data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06339359, orgStudyIdInfo id: 2024-02-014, briefTitle: A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Bundang CHA Hospital, class: OTHER, descriptionModule briefSummary: This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis., conditionsModule conditions: ASD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments, outcomesModule primaryOutcomes measure: K-BSID-Ⅲ, primaryOutcomes measure: ADI-R, primaryOutcomes measure: M-CHAT, primaryOutcomes measure: ADOS-2, primaryOutcomes measure: K-WPPSI-Ⅳ, primaryOutcomes measure: K-CARS-2, primaryOutcomes measure: CBCL, primaryOutcomes measure: SCQ, primaryOutcomes measure: GMFM, primaryOutcomes measure: HFT, primaryOutcomes measure: BOT-2, primaryOutcomes measure: VMI-6, primaryOutcomes measure: SP, primaryOutcomes measure: Eye Tracking, primaryOutcomes measure: Motion Analysis, eligibilityModule sex: ALL, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHA Bundang Medical Center, CHA University, status: RECRUITING, city: Seongnam-si, state: Gyeonggi-do, zip: 463-712, country: Korea, Republic of, contacts name: Minyoung Kim, M.D., Ph.D., role: CONTACT, phone: 82-31-780-1872, email: kmin@cha.ac.kr, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
|
protocolSection identificationModule nctId: NCT06339346, orgStudyIdInfo id: 29BRC24.0028 - PROMOT1, briefTitle: Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study (PROMOT1), acronym: PROMOT1, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Analysis of lymph node invasion rates as a function of tumor characteristics, secondaryOutcomes measure: Population demographics, secondaryOutcomes measure: lesion characteristics, secondaryOutcomes measure: management, secondaryOutcomes measure: recurrence, secondaryOutcomes measure: survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Brest, city: Brest, zip: 29609, country: France, geoPoint lat: 48.3903, lon: -4.48628, hasResults: False
|
protocolSection identificationModule nctId: NCT06339333, orgStudyIdInfo id: RRECB0523EC, briefTitle: Evaluation of ACT Now GAIN Later, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University College Dublin, class: OTHER, descriptionModule briefSummary: The goal of this Randomised Control Trial is to evaluate a Psychologist Guided Self Help Video Parenting Programme based on principles of Acceptance and Commitment Therapy (ACT)The main questions it aims to answer are:Primary Objectives1. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in increasing parental psychological flexibility (measured by Psy-Flex, tool which measures psychological flexibility)? Please find attached.2. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in decreasing child challenging behaviour (measured by the Eyberg Child Behavior Inventory)? Please find attached.Secondary Objectives1. Is ACT Now GAIN Later: an ACT based Parenting Programme, effective in improving parent-child relationships (measured by the Child-Parent Relationship Scale)? Please find attached.2. Does ACT Now GAIN Later increase parental well-being as measured by (Depression Anxiety Stress Scale, Parenting Stress Index and Goal Based Outcome Tool)? Please find attached.3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.Participants will complete a 7 week psychologist guided parenting intervention. Researchers will compare waitlist groups to see if there are differences in psychological flexibility, child behaviour, parent-child relationships, parental well-being or parental self-efficacy., conditionsModule conditions: Psychological Flexibility, conditions: Child Behavior, conditions: Relationship, Parent Child, conditions: Well-Being, Psychological, conditions: Self-efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This quantitative study will be a two arm randomised control trial with an intervention group and waitlist group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: ACT Now GAIN Later, interventions name: Control Group, outcomesModule primaryOutcomes measure: Parental Psychological Flexibility, primaryOutcomes measure: Child Behaviour, secondaryOutcomes measure: Parent-Child Relationships, secondaryOutcomes measure: Parental Well-Being, secondaryOutcomes measure: Parental Self-Efficacy, secondaryOutcomes measure: Parental Self-Efficacy, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339320, orgStudyIdInfo id: PRO00037835, briefTitle: Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2033-10, completionDateStruct date: 2033-10, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS)., conditionsModule conditions: Endoscopic Sleeve Gastroplasty, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Retrospective Registry Study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic Sleeve Gastroplasty (ESG), interventions name: Apollo OverStitch endoscopic suturing device, outcomesModule primaryOutcomes measure: Number of participants with technically successful completion of the ESG procedure, primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Change in body mass index (BMI) measured by kg/m2, secondaryOutcomes measure: Change in hemoglobin A1C (%), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Houston Methodist Hospital, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Thomas R McCarty, MD, MPH, role: CONTACT, phone: 713-363-7436, email: tommccarty3@houstonmethodist.org, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Houston Methodist Hospital - Sugarland, status: RECRUITING, city: Sugar Land, state: Texas, zip: 77479, country: United States, contacts name: Thomas R McCarty, MD, MPH, role: CONTACT, phone: 713-363-7436, email: tommccarty3@houstonmethodist.org, geoPoint lat: 29.61968, lon: -95.63495, hasResults: False
|
protocolSection identificationModule nctId: NCT06339307, orgStudyIdInfo id: DJY004, briefTitle: A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability., conditionsModule conditions: Predictive Cancer Model, conditions: Gastric Cancer, conditions: Lymph Node Metastasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: lymph node metastasis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital of Tianjin Medical University, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, contacts name: Jingyu Deng, M.D., role: CONTACT, phone: +86-22-23340123, email: dengery@126.com, geoPoint lat: 39.14222, lon: 117.17667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-07-01, uploadDate: 2024-03-17T10:10, filename: Prot_000.pdf, size: 131262, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2023-07-01, uploadDate: 2024-03-17T10:11, filename: SAP_001.pdf, size: 158196, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-01, uploadDate: 2024-03-17T10:11, filename: ICF_002.pdf, size: 151390, hasResults: False
|
protocolSection identificationModule nctId: NCT06339294, orgStudyIdInfo id: ZShabbir, briefTitle: Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-16, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Rawalpindi Medical College, class: OTHER, descriptionModule briefSummary: Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14., conditionsModule conditions: Otomycosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Clotrimazole Cream, interventions name: Povidone-Iodine, outcomesModule primaryOutcomes measure: Treatment Response Based on Otoscopy, secondaryOutcomes measure: Condition of External Auditory Canal, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Benazir Bhutto Hospital, city: Rawalpindi, state: Punjab/46000, zip: 46000, country: Pakistan, geoPoint lat: 33.6007, lon: 73.0679, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-16, uploadDate: 2024-03-24T05:10, filename: Prot_SAP_000.pdf, size: 557916, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-06-16, uploadDate: 2024-03-24T05:13, filename: ICF_001.pdf, size: 1206939, hasResults: False
|
protocolSection identificationModule nctId: NCT06339281, orgStudyIdInfo id: 2023YJZ87, briefTitle: A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Li Huiping, class: OTHER, descriptionModule briefSummary: Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: apatinib mesylate+Capecitabine Tablets, interventions name: apatinib mesylate+Fulvestrant injection, outcomesModule primaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339268, orgStudyIdInfo id: MMABelgrade, briefTitle: Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection, acronym: COGNITION, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Military Medical Academy, Belgrade, Serbia, class: OTHER, descriptionModule briefSummary: Postoperative cognitive deficit and its connection with surgery and general anesthesia were first mentioned in the literature in 1955 by Bradford. Cognitive disorders in the postoperative period are postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). POD is an acute dysfunction in cognition, which did not exist preoperatively. Attention deficit disorder is the main symptom of POD and refers to the inability to direct, focus, maintain, or shift attention. Memory impairment, disorientation, or perceptual disturbances may also be present. Cognitive capacity changes in POD patients develop and fluctuate in the first few days after surgery. Unlike POD, there is no formal definition for POCD. Based on data from the existing literature, it is defined as newly diagnosed cognitive deterioration that occurs after surgery. The diagnosis of POCD should be based on pre- and postoperative screening with appropriate psychometric tests. Risk factors for the development of POCD include those related to the surgical procedure, anesthesia, or the patient himself. Compared to less invasive and shorter operations, there is a higher risk of developing POCD after major, invasive, and long-term operations. Additional risk factors are intraoperative (intraoperative bleeding, perioperative transfusion treatment, hypotension) and postoperative complications (respiratory insufficiency, pneumonia, atelectasis, bronchospasm, bronchopleural fistula, and pulmonary edema). Presurgical optimization (Prehabilitation) is a widespread concept that aims to improve the general condition of the patient or optimize comorbidities before major surgery. Prehabilitation is primarily focused on improving physical ability and nutritional status, but it is developing in the direction of a multimodal approach that includes measures to reduce stress and anxiety. Psychological factors are increasingly recognized as an essential element of prehabilitation and are often added to prehabilitation programs.Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasinglyundergoing lung resection. These complications can affect the outcome and speed of postoperative recovery., conditionsModule conditions: Prehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: After setting the indication for operative treatment, patients who meet the criteria for inclusion in the study, after signing the informed consent, will be randomized into two groups:1. The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.2. The second group (control) where patients receive standard treatment., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive training, CogniFit App, outcomesModule primaryOutcomes measure: Postoperative cognitive dysfunction, primaryOutcomes measure: Perioperative depression and anxiety, primaryOutcomes measure: Postoperative delirium, primaryOutcomes measure: Functional status and postoperative recovery, primaryOutcomes measure: Functional status and postoperative recovery, primaryOutcomes measure: Postoperative recovery, primaryOutcomes measure: Functional status and postoperative recovery, secondaryOutcomes measure: Overall outcome: Complication rate, secondaryOutcomes measure: Overall outcome: Morbidity, secondaryOutcomes measure: Overall outcome: Mortality, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military Medical Academy, status: RECRUITING, city: Belgrade, zip: 11000, country: Serbia, contacts name: Vojislava Neskovic, PhD, role: CONTACT, phone: +381 64 1775 320, email: vojkan43@gmail.com, contacts name: Marija Markovic, MD, role: CONTACT, phone: +381 62 666653, email: markovicmarija@hotmail.com, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
|
protocolSection identificationModule nctId: NCT06339255, orgStudyIdInfo id: INT 180/19, briefTitle: Italian Observational Study on CAR-T Therapy for Lymphoma, acronym: CART-SIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-10-30, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Paolo Corradini, class: OTHER, collaborators name: Annalisa Chiappella, collaborators name: Cristiana Carniti, collaborators name: Anna Dodero, descriptionModule briefSummary: The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity., conditionsModule conditions: Diffuse Low Grade B-Cell Lymphoma, conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL), conditions: Mantle Cell Lymphoma, conditions: Follicular Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice, primaryOutcomes measure: Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice, secondaryOutcomes measure: Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria., secondaryOutcomes measure: Evaluation of Outcome: Overall survival (OS), according to Lugano criteria., secondaryOutcomes measure: Evaluation of Outcome: Progression free survival (PFS), secondaryOutcomes measure: Evaluation of Outcome: duration of response (DoR), secondaryOutcomes measure: Evaluation of Outcome: Overall Response rate (ORR), secondaryOutcomes measure: Evaluation of Outcome: Overall survival (OS), secondaryOutcomes measure: Evaluation of Outcome: non-relapse mortality (NRM), secondaryOutcomes measure: Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications, secondaryOutcomes measure: Evaluation of bridging therapy: safety, secondaryOutcomes measure: Evaluation of bridging therapy: efficay, secondaryOutcomes measure: Evaluation of salvage therapy after CAR-T failure, secondaryOutcomes measure: Evaluation of salvage therapy after CAR-T failure, secondaryOutcomes measure: Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety), secondaryOutcomes measure: Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products, otherOutcomes measure: Characterization of biomarkers of early response (circulating tumor cell free DNA versus PET and CT scans), otherOutcomes measure: Characterization of toxicity biomarkers, otherOutcomes measure: Analysis of the immune reconstitution, otherOutcomes measure: Analysis of the CAR-T expression, otherOutcomes measure: Influence of PET quantitative parameters: tMTV changes between baseline and +30 and +90 after CAR T-cell infusion (ΔSUV max) related to outcome, otherOutcomes measure: Influence of PET quantitative parameters: Distance max, otherOutcomes measure: Influence of PET quantitative parameters: Distance max bulky, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale Tumori, status: RECRUITING, city: Milan, zip: 20133, country: Italy, contacts name: Paolo Corradini, Professor, role: CONTACT, phone: +39 02 2390 2950, email: paolo.corradini@istitutotumori.mi.it, contacts name: Anisa Bermema, PhD, role: CONTACT, phone: +39 02 2390 3145, email: anisa.bermema@istitutotumori.mi.it, contacts name: Annalisa Chiappella, MD, role: SUB_INVESTIGATOR, contacts name: Anna Dodero, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06339242, orgStudyIdInfo id: 2024-01-NSCLC, briefTitle: A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, class: OTHER, descriptionModule briefSummary: Leptomeningeal metastasis is a fatal complication of advanced lung cancer. There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs. The Furmonertinib prototype persists longer in brain tissue, and its metabolites can also penetrate the blood-brain barrier. Ommaya cystlateral ventricle chemotherapy can quickly control the progression of intracranial lesions. The aim of this study is to evaluate the LM progression-free survival (LM-PFS) of Furmonertinib combined with lateral ventricular chemotherapy in the treatment of leptomeningeal metastatic NSCLC after third-generation EGFR-TKIs resistance., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Furmonertinib, outcomesModule primaryOutcomes measure: LM-PFS（progression-free survival）, primaryOutcomes measure: LM-ORR（Objective response rate）, secondaryOutcomes measure: LM-OS, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Brain Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: fang S Cun, role: CONTACT, phone: 83728558, phoneExt: 025, email: fang1984@aliyun.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
|
protocolSection identificationModule nctId: NCT06339229, orgStudyIdInfo id: FSYYY-2024-12, briefTitle: Postoperative New-onset Proteinuria and Adverse Outcomes., statusModule overallStatus: COMPLETED, startDateStruct date: 2000-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Yaozhong Kong, class: OTHER, descriptionModule briefSummary: We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate., conditionsModule conditions: Surgery, conditions: Proteinuria, conditions: Mortality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2983899, type: ACTUAL, armsInterventionsModule interventions name: proteinuria, outcomesModule primaryOutcomes measure: mortality, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06339216, orgStudyIdInfo id: OBU-BJ-GC-II-011, briefTitle: A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: Phase II Clinical Study of Adebrelimab Combined with Apatinib and Paclitaxel for Injection(Albumin Bound) as Second-line Therapy in Patients with Advanced Gastric Cancer Previously Treated with Immunotherapy, conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound), outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: DCR, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339203, orgStudyIdInfo id: 5240002, briefTitle: Intraoperative Wound Irrigation in Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, collaborators name: Irrimax Corporation, descriptionModule briefSummary: This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery., conditionsModule conditions: Cesarean Section Complications, conditions: Cesarean Section; Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Irrisept, interventions name: Normal Saline, outcomesModule primaryOutcomes measure: Composite wound evaluation after caesarean delivery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University, city: Loma Linda, state: California, zip: 92354, country: United States, contacts name: Nikia Gray Hutto, AS, role: CONTACT, phone: 909-558-4000, phoneExt: 44428, email: nhutto@llu.edu, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False
