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protocolSection identificationModule nctId: NCT06317246, orgStudyIdInfo id: ECDSUB, briefTitle: Subtypes and Prognostic Factors in Erdheim-Chester Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease., conditionsModule conditions: Erdheim-Chester Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Investigation of BRAF mosaicism, outcomesModule primaryOutcomes measure: Clinical characteristics of patients with Erdheim-Chester Disease, primaryOutcomes measure: Prognostic factors of patients with Erdheim-Chester Disease, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, country: Italy, contacts name: Augusto Vaglio, role: CONTACT, email: augusto.vaglio@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: AOU Parma, status: RECRUITING, city: Parma, country: Italy, contacts name: Domenico Corradi, role: CONTACT, email: domenico.corradi@unipr.it, geoPoint lat: 44.79935, lon: 10.32618, hasResults: False
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protocolSection identificationModule nctId: NCT06317233, orgStudyIdInfo id: STUDY00007131, briefTitle: Outcomes of a Multidisciplinary Program for the Treatment of Chronic Pelvic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Medstar Health Research Institute, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. The main questions it aims to answer are:* How does the handbook and follow-up impact patient satisfaction?* How does the handbook and follow-up impact patient pain and quality of life scores? Participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule., conditionsModule conditions: Chronic Pelvic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Chronic Pelvic Pain Treatment Guide, outcomesModule primaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Pain Catastrophizing, secondaryOutcomes measure: Pelvic Pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-29, uploadDate: 2024-03-03T20:29, filename: Prot_000.pdf, size: 138543, hasResults: False
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protocolSection identificationModule nctId: NCT06317220, orgStudyIdInfo id: 2024P000152, briefTitle: Vedolizumab for the Treatment of Collagenous Gastritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Takeda, collaborators name: Dana-Farber Cancer Institute, descriptionModule briefSummary: The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:* Whether vedolizumab can reduce CG symptoms* Whether vedolizumab is safe to take for patients with CGParticipants in this study will:* Receive vedolizumab through an IV ("infusion")* Complete a survey at each infusion visit* Have blood collected at each infusion visit* Undergo an endoscopy with biopsy, conditionsModule conditions: Collagenous Gastritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Vedolizumab, outcomesModule primaryOutcomes measure: Change in symtpoms, secondaryOutcomes measure: Response durability, secondaryOutcomes measure: Histologic response, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (safety), otherOutcomes measure: Immunologic response in gastric mucosa, otherOutcomes measure: Immunologic response in peripheral blood, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Keri Sullivan, role: CONTACT, phone: 617-724-0195, email: ksullivan79@mgh.harvard.edu, contacts name: Jamie DiCarlo, role: CONTACT, phone: 617-724-9347, email: jdicarlo3@mgh.harvard.edu, contacts name: Michael L Dougan, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lestat Ali, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06317207, orgStudyIdInfo id: PJ2024-01-44, secondaryIdInfos id: 2019b07030004, type: OTHER_GRANT, domain: Anhui Provincial Central Government Guides Local Science and Technology Development Project-Anhui Clinical Research Ce, briefTitle: Evaluation of the Safety of Reoperation for Ipsilateral Recurrent Tumors After Nephron-sparing Partial Nephrectomy, acronym: LiangAH, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Anhui Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy., conditionsModule conditions: Renal Cell Carcinoma, conditions: Robotic Surgical Procedures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Operation time, secondaryOutcomes measure: Estimated blood loss, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06317194, orgStudyIdInfo id: Magnetic Tides, briefTitle: A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-08-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Magnetic Tides, class: INDUSTRY, collaborators name: University of California, Berkeley, descriptionModule briefSummary: Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: kTMP, interventions name: Sham kTMP, outcomesModule primaryOutcomes measure: Fugl- Meyer Assessment (Upper Extremity), secondaryOutcomes measure: Action Research Arm Test (ARAT), secondaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: Trial to Trial Variability (T2TV), secondaryOutcomes measure: Range of Joint Motion (ROM), secondaryOutcomes measure: Grasp to Lift Time, secondaryOutcomes measure: Transport Time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Magnetic Tides, city: El Cerrito, state: California, zip: 94530, country: United States, geoPoint lat: 37.91576, lon: -122.31164, hasResults: False
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protocolSection identificationModule nctId: NCT06317181, orgStudyIdInfo id: DifLivSPECTRUS, briefTitle: Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data, acronym: LivSPECTRUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Technische Universität Dresden, class: OTHER, collaborators name: University Hospital Dresden, collaborators name: University of Leipzig, descriptionModule briefSummary: The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort.The main questions the study aims to answer are:* Can a neuronal network trained on RF Data perform equally good as elastography in the assessment of diffuse liver diseases?* Can a neuronal network trained on RF Data perform better than a neuronal network trained on b-mode images in the assessment of diffuse liver diseases?* Can a neuronal network trained on RF Data distinguish focal pathologies in the liver from healthy tissue?To answer these questions participants with a clinically indicated fibroscan will undergo:* a clinical elastography in Case ob suspected diffuse liver disease* a reliable ground truth (if normal ultrasound is not sufficient e.g. contrast enhanced ultrasound, biopsy, MRI or CT) in case of focal liver diseases, depending on the standard routine of the participating center* a clinical ultrasound examination during which b-mode images and the corresponding RF-Data sets are captured, conditionsModule conditions: Artificial Intelligence, conditions: Ultrasonography, conditions: Elasticity Imaging Techniques, conditions: Liver Diseases, conditions: Metastasis to Liver, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Data is collected in a defined group of patients (all patients listed for elastography or for ultrasonic investigation due to a focal lesion in participating departments). Afterwards performances of algorithms are compared based on this group., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Collection of elastography data, interventions name: Collection of ultrasonic raw data, outcomesModule primaryOutcomes measure: Performance analysis of the trained model, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-01, uploadDate: 2024-03-15T03:02, filename: Prot_000.pdf, size: 271228, hasResults: False
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protocolSection identificationModule nctId: NCT06317168, orgStudyIdInfo id: SIMPLE-AOBP, briefTitle: SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements (Pilot Study), acronym: SIMPLE-AOBP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, class: OTHER, descriptionModule briefSummary: This study aims to assess whether removing single elements of the standardized office BP measurement procedure will affect the accuracy towards the mean awake ambulatory BP. Four arms are planned in a randomized order: 1) full standardized procedure, 2) standardized procedure but with cuff placed on a sleeve, 3) standardized procedure but arm resting vertically, 4) standardized procedure but with non-validated device.This is a pilot study to inform on the sample size required to perform adequately powered large scale studies., conditionsModule conditions: Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Mean awake ambulatory BP measurements, outcomesModule primaryOutcomes measure: Difference with mean awake ambulatory systolic BP, secondaryOutcomes measure: Difference with mean awake ambulatory diastolic BP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317155, orgStudyIdInfo id: BournemouthU-AS, briefTitle: Occupational Therapy for Children and Young People Who Self-harm: A Qualitative Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Bournemouth University, class: OTHER, collaborators name: Dorset HealthCare University NHS Foundation Trust, descriptionModule briefSummary: The goal of this qualitative observational study is to explore the experiences of children and their carers, receiving occupational therapy for self-harm and the experiences of health professionals delivering these interventions. The child cohort within the study will have a history of self-harm and have been under the care of Children and Adolescent Mental Health Services.The main questions it aims to answer are:* What are the experiences of children and their carers who have received occupational therapy interventions as either a standalone, or adjunct, treatment for self-harm, whilst under the care of Tier 4 CAMHS service.* What are the experiences of healthcare professionals delivering occupational therapy interventions working within a T4 CAMHS service.* To understand the participants views on whether occupational therapy interventions are a viable and effective approach to address self-harm amongst young people.Participants will be asked to complete a questionnaire and take part in a single semi-structured interview. 25% of participants may be asked to take part in a further in depth semi-structured interview., conditionsModule conditions: Self Harm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Occupational therapy, outcomesModule primaryOutcomes measure: What was the participants experience of receiving or delivering an occupational therapy informed intervention?, primaryOutcomes measure: What was the participants experience of receiving or delivering an occupational therapy informed intervention?, primaryOutcomes measure: Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm?, primaryOutcomes measure: Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm?, eligibilityModule sex: ALL, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317142, orgStudyIdInfo id: NL84574.068.23, briefTitle: Glucose and Glycogen Dynamics in Prediabetes, acronym: GGD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate changes in nocturnal and postprandial glucose and glycogen metabolism in individuals with impaired fasting glucose and impaired glucose tolerance compared to healthy, non-diabetic, overweight participants (15 per group). In addition, it will be investigated if reducing gluconeogenesis, by using the challenge agent Acipimox, in people with prediabetes can increase glucose tolerance and fat oxidation by increased reliance on hepatic glycogen. The main questions this project aims to answer are:* whether there are differences in nocturnal glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.* whether there are differences in postprandial glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.Participants will visit the university for a screening visit and a visit with overnight stay for measurements of gluconeogenesis, glycogen, and substrate oxidation. A subgroup will receive \[18F\]-FDG to assess tissue-specific postprandial glucose uptake. Thereafter, 20 prediabetic individuals will follow a 4-day treatment with acipimox to decrease gluconeogenesis, followed by a second overnight visit with similar measurements as mentioned for the first visit., conditionsModule conditions: Pre Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Acipimox 250 mg Oral Capsule, outcomesModule primaryOutcomes measure: Hepatic and muscle glycogen measured by 13Carbon-Magnetic resonance spectroscopy (13C-MRS), primaryOutcomes measure: Whole body gluconeogenesis determined by deuterated water, primaryOutcomes measure: Postprandial hepatic and muscle glucose uptake determined by Fluorodeoxyglucose-Positron emission tomography ([18F]-FDG-PET) combined with oral glucose tolerance test (OGTT), secondaryOutcomes measure: Oral glucose tolerance after acipimox treatment measured by OGTT, secondaryOutcomes measure: Hepatic glycogen after acipimox treatment measured by 13C-MRS, secondaryOutcomes measure: Whole body gluconeogenesis after acipimox treatment determined by deuterated water, otherOutcomes measure: Hepatic acetylcarnitine as a measure for hepatic gluconeogenesis determined by H-MRS, otherOutcomes measure: Substrate oxidation (fat and carbohydrate oxidation) determined by indirect calorimetry, otherOutcomes measure: Dynamic water relaxation measurements with 1H-MRS (surrogate glycogen), otherOutcomes measure: Anthropometric measurements, otherOutcomes measure: Body composition determined by Bodpod, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University, status: RECRUITING, city: Maastricht, state: Limburg, zip: 6229ER, country: Netherlands, contacts name: Kay Roumans, PhD, role: CONTACT, phone: 433882124, phoneExt: 31, email: k.roumans@maastrichtuniversity.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06317129, orgStudyIdInfo id: CP000005, briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: BariaTek Medical, class: INDUSTRY, descriptionModule briefSummary: Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic gastric restriction and biliodigestive diversion, outcomesModule primaryOutcomes measure: Safety of the BariTon™, primaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Safety of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, secondaryOutcomes measure: Efficacy of the BariTon™, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov, status: RECRUITING, city: Tashkent, country: Uzbekistan, contacts name: Abdurashid Abdukarimov, Dr, role: CONTACT, geoPoint lat: 41.26465, lon: 69.21627, hasResults: False
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protocolSection identificationModule nctId: NCT06317116, orgStudyIdInfo id: 2023/09-14, briefTitle: Examining the Relationship Between Core Muscles and Bladder Issues in Children, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-29, primaryCompletionDateStruct date: 2024-09-29, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Izmir Bakircay University, class: OTHER, collaborators name: Dokuz Eylul University, collaborators name: Ege University Medical School, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The goal of this observational study is to learn about functional bladder problems in children. The main questions it aims to answer are:* Does bladder symptoms in children have an effect on core muscles?* How do core muscles change based on an increase or decrease in these symptoms?, conditionsModule conditions: Lower Urinary Tract Symptoms, conditions: Skeletal Muscle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: Dysfunctional Voiding and Incontinence Scoring System (DVAISS), primaryOutcomes measure: Bladder and Bowel Dysfunction Questionnaire (BBDQ), primaryOutcomes measure: Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ), primaryOutcomes measure: Bladder Diary, primaryOutcomes measure: Bowel Diary, secondaryOutcomes measure: Superficial Electromyography (EMG), secondaryOutcomes measure: Ultrasonography (USG), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ege University Hospital Pediatric Urology Outpatient Clinic, city: İzmir, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06317103, orgStudyIdInfo id: WAY-CTP-WME01-MSM, briefTitle: A Clinical Trial to Evaluate the Sensitivity and Specificity of "WAYMED Endo" Compared to the Endoscopists in Classifying Early Gastric Cancer (EGC) Based on the Depth of Invasion in Endoscopic Images, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-22, primaryCompletionDateStruct date: 2023-08-22, completionDateStruct date: 2023-08-22, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: WAYCEN Inc, class: INDUSTRY, descriptionModule briefSummary: The purpose of this clinical trial is to prove that the prediction capability of 'WAYMED endo' is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images.The computer-aided detection·diagnosis software is an Artificial Intelligence (AI) software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface (UI)., conditionsModule conditions: Early Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 653, type: ACTUAL, armsInterventionsModule interventions name: WADYMED endo, interventions name: Control group (the endoscopists), outcomesModule primaryOutcomes measure: Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%), primaryOutcomes measure: Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%), secondaryOutcomes measure: Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Gangnam Severance Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06317090, orgStudyIdInfo id: S59813-2, briefTitle: Vertical GBR LPRF Block vs. Autogenous Bone With DBBM, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-02, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group., conditionsModule conditions: Alveolar Bone Resorption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: split-mouth 2 arm RCT, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: neither the patient, nor the outcome assessor was aware at which side which grafting material was used, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: guided bone regeneration, outcomesModule primaryOutcomes measure: bone volume as measured on CBCT scans, secondaryOutcomes measure: Buccal bone thickness around the implants, secondaryOutcomes measure: Buccal bone thickness around the implants, secondaryOutcomes measure: Cumulative survival rate of the implants, secondaryOutcomes measure: rates and types of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06317077, orgStudyIdInfo id: I5-R1-C-FA, briefTitle: Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks, acronym: EventLAB FF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Löwenstein Medical Technology GmbH & Co. KG, class: INDUSTRY, descriptionModule briefSummary: Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing events. For this purpose, breathing events of different classes are detected, counted and identified.This clinical investigation aims to evaluate the performance of prismaLINE devices based on the accuracy of the apnea-hypopnea index (AHI) recorded in the devices. During the PAP titration night, the AHI is similarly detected via polysomnography (PSG) device and a subsequent manual scoring of the recorded PSG data. The validation of the device AHI accuracy refers to the alignment with the manually scored AHI.Further goals of this clinical investigation are the confirmation of safety of the prismaLINE devices, the confirmation of performance and safety of LM full face masks (full face masks of the manufacturer Löwenstein Medical Technology), as well as the investigation of the influence of LM full face masks on therapy quality.The most relevant inclusion criteria are diagnosis of a sleep-related breathing disorder and indication for therapy with continuous positive airway pressure (CPAP). Treatment takes place with prismaLINE PAP therapy devices in combination with LM full face masks., conditionsModule conditions: Sleep Apnea Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: PAP therapy setting, interventions name: exclusive use of Löwenstein Medical full face masks, outcomesModule primaryOutcomes measure: Delta AHI [n/h]= Difference of device AHI (prismaLINE devices of the type WM100TD) and the manual scored AHI of polysomnographic data identified in the Matlab-based SOMNOmat tool, secondaryOutcomes measure: N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration, secondaryOutcomes measure: Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire, secondaryOutcomes measure: N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration, secondaryOutcomes measure: Delta AI [n/h]= difference of apnea-indices (obstructive/central/mixed) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta HI [n/h]= difference of hypopnea-indices (obstructive/central) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta Event_individual [n]= difference of the number (with time, duration, type) of residual breathing events (apneas/hypopneas) device vs. PSG identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: N_influenced phases [n]= number (with time, duration, type) of phases with significant deviations between the synchronized device and PSG files identified in the Matlab-based tool SOMNOmat, secondaryOutcomes measure: Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0, secondaryOutcomes measure: Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0, secondaryOutcomes measure: Delta AHI_mean [n/h]= difference between apnea indices using mean of scoring rule 1A and 1B from AASM manual version 3.0 (AHI_1A + AHI_1B)/2, secondaryOutcomes measure: Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG, secondaryOutcomes measure: N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking, secondaryOutcomes measure: corr_flow-sleep= correlation between flow signal and sleep state, secondaryOutcomes measure: corr_marker= correlation between diagnostic sleep apnea syndrom markers with medical history data, biomarkers of the diagnostic night, therapy pressure and sleep stage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Krankenhaus Bethanien, city: Solingen, state: NRW, zip: 42699, country: Germany, contacts name: Marc Treml, Dr., role: CONTACT, geoPoint lat: 51.17343, lon: 7.0845, hasResults: False
