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protocolSection identificationModule nctId: NCT06287333, orgStudyIdInfo id: 2023PI221, briefTitle: Video-respiratory Polygraphy in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-02-22, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not., conditionsModule conditions: Sleep Apnea, Obstructive, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Polysomnography in routine care, outcomesModule primaryOutcomes measure: OAHI in video-RP significantly correlated with OAHI in PSG, secondaryOutcomes measure: Diagnostic ability of video-RP to identify OSAS in children, secondaryOutcomes measure: Diagnostic ability of video-RP to identify moderate-severe OSAS in children, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287320, orgStudyIdInfo id: Bioplc, briefTitle: The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs)., conditionsModule conditions: Locally Advanced Non-small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: concurrent or sequential chemoradiotherapy, interventions name: Immunotherapy, outcomesModule primaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese Academy of Medical Science and Peking Union Medical College, status: RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Nan Bi, MD, PhD, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06287307, orgStudyIdInfo id: NOK000024, briefTitle: Semaglutide 2.4mg for Low Responders After Bariatric Surgery, acronym: SEABAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Zuyderland Medisch Centrum, class: OTHER, collaborators name: Nederlandse Obestias Kliniek (NOK), descriptionModule briefSummary: In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight., conditionsModule conditions: Obesity, conditions: Obesity, Morbid, conditions: Weight Gain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY], outcomesModule primaryOutcomes measure: Weight change from start study at 3 months post operative until 15 months later, primaryOutcomes measure: Difference between placebo group and treatment group in weight change, secondaryOutcomes measure: Weight loss 3 months after surgery, secondaryOutcomes measure: Weight loss 6 months after surgery, secondaryOutcomes measure: Weight loss 12 months after surgery, secondaryOutcomes measure: Weight loss 18 months after surgery, secondaryOutcomes measure: Metabolic health before surgery (bloodpressure), secondaryOutcomes measure: Metabolic health before surgery (HbA1c), secondaryOutcomes measure: Metabolic health before surgery (glucose), secondaryOutcomes measure: Metabolic health before surgery (triglyceride), secondaryOutcomes measure: Metabolic health before surgery (LDL), secondaryOutcomes measure: Metabolic health before surgery (HDL), secondaryOutcomes measure: Metabolic health before surgery (total cholesterol), secondaryOutcomes measure: Metabolic health 3 months after surgery (Bloodpressure), secondaryOutcomes measure: Metabolic health 3 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health 3 months after surgery (glucose), secondaryOutcomes measure: Metabolic health 3 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health 3 months after surgery (LDL), secondaryOutcomes measure: Metabolic health 3 months after surgery (HDL), secondaryOutcomes measure: Metabolic health 3 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 6 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 6 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 6 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 6 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 6 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 6 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 6 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 12 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 12 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 12 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 12 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 12 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 12 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 12 months after surgery (total cholesterol), secondaryOutcomes measure: Metabolic health at 18 months after surgery (bloodpressure), secondaryOutcomes measure: Metabolic health at 18 months after surgery (HbA1c), secondaryOutcomes measure: Metabolic health at 18 months after surgery (glucose), secondaryOutcomes measure: Metabolic health at 18 months after surgery (triglyceride), secondaryOutcomes measure: Metabolic health at 18 months after surgery (LDL), secondaryOutcomes measure: Metabolic health at 18 months after surgery (HDL), secondaryOutcomes measure: Metabolic health at 18 months after surgery (total cholesterol), secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms before surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms, secondaryOutcomes measure: Health-related quality of life also related to gastro intestinal symptoms, secondaryOutcomes measure: Cardiorespiratory fitness level before surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 3 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 6 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 12 months after surgery, secondaryOutcomes measure: Cardiorespiratory fitness level 18 months after surgery, secondaryOutcomes measure: Change in liver fat and liver stiffness at start of treatment, secondaryOutcomes measure: Change in liver fat and liver stiffness 15 months after semaglutide start, secondaryOutcomes measure: To describe the persistence of therapy, secondaryOutcomes measure: To describe the average weekly dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287294, orgStudyIdInfo id: RS23-042, briefTitle: An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Our Lady's Hospice and Care Services, class: OTHER, descriptionModule briefSummary: Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer., conditionsModule conditions: Taste, Altered, conditions: Xerostomia, conditions: Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire), primaryOutcomes measure: To identify an association of any other oral symptoms present in patients with taste problems and dry mouth who have advanced cancer using the Oral Symptom Assessment Scale (questionnaire), primaryOutcomes measure: To characterise the taste disturbances i.e. to identify reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care (questionnaire) and Waterless Empirical Taste Test (objective taste test), primaryOutcomes measure: To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire)., primaryOutcomes measure: To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Our Lady's Hospice and Care Services, status: RECRUITING, city: Dublin, zip: D6WRY72, country: Ireland, contacts name: Andrew Davies, FRCP, role: CONTACT, phone: 0035314986235, email: [email protected], contacts name: Marie Hannon, BSc, role: CONTACT, phone: 0035314912558, email: [email protected], geoPoint lat: 53.33306, lon: -6.24889, hasResults: False |
protocolSection identificationModule nctId: NCT06287281, orgStudyIdInfo id: Heel01, briefTitle: High-heeled Shoes in a Sample of Young Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Manusapiens, class: OTHER, descriptionModule briefSummary: At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours., conditionsModule conditions: Low Back Pain, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: heel hight shoes, outcomesModule primaryOutcomes measure: effect of high-heeled shoes on trunk inclination, primaryOutcomes measure: effect of high-heeled shoes on pelvic inclination, primaryOutcomes measure: effect of high-heeled shoes on lordotic angle, primaryOutcomes measure: effect of high-heeled shoes on kyphotic angle, primaryOutcomes measure: effect of high-heeled shoes on lumbar arrow, primaryOutcomes measure: effect of high-heeled shoes on cervical arrow, secondaryOutcomes measure: different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic), secondaryOutcomes measure: different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic), secondaryOutcomes measure: different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic), secondaryOutcomes measure: different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic), secondaryOutcomes measure: different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic), secondaryOutcomes measure: different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Spine Center, status: RECRUITING, city: Bologna, zip: 40128, country: Italy, contacts name: Saverio Colonna, MD, role: CONTACT, phone: +39 051 095 2375, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-10, uploadDate: 2024-02-10T21:29, filename: Prot_SAP_000.pdf, size: 222277, hasResults: False |
protocolSection identificationModule nctId: NCT06287268, orgStudyIdInfo id: CETB115G1401, briefTitle: Revolade Tablets Specified Drug-use Survey, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2028-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA)., conditionsModule conditions: Aplastic Anemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: eltrombopag, outcomesModule primaryOutcomes measure: Occurrence of serious adverse events, secondaryOutcomes measure: Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation, secondaryOutcomes measure: Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies), secondaryOutcomes measure: Occurrence of clonal evolution, secondaryOutcomes measure: Hematologic response status, secondaryOutcomes measure: Change over time from baseline in platelet count, secondaryOutcomes measure: Change over time from baseline in hemoglobin, secondaryOutcomes measure: Change over time from baseline in neutrophil count, secondaryOutcomes measure: Change over time from baseline in reticulocyte count, secondaryOutcomes measure: Change over time from baseline in transfusion dependence, secondaryOutcomes measure: Change over time from baseline in transfusion volume, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287255, orgStudyIdInfo id: 2023H0314, briefTitle: Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals, acronym: EIM+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels., conditionsModule conditions: Physical Inactivity, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A single-arm trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: EIM+, outcomesModule primaryOutcomes measure: Feasibility of EIM+, primaryOutcomes measure: Acceptability of EIM+, secondaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in weight, secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Change in hip circumference, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in heart rate variability, secondaryOutcomes measure: Change in hemoglobin A1c, secondaryOutcomes measure: Change in perceived stress, secondaryOutcomes measure: Change in depressive symptoms, secondaryOutcomes measure: Change in diet, secondaryOutcomes measure: Change in activity minutes per week, secondaryOutcomes measure: Change in daily steps total, secondaryOutcomes measure: Change in measured steps per minute, secondaryOutcomes measure: Change in sleep quality, secondaryOutcomes measure: Change in sleep duration, secondaryOutcomes measure: Change in estimated energy expenditure, secondaryOutcomes measure: Change in heart rate, secondaryOutcomes measure: Change in distance moved, secondaryOutcomes measure: Change in minutes of vigorous activity, secondaryOutcomes measure: Change in minutes of moderate activity, secondaryOutcomes measure: Change in minutes of light activity, secondaryOutcomes measure: Change in minutes of sedentary time, secondaryOutcomes measure: Change in number of manually entered and automatically detected physical activities (walking, running, etc.), secondaryOutcomes measure: Change in quality of life measures, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, city: Columbus, state: Ohio, zip: 43202, country: United States, contacts name: Toluwa C Nafiu, B.S., role: CONTACT, phone: 614-293-2404, email: [email protected], contacts name: Joshua Joseph, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06287242, orgStudyIdInfo id: 24-01-282, briefTitle: Validation of the Cervicothoracic Differentiation Test, acronym: EMU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Hartford, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:* rate their pain with neck movement, complete brief questionnaires about their pain,* have their neck range of motion measured,* perform a test known as the cervico-thoracic differentiation test (CTDT),* receive either a cervical or thoracic manipulation,* repeat the range of motion measurements.* A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Blinded research assistants will perform all baseline and follow-up measures. Investigator providing manipulation is blinded to group allocation (matched/unmatched) Participants will not be told if the CTDT indicates that they would benefit from cervical or thoracic manipulation, and the investigator performing the CTDT will only indicate which region is to be manipulated. All investigators are blinded to the work of the others and submit their results to an additional research assistant who will enter the data in a spreadsheet not accessible to the remainder of the research team until the conclusion of the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: spinal manipulation, outcomesModule primaryOutcomes measure: pain with motion, secondaryOutcomes measure: pain at rest, secondaryOutcomes measure: range of motion, secondaryOutcomes measure: neck disability index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Hartford, status: RECRUITING, city: West Hartford, state: Connecticut, zip: 06117, country: United States, contacts name: Brian Swanson, PT, DSc, role: CONTACT, phone: 860-768-5314, email: [email protected], geoPoint lat: 41.76204, lon: -72.74204, hasResults: False |
protocolSection identificationModule nctId: NCT06287229, orgStudyIdInfo id: 2023-0627, secondaryIdInfos id: NCI-2024-01756, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease., conditionsModule conditions: Relapsed/Refractory, conditions: B-cell Acute Lymphocytic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Blinatumomab, interventions name: Inotuzumab Ozogamicin, interventions name: Hyper-CVAD, interventions name: Mini-hyper-CVD, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Elias Jabbour, MD, role: CONTACT, phone: 713-792-4764, email: [email protected], contacts name: Elias Jabbour, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06287216, orgStudyIdInfo id: 2024001, briefTitle: Preliminary Evaluation of a Mental Health Program: a Comparison Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The Royal Ottawa Mental Health Centre, class: OTHER, descriptionModule briefSummary: The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices.We also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group., conditionsModule conditions: Mental Wellbeing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mental Hygiene, interventions name: Self-Care, outcomesModule primaryOutcomes measure: Change in level of mental wellbeing as measured by the WHO-5 index., primaryOutcomes measure: Change in level of mental wellbeing as measured by the WEMWBS., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06287203, orgStudyIdInfo id: Pro2023001498, secondaryIdInfos id: 3R01DA050721-04S1, type: NIH, link: https://reporter.nih.gov/quickSearch/3R01DA050721-04S1, briefTitle: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults, acronym: ARFP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age)., conditionsModule conditions: Substance Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Participants will not be made aware of their condition at baseline; however, they will know their condition once they receives their estimates (or not, in the case of the control condition) and are taken to their follow-up resources., enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Addiction Risk Feedback Program, outcomesModule primaryOutcomes measure: Alcohol Consumption, primaryOutcomes measure: Alcohol Problems, primaryOutcomes measure: Drug Use Problems, primaryOutcomes measure: Readiness to change, primaryOutcomes measure: Future substance use intentions, secondaryOutcomes measure: Worry About Substance Use Disorders, secondaryOutcomes measure: Perceived Susceptibility, secondaryOutcomes measure: Well-Being, secondaryOutcomes measure: Anxiety and Depressive Symptoms, secondaryOutcomes measure: Addiction Risk Program Satisfaction, secondaryOutcomes measure: Feelings About Results, secondaryOutcomes measure: Satisfaction with the Assigned Conditions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rutgers Robert Wood Johnson Medical School, city: Piscataway, state: New Jersey, zip: 08854, country: United States, contacts name: Emily Balcke, role: CONTACT, email: [email protected], contacts name: Danielle Dick, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.49927, lon: -74.39904, hasResults: False |
protocolSection identificationModule nctId: NCT06287190, orgStudyIdInfo id: Self-confidence assessment, briefTitle: Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation, conditionsModule conditions: Self Confidence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 383, type: ESTIMATED, armsInterventionsModule interventions name: Dental interns, outcomesModule primaryOutcomes measure: Self-confidence regarding treatment, secondaryOutcomes measure: difficulties in dental practice through this period, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University, city: Cairo, country: Egypt, contacts name: Sherine E Eldin, Prof, role: CONTACT, phone: +20 1009073142, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06287177, orgStudyIdInfo id: Protocol 28/2023, briefTitle: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy, acronym: CHOLINET, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population, conditionsModule conditions: Hypercholesterolemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Inclisiran, outcomesModule primaryOutcomes measure: Description of adherence to treatment with Inclisiran in a real-life Italian population, primaryOutcomes measure: Description of persistence to treatment with Inclisiran in a real-life Italian population, primaryOutcomes measure: Description of efficacy of treatment with Inclisiran in a real-life Italian population, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Pasquale Perrone Filardi, MD, role: CONTACT, phone: 0817462224, email: [email protected], geoPoint lat: 40.85216, lon: 14.26811, hasResults: False |
