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The primary outcome will measure the proportion of patients achieving favorable functional outcomes (modified Rankin Scale 0-2) at 90 days. Secondary outcomes include the impact of Cerebrolysin on secondary hemorrhagic transformation, brain edema, mortality rates, and quality of life. The study aims to provide comprehensive data on the benefits of adding Cerebrolysin to the standard post-MT care, focusing on its potential to protect against reperfusion injuries and maintain blood-brain barrier integrity.
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Conclusion:
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By evaluating the role of Cerebrolysin in conjunction with MT, this study aims to extend the therapeutic window for AIS treatment, offering hope for improved outcomes for patients who would otherwise be ineligible for current reperfusion therapies. The findings may pave the way for new guidelines in stroke management, emphasizing the importance of integrated care approaches in enhancing patient recovery. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Cerebrolysin measure: Functional Recovery and Complication Rates Post-Thrombectomy measure: Imaging and High cortical Functional Assessment Endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339398 id: 002-2023 briefTitle: To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study acronym: METEX-PD overallStatus: ENROLLING_BY_INVITATION date: 2024-05 date: 2025-12-31 date: 2028-05-31 date: 2024-04-01 date: 2024-04-01 name: Casa di Cura San Raffaele Cassino class: NETWORK name: IRCCS San Raffaele Roma name: San Raffaele Telematic University name: University of Rome Tor Vergata name: University of Urbino "Carlo Bo" briefSummary: This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients.
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Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week).
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The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Aerobic exercise measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin measure: Change in peripheral biomarker of inflammation measure: Change in peripheral biomarker of inflammation measure: Change in peripheral biomarker of inflammation measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples measure: Change in blood lactate levels assessed using finger-stick capillary blood samples measure: Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part II measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part III measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in motor symptoms - MDS-UPDRS part IV measure: Change in movement analysis - stride length measure: Change in movement analysis - stride length measure: Change in movement analysis - stride length measure: Change in movement analysis - cadence measure: Change in movement analysis - cadence measure: Change in movement analysis - cadence measure: Change in movement analysis - propulsion measure: Change in movement analysis - propulsion measure: Change in movement analysis - propulsion measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in movement analysis - Time Up and Go (TUG) measure: Change in walking capacity measure: Change in walking capacity measure: Change in walking capacity measure: Change in postural instability measure: Change in postural instability measure: Change in postural instability measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA) measure: Change in cognitive function - Mini-Mental Examination (MMSE) measure: Change in cognitive function measure: Change in cognitive function measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in cognitive function - Frontal Assessment Battery (FAB) measure: Change in severity of depressive symptomatology measure: Change in severity of depressive symptomatology measure: Change in severity of depressive symptomatology measure: Change in non-motor symptoms measure: Change in non-motor symptoms measure: Change in non-motor symptoms measure: Change in motor fluctuations measure: Change in motor fluctuations measure: Change in motor fluctuations measure: Change in quality of life measure: Change in quality of life measure: Change in quality of life measure: Change in cortical activity measure: Change in cortical activity measure: Change in Brain Connectivity measure: Change in Brain Connectivity sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Raffaele Cassino city: Cassino state: Frosinone zip: 03043 country: Italy lat: 41.48581 lon: 13.82835 hasResults: False
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<|newrecord|> nctId: NCT06339385 id: KY 2020-153-02 briefTitle: Management of PADIS in Emergency Intensive Care Unit overallStatus: COMPLETED date: 2021-06-13 date: 2021-08-12 date: 2021-08-12 date: 2024-04-01 date: 2024-04-02 name: Capital Medical University class: OTHER name: Beijing Tiantan Hospital name: The First Affiliated Hospital of Anhui Medical University name: The First Affiliated Hospital of Dalian Medical University name: Fudan University name: Affiliated hospital of Guilin medical university,China name: The Second Affiliated Hospital of Hainan Medical University name: The First Hospital of Hebei Medical University name: The First Hospital of Jilin University name: Southwest Hospital, China name: General hospital of shenyang military command name: Beijing Anzhen Hospital name: Mianyang Central Hospital name: Tianjin Medical University General Hospital name: The First Affiliated Hospital of Zhengzhou University name: The Jiangxi Provincial People's Hospital briefSummary: Investigate the prevalence of PADIS in EICU, as well as the awareness and clinical implementation status of medical staff towards PADIS.