|
protocolSection identificationModule nctId: NCT06339190, orgStudyIdInfo id: E21-006-72840, briefTitle: Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis, acronym: NAVAIDD, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Monash University, class: OTHER, collaborators name: Eastern Health, collaborators name: University of Melbourne, collaborators name: Wake Forest University, collaborators name: Deakin University, collaborators name: The Florey Institute of Neuroscience and Mental Health, collaborators name: Invitae Corporation, collaborators name: Redenlab, descriptionModule briefSummary: This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample., conditionsModule conditions: Neurodegenerative Diseases, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Venepuncture, outcomesModule primaryOutcomes measure: Nfl correlation with neurodegeneration, secondaryOutcomes measure: Change in speech processing, secondaryOutcomes measure: Change in language processing, secondaryOutcomes measure: Change in Direct Magnitude Estimation, otherOutcomes measure: Modified Rankin Scale, otherOutcomes measure: Montreal Cognitive Assessment score, otherOutcomes measure: Hospital Anxiety and Depression Scale score, otherOutcomes measure: Clinical Global Impression score, otherOutcomes measure: WHO Disability Assessment 12-item telephone interview score, otherOutcomes measure: WHO Disability Assessment 36-item self report score, otherOutcomes measure: DNA sample for testing known pathogenic dementia mutations, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Box Hill Hospital, status: RECRUITING, city: Box Hill, state: Victoria, zip: 3128, country: Australia, contacts name: Svetlana Ivanic, role: CONTACT, email: svetlana.ivanic@monash.edu, geoPoint lat: -37.81887, lon: 145.12545, locations facility: Wantirna Health, status: RECRUITING, city: Wantirna, state: Victoria, zip: 3152, country: Australia, contacts name: Sarah Shue, role: CONTACT, geoPoint lat: -37.85, lon: 145.21667, hasResults: False
|
protocolSection identificationModule nctId: NCT06339177, orgStudyIdInfo id: 10001899, secondaryIdInfos id: 001899-I, briefTitle: Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-10-01, completionDateStruct date: 2031-04-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: Background:Hemophagocytic lymphohistiocytosis (HLH) is a disease caused by disrupted immune function. People with HLH are prone to fevers and illnesses, which can be fatal. Some people develop a genetic form of this disease (pHLH), but researchers do not understand why some other people develop a nongenetic form (sHLH). They also do not have good ways to diagnose and treat sHLH.Objective:To learn about sHLH and why some people get it and others do not.Eligibility:Adults aged 18 years and older with sHLH.Design:Participants will be admitted to the study based on a review of their medical records. Those who join will have at least 3 clinical evaluations over 9 to 12 months. These may occur during an inpatient hospitalization if they require medical care or in the outpatient clinic.Participants will also have a physical exam at each visit. Up to half a cup of blood will be drawn at each visit. Participants may also have their blood drawn by their own doctors, who will send the samples to the researchers. Researchers may also contact these participants by telephone or video calls.The blood will be used for clinical tests as well as research. No new treatments will be administered as part of this study; however, standard medications and treatments may be recommended.Participants may opt to continue their visits once a year for 3 more years. Participants may also opt for an extra clinial evaluation 1 week after starting a new treatment...., conditionsModule conditions: Lymphohistiocytosis, Hemophagocytic, conditions: Secondary Hemophagocytic Lymphohistiocytosis, conditions: Macrophage Activation Syndrome, conditions: Hyperinflammatory Syndromes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions., secondaryOutcomes measure: Prospectively define acute and longitudinal clinical profiles that predict key clinical outcomes., secondaryOutcomes measure: Compare clinical and immune profiles between the classically defined HLH subgroups., secondaryOutcomes measure: Improve the understanding of the pathogenesis of sHLH., secondaryOutcomes measure: Characterize risk factors to identify populations at risk for developing sHLH., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
|
protocolSection identificationModule nctId: NCT06339164, orgStudyIdInfo id: ObGynEASC006, briefTitle: Breech Delivery Skills. Resident Learning Program, acronym: Breech, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: G. d'Annunzio University, class: OTHER, descriptionModule briefSummary: Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation, conditionsModule conditions: Breech Presentation; Before Labor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: skills and learning quality in breech delivery, outcomesModule primaryOutcomes measure: Skills capacities, primaryOutcomes measure: Skills capacities, secondaryOutcomes measure: learning qualities, eligibilityModule sex: ALL, minimumAge: 24 Years, maximumAge: 38 Years, stdAges: ADULT, contactsLocationsModule locations facility: Claudio Celentano, city: Pescara, state: PE, zip: 65100, country: Italy, geoPoint lat: 42.4584, lon: 14.20283, hasResults: False
|
protocolSection identificationModule nctId: NCT06339151, orgStudyIdInfo id: TUH multiple dexamethasone TKA, briefTitle: Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-23, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.The main question\[s\] it aims to answer \[is/are\]:Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?Researchers will compare double dose of dexamethasone group to see if \[insert effects\].Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\]., conditionsModule conditions: Osteo Arthritis Knee, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone before surgery, interventions name: Dexamethasone before and 12 hours after surgery, interventions name: Dexamethasone before and 24 hours after surgery, outcomesModule primaryOutcomes measure: Pain at rest and motion, secondaryOutcomes measure: Nausea and vomiting, secondaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: Blood sugar level, secondaryOutcomes measure: CRP level, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University Hospital, status: RECRUITING, city: Khlong Luang, state: Pathum Thani, zip: 12120, country: Thailand, contacts name: Yot Tanariyakul, M.D., role: CONTACT, phone: 6683930257, email: y.tanariyakul@gmail.com, contacts name: Yot Tanariyakul, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Piya Pinsornsak, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False
|
protocolSection identificationModule nctId: NCT06339138, orgStudyIdInfo id: 17-010944, secondaryIdInfos id: NCI-2024-00971, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 17-010944, type: OTHER, domain: Mayo Clinic in Rochester, briefTitle: Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-20, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study is being done to collect blood, tissue and urine samples to identify a novel high quality methylated DNA marker in patients with renal tumors., conditionsModule conditions: Chromophobe Renal Cell Carcinoma, conditions: Clear Cell Papillary Renal Tumor, conditions: Clear Cell Renal Cell Carcinoma, conditions: Kidney Oncocytoma, conditions: Papillary Renal Cell Carcinoma, conditions: Urothelial Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 874, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: John C. Cheville, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: John B. Kisiel, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
|
protocolSection identificationModule nctId: NCT06339125, orgStudyIdInfo id: 2023p003637, briefTitle: Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent Falls, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Crico, collaborators name: Inspiren Inc, collaborators name: RGI Informatics LLC, descriptionModule briefSummary: Annually, in the United States there are 700,000 - 1,000,000 inpatient falls reported, and one-third of patients sustain an injury. The average estimated cost per fall is $6,694, resulting in over $1.4 -1.9 billion dollars in losses each year (AHRQ, 2017). This study aims to compare the impact of different fall prevention strategies on the rate of occurrence of falls and falls with injury in an academic medical center on three adult medical units. While maintaining the usual standard of care for fall prevention, each unit will add one of the following: (1) use of a fall risk alert to nurses using an algorithm based on electronic health record data or (2) computerized camera visualization or (3) a combination of both., conditionsModule conditions: Falls and Falls With Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An observational cohort, mixed-methods study design will be conducted to determine the impact and effectiveness of usual care and three different fall prevention strategies that exceed the standard of care on three inpatient units at MGH over one year. Unit 1 will employ streaming analytics and the MGH algorithm only, Unit 2 will employee Inspiren's AUGI computer visualization only and Unit 3 will employ the combined streaming analytic/MGH algorithm and Inspiren's AUGI device. Unit 4, the control unit, will serve as an internal comparison group from the same institution. In addition to the study interventions all four units will continue to maintain usual MGH evidence-based practice, standards of care for fall prevention., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 4500, type: ESTIMATED, armsInterventionsModule interventions name: Fall prevention algorithm, interventions name: Inspiren camera visualization, outcomesModule primaryOutcomes measure: Falls, primaryOutcomes measure: Falls with injury, secondaryOutcomes measure: Nurse perceptions, secondaryOutcomes measure: Nurse perceptions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339112, orgStudyIdInfo id: 2024/10, briefTitle: The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G\*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data., conditionsModule conditions: Fear, conditions: Anxiety, conditions: Inhalant Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled experimental study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Playing with toy nebulizer, interventions name: Cartoon, outcomesModule primaryOutcomes measure: fear, primaryOutcomes measure: anxiety, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Tarsus State Hospital, city: Mersin, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
|
protocolSection identificationModule nctId: NCT06339099, orgStudyIdInfo id: P.T.REC/012/002489, briefTitle: Loaded Gait Training on Gross Motor Function in Cerebral Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-26, primaryCompletionDateStruct date: 2023-10-15, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Children were randomly assigned into two equal groups., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blinding. Parents were also blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: Conventional physical therapy program, interventions name: Loaded gait training, outcomesModule primaryOutcomes measure: Gross motor function, primaryOutcomes measure: knee extensor strength, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Physical Therapy, Cairo University, city: Giza, state: Cairo, zip: 12613, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
|
protocolSection identificationModule nctId: NCT06339086, orgStudyIdInfo id: BPR-201-I-III-01, briefTitle: Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Chengdu Brilliant Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 478, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide Injection, interventions name: Semaglutide Injection(Ozempic®), interventions name: Metformin, outcomesModule primaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in FPG, secondaryOutcomes measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5%, secondaryOutcomes measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event, secondaryOutcomes measure: Change in Body Weight, secondaryOutcomes measure: Proportion of participants with Weight Loss≥5%, ≥10% and ≥15%, secondaryOutcomes measure: Change in Diastolic and Systolic Blood Pressure, secondaryOutcomes measure: Changes in Blood Lipids, secondaryOutcomes measure: Incidence and severity of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339073, orgStudyIdInfo id: 2021NZKY-045-01, briefTitle: CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-05, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Jinling Hospital, China, class: OTHER, descriptionModule briefSummary: Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients., conditionsModule conditions: Wounds and Injuries, conditions: Ventilation Therapy; Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1023, type: ACTUAL, armsInterventionsModule interventions name: mechanical ventilation, outcomesModule primaryOutcomes measure: Prolonged mechanical ventilation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the General Surgical Department of Jinling Hospital, city: Nanjing, state: Jiangsu, zip: 210002, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
|
protocolSection identificationModule nctId: NCT06339060, orgStudyIdInfo id: RTS-022, briefTitle: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3)., acronym: PALACE3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group).The 3-year overall survival rate is the primary outcome., conditionsModule conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy), enrollmentInfo count: 356, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Arm 1 Organ preservation, interventions name: Active Comparator: Arm 2 Surgery, outcomesModule primaryOutcomes measure: 3-year overall survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06339047, orgStudyIdInfo id: 2024/09, briefTitle: The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used., conditionsModule conditions: Anxiety and Fear, conditions: Pain, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled experimental study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Projector Kaleidoscope, interventions name: Cartoon, outcomesModule primaryOutcomes measure: Anxiety, primaryOutcomes measure: Fear, primaryOutcomes measure: Pain after surgery, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Tarsus State Hospital, city: Mersin, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
|
protocolSection identificationModule nctId: NCT06339034, orgStudyIdInfo id: STUDY, briefTitle: Repurposing Lithium for Parkinson's Disease: a RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, collaborators name: The Cure Parkinson's Trust, descriptionModule briefSummary: This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, placebo-controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lithium, interventions name: Placebo, outcomesModule primaryOutcomes measure: MRI-derived free water (FW) levels., primaryOutcomes measure: Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression, primaryOutcomes measure: Serum neurofilament light chain (NfL), secondaryOutcomes measure: PBMC superoxide dismutase type-1 (SOD-1) mRNA expression, secondaryOutcomes measure: PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio, secondaryOutcomes measure: PBMC pThr308 and pS473/total protein kinase B (Akt) ratios, secondaryOutcomes measure: Serum interleukin-6, secondaryOutcomes measure: Serum glial fibrillary acidic protein (GFAP), secondaryOutcomes measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination), secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Parkinson's Anxiety Scale, secondaryOutcomes measure: Geriatric Depression Scale-15, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Parkinson's Disease Questionnaire-8, secondaryOutcomes measure: Levodopa equivalent daily dose (LEDD), otherOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UBMD Neurology, city: Williamsville, state: New York, zip: 14221, country: United States, contacts name: Thomas Guttuso, MD, role: CONTACT, phone: 716-932-6080, email: tguttuso@buffalo.edu, contacts name: Amelia Cheney, role: CONTACT, email: acheney4@buffalo.edu, contacts name: Thomas Guttuso, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.96395, lon: -78.73781, hasResults: False
|