protocolSection identificationModule nctId: NCT06287164, orgStudyIdInfo id: 101, briefTitle: Management of Heart Failure in Italian Outpatients Clinics: Observational Study, acronym: OPTIMA-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: HF treatment adherence according to the most recent European Guidelines, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Pasquale Perrone Filardi, MD, role: CONTACT, phone: 0817462224, email: [email protected], geoPoint lat: 40.85216, lon: 14.26811, hasResults: False |
protocolSection identificationModule nctId: NCT06287151, orgStudyIdInfo id: STUDY00002844, briefTitle: Regional Anesthesia EMG Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, descriptionModule briefSummary: This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies., conditionsModule conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Choice of group will be made by attending anesthesiologist based on clinical judgement., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Only the individuals performing data analysis will be blinded to type of anesthetic technique performed., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: BlockSynop surface electromyography device, interventions name: Clonidine, interventions name: Sevoflurane, outcomesModule primaryOutcomes measure: Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude., primaryOutcomes measure: Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. ., primaryOutcomes measure: Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude., primaryOutcomes measure: Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude., secondaryOutcomes measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude., secondaryOutcomes measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude., secondaryOutcomes measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude., secondaryOutcomes measure: Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude., secondaryOutcomes measure: Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes., eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Nationwide Children's Hospital, status: RECRUITING, city: Columbus, state: Ohio, zip: 43205, country: United States, contacts name: Catherine Roth, role: CONTACT, phone: 614-722-2997, email: [email protected], contacts name: Grant Heydinger, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06287138, orgStudyIdInfo id: KY2023-182-03, briefTitle: The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Capital Medical University, class: OTHER, descriptionModule briefSummary: Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients., conditionsModule conditions: Mechanical Ventilation, conditions: Sedation and Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: ciprofol, outcomesModule primaryOutcomes measure: Explore the effect of ciprofol on tidal volume, primaryOutcomes measure: Explore the effect of ciprofol on respiratory rate, primaryOutcomes measure: Explore the effect of ciprofol on minute ventilation, primaryOutcomes measure: Explore the effect of ciprofol on P0.1, primaryOutcomes measure: Explore the effect of ciprofol on PMI, primaryOutcomes measure: Explore the effect of ciprofol on ΔPocc, secondaryOutcomes measure: Explore the effect of ciprofol on tidal volume, secondaryOutcomes measure: Explore the effect of ciprofol on respiratory rate, secondaryOutcomes measure: Explore the effect of ciprofol on minute ventilation, secondaryOutcomes measure: Explore the effect of ciprofol on P0.1, secondaryOutcomes measure: Explore the effect of ciprofol on PMI, secondaryOutcomes measure: Explore the effect of ciprofol on ΔPocc, secondaryOutcomes measure: Explore the effect of ciprofol on systolic blood pressure, secondaryOutcomes measure: Explore the effect of ciprofol on diastolic blood pressure, secondaryOutcomes measure: Explore the effect of ciprofol on mean arterial pressure, secondaryOutcomes measure: Explore the effect of ciprofol on heart rate, secondaryOutcomes measure: Explore the effect of ciprofol on saturation of pulse oxygen, secondaryOutcomes measure: Explore the effect of ciprofol on end-tidal carbon dioxide pressure, secondaryOutcomes measure: Explore the effect of ciprofol on RASS score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100071, country: China, contacts name: Jian-Xin Zhou, MD, role: CONTACT, phone: 8610 59978019, email: [email protected], contacts name: Rui Su, role: CONTACT, phone: +8618611993866, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06287125, orgStudyIdInfo id: Renal assess in SSc and SLE, briefTitle: Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.* Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.* Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.* Correlation between detected markers and other assessment tools., conditionsModule conditions: Systemic Sclerosis and Systemic Lupus Erythematous, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147, outcomesModule primaryOutcomes measure: Evaluate serum levels of CD147 in SSc and SLE patients, primaryOutcomes measure: Evaluate renal resistive index in SSC and SLE patients, primaryOutcomes measure: Evaluate Multiparametric MRI in SSC and SLE, secondaryOutcomes measure: Utility of CD 147 in ssc and SLE patients, secondaryOutcomes measure: Utility of renal resistive index in SSC and SLE patients, secondaryOutcomes measure: Utility of Multiparametric MRI in SSC and SLE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287112, orgStudyIdInfo id: PAC-ETGBD, briefTitle: Prevention of Acute Cholecystitis With ETGBD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2025-02-20, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility., conditionsModule conditions: Biliary Obstruction, conditions: Acute Cholecystitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic transpapillary gallbladder drainage (ETGBD), outcomesModule primaryOutcomes measure: Incidence rate of acute cholecystitis, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287099, orgStudyIdInfo id: 2023-BRL-101-SCD, briefTitle: Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-10-20, completionDateStruct date: 2026-05-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: Nanfang Hospital, Southern Medical University, descriptionModule briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: BRL-101, outcomesModule primaryOutcomes measure: Proportion of stem cell engrafted subjects, primaryOutcomes measure: Time to neutrophil engraftment, primaryOutcomes measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287086, orgStudyIdInfo id: 2024-BRL-101-SCD, briefTitle: Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-14, primaryCompletionDateStruct date: 2025-08-20, completionDateStruct date: 2026-06-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: Chinese Academy of Medical Sciences, descriptionModule briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101), conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule interventions name: BRL-101 autologous hematopoietic stem and progenitor cells injection, outcomesModule primaryOutcomes measure: Proportion of stem cell engrafted subjects, primaryOutcomes measure: Time to neutrophil engraftment, primaryOutcomes measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion.., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287073, orgStudyIdInfo id: 1245-0323, secondaryIdInfos id: EUPAS107293, type: REGISTRY, domain: EU PAS Register, briefTitle: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-08-18, completionDateStruct date: 2025-11-22, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment., conditionsModule conditions: Kidney Disease, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: JARDIANCE®, outcomesModule primaryOutcomes measure: Number of subjects with adverse events, primaryOutcomes measure: Number of subjects with serious adverse event, primaryOutcomes measure: Number of subjects with non-serious adverse events, primaryOutcomes measure: Number of subjects with adverse drug reaction, primaryOutcomes measure: Number of subjects with serious adverse drug reactions, primaryOutcomes measure: Number of subjects with unexpected adverse events, primaryOutcomes measure: Number of subjects with adverse events of special interest, primaryOutcomes measure: Number of subjects with specific adverse events, primaryOutcomes measure: Number of subjects with adverse events leading to temporary or permanent discontinuation, primaryOutcomes measure: Number of subjects with adverse events by intensity, primaryOutcomes measure: Number of subjects with adverse events by outcome of the events, primaryOutcomes measure: Number of subjects with adverse events by causality, primaryOutcomes measure: Number of subjects with adverse events leading to death, secondaryOutcomes measure: Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 03181, country: Korea, Republic of, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 0808802084, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06287060, orgStudyIdInfo id: Strawberry extract, briefTitle: Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining, it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity., conditionsModule conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract, 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: strawberry extract., outcomesModule primaryOutcomes measure: Bleaching effect of strawberry extract versus Hydrogen peroxide., secondaryOutcomes measure: post operative sensitivity., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06287047, orgStudyIdInfo id: spinal needle sizes and DPE, briefTitle: The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-01-31, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications., conditionsModule conditions: Dural Puncture Epidural Technique, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 81 patients meeting the inclusion criteria will be randomly divided into three equal groups: Group A (n=27): Conventional epidural. Group B (n=27): Dural puncture epidural with 25-gauge spinal needle. Group C (n=27): Dural puncture epidural with 27-gauge spinal needle., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelope will be opened by the nurse, the card inside will determine the patient group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 81, type: ACTUAL, armsInterventionsModule interventions name: Epidural analgesia, outcomesModule primaryOutcomes measure: Onset of analgesia, secondaryOutcomes measure: Degree of analgesia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medidcne, Cairo Univerisity, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06287034, orgStudyIdInfo id: RS1833/23, briefTitle: The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-21, primaryCompletionDateStruct date: 2025-03-21, completionDateStruct date: 2025-09-21, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Regina Elena Cancer Institute, class: OTHER, descriptionModule briefSummary: Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT), conditionsModule conditions: Larynx Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Primary suture, outcomesModule primaryOutcomes measure: questionnaires for evaluation of the quality of life, secondaryOutcomes measure: Identification of risk factors, secondaryOutcomes measure: Evaluation of swallowing function, secondaryOutcomes measure: Evaluation of vocal rehabilitation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Regina Elena" National Cancer Institute, status: RECRUITING, city: Rome, zip: 00144, country: Italy, contacts name: Pellini Raul, Doctor, role: CONTACT, phone: 06-52664484, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06287021, orgStudyIdInfo id: TRASERBMD2022, briefTitle: Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Permedica spa, class: INDUSTRY, descriptionModule briefSummary: The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up., conditionsModule conditions: Total Hip Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Controlled, randomized, unblinded, multicenter, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Jump System Traser® cup, interventions name: Jump System HAX-Pore® cup, outcomesModule primaryOutcomes measure: BMD - ROI 1, secondaryOutcomes measure: BMD - ROI 2,3,4, secondaryOutcomes measure: Harris hip score, secondaryOutcomes measure: Moore's osseointegration signs, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico San Siro, city: Milan, zip: 20148, country: Italy, contacts name: Matteo Del Re, MD, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio, city: Milan, zip: 20161, country: Italy, contacts name: Ricardo Ciliberto, MD, role: CONTACT, email: [email protected], contacts name: Laura, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06287008, orgStudyIdInfo id: 2023-0085, briefTitle: ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure., conditionsModule conditions: Kidney Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 239, type: ACTUAL, armsInterventionsModule interventions name: robot-assisted kidney transplantation, outcomesModule primaryOutcomes measure: Graft survival, primaryOutcomes measure: renal function, secondaryOutcomes measure: . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06286995, orgStudyIdInfo id: 6280, briefTitle: Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-14, primaryCompletionDateStruct date: 2024-01-29, completionDateStruct date: 2024-02-14, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS), conditionsModule conditions: Post Operative Pain, conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was designed to be randomized,single- blinded, single-center clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Chemomechanical preparation for root canals, outcomesModule primaryOutcomes measure: Level of post operative pain using 10-cm visual analogue scale ( VAS), secondaryOutcomes measure: Level of inflammatory mediators substance P in apical fluid samples, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06286982, orgStudyIdInfo id: OASIS III, briefTitle: The Oral Symptom Assessment Scale in Older Patients With Frailty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2024-07-06, completionDateStruct date: 2024-07-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Our Lady's Hospice and Care Services, class: OTHER, descriptionModule briefSummary: Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months., conditionsModule conditions: Frailty, conditions: Older Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Oral Symptom Assessment Scale, outcomesModule primaryOutcomes measure: To determine the prevalence of oral symptoms in older patients with frailty, primaryOutcomes measure: To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress), primaryOutcomes measure: To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications, primaryOutcomes measure: To provide initial validation of OSAS in older patients with frailty, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St James's Hospital, status: RECRUITING, city: Dublin, zip: D8, country: Ireland, contacts name: Niamh Cleary, MB MICGP, role: CONTACT, phone: +353876603466 (Ireland), email: [email protected], contacts name: Amanda Lavan, PhD MRCPI, role: SUB_INVESTIGATOR, contacts name: Roman Romero Ortuno, MSc PhD MRCP, role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Our Lady's Hospice and Care Services, status: RECRUITING, city: Dublin, zip: Dublin 6W, country: Ireland, contacts name: Niamh M Cleary, MB MICGP, role: CONTACT, phone: +353876603466 (Ireland), email: [email protected], contacts name: Norah Fagan, RGN MSc, role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False |