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The investigators conducted a multicenter cross-sectional survey in mainland China, including a one-day point prevalence investigation and a questionnaire survey. The inclusion criteria encompassed all adult patients admitted to the participating emergency department intensive care units (EDICUs) during the on-site screening, while exclusion criteria comprised patients aged less than 18 years, EDICU stays duration less than 24 hours before the screening, and participation in other concurrent trials. Hospital and nursing records from the 24 hours preceding enrollment were examined to document the assessment rate of pain, agitation-sedation, and delirium. Physicians and nurses on duty 24 hours before the patients\' enrollment was invited to complete the questionnaire survey regarding the ICU profiles, professional expertise, assessment and treatment of PAD, early mobilization, and sleep improvement practices. conditions: Pain conditions: Agitation, Emergence conditions: Delirium conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 162 type: ACTUAL name: PADIS assessment measure: PADIS assessment rate measure: Rates of analgesic and sedative administration measure: Rate of accidental removal of the catheter during the EICU stay measure: EDICU length of stay measure: The hospital length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan hospital city: Beijing state: Beijing zip: 100070 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06339372 id: AP1912-30102 briefTitle: Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours overallStatus: COMPLETED date: 2023-02-01 date: 2023-08-01 date: 2023-08-01 date: 2024-04-01 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia. conditions: Immunonutrition conditions: Surgical Outcome conditions: Pain conditions: Oral Cavity conditions: Mandibular Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 176 type: ACTUAL name: Standard feeding name: Omega 3 and dipeptiven measure: The incidence of wound infection measure: Fistula formation measure: Length of hospital stay measure: Total dose of intraoperative opioids measure: Total dose of postoperative opioids measure: Degree of pain measure: The incidence of mortality measure: The incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo University city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06339359 id: 2024-02-014 briefTitle: A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-01 date: 2024-04-01 name: Bundang CHA Hospital class: OTHER 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. conditions: ASD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments measure: K-BSID-Ⅲ measure: ADI-R measure: M-CHAT measure: ADOS-2 measure: K-WPPSI-Ⅳ measure: K-CARS-2 measure: CBCL measure: SCQ measure: GMFM measure: HFT measure: BOT-2 measure: VMI-6 measure: SP measure: Eye Tracking measure: Motion Analysis sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: CHA Bundang Medical Center, CHA University status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 463-712 country: Korea, Republic of name: Minyoung Kim, M.D., Ph.D. role: CONTACT phone: 82-31-780-1872 email: kmin@cha.ac.kr lat: 37.43861 lon: 127.13778 hasResults: False
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<|newrecord|> nctId: NCT06339346 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 overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-01 date: 2024-04-01 name: University Hospital, Brest class: OTHER briefSummary: Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.
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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.
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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.
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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. conditions: Colorectal Cancer conditions: Colorectal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Analysis of lymph node invasion rates as a function of tumor characteristics measure: Population demographics measure: lesion characteristics measure: management measure: recurrence measure: survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False
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<|newrecord|> nctId: NCT06339333 id: RRECB0523EC briefTitle: Evaluation of ACT Now GAIN Later overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-01 date: 2024-04-01 name: University College Dublin class: OTHER 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)
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The main questions it aims to answer are:
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Primary Objectives
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1. 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.
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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.
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Secondary Objectives
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1. 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.
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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.
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3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.