protocolSection identificationModule nctId: NCT06339021, orgStudyIdInfo id: DAPT-OCT, briefTitle: OCT or Angiography Guided De-escalation of DAPT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Shenyang Northern Hospital, class: OTHER, descriptionModule briefSummary: Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation., conditionsModule conditions: Optical Coherence Tomography, conditions: Dual Antiplatelet Therapy, conditions: Antiplatelet De-escalation, conditions: Neointimal Coverage, conditions: ST Elevation Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: OCT-guided PCI, interventions name: Conventional angiography-based PCI, interventions name: DAPT de-escalation, interventions name: default DAPT regimen, outcomesModule primaryOutcomes measure: Neointimal thickness after DES implantation, secondaryOutcomes measure: Major adverse cardiovascular and cerebrovascular events (MACCE), secondaryOutcomes measure: BARC types 2-5 bleeding, secondaryOutcomes measure: In-stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Hospital, city: Shenyang, state: Liaoning, country: China, contacts name: Yaling Han, Dr, role: CONTACT, phone: +86-24-28897313, email: cardiology@163.com, contacts name: Yaling Han, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Yang Li, MD, role: SUB_INVESTIGATOR, contacts name: Yi Li, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
|
protocolSection identificationModule nctId: NCT06339008, orgStudyIdInfo id: 18789, secondaryIdInfos id: J2T-MC-KGBT, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2023-508817-18-00, type: OTHER, domain: EU Clinical Trial Number, briefTitle: A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months, conditionsModule conditions: Perennial Allergic Rhinitis (PAR), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: LY3650150, interventions name: Placebo, interventions name: Standard therapy for INCS, outcomesModule primaryOutcomes measure: Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16, secondaryOutcomes measure: Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16, secondaryOutcomes measure: Mean CFBL in RQLQ(S) at week 56, secondaryOutcomes measure: Mean CFBL in TNSS at Week 4, secondaryOutcomes measure: Mean CFBL in TNSS at Week 56, secondaryOutcomes measure: Mean CFBL in Postnasal drip score at Week 16, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern California Research, city: California City, state: California, zip: 92691, country: United States, contacts role: CONTACT, phone: 949-276-4917, contacts name: Warner Carr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.1258, lon: -117.9859, locations facility: 310 Clinical Research, city: Inglewood, state: California, zip: 90301, country: United States, contacts role: CONTACT, phone: 310-878-2636, contacts name: Soheil Hekmat, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.96168, lon: -118.35313, locations facility: Allergy and Asthma, city: San Diego, state: California, zip: 92123, country: United States, contacts role: CONTACT, phone: 858-268-2368, phoneExt: 143, contacts name: Bob Geng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Asthma and Allergy Associates, PC, city: Colorado Springs, state: Colorado, zip: 80907-6231, country: United States, contacts role: CONTACT, phone: 719-473-8330 x5, contacts name: Luke Webb, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.83388, lon: -104.82136, locations facility: Florida Center For Allergy & Asthma Care Aventura, city: Aventura, state: Florida, zip: 33180, country: United States, contacts role: CONTACT, phone: 305-931-7583, contacts name: Jaime Landman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.95648, lon: -80.13921, locations facility: Bluegrass Allergy Research, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts role: CONTACT, phone: 859-303-7191, contacts name: William Greisner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Allergy, Asthma & Sinus Center, city: Greenfield, state: Massachusetts, zip: 53228, country: United States, contacts role: CONTACT, phone: 414-529-8519, contacts name: Gary Steven, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.58759, lon: -72.59953, locations facility: Respiratory Medicine Research Institute of Michigan, PLC, city: Ypsilanti, state: Michigan, zip: 48197, country: United States, contacts role: CONTACT, phone: 734-528-0477, contacts name: Jeffrey Leflein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.24115, lon: -83.61299, locations facility: Clinical Research Institute, city: Minneapolis, state: Minnesota, zip: 55402, country: United States, contacts role: CONTACT, phone: 612-333-2200, phoneExt: 378, contacts name: Gary Berman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Allergy and Asthma Consultants, city: Saint Louis, state: Missouri, zip: 63141, country: United States, contacts role: CONTACT, phone: 314-991-5117, contacts name: Robert Onder, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Dr. Patrick Perin, city: Teaneck, state: New Jersey, zip: 07666, country: United States, contacts name: Patrick Perin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.8976, lon: -74.01597, locations facility: Bernstein Clinical Research Center, LLC, city: Cincinnati, state: Ohio, zip: 45236, country: United States, contacts role: CONTACT, phone: 314-991-5117, contacts name: David Bernstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Northwest Research Center, city: Portland, state: Oregon, zip: 97202, country: United States, contacts role: CONTACT, phone: 503-238-6233, contacts name: Anthony Montanaro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Allergy and Clinical Immunology Associates, city: Pittsburgh, state: Pennsylvania, zip: 15241, country: United States, contacts role: CONTACT, phone: 412-833-4051, phoneExt: 116, contacts name: Michael Palumbo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Kerrville Allergy and Asthma Associates, city: Kerrville, state: Texas, zip: 78028, country: United States, contacts role: CONTACT, phone: 830-896-1433, contacts name: Dale Mohar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.04743, lon: -99.14032, locations facility: Allergy Asthma Research Institute, city: Waco, state: Texas, zip: 76712, country: United States, contacts role: CONTACT, phone: 254-741-8151, contacts name: Niran Amar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.54933, lon: -97.14667, hasResults: False
|
protocolSection identificationModule nctId: NCT06338995, orgStudyIdInfo id: 18790, secondaryIdInfos id: J2T-MC-KGBU, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2023-508760-29-00, type: OTHER, domain: EU CT Number, briefTitle: A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-11-22, completionDateStruct date: 2026-10-25, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months., conditionsModule conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: LY3650150, interventions name: Placebo, interventions name: Standard therapy for INCS, outcomesModule primaryOutcomes measure: Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity, primaryOutcomes measure: Mean CFBL in Endoscopic Nasal Polyp Score (NPS), secondaryOutcomes measure: Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK), secondaryOutcomes measure: Mean change in Forced Expiratory Volume in 1 Second (FEV1), secondaryOutcomes measure: Mean CFBL in Severity of Loss of Smell, secondaryOutcomes measure: Mean CFBL in Postnasal Drip, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS, city: Mandeville, state: Louisiana, zip: 70448, country: United States, contacts name: James Connolly, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.35825, lon: -90.06563, locations facility: Ear Nose and Throat Associates of Texas PA, city: McKinney, state: Texas, zip: 75070-5735, country: United States, contacts name: Dale Ehmer, Jr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.19762, lon: -96.61527, locations facility: Alamo ENT Associates, city: San Antonio, state: Texas, zip: 78258-3227, country: United States, contacts role: CONTACT, phone: 210-545-0404, contacts name: Jeffrey Rosenbloom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Richmond Ear Nose and Throat, city: Richmond, state: Virginia, zip: 23235, country: United States, contacts role: CONTACT, phone: 804-622-3768, contacts name: Michael Armstrong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
|
protocolSection identificationModule nctId: NCT06338982, orgStudyIdInfo id: N-20230059, briefTitle: Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2029-10-31, completionDateStruct date: 2030-10-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Kimie Bols Østergaard, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are:• Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal.Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery., conditionsModule conditions: Impacted Third Molar Tooth, conditions: Osteotomy, conditions: Orthognathic Surgery, conditions: Mandibular Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial with a test group and a control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Interoperative wisdom tooth removal in conjunction with BSSO, outcomesModule primaryOutcomes measure: Fracture pattern following BSSO with or without impacted third molars, primaryOutcomes measure: Condylar segment position following BSSO with or without impacted third molars, primaryOutcomes measure: Oral Health Impact Profile-14 (OHIP-14), primaryOutcomes measure: The Modified Dental Anxiety Scale (MDAS), primaryOutcomes measure: Short Form-36 (SF-36), primaryOutcomes measure: PROMs, secondaryOutcomes measure: Length of the surgical procedure, secondaryOutcomes measure: Intraoperative bleeding, secondaryOutcomes measure: Frequency of intra- and postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aalborg universitets hospital, city: Aalborg, zip: 9000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
|
protocolSection identificationModule nctId: NCT06338969, orgStudyIdInfo id: PostBariKetosis, briefTitle: The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: The Society of Bariatric and Metabolic Surgeons of Kazakhstan, class: OTHER, descriptionModule briefSummary: Background:Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.Objectives:The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year., conditionsModule conditions: Obesity, Morbid, conditions: NASH, conditions: Ketosis, conditions: Keto Acidosis, conditions: Carbohydrate Metabolism Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Carbohydrate Restriction after a Gastric Bypass, outcomesModule primaryOutcomes measure: Cases of ketosis and incidence of ketoacidosis, primaryOutcomes measure: Cases of liver failure, secondaryOutcomes measure: Change in body mass index (Δ BMI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Oral Ospanov, status: RECRUITING, city: Astana, state: Aqmola, zip: 010000, country: Kazakhstan, contacts name: Oral Ospanov, PhD, role: CONTACT, phone: 7015287734, phoneExt: +7, email: bariatric.kz@gmail.com, geoPoint lat: 51.1801, lon: 71.44598, hasResults: False
|
protocolSection identificationModule nctId: NCT06338956, orgStudyIdInfo id: Lipid-PCI, briefTitle: Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI, acronym: Lipid-PCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI., conditionsModule conditions: Coronary Artery Disease, conditions: Hyperlipidemias, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 94189, type: ESTIMATED, armsInterventionsModule interventions name: LDL reduction therapy, outcomesModule primaryOutcomes measure: MACCE, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: Spontaneous myocardial infarction, secondaryOutcomes measure: Repeat revascularization, secondaryOutcomes measure: Ischemic stroke, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ki Hong Choi, MD, role: CONTACT, phone: 82-2-3410-3419, email: cardiokh@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06338943, orgStudyIdInfo id: 02-02/24, briefTitle: Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction, acronym: MAPO-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: National Medical Research Center for Therapy and Preventive Medicine, class: OTHER_GOV, descriptionModule briefSummary: Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?Objectives1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.Study population - 45-60 year-old women with the history of pregnancy (\>20 weeks) in the absence of low left ventricle ejection fraction (\<50%)Primary endpoint: The prevalence of HFpEF in patients with the history of APOs., conditionsModule conditions: Heart Failure Preserved Ejection Fraction, conditions: Pregnancy Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: HFpEF incidence, primaryOutcomes measure: APOs incidence, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Medical Research Center for Therapy and Preventive Medicine, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Olga Dzhioeva, MD, PhD, role: CONTACT, phone: +79166141821, email: odzhioeva@gnicpm.ru, contacts name: Max Shperling, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexandr Mols, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06338930, orgStudyIdInfo id: ROADMAP, briefTitle: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy, acronym: ROADMAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-03-02, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources.Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected.With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags., conditionsModule conditions: Crohn Disease, conditions: Colitis, Ulcerative, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 456, type: ESTIMATED, armsInterventionsModule interventions name: Remote monitoring, outcomesModule primaryOutcomes measure: Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years., secondaryOutcomes measure: Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group., secondaryOutcomes measure: Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire"., secondaryOutcomes measure: Number of telephone/email contacts with the IBD team within one year and within two years., secondaryOutcomes measure: Number of contacts with the general practitioner for IBD related reasons within one year and within two years., secondaryOutcomes measure: Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire., secondaryOutcomes measure: Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale., secondaryOutcomes measure: Number of patients refusing to participate in this trial and the reason why., secondaryOutcomes measure: Reasons to stop remote monitoring., secondaryOutcomes measure: Patient's compliance, measured via missing data in the intervention versus the control group, secondaryOutcomes measure: Satisfaction with the program in the intervention group., secondaryOutcomes measure: System usability in the intervention group., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338917, orgStudyIdInfo id: File 2022 DI 61, briefTitle: Mental Health and Vigorous-intensity Physical Activity, acronym: +MoveMENT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-10, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Vic - Central University of Catalonia, class: OTHER, collaborators name: IRIS-CC, collaborators name: AGAUR, descriptionModule briefSummary: People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities.The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participants in both groups are not aware of the existence of the other group. The health provider in the control group is aware of the existence of the intervention group but does not know which intervention is being carried out., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Vigorous-intensity physical activity program, outcomesModule primaryOutcomes measure: Psychotic symptomatology, primaryOutcomes measure: Depression symptomatology, primaryOutcomes measure: Depression severity, primaryOutcomes measure: Mania symptomatology, primaryOutcomes measure: Mania severity, primaryOutcomes measure: Disability, primaryOutcomes measure: Quality of life, primaryOutcomes measure: Cognitive functioning, primaryOutcomes measure: Mood, secondaryOutcomes measure: Subjective physical activity patron, secondaryOutcomes measure: Subjective sedentary behaviour patron, secondaryOutcomes measure: Perception of physical fitness, secondaryOutcomes measure: Objective physical activity patron, secondaryOutcomes measure: Objective sedentary behavior patron, secondaryOutcomes measure: Cardiorespiratory endurance, secondaryOutcomes measure: Velocity, secondaryOutcomes measure: Agility, secondaryOutcomes measure: Lower limb strength, otherOutcomes measure: Subjective perception of joy, otherOutcomes measure: Subjective perception of calm, otherOutcomes measure: Subjective perception of energy, otherOutcomes measure: Subjective perception of time spent, otherOutcomes measure: Subjective perception of the received information, otherOutcomes measure: Subjective perception of respect received, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vic, city: Vic, state: Barcelona, zip: 08500, country: Spain, geoPoint lat: 41.93012, lon: 2.25486, hasResults: False
|
protocolSection identificationModule nctId: NCT06338904, orgStudyIdInfo id: PID2022-141225OB-I00, briefTitle: Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50, acronym: SOLPROSU50+, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Santiago de Compostela, class: OTHER, collaborators name: Ministry of science and innovation of Spain, descriptionModule briefSummary: Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups., conditionsModule conditions: Suicide, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 212, type: ACTUAL, armsInterventionsModule interventions name: Problem-solving-based psychological intervention, outcomesModule primaryOutcomes measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months., primaryOutcomes measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months., secondaryOutcomes measure: Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months, secondaryOutcomes measure: Treatment adherence, secondaryOutcomes measure: Satisfaction with the service received, otherOutcomes measure: Sociodemographic, familial, personal history, and current suicide risk variables, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Group on Mental Health and Psychopatology, city: Santiago de Compostela, state: A Coruña, zip: 15782, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False