protocolSection identificationModule nctId: NCT06286969, orgStudyIdInfo id: ZSLL-ZN-2024-007-01, briefTitle: Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Xu Xinnan, class: OTHER, descriptionModule briefSummary: Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective., conditionsModule conditions: Lumbar Muscle Strain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: acupuncture, outcomesModule primaryOutcomes measure: clinical efficacy evaluation criteria, secondaryOutcomes measure: Pain visual analog scale (VAS) score, secondaryOutcomes measure: Japanese Orthopaedic Association Scores, secondaryOutcomes measure: Lumbar Joint Mobility Measurement Scale, secondaryOutcomes measure: Improvement of the Ashworth Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286956, orgStudyIdInfo id: vec-pr-1901, briefTitle: Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device, acronym: UNI-VEC, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-19, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-09-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Vecmedical Spain, S.L., class: INDUSTRY, descriptionModule briefSummary: The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial)., conditionsModule conditions: Rectal Polyp, conditions: Rectal Polyps, conditions: Rectal Lesion, conditions: Sessile Colonic Polyp, conditions: Pedunculated Colorectal Polyps, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Treatment of rectal lesions with UNI-VEC, outcomesModule primaryOutcomes measure: Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps, secondaryOutcomes measure: Rate of anorectal hemorrhagic events, secondaryOutcomes measure: Rate of injuries to the anorectal canal and perianal region, secondaryOutcomes measure: Assessment of anorectal continence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de Cabueñes, status: RECRUITING, city: Gijón, state: Asturias, zip: 33394, country: Spain, contacts name: Carlos Álvarez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.53573, lon: -5.66152, locations facility: Hospital Universitari Mútua de Terrassa, status: RECRUITING, city: Terrassa, state: Bercelona, zip: 08221, country: Spain, contacts name: Salvadora Delgado, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Complexo Hospitalario Universitario de A Coruña, status: RECRUITING, city: A Coruña, state: Galicia, zip: 15006, country: Spain, contacts name: José F Noguera, Medicin, role: CONTACT, phone: +34 981178049, email: [email protected], contacts name: José F Noguera, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Quirón-Salud A Coruña, status: RECRUITING, city: A Coruña, state: Galicia, zip: 15006, country: Spain, contacts name: Alba Gómez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Universitario Lucus Augusti, status: RECRUITING, city: Lugo, state: Galicia, zip: 27003, country: Spain, contacts name: Olga Maseda, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Complejo Hospitalario Universitario de Vigo, status: RECRUITING, city: Vigo, state: Galicia, zip: 36204, country: Spain, contacts name: Raquel Sánchez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital del Mar, status: RECRUITING, city: Barcelona, zip: 08003, country: Spain, contacts name: Marta Jiménez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital La Paz, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, contacts name: Mario Álvarez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Reina Sofía de Murcia, status: RECRUITING, city: Murcia, zip: 30003, country: Spain, contacts name: Pedro Parra, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Hospital Universitario Río Hortega, status: RECRUITING, city: Valladolid, zip: 47012, country: Spain, contacts name: Javier Sánchez, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.65518, lon: -4.72372, locations facility: Hospital Universitario La Fe, status: RECRUITING, city: València, zip: 46026, country: Spain, contacts name: Blas Flor, Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06286943, orgStudyIdInfo id: S68124, briefTitle: The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions, acronym: GUTSIE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate).A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory \[WM\], cognitive flexibility \[CF\], response inhibition \[RI\]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment.First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress.Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively, conditionsModule conditions: Executive Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Short Chain Fatty Acids (SCFAs)., interventions name: Placebo, interventions name: Maastricht Acute Stress Task, interventions name: No-stress control task, outcomesModule primaryOutcomes measure: Working memory, secondaryOutcomes measure: Cognitive Flexibility, secondaryOutcomes measure: Response Inhibition, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06286930, orgStudyIdInfo id: STU-2023-0470, briefTitle: Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-02, completionDateStruct date: 2026-01-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies?Primary Outcomes:1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.Secondary Outcomes:1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation., conditionsModule conditions: Anorexia Nervosa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: anodal trans cranial direct current stimulation (tDCS), interventions name: cathodal trans cranial direct current stimulation (tDCS), outcomesModule primaryOutcomes measure: tDCS impact on social behaviors using Cyberball, primaryOutcomes measure: tDCS impact on social behaviors using the Trust Game, primaryOutcomes measure: neurological impacts of tDCS as measured by fMRI imaging, secondaryOutcomes measure: measure the differences of social stimuli and eating disorder/depressive symptomology, secondaryOutcomes measure: measure the differences of social stimuli and eating disorder/depressive symptomology, secondaryOutcomes measure: measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task., secondaryOutcomes measure: measure the differences of social stimuli and mental flexibility with Trail Making Task, secondaryOutcomes measure: measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9., eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286917, orgStudyIdInfo id: R24001, briefTitle: Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency, acronym: InNIVALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Tampere University, class: OTHER, descriptionModule briefSummary: This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are., conditionsModule conditions: Ventilation Therapy, conditions: ALS, conditions: Chronic Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: NIV initiation in patients with ALS, outcomesModule primaryOutcomes measure: NIV usage hours according to different initiation locations in patients with ALS, primaryOutcomes measure: Compliance with NIV according to NIV initiation setting in patients with ALS, primaryOutcomes measure: Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation., otherOutcomes measure: Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tampere University Hospital, status: RECRUITING, city: Tampere, zip: 33520, country: Finland, contacts name: Heidi A Rantala, MD, PhD, role: CONTACT, phone: +3583311611, email: [email protected], contacts name: Lauri Lehtimäki, MD, PhD, role: CONTACT, phone: +3583311611, email: [email protected], contacts name: Hanna Korkeamäki, MD, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Hannele Hasala, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Sirpa Leivo-Korpela, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False |
protocolSection identificationModule nctId: NCT06286904, orgStudyIdInfo id: McMaster-Myant 16633, briefTitle: Sleep Position Pattern Recording, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Myant Medical Corp., class: INDUSTRY, collaborators name: McMaster University, descriptionModule briefSummary: The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth., conditionsModule conditions: Pregnant Women, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Skiin Garment system, outcomesModule primaryOutcomes measure: Accuracy of Skiin Garment system for detecting sleep position of pregnant women, secondaryOutcomes measure: Questionnaire on wearable device invasiveness and satisfaction, secondaryOutcomes measure: Participant recruitment rate, secondaryOutcomes measure: Participant retention rate, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: McMaster University, city: Hamilton, state: Ontario, zip: L8S 4K1, country: Canada, contacts name: Kyle McGowan, role: CONTACT, phone: 905.521.2100, phoneExt: 21334, email: [email protected], contacts name: Eran Ashwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False |
protocolSection identificationModule nctId: NCT06286891, orgStudyIdInfo id: CAAE: 73520523.7.0000.0068, briefTitle: Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET)., conditionsModule conditions: Chronic Thromboembolic Pulmonary Hypertension, conditions: Physical Disability, conditions: Fragility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: To investigate changes in physical performance measured by Six-Minute Walk Test., primaryOutcomes measure: To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB)., primaryOutcomes measure: To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST)., primaryOutcomes measure: To investigate changes in peripheral muscle strength., primaryOutcomes measure: To investigate changes in respiratory muscle strength:, primaryOutcomes measure: To investigate changes in lung function test measure by spirometry:, primaryOutcomes measure: To investigate frailty by Clinical Frailty Scale (CFS), secondaryOutcomes measure: To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss., secondaryOutcomes measure: To investigate changes in hemodynamic and respiratory variables during the funcional tests., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, status: RECRUITING, city: São Paulo, state: SP, zip: 05403-000, country: Brazil, contacts name: Orival Freitas Filho, MD, role: SUB_INVESTIGATOR, contacts name: Fabio B Jatene, MD,PhD, role: SUB_INVESTIGATOR, contacts name: Kelly CO Abud, PT, PhD, role: SUB_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False |
protocolSection identificationModule nctId: NCT06286878, orgStudyIdInfo id: SDC 4620/17/120, briefTitle: Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-08, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo, class: OTHER, descriptionModule briefSummary: Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned., conditionsModule conditions: Myocardial Infarction, conditions: Acute Coronary Syndrome, conditions: Diabetes, conditions: Ventricular Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-center, prospective, randomized, double-blind, placebo-controlled clinical study., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: Platelet aggregation using ADP, secondaryOutcomes measure: Platelet aggregation using ADP at 30 (± 5) days after study therapy, secondaryOutcomes measure: Platelet aggregation using ASPI at 30 (± 5) days after study therapy, otherOutcomes measure: Analyze the primary objective of the study in the following pre-specified subgroups:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, status: RECRUITING, city: Sao Paulo, zip: 05403-900, country: Brazil, contacts name: José Carlos Nicolau, role: CONTACT, phone: 551126615058, email: [email protected], geoPoint lat: -23.5475, lon: -46.63611, hasResults: False |
protocolSection identificationModule nctId: NCT06286865, orgStudyIdInfo id: 260972(REK), briefTitle: Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial, acronym: ClinCode, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital of North Norway, class: OTHER, collaborators name: The Research Council of Norway, descriptionModule briefSummary: The goal of this randomised trial is to learn about the role of AI in clinical coding practice. The main question it aims to answer is:Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding? Participants will be asked to code clinical texts both while they use our CAC system and while they do not., conditionsModule conditions: Gastrointestinal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Easy-ICD, outcomesModule primaryOutcomes measure: Time, primaryOutcomes measure: Accuracy, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Norwegian Centre for E-health Research, status: RECRUITING, city: Tromso, state: Troms, zip: 9019, country: Norway, contacts name: Taridzo F Chomutare, PhD, role: CONTACT, phone: +4747680032, email: [email protected], contacts name: Hercules Dalianis, PhD, role: CONTACT, phone: +46705681359, email: [email protected], geoPoint lat: 69.6489, lon: 18.95508, hasResults: False |
protocolSection identificationModule nctId: NCT06286852, orgStudyIdInfo id: EDE BA, briefTitle: Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder, conditionsModule conditions: Feeding and Eating Disorders of Childhood, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002), interventions name: Administration of ChEDE- Child Version of the EatingDisorder Examination, outcomesModule primaryOutcomes measure: K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire, primaryOutcomes measure: ChEDE (Child Version of the EatingDisorder Examination), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: USL Toscana Centro, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Villa Garda, city: Garda, country: Italy, geoPoint lat: 45.57889, lon: 10.71763, hasResults: False |
protocolSection identificationModule nctId: NCT06286839, orgStudyIdInfo id: AFCRO-150, briefTitle: Study of Cannabidiol (CBD) in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-12, primaryCompletionDateStruct date: 2022-10-28, completionDateStruct date: 2022-12-14, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: NextEvo Inc., class: INDUSTRY, collaborators name: Atlantia Food Clinical Trials, descriptionModule briefSummary: This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults, conditionsModule conditions: Immune System and Related Disorders, conditions: Immune System Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Cannabidiol (CBD), outcomesModule primaryOutcomes measure: Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days, primaryOutcomes measure: Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days, secondaryOutcomes measure: Plasma CBD maximal concentration (Cmax, ng/ml), secondaryOutcomes measure: Plasma CBD time to peak (Tmax, minutes), secondaryOutcomes measure: Percentage Change between groups on whole blood LPS stimulated cytokines (% change), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Altantia Clinical Trials, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06286826, orgStudyIdInfo id: ATRESO, briefTitle: A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2024-10-12, completionDateStruct date: 2026-01-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation, conditionsModule conditions: Atresia Esophagus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Postero-lateral thoracotomy, interventions name: Minithoracotomy, outcomesModule primaryOutcomes measure: incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically, secondaryOutcomes measure: incidence of musculoskeletal abnormalities in the short term, secondaryOutcomes measure: incidence of musculoskeletal abnormalities in the medium term, secondaryOutcomes measure: Evaluation of severity of outcomes in the medium, short and long term, secondaryOutcomes measure: Predective Facotrs evaluation, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Spedali Civili di Brescia, status: RECRUITING, city: Brescia, zip: 25123, country: Italy, contacts name: Daniele Alberti, role: CONTACT, email: [email protected], geoPoint lat: 45.53558, lon: 10.21472, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, zip: 50139, country: Italy, contacts name: Elisa Severi, role: CONTACT, phone: 0555662900, email: [email protected], geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Bambino Gesù di Roma, status: RECRUITING, city: Roma, zip: 00165, country: Italy, contacts name: Andrea Conforti, MD, role: CONTACT, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06286813, orgStudyIdInfo id: Akarakoc, briefTitle: The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2024-05-03, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.Interventional research with two parallel groups and no control group, conditionsModule conditions: Skin Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Plant (natural) oils, outcomesModule primaryOutcomes measure: Neonatal skin condition score, primaryOutcomes measure: Skin moisture meter(DMM):, eligibilityModule sex: ALL, minimumAge: 1 Hour, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital, status: RECRUITING, city: Istanbul, zip: 34854, country: Turkey, contacts name: AYŞE KARAKOÇ, role: CONTACT, phone: +905335695138, email: [email protected], contacts name: Irem Zulal Topçuoglu Arslan, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06286800, orgStudyIdInfo id: PRO00036824, briefTitle: Personalized Transcranial Direct Current Stimulation in Stroke Recovery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-09-14, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial direct current stimulation (tDCS) with OT, interventions name: Sham tDCS with OT, outcomesModule primaryOutcomes measure: fMRI functional connectivity biomarker, secondaryOutcomes measure: Wolf Motor Function Test, secondaryOutcomes measure: Fugl-Meyer assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286787, orgStudyIdInfo id: HSEARS20221110002, briefTitle: Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families., conditionsModule conditions: Resilience, conditions: Well-being, conditions: Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Intervention, interventions name: Placebo, outcomesModule primaryOutcomes measure: Resilience Scale-14 (RS-14), secondaryOutcomes measure: Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), secondaryOutcomes measure: Chinese version of Rosenberg's Self-Esteem Scale (RSES), secondaryOutcomes measure: The children's peak expiratory flow rate, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Asbury Methodist Social Service, status: RECRUITING, city: Hong Kong, country: China, contacts name: Chung, role: CONTACT, email: [email protected], geoPoint lat: 22.39407, lon: 114.13737, hasResults: False |
protocolSection identificationModule nctId: NCT06286774, orgStudyIdInfo id: 2096884, briefTitle: Sleep as a Mechanism of Change in Alcohol Use, acronym: ReTRAIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Missouri-Columbia, class: OTHER, descriptionModule briefSummary: This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes., conditionsModule conditions: Insomnia, conditions: Alcohol; Harmful Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) or waitlist control., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia, outcomesModule primaryOutcomes measure: Insomnia Symptoms, primaryOutcomes measure: Drinking quantity, primaryOutcomes measure: Alcohol-related consequences, secondaryOutcomes measure: Treatment willingness (alcohol), secondaryOutcomes measure: Alcohol craving, secondaryOutcomes measure: Negative emotionality, secondaryOutcomes measure: Response inhibition, secondaryOutcomes measure: Working memory, secondaryOutcomes measure: Delay discounting, secondaryOutcomes measure: Alcohol to help with sleep, secondaryOutcomes measure: Heartrate variability, secondaryOutcomes measure: Dysfunctional Beliefs and Attitudes about Sleep Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Missouri-Columbia, city: Columbia, state: Missouri, zip: 65212, country: United States, geoPoint lat: 38.95171, lon: -92.33407, hasResults: False |
