbulso Marianna, collaborators name: Giannuzzi Vito, collaborators name: De Nucci Sara, collaborators name: Rinaldi Roberta, collaborators name: Sila Annamaria, collaborators name: Tatoli Rossella, collaborators name: Cerabino Nicole, collaborators name: Donghia Rossella, collaborators name: Franco Isabella, collaborators name: Bianco Antonella, collaborators name: Curci Ritanna, collaborators name: Bagnato Claudia Beatrice, collaborators name: Sciarra Sabrina, collaborators name: Prospero Laura, collaborators name: Serino Grazia, collaborators name: Scalavino Viviana, collaborators name: Piccinno Emanuele, collaborators name: Pesole Pasqua Letizia, collaborators name: Coletta Sergio, collaborators name: Stabile Dolores, collaborators name: Riezzo Giuseppe, collaborators name: Ancona Anna, collaborators name: D'Attoma Benedetta, collaborators name: Ignazzi Antonia, descriptionModule briefSummary: The study in question is an interventional study with nutritional intervention.The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;* intestinal barrier;* body composition;* intestinal microbiota;* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD., conditionsModule conditions: NAFLD, conditions: Obesity, conditions: IBS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean diet and moderate intensity physical exercise (outdoor walking)., outcomesModule primaryOutcomes measure: The effect of intervention on CAP value, primaryOutcomes measure: The effect of intervention on FLI value, primaryOutcomes measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk, primaryOutcomes measure: The effect of the intervention on the integrity of the intestinal barrier, secondaryOutcomes measure: The effect of the intervention on the Gastrointestinal Symptoms, secondaryOutcomes measure: The effect of the intervention on the Body Composition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Irccs Saverio de Bellis, city: Castellana Grotte, state: Bari, zip: 70013, country: Italy, geoPoint lat: 40.88643, lon: 17.16549, hasResults: False |
protocolSection identificationModule nctId: NCT06275893, orgStudyIdInfo id: ACM01, briefTitle: IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Implicit Bioscience, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests., conditionsModule conditions: Arrhythmogenic Right Ventricular Dysplasia, conditions: Arrhythmogenic Left Ventricular Cardiomyopathy, conditions: Arrhythmogenic Right Ventricular Cardiomyopathy 1, conditions: Arrhythmogenic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: IC14, outcomesModule primaryOutcomes measure: Safety: Treatment-emergent adverse events and serious adverse events, primaryOutcomes measure: Safety: Incidence of anti-drug antibodies, secondaryOutcomes measure: Inflammatory biomarker C-reactive protein, secondaryOutcomes measure: CCR2+ Myocardial Imaging (optional), secondaryOutcomes measure: Ventricular tachycardia, secondaryOutcomes measure: Ventricular premature contractions, secondaryOutcomes measure: Sustained and non-sustained ventricular tachycardia, secondaryOutcomes measure: Treated ventricular tachycardia, secondaryOutcomes measure: Atrial premature contractions, secondaryOutcomes measure: New York Heart Association (NYHA) Functional Class, secondaryOutcomes measure: Implantable cardioverter/defibrillator (ICD) discharges, secondaryOutcomes measure: Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire, secondaryOutcomes measure: Disease biomarker Troponin I, secondaryOutcomes measure: Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP), secondaryOutcomes measure: Inflammatory biomarker interleukin (IL)1-beta, secondaryOutcomes measure: Pharmacokinetics: Serum IC14 concentration versus time curve, secondaryOutcomes measure: Pharmacokinetics: Peak serum IC14 concentration, secondaryOutcomes measure: Pharmacokinetics: Half life, secondaryOutcomes measure: Pharmacodynamics: Receptor Occupancy, secondaryOutcomes measure: Pharmacodynamics: Effective Concentration 95%, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Philip S. Cuculich, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
protocolSection identificationModule nctId: NCT06275880, orgStudyIdInfo id: F-2023-3201-066, briefTitle: Intraarticular Collagen in Patients With Gonarthrosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-07-30, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Instituto Mexicano del Seguro Social, class: OTHER_GOV, descriptionModule briefSummary: The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks., conditionsModule conditions: Gonarthrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Intra-articular infiltration of PVP Collagen, interventions name: Rehabilitation, outcomesModule primaryOutcomes measure: Western Ontario and McMaster Universities Osteoarthritis Index - Pain, primaryOutcomes measure: Western Ontario and McMaster Universities Osteoarthritis Index - stiffness, primaryOutcomes measure: Western Ontario and McMaster Universities Osteoarthritis Index - functionality, primaryOutcomes measure: Number Analog Scale for pain, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital General Regional No. 1 Lic. Ignacio García Téllez, city: Mérida, state: Yucatán, zip: 97155, country: Mexico, geoPoint lat: 20.97537, lon: -89.61696, hasResults: False |