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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. conditions: Psychological Flexibility conditions: Child Behavior conditions: Relationship, Parent Child conditions: Well-Being, Psychological conditions: Self-efficacy studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: ACT Now GAIN Later name: Control Group measure: Parental Psychological Flexibility measure: Child Behaviour measure: Parent-Child Relationships measure: Parental Well-Being measure: Parental Self-Efficacy measure: Parental Self-Efficacy sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06339320 id: PRO00037835 briefTitle: Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity overallStatus: RECRUITING date: 2024-02-28 date: 2033-10 date: 2033-10 date: 2024-04-01 date: 2024-04-01 name: The Methodist Hospital Research Institute class: OTHER 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). conditions: Endoscopic Sleeve Gastroplasty conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Retrospective Registry Study primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Endoscopic Sleeve Gastroplasty (ESG) name: Apollo OverStitch endoscopic suturing device measure: Number of participants with technically successful completion of the ESG procedure measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Change in body mass index (BMI) measured by kg/m2 measure: Change in hemoglobin A1C (%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Thomas R McCarty, MD, MPH role: CONTACT phone: 713-363-7436 email: tommccarty3@houstonmethodist.org lat: 29.76328 lon: -95.36327 facility: Houston Methodist Hospital - Sugarland status: RECRUITING city: Sugar Land state: Texas zip: 77479 country: United States name: Thomas R McCarty, MD, MPH role: CONTACT phone: 713-363-7436 email: tommccarty3@houstonmethodist.org lat: 29.61968 lon: -95.63495 hasResults: False
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<|newrecord|> nctId: NCT06339307 id: DJY004 briefTitle: A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-12-31 date: 2024-04-01 date: 2024-04-01 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER 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. conditions: Predictive Cancer Model conditions: Gastric Cancer conditions: Lymph Node Metastasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: lymph node metastasis sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital of Tianjin Medical University status: RECRUITING city: Tianjin state: Tianjin country: China name: Jingyu Deng, M.D. role: CONTACT phone: +86-22-23340123 email: dengery@126.com lat: 39.14222 lon: 117.17667 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 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 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
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<|newrecord|> nctId: NCT06339294 id: ZShabbir briefTitle: Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment overallStatus: COMPLETED date: 2023-06-16 date: 2023-12-15 date: 2023-12-31 date: 2024-04-01 date: 2024-04-01 name: Rawalpindi Medical College class: OTHER briefSummary: Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.
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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. conditions: Otomycosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ACTUAL name: Clotrimazole Cream name: Povidone-Iodine measure: Treatment Response Based on Otoscopy measure: Condition of External Auditory Canal sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Benazir Bhutto Hospital city: Rawalpindi state: Punjab/46000 zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 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 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
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<|newrecord|> nctId: NCT06339281 id: 2023YJZ87 briefTitle: A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06 date: 2026-12 date: 2024-04-01 date: 2024-04-19 name: Li Huiping class: OTHER 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. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: apatinib mesylate+Capecitabine Tablets name: apatinib mesylate+Fulvestrant injection measure: Progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339268 id: MMABelgrade briefTitle: Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection acronym: COGNITION overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2026-03-01 date: 2024-04-01 date: 2024-04-01 name: Military Medical Academy, Belgrade, Serbia class: OTHER 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.
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Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasingly
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undergoing lung resection. These complications can affect the outcome and speed of postoperative recovery. conditions: Prehabilitation studyType: INTERVENTIONAL phases: NA 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:
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1. The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
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2. The second group (control) where patients receive standard treatment. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Cognitive training, CogniFit App measure: Postoperative cognitive dysfunction measure: Perioperative depression and anxiety measure: Postoperative delirium measure: Functional status and postoperative recovery measure: Functional status and postoperative recovery measure: Postoperative recovery measure: Functional status and postoperative recovery measure: Overall outcome: Complication rate measure: Overall outcome: Morbidity measure: Overall outcome: Mortality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Medical Academy status: RECRUITING city: Belgrade zip: 11000 country: Serbia name: Vojislava Neskovic, PhD role: CONTACT phone: +381 64 1775 320 email: vojkan43@gmail.com name: Marija Markovic, MD role: CONTACT phone: +381 62 666653 email: markovicmarija@hotmail.com lat: 44.80401 lon: 20.46513 hasResults: False
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<|newrecord|> nctId: NCT06339255 id: INT 180/19 briefTitle: Italian Observational Study on CAR-T Therapy for Lymphoma acronym: CART-SIE overallStatus: RECRUITING date: 2019-10-30 date: 2028-12-31 date: 2029-12-31 date: 2024-04-01 date: 2024-04-01 name: Paolo Corradini class: OTHER name: Annalisa Chiappella name: Cristiana Carniti name: Anna Dodero 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.