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protocolSection identificationModule nctId: NCT06317064, orgStudyIdInfo id: LMRC-Aprepitant-Pain-01, briefTitle: Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Lahore Medical Research Center, LLP, class: INDUSTRY, descriptionModule briefSummary: Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses. Substance P (SP) and NK1R mediate the symptoms of various pain disorders with chronic and/or neuropathic pain. Objective: To evaluate diagnostic and therapeutic potential of Substance P/ NK1R receptor in primary dysmenorrhea. Study Design: This was a randomized controlled trial which took place at Lahore Medical Research Center from April 2023 to August 2023. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. The study comprised of three phases, Phase 1 (Before medication), Phase 2 (NSAIDs) and Phase 3(Dexamethasone + Aprepitant). 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles. 20 dysmenhorric and 6 controls were analyzed for NK1R levels. Several assessment tools were also used in the study,, conditionsModule conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Group 1: Controls 10 females with no dysmenorrhea participated as controls. Group 2: NSAIDS All 30 participants in this group used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Same patients from phase 2 (n=30) in next cycle received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Ibuprofen and Aprepitant, outcomesModule primaryOutcomes measure: Visual Analogue Scale Score (Pain scale), primaryOutcomes measure: Mini Nutritional Assessment (MNA) Score, primaryOutcomes measure: DASS-21 (Depression Anxiety Stress Scale), primaryOutcomes measure: Pictorial Blood Loss Assessment Chart (PBAC), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Prof. Dr. Riffat Mehboob, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06317051, orgStudyIdInfo id: OPTIMAR, briefTitle: Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART), acronym: OPTIMAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Kirby Institute, class: OTHER_GOV, descriptionModule briefSummary: People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART., conditionsModule conditions: HIV Infections, conditions: Weight Gain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Pitavastatin 4 Mg Oral Tablet, interventions name: Rosuvastatin and Ezetimibe, interventions name: Placebo, outcomesModule primaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo on weight reduction, primaryOutcomes measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration, secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2, secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio, secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio, secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem., secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples), secondaryOutcomes measure: To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events., secondaryOutcomes measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L), secondaryOutcomes measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem., secondaryOutcomes measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples), secondaryOutcomes measure: To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317038, orgStudyIdInfo id: 89814415, briefTitle: To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Tauber Eye Center, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data., conditionsModule conditions: Eye Strain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label Observation, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Total 30 Contact Lens, outcomesModule primaryOutcomes measure: Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear)., secondaryOutcomes measure: Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear., secondaryOutcomes measure: Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire., secondaryOutcomes measure: Report on total daily wear time and digital device usage., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317025, orgStudyIdInfo id: SHOUFA2022-2Z-2039, briefTitle: Design and Development of Multi-modal Intelligent Anesthesia Monitoring System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Beijing Chao Yang Hospital, class: OTHER, descriptionModule briefSummary: This project integrates the characteristics of electroencephalo-graph（EEG）, cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs., conditionsModule conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Multi-modal Intelligent Anesthesia Monitoring System, outcomesModule primaryOutcomes measure: the depth of anesthesia (too deep or too shallow), secondaryOutcomes measure: EEG characteristics of loss of consciousness induced by different general anesthesia drugs, secondaryOutcomes measure: Characteristics of perioperative neurovascular coupling, eligibilityModule sex: ALL, maximumAge: 85 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06317012, orgStudyIdInfo id: 0407-03/2022, briefTitle: Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hams Hamed Abdelrahman, class: OTHER, descriptionModule briefSummary: Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month., conditionsModule conditions: Le Fort; I, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate, outcomesModule primaryOutcomes measure: Change in pain, primaryOutcomes measure: change in edema, primaryOutcomes measure: Change in post operative osteotomy position, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alexandria Faculty of Dentistry, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06316999, orgStudyIdInfo id: 23-012169, briefTitle: Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA)., conditionsModule conditions: Ulcerative Colitis, conditions: Pouchitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Intestinal Ultrasound, outcomesModule primaryOutcomes measure: Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Darrell Pardi, MD, MS, role: CONTACT, phone: 507-284-2511, email: pardi.darrell@mayo.edu, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06316986, orgStudyIdInfo id: 2023-A02294-41, briefTitle: Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care., acronym: NGPOD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fondation Hôpital Saint-Joseph, class: OTHER, descriptionModule briefSummary: In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray., conditionsModule conditions: Intensive Care, conditions: Nutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: pH indication with NGPOD, outcomesModule primaryOutcomes measure: Ability of the NGPOD device to detect correct positioning of the gastric tube., secondaryOutcomes measure: Probe malpositioning, secondaryOutcomes measure: Time to validate correct positioning of gastric tube, secondaryOutcomes measure: Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system, secondaryOutcomes measure: x-ray manipulators time, secondaryOutcomes measure: Adverse events occurring during the study period, secondaryOutcomes measure: Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Marie Lannelongue, city: Le Plessis-Robinson, zip: 92350, country: France, contacts name: Audrey IMBERT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.78889, lon: 2.27078, hasResults: False
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protocolSection identificationModule nctId: NCT06316973, orgStudyIdInfo id: CS-1103-01, secondaryIdInfos id: U01DA053054, type: NIH, link: https://reporter.nih.gov/quickSearch/U01DA053054, briefTitle: A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Clear Scientific, Inc., class: INDUSTRY, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants., conditionsModule conditions: Substance Use Disorders, conditions: Methamphetamine Abuse, conditions: Methamphetamine Intoxication, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CS-1103, interventions name: Sterile Saline, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events (AEs) assessed by physical examinations, primaryOutcomes measure: Number of participants with treatment-related adverse events (AEs) assessed by vital signs, primaryOutcomes measure: Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs), primaryOutcomes measure: Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters, secondaryOutcomes measure: Time course of CS-1103 blood and urine concentrations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dr. Vince Clinical Research, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66212, country: United States, contacts name: Lori Adriano, role: CONTACT, phone: 913-333-3000, contacts name: Steven Hull, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, hasResults: False
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protocolSection identificationModule nctId: NCT06316960, orgStudyIdInfo id: AVACBFKIT, briefTitle: Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation., conditionsModule conditions: AML, Childhood, conditions: Relapse/Recurrence, conditions: Refractory AML, conditions: Core Binding Factor Acute Myeloid Leukemia, conditions: C-KIT Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Avapritinib, interventions name: Azacitidine Injection, interventions name: Decitabine Injection, interventions name: Idarubicin Hydrochloride, interventions name: Cytarabine, interventions name: Granulocyte Colony-Stimulating Factor, outcomesModule primaryOutcomes measure: Composite remission rate (CRc), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital Of University of Science and Technology of China, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Chun Li, MD,PhD, role: CONTACT, phone: +86-13865992676, email: lichun1230@sohu.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Hospital of Anhui Medical University, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Ninglin Wang, MD, role: CONTACT, phone: +86-13721113063, email: zwnltt@126.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Guangzhou Women and Children Medical Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Hua Jiang, MD, PhD, role: CONTACT, phone: +86-13533330985, email: jiang_hua18@sina.cn, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, status: NOT_YET_RECRUITING, city: Nanning, state: Guangxi, zip: 530000, country: China, contacts name: Ning Liao, MD, role: CONTACT, phone: +86-13978812808, email: ln12808@163.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Kaifeng Children's Hospital, status: NOT_YET_RECRUITING, city: Kaifeng, state: Henan, zip: 475000, country: China, contacts name: Jixia Luo, MD, role: CONTACT, phone: +86-13592146539, email: luojixia@163.com, geoPoint lat: 34.7986, lon: 114.30742, locations facility: The First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, contacts name: Yufeng Liu, MD,PhD, role: CONTACT, phone: +86-13673666608, email: lyf6012@126.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Third Xiangya Hospital of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410000, country: China, contacts name: Minghua Yang, MD, role: CONTACT, phone: +86-13973135843, email: yamahua123@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: XiangYa Hospital Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Liangchun Yang, MD,PhD, role: CONTACT, phone: +86-13974927514, email: yangliangchung@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Children's Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Shaoyan Hu, MD, PhD, role: CONTACT, phone: +86-13771835430, email: hsy139@126.com, contacts name: Li Gao, MD, role: CONTACT, phone: +86-15821963190, email: joygaoli@163.com, contacts name: Shaoyan Hu, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Peifang Xiao, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Li Gao, MD, role: SUB_INVESTIGATOR, contacts name: Jun Lu, MD, role: SUB_INVESTIGATOR, contacts name: Jie Li, MD, role: SUB_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Xuzhou Children's Hospital, status: NOT_YET_RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, contacts name: Qi An, MD, role: CONTACT, phone: +86-13814422329, email: anqi1974@sina.com, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Qilu Hospital of Shandong University, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Xiuli Ju, MD,PhD, role: CONTACT, phone: +86-13869192944, email: shellysdcn@hotmail.com, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Children's Hospital Of Fudan University, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xiaowen Zhai, MD, PhD, role: CONTACT, phone: +86-18017590808, email: zhaixiaowendy@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06316947, orgStudyIdInfo id: FMCH-2024-32723, briefTitle: Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-02-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans.This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules., conditionsModule conditions: Shisha, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: CHW-delivered intervention, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Retention rate measure, primaryOutcomes measure: pre-/post- survey completion rates, primaryOutcomes measure: pre-/post- biospecimen completion rates, secondaryOutcomes measure: shisha use changes, secondaryOutcomes measure: tobacco product use changes, secondaryOutcomes measure: smoke-free home rules, secondaryOutcomes measure: the cotinine levels of parents and children., eligibilityModule sex: ALL, minimumAge: 6 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316934, orgStudyIdInfo id: IRB202302181, briefTitle: Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo., conditionsModule conditions: Anxiety, conditions: Pain, Procedural, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be randomized into two arms - aromatherapy or placebo. The protocol will be the same for the two arms except that the towel held over the mouth will be scented either with lavender essential oil or distilled water. The clinic nurse will prepare the scented towel and hand it to the participant according to the random assignment., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, maskingDescription: Randomization will be performed once the patient agrees to participate and has signed the consent document. A random number generator will be used to designate each arm of the study. Odd numbers will be assigned to the aromatherapy arm while the even numbers will be assigned to the placebo arm. Each assignment will be placed into a sealed opaque numbered enveloped. After the participant has agreed to participate, the clinic nurse will open the envelope to identify the study arm., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lavandula angustifolia, Aura Cacia, interventions name: Placebo, outcomesModule primaryOutcomes measure: Determine the change in pain scores from baseline to immediate post-procedure., primaryOutcomes measure: Determine change in anxiety scores from baseline to immediate post-procedure., primaryOutcomes measure: Determine level of satisfaction after the procedure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, contacts name: Tiffani-Amber Miller, MD, role: CONTACT, phone: 352-273-7660, email: tiffani12@ufl.edu, contacts name: Amira Quevedo, MD, role: CONTACT, phone: 352-273-7660, email: amiraquevedo@ufl.edu, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False
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protocolSection identificationModule nctId: NCT06316921, orgStudyIdInfo id: TCHIRB-11003008-E, briefTitle: Epidural PCA on Pain Relief After L-spine Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Taipei City Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level., conditionsModule conditions: Pain, Postoperative, conditions: Lumbar Spine Degeneration, conditions: Analgesia, Patient-Controlled, conditions: Epidural Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 209, type: ACTUAL, armsInterventionsModule interventions name: Epidural patient-controlled analgesia, interventions name: Standard postoperative pain management, outcomesModule primaryOutcomes measure: Pain degree, secondaryOutcomes measure: The number of morphine injections, otherOutcomes measure: Length of hospitalization, otherOutcomes measure: Drainage amount, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei City Hospital, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06316908, orgStudyIdInfo id: ERC-2019/A187, briefTitle: Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-02-25, primaryCompletionDateStruct date: 2022-07-15, completionDateStruct date: 2023-03-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sindh Institute of Urology and Transplantation, class: OTHER, descriptionModule briefSummary: The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.The main questions it aimed to answer are:1. Whether unilateral or bilateral NCPB technique has a better pain relief2. Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.Pain scores and adverse events at multiple time points post-procedure were recorded., conditionsModule conditions: Abdominal Cancer, conditions: Cancer Pain, conditions: Cancer of Pancreas, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance.Bilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol, interventions name: Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol, outcomesModule primaryOutcomes measure: Pain Score using the Visual Analog Scale, secondaryOutcomes measure: Change in Mean Arterial Pressure, secondaryOutcomes measure: Incidence of Patient-Reported Nausea Feeling, secondaryOutcomes measure: Incidence of Vomiting, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sindh Institute of Urology and Transplantation, city: Karachi, state: Sindh, zip: 74200, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06316895, orgStudyIdInfo id: S2023-706, briefTitle: The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;, conditionsModule conditions: Papillary Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3772, type: ESTIMATED, armsInterventionsModule interventions name: thyroid surgery, interventions name: ultrasound-guided thermal ablation, outcomesModule primaryOutcomes measure: rate of disease progression, secondaryOutcomes measure: Rate of complications, secondaryOutcomes measure: Rate of tumor disappearance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316882, orgStudyIdInfo id: ROCGAS 01, secondaryIdInfos id: ROGCAS Study, type: OTHER, domain: ULSNA, briefTitle: Opportunistic Gastric Cancer Screening, acronym: ROCGAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-03, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Unidade Local De Saúde Do Norte Alentejano, class: OTHER, collaborators name: NOVA Medical School, descriptionModule briefSummary: Endoscopic screening of gastric cancer combined with screening colonoscopy, conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 139, type: ESTIMATED, armsInterventionsModule interventions name: Screening endoscopy, outcomesModule primaryOutcomes measure: number of gastric adenocarcinoma, secondaryOutcomes measure: number of pre-malignant lesions, secondaryOutcomes measure: Costs of screening endoscopy, secondaryOutcomes measure: Socio-demographic characteristics of population in screening program, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ULSNA, status: RECRUITING, city: Portalegre, zip: 7300-853, country: Portugal, contacts name: Beatriz Mourato, MD, role: CONTACT, phone: 00351910311213, email: 2091@ulsna.min-saude.pt, contacts name: Beatriz Mourato, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Guilherme Santos, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Sara Morais, MD, role: SUB_INVESTIGATOR, contacts name: Nuno Pratas, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Filipa Taré, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29379, lon: -7.43122, hasResults: False