protocolSection identificationModule nctId: NCT06275867, orgStudyIdInfo id: SOPRIMA//T023635, briefTitle: Improved Access to Quality Care and Healthcare Use, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: London School of Economics and Political Science, class: OTHER, collaborators name: University of Witwatersrand, South Africa, descriptionModule briefSummary: This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5, conditionsModule conditions: Health Care Utilization, conditions: Health Knowledge, Attitudes, Practice, conditions: Health, Subjective, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Free high-quality care, interventions name: Close distance, interventions name: Far distance, outcomesModule primaryOutcomes measure: Underuse, primaryOutcomes measure: Overuse, secondaryOutcomes measure: Illness duration, secondaryOutcomes measure: Out-of-pocket expenditures, secondaryOutcomes measure: Health knowledge, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: HDSS Soweto clusters, status: RECRUITING, city: Soweto, state: Gauteng, country: South Africa, contacts name: Nomalanga Boyce, role: CONTACT, email: [email protected], geoPoint lat: -26.26781, lon: 27.85849, hasResults: False |
protocolSection identificationModule nctId: NCT06275854, orgStudyIdInfo id: 22265, briefTitle: YASU Research Registry: For Young Adults With Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Young Adult Survivors United, class: OTHER, collaborators name: Staunton Farm Foundation, collaborators name: Elsie H. Hillman Foundation, descriptionModule briefSummary: The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\[s\] it aims to understand are:* What are the levels of depression, anxiety, social support, and financial distress* Determine effectiveness of YASU programming by measuring changes over timeWith this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry., conditionsModule conditions: Cancer, conditions: Leukemia, conditions: Sarcoma, conditions: Germ Cell Cancer, conditions: Lymphoma, conditions: Colorectal Cancer, conditions: Melanoma, conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Anxiety, primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: Social Support, primaryOutcomes measure: Financial Toxicity, primaryOutcomes measure: Needs Assessment, secondaryOutcomes measure: Name, address, email, phone number, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275841, orgStudyIdInfo id: C4891035, briefTitle: A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-05-03, completionDateStruct date: 2024-05-24, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, collaborators name: Arvinas Estrogen Receptor, Inc., descriptionModule briefSummary: The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to determine if the PPI affects how vepdegestrant is processed differently in healthy adults., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: vepdegestrant, interventions name: esomeprazole, outcomesModule primaryOutcomes measure: Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone, primaryOutcomes measure: Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole, primaryOutcomes measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone, primaryOutcomes measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole, secondaryOutcomes measure: number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Number of participans with clinically significant change from baseline in vital signs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pfizer Clinical Research Unit - New Haven, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06511, country: United States, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False |
protocolSection identificationModule nctId: NCT06275828, orgStudyIdInfo id: PoliceGeneralHospiral, briefTitle: The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Police General Hospital, Thailand, class: OTHER, descriptionModule briefSummary: study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score, conditionsModule conditions: Anterior Cruciate Ligament Tear, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: slow beat mesic listening by headphone, outcomesModule primaryOutcomes measure: visual analog scale, secondaryOutcomes measure: analgesic drug use, secondaryOutcomes measure: Amsterdam Preoperative Anxiety and Information Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Police General Hospital, city: Bangkok, state: Pathuwam, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06275815, orgStudyIdInfo id: R01DC020958, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DC020958, briefTitle: Promoting Caregiver Implementation of an Effective Early Learning Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2028-07-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: Nationwide Children's Hospital, descriptionModule briefSummary: The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions., conditionsModule conditions: Developmental Language Disorder, conditions: Reading; Difficult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Sit Together and Read (STAR), interventions name: Monetary Reward, interventions name: Text Encouragement, outcomesModule primaryOutcomes measure: Preschool Word and Print Awareness (PWPA), primaryOutcomes measure: Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing, primaryOutcomes measure: The Reading House (THR), primaryOutcomes measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification, primaryOutcomes measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension, eligibilityModule sex: ALL, minimumAge: 48 Months, maximumAge: 66 Months, stdAges: CHILD, contactsLocationsModule locations facility: Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy, status: RECRUITING, city: Columbus, state: Ohio, zip: 43201, country: United States, contacts name: Jennifer M Bostic, MA, role: CONTACT, phone: 614-292-5715, email: [email protected], contacts name: Laura M Justice, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rebecca Dore, PhD, role: SUB_INVESTIGATOR, contacts name: Hui Jiang, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Nationwide Children's Hospital, status: RECRUITING, city: Columbus, state: Ohio, zip: 43205, country: United States, contacts name: Jamie B Boster, PhD, role: CONTACT, phone: 614-722-8756, email: [email protected], contacts name: Jamie B Boster, PhD, CCC-SLP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06275802, orgStudyIdInfo id: 22-5.1T/2, briefTitle: The Effect of Nutrition Education Interventions for Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-06, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated., conditionsModule conditions: Nutrition, Healthy, conditions: Nutrition Disorders in Adolescence, conditions: Eating Habit, conditions: Eating Behavior, conditions: Body Image, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition Education, interventions name: nutritional status, eating habits, outcomesModule primaryOutcomes measure: nutrition literacy, primaryOutcomes measure: Mediterranean Diet Quality Index (KID-MED), primaryOutcomes measure: Eating Attitudes Test 26 (EAT-26), primaryOutcomes measure: weight and height measurement, primaryOutcomes measure: waist circumference measurement, primaryOutcomes measure: Food Consumption Record, primaryOutcomes measure: International Physical Activity Questionnaire (IPAQ- Short Form), eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Menemen District Directorate of National Education, status: RECRUITING, city: İzmir, country: Turkey, contacts name: Sibel ÖZER, role: CONTACT, phone: (0232) 832 26 29, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False |
protocolSection identificationModule nctId: NCT06275789, orgStudyIdInfo id: 2023-268, briefTitle: Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation?, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Nova Southeastern University, class: OTHER, collaborators name: Geistlich Pharma AG, collaborators name: ZimVie, descriptionModule briefSummary: The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared., conditionsModule conditions: Alveolar Ridge Preservation, conditions: Dental Extraction, conditions: Bone Graft, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Alveolar ridge preservation, outcomesModule primaryOutcomes measure: changes in horizontal dimensions of the alveolar ridge, primaryOutcomes measure: changes in vertical dimensions of the alveolar ridge, secondaryOutcomes measure: vital bone percentage, otherOutcomes measure: thickness of the buccal plate in mm and its influence on the ridge dimension, otherOutcomes measure: the thickness of the lingual plate in mm and its influence on the ridge dimension, otherOutcomes measure: the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension, otherOutcomes measure: the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension, otherOutcomes measure: # of cigarettes and its influence on the ridge dimension, otherOutcomes measure: oral hygiene using the plaque index and its influence on the ridge dimension, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nova Southeastern University, status: RECRUITING, city: Fort Lauderdale, state: Florida, zip: 33328, country: United States, contacts name: Saynur Vardar-Sengul, DDS, PhD, role: CONTACT, phone: 954-262-1815, email: [email protected], geoPoint lat: 26.12231, lon: -80.14338, hasResults: False |
protocolSection identificationModule nctId: NCT06275776, orgStudyIdInfo id: OC-2022-005, briefTitle: HIP-STITCH (Wound Recovery After THA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Reinier Haga Orthopedisch Centrum, class: OTHER, descriptionModule briefSummary: This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA., conditionsModule conditions: Wound Healing Disturbance of, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Test subjects are randomised into one of four study arms. Each study arm corresponds with one of the suturing techniques that are going to be used to close the superficial skin after Total Hip Arthroplasty., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: No one in this study can reasonably be blinded for the suturing technique during the duration of the study, since the suturing techniques differ substantially in shape, appearance and size. The only blinding in this study is the blinding of the outcome assessor to data of the test subjects. The assessor will only see the photographs of the wound/plaster, and the moment on which the photograph was taken. Additional information on the test subject, such as age, comorbidities, et cetera, will be withheld from the assessor., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 236, type: ESTIMATED, armsInterventionsModule interventions name: Ethicon Monocryl Smooth Suture, interventions name: Ethicon Vicryl Rapide Braided Suture, interventions name: Flexifuze Indermil