protocolSection identificationModule nctId: NCT06286761, orgStudyIdInfo id: 2100332, briefTitle: Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL), acronym: VAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Bettina Mittendorfer, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: endothelial cell collection, outcomesModule primaryOutcomes measure: Validation and reproducibility testing for blood assays, primaryOutcomes measure: Validation and reproducibility testing for endothelial cell collection, primaryOutcomes measure: Validation and reproducibility testing for mixed meal ingestion, primaryOutcomes measure: Validation and reproducibility testing for glucose tolerance testing, primaryOutcomes measure: Validation and reproducibility testing for DEXA, primaryOutcomes measure: Validation and reproducibility testing for MRI, primaryOutcomes measure: Validation and reproducibility testing for MRS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286748, orgStudyIdInfo id: DeniseMafra19, briefTitle: Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-10, completionDateStruct date: 2024-12-10, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, descriptionModule briefSummary: Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Beetroot juice, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change individual quality of life, primaryOutcomes measure: Change physical activity level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06286735, orgStudyIdInfo id: DeniseMafra18, briefTitle: Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-22, primaryCompletionDateStruct date: 2024-11-22, completionDateStruct date: 2024-12-22, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, descriptionModule briefSummary: Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cinnamomum, interventions name: Placebo, outcomesModule primaryOutcomes measure: Concentration of Nuclear factor kappa B (NF-KB), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06286722, orgStudyIdInfo id: LollandCD, briefTitle: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study, acronym: ENHANCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Lolland Community, Denmark, class: OTHER, collaborators name: Vordingborg Municipality, collaborators name: Stevns Municipality, collaborators name: Guldborgsund Municipality, descriptionModule briefSummary: Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided., conditionsModule conditions: Hip Fractures, conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Feasibility study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Progressive, individualized and structured exercise program, outcomesModule primaryOutcomes measure: The New Mobility Score, secondaryOutcomes measure: Mini Mental State Examination, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Tandem balance test, secondaryOutcomes measure: The Barthel-20, secondaryOutcomes measure: 30 sec chair raise test, secondaryOutcomes measure: Brief Assessment of Impaired Cognition Questionaire, secondaryOutcomes measure: Handgrip strength measurement, secondaryOutcomes measure: The Cumulated Ambulation Score, secondaryOutcomes measure: Four meter walk test, secondaryOutcomes measure: Euroqol 5 dimensions, secondaryOutcomes measure: Clinical Frailty Scale, secondaryOutcomes measure: The Verbal Rating Scale, secondaryOutcomes measure: Activity accelerometers, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stevns Healthcare Center, Stevns Municipality, status: NOT_YET_RECRUITING, city: Hårlev, zip: 4652, country: Denmark, contacts name: Lotte Bylov, role: CONTACT, email: [email protected], geoPoint lat: 55.34936, lon: 12.23382, locations facility: Maribo Health Center, Lolland Municipality, status: RECRUITING, city: Maribo, zip: 4930, country: Denmark, contacts name: Jan Arnholtz Overgaard, MSc., role: CONTACT, phone: +4554677700, email: [email protected], contacts name: Gwen Tremmel, role: CONTACT, phone: +4554677700, email: [email protected], contacts name: Jan A Overgaard, MSc., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.77662, lon: 11.50017, locations facility: Guldborgsund Healthcare Center, Guldborgsund Municipality, status: RECRUITING, city: Nykøbing Falster, zip: 4800, country: Denmark, contacts name: Cecilie Kristensen, role: CONTACT, email: [email protected], geoPoint lat: 54.76906, lon: 11.87425, locations facility: Vordingborg Healthcare Center, Vordingborg Municipality, status: RECRUITING, city: Vordingborg, zip: 4760, country: Denmark, contacts name: Line Flemmer, Bachelor, role: CONTACT, email: [email protected], geoPoint lat: 55.00801, lon: 11.91057, hasResults: False |
protocolSection identificationModule nctId: NCT06286709, orgStudyIdInfo id: RG_22-063, briefTitle: FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis, acronym: FARGO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-07-29, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Birmingham, class: OTHER, collaborators name: PSC Support, collaborators name: Life Arc, descriptionModule briefSummary: FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease., conditionsModule conditions: Primary Sclerosing Cholangitis, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Single-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Faecal Microbiota Transplant, interventions name: FMT Placebo, outcomesModule primaryOutcomes measure: Serum Alkaline Phosphatase (ALP), secondaryOutcomes measure: Patient-reported outcome (PRO) measures, secondaryOutcomes measure: Patient-reported outcome (PRO) measures, secondaryOutcomes measure: Patient-reported outcome (PRO) measures, secondaryOutcomes measure: Patient-reported outcome (PRO) measures, secondaryOutcomes measure: Surrogate biomarkers of liver fibrosis, secondaryOutcomes measure: Surrogate biomarkers of liver fibrosis, secondaryOutcomes measure: Routine liver laboratory parameters, secondaryOutcomes measure: Routine liver laboratory parameters, secondaryOutcomes measure: Routine liver laboratory parameters, secondaryOutcomes measure: Routine liver laboratory parameters, secondaryOutcomes measure: Routine liver laboratory parameters, secondaryOutcomes measure: PSC specific prognostic scores, secondaryOutcomes measure: PSC specific prognostic scores, secondaryOutcomes measure: Quantitative assessment of Inflammatory Bowel Disease (IBD) activity, secondaryOutcomes measure: Quantitative assessment of IBD activity, secondaryOutcomes measure: Quantitative assessment of IBD activity, secondaryOutcomes measure: The incidence of clinical non-trial endpoint events, secondaryOutcomes measure: The incidence of trial endpoint events, secondaryOutcomes measure: Occurrence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, city: Birmingham, zip: B15 2TH, country: United Kingdom, contacts name: Palak Trivedi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, locations facility: St Mark's Hospital, London North West University Healthcare NHS Trust, city: London, zip: NW10 7NS, country: United Kingdom, contacts name: Ailsa Hart, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Free Hospital, Royal Free London NHS Foundation Trust, city: London, zip: NW3 2QG, country: United Kingdom, contacts name: Douglas Thorburn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: King's College Hospital, King's College Hospital NHS Foundation Trust, city: London, zip: SE5 9RS, country: United Kingdom, contacts name: Deepak Joshi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust, city: Norwich, zip: NR4 7UY, country: United Kingdom, contacts name: Simon Rushbrook, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.62783, lon: 1.29834, locations facility: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, city: Oxford, zip: OX3 9DU, country: United Kingdom, contacts name: Emma Culver, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False |
protocolSection identificationModule nctId: NCT06286696, orgStudyIdInfo id: NL84914.058.23, briefTitle: Optic Nerve Sheath Diameter in Hypertensive Emergency, acronym: OpticUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor., conditionsModule conditions: Hypertensive Emergency, conditions: Papilledema, conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Optic Nerve Sheath Diameter, outcomesModule primaryOutcomes measure: Papilledema, secondaryOutcomes measure: Hypertensive retinopathy grade 3 & 4 combined, secondaryOutcomes measure: Hypertensive encephalopathy, secondaryOutcomes measure: Rapid acting medications administered intravenously to lower the elevated blood pressure, secondaryOutcomes measure: Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286683, orgStudyIdInfo id: APHP231706, briefTitle: Impact of Early Mobilization on SAH Patients Physiological Parameters, acronym: MOBALPAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters., conditionsModule conditions: Subarachnoid Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: lung ultrasound, interventions name: Transcranial Doppler, interventions name: near-infrared spectroscopy (NIRS), interventions name: clinical examination, outcomesModule primaryOutcomes measure: Impact on lung aeration, secondaryOutcomes measure: Impact on cerebral blood flow, secondaryOutcomes measure: Impact on cerebral tissue oxygenation, secondaryOutcomes measure: Impact on heart rate, secondaryOutcomes measure: Impact on arterial pressure, secondaryOutcomes measure: Impact on Saturation, secondaryOutcomes measure: Impact on neurological examination, secondaryOutcomes measure: Impact on patient comfort, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Adéla FOUDHAÏLI, city: Paris, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06286670, orgStudyIdInfo id: IRB00108312, secondaryIdInfos id: HT94252311075, type: OTHER, domain: Department of Defense, briefTitle: Single Versus Dual Implant Fixation of Distal Femur Fractures, acronym: PRORP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities., conditionsModule conditions: Articular Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Single Implant Fixation, interventions name: Dual Implant Fixation, outcomesModule primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, primaryOutcomes measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores, secondaryOutcomes measure: Number of Unions, secondaryOutcomes measure: Number of Resource Utilizations, secondaryOutcomes measure: Number of Reoperations, secondaryOutcomes measure: Number of Complications, secondaryOutcomes measure: Time to Walking Without an Assistive Device, secondaryOutcomes measure: Prescribed Weight Bearing Status, secondaryOutcomes measure: Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores, secondaryOutcomes measure: Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores, secondaryOutcomes measure: Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores, secondaryOutcomes measure: Change in the Work Productivity and Activity Impairment Questionnaire Scores, secondaryOutcomes measure: Change in Numeric Pain Rating, secondaryOutcomes measure: Change in Pain Inventory (BPI), secondaryOutcomes measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference, secondaryOutcomes measure: Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification, secondaryOutcomes measure: Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS, secondaryOutcomes measure: Isokinetic Knee Flexion/Extension Strength Testing, secondaryOutcomes measure: Counter-Movement Jump measurement, secondaryOutcomes measure: Single Leg Static and Dynamic Postural Stability Index, secondaryOutcomes measure: Triple Hop Performance Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atrium Health Musculoskeletal Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, contacts name: Erica Grochowski, role: CONTACT, email: [email protected], contacts name: Laurence Kempton, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, hasResults: False |
protocolSection identificationModule nctId: NCT06286657, orgStudyIdInfo id: UVienna23a, briefTitle: Xanthohumol and Viral Infections (XL), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, descriptionModule briefSummary: The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections., conditionsModule conditions: Infection Viral, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Xanthohumol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in severity and duration of viral infections, secondaryOutcomes measure: Changes in blood lipid levels, secondaryOutcomes measure: Changes in cognitive skills, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Ina Bergheim, Prof. Dr., role: CONTACT, phone: +43-1-4277-54981, email: [email protected], geoPoint lat: 48.20849, lon: 16.37208, hasResults: False |
protocolSection identificationModule nctId: NCT06286644, orgStudyIdInfo id: UVienna23, briefTitle: Hop Compounds on the Immune System (VH), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, descriptionModule briefSummary: The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours., conditionsModule conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Xanthohumol, interventions name: Iso-alpha-Acids, interventions name: Xanthohumol + Iso-alpha-Acids, outcomesModule primaryOutcomes measure: Changes in parameters of immune response, primaryOutcomes measure: Changes in parameters of immune response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Ina Bergheim, Prof. Dr., role: CONTACT, phone: +431427754981, email: [email protected], geoPoint lat: 48.20849, lon: 16.37208, hasResults: False |
protocolSection identificationModule nctId: NCT06286631, orgStudyIdInfo id: Rating scale-202402, briefTitle: Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients., conditionsModule conditions: Papillary Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Height, primaryOutcomes measure: Weight, primaryOutcomes measure: Age, primaryOutcomes measure: Genders, primaryOutcomes measure: BMI, primaryOutcomes measure: Whether lymph node dissection was performed during previous surgery, primaryOutcomes measure: Tumor Diameter Size, primaryOutcomes measure: Tumor limitation of the primary focus, primaryOutcomes measure: Extratumoral invasion, primaryOutcomes measure: Pathologic lymph node metastasis, primaryOutcomes measure: Tumor cystic solidity on preoperative ultrasound, primaryOutcomes measure: Preoperative ultrasound tumor echo intensity, primaryOutcomes measure: Preoperative ultrasound tumor boundaries, primaryOutcomes measure: Preoperative ultrasound tumor for the presence of calcifications, primaryOutcomes measure: Preoperative ultrasound tumor aspect ratios, primaryOutcomes measure: Preoperative ultrasound for enlarged cervical lymph nodes, primaryOutcomes measure: TSH, primaryOutcomes measure: TPOAb, primaryOutcomes measure: TgAb, primaryOutcomes measure: Calcium, primaryOutcomes measure: B-raf gene mutation, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710000, country: China, contacts name: Yang Liu, doctor, role: CONTACT, phone: 0086+029-13384986500, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-29, uploadDate: 2024-02-22T03:07, filename: Prot_000.pdf, size: 79490, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-29, uploadDate: 2024-02-22T03:08, filename: ICF_001.pdf, size: 132491, hasResults: False |
protocolSection identificationModule nctId: NCT06286618, orgStudyIdInfo id: HHSN268201800015I, briefTitle: Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Southern Mississippi, class: OTHER, collaborators name: My Brother's Keeper, descriptionModule briefSummary: The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Psychosocial Intervention, interventions name: Structural Intervention, interventions name: Traditional Psychosocial+Structural, interventions name: Integrated Psychosocial+Structural, outcomesModule primaryOutcomes measure: Participant Burden, secondaryOutcomes measure: Diet Quality, secondaryOutcomes measure: cost effectiveness, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Southern Mississippi, city: Hattiesburg, state: Mississippi, zip: 39406-0001, country: United States, geoPoint lat: 31.32712, lon: -89.29034, hasResults: False |
protocolSection identificationModule nctId: NCT06286605, orgStudyIdInfo id: UNISS_PHD_Osstem_4, briefTitle: RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, 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: The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group)., conditionsModule conditions: Guided Bone Regeneration, conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter, randomized controlled trial of parallel-group design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: A-oss and autogenous bone, interventions name: A-oss an LCR-A, outcomesModule primaryOutcomes measure: Rate of Implants survival, primaryOutcomes measure: Number of Participants with prosthesis failure, primaryOutcomes measure: Number of complications, secondaryOutcomes measure: Horizontal and volumetric dimensional changes, secondaryOutcomes measure: Rate of peri-implant marginal bone level, secondaryOutcomes measure: Plaque Index and bleeping on probing, secondaryOutcomes measure: Valuation of patient satisfaction, secondaryOutcomes measure: Valuation of soft tissue thickness and amount of keratinized tissue, secondaryOutcomes measure: Rate of pes score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marco Tallarico, city: Sassari, zip: 07100, country: Italy, contacts name: Dario Melodia, Dr, role: CONTACT, phone: 3331226618, email: [email protected], contacts name: Marco Tallarico, Prof, role: CONTACT, phone: 3280758769, email: [email protected], geoPoint lat: 40.72586, lon: 8.55552, hasResults: False |