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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. conditions: Diffuse Low Grade B-Cell Lymphoma conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL) conditions: Mantle Cell Lymphoma conditions: Follicular Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5300 type: ESTIMATED measure: Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice measure: Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice measure: Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria. measure: Evaluation of Outcome: Overall survival (OS), according to Lugano criteria. measure: Evaluation of Outcome: Progression free survival (PFS) measure: Evaluation of Outcome: duration of response (DoR) measure: Evaluation of Outcome: Overall Response rate (ORR) measure: Evaluation of Outcome: Overall survival (OS) measure: Evaluation of Outcome: non-relapse mortality (NRM) measure: Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications measure: Evaluation of bridging therapy: safety measure: Evaluation of bridging therapy: efficay measure: Evaluation of salvage therapy after CAR-T failure measure: Evaluation of salvage therapy after CAR-T failure measure: Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety) measure: Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products measure: Characterization of biomarkers of early response (circulating tumor cell free DNA versus PET and CT scans) measure: Characterization of toxicity biomarkers measure: Analysis of the immune reconstitution measure: Analysis of the CAR-T expression measure: Influence of PET quantitative parameters: tMTV changes between baseline and +30 and +90 after CAR T-cell infusion (ΔSUV max) related to outcome measure: Influence of PET quantitative parameters: Distance max measure: Influence of PET quantitative parameters: Distance max bulky sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale Tumori status: RECRUITING city: Milan zip: 20133 country: Italy name: Paolo Corradini, Professor role: CONTACT phone: +39 02 2390 2950 email: paolo.corradini@istitutotumori.mi.it name: Anisa Bermema, PhD role: CONTACT phone: +39 02 2390 3145 email: anisa.bermema@istitutotumori.mi.it name: Annalisa Chiappella, MD role: SUB_INVESTIGATOR name: Anna Dodero, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06339242 id: 2024-01-NSCLC briefTitle: A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis overallStatus: RECRUITING date: 2024-01-01 date: 2025-07-01 date: 2026-01-31 date: 2024-04-01 date: 2024-04-01 name: Jiangsu Province Nanjing Brain Hospital class: OTHER 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. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Furmonertinib measure: LM-PFS（progression-free survival） measure: LM-ORR（Objective response rate） measure: LM-OS measure: Incidence of Treatment-Emergent Adverse Events measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Brain Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: fang S Cun role: CONTACT phone: 83728558 phoneExt: 025 email: fang1984@aliyun.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06339229 id: FSYYY-2024-12 briefTitle: Postoperative New-onset Proteinuria and Adverse Outcomes. overallStatus: COMPLETED date: 2000-01-01 date: 2022-12-31 date: 2023-11-01 date: 2024-04-01 date: 2024-04-01 name: Yaozhong Kong class: OTHER 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. conditions: Surgery conditions: Proteinuria conditions: Mortality studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2983899 type: ACTUAL name: proteinuria measure: mortality sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339216 id: OBU-BJ-GC-II-011 briefTitle: A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-30 date: 2026-11-30 date: 2024-04-01 date: 2024-04-01 name: Chinese PLA General Hospital class: OTHER 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 conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound) measure: ORR measure: PFS measure: DCR measure: OS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339203 id: 5240002 briefTitle: Intraoperative Wound Irrigation in Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-01 date: 2024-04-01 name: Loma Linda University class: OTHER name: Irrimax Corporation 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. conditions: Cesarean Section Complications conditions: Cesarean Section; Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Irrisept name: Normal Saline measure: Composite wound evaluation after caesarean delivery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University city: Loma Linda state: California zip: 92354 country: United States name: Nikia Gray Hutto, AS role: CONTACT phone: 909-558-4000 phoneExt: 44428 email: nhutto@llu.edu lat: 34.04835 lon: -117.26115 hasResults: False
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<|newrecord|> nctId: NCT06339190 id: E21-006-72840 briefTitle: Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis acronym: NAVAIDD overallStatus: RECRUITING date: 2021-08-01 date: 2025-12 date: 2027-12 date: 2024-04-01 date: 2024-04-01 name: Monash University class: OTHER name: Eastern Health name: University of Melbourne name: Wake Forest University name: Deakin University name: The Florey Institute of Neuroscience and Mental Health name: Invitae Corporation name: Redenlab 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.