|
protocolSection identificationModule nctId: NCT06338891, orgStudyIdInfo id: ACPM34, briefTitle: Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten/wheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten/Sensitivity, NCGS/NCWS).Therefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten/wheat sensitivity in patients with FMF., conditionsModule conditions: Familial Mediterranean Fever, conditions: Non-celiac Gluten Sensitivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Main questionnaire, interventions name: Secondary questionnaire, outcomesModule primaryOutcomes measure: Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF), primaryOutcomes measure: Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF, primaryOutcomes measure: Prevalence of self-reported NCGS/NCWS in patients with FMF, secondaryOutcomes measure: Genetic differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Genetic differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Ethnic group differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Ethnic group differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Education level differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Education level differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Working activity differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Working activity differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in marital status between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in marital status between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Palermo, status: RECRUITING, city: Palermo, state: Sicily, zip: 90127, country: Italy, contacts name: Pasquale Mansueto, role: CONTACT, phone: 00390916554815, email: pasquale.mansueto@unipa.it, contacts name: Pasquale Mansueto, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Carroccio, role: SUB_INVESTIGATOR, contacts name: Aurelio Seidita, role: SUB_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
|
protocolSection identificationModule nctId: NCT06338878, orgStudyIdInfo id: 2023PI087, briefTitle: PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes, acronym: PATHWAY-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Pr. Nicolas GIRERD, class: OTHER, descriptionModule briefSummary: This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: All-cause post-hospitalization mortality, primaryOutcomes measure: Rehospitalization for heart failure, secondaryOutcomes measure: Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations, secondaryOutcomes measure: Influenza and pneumococcal vaccination status, secondaryOutcomes measure: Evolution of renal function, secondaryOutcomes measure: All-cause Rehospitalization, secondaryOutcomes measure: All-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU de Nancy, status: RECRUITING, city: Nancy, country: France, contacts name: Laura FILIPPETTI, role: CONTACT, email: l.filippetti@chru-nancy.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
|
protocolSection identificationModule nctId: NCT06338865, orgStudyIdInfo id: Study00003146, briefTitle: Short Title: Standard vs. Lower Pressure Pneumoperitoneum, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Cedars-Sinai Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon., conditionsModule conditions: Laparoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Patients and post-anesthesia care unit nurses will be masked., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 294, type: ESTIMATED, armsInterventionsModule interventions name: Carbon dioxide, interventions name: Bupivacaine, interventions name: Oxycodone, outcomesModule primaryOutcomes measure: Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10), secondaryOutcomes measure: First reported pain score in PACU (numerical rating scale, 0-10), secondaryOutcomes measure: Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10), secondaryOutcomes measure: Inpatient morphine milligram equivalents, secondaryOutcomes measure: Total number of 5mg oxycodone pills taken in the 2 weeks following discharge, secondaryOutcomes measure: Need for insufflation pressure increase intra-operatively due to inadequate visualization, secondaryOutcomes measure: Operative time, secondaryOutcomes measure: Estimated blood loss, secondaryOutcomes measure: Intraoperative complications, secondaryOutcomes measure: Conversion to laparotomy, secondaryOutcomes measure: Postoperative length of stay, secondaryOutcomes measure: Surgeon-reported adequacy of assigned insufflation pressure, secondaryOutcomes measure: Need for adjustment of insufflation pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338852, orgStudyIdInfo id: 4347, briefTitle: Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2023-06-03, completionDateStruct date: 2023-07-03, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this study will be to detect if there is awareness of gynecologists about the role of physical therapy in genital prolapse.Physical therapy plays an important role in assessment, prevention and treatment of pelvic floor dysfunction and genital prolapse, it helps to stimulate and strength pelvic floor muscle.Physical therapy treatments for the pelvic floor may include bladder training, pelvic floor muscles training with or without biofeedback, vaginal cones, electro stimulation or other adjuncts to training., conditionsModule conditions: Genital Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 370, type: ACTUAL, armsInterventionsModule interventions name: Socio demographic and evaluation questionnaires, outcomesModule primaryOutcomes measure: Socio demographic and evaluation questionnaires, eligibilityModule sex: ALL, minimumAge: 29 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy cairo university, city: Cairo, zip: 37617692, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06338839, orgStudyIdInfo id: D8450R00006, briefTitle: Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia, acronym: TETRAMER, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-28, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis, conditionsModule conditions: Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 6000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation, secondaryOutcomes measure: demographic and clinical characteristics, and test results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Akhtubinsk, country: Russian Federation, geoPoint lat: 48.27955, lon: 46.17217, locations facility: Research Site, status: RECRUITING, city: Astrakhan, country: Russian Federation, geoPoint lat: 46.34968, lon: 48.04076, locations facility: Research Site, status: RECRUITING, city: Beslan, country: Russian Federation, geoPoint lat: 43.19217, lon: 44.54313, locations facility: Research Site, status: RECRUITING, city: Izhevsk, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations facility: Research Site, status: RECRUITING, city: Kaluga, country: Russian Federation, geoPoint lat: 54.5293, lon: 36.27542, locations facility: Research Site, status: RECRUITING, city: Krasnodar, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, locations facility: Research Site, status: RECRUITING, city: Rostov-on-Don, country: Russian Federation, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Research Site, status: RECRUITING, city: Smolensk, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations facility: Research Site, status: RECRUITING, city: Vladimir, country: Russian Federation, geoPoint lat: 56.13655, lon: 40.39658, locations facility: Research Site, status: RECRUITING, city: Vladivostok, country: Russian Federation, geoPoint lat: 43.10562, lon: 131.87353, locations facility: Research Site, status: RECRUITING, city: Volgograd, country: Russian Federation, geoPoint lat: 48.71939, lon: 44.50183, locations facility: Research Site, status: RECRUITING, city: Yaroslavl, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False
|
protocolSection identificationModule nctId: NCT06338826, orgStudyIdInfo id: ANRS0250s-BI-LIGHT, briefTitle: Study Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses, acronym: BI-LIGHT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: ANRS, Emerging Infectious Diseases, class: OTHER_GOV, descriptionModule briefSummary: The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy, conditionsModule conditions: HIV Infections, conditions: HBV Coinfection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year.Participants will be randomized 1:2:2 into 3 parallel arms:* Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF* Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days* Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI, interventions name: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR), outcomesModule primaryOutcomes measure: The proportion of participants with HBV virological failure at 96 weeks., secondaryOutcomes measure: • HBV virological success rate at 48 weeks, secondaryOutcomes measure: • HIV virological success rate at 48 and 96 weeks, secondaryOutcomes measure: • Time to virological failure (rebound HBV and/or HIV viral load), secondaryOutcomes measure: • The rate of participants with at least one HBV viral load blip until W48 and until W96, secondaryOutcomes measure: • Selection of HBV resistance mutations at the time of virological failure, secondaryOutcomes measure: • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96, secondaryOutcomes measure: • Evolution of CD4 from W0 to W48 and W96, secondaryOutcomes measure: • Evolution of total cholesterol from W0 to W48 and W96, secondaryOutcomes measure: • Evaluation of the adherence by self-reported questionnaire, secondaryOutcomes measure: • Evaluation of quality of life using the Pro-Qol self-questionnaire, secondaryOutcomes measure: Evolution of CD8 T lymphocytes from W0 to W48 and W96, secondaryOutcomes measure: Evolution of the CD4/CD8 ratio from W0 to W48 and W96, secondaryOutcomes measure: Evolution of LDL-c from W0 to W48 and W96, secondaryOutcomes measure: Evolution of HDL-c from W0 to W48 and W96, secondaryOutcomes measure: Evolution of triglycerides from W0 to W48 and W96, secondaryOutcomes measure: Evolution of fasting blood sugar from W0 to W48 and W96, secondaryOutcomes measure: HBV virological success rate at 96 weeks between arms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338813, orgStudyIdInfo id: Merve Unutmaz, briefTitle: Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-30, primaryCompletionDateStruct date: 2023-02-22, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Although many measurement techniques have been tried for intra-abdominal pressure, the Kron technique is currently the gold standard method. However, the search for other methods continues due to its long application time, the need for more equipment, and impracticality. Consequently, the investigators sought to investigate a quicker and more accessible method suitable for successful intra-abdominal pressure measurement in the emergency department. This study aimed to compare intra-abdominal pressure measurements in patients diagnosed with ileus using a digital manometer and the Kron Technique., conditionsModule conditions: Ileus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SCREENING, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Digital Manometry, outcomesModule primaryOutcomes measure: Digital manometer measuring for Intraabdominal Pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06338800, orgStudyIdInfo id: PSY-2324-S-0134, briefTitle: One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Accare, class: OTHER, descriptionModule briefSummary: The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:1. What are the expectations of children and adolescents and therapists with VR exposure?2. What is the acceptability of the VR session (positive and negative effects)?3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR., conditionsModule conditions: Anxiety Disorders, conditions: Exposure, conditions: Social Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: During ongoing treatment for their anxiety disorder 30 children and adolescents (8-18 years) with an anxiety disorder will receive a session of exposure with VR. Before the session expectations of VR exposure will be assessed. Before and after the session willingness to participate in exposure in vivo will be measured. During the session anxiety, idiosyncratic expectations, and self-efficacy are measured. After the session, positive effects, experiences, and negative side effects will be asked for., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: One session exposure with Virtual Reality, outcomesModule primaryOutcomes measure: Willingness to participate in exposure in vivo, secondaryOutcomes measure: Idiosyncratic expectations, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Expectations of Virtual Reality, secondaryOutcomes measure: Acceptability, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338787, orgStudyIdInfo id: 23-0826.2, briefTitle: A Novel Iron-Based Supplement for Athletes Aged 14-17, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Mitacs, collaborators name: Natural Sciences and Engineering Research Council, Canada, descriptionModule briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females., conditionsModule conditions: Iron Deficiencies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FeSC, outcomesModule primaryOutcomes measure: Iron Status, primaryOutcomes measure: Hemoglobin, primaryOutcomes measure: Lower Gut microbiome, secondaryOutcomes measure: Exercise Capacity, otherOutcomes measure: Gastrointestinal Symptoms 1, otherOutcomes measure: Gastrointestinal Symptoms 2, otherOutcomes measure: Sleepiness, otherOutcomes measure: Stress and Recovery, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338774, orgStudyIdInfo id: 202310129, secondaryIdInfos id: R33AG078041, type: NIH, link: https://reporter.nih.gov/quickSearch/R33AG078041, briefTitle: Cognitive Control to Boost Physical Activity Adherence, acronym: BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Iowa, class: OTHER, collaborators name: Northeastern University, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:* Can cognitive training designed to improve cognitive control improve physical activity adherence?* What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?Participants will* Complete a 6-week home-based, computerized cognitive training program* Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer* Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer* Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness, conditionsModule conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Six week parallel group intervention, followed by a 12 week exercise program., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive training, interventions name: Exercise, outcomesModule primaryOutcomes measure: Physical Activity Adherence, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Psychological and Brain Sciences Building, city: Iowa City, state: Iowa, zip: 52242, country: United States, contacts name: Michelle W Voss, PhD, role: CONTACT, phone: 319-335-2057, email: michelle-voss@uiowa.edu, contacts name: Ruthina Malone, role: CONTACT, phone: 319-335-2407, email: ruthina-malone@uiowa.edu, contacts name: Michelle Voss, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66113, lon: -91.53017, locations facility: Center for Cognitive and Brain Health, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Charles Hillman, PhD, role: CONTACT, phone: 617-373-8342, email: c.hillman@northeastern.edu, contacts name: Virginia Davis, role: CONTACT, phone: 617-373-3448, email: vi.davis@northeastern.edu, contacts name: Charles Hillman, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Arthur F Kramer, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06338761, orgStudyIdInfo id: E-cigarette PCI, briefTitle: Switching to E-cigarette After PCI, acronym: E-cig-PCI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 17442, type: ESTIMATED, armsInterventionsModule interventions name: Smoking cessation, interventions name: Switching to E-cigarette, outcomesModule primaryOutcomes measure: MACE, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Spontaneous myocardial infarction, secondaryOutcomes measure: Repeat revascularization, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ki Hong Choi, MD, role: CONTACT, phone: 82-2-3410-3419, email: cardiokh@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06338748, orgStudyIdInfo id: 24-157, briefTitle: Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery, acronym: DexcomG7, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, collaborators name: DexCom, Inc., descriptionModule briefSummary: This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated., conditionsModule conditions: Continuous Glucose Monitoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients undergoing heart surgery at the Cleveland Clinic (main campus) who would normally be tested for high sugar levels by poking a finger and using a test strip., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode, outcomesModule primaryOutcomes measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU, primaryOutcomes measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Foundation, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Kimberly Jenkins, role: CONTACT, phone: 216-445-4791, email: jenkink@ccf.org, contacts name: Kimberly Jenkins, role: CONTACT, phone: (216) 445-4791, email: jenkink@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