protocolSection identificationModule nctId: NCT06286592, orgStudyIdInfo id: Pro2023002053, briefTitle: LUNGevity: Lung Cancer Stigma Community Based Participatory Research, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: Lung cancer survival rates are low for intersectional underserved groups. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators will use Community Based Participatory Research framework and MOST methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma, through first building a diverse coalition of lung cancer patients on a participatory action council., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Details of the specific interventions will be selected in collaboration with the Community Advisory Board.Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ultra-brief mindfulness intervention video, interventions name: Forgiveness video, interventions name: ACT values video, outcomesModule primaryOutcomes measure: Lung Cancer Stigma Inventory (LCSI), primaryOutcomes measure: Tobacco use quit likelihood, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286579, orgStudyIdInfo id: UNISS_PHD_Osstem_3, briefTitle: SOI Immediately vs Delayed, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Università degli Studi di Sassari, class: OTHER, collaborators name: Dr. Dario Melodia, collaborators name: Dr. Milena Pisano, collaborators name: Dr. Aurea M. I. Lumbau, collaborators name: Prof. Silvio Mario Meloni, collaborators name: Prof. Edoardo Baldoni, descriptionModule briefSummary: The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface, conditionsModule conditions: Dental Implant, conditions: Dental Implant-Abutment Design, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled trial of parallel group design., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: One "blinded (when possible)" independent assessor, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Immediately implant placement, interventions name: Delayed, outcomesModule primaryOutcomes measure: Number of prosthesis failure, primaryOutcomes measure: Number of implant failure, primaryOutcomes measure: Number of complications, secondaryOutcomes measure: Rate of peri-implant marginal bone level changes, secondaryOutcomes measure: Valuation of patient satisfaction, secondaryOutcomes measure: Rate of implant stability quotient (ISQ), secondaryOutcomes measure: Valuation of soft tissue thickness and amount of keratinized tissue, secondaryOutcomes measure: Number of PES score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marco Tallarico, city: Sassari, zip: 07100, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, hasResults: False |
protocolSection identificationModule nctId: NCT06286566, orgStudyIdInfo id: UNISS_PHD_Osstem_2, briefTitle: Soi TS3 Surface in Patients With and Without Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Università degli Studi di Sassari, class: OTHER, collaborators name: Dr. Dario Melodia, collaborators name: Dr. Milena Pisano, collaborators name: Dr. Aurea M. I. Lumbau, collaborators name: Prof. Silvio Mario Meloni, collaborators name: Prof. Edoardo Baldoni, descriptionModule briefSummary: The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes., conditionsModule conditions: Dental Implant, conditions: Dental Implant-Abutment Design, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter prospective cohort study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: centralized radiographic assessor, outcome assessors(when possible), and the statistical advisors will be blind to the used implants, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Implant placement with soi surface in diabetic subjects, interventions name: Implant placement with soi surface in healthy subjects, outcomesModule primaryOutcomes measure: Number of prosthesis failure:, primaryOutcomes measure: Number of implant failure, primaryOutcomes measure: Number of complication, secondaryOutcomes measure: Rate of peri-implant marginal bone level changes, secondaryOutcomes measure: Valuation of patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marco Tallarico, city: Rome, state: Sassari, zip: 07100, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06286553, orgStudyIdInfo id: DRA Rehab TEG & IMT, briefTitle: Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training, acronym: DR-TIME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Patras, class: OTHER, descriptionModule briefSummary: Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study.Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA.In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT)., conditionsModule conditions: Diastasis Recti And Weakness Of The Linea Alba, conditions: Diastasis, Muscle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this interventional study, three distinct groups are included. The Trunk Exercise Group (TEG) will partake in a comprehensive 12-week therapeutic exercise program that involves progressive strengthening exercises specifically targeting the trunk and pelvic floor muscles, alongside functional retraining exercises. The Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will adhere to the same 12-week therapeutic exercise program as TEG, with additional exercises focusing on strengthening the inspiratory muscles using inspiratory resistance (IMT). The control group (CG) will not participate in the 12-week exercise program but will receive a single exercise session and general management information (oral and written) for DRA., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Trunk exercise, interventions name: Inspiratory Muscle Training (IMT), interventions name: Control Group, outcomesModule primaryOutcomes measure: Inter-recti distance (IRD), secondaryOutcomes measure: Diaphragmatic Thickness, secondaryOutcomes measure: Diaphragmatic Excursion, secondaryOutcomes measure: Maximum Inspiratory Pressure (MIP), secondaryOutcomes measure: Strength Index (S-Index), secondaryOutcomes measure: Peak Inspiratory Flow (PIF), secondaryOutcomes measure: Trunk flexion test, secondaryOutcomes measure: Plank test, secondaryOutcomes measure: Side plank test, secondaryOutcomes measure: McGill's trunk flexor endurance test, secondaryOutcomes measure: Body Image States Scale (BISS), secondaryOutcomes measure: Activities Assessment Scale (AAS), secondaryOutcomes measure: Hernia-Related Quality-of-Life Survey (HerQLes), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras, status: RECRUITING, city: Patras, state: Achaia, Greece, zip: 26504, country: Greece, contacts name: Evdokia Billis, PhD, role: CONTACT, phone: 00306973047170, email: [email protected], contacts name: Anastasia Skoura, MSc, role: CONTACT, phone: 00306947784948, email: [email protected], geoPoint lat: 38.24444, lon: 21.73444, hasResults: False |
protocolSection identificationModule nctId: NCT06286540, orgStudyIdInfo id: 26031993, briefTitle: Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-22, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Petrovsky National Research Centre of Surgery, class: OTHER, descriptionModule briefSummary: Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data., conditionsModule conditions: Aorta Abdominalis; Aneurysm, conditions: Aorta Thoracic; Aneurysm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Lymphoblock, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea), primaryOutcomes measure: Number of Participants with Lymphocele, secondaryOutcomes measure: The amount of drainage discharge 1, secondaryOutcomes measure: The amount of drainage discharge 2, secondaryOutcomes measure: The amount of drainage discharge 3, secondaryOutcomes measure: Concentration of triglycerides in the drainage discharge, secondaryOutcomes measure: Concentration of triglycerides in blood plasma, secondaryOutcomes measure: Concentration of cholesterol in the drainage discharge, secondaryOutcomes measure: Concentration of cholesterol in the blood plasma, secondaryOutcomes measure: Concentration of protein in the drainage discharge, secondaryOutcomes measure: Concentration of protein in the blood plasma, secondaryOutcomes measure: Concentration of albumin in the drainage discharge, secondaryOutcomes measure: Concentration of albumin in the blood plasma, secondaryOutcomes measure: Concentration of lactate dehydrogenase in the drainage discharge, secondaryOutcomes measure: Concentration of lactate dehydrogenase in the blood plasma, secondaryOutcomes measure: Concentration of glucose in the drainage discharge, secondaryOutcomes measure: Concentration of glucose in the blood plasma, secondaryOutcomes measure: Number of Participants with Pleural effusion within 10 days, secondaryOutcomes measure: Number of Participants with Lymphocele 3 months after the surgery, secondaryOutcomes measure: Number of Participants with Pleural effusion 3 months after the surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Petrovsky NRCS, status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Denis Breshenkov, Phd, role: CONTACT, phone: +79773439041, email: [email protected], contacts name: Boris Tivelev, role: CONTACT, phone: +79044244886, email: [email protected], contacts name: Omar Mutaev, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False |
protocolSection identificationModule nctId: NCT06286527, orgStudyIdInfo id: EssaiClinique_PREP-QUAL-VS, briefTitle: Quality of Sexual Life of PrEP Users, acronym: PREP-QUAL-VS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-09-06, completionDateStruct date: 2024-09-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life., conditionsModule conditions: HIV Pre-exposure Prophylaxis Use, conditions: Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: anonymous self-administered online questionnaire, outcomesModule primaryOutcomes measure: quality of sexual life as assessed by a set of questions, primaryOutcomes measure: perceived influence of PrEP use on the quality of sexual life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Olivier EPAULARD, city: Grenoble, state: Is, zip: 38043, country: France, contacts name: Olivier EPAULARD, MD, PhD, role: CONTACT, phone: +33476765291, email: [email protected], geoPoint lat: 45.16667, lon: 5.71667, hasResults: False |
protocolSection identificationModule nctId: NCT06286514, orgStudyIdInfo id: STUDY00019996, briefTitle: Food at Home Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish., conditionsModule conditions: Obesity, conditions: Diet, Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Usability of HFI core, primaryOutcomes measure: Acceptability of HFI core, primaryOutcomes measure: Concurrent criterion validity of HFI core, primaryOutcomes measure: Concurrent criterion validity of HFI core, primaryOutcomes measure: Convergent construct validity of HFI core, primaryOutcomes measure: Convergent construct validity of HFI core, primaryOutcomes measure: Test-retest reliability of HFI core, primaryOutcomes measure: Usability of eHFI, primaryOutcomes measure: Acceptability of eHFI, primaryOutcomes measure: Concurrent criterion validity of eHFI, primaryOutcomes measure: Concurrent criterion validity of eHFI, primaryOutcomes measure: Convergent construct validity of eHFI, primaryOutcomes measure: Convergent construct validity of eHFI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Sarah Friend, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06286501, orgStudyIdInfo id: R23060L, briefTitle: Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases, acronym: LumoPrevent, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Wellbeing Services County of Pirkanmaa, class: OTHER, collaborators name: Tampere University, collaborators name: University of Helsinki, collaborators name: Metropolia University of Applied Sciences, descriptionModule briefSummary: The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging., conditionsModule conditions: Dental Caries in Children, conditions: Dental Plaque, conditions: Tooth Decay, conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical study on a CE-approved medical device, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Lumoral Treatment, interventions name: Standard, personalized oral health care, outcomesModule primaryOutcomes measure: Bleeding on probing (BOP), primaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Active matrix metalloproteinase 8 (aMMP-8), secondaryOutcomes measure: Probing Pocket Depth (PPD), secondaryOutcomes measure: Probing Pocket Depth (PPD), secondaryOutcomes measure: Visible plaque index (VPI), secondaryOutcomes measure: Visible plaque index (VPI), secondaryOutcomes measure: Decayed tooth assessment (DT), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Microbiological evaluation/16S rRNA analysis, secondaryOutcomes measure: Microbiological evaluation/16S rRNA analysis, secondaryOutcomes measure: Oral-related quality of life measurement (OHIP-14), secondaryOutcomes measure: Absence of adverse effects, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Wellbeing Services of County Pirkanmaa, city: Tampere, state: Pirkanmaa, zip: 33520, country: Finland, contacts name: Milla Sarja, dentist, role: CONTACT, phone: +358405337979, email: [email protected], contacts name: Mikko Kylmänen, role: CONTACT, email: [email protected], contacts name: Anna Maria Heikkinen, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False |
protocolSection identificationModule nctId: NCT06286488, orgStudyIdInfo id: KB/96/2020, briefTitle: Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-09-15, primaryCompletionDateStruct date: 2023-08-23, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant)., conditionsModule conditions: Influenza, conditions: Obesity, conditions: Pregnancy; Infection, conditions: Elderly Infection, conditions: Vaccine Reaction, conditions: Vaccine Adverse Reaction, conditions: Tolerance, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ACTUAL, armsInterventionsModule interventions name: Vaxigrip, outcomesModule primaryOutcomes measure: influenza vaccine immunogenicity, seroconversion and seroprotection, secondaryOutcomes measure: assessment of vaccination tolerance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Social Medicine and Public Health, Medical University of Warsaw, city: Warsaw, zip: 02-077, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06286475, orgStudyIdInfo id: VGCS-50635-003, briefTitle: A Study of VRG50635 in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Verge Genomics, class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a 2-part study that includes both an open-label (Part 1) and a double-blind, placebo-controlled (Part 2) design. In Part 1, participants will be randomly assigned to receive open-label VRG50635 in 1 of 2 treatment sequences. In Part 2, participants will receive VRG50635 or placebo in a double-blind manner., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: VRG50635, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events, primaryOutcomes measure: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf), primaryOutcomes measure: Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast), primaryOutcomes measure: Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24), primaryOutcomes measure: Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau), primaryOutcomes measure: Maximum Observed Concentration (Cmax), primaryOutcomes measure: Half-life (t1/2), primaryOutcomes measure: Time of Maximal Plasma Concentration (tmax), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Site 001, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68502, country: United States, geoPoint lat: 40.8, lon: -96.66696, hasResults: False |
protocolSection identificationModule nctId: NCT06286462, orgStudyIdInfo id: R01CA278617, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA278617, briefTitle: Evaluation of the Cancer Tracking System (CATSystem), acronym: CATSystem, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, collaborators name: Global Health Innovations, collaborators name: DARTNet Institute, collaborators name: San Diego State University, collaborators name: University of Michigan, descriptionModule briefSummary: Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care)., conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Matched, cluster randomized controlled design, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 6600, type: ESTIMATED, armsInterventionsModule interventions name: Cancer Tracking System (CATSystem), outcomesModule primaryOutcomes measure: Guideline adherent treatment for a positive screen, primaryOutcomes measure: Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes, secondaryOutcomes measure: Cervical cancer screening, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Akala Health Center, status: RECRUITING, city: Akala, country: Kenya, contacts name: May H Maloba, MCH, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, BA, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: -0.06003, lon: 34.42693, locations facility: Bondo Referral Hospital, status: RECRUITING, city: Bondo, country: Kenya, contacts name: May H Maloba, MCH, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, BA, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.23861, lon: 34.26944, locations facility: Alupe Sub-County Hospital, status: RECRUITING, city: Busia, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.46005, lon: 34.11169, locations facility: Busia County Referral Hospital, status: RECRUITING, city: Busia, country: Kenya, contacts name: May H Maloba, MCH, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, BA, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.46005, lon: 34.11169, locations facility: Khunyangu Sub-County Hospital, status: RECRUITING, city: Busia, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.46005, lon: 34.11169, locations facility: Matayos Health Center, status: RECRUITING, city: Busia, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.46005, lon: 34.11169, locations facility: Port Victoria Sub-County Hospital, status: RECRUITING, city: Busia, country: Kenya, contacts name: May H Maloba, MCH, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, BA, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.46005, lon: 34.11169, locations facility: Nambale Sub-County Hospital, status: RECRUITING, city: Siaya, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.06116, lon: 34.28823, locations facility: Yala Sub-County Hospital, status: RECRUITING, city: Siaya, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.06116, lon: 34.28823, locations facility: Ukwala Sub-County Hospital, status: RECRUITING, city: Ukwala, country: Kenya, contacts name: May H Maloba, role: CONTACT, phone: +254720254069, email: [email protected], contacts name: John Ochieng, role: CONTACT, phone: +254735870242, email: [email protected], geoPoint lat: 0.19039, lon: 34.18908, hasResults: False |