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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.
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Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample. conditions: Neurodegenerative Diseases conditions: Dementia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Venepuncture measure: Nfl correlation with neurodegeneration measure: Change in speech processing measure: Change in language processing measure: Change in Direct Magnitude Estimation measure: Modified Rankin Scale measure: Montreal Cognitive Assessment score measure: Hospital Anxiety and Depression Scale score measure: Clinical Global Impression score measure: WHO Disability Assessment 12-item telephone interview score measure: WHO Disability Assessment 36-item self report score measure: DNA sample for testing known pathogenic dementia mutations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Box Hill Hospital status: RECRUITING city: Box Hill state: Victoria zip: 3128 country: Australia name: Svetlana Ivanic role: CONTACT email: svetlana.ivanic@monash.edu lat: -37.81887 lon: 145.12545 facility: Wantirna Health status: RECRUITING city: Wantirna state: Victoria zip: 3152 country: Australia name: Sarah Shue role: CONTACT lat: -37.85 lon: 145.21667 hasResults: False
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<|newrecord|> nctId: NCT06339177 id: 10001899 id: 001899-I briefTitle: Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study overallStatus: RECRUITING date: 2024-05-01 date: 2030-10-01 date: 2031-04-01 date: 2024-04-01 date: 2024-04-26 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: Background:
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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.
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Objective:
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To learn about sHLH and why some people get it and others do not.
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Eligibility:
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Adults aged 18 years and older with sHLH.
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Design:
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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.
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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.
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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.
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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.... conditions: Lymphohistiocytosis, Hemophagocytic conditions: Secondary Hemophagocytic Lymphohistiocytosis conditions: Macrophage Activation Syndrome conditions: Hyperinflammatory Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions. measure: Prospectively define acute and longitudinal clinical profiles that predict key clinical outcomes. measure: Compare clinical and immune profiles between the classically defined HLH subgroups. measure: Improve the understanding of the pathogenesis of sHLH. measure: Characterize risk factors to identify populations at risk for developing sHLH. sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center status: RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06339164 id: ObGynEASC006 briefTitle: Breech Delivery Skills. Resident Learning Program acronym: Breech overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-06-30 date: 2024-04-01 date: 2024-04-01 name: G. d'Annunzio University class: OTHER 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 conditions: Breech Presentation; Before Labor studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: skills and learning quality in breech delivery measure: Skills capacities measure: Skills capacities measure: learning qualities sex: ALL minimumAge: 24 Years maximumAge: 38 Years stdAges: ADULT facility: Claudio Celentano city: Pescara state: PE zip: 65100 country: Italy lat: 42.4584 lon: 14.20283 hasResults: False
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<|newrecord|> nctId: NCT06339151 id: TUH multiple dexamethasone TKA briefTitle: Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA overallStatus: RECRUITING date: 2024-03-23 date: 2025-10-31 date: 2025-10-31 date: 2024-04-01 date: 2024-04-01 name: Thammasat University Hospital class: OTHER 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.
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The main question\[s\] it aims to answer \[is/are\]:
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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?
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Researchers will compare double dose of dexamethasone group to see if \[insert effects\].