Topical Skin Adhesive, interventions name: Dermabond Prineo Skin Closure System, interventions name: Stryker Zip Skin Closure System, outcomesModule primaryOutcomes measure: Number of Participants with Aberrant Wound Recovery, secondaryOutcomes measure: Number of Participants with Superficial or Deep Wound Infection, secondaryOutcomes measure: Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire), secondaryOutcomes measure: Costs, secondaryOutcomes measure: Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire), secondaryOutcomes measure: Patient reported outcome measure: Number of Participants with Other postoperative symptoms, secondaryOutcomes measure: Number and Type of Complications, secondaryOutcomes measure: Number of Visits to a Healthcare Professional, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reinier Haga Orthopedisch Centrum, city: Zoetermeer, state: Zuid Holland, zip: 2725NA, country: Netherlands, contacts name: Brechtje Hesseling, Msc, role: CONTACT, phone: 003179-2065595, email: [email protected], contacts name: Nina MC Mathijssen, Dr., role: CONTACT, phone: 003179-2065595, email: [email protected], geoPoint lat: 52.0575, lon: 4.49306, hasResults: False |
protocolSection identificationModule nctId: NCT06275763, orgStudyIdInfo id: 2020/ABM/01/00037, briefTitle: Optimal Medical Treatment of Difficult-to-treat Hypertension, acronym: OPTIMAL-HT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Institute of Cardiology, Warsaw, Poland, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs, conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Phase C: Eplerenone, interventions name: Phase C: Spironolactone, interventions name: Phase C: Torasemide, interventions name: Phase B: Triplixam / Elestar HCT, interventions name: Phase A: Confirmation of uncontrolled hypertension, outcomesModule primaryOutcomes measure: Patients with uncontrolled BP on ABPM, primaryOutcomes measure: Patients with controlled BP after 12 weeks on triple SPC, primaryOutcomes measure: Systolic BP reduction on 4th antihypertensive drug, secondaryOutcomes measure: Percentage of patients with BP controlled confirmed by HBPM, secondaryOutcomes measure: Consistency of the rate of uncontrolled BP, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, secondaryOutcomes measure: Percentage of patients requiring an increase in the dose, secondaryOutcomes measure: Consistency of the rate of uncontrolled BP, secondaryOutcomes measure: The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks, secondaryOutcomes measure: The magnitude of changes in HBPM and ABPM derived indices after 12 weeks, secondaryOutcomes measure: Phase C, secondaryOutcomes measure: Changes of SBP on ABPM (24h mean) after 12 weeks of treatment, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM, secondaryOutcomes measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, secondaryOutcomes measure: Phase C continuation, secondaryOutcomes measure: Phase C continuation, secondaryOutcomes measure: Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups, secondaryOutcomes measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone, secondaryOutcomes measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline, secondaryOutcomes measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups, secondaryOutcomes measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups, secondaryOutcomes measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups, secondaryOutcomes measure: Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks, secondaryOutcomes measure: Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups, secondaryOutcomes measure: Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups, secondaryOutcomes measure: Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Cardiology, status: RECRUITING, city: Warsaw, state: Mazowieckie, zip: 04628, country: Poland, contacts name: Agata Skutnik, role: CONTACT, email: [email protected], geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06275750, orgStudyIdInfo id: CEI 175/23, briefTitle: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2023-11-29, completionDateStruct date: 2024-01-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Hospital Civil de Guadalajara, class: OTHER, descriptionModule briefSummary: The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.The main questions it aims to answer were:* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group., conditionsModule conditions: Low Back Pain, conditions: Sciatica, conditions: Lumbar Disc Herniation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.), outcomesModule primaryOutcomes measure: Self-reported disability, primaryOutcomes measure: Pain intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Civil de Guadalajara Fray Antonio Alcalde, city: Guadalajara, state: Jalisco, zip: 44280, country: Mexico, geoPoint lat: 20.66682, lon: -103.39182, hasResults: False |