|
protocolSection identificationModule nctId: NCT06338735, orgStudyIdInfo id: 14540, briefTitle: Ultra-High Frequency Ultrasonography in Sjögren's Syndrome, acronym: UltraSjögren, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01-11, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Pisa, class: OTHER, descriptionModule briefSummary: Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Ultra-High Frequency Ultrasound scan of minor salivary glands, outcomesModule primaryOutcomes measure: OMERACT score, primaryOutcomes measure: Correspondence between ultrasonography and histology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pisa, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Rossana Izzetti, role: CONTACT, phone: +39050993037, email: rossana.izzetti@unipi.it, contacts name: Rossana Izzetti, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
|
protocolSection identificationModule nctId: NCT06338722, orgStudyIdInfo id: 23-397, briefTitle: Making it Work Program for Systemic Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of New Mexico, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time., conditionsModule conditions: Scleroderma, Systemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention receives the Making it work program Wait list Control receives usual care but will be offered the program after the intervention groups finish, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: People will know what group they are in when they are invited to attend the intervention sessions, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Making it Work Systemic Sclerosis, outcomesModule primaryOutcomes measure: Job Related Self-efficacy Scale, primaryOutcomes measure: Job Self-Efficacy Scale, secondaryOutcomes measure: Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale, secondaryOutcomes measure: The Work Instability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 67 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of New Mexico, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87131-0001, country: United States, contacts name: Janet L Poole, PhD, role: CONTACT, phone: 505-272-8276, email: jpoole@salud.unm.edu, geoPoint lat: 35.08449, lon: -106.65114, hasResults: False
|
protocolSection identificationModule nctId: NCT06338709, orgStudyIdInfo id: 11-002, briefTitle: Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Advanced Bariatric Technology, class: INDUSTRY, collaborators name: NAMSA, descriptionModule briefSummary: Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: BariClip® Device Treatment, outcomesModule primaryOutcomes measure: Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects, primaryOutcomes measure: Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group, secondaryOutcomes measure: Weight and Height will be combined to report BMI in kg/m^2, secondaryOutcomes measure: Blood Pressure (BP) in mmHg, both systolic and diastolic, secondaryOutcomes measure: Diagnosis and/or Change in Severity of Diabetes Mellitus (DM), secondaryOutcomes measure: Weight in kilograms, secondaryOutcomes measure: Height in meters, secondaryOutcomes measure: Waist Circumference in centimeters, otherOutcomes measure: Incidence of Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338696, orgStudyIdInfo id: COA-CREC070/2023, briefTitle: Thailand ATTR-CM Registry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2030-06-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: Pfizer, descriptionModule briefSummary: The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand., conditionsModule conditions: Transthyretin Amyloid Cardiomyopathy (ATTR-CM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Rate of death, primaryOutcomes measure: Rate of heart failure hospitalization, secondaryOutcomes measure: Transthyretin (ATTR) amyloidosis medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine at Chulalongkorn University, city: Bangkok, country: Thailand, contacts name: Sarinya Puwanant, MD, role: CONTACT, contacts name: Sarinya Puwanant, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Faculty of Medicine Ramathibodi hospital, Mahidol University, city: Bangkok, country: Thailand, contacts name: Teerapat Yingchoncharoen, MD, role: CONTACT, contacts name: Teerapat Yingchoncharoen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Faculty of Medicine Siriraj Hospital, Mahidol University, city: Bangkok, country: Thailand, contacts name: Kanchalaporn Jirataiporn, B.N.S, role: CONTACT, contacts name: Srisakul Chirakarnjanakorn, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Adisak Maneesai, MD, role: SUB_INVESTIGATOR, contacts name: Porntera Sethalao, MD, role: SUB_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Phramongkutklao Hospital, city: Bangkok, country: Thailand, contacts name: Hutsaya Prasitdumrong, MD, role: CONTACT, contacts name: Hutsaya Prasitdumrong, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Faculty of Medicine Chiang Mai University, city: Chiang Mai, country: Thailand, geoPoint lat: 18.79038, lon: 98.98468, locations facility: Queen Sirikit Heart Center of The Northeast, city: Khon Kaen, country: Thailand, contacts name: Vichai Senthong, MD, role: CONTACT, contacts name: Vichai Senthong, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 16.44671, lon: 102.833, locations facility: Faculty of Medicine, Thammasat University, city: Pathum Thani, country: Thailand, contacts name: Adisai Buakhamsri, MD, role: CONTACT, contacts name: Adisai Buakhamsri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 14.01346, lon: 100.53049, locations facility: Prince of Songkla University, city: Songkhla, country: Thailand, geoPoint lat: 7.19882, lon: 100.5951, hasResults: False
|
protocolSection identificationModule nctId: NCT06338683, orgStudyIdInfo id: QRCH-2024001, briefTitle: Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Qinghai Red Cross Hospital, class: OTHER, descriptionModule briefSummary: This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival., conditionsModule conditions: Advanced Cancer, conditions: Olanzapine, conditions: Progression Free Survival, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Olanzapine 2.5 MG, interventions name: Standard anti-tumor treatment, interventions name: Nutritional advice, outcomesModule primaryOutcomes measure: Comparing the difference in Median PFS between the two groups, secondaryOutcomes measure: Comparing the difference in Median OS between the two groups, secondaryOutcomes measure: Comparing the difference in ORR between the two groups, secondaryOutcomes measure: Comparing the difference in the incidence of ≥3% weight loss between the two groups, secondaryOutcomes measure: Comparing the difference in BMI between the two groups, secondaryOutcomes measure: Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups, secondaryOutcomes measure: Comparing the difference in Quality of life in the overall stage between the two groups, secondaryOutcomes measure: neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: platelet-to-lymphocyte ratio, secondaryOutcomes measure: C-reactive protein (CRP) concentration, secondaryOutcomes measure: concentration of albumin, secondaryOutcomes measure: Level of interleukin (IL)-6 and IL-8, secondaryOutcomes measure: Comparing the difference in the side effects of olanzapine treatment between the two groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qinghai Red Cross Hospital, status: RECRUITING, city: Xining, state: Qinghai, zip: 810000, country: China, contacts name: Qiuxia Dong, Dr, role: CONTACT, phone: 0971-8267613, email: 2816278916@qq.com, geoPoint lat: 36.62554, lon: 101.75739, hasResults: False
|
protocolSection identificationModule nctId: NCT06338670, orgStudyIdInfo id: CLTD5839, briefTitle: Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users, acronym: RECONNECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-11-22, completionDateStruct date: 2024-11-22, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Cochlear, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors., conditionsModule conditions: Hearing Loss, Mixed Conductive-Sensorineural, conditions: Hearing Loss, Conductive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Within-subject, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Cochlear Osia 3 Sound Processor, interventions name: Cochlear™ Osia® 2 Sound Processor, outcomesModule primaryOutcomes measure: Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL, primaryOutcomes measure: Change (within subject) in word recognition score in quiet measured at 65 dB SPL, primaryOutcomes measure: Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz, primaryOutcomes measure: Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips, primaryOutcomes measure: Percentage of participants who preferred Osia 3 over Osia 2 sound processor, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The HEARing CRC, city: Melbourne, state: Victoria, zip: 3053, country: Australia, contacts name: Robert Cowan, role: CONTACT, phone: +61418780198, email: r.cowan@unimelb.edu.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
|
protocolSection identificationModule nctId: NCT06338657, orgStudyIdInfo id: 7H-23-5, secondaryIdInfos id: NCI-2024-01367, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 7H-23-5, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-04-04, completionDateStruct date: 2027-04-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: PEOX-based Polymer Encapsulated Paclitaxel FID-007, interventions name: Tumor Resection, outcomesModule primaryOutcomes measure: Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Major pathologic response rate, secondaryOutcomes measure: Complete pathologic response rate, secondaryOutcomes measure: Rate of locoregional recurrence, secondaryOutcomes measure: Rate of distant metastasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Angeles General Medical Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Sandy Tran, MS, role: CONTACT, phone: 323-865-0451, email: Sandy.tran@med.usc.edu, contacts name: Jacob S. Thomas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Sandy Tran, MS, role: CONTACT, phone: 323-865-0451, email: Sandy.tran@med.usc.edu, contacts name: Jacob S. Thomas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
|
protocolSection identificationModule nctId: NCT06338644, orgStudyIdInfo id: HelwanUY, briefTitle: Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients., acronym: Palbociclib, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Helwan University, class: OTHER, descriptionModule briefSummary: Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies, conditionsModule conditions: Hormone-receptor-positive Breast Cancer, conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, conditions: Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Palbociclib, outcomesModule primaryOutcomes measure: 1-year Progression free survival (PFS), secondaryOutcomes measure: Neutropenia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338631, orgStudyIdInfo id: 43C301, briefTitle: Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess", acronym: OB-KID, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk.It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients.The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity.The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Diet, outcomesModule primaryOutcomes measure: Glomerular filtration rate, primaryOutcomes measure: Microalbuminuria, primaryOutcomes measure: Glycemia, primaryOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Città Studi ICANS, status: RECRUITING, city: Milano, zip: 20100, country: Italy, contacts name: Alberto Battezzati, Prof, role: CONTACT, phone: +390261911, email: a.battezzati@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli, status: RECRUITING, city: Naples, country: Italy, contacts name: Bruna Guida, Prof., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
|
protocolSection identificationModule nctId: NCT06338618, orgStudyIdInfo id: 1532-N-23, briefTitle: Manual Therapy in Metabolic Liver Disease, acronym: OSTEO-EHMet, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver., conditionsModule conditions: NAFLD, Non-alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: liver treatment protocol, outcomesModule primaryOutcomes measure: Hepatic steatosis index, secondaryOutcomes measure: FIB-4 index, secondaryOutcomes measure: NAFLD-fibrosis index, secondaryOutcomes measure: HOMA index, secondaryOutcomes measure: TyG index, secondaryOutcomes measure: Change from baseline in algometry, secondaryOutcomes measure: Visual analogue Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitary Hospital Juan Ramón Jiménez, status: RECRUITING, city: Huelva, zip: 21005, country: Spain, contacts name: Javer Carrasco Sánchez, Dr, role: CONTACT, phone: 682289772, email: fjcarrascos@icloud.com, geoPoint lat: 37.26638, lon: -6.94004, hasResults: False
|
protocolSection identificationModule nctId: NCT06338605, orgStudyIdInfo id: MEC-2023-0715, briefTitle: Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis, acronym: CYSTATINcDK4/6, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, observational study of AKI under CDK4/6 inhibitor treatment, outcomesModule primaryOutcomes measure: Pseudo-AKI in patients on CDK4/6 inhibitors, secondaryOutcomes measure: Pseudo-AKI in patients on CDK4/6 inhibitors per drug, secondaryOutcomes measure: AKI in patients, secondaryOutcomes measure: Influencing factors cystatin C levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
|
protocolSection identificationModule nctId: NCT06338592, orgStudyIdInfo id: UUtah_00153806, briefTitle: The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale, acronym: MyLungHealth, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-03-27, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making., conditionsModule conditions: Lung Cancer, conditions: Lung Neoplasms/Diagnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a patient randomized trial that includes two sub-studies, with 2 arms each., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 42415, type: ESTIMATED, armsInterventionsModule interventions name: MyLungHealth, interventions name: DecisionPrecision+, outcomesModule primaryOutcomes measure: Study 1 primary outcome: Percentage of participants identified as eligible for LCS., primaryOutcomes measure: Study 2 primary outcome: Percentage of participants for whom LDCT was ordered., secondaryOutcomes measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered., secondaryOutcomes measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was completed., secondaryOutcomes measure: Study 2 secondary outcome: Percentage of participants for whom LDCT was completed., secondaryOutcomes measure: Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Devin Mann, MD, role: CONTACT, email: devin.mann@nyulangone.org, contacts name: Devin Mann, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Utah Health, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Kensaku Kawamoto, MD, PhD, MHS, role: CONTACT, email: kensaku.kawamoto@utah.edu, contacts name: Kensaku Kawamoto, MD, PhD, MHS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
|
protocolSection identificationModule nctId: NCT06338579, orgStudyIdInfo id: 2023PPRC04, secondaryIdInfos id: 2023-A01763-42, type: OTHER, domain: IDRCB, briefTitle: Overview of Self-medication Among French Navy Personnel, acronym: AutoMMaN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Direction Centrale du Service de Santé des Armées, class: OTHER, descriptionModule briefSummary: The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship., conditionsModule conditions: Self Medication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: percentage of patients who have self-medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338566, orgStudyIdInfo id: 2021PPRC10, secondaryIdInfos id: 2023-A01975-40, type: OTHER, domain: IDRCB, briefTitle: Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle, acronym: PROCLOU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Direction Centrale du Service de Santé des Armées, class: OTHER, descriptionModule briefSummary: The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.Patients will be asked to complete a questionnaire during follow-up consultations., conditionsModule conditions: Ankle Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Follow-up, outcomesModule primaryOutcomes measure: bony outcome of transcalcaneal nailing, secondaryOutcomes measure: functional result of the procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338553, orgStudyIdInfo id: 231620, briefTitle: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab, acronym: GLP-TEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The first meal test is pre-teplizumab, followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In this study, participants with stage 2 T1DM undergoing Teplizumab (TZIELD®) treatment will be randomly assigned to receive single doses of either a GLP-1Ra or a placebo. Three separate MMTT tests will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. The first test will occur before TZIELD® treatment and participants will receive a placebo at this MMTT. The other two tests will take place 3-5 months after TZIELD® treatment. In these post-treatment tests, the study team will 'cross over', or switch, the order in which participants receive the GLP-1Ra or placebo, with a minimum one-week gap to avoid overlap of effects. For example, a participant may take the GLP-1Ra then placebo or the placebo then the GLP-1Ra. In some cases, the investigator may allow participants who have already received TZIELD® treatment prior to joining the study to skip the pre-treatment test and proceed directly to the post-treatment tests., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: For applicable participants, a placebo will be given prior to a pre-TZIELD® meal test. For participants who have already received Teplizumab (TZIELD®) or those who are progressing to the 2 remaining study visits, a GLP-1Ra or placebo will be given in random orders at these two visits. The GLP-1Ra will only be given one time., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Semaglutide (Rybelsus®), outcomesModule primaryOutcomes measure: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study, primaryOutcomes measure: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study, primaryOutcomes measure: Determine the impact of GLP-1Ra on endothelial function in a pilot study, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Justin M Gregroy, MD, MSCI, role: CONTACT, phone: (615) 322- 7427, email: metabolism@vumc.org, contacts name: Tyler J Smith, DNP, APRN, FNP-C, role: CONTACT, email: metabolism@vumc.org, contacts name: Justin M Gregory, MD, MSCI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-27, uploadDate: 2024-03-01T16:04, filename: Prot_000.pdf, size: 567921, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-21, uploadDate: 2024-03-01T15:15, filename: ICF_001.pdf, size: 2385304, hasResults: False