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protocolSection identificationModule nctId: NCT06316869, orgStudyIdInfo id: STVi, briefTitle: Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows:* What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)?* Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated.* To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator.The HVPG is considered as the gold standard in our study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH., conditionsModule conditions: Portal Hypertension, conditions: Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: STVi index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital the First Affiliated Hospital, city: Wenzhou, state: Zhejiang, zip: 325006, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
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protocolSection identificationModule nctId: NCT06316856, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-002, briefTitle: CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled., conditionsModule conditions: T-Cell Acute Lymphocytic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Autologous CD5 CAR T-cells, interventions name: Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells, interventions name: Newly matched donor-derived CD5 CAR T-cells, outcomesModule primaryOutcomes measure: Phase 1-The incidence and type of dose-limiting toxicity (DLT), primaryOutcomes measure: Phase 1-The incidence and severity of adverse events (AEs), primaryOutcomes measure: Phase 2-Antitumor effect, secondaryOutcomes measure: Phase 1-Objective response rate (ORR), secondaryOutcomes measure: Phase 1-Pharmacokinetics of CD5 CAR T cells, secondaryOutcomes measure: Phase 1-The incidence and severity of adverse events (AEs)., secondaryOutcomes measure: Phase 1-Best overall response (BOR) rate., secondaryOutcomes measure: Phase 2-Objective response rate (ORR), secondaryOutcomes measure: Phase 2- The incidence and severity of AEs, secondaryOutcomes measure: Phase 2- Progression free survival (PFS), secondaryOutcomes measure: Phase 2- Overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316843, orgStudyIdInfo id: BHC202 v2.1, briefTitle: Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2, acronym: PASC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bateman Horne Center, class: OTHER, descriptionModule briefSummary: To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19., conditionsModule conditions: Long COVID, conditions: PASC Post Acute Sequelae of COVID 19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Valacyclovir celecoxib dose 1, interventions name: Valacyclovir celecoxib dose 2, interventions name: Placebo, outcomesModule primaryOutcomes measure: Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bateman Horne Center, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84102, country: United States, contacts name: Lucinda Bateman, MD, role: CONTACT, phone: 801-359-7400, email: lbateman@batemanhornecenter.org, contacts name: Suzanne D Vernon, PhD, role: CONTACT, phone: (801) 359-7400, email: sdvernon@batemanhornecenter.org, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06316830, orgStudyIdInfo id: STUDY00000075, briefTitle: Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose, acronym: Optimal Bup, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Rhode Island Hospital, class: OTHER, collaborators name: Brown University, descriptionModule briefSummary: The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), decreased use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (secondary outcome)., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Buprenorphine, outcomesModule primaryOutcomes measure: Treatment Engagement, secondaryOutcomes measure: Use of non-prescribed opioids, secondaryOutcomes measure: Control of Opioid Cravings, secondaryOutcomes measure: Rate of Non-fatal or Fatal Opioid Overdose, secondaryOutcomes measure: Use of non-prescribed opioids, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316817, orgStudyIdInfo id: 23-0184-E, briefTitle: FloPatch for Prevention of Hypotension After Induction of General Anesthesia, acronym: HI-CAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-02, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mount Sinai Hospital, Canada, class: OTHER, descriptionModule briefSummary: This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. The investigators will be testing this in adults who are having elective non-heart surgery. Basically, the goal is to see if this device can help predict who might have low blood pressure during surgery.Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury. Myocardial injury after non-cardiac surgery (MINS) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development.In the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. For surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. Optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. Since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it.The hypothesis is that the corrected Flow Time (cFT) measured by the FloPatch will help predict hypotension after the induction of general anesthesia., conditionsModule conditions: Hypotension on Induction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 172, type: ESTIMATED, armsInterventionsModule interventions name: FloPatch, outcomesModule primaryOutcomes measure: Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH)., secondaryOutcomes measure: Passive leg raising (PLR) in predicting Post Induction Hypotension(PIH)., secondaryOutcomes measure: Thresholds of common carotid artery corrected Flow Time (cFT) change during Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH)., secondaryOutcomes measure: Thresholds of common carotid artery corrected Flow Time (cFT) change after Passive Leg Raising(PLR) in predicting Post Induction Hypotension (PIH)., secondaryOutcomes measure: Time required to get common carotid artery corrected Flow Time(cFT) data., secondaryOutcomes measure: Common carotid artery corrected Flow Time (cFT) during induction correlation with Post Induction Hypotension(PIH)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, city: Toronto, state: Ontario, zip: M5G 1X5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06316804, orgStudyIdInfo id: 2022P000580, secondaryIdInfos id: 1K23MH128535-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23MH128535-01A1, briefTitle: Mobile Mental Health Stigma Reduction Intervention Among Black Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety., conditionsModule conditions: Anxiety, conditions: Depression, conditions: Health Knowledge, Attitudes, Practice, conditions: Stigmatization, conditions: Mobile Phone Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of three intervention arms., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, maskingDescription: Random assignment to the 3 arms in a 1:1:1 allocation ratio will be determined centrally by the PI according to a random schedule. There is no practical way to blind the study participants to treatment and accomplish the objectives of the study. However, the study participants will be unaware of the aims of the arm to which they were assigned. Because they will not be blinded to the video exposure, the study participants assigned to one of the video contact arms will be aware that they are being exposed to a video-based contact intervention, and the study participants assigned to the waitlist control arm will be aware that they are being waitlisted. The research coordinator/team member (who will be conducting the outcome assessments) will be blinded to treatment assignment status., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Video Intervention 1, interventions name: Video Intervention 2, interventions name: Video Intervention 3, outcomesModule primaryOutcomes measure: Treatment Inventory of Costs in Patients with Psychiatric Disorders, primaryOutcomes measure: Release of Information Form, secondaryOutcomes measure: Reported and Intended Behavior Scale, secondaryOutcomes measure: Internalized Stigma of Mental Illness, secondaryOutcomes measure: The Group Based Medical Mistrust Scale, secondaryOutcomes measure: Group Help Seeking Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Aderonke Bamgbose Pederson, MD, role: CONTACT, phone: 617-724-4587, email: apederson@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06316791, orgStudyIdInfo id: HY001007, briefTitle: Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-14, primaryCompletionDateStruct date: 2024-12-13, completionDateStruct date: 2025-12-13, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Juventas Cell Therapy Ltd., class: INDUSTRY, descriptionModule briefSummary: Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care., conditionsModule conditions: Lupus Erythematosus, Systemic, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: single dose of CNCT19, outcomesModule primaryOutcomes measure: Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE）, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: SELENA-SLEDAI, secondaryOutcomes measure: The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period, secondaryOutcomes measure: To evaluate disease related biomarkers, secondaryOutcomes measure: To evaluate disease related biomarkers, secondaryOutcomes measure: To evaluate disease related biomarkers, secondaryOutcomes measure: To evaluate disease related biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Yi Zhang, Dr., role: CONTACT, contacts name: Shengyun Liu, Dr., role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06316778, orgStudyIdInfo id: 2023-038, briefTitle: Pelvic Floor Muscle Training for Women With Myotonic Dystrophy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, collaborators name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, collaborators name: Interdisciplinary research team on neuromuscular diseases (GRIMN), collaborators name: CIUSSS Saguenay-Lac-Saint-Jean, descriptionModule briefSummary: Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population., conditionsModule conditions: Myotonic Dystrophy Type 1, conditions: Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pre-treatment assessment - intervention (12 weeks) - post-treatment assessment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor muscle training, outcomesModule primaryOutcomes measure: Percentage of attended treatment sessions, primaryOutcomes measure: Percentage of home exercises performed, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Intervention Acceptability Questionnaire, secondaryOutcomes measure: Change in the frequency of urinary incontinence episodes, secondaryOutcomes measure: Change in urinary incontinence symptoms, secondaryOutcomes measure: Change in pelvic floor disorder symptoms, secondaryOutcomes measure: Change in pelvic floor disorder symptoms related impact on quality of life, secondaryOutcomes measure: Change in pelvic floor muscles morphometry, secondaryOutcomes measure: Change in pelvic floor muscles function, secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Patient's global impression of change, secondaryOutcomes measure: Patient's estimated improvement, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique des maladies neuromusculaires, city: Jonquière, state: Quebec, zip: G7X 7X2, country: Canada, geoPoint lat: 48.41648, lon: -71.24884, hasResults: False
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protocolSection identificationModule nctId: NCT06316765, orgStudyIdInfo id: 118/10, briefTitle: A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, descriptionModule briefSummary: Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet., conditionsModule conditions: Neonatology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Intubation with stylet, outcomesModule primaryOutcomes measure: The primary outcome was defined as successful initial intubation attempt., secondaryOutcomes measure: Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06316752, orgStudyIdInfo id: 202107158RINB, briefTitle: The Natural History of Sialidosis Type I, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2024-03-16, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Sialidosis type 1 is an autosomal recessive disorder caused by bialleic NEU1 gene mutations. Patients with sialidosis type I present variable neurological and eye dysfunction and the progression rate is variable. The goal of this protocol is to assess the neurological and ophthalmological status of these patients and characterize the clinical and laboratory abnormalities in order to determine the natural history of the disease. Patients will be followed every 6 month with comprehensive clinical, neurological and ophthalmological examinations combined with neuropsychological, blood, radiological and electrophysiological tests., conditionsModule conditions: Observational Study, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Observational study, outcomesModule primaryOutcomes measure: Scale for the Assessment and Rating of Ataxia (SARA), primaryOutcomes measure: Unified Myoclonus Rating Scale (UMRS), secondaryOutcomes measure: MRI of the brain, secondaryOutcomes measure: Blood test for alpha-N -acetyl neuraminidase activity and neruofilamment light chain, secondaryOutcomes measure: Electrophysyiology test on peripheral nerves, secondaryOutcomes measure: Opathalmology examinations for cherry-red spots, secondaryOutcomes measure: Montreal cognitive assessment score, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: Chin-Hsien Lin, MD, PhD, role: CONTACT, phone: 882-23123456, email: chlin@ntu.edu.tw, contacts name: Wuh-Liang Hwu, MD, PhD, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06316739, orgStudyIdInfo id: R34DA057166, type: NIH, link: https://reporter.nih.gov/quickSearch/R34DA057166, briefTitle: The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI), class: OTHER, collaborators name: City University of New York, School of Public Health, descriptionModule briefSummary: The goal of this pilot clinical trial is to learn if an intervention that trains Gancheros (people who provide injection services in exchange for drugs or money) to conduct risk-reduction outreach could help lower risk for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and overdose among migrant Puerto Rican people who inject drugs (PWID) in New York City. The main questions it aims to answer are:* Can the Ganchero intervention be carried out successfully and will Gancheros and their clients like it?* Could the Ganchero intervention help Puerto Rican PWID who are clients of Gancheros use sterile syringes and carry naloxone (a medication to reverse opioid overdoses) more often?Gancheros who participate in the trial will be asked to attend a 6-session training on HIV, HCV, and overdose prevention and then to share key prevention messages and supplies (e.g., naloxone, sterile syringes and other injection equipment) with their clients during 4 months of outreach. The intervention will be carried out with Gancheros and their clients in two Bronx neighborhoods, one after the other, so the investigators can see if clients in the neighborhood that received the intervention first have better outcomes than clients in the neighborhood that did not yet receive the intervention., conditionsModule conditions: HIV Infections, conditions: HCV, conditions: Overdose, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Non-randomized wait-list controlled trial. The intervention will be implemented in 2 neighborhoods (in the Bronx, New York City) sequentially. Outcomes among participants in the immediate intervention neighborhood will be compared to outcomes among participants in the delayed intervention neighborhood., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Ganchero intervention, outcomesModule primaryOutcomes measure: sterile syringe use, secondaryOutcomes measure: naloxone carriage, otherOutcomes measure: Feasibility of intervention - Ganchero Engagement, otherOutcomes measure: Feasibility of intervention - Client Engagement, otherOutcomes measure: Acceptability of the intervention's training component to Gancheros, otherOutcomes measure: Acceptability of the intervention's outreach component to Gancheros, otherOutcomes measure: Acceptability of intervention to Clients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316726, orgStudyIdInfo id: 202100409A3, briefTitle: The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-15, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries., conditionsModule conditions: Pressure Injury, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care)., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 461, type: ACTUAL, armsInterventionsModule interventions name: full bed silicone mattress plus other measures, outcomesModule primaryOutcomes measure: the occurrence of surgery-related pressure injuries, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taoyuan Chang Gung Memorial Hospital, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06316713, orgStudyIdInfo id: IRB_00166637, briefTitle: One MORE for Chronic Pain in Latinos, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: One MORE (Spanish Adaptation), outcomesModule primaryOutcomes measure: Pain Intensity & Interference, secondaryOutcomes measure: Acute Pain, secondaryOutcomes measure: Acceptability, otherOutcomes measure: Pain Catastrophizing, otherOutcomes measure: Well-Being, otherOutcomes measure: Depression, otherOutcomes measure: Anxiety, otherOutcomes measure: Mindful Reappraisal of Pain Sensations, otherOutcomes measure: Trait Self-Transcendence, otherOutcomes measure: Decentering, otherOutcomes measure: State Self-Transcendence, otherOutcomes measure: State Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Eric Garland, PhD, role: CONTACT, phone: 801-581-3826, email: eric.garland@socwk.utah.edu, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06316700, orgStudyIdInfo id: AG-02-0124, briefTitle: A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Athletic Greens International, class: INDUSTRY, descriptionModule briefSummary: This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional supplement, interventions name: Placebo, outcomesModule primaryOutcomes measure: Plasma concentration of zinc following consumption of study products, primaryOutcomes measure: Plasma concentration of Vitamin C following consumption of study products, primaryOutcomes measure: Plasma concentration of Folate following consumption of study products, primaryOutcomes measure: Plasma concentration of calcium following consumption of study products, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Applied Health Sciences, city: Canfield, state: Ohio, zip: 44046, country: United States, geoPoint lat: 41.02506, lon: -80.76091, hasResults: False