protocolSection identificationModule nctId: NCT06286449, orgStudyIdInfo id: CSV_AUD, briefTitle: Identification of Cellular and Molecular Mechanisms Involved in the Pathophysiology of Alcohol Use Disorder by Examination of Cerebrospinal Fluid, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: BACKGROUNDThe brain and spinal cord are enveloped by cerebrospinal fluid (CSF), which extends down to the base of the spine, a few centimeters below the termination of the spinal cord. Here, it can be collected through a minor needle puncture. This procedure enables the gathering of information about otherwise concealed molecular and cellular processes in the brain. Analyzing various specific molecules in the CSF has yielded crucial insights into the underlying mechanisms of many neurological and psychiatric disorders, such as multiple sclerosis (MS) and dementia, significantly enhancing the prospects for its treatment. However, for several brain disorders, including Alcohol Use Disorder (AUD) and substance use disorders, CSF studies are absent. AUD, a brain disease affecting the reward system, is characterized by an inability to limit alcohol consumption. High levels of alcohol intake, as seen in AUD, are a leading cause of morbidity and premature mortality. Yet, there is a lack of effective medications for its treatment. Analyzing molecules in CSF, believed to be significant for the development and maintenance of AUD, could enhance the development of effective pharmacological treatments. At present, there are no CSF studies on individuals with AUD, that explore the underlying mechanisms of the disease. Additionally, several CSF studies lack a representative control group of truly healthy controls (i.e. have not presented any neurological or psychiatric symptoms), which is crucial for drawing accurate conclusions.OBJECTIVESub-study 1 aims to collect CSF from individuals with AUD across various ages to analyze brain molecules that contribute to the development and maintenance of the disease.Sub-study 2 aims to gather CSF from healthy controls across various ages to study molecules involved in neurological and psychiatric conditions, including AUD, substance dependency, brain inflammation, and narcolepsy. The goal is to create a reference group of CSF from healthy controls for comparison with CSF collected from individuals with the aforementioned conditions.We hypothesize that levels of certain molecules, such as dopamine, differ between healthy controls and those with e.g. AUD. This study may provide insights into cellular and molecular mechanisms underlying brain disorders, which is in turn crucial for developing new, effective treatments.Sub-study 3 will examine how the incubation of nerve cells in CSF collected in sub-study 1 and 2 affects their excitability and ability to form new synapses, essential for communication in the brain.We hypothesize that the excitability and synaptogenesis of nerve cells will vary depending on whether they are incubated in CSF from neurologically and psychiatrically healthy individuals versus those with AUD, substance use disorders, brain inflammation, and narcolepsy. Understanding how CSF composition influences brain function in these conditions could be instrumental in creating new therapeutic drugs.METHODSIndividuals with AUD, as well as psychiatrically and neurologically healthy volunteers, will be successively recruited for CSF collection and analyses. Recruitment will be performed through media advertisements and posters within healthcare facilities (The Sahlgrenska University Hospital) and the University of Gothenburg. Additional participants will be recruited from parallel research projects performed within the group (IV-ASA BO10 dnr: 2019-04120, COMB BO8 dnr 431-18, GlycinA BO5 dnr 806-14, PI Bo Söderpalm and NordAlc BO9 dnr: 430-18, PI Andrea de Bejczy) CSF will be obtained through lumbar puncture (spinal tap), a procedure where a thin needle is inserted below the end of the spinal cord. Local anesthesia will be administered in order to mitigate potential discomfort. The lumbar puncture will be performed by an experienced physician, minimizing the risk of injury. Blood samples will also be collected to correlate molecule levels in CSF with those in the blood. Participants will be interviewed about their medical history including their alcohol consumption, and a comprehensive medical examination will be performed.SIGNIFICANCECSF studies offers unique insights into the cellular and molecular processes within the brain. This approach has been utilized for exploring the mechanisms behind several psychiatric and neurological disorders, but not for certain brain diseases like AUD. AUD inflicts significant suffering for affected individuals, contributes to high mortality rates, and imposes considerable burdens on the society. Moreover, a deeper understanding of the cellular and molecular underpinnings of brain diseases such as AUD, can facilitate the development of novel, more effective medications for its treatment., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The intervention in this study consists of a spinal tap that all study participants undergo. We are comparing biomarkers in cerebrospinal fluid collected from either participants with Alcohol Use Disorder or from healthy controls., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spinal tap, outcomesModule primaryOutcomes measure: CSF-DA levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286436, orgStudyIdInfo id: IR.SBMU.RETECH.REC.1401.842, briefTitle: Effect of Dual-task Training on the Number of EEG Band in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-04-29, completionDateStruct date: 2024-05-29, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Universidad de Zaragoza, class: OTHER, descriptionModule briefSummary: Stroke is a prevalent global health concern, causing widespread disability as it disrupts blood supply to the brain, leading to functional impairments. Upper limb dysfunction affects over 80% of stroke survivors acutely and becomes permanent in approximately 60%, hindering daily activities and autonomy. Dual-task training (DTT), involving simultaneous cognitive and motor tasks resembling daily activities, is proposed as an effective intervention.The study suggests using electroencephalogram (EEG) analysis, particularly the Fast Fourier Transform (FFT), to assess changes in brain signals pre- and post-DTT intervention. EEG provides real-time insights into brain function, and FFT analyzes signal frequencies. The intervention involves three tasks performed concurrently with mental calculations, such as sorting blocks and manipulating objects. This 12-session, four-week intervention aims to improve upper limb function. The study explores EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies., conditionsModule conditions: Stroke, conditions: Electroencephalography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Dual-task training, outcomesModule primaryOutcomes measure: EEG Data, secondaryOutcomes measure: Upper limb function, secondaryOutcomes measure: Elbow flexor muscle tone, secondaryOutcomes measure: Wrist extension range of motion, secondaryOutcomes measure: ADLs, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shahid Beheshti University of Medical Sciences, city: Tehran, state: Velenjak, country: Iran, Islamic Republic of, contacts name: Borhan Asadi, Eng, role: CONTACT, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False |
protocolSection identificationModule nctId: NCT06286423, orgStudyIdInfo id: HSR220446, briefTitle: Colchicine in Acutely Decompensated HFREF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo.Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol.These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo.Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time., conditionsModule conditions: Heart Failure, conditions: Decompensated Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study team is planning to use controls in the present study. Controls will be patients from the target population, i.e. acutely decompensated heart failure with reduced ejection fraction., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Colchicine 0.6 mg, interventions name: Control/Placebo group, outcomesModule primaryOutcomes measure: Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment, secondaryOutcomes measure: Difference in hsCRP area under curve between colchicine and placebo arm at 14 days, secondaryOutcomes measure: Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment, otherOutcomes measure: Difference in the incidence of a composite of all-cause mortality or hospitalizations for heart failure at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UVA Health, status: RECRUITING, city: Charlottesville, state: Virginia, zip: 22908, country: United States, contacts name: Austin Hogwood, role: CONTACT, email: [email protected], contacts name: Francesco Moroni, MD, role: CONTACT, email: [email protected], contacts name: Antonio Abbate, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False |
protocolSection identificationModule nctId: NCT06286410, orgStudyIdInfo id: 184950, briefTitle: Accommodation Response in Hypermetropic Anisometropia (ARIHA Study), acronym: ARIHA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Sheffield, class: OTHER, collaborators name: Sheffield Children's NHS Foundation Trust, descriptionModule briefSummary: Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye.With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others.Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics.The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future., conditionsModule conditions: Anisometropic Amblyopia, conditions: Accommodation Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During Phase 2 of the study:The participants found to have residual amblyopia following standard care treatment (completed treatment but still have unequal vision) and asymmetrical accommodation (following their PR3 measurements and data interpretation), will be offered an intervention dependent upon their type of asymmetrical accommodation. There will not be any cross over in the treatment arms, and no randomisation during this pilot study, as the interventions differ and are bespoke to each patient.Asymmetrical accommodation can be one of two things: Aniso-A and Anti-A., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Bespoke glasses prescription worn during amblyopia treatment., outcomesModule primaryOutcomes measure: Change in visual acuity, secondaryOutcomes measure: Change in PR3 accommodation measurements, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield, city: Sheffield, state: South Yorkshire, zip: S10 2RX, country: United Kingdom, contacts name: Holly Geraghty, role: CONTACT, phone: 0114 215 9005, email: [email protected], contacts name: Gemma Arblaster, role: CONTACT, phone: 0114 215 9005, email: [email protected], contacts name: Holly Geraghty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False |
protocolSection identificationModule nctId: NCT06286397, orgStudyIdInfo id: 855173, briefTitle: Topical Anti-Androgens in Pilonidal Sinus Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:* Does clascoterone improve the severity of pilonidal disease as scored by a physician?* Does clascoterone improve patient symptoms due to pilonidal disease?* Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.Researchers will compare participants who received clascoterone treatment to those who received placebo., conditionsModule conditions: Pilonidal Disease, conditions: Pilonidal Disease of Natal Cleft, conditions: Pilonidal Sinus, conditions: Pilonidal Cyst, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Blinded, Placebo-Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: 1% Clascoterone, interventions name: Vehicle Cream, outcomesModule primaryOutcomes measure: Physician-Assessed Disease Severity Assessment, primaryOutcomes measure: Dermatology Life Quality Index, secondaryOutcomes measure: Subcutaneous Inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, contacts name: Lillias Maguire, MD, role: CONTACT, phone: 215-662-2078, email: [email protected], contacts name: Lillias Maguire, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06286384, orgStudyIdInfo id: LEMU47, briefTitle: Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-03, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Jinan University, class: OTHER, descriptionModule briefSummary: By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy., conditionsModule conditions: Facial Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, outcomesModule primaryOutcomes measure: Total Volume Change of Nasolabial Folds, primaryOutcomes measure: Change in Maximum Depth of Nasolabial Folds, primaryOutcomes measure: Vertical Elevation Value of Nasolabial Fold Curve Projection Curve, primaryOutcomes measure: Elevation Value of Nasolabial Fold Curve Projection Curve (Along the Nasal Wing Method, primaryOutcomes measure: Change in Mid-Facial Volume, primaryOutcomes measure: Brow Lift Height, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Xuangu LI, role: CONTACT, phone: +8613825136477, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06286371, orgStudyIdInfo id: 2023-13/37, briefTitle: Pelvic Neuro-Angiogenesis in Deep Endometriosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Uludag University, class: OTHER, descriptionModule briefSummary: Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women.Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis.In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy., conditionsModule conditions: Endometriosis-related Pain, conditions: Endometriosis, conditions: Deep Endometriosis, conditions: Endometriosis; Peritoneum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopic Endometriosis Surgery, outcomesModule primaryOutcomes measure: Density of Neuro-Angiogenesis, primaryOutcomes measure: Density of Pain Mediators in Pelvic Peritoneum, secondaryOutcomes measure: Relationship between Neuro-Angiogenesis Density and Pelvic Pain Scores, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Uludag University Faculty Hospital, status: RECRUITING, city: Bursa, state: Gorukle, zip: 16285, country: Turkey, contacts name: Kiper Aslan, Assoc. Prof., role: CONTACT, phone: +905548127272, email: [email protected], contacts name: Erberk Cimer, M.D., role: CONTACT, phone: +905316770596, contacts name: Kiper Aslan, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Erberk Cimer, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Isil Kasapoglu, Assoc. Prof., role: SUB_INVESTIGATOR, contacts name: Cihan Cakir, M.D., role: SUB_INVESTIGATOR, contacts name: Berrin Avci, Prof., role: SUB_INVESTIGATOR, contacts name: Gurkan Uncu, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False |
protocolSection identificationModule nctId: NCT06286358, orgStudyIdInfo id: P2023/346 / CCB : B40620230001, briefTitle: Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK), acronym: ARTIK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Université Libre de Bruxelles, class: OTHER, collaborators name: Erasme University Hospital, descriptionModule briefSummary: Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm.In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG., conditionsModule conditions: Aortic Valve Disease, conditions: Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Kinocardiography, outcomesModule primaryOutcomes measure: Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA, secondaryOutcomes measure: Comparing KCG to clinical assessment, secondaryOutcomes measure: Asses the clinical application of KCG to diagnose AVD and TAA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasme hospital, status: RECRUITING, city: Brussels, zip: 1070, country: Belgium, contacts name: Philippe van de Borne, MD, PhD, role: CONTACT, phone: 2 555 39 60, phoneExt: +32, email: [email protected], contacts name: Philippe van de Borne, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Elza Abdessater, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06286345, orgStudyIdInfo id: 17644, briefTitle: Lifestyle InterVEntion Study in General Practice: LIVES - GP, acronym: LIVES-GP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: GGZ Drenthe Mental Health Institution, descriptionModule briefSummary: Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply., conditionsModule conditions: Depression, Unipolar, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Uncontrolled cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: GLI-LEEF, outcomesModule primaryOutcomes measure: Reach of GLI-LEEF, primaryOutcomes measure: General practice adoption of GLI-LEEF, primaryOutcomes measure: General practitioner adoption of GLI-LEEF, primaryOutcomes measure: Lifestyle coach adoption of GLI-LEEF, primaryOutcomes measure: Adherence to GLI-LEEF, primaryOutcomes measure: Drop-out from GLI-LEEF, primaryOutcomes measure: Barriers and facilitators of the GLI-LEEF implementation, secondaryOutcomes measure: Body weight of the participant as assessed by a medical weight scale, secondaryOutcomes measure: Body height of the participant as assessed by a stadiometer, secondaryOutcomes measure: Waist circumference of the participant as assessed using a tape meter line, secondaryOutcomes measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer, secondaryOutcomes measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45), secondaryOutcomes measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC), secondaryOutcomes measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF), secondaryOutcomes measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES), secondaryOutcomes measure: Insomnia according to the Insomnia Severity Index (ISI), secondaryOutcomes measure: Quality of life according to the Recovering Quality of Life (ReQol), secondaryOutcomes measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Groningen, status: RECRUITING, city: Groningen, zip: 9700 AD, country: Netherlands, contacts name: Huibert Burger, MD PhD, role: CONTACT, phone: +31(0)50 361 6722, phoneExt: 6722, email: [email protected], contacts name: Patrick Brink, role: CONTACT, phone: +31(0)50 361 6724, phoneExt: 6724, email: [email protected], geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06286332, orgStudyIdInfo id: Interventional, briefTitle: Music Therapy in Acute Leukemia Patients With Fatigue, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Chang Gung University, class: OTHER, descriptionModule briefSummary: The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Fatigue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music Therapy, outcomesModule primaryOutcomes measure: Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21., secondaryOutcomes measure: Change from baseline in neutrophil, hemoglobin, abumin at day 21., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286319, orgStudyIdInfo id: 23-00726, briefTitle: Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler", statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period., conditionsModule conditions: Lung Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Angel Cooler, outcomesModule primaryOutcomes measure: Proportion of Devices Deemed "Functional", eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06286306, orgStudyIdInfo id: 2022_0232, secondaryIdInfos id: 2022-A02813-40, type: OTHER, domain: ID-RCB number, ANSM, briefTitle: Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure, acronym: PRIVACY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-24, primaryCompletionDateStruct date: 2025-05-25, completionDateStruct date: 2025-05-25, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Lille, class: OTHER, descriptionModule briefSummary: Acute respiratory failure represents a frequent cause of admission to intensive care units (ICUs). In the absence of tailored interventions, it poses an imminent threat to patients' lives. Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function.This practice is grounded in the concept of " preload responsiveness ". However, the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality.Consequently, preload unresponsiveness assumes a pathological character, potentially indicative of fluid overload or right ventricular dysfunction, both deleterious conditions linked to unfavorable outcomes.Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation.The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic, non-hypercapnic respiratory failure.* Main objective: To evaluate the association between fluid responsiveness, assessed by the inferior vena cava collapsibility index (cIVC) with trans-thoracic echocardiography within the initial 48 hours post-ICU admission, and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic, non-hypercapnic acute respiratory failure.* Secondary objectives: To evaluate the association between fluid responsiveness and mortality at day 28 and day 90, the need of invasive mechanical ventilation, and the number of days free from organ support (vasopressors, mechanical ventilation and renal replacement therapy) by day 28.Upon receipt of both oral and written information, patients will provide non-objection to participate in the study. This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval (No. 2022-A02813-40)., conditionsModule conditions: Hypoxemic Without Hypercapnia Acute Respiratory Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Association between fluid responsiveness and death or the need of invasive mechanical ventilation, secondaryOutcomes measure: All cause mortality, secondaryOutcomes measure: Need of invasive mechanical ventilation, secondaryOutcomes measure: Days alive without vasopressor agents, secondaryOutcomes measure: Days alive without mechanical ventilation or oxygen support, secondaryOutcomes measure: Days alive without renal replacement therapy, secondaryOutcomes measure: Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Roger Salengro, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: PREAU Sebastien, Md PHd, role: CONTACT, phone: 03 20 44 64 45, email: [email protected], contacts name: Delforge Quentin, Md, role: CONTACT, phone: 0320446445, email: [email protected], geoPoint lat: 50.63297, lon: 3.05858, hasResults: False |
protocolSection identificationModule nctId: NCT06286293, orgStudyIdInfo id: 18171, briefTitle: YOD-RiSoCo: Social Cognition and Risky Decision-making in Patients With Young-onset Dementia, acronym: YOD-RiSoCo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.* Examine if there is a relation between social cognition tests and measures of risky behaviour.Participants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited., conditionsModule conditions: Young-onset Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological assessment, driving simulator task, outcomesModule primaryOutcomes measure: Social cognitive performance, secondaryOutcomes measure: Association between social cognition and risky decision-making, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286280, orgStudyIdInfo id: AZ221/21, secondaryIdInfos id: F/23/22, type: OTHER_GRANT, domain: German Foundation of Heart Research, briefTitle: Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery, acronym: ROCKSTAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, collaborators name: Deutsche Stiftung für Herzforschung, descriptionModule briefSummary: Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell (EPCs) activation during extracorporeal circulation (ECC) is lacking.This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation., conditionsModule conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: single-center, two-arm randomized-controlled prospective study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participant will not be informed about group allocation, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: cytokine adsorber (CytoSorb®), outcomesModule primaryOutcomes measure: correlation of endothelial progenitor cells with cytokine levels with and without adsorber use, secondaryOutcomes measure: Overall mortality rate, secondaryOutcomes measure: Days on ventilator, vasopressor and renal replacement therapy, secondaryOutcomes measure: incidence of stroke, secondaryOutcomes measure: length of ICU and in-hospital stay, secondaryOutcomes measure: Echocardiographic changes, secondaryOutcomes measure: Influence of Cytokine on endothelial progenitor cells, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universityhospital Giessen, Department of Cardiovascular Surgery, status: RECRUITING, city: Giessen, zip: 35392, country: Germany, contacts name: Zulfugar T Taghiyev, MD, MBA, role: CONTACT, phone: 80064198556743, email: [email protected], contacts name: Zulfugar T Taghiyev, MD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.58727, lon: 8.67554, hasResults: False |
protocolSection identificationModule nctId: NCT06286267, orgStudyIdInfo id: SYSKY-2023-351-02, briefTitle: AI-Assisted System for Accurate Diagnosis and Prognosis of Breast Phyllodes Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, collaborators name: Sun Yat-sen University, collaborators name: Peking University Shenzhen Hospital, collaborators name: Guangdong Provincial Maternal and Child Health Hospital, collaborators name: The Third Affiliated Hospital of Guangzhou Medical University, descriptionModule briefSummary: Breast phyllodes tumor (PT) is a rare fibroepithelial tumor, accounting for 1% to 3% of all breast tumors, categorized by the WHO into benign, borderline, and malignant, based on histopathology features such as tumor border, stromal cellularity, stromal atypia, mitotic activity and stromal overgrowth. Malignant PTs account for 18%-25%, with high local recurrence (up to 65%) and distant metastasis rates (16%-25%). Benign PT could progress to malignancy after multiple recurrences. Therefore, Early, accurate diagnosis and identification of therapeutic targets are crucial for improving outcomes and survival rates.In recent years, there has been growing interest in the application of artificial intelligence (AI) in medical diagnostics. AI can integrate clinical information, histopathological images, and multi-omics data to assist in pathological and clinical diagnosis, prognosis prediction, and molecular profiling.AI has shown promising results in various areas, including the diagnosis of different cancers such as colorectal cancer, breast cancer, and prostate cancer. However, PT differs from breast cancer in diagnosis and treatment approach. Therefore, establishing an AI-based system for the precise diagnosis and prognosis assessment of PT is crucial for personalized medicine.The research team, led by Dr. Nie Yan, is one of the few in Guangdong Province and even nationally, specializing in PT research. Their team has been conducting research on the malignant progression, metastasis mechanisms, and molecular markers for PT. The team has identified key mechanisms, such as fibroblast-to-myofibroblast differentiation, and the role of tumor-associated macrophages in promoting this differentiation. They have also identified molecular markers, including miR-21, α-SMA, CCL18, and CCL5, which are more accurate in predicting tumor recurrence risk compared to traditional histopathological grading.The project has collected high-quality data from nearly a thousand breast PT patients, including imaging, histopathology, and survival data, and has performed transcriptome gene sequencing on tissue samples. They aim to build a comprehensive multi-omics database for breast PT and create an AI-based model for early diagnosis and prognosis prediction. This research has the potential to improve the diagnosis and treatment of breast PT, address the disparities in breast PT care across different regions in China, and contribute to the development of new therapeutic targets., conditionsModule conditions: Phyllodes Breast Tumor, conditions: Artificial Intelligence, conditions: Multiomics, conditions: Prognostic Cancer Model, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: imaging, outcomesModule primaryOutcomes measure: Sensitivity, primaryOutcomes measure: False-negative Rate, primaryOutcomes measure: Specificity, primaryOutcomes measure: False-positive Rate, primaryOutcomes measure: Receiver Operating Characteristic Curve, primaryOutcomes measure: Area under roc Curve, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510050, country: China, contacts name: Feng Ye, Prof.Dr., role: CONTACT, phone: 15914388994, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Yan Nie, Prof.Dr., role: CONTACT, phone: +86 020-81332587, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510145, country: China, contacts name: Hui Mai, Prof.Dr., role: CONTACT, phone: 13925129112, geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangdong Maternal and Child Health Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 511400, country: China, contacts name: Yu Tan, Prof.Dr., role: CONTACT, phone: 13632356526, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06286254, orgStudyIdInfo id: CYCL-NTTF-2023, briefTitle: Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: POLYSAN Scientific & Technological Pharmaceutical Company, class: INDUSTRY, descriptionModule briefSummary: The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings., conditionsModule conditions: Acute Respiratory Viral Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 742, type: ACTUAL, armsInterventionsModule interventions name: Cycloferone, outcomesModule primaryOutcomes measure: Average fever duration according to the data of the Patient's Diary, secondaryOutcomes measure: Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)**, secondaryOutcomes measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4, secondaryOutcomes measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale., secondaryOutcomes measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale., secondaryOutcomes measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale., secondaryOutcomes measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy., secondaryOutcomes measure: Frequency of the need to administer the systemic antibacterial therapy, secondaryOutcomes measure: Percentage of patients who needed hospitalization, secondaryOutcomes measure: Average duration of the temporary incapacity period., secondaryOutcomes measure: Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen., secondaryOutcomes measure: Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic Zvezdnaya, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical center Astarta, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Energiya Zdoroviy, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Meily, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Oris, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center PiterClinica, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Reavita Med, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center SOGAZ, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Center Eco-Safety, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No. 117, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No. 44, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity clinic No.109, city: Saint Petersburg, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Сity hospital No. 40, city: Sestroretsk, country: Russian Federation, geoPoint lat: 60.09801, lon: 29.96378, hasResults: False |
protocolSection identificationModule nctId: NCT06286241, orgStudyIdInfo id: 877/2564(IRB2), briefTitle: Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room, acronym: Step down ward, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, collaborators name: Faculty of Medicine Siriraj Hospital, descriptionModule briefSummary: The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:* The incidence of febrile neutropenia, infection, and duration of hospital stay* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: febrile neutropenia, primaryOutcomes measure: Infection, primaryOutcomes measure: duration of admission, primaryOutcomes measure: progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286228, orgStudyIdInfo id: 751/2563(IRB4), briefTitle: Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease, acronym: Haplo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, collaborators name: Faculty of Medicine Siriraj Hospital, descriptionModule briefSummary: The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:* 1-year progression free survival rate* 1-year overall survival rate* Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year* Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year* Rate of Neutrophil and platelet engraftment* Efficacy of donor specific antibody desensitization* Relapsed rate* Primary and late graft failure* Safety and complication of haploHSCT* Complication of viral, bacterial, and fungal infection* Viral reactivation* Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT* Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 43, type: ESTIMATED, outcomesModule primaryOutcomes measure: register hematologic patients with haploidentical hematopoietic stem cell transplantation, secondaryOutcomes measure: progression free survival rate, secondaryOutcomes measure: overall survival rate, secondaryOutcomes measure: Chronic Graft-versus-host free relapsed free survival, secondaryOutcomes measure: Relapsed rate, secondaryOutcomes measure: Primary and late graft failure, secondaryOutcomes measure: Rate of Neutrophil and platelet engraftment, secondaryOutcomes measure: Efficacy of donor specific antibody desensitization, secondaryOutcomes measure: Safety and complication of haploHSCT, secondaryOutcomes measure: Complication of viral, bacterial, and fungal infection, secondaryOutcomes measure: Viral reactivation, secondaryOutcomes measure: outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT, secondaryOutcomes measure: cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286215, orgStudyIdInfo id: 586/2564(IRB2), briefTitle: Registry of Patients With Plasma Cell Disorders, acronym: Registry PCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2034-04-01, completionDateStruct date: 2035-04-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, collaborators name: Faculty of Medicine Siriraj Hospital, descriptionModule briefSummary: The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:* The incidence of plasma cell disorders both before and after malignancy* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)* Progression free survival (PFS)* overall survival* factors influencing overall survival, progression-free survival, and time to progression* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.* genetic characteristics of plasma cell disorder* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record., conditionsModule conditions: Plasma Cell Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 750, type: ESTIMATED, outcomesModule primaryOutcomes measure: register the plasma cell disorder patients, secondaryOutcomes measure: incidence of plasma cell disorders, secondaryOutcomes measure: Time to progression, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: influencing factors, secondaryOutcomes measure: Symptoms and signs, secondaryOutcomes measure: genetic characteristics, secondaryOutcomes measure: cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286202, orgStudyIdInfo id: RECAS-0306, briefTitle: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Singapore Institute of Technology, class: OTHER, collaborators name: Singapore Anglican Community Services, descriptionModule briefSummary: Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied.Therefore, the aims of the study are:* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings.* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability.Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers.This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later., conditionsModule conditions: Schizophrenia, conditions: Schizoaffective Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention study model is a parallel randomized controlled trial. There will be two arms. The experimental arm is 'cognitive remediation' and the control arm is 'standard psychiatric rehabilitation'. Participants will be assigned to one of the treatment arms at the beginning of the trial and will continue in that arm throughout the length of the trial. Assignment to the group is done using a computer randomization generator. All eligible participants will be randomly assigned to one of the treatment arms (experimental or control arm) based on a 1:1 treatment allocation. Hence, those who are randomly allocated to the experimental arm will receive cognitive remediation throughout the trial, while those randomly allocated to the control arm will receive standard psychiatric rehabilitation throughout the trial. Both treatment arms will run in parallel., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Upon randomization, the co-investigators will indicate the allocated group in a separate spreadsheet from the outcome measurements. The co-investigator who is collecting baseline, post-intervention and 8-week outcome measurements will be blinded to the treatment allocation of each participant., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR), interventions name: Standard Psychiatric Rehabilitation at Anglican Care Centers, outcomesModule primaryOutcomes measure: Brief Assessment of Cognition in Schizophrenia (BACS), primaryOutcomes measure: Penn Emotion Recognition Task (ER40), primaryOutcomes measure: The Awareness of Social Inference Test (TASIT)- Part 3, primaryOutcomes measure: Goal Attainment Scale, primaryOutcomes measure: Social and Occupational Functioning Assessment Scale (SOFAS), primaryOutcomes measure: Recovery Assessment Scale-Domain and Stages (RAS-DS), secondaryOutcomes measure: Positive and Negative Syndrome Scale (PANSS), secondaryOutcomes measure: Brief Negative Symptom Scale (BNSS), secondaryOutcomes measure: Brief Regulation of Motivation Scale (BRoMS), otherOutcomes measure: The Global Assessment of Functioning Scale (GAF), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Anglican Care Center-Bukit Batok, city: Singapore, country: Singapore, contacts name: Jonathan Poh, MA, role: CONTACT, phone: +6592333020, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, locations facility: Anglican Care Center-Hougang, city: Singapore, country: Singapore, contacts name: Mingxiu Cai, BSc (Hons), role: CONTACT, phone: +6563869338, phoneExt: 101, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, locations facility: Anglican Care Center-Simei, city: Singapore, country: Singapore, contacts name: Noel Tan, MA, role: CONTACT, phone: +6591853094, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
protocolSection identificationModule nctId: NCT06286189, orgStudyIdInfo id: 2020P002760-t, briefTitle: Trazodone on OSA Endotypes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Placebo oral tablet, interventions name: Trazodone Hydrochloride, outcomesModule primaryOutcomes measure: Effect of trazodone on arousal threshold (%eupnea), secondaryOutcomes measure: Effect of trazodone on apnea hypopnea index (events/h), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Nicole Calianese, BS, role: CONTACT, phone: 617-732-8976, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06286176, orgStudyIdInfo id: LIUIRB-200311-NR1, briefTitle: Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-17, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Nabiha Ramadan, class: OTHER, collaborators name: Universitat de Girona, descriptionModule briefSummary: The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information, and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis., conditionsModule conditions: Breast Feeding, conditions: Exclusive Breastfeeding, conditions: Salutogenesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 101, type: ACTUAL, armsInterventionsModule interventions name: Videos with breastfeeding education material and encouraging messages, interventions name: Whatsapp group, outcomesModule primaryOutcomes measure: breastfeeding initiation, primaryOutcomes measure: Duration of Exclusive breastfeeding, secondaryOutcomes measure: Mean change in Self- esteem in participants from baseline to 6 months postpartum, secondaryOutcomes measure: The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lebanese International University, city: Beirut, zip: 146404, country: Lebanon, geoPoint lat: 33.88894, lon: 35.49442, hasResults: False |
protocolSection identificationModule nctId: NCT06286163, orgStudyIdInfo id: PA4099, briefTitle: Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This study is being done in order to understand what causes people to have a chronic cough, which is defined as a cough lasting for more than 8 weeks. The research team wish to find out whether there is any inflammation in the lungs of patients with chronic cough. The research team will also determine whether a suspected chemical produced in the body, called adenosine triphosphate (ATP) can be responsible for causing the chronic cough. In order to be able to find out what is abnormal in those who have a chronic cough, The research team will need to compare their results with those that do not have a chronic cough.In this study, the research team will examine 10 participants who suffer from chronic cough and 8 individuals who do not have a chronic cough and are healthy., conditionsModule conditions: Chronic Cough, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Presence of ATP in airways of idiopathic chronic cough patients and the localisation of P2X2/3 receptors in the airways, primaryOutcomes measure: Cough sensitivity and laryngeal sensitivity to exogenous ATP, primaryOutcomes measure: Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Brompton & Harefield NHS Trust,, status: RECRUITING, city: London, zip: SW3 6HP, country: United Kingdom, contacts name: Sally Meah, SRN, role: CONTACT, phone: 0207 3518051, email: [email protected], contacts name: Pankaj K Bhavsar, role: CONTACT, phone: 02075947961, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Brompton Hospital, status: RECRUITING, city: London, zip: SW3 6HP, country: United Kingdom, contacts name: Kian Fan Chung, MD, role: CONTACT, phone: 44205947959, email: [email protected], contacts name: Sally Meah, SRN, role: CONTACT, phone: 02073518051, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06286150, orgStudyIdInfo id: EC-2023-087(QX)-03, briefTitle: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2027-07-15, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Surgical robot system, outcomesModule primaryOutcomes measure: Intraoperative conversion rate, primaryOutcomes measure: Surgical complications rate, secondaryOutcomes measure: Intraoperating bleeding volume, secondaryOutcomes measure: Surgical time, secondaryOutcomes measure: Length of hospital admissions, secondaryOutcomes measure: Postoperative wound pain score, secondaryOutcomes measure: Surgeon satisfaction, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Rate of re-admission to hospital, secondaryOutcomes measure: Rate of reoperation, secondaryOutcomes measure: Postoperative mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jianxing He, M.D., role: CONTACT, phone: +86-20-83337792, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06286137, orgStudyIdInfo id: NL82922.078.22, briefTitle: Duration of Music Interventions and Pain Tolerance (DOMINANT), acronym: DOMINANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance., conditionsModule conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The randomized controlled trial will have four study arms. Subjects will be assigned to one of the four arms: control without music and music groups with 1 minute, 5 minutes and 20 minutes. All subjects will receive electric stimuli in three phases. In each phase, subject will be exposed to three consecutive stimuli. First a detection threshold will be measured. Secondly a baseline test will be performed in order to assess basic levels of pain endurance. Hereafter, the intervention phase starts. Subjects in the music groups will listen to 1, 5 and 20 minutes of their own preferred music through headphones. Directly after, all subjects will again receive three electric stimuli., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Due to the nature of the study and the music intervention, it is not possible to blind participants and investigators. However, participants will not be informed of the study arm to which they are randomized in advance., enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Listening to music for 1 minute, interventions name: Listening to music for 5 minutes, interventions name: Listening to music for 20 minutes, interventions name: Not listening to music, outcomesModule primaryOutcomes measure: Pain tolerance, secondaryOutcomes measure: Heart rate variability (HRV), secondaryOutcomes measure: Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire, secondaryOutcomes measure: Valence and arousal, Self-Assessment manikin (SAM) questionnaire, secondaryOutcomes measure: Music listening Questionnaire, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pain unpleasantness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, city: Rotterdam, zip: 3015 GD, country: Netherlands, contacts name: Emy S van der Valk Bouman, MD, role: CONTACT, phone: +31646461901, email: [email protected], contacts name: Antonia S Becker, MD, role: CONTACT, phone: +31641188966, email: [email protected], contacts name: Markus Klimek, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06286124, orgStudyIdInfo id: 8612, briefTitle: Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA), acronym: HYDRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Medtronic, collaborators name: Alrijne Hospital, descriptionModule briefSummary: The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine., conditionsModule conditions: Incisional Hernia of Midline of Abdomen, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Hybrid Surgery, outcomesModule primaryOutcomes measure: Mean peak torque 1 year, secondaryOutcomes measure: Mean peak torque 2 years, secondaryOutcomes measure: Recurrent Incisional Hernia, secondaryOutcomes measure: Severity of surgical complications, secondaryOutcomes measure: Surgical complications, secondaryOutcomes measure: General Quality of Life, secondaryOutcomes measure: Mesh specific Quality of Life, secondaryOutcomes measure: Scar satisfaction, secondaryOutcomes measure: Pain in the abdominal region, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alrijne Hospital, city: Leiden, country: Netherlands, contacts name: Willem Hueting, MSc, role: CONTACT, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False |
protocolSection identificationModule nctId: NCT06286111, orgStudyIdInfo id: ASU MD, briefTitle: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF, conditionsModule conditions: Atrial Fibrillation, conditions: Inflammatory Marker, conditions: Heart; Surgery, Heart, Functional Disturbance as Result, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 76, type: ESTIMATED, outcomesModule primaryOutcomes measure: Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06286098, orgStudyIdInfo id: ALA in Pediatrics on HD, briefTitle: Alpha Lipoic Acid in Pediatrics on Hemodialysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-20, completionDateStruct date: 2024-10-20, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, collaborators name: Eva Pharma, descriptionModule briefSummary: The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:* Will the use of alpha lipoic acid lower cardiovascular events in that population?* Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?* Will the drug cause side effects?Participants will:* take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.* be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)* be monitored for the occurrence of side effects* give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme* undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet., conditionsModule conditions: Hemodialysis Complication, conditions: Pediatric Kidney Disease, conditions: Cardiovascular Complication, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Alpha lipoic acid, interventions name: Placebo, outcomesModule primaryOutcomes measure: Serum level of E-Selectin, secondaryOutcomes measure: Serum levels of superoxide dismutase (SOD), secondaryOutcomes measure: Number of cardiovascular events, secondaryOutcomes measure: Number of Adverse effects, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: New Pediatrics Hospital, Faculty of Medicine, Ain Shams University, city: Cairo, state: El Weili, zip: 11381, country: Egypt, contacts name: Mahmoud Mohsen, Pharmacist, role: CONTACT, phone: +201275811494, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06286085, orgStudyIdInfo id: 337788, briefTitle: A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma, acronym: MODELS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2024-07-24, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Portsmouth Hospitals NHS Trust, class: OTHER_GOV, descriptionModule briefSummary: This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Lung function tests, outcomesModule primaryOutcomes measure: International asthma guidelines scores, primaryOutcomes measure: non-guideline physiologic criteria, secondaryOutcomes measure: non-guideline physiologic criteria for asthma., secondaryOutcomes measure: Comparison of the diagnostic outcomes of each guideline with a "reference standard"., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Portsmouth Hospitals University NHS Trust, status: RECRUITING, city: Portsmouth, country: United Kingdom, contacts name: Laura Marshall, role: CONTACT, phone: 02392286000, email: [email protected], geoPoint lat: 50.79899, lon: -1.09125, hasResults: False |
protocolSection identificationModule nctId: NCT06286072, orgStudyIdInfo id: YCEYHANS, briefTitle: The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.The main questions it aims to answer are:1. Does the training given in COPD affect the level of fatigue?2. Do the education given and text messages sent regarding COPD affect the level of fatigue?In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.The initial information of all groups was taken again at the end of the 8th week.Main outcomes:* Dyspnea severity,* COPD general conditions and* Fatigue level. The results obtained will be interpreted by comparing between 3 groups., conditionsModule conditions: Copd, conditions: Fatigue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled Trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Education and message, outcomesModule primaryOutcomes measure: Fatigue Level, primaryOutcomes measure: Dyspnea Severity, secondaryOutcomes measure: COPD general condition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasemin CEYHAN, status: RECRUITING, city: Kırşehir, state: Center, zip: 40100, country: Turkey, contacts name: Yasemin CEYHAN, PhD, role: CONTACT, phone: +9054645898065, email: [email protected], contacts role: CONTACT, phoneExt: CEYHAN, email: [email protected], contacts name: Yasemin CEYHAN, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False |
protocolSection identificationModule nctId: NCT06286059, orgStudyIdInfo id: Phentolamine for CA-AKI, briefTitle: Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI., conditionsModule conditions: CA-AKI - Contrast-Associated Acute Kidney Injury, conditions: Coronary Artery Disease, conditions: Acute Coronary Syndrome, conditions: Adrenergic Receptor Antagonist Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Single Blinded, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Phentolamine, outcomesModule primaryOutcomes measure: Rate of CA-AKI, secondaryOutcomes measure: Peak of serum creatinine elevation, secondaryOutcomes measure: Duration of CA-AKI, secondaryOutcomes measure: Change in HR, secondaryOutcomes measure: Change in SBP, secondaryOutcomes measure: Change in DBP, secondaryOutcomes measure: Urine output, secondaryOutcomes measure: Rate of RRT, secondaryOutcomes measure: Rate of MACE, secondaryOutcomes measure: Rate of rehospitalization, secondaryOutcomes measure: Duration of hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Badr university hospital, status: RECRUITING, city: Badr, state: Cairo, country: Egypt, contacts name: Mohammed Soliman, MBBCH, role: CONTACT, phone: +201032137563, email: [email protected], hasResults: False |
protocolSection identificationModule nctId: NCT06286046, orgStudyIdInfo id: AG348-C-026, secondaryIdInfos id: 2023-510289-28-00, type: OTHER, domain: EU Clinical Trial Number, briefTitle: A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Agios Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy., conditionsModule conditions: Sickle Cell Disease, conditions: Nephropathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mitapivat, outcomesModule primaryOutcomes measure: Percentage of Participants With Albumin Creatinine Ratio (ACR) Response, secondaryOutcomes measure: Change From Baseline in Cystatin C and Creatinine-based Estimated Glomerular Filtration Rate (eGFRcr-cys), secondaryOutcomes measure: Change From Baseline in Albumin Creatinine Ratio (ACR), secondaryOutcomes measure: Percentage of Participants With Stable ACR, secondaryOutcomes measure: Annualized Rate of Emergency Room (ER) Visits, secondaryOutcomes measure: Annualized Rate of Days of Hospitalizations, secondaryOutcomes measure: Type, Frequency, Severity, and Relationship to Study Drug of Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
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