|
protocolSection identificationModule nctId: NCT06338540, orgStudyIdInfo id: A26020822, briefTitle: Relation of Caries Color to Caries Severity and Its Microbial Load, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This study is to find the relation of caries color to caries severity and its microbial load in primary molars., conditionsModule conditions: Relation of Caries Color, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Black color of caries, interventions name: dark brown color of caries, interventions name: light brown color of caries, interventions name: yellow color of caries, outcomesModule primaryOutcomes measure: Caries color related to history of pain, primaryOutcomes measure: Caries color related to ICDAS, primaryOutcomes measure: Caries color related to pulp exposed, primaryOutcomes measure: Caries color related to microbial load, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mansoura university, city: Mansoura, state: Dakahlia, zip: 35511, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
|
protocolSection identificationModule nctId: NCT06338527, orgStudyIdInfo id: 2024YX321, briefTitle: Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Weifang Medical University, class: OTHER, descriptionModule briefSummary: The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer., conditionsModule conditions: Sleep Quality, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Aromatherapy, interventions name: No intervention, outcomesModule primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weifang People's Hospital, city: Weifang, state: Shangdong, zip: 261000, country: China, contacts name: Shirong Fang, M.D., role: CONTACT, email: fsr0536@163.com, geoPoint lat: 36.71, lon: 119.10194, hasResults: False
|
protocolSection identificationModule nctId: NCT06338514, orgStudyIdInfo id: KutahyaHSU-DRYNEEDLE-dorsalgia, briefTitle: The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: Back pain is commonly seen in the working-age population, with the peak occurrence around the age of 40. Its frequency does not increase with age and is not associated with age-related degenerative changes in the spine. Especially when the underlying cause is conditions such as myofascial pain syndrome (MPS), where regional muscle sensitivity in the rhomboid and trapezius areas is prominent, dry needling treatment has become increasingly popular and the subject of numerous studies in recent years. In the diagnosis of MPS, two valuable findings include the detection of a taut band upon palpation and the presence of trigger points in muscle fibers with mild finger pressure. The study we are planning involves a double-blind efficacy trial where real and sham dry needling procedures will be performed under ultrasound guidance, ensuring that both the patient and the evaluator are blinded. This study design has the potential to make a significant contribution to the literature in this field., conditionsModule conditions: Myofascial Trigger Point Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-group, sham-controlled, double-blind, prospective, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful dorsal trapezius and rhomboid muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Real dry needling, interventions name: Sham dry needling, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Patient-Specific Functional Scale, primaryOutcomes measure: Pressure Pain Threshold Measurement, secondaryOutcomes measure: What does Oswestry stand for? The Oswestry Disability Index (ODI), secondaryOutcomes measure: The 12-item Short-Form Health Survey version 2 (SF-12v2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338501, orgStudyIdInfo id: 77325224.4.0000.5235, briefTitle: Assessment of Heart Rate Variability, Performance and Dehydration in Muay Thai Athletes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centro Universitário Augusto Motta, class: OTHER, descriptionModule briefSummary: Known as "Thai boxing," Muay Thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." It is practiced worldwide and is a prominent discipline in many mixed martial arts (MMA) training camps. In this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. In the context of combat sports, such as Muay Thai, heart rate variability (HRV) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. Additionally, HRV can also serve as a tool for assessing recovery after training or competition. If HRV does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. Due to the absence of studies in the literature that have assessed a possible association between HRV and dehydration and rehydration processes in amateur Muay Thai athletes, it becomes essential to evaluate this correlation. Given the growing interest in practicing Muay Thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. Therefore, the aim of this study is to investigate the relationship between dehydration indicators, HRV parameters, and performance in the frequency speed kick test (FSKT). Participants will be assessed before and after an eight-week training program, conducted three times a week. Assessments will include resting HRV measurement and FSKT; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. It is expected that the results will reveal changes in HRV, performance, and body composition of the athletes after training., conditionsModule conditions: Nervous System Diseases, conditions: Dehydration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Specifical Functional Training Exercises, outcomesModule primaryOutcomes measure: HRV during specifical physical test, secondaryOutcomes measure: Correlation with BIA analysis, HRV and Specific Physical Test, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338488, orgStudyIdInfo id: KutahyaHSU-DRYNEEDLE-SHOULDER, briefTitle: The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field., conditionsModule conditions: Shoulder Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective double-blind randomized sham-controlled study., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful shoulder's trapezius and infraspinatus muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Real dry needling, interventions name: Sham dry needling, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Patient-Specific Functional Scale, primaryOutcomes measure: Pressure Pain Threshold Measurement, secondaryOutcomes measure: The Shoulder Pain and Disability Index (SPADI), secondaryOutcomes measure: The Quick DASH Outcome Measure, secondaryOutcomes measure: The 12-item Short-Form Health Survey version 2 (SF-12v2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338475, orgStudyIdInfo id: 20205703, briefTitle: A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult cancer survivors. Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers.Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Goal-Focused Emotion-Regulation Therapy (GET), interventions name: Individual Supportive Listening (ISL), outcomesModule primaryOutcomes measure: Change in Hospital Anxiety and Depression Scale (HADS), primaryOutcomes measure: Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII), primaryOutcomes measure: Change in Salivary Diurnal Cortisol Slope and Daily Output, secondaryOutcomes measure: Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score, secondaryOutcomes measure: Change in Career Thoughts Inventory (CTI) Global Score, secondaryOutcomes measure: Change in Emotion Regulation Questionnaire (ERQ) Scale Scores, secondaryOutcomes measure: Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score, secondaryOutcomes measure: Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338462, orgStudyIdInfo id: 2000034128, secondaryIdInfos id: R21AI174129, type: NIH, link: https://reporter.nih.gov/quickSearch/R21AI174129, briefTitle: Cali Sin Tos Aim 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique)., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: target sample size is an anticipated 120 index persons with TB enrolled over three design cycles, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Chatbot, interventions name: Oral testing, outcomesModule primaryOutcomes measure: Implementation of the mHealth strategy to assess feasibility., primaryOutcomes measure: Oral specimen collection to assess feasibility., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM), city: Cali, country: Colombia, geoPoint lat: 3.43722, lon: -76.5225, hasResults: False
|
protocolSection identificationModule nctId: NCT06338449, orgStudyIdInfo id: XZMU-2022-ZK068, briefTitle: The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-13, primaryCompletionDateStruct date: 2022-12-20, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Xuzhou Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?Participants will:Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen., conditionsModule conditions: Non-alcoholic Fatty Liver Disease NAFLD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The specific exercise plan and grouping are as follows:Participants were randomly (Using an electronic random number generator) divided into four groups: control group (Control), aerobic training group (AT), resistance training group (RT), and combined aerobic and resistance training group (AT + RT), with each group consisting of 10 individuals, totaling 40 participants. All participants were young adults aged between 18 and 21 years old., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: After the data is obtained, the person analyzing the data will not know the specific grouping and participant information. The groups will be replaced by Group A, B, C, D, and the participants will be indicated by their IDs., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Aerobic training (AT), interventions name: Resistance training (RT), interventions name: Combined aerobic and resistance training (AT + RT), outcomesModule primaryOutcomes measure: Changes in body weight compared to baseline at 8 weeks, primaryOutcomes measure: Changes in Body Mass Index compared to baseline at 8 weeks, primaryOutcomes measure: Changes in total cholesterol compared to baseline at 8 weeks, primaryOutcomes measure: Changes in triglycerides compared to baseline at 8 weeks, primaryOutcomes measure: Changes in high-density lipoprotein compared to baseline at 8 weeks, primaryOutcomes measure: Changes in low-density lipoprotein compared to baseline at 8 weeks, primaryOutcomes measure: Changes in alanine aminotransferase compared to baseline at 8 weeks, primaryOutcomes measure: Changes in aspartate aminotransferase compared to baseline at 8 weeks, primaryOutcomes measure: Changes in alkaline phosphatase compared to baseline at 8 weeks, primaryOutcomes measure: Changes in gamma-glutamyl transferase compared to baseline at 8 weeks, primaryOutcomes measure: Changes in direct bilirubin compared to baseline at 8 weeks, primaryOutcomes measure: Changes in total bile acids compared to baseline at 8 weeks, primaryOutcomes measure: Changes in adenosine deaminase compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in percentage of body fat compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in waist-to-hip ratio compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in blood glucose compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in the level of insulin compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in albumin compared to baseline at 8 weeks, secondaryOutcomes measure: Changes in C-reactive protein compared to baseline at 8 weeks, otherOutcomes measure: Changes in other subtypes of bile acids compared to baseline at 8 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule locations facility: Outdoor track and field facility of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, hasResults: False
|
protocolSection identificationModule nctId: NCT06338436, orgStudyIdInfo id: VAR-2022-05, briefTitle: Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-21, primaryCompletionDateStruct date: 2023-09-26, completionDateStruct date: 2023-11-13, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Varian, a Siemens Healthineers Company, class: INDUSTRY, descriptionModule briefSummary: This study is prospective, single-center, single-arm objective performance criteria.This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration., conditionsModule conditions: Tumor, Solid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a clinical study of prospective, single-arm objective performance criteria, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Proton Radiation Therapy System (ProBeam), outcomesModule primaryOutcomes measure: Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion, primaryOutcomes measure: Safety evaluation: Incidence of Acute radiation injury, primaryOutcomes measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06338423, orgStudyIdInfo id: JagiellonianU-08, briefTitle: Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.Method PatientsA prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:* January 2015 - December 2016 - only standard mattresses were used* January 2017 - December 2019 - both types of mattresses were used* January 2020 - December 2022 - only vacuum mattresses were usedParticipants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol \< 85%.Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center\[\]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day, conditionsModule conditions: Rhabdomyolysis, conditions: Acute Kidney Injury, conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1184, type: ACTUAL, armsInterventionsModule interventions name: vacuum mattress, interventions name: Standard Mattress, outcomesModule primaryOutcomes measure: Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI), secondaryOutcomes measure: Concentration of myoglobin marker, secondaryOutcomes measure: Concentration of creatine kinase marker, secondaryOutcomes measure: Concentration of creatinine marker, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University Mecical Collage, city: Kraków, state: Malopolskie, zip: 31-501, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
|
protocolSection identificationModule nctId: NCT06338410, orgStudyIdInfo id: UHS/Education/126-24/131, briefTitle: Effect of Kangaroo Mother Care on Oxidative Stress and Bonding, acronym: KMC, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Lahore, class: OTHER, collaborators name: Services Hospital, Lahore, descriptionModule briefSummary: The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:* Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?* Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.Participants will be:* given Kangaroo mother care on third day of life or standard incubator care for one hour* Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.* Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care, conditionsModule conditions: Kangaroo Mother Care, conditions: Oxidative Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Kangaroo Mother Care, outcomesModule primaryOutcomes measure: biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants, primaryOutcomes measure: Mother- Infant Bonding, eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 3 Days, stdAges: CHILD, contactsLocationsModule locations facility: Services Hospital, Lahore, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
|