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protocolSection identificationModule nctId: NCT06316687, orgStudyIdInfo id: prevalence of dental caries, briefTitle: Prevalence of Dental Caries in a Group of Egyptian Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Prevalence of Dental Caries in a group of Egyptian children and its relation to TV and other screens time and sugar consumption (Observational cross-sectional study), conditionsModule conditions: Prevalence of Dental Caries and Its Relation to Screen Time and Sugar Consumption, conditions: Prevalence,Patient, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire for food consumption frequency, outcomesModule primaryOutcomes measure: Prevalence of dental caries, secondaryOutcomes measure: Dental neglect Dental neglect Dental neglect, secondaryOutcomes measure: Screen time evaluation, secondaryOutcomes measure: A sugar consumption evaluation, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo University, city: Cairo, state: Al Manial, country: Egypt, contacts name: rasha ad el, phd, role: CONTACT, phone: 00201111511145, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06316674, orgStudyIdInfo id: 03C304, briefTitle: The Malleability of Body Representation in Anorexia Nervosa: the Sixth Finger Illusion, acronym: SESTODITO_AN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: Heriot-Watt University, collaborators name: Birkbeck, University of London, collaborators name: Catholic University of the Sacred Heart, descriptionModule briefSummary: Body representation can be explored using behavioural tasks such as motor imagery tasks as well as body illusions.In both cases, evidence from studies on healthy individuals as well as patients with lesions to the central nervous system show that body representation is not set in stone: how we imagine our bodies is a dynamic and continuously updated process, to reflect changes in our own body as well as the environment.In anorexia nervosa the representation of the body is very different from that of healthy individuals: the representation is more malleable, and easier to manipulate, while at the same time being more detached from physical constraints. These features of body representation in anorexia nervosa might contribute to the persistence of symptoms and to relapses too. Body representation has clear implications for treatment of anorexia nervosa too.The study aims at evaluating the presence of differences in the malleability of the body representation, explored through the illusion of the sixth finger, between a group of people with AN and a group of normal weight people, taking into account the biomechanical constraints that characterize the physical and mentally represented body., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: sixth finger illusion, outcomesModule primaryOutcomes measure: Sixth finger illusion questionnaire, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Auxologico italiano IRCSS, status: RECRUITING, city: Milan, country: Italy, contacts name: Federico Brusa, Ph.D, role: CONTACT, email: f.brusa@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06316661, orgStudyIdInfo id: 09C921, briefTitle: CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF, acronym: MAPPED, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-03-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients., conditionsModule conditions: Microvascular Coronary Artery Disease, conditions: Heart Failure With Reduced Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: stress perfusion cardiac magnetic resonance, interventions name: cardiopulmonary exercise test, outcomesModule primaryOutcomes measure: Peak stress perfusion, primaryOutcomes measure: Extracellular volume, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20149, country: Italy, contacts name: Camilla Torlasco, role: CONTACT, phone: +390261911, phoneExt: 2932, email: c.torlasco@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06316648, orgStudyIdInfo id: 210366, briefTitle: Whey Intake Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2021-04-20, completionDateStruct date: 2021-07-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery, conditionsModule conditions: Elective Hip Fracture Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multidisciplinary cooperation was performed for the effective and efficient conduct of the study. In determining the patients to administer Whey according to the study's inclusion criteria, an orthopedic and traumatological specialist's support was received, as well as that of an anesthesiologist. On the other hand, the researcher cooperated with a nutritionist in preparing and assessing the Whey content to be administered to the patients., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: whey intake group, interventions name: control group, outcomesModule primaryOutcomes measure: blood glucose, secondaryOutcomes measure: Fasting, Thirst, secondaryOutcomes measure: Nausea and Vomiting, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University, city: Kayseri̇, state: Talas, zip: 38000, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06316635, orgStudyIdInfo id: 2023/209, secondaryIdInfos id: self-funding, type: OTHER, domain: Erciyes University, briefTitle: Microplastics in Otitis Media With Effusion Material, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Kerem Kökoğlu, class: OTHER, descriptionModule briefSummary: Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME., conditionsModule conditions: Microplastics, conditions: Otitis Media With Effusion, conditions: Biofilms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ventilation tube insertion, outcomesModule primaryOutcomes measure: Microplastic presence, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Erciyes University Medical School, status: RECRUITING, city: Kayseri, zip: 38039, country: Turkey, contacts name: KEREM KÖKOĞLU, role: CONTACT, phone: 535-205-6780, email: dr.kokoglu@gmail.com, contacts name: Onat B Taş, M.D., role: CONTACT, phone: 90 505-702-2227, email: onat-berkay@hotmail.com, contacts name: Mehmet I Şahin, Assoc. Prof, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06316622, orgStudyIdInfo id: 2021/08/42, briefTitle: Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-08, primaryCompletionDateStruct date: 2022-10-01, completionDateStruct date: 2022-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG., conditionsModule conditions: Anesthesia Awareness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: relationship between body mass index and the skin epidural space distance, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: relationship between body mass index and the skin epidural space distance, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: ultrasound, outcomesModule primaryOutcomes measure: We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 58 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dokuz Eylul Unicersity, city: İzmir, state: Narlidere, zip: 35150, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, locations facility: Dokuz Eylul University, city: İzmir, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06316609, orgStudyIdInfo id: AD2016-2027, briefTitle: Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis, acronym: PECCAD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2016-06, primaryCompletionDateStruct date: 2018-04-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Fudan University, class: OTHER, collaborators name: Minhang Maternal and Children Health Care Hospital, collaborators name: School of Public Health，Fudan University, descriptionModule briefSummary: This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring., conditionsModule conditions: Atopic Dermatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 456, type: ACTUAL, armsInterventionsModule interventions name: Gestational Exposure to Emerging Contaminants (ECs), outcomesModule primaryOutcomes measure: atopic dermatitis: Infant atopic dermatitis incidence, secondaryOutcomes measure: atopic dermatitis, secondaryOutcomes measure: atopic dermatitis, secondaryOutcomes measure: atopic dermatitis, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester, secondaryOutcomes measure: prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester, secondaryOutcomes measure: Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood, secondaryOutcomes measure: Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs), secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy, secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy, secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy, secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester, secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester, secondaryOutcomes measure: prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester, secondaryOutcomes measure: Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood, secondaryOutcomes measure: Umbilical cord serum Organophosphate Flame Retardants (OPFRs), secondaryOutcomes measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）, secondaryOutcomes measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）, secondaryOutcomes measure: Infant skin barrier function (Transepidermal Water Loss, TEWL）, secondaryOutcomes measure: Infant skin barrier function (Stratum corneum hydration, SCH), secondaryOutcomes measure: Infant skin barrier function (Stratum corneum hydration, SCH), secondaryOutcomes measure: Infant skin barrier function (Stratum corneum hydration, SCH), secondaryOutcomes measure: Infant skin barrier function (sebum content), secondaryOutcomes measure: Infant skin barrier function (sebum content), secondaryOutcomes measure: Infant skin barrier function (sebum content), secondaryOutcomes measure: Infant skin barrier function (skin surface pH), secondaryOutcomes measure: Infant skin barrier function (skin surface pH), secondaryOutcomes measure: Infant skin barrier function (skin surface pH), secondaryOutcomes measure: prenatal exposure to Microplastics at early pregnancy, secondaryOutcomes measure: prenatal exposure to Microplastics at mid pregnancy, secondaryOutcomes measure: prenatal exposure to Microplastics at late pregnancy, secondaryOutcomes measure: prenatal exposure to Microplastics at first trimester, secondaryOutcomes measure: prenatal exposure to Microplastics at second trimester, secondaryOutcomes measure: prenatal exposure to Microplastics at third trimester, secondaryOutcomes measure: Microplastics in Umbilical cord whole blood, secondaryOutcomes measure: Umbilical cord serum Microplastics, secondaryOutcomes measure: Allergic rhinitis, secondaryOutcomes measure: Asthma, secondaryOutcomes measure: Infantile hemangioma, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children Hospital of Fudan University, city: Shanghai, state: Shanghai, zip: 201102, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06316596, orgStudyIdInfo id: 2011-KAEK-25 2023/09-16, briefTitle: Brain Oxygenation in Newborns Due to Neuroaksial Methods, acronym: oxygenation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Bursa Yüksek İhtisas Education and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS)., conditionsModule conditions: Cesarean Section, conditions: Pregnancy Related, conditions: Cerebral Hypoxia, conditions: Anesthesia, Regional, conditions: Oxygen Saturation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research is a prospective controlled,randomized,double-blind study, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The research is a prospective, randomized, single-blind, parallel group study. In the study, the Quincke needle will be used for spinal anesthesia and the Tuoghy needle will be used for epidural anesthesia. Oxygenation will be evaluated with the help of NIRS probe in the post-cesarean newborns of pregnant women who will undergo elective cesarean section.Vitals will be monitored throughout the case with electrocardiography (ECG), non-invasive blood pressure monitoring and spO2. The amount of vasopressor agent and hydration required by the mother throughout the case will be recorded. While one anesthesiologist will monitor the anesthesia method and maternal vitals, the other anesthetist will monitor the NIRS monitoring attached to the newborn., whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Anesthesia, interventions name: Epidural Anesthesia, outcomesModule primaryOutcomes measure: Near İnfrared Spectroscopi, secondaryOutcomes measure: Maternal mean arterial pressure, secondaryOutcomes measure: Newborn vitalty, secondaryOutcomes measure: Newborn vitalty, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316583, orgStudyIdInfo id: BJH-001, briefTitle: Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, collaborators name: Beijing Municipal Health Commission, descriptionModule briefSummary: Primary dysmenorrhea refers to menstrual pain not caused by pelvic organic lesions, commonly seen in young women, significantly affecting patients' quality of life. Dry needling therapy targeting myofascial trigger points for primary dysmenorrhea has been preliminarily applied in clinical settings. However, related research is limited with questionable quality, hindering its widespread clinical application. Furthermore, is there a connection between myofascial trigger points in dry needling and acupuncture acupoints in terms of selection and mechanism of action? Could this be a new interpretation of acupuncture theory? These are important questions that have garnered widespread attention. This study employs a randomized patient-blinded controlled design, enrolling primary dysmenorrhea patients aged 18 to 30 years. They are randomly divided into three groups: the trigger point dry needling group, traditional acupuncture treatment group, and trigger point sham needle (placebo) group. Changes in pain levels, quality of life scores, inflammatory factor levels, and local blood flow before and after treatment among the three groups are observed. The aim is to assess the therapeutic effects of dry needling trigger points and acupuncture treatments on primary dysmenorrhea and explore their potential mechanisms of action. By comparing the differences and similarities between dry needling trigger points and acupuncture treatments in terms of acupoint selection, treatment effects, and potential mechanisms of action, this study seeks to preliminarily explore the feasibility of integrating trigger point theory into the meridian 'acupoint' theory, laying the foundation for a modern interpretation of acupuncture, conditionsModule conditions: Trigger Point Pain, Myofascial, conditions: Acupuncture, conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Using a single-center randomized controlled patient-blind study design, 150 eligible participants are randomly assigned to three groups: a placebo group (sham trigger point needling), a dry-needling trigger points treatment (TrP-DN)group, and a traditional acupuncture group. Compared to the placebo group, this study assesses the effects of TrP-DN and traditional acupuncture on pain and quality of life for primary dysmenorrhea patients, as well as their long-term outcomes. Additionally, the study observes their impact on inflammatory factors and local uterine blood flow, aiming to explore the mechanisms underlying TrP-DN and traditional acupuncture treatments for PD., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This experiment is a single-blind study where randomization occurs centrally through an online data management system after collecting baseline data from participants. A designated research coordinator manages the randomization process and facilitates communication among research personnel. Due to the nature of the intervention, operators are aware of the group assignments, but evaluators, unaware of these assignments, assess and collect baseline, post-treatment, and follow-up data. Since none of the participants have received any prior acupuncture or trigger point dry needling treatments, using a scalable sham needle on the same trigger points ensures blinding by simulating the effects of actual treatment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: TrP-DN and Acupuncture, outcomesModule primaryOutcomes measure: mean intensity of pain, secondaryOutcomes measure: mean intensity of painscale during period a 100mm horizontal line, with the ends of the line representing the extreme expressions of pain (no pain to maximum pain).The mean intensity of all days with menstrual pain is used for the analysis, secondaryOutcomes measure: Short Form Health Survey, secondaryOutcomes measure: Global Rating of Change Scale, secondaryOutcomes measure: the amount of NSAIDs used, secondaryOutcomes measure: the frenquecy of NSAIDs used, secondaryOutcomes measure: inflammatory factors, secondaryOutcomes measure: local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio, secondaryOutcomes measure: local uterine blood flow：Pulsatility Index (PI), secondaryOutcomes measure: local uterine blood flow：The Resistance Index (RI), secondaryOutcomes measure: Number of Participants with adverse effects with treatment, otherOutcomes measure: Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments, otherOutcomes measure: Rate of same points used between dry-needling group and traditional acupuncture group, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yanxia Sun, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Yanxia Sun, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Yanxia Sun, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: LiHua Yang, role: CONTACT, phone: 8616601298893, contacts name: Yi Ren, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06316570, orgStudyIdInfo id: HX-A-2023044, secondaryIdInfos id: SF 2024-2-2045, type: OTHER_GRANT, domain: Capital health development research project, briefTitle: Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke, acronym: TAPIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke., conditionsModule conditions: Ischemic Stroke, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1380, type: ESTIMATED, armsInterventionsModule interventions name: Early Dual Antiplatelet Therapy, interventions name: Placebo, outcomesModule primaryOutcomes measure: Excellent functional outcome, secondaryOutcomes measure: mRS score of 0-2 points, secondaryOutcomes measure: Distribution of mRS score, secondaryOutcomes measure: Neurologic improvement, secondaryOutcomes measure: Quality of life (EQ-5D scale), secondaryOutcomes measure: Activity of daily living (Barthel index ≥95 points), secondaryOutcomes measure: Recurrent ischemic stroke, secondaryOutcomes measure: Symptomatic intracranial hemorrhage (ECASS-III), secondaryOutcomes measure: Symptomatic intracranial hemorrhage (ECASS-III), secondaryOutcomes measure: Parenchymal hematoma type 2 (SIST-MOST), secondaryOutcomes measure: Parenchymal hematoma type 2 (SIST-MOST), secondaryOutcomes measure: Bleeding events (GUSTO), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Severe adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316557, orgStudyIdInfo id: HX-A-2022063, briefTitle: High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment, acronym: HOPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days., conditionsModule conditions: Post-stroke Cognitive Impairment, conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter Randomized Double-Blind Controlled Study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: rTMS group, interventions name: control group, outcomesModule primaryOutcomes measure: The efficacy of rTMS in improving cognitive function of post-stroke cognitive impairment, secondaryOutcomes measure: The safety of rTMS in improving cognitive function of post-stroke cognitive impairment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316544, orgStudyIdInfo id: CECMed, secondaryIdInfos id: 2021ZD0111000, type: OTHER_GRANT, domain: National Science and Technology Major Project, briefTitle: China Elderly Comorbidity Medical Database, acronym: CECMed, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, collaborators name: Chinese Academy of Medical Sciences, Fuwai Hospital, collaborators name: The First Affiliated Hospital of Zhengzhou University, descriptionModule briefSummary: The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and high individual heterogeneity? How to explore the key indicators and influencing factors of adverse events in elderly patients.. Participants will be followed up at 1, 3, 6, 9, and 12 months to obtain adverse event information., conditionsModule conditions: Coronary Artery Disease, conditions: Hypertension, conditions: Diabetes Mellitus, conditions: Osteoporosis, conditions: COPD Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 4100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pneumonia/pulmonary infection, primaryOutcomes measure: respiratory failure, primaryOutcomes measure: pulmonary encephalopathy, primaryOutcomes measure: acute exacerbation of chronic obstructive pulmonary disease, primaryOutcomes measure: unstable angina pectoris, primaryOutcomes measure: acute myocardial infarction, primaryOutcomes measure: acute hemorrhagic stroke, primaryOutcomes measure: acute ischemic stroke, primaryOutcomes measure: acute heart failure/acute exacerbation of chronic heart failure, primaryOutcomes measure: malignant ventricular arrhythmia, primaryOutcomes measure: sudden death, primaryOutcomes measure: falls, primaryOutcomes measure: fractures, primaryOutcomes measure: gastrointestinal bleeding, primaryOutcomes measure: pulmonary embolism, primaryOutcomes measure: deep vein thrombosis, primaryOutcomes measure: diabetes ketoacidosis, primaryOutcomes measure: diabetes hyperosmolar coma, primaryOutcomes measure: rehospitalization, primaryOutcomes measure: admission to ICU, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Bingbing Ke, Dr, role: CONTACT, phone: 15510286857, email: 1017120710@qq.com, contacts name: Hongwei Li, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06316531, orgStudyIdInfo id: BL-M07D1-301, briefTitle: A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab., conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 268, type: ESTIMATED, armsInterventionsModule interventions name: BL-M07D1, interventions name: T-DM1, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Erwei Song, role: CONTACT, contacts name: Erwei Song, role: PRINCIPAL_INVESTIGATOR, contacts name: Herui Yao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06316518, orgStudyIdInfo id: AIBU-HF-YS-01, briefTitle: The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups with a supportive care control groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: mindfulness group, outcomesModule primaryOutcomes measure: Pregnancy Stress Assessment Scale (PSAS), primaryOutcomes measure: Self-Efficacy Scale for Normal Childbirth, primaryOutcomes measure: Prenatal Attachment Inventory (PAI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06316505, orgStudyIdInfo id: 11/2023-58, briefTitle: Oral Photographs of Patients on Oral Hygiene Motivation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Didem OZKAL EMINOGLU, class: OTHER, descriptionModule briefSummary: Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters., conditionsModule conditions: Periodontal Diseases, conditions: Motivation, conditions: Hygiene, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Oral hygiene motivation with individual oral photograps, outcomesModule primaryOutcomes measure: Clinical periodontal parameters / plaque index (PI), primaryOutcomes measure: Clinical periodontal parameters / gingival index (GI), primaryOutcomes measure: Clinical periodontal parameters / probing pocket depth (PPD)., primaryOutcomes measure: Clinical periodontal parameters / bleeding on probing (BOP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atatürk University, city: Erzurum, zip: 25240_, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06316492, orgStudyIdInfo id: 101919039932, briefTitle: A Study Done by a Demonstrator and Two Professors in Public Health and Community Medicine Department in Faculty of Medicine in Assiut and New Valley University to Assess Knowledge, Attitude ,and Practice of Rural Population in a Remote Governorate ( New Valley ) Towards Hepatitis B and C Viruses, acronym: rural_remote, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study is a research aiming to identify knowledge, attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be orally answered by the participants to be recorded in papers by the researcher., conditionsModule conditions: Hepatitis B, conditions: Hepatitis C, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 450, type: ESTIMATED, outcomesModule primaryOutcomes measure: Assess proportion of adequate knowledge, attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate, secondaryOutcomes measure: Assess proportion of high risk groups of viral hepatitis B and C in these population thus behaviours made them candidates for viral hepatitis B and C infection, secondaryOutcomes measure: 2- Proportion of health-seeking behaviour of cases ( confirmation of diagnosis, treatment, and follow up ) and proportion of high risk group seeking for screening, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316479, orgStudyIdInfo id: CI-001-23, briefTitle: Safety and Performance of PTMC Dermal Filler, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Aqpha Medical B.V., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.The main questions it aims to answer are:* Does the PTMC dermal filler maintain its performance for a minimum of 6 months?