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Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\]. conditions: Osteo Arthritis Knee conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Dexamethasone before surgery name: Dexamethasone before and 12 hours after surgery name: Dexamethasone before and 24 hours after surgery measure: Pain at rest and motion measure: Nausea and vomiting measure: Morphine consumption measure: Blood sugar level measure: CRP level measure: Range of motion measure: Length of hospital stay measure: Complication sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital status: RECRUITING city: Khlong Luang state: Pathum Thani zip: 12120 country: Thailand name: Yot Tanariyakul, M.D. role: CONTACT phone: 6683930257 email: y.tanariyakul@gmail.com name: Yot Tanariyakul, M.D. role: PRINCIPAL_INVESTIGATOR name: Piya Pinsornsak, M.D. role: PRINCIPAL_INVESTIGATOR lat: 14.06467 lon: 100.64578 hasResults: False
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<|newrecord|> nctId: NCT06339138 id: 17-010944 id: NCI-2024-00971 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) 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 overallStatus: RECRUITING date: 2018-02-20 date: 2027-01-31 date: 2027-01-31 date: 2024-04-01 date: 2024-04-01 name: Mayo Clinic class: OTHER 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. 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 874 type: ESTIMATED name: Non-Interventional Study measure: Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: John C. Cheville, M.D. role: PRINCIPAL_INVESTIGATOR name: John B. Kisiel, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06339125 id: 2023p003637 briefTitle: Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent Falls overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-04-01 date: 2024-04-01 name: Massachusetts General Hospital class: OTHER name: Crico name: Inspiren Inc name: RGI Informatics LLC 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. conditions: Falls and Falls With Injury studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 4500 type: ESTIMATED name: Fall prevention algorithm name: Inspiren camera visualization measure: Falls measure: Falls with injury measure: Nurse perceptions measure: Nurse perceptions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339112 id: 2024/10 briefTitle: The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Tarsus University class: OTHER 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. conditions: Fear conditions: Anxiety conditions: Inhalant Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled experimental study primaryPurpose: OTHER masking: NONE count: 114 type: ESTIMATED name: Playing with toy nebulizer name: Cartoon measure: fear measure: anxiety sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Tarsus State Hospital city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06339099 id: P.T.REC/012/002489 briefTitle: Loaded Gait Training on Gross Motor Function in Cerebral Palsy overallStatus: COMPLETED date: 2023-02-26 date: 2023-10-15 date: 2024-03-15 date: 2024-04-01 date: 2024-04-01 name: Cairo University class: OTHER 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. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Children were randomly assigned into two equal groups. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blinding. Parents were also blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: Conventional physical therapy program name: Loaded gait training measure: Gross motor function measure: knee extensor strength sex: ALL minimumAge: 5 Years maximumAge: 7 Years stdAges: CHILD facility: Faculty of Physical Therapy, Cairo University city: Giza state: Cairo zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06339086 id: BPR-201-I-III-01 briefTitle: Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08-30 date: 2025-12-30 date: 2024-04-01 date: 2024-04-01 name: Chengdu Brilliant Pharmaceutical Co., Ltd. class: INDUSTRY 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.
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Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.
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Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 478 type: ESTIMATED name: Semaglutide Injection name: Semaglutide Injection(Ozempic®) name: Metformin measure: Change in HbA1c measure: Change in HbA1c measure: Change in FPG measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% measure: Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event measure: Change in Body Weight measure: Proportion of participants with Weight Loss≥5%, ≥10% and ≥15% measure: Change in Diastolic and Systolic Blood Pressure measure: Changes in Blood Lipids measure: Incidence and severity of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339073 id: 2021NZKY-045-01 briefTitle: CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma overallStatus: COMPLETED date: 2023-10-01 date: 2023-12-15 date: 2024-02-05 date: 2024-04-01 date: 2024-04-01 name: Jinling Hospital, China class: OTHER 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. conditions: Wounds and Injuries conditions: Ventilation Therapy; Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1023 type: ACTUAL name: mechanical ventilation measure: Prolonged mechanical ventilation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the General Surgical Department of Jinling Hospital city: Nanjing state: Jiangsu zip: 210002 country: China lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06339060 id: RTS-022 briefTitle: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3). acronym: PALACE3 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-01 date: 2028-03-01 date: 2024-04-01 date: 2024-04-01 name: Ruijin Hospital class: OTHER 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).
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The 3-year overall survival rate is the primary outcome. conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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) count: 356 type: ESTIMATED name: Experimental: Arm 1 Organ preservation name: Active Comparator: Arm 2 Surgery measure: 3-year overall survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06339047 id: 2024/09 briefTitle: The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-01 date: 2024-12-01 date: 2024-04-01 date: 2024-04-01 name: Tarsus University class: OTHER briefSummary: The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.
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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.