protocolSection identificationModule nctId: NCT06338397, orgStudyIdInfo id: 2023_0455, briefTitle: Social & Affective Cognition in Alzheimer's Disease & Associated Disorders, acronym: SOCIALIZE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2027-05-02, completionDateStruct date: 2027-05-02, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Lille, class: OTHER, collaborators name: France Alzheimer, descriptionModule briefSummary: Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains., conditionsModule conditions: Alzheimer's Disease, conditions: Frontotemporal Degeneration (Semantic & Behavioral Variants), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: SCANN, outcomesModule primaryOutcomes measure: Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants., secondaryOutcomes measure: Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants., secondaryOutcomes measure: Correlation coefficient between the SBOC score with MRI markers in all participants, secondaryOutcomes measure: Correlation coefficient between mini-SEA sub scores & MRI markers in all participants., secondaryOutcomes measure: Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups., secondaryOutcomes measure: Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338384, orgStudyIdInfo id: 44735129, briefTitle: Examining Engagement Trends Among Participants in Peripheral Neuropathy Clinical Research, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: This trial aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in peripheral neuropathy clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.Ultimately, this trial endeavors to deepen our understanding of the factors impacting peripheral neuropathy clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition., conditionsModule conditions: Peripheral Neuropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of peripheral neuropathy patients who decide to enroll in a clinical research, primaryOutcomes measure: Rate of peripheral neuropathy patients who remain in clinical trial to trial completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-22, uploadDate: 2024-03-22T09:04, filename: ICF_000.pdf, size: 67357, hasResults: False
|
protocolSection identificationModule nctId: NCT06338371, orgStudyIdInfo id: IZTU-TEKBAŞ-001, briefTitle: Effect of Pelvic Floor Muscle Exercise on Sexual Function, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2022-04-06, completionDateStruct date: 2022-05-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Serap Tekbas, class: OTHER, descriptionModule briefSummary: The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months, conditionsModule conditions: Pelvic Floor Muscle Weakness, conditions: Sexuality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 77, type: ACTUAL, armsInterventionsModule interventions name: Pelvic Floor exercise training, outcomesModule primaryOutcomes measure: Determining Number of Participants, primaryOutcomes measure: Initial scale application, primaryOutcomes measure: Distribution of participants into groups, secondaryOutcomes measure: Providing pelvic floor exercise for training group, secondaryOutcomes measure: Female Sexual Function Index, secondaryOutcomes measure: Female Sexual Function Index, secondaryOutcomes measure: Female Sexual Function Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Izmir Tinaztepe University, city: İzmir, state: Buca, zip: 35400, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
|
protocolSection identificationModule nctId: NCT06338358, orgStudyIdInfo id: 44519568, briefTitle: Understanding Participation Habits Among Plaque Psoriasis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.The data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups., conditionsModule conditions: Plaque Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients who decide to enroll in a plaque psoriasis clinical research., primaryOutcomes measure: Number of plaque psoriasis study participants who remain in clinical study until completion., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-22, uploadDate: 2024-03-22T09:21, filename: ICF_000.pdf, size: 67831, hasResults: False
|
protocolSection identificationModule nctId: NCT06338345, orgStudyIdInfo id: 38RC23.0222, briefTitle: Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients, acronym: KAMELOT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams, conditionsModule conditions: Cardiogenic Shock, conditions: Post-cardiac Surgery, conditions: Cardiac Arrest, conditions: Extracorporeal Membrane Oxygenation Complication, conditions: Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic drug monitoring of beta-lactam, outcomesModule primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied, city: Clermont-Ferrand, zip: 63003, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Dijon-Bourgogne, city: Dijon, zip: 21000, country: France, contacts name: Pierre-Alain BAHR, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Aphp Pitie Salpetriere, city: Paris, zip: 75013, country: France, contacts name: PAULINE DUREAU, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU ROUEN - Hôpital Charles-Nicolle, city: Rouen, zip: 76031, country: France, contacts name: Emmanuel BESNIER, MD, PhD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Hôpital Rangueil - CHU Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Stéphanie RUIZ, MD, role: CONTACT, contacts name: Camille MANE, MD, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
|
protocolSection identificationModule nctId: NCT06338332, orgStudyIdInfo id: AW23.050, W19.249, briefTitle: Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer, acronym: OCCBRIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Amphia Hospital, class: OTHER, descriptionModule briefSummary: Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events., conditionsModule conditions: Colonic Neoplasms Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Complication-free survival, secondaryOutcomes measure: Complications overall, secondaryOutcomes measure: Type of surgical intervention, secondaryOutcomes measure: Time till surgery, secondaryOutcomes measure: Resection, secondaryOutcomes measure: TNM, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: One year stoma rate, secondaryOutcomes measure: One year survival rates, secondaryOutcomes measure: Disease free survival rates one year, secondaryOutcomes measure: Disease free survival rates three years, secondaryOutcomes measure: Three year survival rates, secondaryOutcomes measure: Tumour type (obstructing, not obstructing),, secondaryOutcomes measure: Metastasis preoperative, secondaryOutcomes measure: Pre-operative diagnostics, secondaryOutcomes measure: Type of bridge-to-surgery, secondaryOutcomes measure: Nutrition (TPN/extra nutrition), secondaryOutcomes measure: Consultation of other specialist, otherOutcomes measure: Gender, otherOutcomes measure: Age at surgery, otherOutcomes measure: ASA, otherOutcomes measure: Bodyweight, otherOutcomes measure: Height, otherOutcomes measure: Concomitant and previous therapy, otherOutcomes measure: C-reactive protein, otherOutcomes measure: Haemoglobin, otherOutcomes measure: Laboratory values, otherOutcomes measure: Leukocytes, otherOutcomes measure: Prothrombin time, otherOutcomes measure: Sodium, otherOutcomes measure: Potassium, otherOutcomes measure: Glomerular filtration rate, otherOutcomes measure: Albumin, otherOutcomes measure: Bilirubin, otherOutcomes measure: ASAT, otherOutcomes measure: ALAT, otherOutcomes measure: LDH, otherOutcomes measure: ALP, otherOutcomes measure: Gamma-GT, otherOutcomes measure: Creatinkinase, otherOutcomes measure: Phosphate, otherOutcomes measure: Lactate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amphia Hospital, status: RECRUITING, city: Breda, state: Noord-Brabant, zip: 4818CK, country: Netherlands, contacts name: Elze Lockhorst, Drs., role: CONTACT, phone: +31 613723827, email: elockhorst@amphia.nl, contacts name: Jennifer Schreinemakers, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, hasResults: False
|
protocolSection identificationModule nctId: NCT06338319, orgStudyIdInfo id: 23-048-E, briefTitle: Book Sharing for Toddlers With Clefts, acronym: BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: University of Washington, collaborators name: Nationwide Children's Hospital, collaborators name: Children's Hospital Los Angeles, collaborators name: Ohio State University, descriptionModule briefSummary: Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups., conditionsModule conditions: Cleft Palate, conditions: Cleft Lip and Palate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Book-Sharing for Toddlers with Clefts (BOOST), outcomesModule primaryOutcomes measure: Expressive One Word Picture Vocabulary Test-Fourth Edition, primaryOutcomes measure: Receptive One Word Picture Vocabulary Test-Fourth Edition, primaryOutcomes measure: Child Language Sample, primaryOutcomes measure: MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test, secondaryOutcomes measure: Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants, otherOutcomes measure: Frequency of Shared Reading, otherOutcomes measure: Quality of Shared Reading, otherOutcomes measure: Child Language During Reading, eligibilityModule sex: ALL, minimumAge: 24 Months, maximumAge: 32 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338306, orgStudyIdInfo id: 08073421, briefTitle: Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-07, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, descriptionModule briefSummary: Heart transplant is the only effective treatment for people with advanced heart failure.Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors.To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant.Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes.Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent.The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them.This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors.The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC".The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC).The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy., conditionsModule conditions: Heart Transplant Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus（FK506）, outcomesModule primaryOutcomes measure: Tacrolimus quantification in an unconventional matrix, primaryOutcomes measure: Tacrolimus quantification in PBMCs, primaryOutcomes measure: Tacrolimus quantification in whole blood, secondaryOutcomes measure: Genetic profile in heart transplant recipients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Ferrari Alessandra, PharmD, role: CONTACT, phone: +390382503689, email: alessandra.ferrari@smatteo.pv.it, contacts name: Simona De Gregori, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
|
protocolSection identificationModule nctId: NCT06338293, orgStudyIdInfo id: KY20240123-02, briefTitle: Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques, acronym: EItoCVP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Inclisiran sodium, interventions name: Rosuvastatin, outcomesModule primaryOutcomes measure: The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%), secondaryOutcomes measure: The change rate of TAV and plaque load of the target vascular lesion;, secondaryOutcomes measure: The change rate of lipid composition of plaque: including the lipid volume, the maximum area and angle of lipid, the length of vulnerable plaque, etc., secondaryOutcomes measure: The change rates of other components of plaque (fiber, calcification, crystal, macrophage), secondaryOutcomes measure: The change rates of lesion OFR and target vessel OFR, secondaryOutcomes measure: The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338280, orgStudyIdInfo id: VDW002, briefTitle: Remotely Observed Methadone Evaluation II, acronym: ROME II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sonara Health, class: INDUSTRY, descriptionModule briefSummary: Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Sonara, outcomesModule primaryOutcomes measure: Retention, primaryOutcomes measure: Take homes received over time, secondaryOutcomes measure: Opioid cravings, secondaryOutcomes measure: Urine toxicology, secondaryOutcomes measure: Opioid withdrawal severity, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Drug Abuse Treatment Costs Analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06338267, orgStudyIdInfo id: SENS-102-RSRT, briefTitle: Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking, acronym: VIBRANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Rett Syndrome Research Trust, class: OTHER, descriptionModule briefSummary: The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in the use of these devices in clinical trials. VIBRANT will use several FDA-cleared wearable biosensors and a non-wearable device to collect symptom data from patients with Rett syndrome for up to 9 weeks. Symptoms of interest include heart rate, breathing, sleep, blood oxygen levels, and movement. Participants will use the biosensors intermittently at home, document device use and symptom status, and will come to the clinic for 1 overnight sleep study. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.The study will provide information on the feasibility and ease of use for families at home, biosensor data will be compared to data collected at the same time from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome, and Emerald will be developed to include movement as a measurable symptom., conditionsModule conditions: Rett Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assess breathing rate and apnea (breath holds) with RespiraSense, primaryOutcomes measure: Assess heart rate variability with Vivalink VV330 ECG patch, primaryOutcomes measure: Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring, primaryOutcomes measure: Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG, primaryOutcomes measure: Validate ECG-derived breathing compared to in-lab PSG, primaryOutcomes measure: Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG, primaryOutcomes measure: Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter, primaryOutcomes measure: Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG, primaryOutcomes measure: Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator, primaryOutcomes measure: Develop Emerald ability to measure daytime movement, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: Pallavi Patawi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: David Lieberman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Baylor College of Medicine, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: Bernhard Suter, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
|
protocolSection identificationModule nctId: NCT06338254, orgStudyIdInfo id: E-10840098-772.02-5416, briefTitle: Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-04, primaryCompletionDateStruct date: 2023-06-04, completionDateStruct date: 2023-06-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women., conditionsModule conditions: Pregnancy Complications, conditions: Edema Leg, conditions: Physiotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The participants are blinded., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: percussion massage therapy, outcomesModule primaryOutcomes measure: The Visual Analog Scale (VAS), primaryOutcomes measure: Evaluation of edema, primaryOutcomes measure: Fatigue Severity Scale (FSS), primaryOutcomes measure: Short Form-36 (SF-36), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06338241, orgStudyIdInfo id: CPP2021-008391, briefTitle: Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model, acronym: Galibone, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2025-06-02, completionDateStruct date: 2025-09-02, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mario Pérez Sayáns, class: OTHER, collaborators name: Universidad de Murcia, descriptionModule briefSummary: The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars., conditionsModule conditions: Bone Loss, conditions: Regenerative Inflammation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin, interventions name: Bovine Hydroxyapatite, outcomesModule primaryOutcomes measure: Bone Regeneration_Reduction in radiolucent volume, primaryOutcomes measure: Bone Regeneration_bone volume, primaryOutcomes measure: Bone Regeneration_bone density, primaryOutcomes measure: Bone Regeneration_Fractal dimension, secondaryOutcomes measure: Pain levels through visual analog scale, secondaryOutcomes measure: Clinical Inflammation evaluating by presence/absence, secondaryOutcomes measure: Healing measured by healing index, secondaryOutcomes measure: Post-surgical complications evaluated by presence or absense, secondaryOutcomes measure: Oral Health-related Quality of Life measured by OHIP-14 test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry of Universidade de Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15705, country: Spain, contacts name: MARIO PEREZ SAYANS GARCIA, PHD, PHD, role: CONTACT, email: mario.perez@usc.es, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Faculty of Dentistry University of Murcia, status: RECRUITING, city: Murcia, country: Spain, contacts name: FABIO CAMACHO ALONSO, PHD, role: CONTACT, email: fcamacho@um.es, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
|
protocolSection identificationModule nctId: NCT06338228, orgStudyIdInfo id: 2023-A02458-37, briefTitle: A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study, acronym: FANAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients...). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitationsThe lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center., conditionsModule conditions: Management of Acetabular Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital, secondaryOutcomes measure: Define the prognostic factors associated with poor clinical outcomes and total hip replacement surgery, secondaryOutcomes measure: Compare clinical and radiological findings with the literature, secondaryOutcomes measure: Compare clinical and radiological findings with the literature, secondaryOutcomes measure: Compare clinical and radiological findings with the literature, secondaryOutcomes measure: Compare clinical and radiological findings with the literature, secondaryOutcomes measure: Compare clinical and radiological findings with the literature, secondaryOutcomes measure: Propose a new assessment of the traumatic hip joint based on PROMs (Patient Reported Outcomes Measures) via a dedicated digital application (Orthense by Digikare), secondaryOutcomes measure: Evaluation of Outcomes and Complications of Early Weight Bearing in Older Adults, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grenoble Alpes University Hospital,La tronche, status: RECRUITING, city: Grenoble, zip: 38700, country: France, contacts name: Sarah, Pharm D, role: CONTACT, phone: 0033 4 76 76 75 24, email: SUneisi@chu-grenoble.fr, contacts name: Mehdi BOUDISSA, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False