* Is the treatment considered safe for participants?Participants will:* Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds.* You'll receive one injection of the PTMC Dermal filler during your initial visit.* For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site.* At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study.* Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months.* Each visit will last approximately 60-90 minutes. The visits will be conducted in person., conditionsModule conditions: Moderate to Severe Nasolabial Fold, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: PTMC Dermal Filler, outcomesModule primaryOutcomes measure: Nasolabial fold severity, secondaryOutcomes measure: Safety (Adverse events), secondaryOutcomes measure: Nasolabial fold severity, secondaryOutcomes measure: Responder rate, secondaryOutcomes measure: Overall aesthetic improvement (by the investigator), secondaryOutcomes measure: Overall aesthetic improvement (by the subject), secondaryOutcomes measure: Subject satisfaction, otherOutcomes measure: Visual Analog Scale (VAS) for pain, otherOutcomes measure: Treatment satisfaction, otherOutcomes measure: Ease of use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 67 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06316466, orgStudyIdInfo id: QYFYWZLL28521, briefTitle: Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: jingxue, class: OTHER, descriptionModule briefSummary: Background: This study aims to assess the prognostic significance of serum lipoprotein (a) \[Lp (a)\] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).Methods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients., conditionsModule conditions: Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Lp(a), outcomesModule primaryOutcomes measure: OS, secondaryOutcomes measure: PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Qingdao University, status: RECRUITING, city: Qingdao, state: Shandong, country: China, contacts name: Jinyue Liu, role: CONTACT, phone: 17854269227, email: liujinyue99@163.com, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
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protocolSection identificationModule nctId: NCT06316453, orgStudyIdInfo id: PARADISE-PK-09-03-2024, briefTitle: Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Advanced Education & Research Center, class: OTHER, collaborators name: University of Karachi, collaborators name: Pakistan Cardiac Society (Heart House), descriptionModule briefSummary: This study aims to conduct a 10-year follow-up to assess ASCVD risk in Pakistan among individuals aged 30 years and above without a known history of ASCVD. The focus will be on evaluating ASCVD risk over this specific 10-year timeframe. The study will also validate risk assessment scores for identifying high-risk individuals and examine the incidence rate of ASCVD events during long-term follow-up., conditionsModule conditions: Atherosclerotic Cardiovascular Diseases (ASCVD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3513, type: ESTIMATED, armsInterventionsModule interventions name: Evaluating ASCVD risk over 10 and 30 year and lifetime, outcomesModule primaryOutcomes measure: 10-year ASCVD risk Categorization, primaryOutcomes measure: 30-year ASCVD risk Categorization, primaryOutcomes measure: Lifetime ASCVD risk evaluation, primaryOutcomes measure: Genetic Risk Assessment of ApoB, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Education Institute and Research Center, status: RECRUITING, city: Karachi, state: Sindh, zip: 75270, country: Pakistan, contacts name: Shamoon Noushad, role: CONTACT, phone: 03333549258, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06316440, orgStudyIdInfo id: noise and postoperative pain, briefTitle: Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Chongqing Medical University, class: OTHER, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: Shapingba People's Hospital of Chongqing University, collaborators name: Chongganng General Hospital, collaborators name: Wuhan University, collaborators name: Tongji Hospital, descriptionModule briefSummary: To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Wear noise-cancelling earphones, outcomesModule primaryOutcomes measure: The incidence of moderate to severe postoperative pain, secondaryOutcomes measure: Patient controlled analgesia pump analgesic consumption, secondaryOutcomes measure: Patient controlled analgesia pump analgesic consumption, secondaryOutcomes measure: The incidence of additional analgesic requirements, secondaryOutcomes measure: Maximum pain score (NRS score) at 0-48 hours postoperatively, secondaryOutcomes measure: The incidence of moderate to severe postoperative pain, secondaryOutcomes measure: Accumulative postoperative pain NRS, otherOutcomes measure: Pain score (NRS score) at 0-6 hours postoperatively, otherOutcomes measure: Pain score (NRS score) at 6-12 hours postoperatively, otherOutcomes measure: Pain score (NRS score) at 12-24 hours postoperatively, otherOutcomes measure: Pain score (NRS score) at 24-48 hours postoperatively, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Guangyou Duan, MD, role: CONTACT, phone: (+86)18323376014, email: duangy@hospital.cqmu.edu.cn, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06316427, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-003, briefTitle: Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2028-03-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled., conditionsModule conditions: T-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigator Initiate Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Autologous CD7 CAR T-cell, interventions name: Prior-HSCT donor-derived CD7 CAR T-cell, interventions name: New donor-derived CD7 CAR T-cell, outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity (DLT) in phase I, primaryOutcomes measure: Overall Response Rate (ORR) in phase II, secondaryOutcomes measure: Overall Response Rate (ORR) in phase I, secondaryOutcomes measure: Safety in phase II, secondaryOutcomes measure: Progression-Free Survival (PFS) in phase II, secondaryOutcomes measure: Duration of Remission (DOR) in phase II, secondaryOutcomes measure: Overall Survival (OS) in phase II, secondaryOutcomes measure: Levels of CD7 CAR-T Cells in phase II, secondaryOutcomes measure: Levels of CAR transgene in phase II, secondaryOutcomes measure: Levels of immune cells in phase II, secondaryOutcomes measure: Levels of cytokines in phase II, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06316414, orgStudyIdInfo id: 1501/17, briefTitle: Omalizumab in Severe Asthmatics With Food Allergy, acronym: OSAFA, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2023-03-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Bambino Gesù Hospital and Research Institute, class: OTHER, descriptionModule briefSummary: A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment., conditionsModule conditions: Food; Allergy, Anaphylactic Shock, conditions: Asthma in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 65, type: ACTUAL, armsInterventionsModule interventions name: Omalizumab, outcomesModule primaryOutcomes measure: Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1., secondaryOutcomes measure: Proportion of negative OFCs at T1, secondaryOutcomes measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2., secondaryOutcomes measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3., secondaryOutcomes measure: Change in number of anaphylactic events, secondaryOutcomes measure: Rate of severity of anaphylactic events, secondaryOutcomes measure: Asthma Control Test (ACT), secondaryOutcomes measure: Quality of Life score, secondaryOutcomes measure: Total IgE, secondaryOutcomes measure: Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt, city: Roma, zip: 00145, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06316401, orgStudyIdInfo id: 03-2024, briefTitle: Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Azienda USL Modena, class: OTHER, descriptionModule briefSummary: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS)., conditionsModule conditions: Colorectal (Colon or Rectal) Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: ESD of large LSTs under SA, outcomesModule primaryOutcomes measure: Technical success of ESD under SA, primaryOutcomes measure: Safety of ESD under SA, secondaryOutcomes measure: Intra- and post-procedural need for additional opioid or other analgesic drug administration, secondaryOutcomes measure: ESD- and colonoscopy-related AEs, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Median ESD duration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mauro Manno, city: Carpi, state: MO, zip: 41012, country: Italy, geoPoint lat: 44.78237, lon: 10.8777, hasResults: False
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protocolSection identificationModule nctId: NCT06316388, orgStudyIdInfo id: TDME, briefTitle: Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-03-11, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Rehab Azzam, class: OTHER, descriptionModule briefSummary: 1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) .2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME., conditionsModule conditions: Diabetic Macular Edema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: vitrectomy, outcomesModule primaryOutcomes measure: assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema, primaryOutcomes measure: assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema, secondaryOutcomes measure: correlation CDVA with mf-ERG and OCT finding, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316375, orgStudyIdInfo id: STUMBL blunt chest trauma, briefTitle: STUMBL Score as a Risk Stratification Tool for Management of Blunt Chest Trauma Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals., conditionsModule conditions: Blunt Injury of Thorax, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors, secondaryOutcomes measure: Secondary outcomes validated the STUMBL score using a composite of early and delayed complications., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316362, orgStudyIdInfo id: SMOF in carbamazepine toxicity, briefTitle: Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-02-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute, moderate-to-severe carbamazepine poisoning., conditionsModule conditions: Acute Poisoning, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: SMOF lipid 20%, outcomesModule primaryOutcomes measure: Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS), secondaryOutcomes measure: Assessment of Intubation Requirement Using GCS and APACHE, secondaryOutcomes measure: Length of Intensive Care Unit (ICU) Stay, secondaryOutcomes measure: length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 54 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06316349, orgStudyIdInfo id: CAAE: 75727323.3.0000.0068, briefTitle: Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-01-10, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, descriptionModule briefSummary: The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.* Evaluating the strength of the femoral quadriceps muscle* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs The protocol will have a total duration of 35 days, with an initial intervention period of 21 days (5 days per week), followed by a 14-day follow-up period., conditionsModule conditions: Heart Failure, conditions: Physical Therapy, conditions: Neuromuscular Electrical Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Rondomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The researcher responsible for conducting the ultrasonographic measurements will be blinded regarding the randomization and allocation groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Isolated Resistance Training Program, interventions name: Neuromuscular electrical stimulation, outcomesModule primaryOutcomes measure: To investigate echo intensity of the rectus femoris muscle, secondaryOutcomes measure: To investigate cross-sectional area of the rectus femoris muscle, secondaryOutcomes measure: To investigate pennation angle of the rectus femoris muscle, secondaryOutcomes measure: To investigate changes in quadriceps femoral muscle strength, secondaryOutcomes measure: To investigate changes in arterial blood pressure during the protocol, secondaryOutcomes measure: To investigate changes in heart rate during the protocol, secondaryOutcomes measure: To investigate changes in peripheral oxygen saturation during the protocol, secondaryOutcomes measure: To investigate changes in the veno-arterial difference in carbon dioxide partial pressure, 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, city: Sao Paulo, zip: 05403-000, country: Brazil, contacts name: Silvia HG Lage, MD,PhD, role: SUB_INVESTIGATOR, contacts name: Kelly CO Abud, PT,PhD, role: SUB_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
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protocolSection identificationModule nctId: NCT06316336, orgStudyIdInfo id: BE24-005, briefTitle: Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions, acronym: BE24-005, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2024-06-22, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Pharma Nueva, class: INDUSTRY, descriptionModule briefSummary: Objectives:To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulationsStudy Design:An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2., conditionsModule conditions: Healthy Vollunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Alfuzosin Hydrochloride 10 mg, interventions name: Xatral® XL 10 mg, outcomesModule primaryOutcomes measure: Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316323, orgStudyIdInfo id: REC/09/2021 (FB/51), briefTitle: The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-09-29, completionDateStruct date: 2024-01-26, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universiti Teknologi Mara, class: OTHER, descriptionModule briefSummary: Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management., conditionsModule conditions: Early Childhood Caries, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one group received silver diamine fluoride treatment, and another group received sodium fluoride varnish treatment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Subjects that participated in this study were randomly allocated to two groups; Group A and Group B. Group A subjects were treated with 38% SDF and Group B subjects were treated with 5% NaF varnish. The randomisations of the subjects were done using a sealed envelope. Sequentially numbered, opaque sealed envelopes (SNOSE) method was used for the allocation concealments. This study was conducted in a non-blinded manner, as it was deemed impossible to blind the subjects. The treatment solutions utilized in this study were clearly distinct, with the SDF solution comprising a two-step process, while NaF varnish only required a single step. Additionally, the treatments exhibited different colors and textures. Consequently, the principal investigator had to closely supervise the treatment of each group. Due to the risk of blackish staining associated with SDF, parents and children were not blinded and were informed of the treatment they would receive., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: Silver diamine fluoride, interventions name: Sodium fluoride, outcomesModule primaryOutcomes measure: comparison of salivary pH, primaryOutcomes measure: comparison of salivary counts of Streptococcus mutans, primaryOutcomes measure: comparison of salivary counts of Lactobacillus, secondaryOutcomes measure: Detection and comparison of salivary counts of Lactobacillus acidophilus, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Technology MARA, city: Sungai Buloh, state: Selangor, zip: 47000, country: Malaysia, geoPoint lat: 3.2, lon: 101.58333, hasResults: False