protocolSection identificationModule nctId: NCT06275737, orgStudyIdInfo id: POP-UP G-128, briefTitle: POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer, acronym: POP-UP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: GERCOR - Multidisciplinary Oncology Cooperative Group, class: OTHER, descriptionModule briefSummary: This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) ., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Two-cohort, open-label, single-arm feasibility study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation program, outcomesModule primaryOutcomes measure: Rate of patients with successful completion of an 8-week trimodal prehabilitation program, secondaryOutcomes measure: Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately., secondaryOutcomes measure: Health-related quality of life (HRQoL) assessment, secondaryOutcomes measure: Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions, secondaryOutcomes measure: Nutritional status assessment, secondaryOutcomes measure: Physical/functional test assessment, secondaryOutcomes measure: Number of patients with reduced chemotherapy tolerance, secondaryOutcomes measure: Number of patients with chemotherapy dose modification, secondaryOutcomes measure: Rate of patients who complete the strategy, secondaryOutcomes measure: Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia, secondaryOutcomes measure: Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption, secondaryOutcomes measure: Rate of surgical complications, secondaryOutcomes measure: Overall survival (OS) assessment, secondaryOutcomes measure: Disease-free survival (DFS) assessment, secondaryOutcomes measure: Adherence to Adapted Physical Activity (APA) program assessment, secondaryOutcomes measure: Physical activity behavior changes assessment, secondaryOutcomes measure: Nurse coordination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275724, orgStudyIdInfo id: CKJX839A11401, briefTitle: Specified Drug-use Survey of Leqvio for s.c. Injection., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice, conditionsModule conditions: Familial Hypercholesterolaemia, conditions: Hypercholesterolaemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 560, type: ESTIMATED, armsInterventionsModule interventions name: inclisiran, outcomesModule primaryOutcomes measure: Number of patients with adverse events, primaryOutcomes measure: Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions, secondaryOutcomes measure: Number of patients with adverse events leading to discontinuation of treatment with the product, secondaryOutcomes measure: Percent change from baseline in LDL-C levels, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis Investigative Site, status: RECRUITING, city: Handa, state: Aichi, zip: 475-0817, country: Japan, geoPoint lat: 34.88333, lon: 136.93333, locations facility: Novartis Investigative Site, status: RECRUITING, city: Ichinomiya, state: Aichi, zip: 491-8551, country: Japan, geoPoint lat: 35.3, lon: 136.8, locations facility: Novartis Investigative Site, status: RECRUITING, city: Komaki, state: Aichi, zip: 485-8520, country: Japan, geoPoint lat: 35.28333, lon: 136.91667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nagoya, state: Aichi, zip: 454-0933, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nagoya, state: Aichi, zip: 461-0045, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Novartis Investigative Site, status: RECRUITING, city: Toyoake city, state: Aichi, zip: 470 1192, country: Japan, geoPoint lat: 35.038, lon: 136.99931, locations facility: Novartis Investigative Site, status: RECRUITING, city: Matsuyama, state: Ehime, zip: 791-8016, country: Japan, geoPoint lat: 33.83916, lon: 132.76574, locations facility: Novartis Investigative Site, status: RECRUITING, city: Fukuoka-city, state: Fukuoka, zip: 811-0213, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kitakyushu, state: Fukuoka, zip: 800-0031, country: Japan, geoPoint lat: 33.85181, lon: 130.85034, locations facility: Novartis Investigative Site, status: RECRUITING, city: Shirakawa, state: Fukushima, zip: 961-0005, country: Japan, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kure-city, state: Hiroshima, zip: 737-0023, country: Japan, geoPoint lat: 34.23222, lon: 132.56658, locations facility: Novartis Investigative Site, status: RECRUITING, city: Asahikawa, state: Hokkaido, zip: 078-8214, country: Japan, geoPoint lat: 43.77063, lon: 142.36489, locations facility: Novartis Investigative Site, status: RECRUITING, city: Sapporo, state: Hokkaido, zip: 004-0052, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Novartis Investigative Site, status: RECRUITING, city: Sapporo, state: Hokkaido, zip: 065-0027, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Novartis Investigative Site, status: RECRUITING, city: Amagasaki, state: Hyogo, zip: 660-8511, country: Japan, geoPoint lat: 34.71667, lon: 135.41667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Himeji, state: Hyogo, zip: 670-8560, country: Japan, geoPoint lat: 34.81667, lon: 134.7, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kobe, state: Hyogo, zip: 654-0026, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Novartis Investigative Site, status: RECRUITING, city: Takarazuka-city, state: Hyogo, zip: 665-0873, country: Japan, geoPoint lat: 34.79936, lon: 135.35697, locations facility: Novartis Investigative Site, status: RECRUITING, city: Moriya-city, state: Ibaraki, zip: 302-0102, country: Japan, geoPoint lat: 35.93333, lon: 140.0, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kanazawa-city, state: Ishikawa, zip: 920-8641, country: Japan, geoPoint lat: 36.6, lon: 136.61667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Fujisawa, state: Kanagawa, zip: 252-0802, country: Japan, geoPoint lat: 35.34926, lon: 139.47666, locations facility: Novartis Investigative Site, status: RECRUITING, city: Yokohama, state: Kanagawa, zip: 235-0016, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Novartis Investigative Site, status: RECRUITING, city: Yokosuka, state: Kanagawa, zip: 238-8567, country: Japan, geoPoint lat: 35.28361, lon: 139.66722, locations facility: Novartis Investigative Site, status: RECRUITING, city: Yokosuka, state: Kanagawa, zip: 240-0101, country: Japan, geoPoint lat: 35.28361, lon: 139.66722, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kumamoto-city, state: Kumamoto, zip: 861-4193, country: Japan, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Novartis Investigative Site, status: RECRUITING, city: Yatsushiro-city, state: Kumamoto, zip: 866-8533, country: Japan, geoPoint lat: 32.55723, lon: 130.65285, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kyotanabe, state: Kyoto, zip: 610-0334, country: Japan, geoPoint lat: 34.8045, lon: 135.76681, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kyoto-city, state: Kyoto, zip: 602-8566, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kyoto-city, state: Kyoto, zip: 607-8062, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Novartis Investigative Site, status: RECRUITING, city: Omura, state: Nagasaki, zip: 856-8562, country: Japan, geoPoint lat: 32.92139, lon: 129.95389, locations facility: Novartis Investigative Site, status: RECRUITING, city: Ikoma, state: Nara, zip: 636-0802, country: Japan, geoPoint lat: 34.68333, lon: 135.7, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kashihara, state: Nara, zip: 634-0045, country: Japan, geoPoint lat: 34.50896, lon: 135.7929, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nagaoka-city, state: Niigata, zip: 940-8621, country: Japan, geoPoint lat: 37.45, lon: 138.85, locations facility: Novartis Investigative Site, status: RECRUITING, city: Oita-city, state: Oita, zip: 870-0263, country: Japan, geoPoint lat: 33.23333, lon: 131.6, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kurashiki, state: Okayama, zip: 713-8121, country: Japan, geoPoint lat: 34.58333, lon: 133.76667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Okayama-city, state: Okayama, zip: 700-8558, country: Japan, geoPoint lat: 34.65, lon: 133.93333, locations facility: Novartis Investigative Site, status: RECRUITING, city: Urasoe, state: Okinawa, zip: 901-2102, country: Japan, geoPoint lat: 26.25902, lon: 127.73012, locations facility: Novartis Investigative Site, status: RECRUITING, city: Uruma, state: Okinawa, zip: 904-2293, country: Japan, geoPoint lat: 26.37609, lon: 127.85908, locations facility: Novartis Investigative Site, status: RECRUITING, city: Izumisano-city, state: Osaka, zip: 598-8577, country: Japan, geoPoint lat: 34.41663, lon: 135.31667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Moriguchi, state: Osaka, zip: 570-8507, country: Japan, geoPoint lat: 34.73333, lon: 135.56667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka-city, state: Osaka, zip: 540-0006, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka-city, state: Osaka, zip: 543-0035, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka-city, state: Osaka, zip: 543-8555, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Novartis Investigative Site, status: RECRUITING, city: Takatsuki-city, state: Osaka, zip: 569-0852, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Novartis Investigative Site, status: RECRUITING, city: Takatsuki-city, state: Osaka, zip: 569-8686, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Novartis Investigative Site, status: RECRUITING, city: Takatsuki, state: Osaka, zip: 569-1121, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Novartis Investigative Site, status: RECRUITING, city: Toyonaka, state: Osaka, zip: 560-0083, country: Japan, geoPoint lat: 34.78244, lon: 135.46932, locations facility: Novartis Investigative Site, status: RECRUITING, city: Asaka, state: Saitama, zip: 351-0021, country: Japan, geoPoint lat: 35.80472, lon: 139.60194, locations facility: Novartis Investigative Site, status: RECRUITING, city: Gyoda, state: Saitama, zip: 361-0056, country: Japan, geoPoint lat: 36.14074, lon: 139.46011, locations facility: Novartis Investigative Site, status: RECRUITING, city: Tokorozawa, state: Saitama, zip: 359-1142, country: Japan, geoPoint lat: 35.79916, lon: 139.46903, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nagahama, state: Shiga, zip: 526-8580, country: Japan, geoPoint lat: 35.38333, lon: 136.26667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Hachioji-city, state: Tokyo, zip: 192-0918, country: Japan, geoPoint lat: 35.65583, lon: 139.32389, locations facility: Novartis Investigative Site, status: RECRUITING, city: Machida, state: Tokyo, zip: 194-0021, country: Japan, geoPoint lat: 35.54028, lon: 139.45083, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nerima-ku, state: Tokyo, zip: 176-8530, country: Japan, locations facility: Novartis Investigative Site, status: RECRUITING, city: Shinjuku, state: Tokyo, zip: 160-8488, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Novartis Investigative Site, status: RECRUITING, city: Toshima-ku, state: Tokyo, zip: 171-0014, country: Japan, locations facility: Novartis Investigative Site, status: RECRUITING, city: Takaoka, state: Toyama, zip: 939-1104, country: Japan, geoPoint lat: 36.75, lon: 137.01667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Hashimoto, state: Wakayama, zip: 648-0005, country: Japan, geoPoint lat: 34.31667, lon: 135.61667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Sakata-city, state: Yamagata, zip: 998-8501, country: Japan, geoPoint lat: 38.91667, lon: 139.855, locations facility: Novartis Investigative Site, status: RECRUITING, city: Fukuoka, zip: 815-0082, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Novartis Investigative Site, status: RECRUITING, city: Gifu, zip: 500-8384, country: Japan, geoPoint lat: 35.42291, lon: 136.76039, locations facility: Novartis Investigative Site, status: RECRUITING, city: Kagoshima, zip: 892-0853, country: Japan, geoPoint lat: 31.56667, lon: 130.55, locations facility: Novartis Investigative Site, status: RECRUITING, city: Nagasaki, zip: 852-8055, country: Japan, geoPoint lat: 32.75, lon: 129.88333, locations facility: Novartis Investigative Site, status: RECRUITING, city: Oita, zip: 870-1133, country: Japan, geoPoint lat: 33.23333, lon: 131.6, locations facility: Novartis Investigative Site, status: RECRUITING, city: Oita, zip: 879-7761, country: Japan, geoPoint lat: 33.23333, lon: 131.6, locations facility: Novartis Investigative Site, status: RECRUITING, city: Osaka, zip: 545-8586, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, hasResults: False |
protocolSection identificationModule nctId: NCT06275711, orgStudyIdInfo id: 223K003, briefTitle: The Effect of Therapeutic Communication Methods on the Psychological State of Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2023-12-06, completionDateStruct date: 2023-12-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected.Due to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions.The aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake.Hypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease.H2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease.H3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease.H4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase., conditionsModule conditions: Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pre-test post-test quasi-experimental study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Therapeutic communication methods, outcomesModule primaryOutcomes measure: State Anxiety Scale on Children, primaryOutcomes measure: Trait Anxiety Scale on Children, primaryOutcomes measure: Me and My Feelings Scale on Children, primaryOutcomes measure: Child and Youth Resilience Measure, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: K-1 Container City, city: Adıyaman, state: Altınsehir, zip: 02040, country: Turkey, geoPoint lat: 37.76441, lon: 38.27629, hasResults: False |
protocolSection identificationModule nctId: NCT06275698, orgStudyIdInfo id: RD2023-14 HONEY-POT, secondaryIdInfos id: 323188, type: OTHER, domain: IRAS, secondaryIdInfos id: 56974, type: OTHER_GRANT, domain: CPMS, briefTitle: HONEY for the Treatment of POst-Tonsillectomy Pain, acronym: HONEY-POT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2025-09-04, completionDateStruct date: 2025-09-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: East and North Hertfordshire NHS Trust, class: OTHER_GOV, collaborators name: Manuka Doctor UK Ltd, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials., conditionsModule conditions: Post Surgical Pain, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events.Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Manuka honey MGO 1000, interventions name: Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, outcomesModule primaryOutcomes measure: VAS pain scores, secondaryOutcomes measure: Number and frequency of concurrent analgesia usage, secondaryOutcomes measure: Rate of readmission to hospital, secondaryOutcomes measure: Rate of secondary haemorrhage, secondaryOutcomes measure: Rate of infection requiring antibiotics treatment, secondaryOutcomes measure: Speed of return to work, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lister Hospital, status: RECRUITING, city: Stevenage, zip: SG1 4AB, country: United Kingdom, contacts name: Toral Odedra, role: CONTACT, phone: 07918 360 060, email: [email protected], geoPoint lat: 51.90224, lon: -0.20256, hasResults: False |
protocolSection identificationModule nctId: NCT06275685, orgStudyIdInfo id: CIP-0001510, briefTitle: Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking, acronym: Foresight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Empatica, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.The main questions it aims to answer are:* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.* does this tool improve the lives of people with epilepsy?Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life., conditionsModule conditions: Epilepsy; Seizure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: SeizureWise algorithm, interventions name: Multi-day Visualizations, outcomesModule primaryOutcomes measure: Sensitivity of SeizureWise, secondaryOutcomes measure: Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P), secondaryOutcomes measure: Qualitative assessment of multi-day visualizations, secondaryOutcomes measure: Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8), secondaryOutcomes measure: Modifiable behavior change, secondaryOutcomes measure: Accuracy of SeizureWise low-likelihood forecast, secondaryOutcomes measure: Accuracy of SeizureWise high-likelihood forecast, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275672, orgStudyIdInfo id: TREAT INTERACT, briefTitle: Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda, acronym: TREAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Norwegian Center for Violence and Traumatic Stress Studies, class: OTHER, collaborators name: Makerere University, collaborators name: University of Bergen, collaborators name: Norwegian Institute of Public Health, collaborators name: Norwegian University of Science and Technology, descriptionModule briefSummary: This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) "Mental Health Gap Action Programme Intervention Guide" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children., conditionsModule conditions: Mental Health Issue, conditions: Stigma, Social, conditions: Child Development, conditions: Child Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Adapted version of the mhGAP-IG, outcomesModule primaryOutcomes measure: Reach questionnaire, developed by the project group, primaryOutcomes measure: The Program Sustainability tool (Finch et al., 2013), primaryOutcomes measure: Service measure on access to mental health care, developed by the project group, primaryOutcomes measure: Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire, primaryOutcomes measure: The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007), primaryOutcomes measure: Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD"), secondaryOutcomes measure: The Implementation Quality Questionnaire (Bogen, 2020), secondaryOutcomes measure: Fidelity Scale, developed by the project group, secondaryOutcomes measure: General Health Questionnaire (GHQ; Goldberg, 1970), secondaryOutcomes measure: Attitudes on Gender Norms (Waszak et al., 2000) questionnaire, secondaryOutcomes measure: Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022, secondaryOutcomes measure: Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998), secondaryOutcomes measure: Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008), secondaryOutcomes measure: Teacher violence scale (Piskin et al, 2014), secondaryOutcomes measure: The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007), secondaryOutcomes measure: The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014), secondaryOutcomes measure: Organizational Readiness for Implementing Change (Shea et al., 2014), secondaryOutcomes measure: Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022, secondaryOutcomes measure: Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021), secondaryOutcomes measure: Mental health knowledge (Evans-Lacko et al.,, secondaryOutcomes measure: AUDIT scale (WHO), secondaryOutcomes measure: Child alcohol use, developed by the project group, secondaryOutcomes measure: Child mental health - Pediatric symptoms (Jelinek et al.), secondaryOutcomes measure: Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008), secondaryOutcomes measure: Sexual violence, developed by the project group, secondaryOutcomes measure: Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nowegian Center for Violence and Traumatic Stress Studies, status: RECRUITING, city: Oslo, zip: 0655, country: Norway, contacts name: Ane-Marthe Skar, PhD, role: CONTACT, phone: 97661591, email: [email protected], geoPoint lat: 59.91273, lon: 10.74609, hasResults: False |
protocolSection identificationModule nctId: NCT06275659, orgStudyIdInfo id: CT-100-D-003, briefTitle: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-02-23, completionDateStruct date: 2024-03-18, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Click Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health., conditionsModule conditions: Psoriasis, conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: CT-100-004-A, interventions name: CT-100-004-B, outcomesModule primaryOutcomes measure: Change in Peak Pruritus Numerical Rating Scale, primaryOutcomes measure: Change in Dermatology Life Quality Index, primaryOutcomes measure: Change in Quality of Life symptoms, primaryOutcomes measure: Time in App, primaryOutcomes measure: Experience with Study App, primaryOutcomes measure: Improved global rating of change, secondaryOutcomes measure: Frequency of Adverse Events, secondaryOutcomes measure: Severity of Adverse Events, secondaryOutcomes measure: Frequency of Serious Adverse Events, secondaryOutcomes measure: Severity of Serious Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Click Therapeutics, city: New York, state: New York, zip: 10013, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06275646, orgStudyIdInfo id: Adeel2, briefTitle: Comparison Of Outcome Of Different Layers in Hypospadias Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Children Hospital and Institute of Child Health, Lahore, class: OTHER, descriptionModule briefSummary: To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied, conditionsModule conditions: Hypospadias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ACTUAL, armsInterventionsModule interventions name: PRP layer, interventions name: dartos flap, outcomesModule primaryOutcomes measure: wound infectiom, primaryOutcomes measure: frequency of glans dehiscence, primaryOutcomes measure: frequency of meatal stenosis, eligibilityModule sex: MALE, minimumAge: 6 Months, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Children Hospital, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
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