|
protocolSection identificationModule nctId: NCT06338215, orgStudyIdInfo id: UNATI_2024, secondaryIdInfos id: 101097681, type: OTHER_GRANT, domain: European Research Council, briefTitle: Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality, acronym: UNATI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases., conditionsModule conditions: All Cause Mortality, conditions: Cardiovascular Diseases, conditions: Invasive Cancer, conditions: Liver Cirrhosis, conditions: Type 2 Diabetes, conditions: Depression, conditions: Dementia, conditions: Injury Traumatic, conditions: Tuberculosis, conditions: Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Moderate Alcohol Drinking Pattern, interventions name: Abstention, outcomesModule primaryOutcomes measure: Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases, secondaryOutcomes measure: Comparison between groups of the incidence of the most severe outcomes, otherOutcomes measure: Comparison between groups of invasive cancer incidence with extended follow-up, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Navarra, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Estíbaliz Goñi, Nutritionist, role: CONTACT, phone: 34948425600, phoneExt: 80-6596, email: egonioch@unav.es, contacts name: Rafael Perez-Araluce, PharmD, role: CONTACT, phone: +34948425600, phoneExt: 80-6672, email: rperez.21@alumni.unav.es, contacts name: Miguel A Martinez-Gonzalez, MD, MPH, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False
|
protocolSection identificationModule nctId: NCT06338202, orgStudyIdInfo id: CV027-1137, briefTitle: Real-World Effectiveness of Mavacamten in Canada, acronym: MAVEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada., conditionsModule conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mavacamten, outcomesModule primaryOutcomes measure: Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation, secondaryOutcomes measure: Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation, secondaryOutcomes measure: Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation, secondaryOutcomes measure: Age, secondaryOutcomes measure: Sex at birth, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Employment status, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Obstructive hypertrophic cardiomyopathy (oHCM) disease duration, secondaryOutcomes measure: Proportion of patients in each New York Heart Association (NYHA) functional class II and III, secondaryOutcomes measure: Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient, secondaryOutcomes measure: Left ventricular ejection fraction by 2D echocardiogram (LVEFb), secondaryOutcomes measure: Mavacamten dose regimen, secondaryOutcomes measure: Proportion of patients who discontinued mavacamten, secondaryOutcomes measure: Duration of treatment prior to mavacamten discontinuation, secondaryOutcomes measure: Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation, secondaryOutcomes measure: Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation, secondaryOutcomes measure: Reason for discontinuing mavacamten treatment, secondaryOutcomes measure: Functional assessment schedule, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Science Centre (LHSC), city: London, state: Ontario, zip: N6A 5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False
|
protocolSection identificationModule nctId: NCT06338189, orgStudyIdInfo id: USuffolk, briefTitle: The 5Ad Diet for Functional Bowel Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Suffolk, class: OTHER, descriptionModule briefSummary: The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.The primary aims of this RCT are to determine:* Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.* Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation., conditionsModule conditions: Functional Bowel Disorder, conditions: Irritable Bowel Syndrome, conditions: Food Intolerance, conditions: Food Intolerance Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: The 5Ad Diet, interventions name: The Low FODMAP Diet, outcomesModule primaryOutcomes measure: Abdominal Pain, primaryOutcomes measure: Abdominal Bloating, primaryOutcomes measure: Flatulence, primaryOutcomes measure: Bowel Urgency, primaryOutcomes measure: Straining, primaryOutcomes measure: Incomplete Defecation, primaryOutcomes measure: Stool Form, primaryOutcomes measure: Frequency of defecation, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Mental Fatigue, secondaryOutcomes measure: Physical Fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Suffolk, status: RECRUITING, city: Ipswich, state: Suffolk, zip: IP4 1QJ, country: United Kingdom, contacts name: Camilla Bunn, role: CONTACT, phone: +44 1473 338332, email: c.bunn2@uos.ac.uk, contacts name: Dr Fandi Ibrahim, role: CONTACT, phone: +44 1473 338623, email: f.ibrahim@uos.ac.uk, contacts name: Camilla Bunn, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr Fandi Ibrahim, role: SUB_INVESTIGATOR, contacts name: Dr Federica Masieri, role: SUB_INVESTIGATOR, contacts name: Martin Sinclair, role: SUB_INVESTIGATOR, geoPoint lat: 52.05917, lon: 1.15545, hasResults: False
|
protocolSection identificationModule nctId: NCT06338176, orgStudyIdInfo id: Pro00128904, briefTitle: Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, collaborators name: Alberta Health services, descriptionModule briefSummary: Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system., conditionsModule conditions: Staph Aureus Bacteremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: OPTIMUS-SAB clinical care pathway, outcomesModule primaryOutcomes measure: Adherence to quality-of-care indicators, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Hospital re-admission rates, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: In hospital mortality, secondaryOutcomes measure: Costing evaluation, secondaryOutcomes measure: Implementation evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06338163, orgStudyIdInfo id: POSSIBLE 1.6, briefTitle: Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery, acronym: POSSIBLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Marco Catarci, class: OTHER, collaborators name: Associazione Chirurghi Ospedalieri Italiani, descriptionModule briefSummary: This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center., conditionsModule conditions: Surgical Site Infection, conditions: Surgical Procedures, Operative, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled prospective multicenter, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessor of the primary outcome will be masked concerning arm allocation, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Polihexanide-based bundle, interventions name: Standard bundle, outcomesModule primaryOutcomes measure: Surgical Site Infections rate, primaryOutcomes measure: Incisional (superficial and deep) Surgical Site Infections rate, primaryOutcomes measure: Infectious morbidity rates, secondaryOutcomes measure: Anastomotic leakage rates, secondaryOutcomes measure: Overall morbidity rates, secondaryOutcomes measure: Major morbidity rates, secondaryOutcomes measure: Comprehensive complication index, secondaryOutcomes measure: Overall length of postoperative hospital stay, secondaryOutcomes measure: Readmission rates, otherOutcomes measure: Patient-reported outcome measures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OSpedale Santa Maria Annunziata, city: Firenze, state: FI, zip: 50012, country: Italy, contacts name: Marco Scatizzi, MD, role: CONTACT, phone: 393474137246, email: marcoscatizzi@gmail.com, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Civile di Macerata, city: Macerata, state: MC, zip: 62100, country: Italy, contacts name: Massimo Sartelli, MD, role: CONTACT, phone: +393405369701, email: massimosartelli@gmail.com, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Ospedale Sandro Pertini, city: Roma, state: RM, zip: 00157, country: Italy, contacts name: Marco Catarci, MD, role: CONTACT, phone: +393298610040, email: marco.catarci@aslroma2.it, contacts name: Michele Benedetti, MD, role: SUB_INVESTIGATOR, contacts name: Paolo Ciano, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06338150, orgStudyIdInfo id: STUDY-23-00503, secondaryIdInfos id: GCO 19-0175, type: OTHER_GRANT, domain: Icahn School of Medicine at Mount Sinai, secondaryIdInfos id: 5R01CA244899, type: NIH, link: https://reporter.nih.gov/quickSearch/5R01CA244899, briefTitle: Precision Medicine Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (n=100). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis, de-identified samples or data may be sent out to third parties for additional analysis. The study will be using GenPath, a division of BioReference® Health, LLC for this project which is a CLIA certified lab. All genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians and patients. Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the participant and treating physician during a follow-up results session and any findings obtained explained. This study is not intended to implement findings, only to report them., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Total number of somatic Single-nucleotide variants (SNVs) per patient, secondaryOutcomes measure: Total number of somatic insertions (INS) per patient, secondaryOutcomes measure: Total number of somatic deletions (DEL) per patient, secondaryOutcomes measure: Number of SNVs per megabase of the MM genome, secondaryOutcomes measure: Number of INS per megabase of the MM genome, secondaryOutcomes measure: Number of DEL per megabase of the MM genome, secondaryOutcomes measure: Number of mutations per megabase among MM subgroups, secondaryOutcomes measure: Number of mutations per megabase among genomic regions for all MM and mutational subgroups, secondaryOutcomes measure: Gene mutations identified, secondaryOutcomes measure: Chromosomal abnormalities identified, secondaryOutcomes measure: Molecular signatures identified, secondaryOutcomes measure: Established Prognostic markers identified, secondaryOutcomes measure: Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data), secondaryOutcomes measure: Network-informed key driver variants identified, secondaryOutcomes measure: Transcriptome variations identified, secondaryOutcomes measure: Germline mutations identified in cancer predisposition genes, secondaryOutcomes measure: FDA approved drugs available that block enzymes produced in those pathways identified, secondaryOutcomes measure: Treatment recommended by computational pipeline based on patient's clinical and genetic, secondaryOutcomes measure: Germline whole exome sequencing profile, secondaryOutcomes measure: Tumor genome whole exome sequencing profile, secondaryOutcomes measure: Tumor transcriptome profile, secondaryOutcomes measure: Single-cell sequencing profile, secondaryOutcomes measure: Cytometric profile, secondaryOutcomes measure: Signaling Pathways associated, secondaryOutcomes measure: Enzymes associated with each signaling pathway identified, secondaryOutcomes measure: Improvement of cancer sequencing-guided treatment recommendations by machine learning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Health System, city: New York, state: New York, zip: 10029, country: United States, contacts name: Cesar Rodriguez Valdes, MD, PhD, role: CONTACT, email: Cesar.Rodriguez@mssm.edu, contacts name: Katherine Vandris, role: CONTACT, email: Katherine.Vandris@mssm.edu, contacts name: Cesar Rodriguez Valdes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06338137, orgStudyIdInfo id: 4-2024urol, briefTitle: Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-25, primaryCompletionDateStruct date: 2023-08-25, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, descriptionModule briefSummary: Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy., conditionsModule conditions: Renal Stone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Holmium Yag laser, outcomesModule primaryOutcomes measure: Stone free rates, secondaryOutcomes measure: Preoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hossam Kandeel, city: Shibīn Al Kawm, state: State Or Province, zip: 32511, country: Egypt, geoPoint lat: 30.55258, lon: 31.00904, hasResults: False
|
protocolSection identificationModule nctId: NCT06338124, orgStudyIdInfo id: David Ibrahim, briefTitle: Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG), Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels ., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Triglyceride glucose index, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assuit University Hospital, city: Assiut, country: Egypt, contacts name: Dina Hamad, Assist.Prof, role: CONTACT, phone: +201063040703, email: dinaalihamad@yahoo.com, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
|
protocolSection identificationModule nctId: NCT06338111, orgStudyIdInfo id: 2461, briefTitle: Interventions Meant to Improve the Outcome of Critical Care Patients in the ED, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-09, primaryCompletionDateStruct date: 2022-12-06, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Iuliu Hatieganu University of Medicine and Pharmacy, class: OTHER, descriptionModule briefSummary: This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department., conditionsModule conditions: Sepsis Syndrome, conditions: Emergency Department, conditions: Biomarker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 67, type: ACTUAL, armsInterventionsModule interventions name: ELISA Sepsis Biomarkers dosage, outcomesModule primaryOutcomes measure: Can we better predict mortality in septic patients from the Emergency Department?, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cluj County Hospital Emergency Department, city: Cluj-Napoca, state: Cluj, zip: 400006, country: Romania, geoPoint lat: 46.76667, lon: 23.6, hasResults: False
|
protocolSection identificationModule nctId: NCT06338098, orgStudyIdInfo id: HFNVSH.001, briefTitle: Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-28, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2023-10-02, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Heartfulness Institute, class: OTHER, collaborators name: Angell Animal Medical Center, descriptionModule briefSummary: This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout., conditionsModule conditions: Stress, conditions: Burnout, Professional, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: 8-week wellness and relaxation meditation program, outcomesModule primaryOutcomes measure: Assess the current level of Anxiety, primaryOutcomes measure: Changes level of Stress, primaryOutcomes measure: Assess the current level of Burnout, primaryOutcomes measure: Changes level of Burnout, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Angell Animal Medical Center,, city: Boston, state: Massachusetts, zip: 02130, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06338085, orgStudyIdInfo id: meryemvrlshn00000000002, briefTitle: The Effect of Emotional Freedom Technique (EFT) on Depression in Postmenopausal Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-05-04, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Meryem Vural Şahin, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care., conditionsModule conditions: Menopause, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: the groups with a conventional therapy control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: emotional liberation technique, outcomesModule primaryOutcomes measure: Beck Depression Scale, secondaryOutcomes measure: Menopause Rating Scale (MRS), eligibilityModule sex: FEMALE, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: family health center no. 1 in Çayyolu, status: RECRUITING, city: Ankara, state: Çankaya, country: Turkey, contacts name: MERYEM VURAL ŞAHİN, role: CONTACT, phone: 05535344779, email: meryemyasam@gmail.com, contacts name: Meltem UĞURLU, role: PRINCIPAL_INVESTIGATOR, contacts name: Derya Yüksel KOÇAK, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06338072, orgStudyIdInfo id: DIABETEXX/1, briefTitle: Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1)., acronym: DIABETEXX/1, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, class: OTHER, collaborators name: Universitat Politècnica de València, descriptionModule briefSummary: The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control., conditionsModule conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 119, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Time in range, secondaryOutcomes measure: Time below range, secondaryOutcomes measure: Time above range, secondaryOutcomes measure: Caloric intake, secondaryOutcomes measure: Temperature, secondaryOutcomes measure: Photoplethysmography, secondaryOutcomes measure: Accelerometry, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lía Nattero-Chávez, city: Madrid, zip: 28034, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.