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protocolSection identificationModule nctId: NCT06316310, orgStudyIdInfo id: XSF20240312, briefTitle: Effect of Acupoint Thread Embedding on Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Municipal Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group).group)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: acupoint thread embedding, outcomesModule primaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Changes in body circumference, secondaryOutcomes measure: Body composition analysis, secondaryOutcomes measure: Abdominal visceral fat tissue thickness, secondaryOutcomes measure: Fasting blood glucose (FPG), secondaryOutcomes measure: Blood lipid profile, secondaryOutcomes measure: Impact of Weight on Quality-of-Life Scale (IWQOL-Lite), secondaryOutcomes measure: Well-Being Index (WHO-5), secondaryOutcomes measure: Visual analog scale (VAS) of appetite, secondaryOutcomes measure: Hamilton Anxiety Scale (HAMA), secondaryOutcomes measure: Adverse effects, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Municipal Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200071, country: China, contacts name: Shifen Xu, PhD, role: CONTACT, phone: +8613761931393, email: xu_teacher2006@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06316297, orgStudyIdInfo id: VBE00001, secondaryIdInfos id: U1111-1295-3154, type: REGISTRY, domain: ICTRP, briefTitle: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2027-12-22, completionDateStruct date: 2027-12-23, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US., conditionsModule conditions: Acne, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential and parallel design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 386, type: ESTIMATED, armsInterventionsModule interventions name: Acne mRNA vaccine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with unsolicited systemic AEs, primaryOutcomes measure: Number of participants with solicited injection site and systemic reactions, primaryOutcomes measure: Number of participants with unsolicited AEs, primaryOutcomes measure: Number of participants with MAAEs, primaryOutcomes measure: Number of patients with SAEs, primaryOutcomes measure: Number of patients with related SAEs, fatal SAEs and AESIs, primaryOutcomes measure: Change in grade from baseline in biological test results, primaryOutcomes measure: Absolute change from baseline in the number of inflammatory acne lesions on face, primaryOutcomes measure: Percentage change from baseline in the number of inflammatory acne lesions on face, primaryOutcomes measure: Absolute change from baseline in the number of non-inflammatory acne lesions on face, primaryOutcomes measure: Percentage change from baseline in the number of non-inflammatory acne lesions on face, primaryOutcomes measure: At least two-grade improvement in IGA scores, secondaryOutcomes measure: Assessment of vaccine-antigen-specific serum antibody titers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: True Blue Clinical Research Site Number : 8400016, status: RECRUITING, city: Brandon, state: Florida, zip: 33511, country: United States, geoPoint lat: 27.9378, lon: -82.28592, locations facility: Jacksonville Center for Clinical Research Site Number : 8400006, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: DelRicht Research Site Number : 8400013, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70115, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Metro Boston Clinical Partners Site Number : 8400008, status: RECRUITING, city: Brighton, state: Massachusetts, zip: 02135, country: United States, geoPoint lat: 42.3501, lon: -71.15644, locations facility: DermResearch Center of New York, Inc Site Number : 8400010, status: RECRUITING, city: Stony Brook, state: New York, zip: 11790, country: United States, geoPoint lat: 40.92565, lon: -73.14094, locations facility: Lynn Health Science Institute (LHSI) Site Number : 8400004, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Dermresearch Site Number : 8400009, status: RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Center for Clinical Studies, LTD. LLP Site Number : 8400002, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06316284, orgStudyIdInfo id: miRNA-CKD, briefTitle: miRNA in Chronic Kidney Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Josip Juraj Strossmayer University of Osijek, class: OTHER, collaborators name: University Hospital Center Osijek, descriptionModule briefSummary: Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Systemic microvascular function, primaryOutcomes measure: Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase, primaryOutcomes measure: Detecton of miRNA of interest, secondaryOutcomes measure: Body fluid compartments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine Osijek, city: Osijek, zip: 31000, country: Croatia, geoPoint lat: 45.55111, lon: 18.69389, hasResults: False
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protocolSection identificationModule nctId: NCT06316271, orgStudyIdInfo id: PreHT 2024, briefTitle: Endothelial Function in Prehypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Josip Juraj Strossmayer University of Osijek, class: OTHER, collaborators name: University Hospital Center Osijek, descriptionModule briefSummary: In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established., conditionsModule conditions: Hypertension,Essential, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Systemic microvascular function, primaryOutcomes measure: Systemic macrovascular function, primaryOutcomes measure: Aortic stiffness, primaryOutcomes measure: Left ventricle global longitudinal strain, secondaryOutcomes measure: Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α), secondaryOutcomes measure: Activity of renin-angiotensin system (RAS), secondaryOutcomes measure: Endothelial progenitor cells (EPCs), secondaryOutcomes measure: Endothelial extracellular vesicles (eEVs), secondaryOutcomes measure: Systemic peripheral vascular resistance, secondaryOutcomes measure: Autonomic nervous system (ANS) activity, secondaryOutcomes measure: Matrix metalloproteinase 9, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine Osijek, city: Osijek, zip: 31000, country: Croatia, geoPoint lat: 45.55111, lon: 18.69389, hasResults: False
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protocolSection identificationModule nctId: NCT06316258, orgStudyIdInfo id: 333112, briefTitle: Evaluating a CFT Group for Adults With Acquired Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, descriptionModule briefSummary: Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group.The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group.This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting., conditionsModule conditions: Acquired Brain Injury Including Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Compassion focused therapy group, outcomesModule primaryOutcomes measure: Demand - patients referred and screened for the group, primaryOutcomes measure: Demand - patients recruited, primaryOutcomes measure: Demand - attendance, primaryOutcomes measure: Implementation - patients per group, primaryOutcomes measure: Implementation - group sessions completed, primaryOutcomes measure: Implementation - practice sessions completed, primaryOutcomes measure: Practicality - delivery of intervention, primaryOutcomes measure: Acceptability - end of session ratings scores, primaryOutcomes measure: Acceptability - patient interview feedback, secondaryOutcomes measure: Change in emotional distress questionnaire score, secondaryOutcomes measure: Change in mental well-being questionnaire score, secondaryOutcomes measure: Change in self-compassion questionnaire score, secondaryOutcomes measure: Change in quality of life questionnaire score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06316245, orgStudyIdInfo id: 2024/178, briefTitle: Functional Capacity and Days Alive Out of Hospital at 30 Days, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-10-19, completionDateStruct date: 2024-12-19, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor., conditionsModule conditions: Gastrointestinal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: DASI questionnaire, outcomesModule primaryOutcomes measure: Days alive and out of hospital at 30 days (DAOH-30), secondaryOutcomes measure: Days alive and out of hospital at 90 days (DAOH-90), secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: The Postoperative Morbidity Survey (POMS) defined morbidity, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Intensive care unit (ICU) stay, secondaryOutcomes measure: Length of hospital stay after index surgery, secondaryOutcomes measure: Rehospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34093, country: Turkey, contacts name: Muserref B Dincer, role: CONTACT, phone: +905321624712, email: mberildincer@gmail.com, contacts name: Ahmet K Koltka, role: CONTACT, email: koltkak@yahoo.com, contacts name: Muserref B Dincer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06316232, orgStudyIdInfo id: DBS-FOG 2023, briefTitle: DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Istituto delle Scienze Neurologiche di Bologna, class: OTHER, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, descriptionModule briefSummary: Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa., conditionsModule conditions: Freezing of Gait, conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions:1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally,2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: STIM ON plus, interventions name: MED ON plus, outcomesModule primaryOutcomes measure: Time spent with FOG during protocol, secondaryOutcomes measure: Gait performance, secondaryOutcomes measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, secondaryOutcomes measure: Patient global impression of change (PGI-C), secondaryOutcomes measure: Trail Making test A and B, secondaryOutcomes measure: Phonemic/Semantic alternate Fluency test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, status: RECRUITING, city: Bologna, zip: 40139, country: Italy, contacts name: Ilaria Cani, role: CONTACT, phone: 0039 051 4966959, email: ilaria.cani@studio.unibo.it, contacts name: Giulia Giannini, role: CONTACT, phone: 0039 051 4966959, email: giulia.giannini15@unibo.it, contacts name: Giovanna Calandra Buonaura, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Ilaria Cani, MD, role: SUB_INVESTIGATOR, contacts name: Carlo Alberto Artusi, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Giulia Giannini, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06316219, orgStudyIdInfo id: ZOEPREP, briefTitle: The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Nomegestrol Acetate/Estradiol, in rapid preparation of endometrium for hysteroscopic polypectomy., conditionsModule conditions: Endometrial Polyp, conditions: Endometrial Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Nomegestrol Acetate/Estradiol 2.5mg/1.5mg, outcomesModule primaryOutcomes measure: Quality of endometrial preparation, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andrea Etrusco, city: Palermo, zip: 90123, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Marco Monti, city: Rome, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06316206, orgStudyIdInfo id: EFFIPREP, briefTitle: The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy., conditionsModule conditions: Endometrial Polyp, conditions: Endometrial Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Ethinylestradiol/Dienogest 0.03mg/2mg, outcomesModule primaryOutcomes measure: Quality of endometrial preparation, eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andrea Etrusco, city: Palermo, zip: 90123, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Marco Monti, city: Roma, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06316193, orgStudyIdInfo id: DiaPaNeo, briefTitle: The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel., acronym: DiaPaNeo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population:* Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital.* Health workers of the O.U. of Neonatal Pathology., conditionsModule conditions: Experience, Life, conditions: Stress, conditions: Depression, Postpartum, conditions: Support, Family, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Diary, outcomesModule primaryOutcomes measure: The objective of the qualitative phase is to provide a description of the experience of the parents of infants admitted to Neonatal Pathology and the healthcare personnel who participated in the compilation of the diary., secondaryOutcomes measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The instruments will be administered by one of the appropriately trained nurses., secondaryOutcomes measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Stressor Scale (PSS)., secondaryOutcomes measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Edinburgh Postnatal Depression Scale (EPDS)., secondaryOutcomes measure: The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The Nurse Parental Support Tool (NPST)., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, city: Milano, state: MI, zip: 20132, country: Italy, contacts name: Roberta Ranzani, role: CONTACT, phone: +393408896175, email: ranzani.roberta@hsr.it, contacts name: Alessia De simone, role: CONTACT, phone: +393311637516, email: desimone.alessia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06316180, orgStudyIdInfo id: DROVPREP, briefTitle: The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy., conditionsModule conditions: Endometrial Polyp, conditions: Endometrial Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: drospirenone/estetrol 3mg/14.2mg, outcomesModule primaryOutcomes measure: Quality of endometrial preparation, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andrea Etrusco, city: Palermo, zip: 90123, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Marco Monti, city: Rome, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06316167, orgStudyIdInfo id: Hiatoplasty-2024, briefTitle: Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Instituto Mexicano del Seguro Social, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.The main question\[s\] it aims to answer are:* Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty* Comparison of postoperative complication rates, including GERDParticipants will answer a follow-up questionnaire, about postoperative quality of life, conditionsModule conditions: Postgastrectomy Syndromes, conditions: Gastroesophageal Reflux, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 275, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of participants without postoperative GERD, secondaryOutcomes measure: Comorbidities in patients undergoing gastric sleeve with hiatoplasty, secondaryOutcomes measure: Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty, secondaryOutcomes measure: Comparison of postoperative complication rates, including GERD, secondaryOutcomes measure: Postoperative quality of life analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico, status: RECRUITING, city: Guadalajara, state: Jalisco, zip: 44329, country: Mexico, contacts name: Alejandro González-Ojeda, MD, PhD, role: CONTACT, phone: 3331294165, email: avygail5@gmail.com, geoPoint lat: 20.66682, lon: -103.39182, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-10, uploadDate: 2024-03-11T14:29, filename: Prot_000.pdf, size: 2544381, hasResults: False
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protocolSection identificationModule nctId: NCT06316154, orgStudyIdInfo id: 12032024, briefTitle: Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis, acronym: PAFCLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-22, primaryCompletionDateStruct date: 2024-10-22, completionDateStruct date: 2024-12-22, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov, class: OTHER, descriptionModule briefSummary: The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts., conditionsModule conditions: Echinococcosis, Hepatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Echinococcectomy, outcomesModule primaryOutcomes measure: Presence of viable germinal elements of echinococcosis, secondaryOutcomes measure: Recurrence of liver echinococcosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov, status: RECRUITING, city: Tashkent, zip: 100115, country: Uzbekistan, contacts name: Azam Babadjanov, Professor, role: CONTACT, phone: +998901751703, email: azam746@mail.ru, geoPoint lat: 41.26465, lon: 69.21627, hasResults: False
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protocolSection identificationModule nctId: NCT06316141, orgStudyIdInfo id: REC/RCR&AHS/23/0352, briefTitle: Effects of Aquatic vs Land Based Jogging in Overweight, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Obesity raises the risk of chronic illnesses in adults, especially heart disease, type II diabetes, and osteoarthritis. One way to combat obesity is by physical activity, and water-based exercise (hydrotherapy) is recognized as an enhancement of the more common on land physical activity. Obesity is associated with several negative health outcomes, including cardiovascular disease (CVD), cardiac enlargement, gallbladder disease, diabetes, several cancers, osteoarthritis, and sleeping disorders .In addition to being a significant predictor of coronary heart disease and heart failure. obesity is indirectly related to cardiovascular health through its association with several other CVD risk factors, including hypertension, high cholesterol, low high-density lipoprotein (HDL) cholesterol, high triglycerides, and diabetes Therefore, obesity is a primary target for interventions to decrease overall cardiovascular risk. It is a randomized clinical trial conducted at the University OF Central Punjab Lahore. Convenience sampling technique will be used .Participants will be recruited through simple random sampling by sealed opaque envelope method into two Groups .Group A and Group B. Group A:Aqua jogging group: This group will perform aqua jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Group B: Land based jogging group: This group will perform land jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Assessment tools for this study will be cooper's 1.5 miles run test for cardiorespiratory endurance and health related quality of life questionnaire for Quality of life. The study will be completed within 10 months after synopsis approval from ethical Committee of RCRS \& AHS .Data will be entered and analysed by SPSS version 25. After assessing the normality of data, it will be decided either parametric or non-parametric test will be use within a group or between two groups., conditionsModule conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Aqua Jogging, interventions name: Land based Jogging, outcomesModule primaryOutcomes measure: Cardiorespiratory Endurance(cooper; s1.5 miles run), primaryOutcomes measure: Quality of life (health related QOL SF 36 Questionnaire), primaryOutcomes measure: BMI, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Central Punjab (sports complex) Lahore., city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06316128, orgStudyIdInfo id: K26, briefTitle: EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian CCUs, acronym: EYESHOT-2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Heart Care Foundation, class: OTHER, descriptionModule briefSummary: This registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis NSTEMI or STEMI in Italian Cardiac care Units (CCUs) during a four-week study period., conditionsModule conditions: Acute Coronary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Antithrombotic therapies, otherOutcomes measure: Assessment of in-hospital clinical events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Santo Spirito - Sc Cardiologia, city: Casale, state: AL, zip: 15033, country: Italy, geoPoint lat: 41.21972, lon: 14.00231, locations facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic, city: Ancona, state: AN, zip: 60122, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia, city: Ancona, state: AN, zip: 60131, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale San Donato - U.O.C Cardiologia, city: Arezzo, state: AR, zip: 52100, country: Italy, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari, city: Montevarchi, state: AR, zip: 52027, country: Italy, geoPoint lat: 43.5252, lon: 11.57238, locations facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti', city: Avellino, state: AV, zip: 83100, country: Italy, geoPoint lat: 40.91494, lon: 14.79103, locations facility: Ospedale Miulli - U.O.C. Cardiologia - Utic, city: Acquaviva Delle Fonti, state: BA, zip: 70021, country: Italy, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic, city: Altamura, state: BA, zip: 70022, country: Italy, geoPoint lat: 40.82664, lon: 16.54952, locations facility: Ospedale San Paolo - Cardiologia-Utic, city: Bari, state: BA, zip: 70123, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Aou Policlinico - Uoc Cardiologia Ospedaliera, city: Bari, state: BA, zip: 70124, country: Italy, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Di Venere - U.O.C. Di Cardiologia, city: Carbonara Di Bari, state: BA, zip: 70012, country: Italy, geoPoint lat: 41.06667, lon: 16.86667, locations facility: Ospedale Bolognini - Cardiologia E Unita' Coronarica, city: Seriate, state: BG, zip: 24068, country: Italy, geoPoint lat: 45.68532, lon: 9.72487, locations facility: Ospedali Treviglio-Caravaggio - Cardiologia, city: Treviglio, state: BG, zip: 24047, country: Italy, geoPoint lat: 45.52081, lon: 9.59102, locations facility: Ospedale Degli Infermi - Sc Di Cardiologia, city: Ponderano, state: BI, zip: 13875, country: Italy, geoPoint lat: 45.53846, lon: 8.05592, locations facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic, city: Feltre, state: BL, zip: 32032, country: Italy, geoPoint lat: 46.02085, lon: 11.90031, locations facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura, city: Bentivoglio, state: BO, zip: 40010, country: Italy, geoPoint lat: 44.6369, lon: 11.41737, locations facility: Ospedale Maggiore - U.O.C. Di Cardiologia, city: Bologna, state: BO, zip: 40133, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Galie', city: Bologna, state: BO, zip: 40138, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Perrino - U.O.C. Di Cardiologia, city: Brindisi, state: BR, zip: 72100, country: Italy, geoPoint lat: 40.63215, lon: 17.93607, locations facility: Asst Spedali Civili - Cardiologia, city: Brescia, state: BS, zip: 25123, country: Italy, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Asst Franciacorta - Presidio Chiari - Cardiologia/Utic, city: Chiari, state: BS, zip: 25032, country: Italy, geoPoint lat: 45.53763, lon: 9.92699, locations facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C., city: Desenzano Del Garda, state: BS, zip: 25015, country: Italy, geoPoint lat: 45.47127, lon: 10.53559, locations facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia, city: Gavardo, state: BS, zip: 25085, country: Italy, geoPoint lat: 45.58939, lon: 10.44257, locations facility: Istituto Clinico San Rocco - Unita' Operativa Di Cardiologia, city: OME, state: BS, zip: 25050, country: Italy, geoPoint lat: 45.62728, lon: 10.12137, locations facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali, city: Bolzano, state: BZ, zip: 39100, country: Italy, geoPoint lat: 46.49067, lon: 11.33982, locations facility: Arnas G. Brotzu - Cardiologia Con Utic, city: Cagliari, state: CA, zip: 09134, country: Italy, geoPoint lat: 39.23054, lon: 9.11917, locations facility: A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica, city: Monserrato, state: CA, zip: 09124, country: Italy, geoPoint lat: 39.25642, lon: 9.1444, locations facility: Ospedale A. Cardarelli - U.O. Cardiologia E Utic, city: Campobasso, state: CB, zip: 86100, country: Italy, geoPoint lat: 41.55947, lon: 14.66737, locations facility: Presidio Ospedaliero Moscati - U.O.C. Cardiologia-Utic, city: Aversa, state: CE, zip: 81031, country: Italy, geoPoint lat: 40.97259, lon: 14.20745, locations facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic, city: Caserta, state: CE, zip: 81100, country: Italy, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Casa Di Cura San Michele - Uo Cardiologia, city: Maddaloni, state: CE, zip: 81024, country: Italy, geoPoint lat: 41.03578, lon: 14.3823, locations facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic, city: Santa Maria Capua Vetere, state: CE, zip: 81055, country: Italy, geoPoint lat: 41.08156, lon: 14.25342, locations facility: Presidio Ospedaliero San Rocco - U.O.C. Cardiologia - Utic, city: Sessa Aurunca, state: CE, zip: 81037, country: Italy, geoPoint lat: 41.23987, lon: 13.92966, locations facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic, city: Chieti, state: CH, zip: 66013, country: Italy, geoPoint lat: 42.34827, lon: 14.16494, locations facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia, city: Cuneo, state: CN, zip: 12100, country: Italy, geoPoint lat: 44.39071, lon: 7.54828, locations facility: Ospedale Pietro E Michele Ferrero - Cardiologia E Utic, city: Verduno, state: CN, zip: 12060, country: Italy, geoPoint lat: 44.66614, lon: 7.93074, locations facility: Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia, city: Gravedona, state: CO, zip: 22015, country: Italy, geoPoint lat: 46.14639, lon: 9.30094, locations facility: Ospedale Maggiore - U.O. Cardiologia E Utic, city: Crema, state: CR, zip: 26013, country: Italy, geoPoint lat: 45.36264, lon: 9.68176, locations facility: P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica, city: Catanzaro, state: CZ, zip: 88100, country: Italy, geoPoint lat: 38.88247, lon: 16.60086, locations facility: Ospedale M. Bufalini - U.O. Di Cardiologia-Utic, city: Cesena, state: FC, zip: 47521, country: Italy, geoPoint lat: 44.1391, lon: 12.24315, locations facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia, city: Forli', state: FC, zip: 47121, country: Italy, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Arcispedale Sant'Anna - U.O. Cardiologia, city: Ferrara, state: FE, zip: 44124, country: Italy, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic, city: Foggia, state: FG, zip: 71100, country: Italy, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica, city: San Giovanni Rotondo, state: FG, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Ospedale Santa Maria Annunziata - Sos Cardiologia Clinica, city: Bagno A Ripoli, state: FI, zip: 50011, country: Italy, geoPoint lat: 43.75115, lon: 11.32252, locations facility: Ospedale San Giuseppe - Cardiologia, city: Empoli, state: FI, zip: 50053, country: Italy, geoPoint lat: 43.71795, lon: 10.94758, locations facility: Ospedale Santa Maria Nuova - Cardiologia, city: Firenze, state: FI, zip: 50122, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Aou Careggi - Interventistica Cardiologica Strutturale, city: Firenze, state: FI, zip: 50134, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Padre Antero Micone - Sc Cardiologia - Utic, city: Genova, state: GE, zip: 16100, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Villa Scassi - Asl 3 Ligure - Sc Cardiologia Utic, city: Genova, state: GE, zip: 16149, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic, city: Lavagna, state: GE, zip: 16033, country: Italy, geoPoint lat: 44.3062, lon: 9.35383, locations facility: Presidio Ospedaliero - U.O. Cardiologia, city: Sanremo, state: IM, zip: 18038, country: Italy, geoPoint lat: 43.81725, lon: 7.7772, locations facility: Ospedale San Leopoldo Mandic - Cardiologia - Ucc, city: Merate, state: LC, zip: 23807, country: Italy, geoPoint lat: 45.68858, lon: 9.4208, locations facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica, city: Lecce, state: LE, zip: 73100, country: Italy, geoPoint lat: 40.35481, lon: 18.17244, locations facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei", city: Scorrano, state: LE, zip: 73020, country: Italy, geoPoint lat: 40.09018, lon: 18.29993, locations facility: Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic, city: Tricase, state: LE, zip: 73039, country: Italy, geoPoint lat: 39.93018, lon: 18.35421, locations facility: Ospedale Civile Bassa Val Di Cecina - Unita Operativa Di Cardiologia E Utic, city: Cecina, state: LI, zip: 57023, country: Italy, geoPoint lat: 43.30621, lon: 10.51729, locations facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic, city: Livorno, state: LI, zip: 57124, country: Italy, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Ospedale Villamarina - Cardiologia E Utic Piombino Elba, city: Piombino, state: LI, zip: 57025, country: Italy, geoPoint lat: 42.92554, lon: 10.52585, locations facility: Ospedale Maggiore Di Lodi - U.O.C. Cardiologia, city: Lodi, state: LO, zip: 26900, country: Italy, geoPoint lat: 45.30989, lon: 9.50085, locations facility: Nuovo Ospedale Versilia - Sc Cardiologia, city: Camaiore, state: LU, zip: 55041, country: Italy, geoPoint lat: 43.94265, lon: 10.29754, locations facility: Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist., city: Castelnuovo Di Garfagnana, state: LU, zip: 55032, country: Italy, geoPoint lat: 44.1126, lon: 10.40518, locations facility: Ospedale Pio Xi - U.O.C. Di Cardiologia, city: Desio, state: MB, zip: 20832, country: Italy, geoPoint lat: 45.61831, lon: 9.20249, locations facility: Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia, city: Monza, state: MB, zip: 20900, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, locations facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic, city: Vimercate, state: MB, zip: 20871, country: Italy, geoPoint lat: 45.61545, lon: 9.36801, locations facility: Presidio Osp. Di Civitanova Marche - Sc Cardiologia, city: Civitanova Marche, state: MC, zip: 62012, country: Italy, geoPoint lat: 43.30491, lon: 13.72068, locations facility: Irccs Centro Neurolesi Bonino Pulejo - P.O. Piemonte - Cardiologia E Utic, city: Messina, state: ME, zip: 98124, country: Italy, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Humanitas Gavazzeni - U.O. Cardiologia, city: Bergamo, state: MI, zip: 24125, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc, city: Cernusco Sul Naviglio, state: MI, zip: 20063, country: Italy, geoPoint lat: 45.52526, lon: 9.33297, locations facility: Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg), city: Cinisello Balsamo, state: MI, zip: 20092, country: Italy, geoPoint lat: 45.55823, lon: 9.21495, locations facility: Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica, city: Legnano, state: MI, zip: 20025, country: Italy, geoPoint lat: 45.59788, lon: 8.91506, locations facility: Ospedale Civile Fornaroli - U.O. Cardiologia, city: Magenta, state: MI, zip: 20013, country: Italy, geoPoint lat: 45.46456, lon: 8.88453, locations facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari, city: Milano, state: MI, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Centro Cardiologico Monzino Irccs - Terapia Intensiva Cardiologica (Utic), city: Milano, state: MI, zip: 20138, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale San Luca Irccs - Istituto Auxologico - Area Critica Cardiologica, city: Milano, state: MI, zip: 20149, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC, city: Milano, state: MI, zip: 20153, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale L. Sacco - Sc Cardiologia, city: Milano, state: MI, zip: 20157, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica, city: Milano, state: MI, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Civile - Unita' Operativa Di Cardiologia, city: RHO, state: MI, zip: 20017, country: Italy, geoPoint lat: 45.53245, lon: 9.0402, locations facility: Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc, city: Rozzano, state: MI, zip: 20089, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Irccs Policlinico San Donato - U.O. Cardiologia Con Utic, city: San Donato Milanese, state: MI, zip: 20097, country: Italy, geoPoint lat: 45.41047, lon: 9.26838, locations facility: Irccs Policlinico Multimedica - Uo Di Cardiologia, city: Sesto San Giovanni, state: MI, zip: 20099, country: Italy, geoPoint lat: 45.53329, lon: 9.22585, locations facility: Ospedale Madonna Delle Grazie - Ssd Utic, city: Matera, state: Mount, zip: 75100, country: Italy, geoPoint lat: 40.66599, lon: 16.60463, locations facility: Ospedale Civile Di Baggiovara - U.O. Di Cardiologia, city: Modena, state: MO, zip: 41126, country: Italy, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Di Sassuolo - Cardiologia, city: Sassuolo, state: MO, zip: 41049, country: Italy, geoPoint lat: 44.5432, lon: 10.7848, locations facility: Ospedale Apuane - U.O. Cardiologia-Utic, city: Massa, state: MS, zip: 54100, country: Italy, geoPoint lat: 44.03541, lon: 10.13927, locations facility: Ospedale San Francesco - Cardiologia - Utic, city: Nuoro, state: NU, zip: 08100, country: Italy, geoPoint lat: 40.31991, lon: 9.32568, locations facility: Ospedale Giovanni Paolo Ii - Utic - Cardiologia, city: Olbia, state: OT, zip: 07026, country: Italy, geoPoint lat: 40.92337, lon: 9.49802, locations facility: Fondazione G. Giglio - U.O. Di Cardiologia, city: Cefalu', state: PA, zip: 90015, country: Italy, geoPoint lat: 38.03856, lon: 14.02285, locations facility: Aou Policlinico P. Giaccone - U.O.C. Cardiologia, city: Palermo, state: PA, zip: 90127, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Arnas P.O. Civico E Benfratelli - Uoc Utic, city: Palermo, state: PA, zip: 90127, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale G.F. Ingrassia - Cardiologia - Utic, city: Palermo, state: PA, zip: 90129, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Maria Eleonora Hospital - Cardiologia, city: Palermo, state: PA, zip: 90135, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello, city: Palermo, state: PA, zip: 90146, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia, city: Palermo, state: PA, zip: 90146, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic, city: Piacenza, state: PC, zip: 29100, country: Italy, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic, city: Pescara, state: PE, zip: 65124, country: Italy, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic, city: Citta' Di Castello, state: PG, zip: 06012, country: Italy, geoPoint lat: 43.46556, lon: 12.2375, locations facility: Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia, city: Foligno, state: PG, zip: 06034, country: Italy, geoPoint lat: 42.95488, lon: 12.70268, locations facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia, city: Gubbio, state: PG, zip: 06024, country: Italy, geoPoint lat: 43.34996, lon: 12.57309, locations facility: Azienda Ospedaliera Di Perugia - S.C. Cardiologia, city: Perugia, state: PG, zip: 06129, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare, city: Pisa, state: PI, zip: 56124, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale Ss. Cosma E Damiano - Sos Cardiologia, city: Pescia, state: Point, zip: 51017, country: Italy, geoPoint lat: 43.8871, lon: 10.68849, locations facility: Ospedale San Jacopo - Soc Cardiologia, city: Pistoia, state: Point, zip: 51100, country: Italy, geoPoint lat: 43.93064, lon: 10.92365, locations facility: Ospedale Santo Stefano - U.O. Cardiologia, city: Prato, state: PO, zip: 59100, country: Italy, geoPoint lat: 43.8805, lon: 11.09699, locations facility: Ospedale Civile - U.O.C. Cardiologia - Utic, city: Fidenza, state: PR, zip: 43036, country: Italy, geoPoint lat: 44.86694, lon: 10.06039, locations facility: Azienda Ospedaliera Universitaria Parma - U.O.C. Di Cardiologia, city: Parma, state: PR, zip: 43126, country: Italy, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic, city: Pesaro, state: PU, zip: 61121, country: Italy, geoPoint lat: 43.90921, lon: 12.9164, locations facility: Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Civile - U.O. Di Cardiologia, city: Voghera, state: PV, zip: 27058, country: Italy, geoPoint lat: 44.99151, lon: 9.01175, locations facility: Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica, city: Potenza, state: PZ, zip: 85100, country: Italy, geoPoint lat: 40.64175, lon: 15.80794, locations facility: Ospedale Civile - Uo Servizio Cardiologia, city: Lugo, state: RA, zip: 48022, country: Italy, geoPoint lat: 44.42137, lon: 11.91094, locations facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia, city: Ravenna, state: RA, zip: 48121, country: Italy, geoPoint lat: 44.41344, lon: 12.20121, locations facility: Grande Ospedale Metropolitano - Osp Riuniti Bianchi Melacrino - Uoc Cardiologia E Utic, city: Reggio Calabria, state: RC, zip: 89124, country: Italy, geoPoint lat: 38.11047, lon: 15.66129, locations facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord, city: Guastalla, state: RE, zip: 42016, country: Italy, geoPoint lat: 44.91172, lon: 10.66186, locations facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera, city: Reggio Emilia, state: RE, zip: 42100, country: Italy, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic, city: Ragusa, state: RG, zip: 97100, country: Italy, geoPoint lat: 36.92574, lon: 14.72443, locations facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia, city: Rieti, state: RI, zip: 02100, country: Italy, geoPoint lat: 42.40476, lon: 12.85735, locations facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic, city: Ariccia, state: RM, zip: 00072, country: Italy, geoPoint lat: 41.72063, lon: 12.6723, locations facility: European Hospital - U.O.C. Cardiologia Interventistica, city: Roma, state: RM, zip: 00149, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Camillo - Uoc Cardiologia, city: Roma, state: RM, zip: 00152, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini - Uoc Cardiologia, city: Roma, state: RM, zip: 00157, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Aurelia Hospital - U.O.C Cardiologia, city: Roma, state: RM, zip: 00163, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Casilino - U.O.C. Cardiologia, city: Roma, state: RM, zip: 00169, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia, city: Roma, state: RM, zip: 00177, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic, city: Roma, state: RM, zip: 00188, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Santo Spirito - Uoc Cardiologia, city: Roma, state: RM, zip: 00193, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic, city: Tivoli, state: RM, zip: 00019, country: Italy, geoPoint lat: 41.95952, lon: 12.8016, locations facility: Ospedale Infermi - U.O. Cardiologia, city: Rimini, state: RN, zip: 47900, country: Italy, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Ospedale S. Maria Incoronata Dell'Olmo - U.O.C. Cardiologia-Utic, city: Cava De' Tirreni, state: SA, zip: 84013, country: Italy, geoPoint lat: 40.69954, lon: 14.70773, locations facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic, city: Eboli, state: SA, zip: 84025, country: Italy, geoPoint lat: 40.61747, lon: 15.05693, locations facility: Presidio Ospedaliero Umberto I - Uoc Cardiologia - Utic, city: Nocera Inferiore, state: SA, zip: 84014, country: Italy, geoPoint lat: 40.7454, lon: 14.64542, locations facility: Presidio Ospedaliero Luigi Curto - Uo Cardiologia-Utic, city: Polla, state: SA, zip: 84035, country: Italy, geoPoint lat: 40.51433, lon: 15.49715, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic, city: Salerno, state: SA, zip: 84131, country: Italy, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Ospedale San Luca - U.O. Utic - Cardiologia, city: Vallo Della Lucania, state: SA, zip: 84078, country: Italy, geoPoint lat: 40.22786, lon: 15.26635, locations facility: Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic, city: Poggibonsi, state: SI, zip: 53036, country: Italy, geoPoint lat: 43.47064, lon: 11.14804, locations facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia, city: Siena, state: SI, zip: 53100, country: Italy, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Ospedale S. Andrea - S.C. Cardiologia, city: La Spezia, state: SP, zip: 19124, country: Italy, geoPoint lat: 44.103, lon: 9.82375, locations facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic, city: Augusta, state: SR, zip: 96011, country: Italy, geoPoint lat: 37.24065, lon: 15.22121, locations facility: Ospedale G. Di Maria - Cardiologia Utic, city: Avola, state: SR, zip: 96012, country: Italy, geoPoint lat: 36.9084, lon: 15.13937, locations facility: P.O. Lentini - Uosd Di Cardiologia Con Utic, city: Lentini, state: SR, zip: 96016, country: Italy, geoPoint lat: 37.28556, lon: 14.99737, locations facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica, city: Sassari, state: SS, zip: 07100, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic, city: San Gavino Monreale, state: SU, zip: 09037, country: Italy, geoPoint lat: 39.55008, lon: 8.79065, locations facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente, city: Pietra Ligure, state: SV, zip: 17027, country: Italy, geoPoint lat: 44.1492, lon: 8.28206, locations facility: P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante, city: Savona, state: SV, zip: 17100, country: Italy, geoPoint lat: 44.30905, lon: 8.47715, locations facility: Ospedale Di Castellaneta - S.C. Cardiologia, city: Castellaneta, state: TA, zip: 74011, country: Italy, geoPoint lat: 40.62794, lon: 16.9329, locations facility: Casa Di Cura Villa Verde - Cardiologia, city: Taranto, state: TA, zip: 74100, country: Italy, geoPoint lat: 40.46435, lon: 17.24707, locations facility: Ospedale Ss. Annunziata - S.C. Cardiologia-Utic, city: Taranto, state: TA, zip: 74100, country: Italy, geoPoint lat: 40.46435, lon: 17.24707, locations facility: Ospedale Santa Chiara - Divisione Di Cardiologia, city: Trento, state: TN, zip: 38122, country: Italy, geoPoint lat: 46.06787, lon: 11.12108, locations facility: Ospedale Civico - Sc Cardiologia, city: Chivasso, state: TO, zip: 10034, country: Italy, geoPoint lat: 45.19093, lon: 7.88981, locations facility: Por Cirie'- Lanzo Presidio Cirie' - S.C. Cardiologia, city: Cirié, state: TO, zip: 10073, country: Italy, geoPoint lat: 45.23486, lon: 7.60125, locations facility: Ospedale Santa Croce - Cardiologia, city: Moncalieri, state: TO, zip: 10024, country: Italy, geoPoint lat: 44.9994, lon: 7.68236, locations facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia, city: Orbassano, state: TO, zip: 10043, country: Italy, geoPoint lat: 45.00547, lon: 7.53813, locations facility: Ospedale Degli Infermi - Sc Cardiologia, city: Rivoli, state: TO, zip: 10098, country: Italy, geoPoint lat: 45.07073, lon: 7.51465, locations facility: Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U, city: Torino, state: To, zip: 10126, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Mauriziano Umberto I - Sc Cardiologia, city: Torino, state: TO, zip: 10128, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Martini - Cardiologia (Mrt-Mv), city: Torino, state: TO, zip: 10142, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Maria Vittoria - Cardiologia (Mrt-Mv), city: Torino, state: TO, zip: 10149, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale San Giovanni Bosco - Sc Cardiologia, city: Torino, state: TO, zip: 10154, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Po S. Antonio Abate Di Trapani - U.O.C. Di Cardiologia, Utic Ed Emodinamica, city: Erice, state: TP, zip: 91016, country: Italy, geoPoint lat: 38.03785, lon: 12.58778, locations facility: Osp Abele Ajello - U.O.C. Cardiologia Con Utic, city: Mazara Del Vallo, state: TP, zip: 91026, country: Italy, geoPoint lat: 37.65535, lon: 12.58987, locations facility: Ospedale San Valentino - U.O.C. Cardiologia, city: Montebelluna, state: TV, zip: 31044, country: Italy, geoPoint lat: 45.77504, lon: 12.04904, locations facility: Ospedale Ca' Foncello - U.O.C. Cardiologia, city: Treviso, state: TV, zip: 31100, country: Italy, geoPoint lat: 45.66673, lon: 12.2416, locations facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia, city: Udine, state: UD, zip: 33100, country: Italy, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia, city: Saronno, state: VA, zip: 21047, country: Italy, geoPoint lat: 45.62513, lon: 9.03517, locations facility: Ospedale San Biagio - Soc Cardiologia Vco, city: Domodossola, state: VB, zip: 28845, country: Italy, geoPoint lat: 46.1165, lon: 8.29313, locations facility: Ospedale Castelli - Soc Cardiologia Vco, city: Verbania, state: VB, zip: 28922, country: Italy, geoPoint lat: 45.92136, lon: 8.55183, locations facility: Ospedale Dell'Angelo - U.O.C. Cardiologia, city: Mestre, state: VE, zip: 30171, country: Italy, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Presidio Ospedaliero Di Mirano - U.O.C. Di Cardiologia, city: Mirano, state: VE, zip: 30035, country: Italy, geoPoint lat: 45.49458, lon: 12.10775, locations facility: Ospedale Civile - U.O.C. Di Cardiologia, city: San Dona' Di Piave, state: VE, zip: 30027, country: Italy, geoPoint lat: 45.63019, lon: 12.5681, locations facility: Ospedale Civile - U.O.C. Di Cardiologia, city: Arzignano, state: VI, zip: 36071, country: Italy, geoPoint lat: 45.52027, lon: 11.33446, locations facility: Ospedale Civile San Bortolo - U.O.C. Cardiologia, city: Vicenza, state: VI, zip: 36100, country: Italy, geoPoint lat: 45.54672, lon: 11.5475, locations facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia, city: San Bonifacio, state: VR, zip: 37047, country: Italy, geoPoint lat: 45.39595, lon: 11.27352, locations facility: Aoui Di Verona - U.O. Cardiologia, city: Verona, state: VR, zip: 37126, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Ospedale Belcolle - Uosd Utic Polo, city: Viterbo, state: VT, zip: 01100, country: Italy, geoPoint lat: 42.41937, lon: 12.1056, locations facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia, city: Borgomanero, zip: 28021, country: Italy, geoPoint lat: 45.69873, lon: 8.4623, locations facility: Ospedale Civile Di Boscotrecase - Utic Cardiologia, city: Boscotrecase, zip: 80042, country: Italy, geoPoint lat: 40.77296, lon: 14.46185, locations facility: Ospedale San Leonardo - U.O. Di Cardiologia-Utic, city: Castellammare Di Stabia, zip: 80053, country: Italy, geoPoint lat: 40.70211, lon: 14.48685, locations facility: Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic, city: Frattamaggiore, zip: 80027, country: Italy, geoPoint lat: 40.9414, lon: 14.27588, locations facility: Presidio Ospedaliero San Giugliano - U.O. Cardiologia - Utic, city: Giugliano in Campania, zip: 80014, country: Italy, geoPoint lat: 40.92849, lon: 14.20197, locations facility: Ospedale Civile - S.C. Cardiologia, city: Ivrea, zip: 10015, country: Italy, geoPoint lat: 45.46723, lon: 7.87617, locations facility: Ospedale Anna Rizzoli - Cardiologia-Utic, city: Lacco Ameno, zip: 80076, country: Italy, geoPoint lat: 40.74901, lon: 13.88718, locations facility: Aorn Cardarelli - U.O. Cardiologia Con Utic, city: Napoli, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uoc Cardiologia-Utic, city: Napoli, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale Dei Pellegrini - Uoc Cardiologia-Utic, city: Napoli, zip: 80134, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale Del Mare - U.O. Cardiologia Con Utic-Emodinamica, city: Napoli, zip: 80147, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic, city: Nola, zip: 80035, country: Italy, geoPoint lat: 40.92606, lon: 14.52816, locations facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii, city: Novara, zip: 28100, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica, city: Pozzuoli, zip: 80078, country: Italy, geoPoint lat: 40.84394, lon: 14.0952, hasResults: False
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protocolSection identificationModule nctId: NCT06316115, orgStudyIdInfo id: HRRU-KMY-FA-01, briefTitle: Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Harran University, class: OTHER, descriptionModule briefSummary: Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement., conditionsModule conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement, outcomesModule primaryOutcomes measure: Introductory Information Form, secondaryOutcomes measure: Meggit-Wagner classification of diabetic foot, otherOutcomes measure: Visual Comparison Scale, otherOutcomes measure: State Anxiety scale (STAI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Harran Universitesi, status: RECRUITING, city: Şanlıurfa, country: Turkey, contacts name: Fatma ASLAN, role: CONTACT, phone: +905427760715, email: fatmaaslan62@gmail.com, geoPoint lat: 37.16708, lon: 38.79392, hasResults: False
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protocolSection identificationModule nctId: NCT06316102, orgStudyIdInfo id: 22-3282, briefTitle: Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Instituto Dermatológico y Cirugía de Piel (IDCP), collaborators name: George Washington University, descriptionModule briefSummary: This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2)., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 121, type: ACTUAL, armsInterventionsModule interventions name: Gender Affirming Abriendo Puertas (Opening Doors) (GAP), outcomesModule primaryOutcomes measure: Viral Suppression (HIV), 6 months, primaryOutcomes measure: Viral Suppression (HIV), 1 year, primaryOutcomes measure: Retention in HIV care, 6 months, primaryOutcomes measure: Retention in HIV care, 1 year, primaryOutcomes measure: Antiretroviral therapy adherence, 6 months, primaryOutcomes measure: Antiretroviral therapy adherence, 1 year, primaryOutcomes measure: Antiretroviral therapy interruption, 6 months, primaryOutcomes measure: Antiretroviral therapy interruption, 1 year, secondaryOutcomes measure: Depression, 6 months, secondaryOutcomes measure: Depression, 1 year, secondaryOutcomes measure: Anxiety, 6 months, secondaryOutcomes measure: Anxiety, 1 year, secondaryOutcomes measure: Substance use, 6 months, secondaryOutcomes measure: Substance use, 1 year, secondaryOutcomes measure: Binge drinking, 6 months, secondaryOutcomes measure: Binge drinking, 1 year, secondaryOutcomes measure: Self-esteem, 6 months, secondaryOutcomes measure: Self-esteem, 1 year, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto Dermatológico y Cirugía de Piel (IDCP), city: Santo Domingo, country: Dominican Republic, geoPoint lat: 18.50012, lon: -69.98857, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-03-21, uploadDate: 2024-03-22T10:41, filename: SAP_000.pdf, size: 86302, hasResults: False
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protocolSection identificationModule nctId: NCT06316089, orgStudyIdInfo id: K23DA054003, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DA054003, briefTitle: An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Rhode Island Hospital, class: OTHER, descriptionModule briefSummary: Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community., conditionsModule conditions: Hiv, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: PrEPared for Release, outcomesModule primaryOutcomes measure: PrEP initiation, secondaryOutcomes measure: Adherence to PrEP, secondaryOutcomes measure: Linkage to PrEP care in the community, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06316076, orgStudyIdInfo id: RJMty19-AID001, briefTitle: Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Guangdong Ruishun Biotech Co., Ltd, descriptionModule briefSummary: To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases, conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, conditions: Idiopathic Inflammatory Myopathies, conditions: Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: CD19-CAR-DNT cells, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: MTD, primaryOutcomes measure: Incidence of abnormalities, secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Cmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (AUC), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Tmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (T1/2), secondaryOutcomes measure: Disease response rate at 6 months, secondaryOutcomes measure: Duration of Response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University, status: RECRUITING, city: Shanghai, country: China, contacts name: Qiong Fu, MD, PhD, role: CONTACT, phone: 86-13585603288, email: fuqiong@renji.com, contacts name: Shuang Ye, MD, PhD, role: CONTACT, phone: 86-15801706421, email: Yeshuang@renji.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06316063, orgStudyIdInfo id: 2023-, briefTitle: Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study, acronym: CAPOX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-03-25, completionDateStruct date: 2026-03-25, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Karolinska Institutet, descriptionModule briefSummary: During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular collapse and fatal arrhythmias. In our knowledge, no studies have investigated the haemodynamic effects of apnoeic oxygenation with HFNO.The general purpose of this project is to investigate haemodynamic alternations during apnoeic oxygenation with HFNO compared to mechanical ventilation in relatively healthy patients under general anaesthesia during laryngeal surgery., conditionsModule conditions: Laryngeal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Apnoeic oxygenation with high-flow nasal oxygen, interventions name: Mechanical ventilation, outcomesModule primaryOutcomes measure: Significant haemodynamic effects during apnoeic oxygenation with HFNO, secondaryOutcomes measure: Alterations in FloTrac derived central haemodynamic parameters, secondaryOutcomes measure: Alterations in Electrocardiogram, secondaryOutcomes measure: Alterations in arterial carbon dioxide, oxygen and pH, secondaryOutcomes measure: Alterations in blood catecholamines and cardiac biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316050, orgStudyIdInfo id: cst, briefTitle: Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2021-08-31, completionDateStruct date: 2023-06-28, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de Terrassa, class: OTHER, descriptionModule briefSummary: Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion., conditionsModule conditions: Rotator Cuff Tears, conditions: Rotator Cuff Tear Arthropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Open randomized controlled clinical trial., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: humeral retroversion, outcomesModule primaryOutcomes measure: INTERNAL ROTATION, primaryOutcomes measure: INTERNAL ROTATION, secondaryOutcomes measure: EXTERNAL ROTATION, secondaryOutcomes measure: FORWARD ELEVATION, secondaryOutcomes measure: Simple shoulder test, secondaryOutcomes measure: Constant test, secondaryOutcomes measure: ASES test, secondaryOutcomes measure: Glenoid inclination angle, secondaryOutcomes measure: glenoid retroversion angle, secondaryOutcomes measure: abduction, secondaryOutcomes measure: center of rotation, secondaryOutcomes measure: lateralizaiton offset, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JM MORA, city: Terrassa, state: Barcelona, zip: 08227, country: Spain, geoPoint lat: 41.56667, lon: 2.01667, hasResults: False
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protocolSection identificationModule nctId: NCT06316037, orgStudyIdInfo id: 2024 DUTHEIL ADAPTAWORK_2, briefTitle: Adaptation of Work in a Hospital and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face, acronym: ADAPTAWORK_2, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-12, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic.Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs, conditionsModule conditions: Work-Related Stress, conditions: Work-Related Condition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 945, type: ACTUAL, outcomesModule primaryOutcomes measure: Feeling about teleworking, secondaryOutcomes measure: Musculo-squeletic pain, secondaryOutcomes measure: psychosocial risks, secondaryOutcomes measure: purchases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False
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protocolSection identificationModule nctId: NCT06316024, orgStudyIdInfo id: IRB2023056, briefTitle: Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Chiayi Christian Hospital, class: OTHER, descriptionModule briefSummary: The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding., conditionsModule conditions: Cesarean Section, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: water, interventions name: juice/sport drink group, interventions name: Chewing gum group, outcomesModule primaryOutcomes measure: first time to bowel sound, primaryOutcomes measure: beginning of breastmilk lactation, primaryOutcomes measure: length of hospital stay, secondaryOutcomes measure: time to first drink, secondaryOutcomes measure: time to first solid food intake, secondaryOutcomes measure: duration of IV hydration, secondaryOutcomes measure: IV cannulae removal, secondaryOutcomes measure: first ambulation, secondaryOutcomes measure: first stool, secondaryOutcomes measure: satisfaction VAS (0-100) regarding the early intake, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06316011, orgStudyIdInfo id: MCG-chestpain, briefTitle: MCG for Risk Stratifications of Patients With Chest Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）., conditionsModule conditions: Acute Coronary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3620, type: ESTIMATED, armsInterventionsModule interventions name: Magnetocardiography, outcomesModule primaryOutcomes measure: Efficacy of MCG for the detection and risk stratification in patients with chest pain, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315998, orgStudyIdInfo id: MCG-Structural, briefTitle: Diagnosis of Structural Heart Disease Using MCG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard., conditionsModule conditions: Structural Heart Abnormality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2914, type: ESTIMATED, armsInterventionsModule interventions name: Magnetocardiography, outcomesModule primaryOutcomes measure: The efficacy of the MCG in identifying structural heart disease, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06315985, orgStudyIdInfo id: GAksoy, briefTitle: Classical Turkish Music for Pregnant Women With Preeclampsia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: Stress and Sleep of Classical Turkish Music in Pregnant Women Diagnosed with Preeclampsia in Clinics The study to be carried out to determine the effect on quality is a randomized controlled experimental research. All patients who comply with the limitations of the study and volunteer will be included in the study. When the studies in the literature are examined, there are a limited number of studies on the effects of music on pregnant women diagnosed with preeclampsia, and no studies have been found on the effects of music on stress and sleep quality in pregnant women with preeclampsia. This research aimed to determine the effect of Classical Turkish Music on stress and sleep quality in pregnant women diagnosed with Preeclampsia in clinics., conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This was a parallel group, randomized controlled trial conducted in a tertiary hospital in Mersin city center, Turkey. In parallel with the purpose of the study, participants were selected from the pregnant women diagnosed with preeclampsia who were hospitalized at Mersin City Training and Research Hospital.The population of the research is the G\* Power 3.1.9.4 was determined by analysis using. In the analysis, the sample size was taken as a sample size of at least 80%, a medium effect size (0.5) and a two-way type 1 error value of 0.05, since no study similar to the study could be found, and a total of 128 pregnant women were included in the two groups (in each group) to determine the difference between the averages of two independent groups. It was calculated as 64 pregnant women). Considering the drop out rate of 10% during the research, the total number of samples was found to be 142 (experimental group: n=71, control group: n=71) pregnant women., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participant will be masking., whoMasked: PARTICIPANT, enrollmentInfo count: 142, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia, outcomesModule primaryOutcomes measure: Perceived Stress, secondaryOutcomes measure: Sleep Quality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gülay Aksoy, city: Mersin, zip: 33080, country: Turkey, contacts name: Gülay Aksoy, role: CONTACT, phone: +905518627438, email: 220931003@tarsus.edu.tr, contacts name: Eylem Toker, role: CONTACT, email: eylemtoker@tarsus.edu.tr, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
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protocolSection identificationModule nctId: NCT06315972, orgStudyIdInfo id: 2022-000054-28, briefTitle: Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity, acronym: OligoTreat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: LMU Klinikum, class: OTHER, descriptionModule briefSummary: Schizophrenia (SZ) is a broad clinical entity characterized by different subjective symptoms,behavioural signs, and disease course. Research has pointed to numerous biological indicators tentatively associated with neurocognitive dysfunction, brain structural and neurochemical alterations. Cognitive deficits occur as early as the prodromal phase of the illness and significantly determine its outcome. Pathophysiologically, SZ is regarded as a disconnectome disorder in which frontal and temporal brain regions are functionally disconnected, which contributes substantially to the development of cognitive dysfunction.Impaired connectivity is related to synaptic (microconnectivity) and myelin (macroconnectivity) plasticity. With design-based stereology, a decreased number of oligodendrocytes (OLs) in the CA4 hippocampal subregion as the basis for disturbed myelination and impaired cognition, but also a decrease in the prefrontal cortex were observed. Animal studies demonstrated that clemastine enhances remyelination by increasing the differentiation of oligodendrocyte precursor cells (OPCs) and showed that aerobic exercise increases the rate of remyelination and proliferation of OPCs; this clinically meaningful effect of aerobic exercise is stronger in combination with clemastine. Furthermore, aerobic exercise improves everyday functioning, measured by the Global Assessment of Functioning (GAF) scale, and cognitive dysfunction in SZ and increases hippocampal volume, especially the volume in the hippocampal CA4 subregion. This regional volume change correlates negatively with global and cell-specific polygenic risk scores (PRSs), indicating that OPCs are involved in the genetic risk mechanisms and disturbed plasticity underlying SZ. In patients with multiple sclerosis, 90 days' administration of clemastine fumarate 10.72 mg/day, corresponding to clemastine 8 mg/day, significantly decreased the P100 latency delay of visual evoked potentials (VEPs) as a sign of myelin repair. In a bicentric, randomized, double-blind, controlled phase IIb clinical trial with a 2-arm parallel group design in patients with SZ, the study will compare the effects of aerobic exercise training plus clemastine vs. aerobic exercise training plus placebo over a period of 3 months on 1) everyday functioning and 2) working memory as primary outcomes., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: clemastine (8 mg/day), interventions name: Placebo, outcomesModule primaryOutcomes measure: change in Global Assessment of Functioning, primaryOutcomes measure: change in working memory performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06315959, orgStudyIdInfo id: ESPCHRONIC2023, briefTitle: Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale., conditionsModule conditions: Chronic Pain, conditions: Cardiac Surgery, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral ultrasound guided erector spinae plane block, interventions name: morphine PCA, interventions name: Control group, interventions name: morphine PCA, outcomesModule primaryOutcomes measure: Chronic pain status, secondaryOutcomes measure: Postoperative opioid consumption in the first 24 Hours, secondaryOutcomes measure: Postoperative pain scores, secondaryOutcomes measure: The incidences of post-operative nausea and vomiting (PONV), secondaryOutcomes measure: The number of patient requiring rescue analgesic, secondaryOutcomes measure: Time to extubation, secondaryOutcomes measure: The number of patients with complications, secondaryOutcomes measure: Chronic pain status at 6 months., secondaryOutcomes measure: Length of stay in the ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayis University, status: RECRUITING, city: Samsun, state: Atakum, zip: 55139, country: Turkey, contacts name: BURHAN DOST, role: CONTACT, phone: 05327042493, email: burhandost@hotmail.com, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False
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