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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. conditions: Anxiety and Fear conditions: Pain conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled experimental study primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Projector Kaleidoscope name: Cartoon measure: Anxiety measure: Fear measure: Pain after surgery sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Tarsus State Hospital city: Mersin country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06339034 id: STUDY briefTitle: Repurposing Lithium for Parkinson's Disease: a RCT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-10 date: 2024-04-01 date: 2024-04-01 name: State University of New York at Buffalo class: OTHER name: The Cure Parkinson's Trust 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. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Lithium name: Placebo measure: MRI-derived free water (FW) levels. measure: Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression measure: Serum neurofilament light chain (NfL) measure: PBMC superoxide dismutase type-1 (SOD-1) mRNA expression measure: PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio measure: PBMC pThr308 and pS473/total protein kinase B (Akt) ratios measure: Serum interleukin-6 measure: Serum glial fibrillary acidic protein (GFAP) measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) measure: Montreal Cognitive Assessment (MoCA) measure: Parkinson's Anxiety Scale measure: Geriatric Depression Scale-15 measure: Fatigue Severity Scale measure: Insomnia Severity Index measure: Parkinson's Disease Questionnaire-8 measure: Levodopa equivalent daily dose (LEDD) measure: Adverse events sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UBMD Neurology city: Williamsville state: New York zip: 14221 country: United States name: Thomas Guttuso, MD role: CONTACT phone: 716-932-6080 email: tguttuso@buffalo.edu name: Amelia Cheney role: CONTACT email: acheney4@buffalo.edu name: Thomas Guttuso, MD role: PRINCIPAL_INVESTIGATOR lat: 42.96395 lon: -78.73781 hasResults: False
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<|newrecord|> nctId: NCT06339021 id: DAPT-OCT briefTitle: OCT or Angiography Guided De-escalation of DAPT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-01 date: 2024-04-01 name: Shenyang Northern Hospital class: OTHER 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.
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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. conditions: Optical Coherence Tomography conditions: Dual Antiplatelet Therapy conditions: Antiplatelet De-escalation conditions: Neointimal Coverage conditions: ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: OCT-guided PCI name: Conventional angiography-based PCI name: DAPT de-escalation name: default DAPT regimen measure: Neointimal thickness after DES implantation measure: Major adverse cardiovascular and cerebrovascular events (MACCE) measure: BARC types 2-5 bleeding measure: In-stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Hospital city: Shenyang state: Liaoning country: China name: Yaling Han, Dr role: CONTACT phone: +86-24-28897313 email: cardiology@163.com name: Yaling Han, MD role: PRINCIPAL_INVESTIGATOR name: Yang Li, MD role: SUB_INVESTIGATOR name: Yi Li, MD role: SUB_INVESTIGATOR lat: 41.79222 lon: 123.43278 hasResults: False
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<|newrecord|> nctId: NCT06339008 id: 18789 id: J2T-MC-KGBT type: OTHER domain: Eli Lilly and Company 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) overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2025-05-30 date: 2026-05-01 date: 2024-04-01 date: 2024-04-15 name: Eli Lilly and Company class: INDUSTRY 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 conditions: Perennial Allergic Rhinitis (PAR) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 450 type: ESTIMATED name: LY3650150 name: Placebo name: Standard therapy for INCS measure: Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16 measure: Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16 measure: Mean CFBL in RQLQ(S) at week 56 measure: Mean CFBL in TNSS at Week 4 measure: Mean CFBL in TNSS at Week 56 measure: Mean CFBL in Postnasal drip score at Week 16 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern California Research city: California City state: California zip: 92691 country: United States role: CONTACT phone: 949-276-4917 name: Warner Carr role: PRINCIPAL_INVESTIGATOR lat: 35.1258 lon: -117.9859 facility: 310 Clinical Research city: Inglewood state: California zip: 90301 country: United States role: CONTACT phone: 310-878-2636 name: Soheil Hekmat role: PRINCIPAL_INVESTIGATOR lat: 33.96168 lon: -118.35313 facility: Allergy and Asthma city: San Diego state: California zip: 92123 country: United States role: CONTACT phone: 858-268-2368 phoneExt: 143 name: Bob Geng role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Asthma and Allergy Associates, PC city: Colorado Springs state: Colorado zip: 80907-6231 country: United States role: CONTACT phone: 719-473-8330 x5 name: Luke Webb role: PRINCIPAL_INVESTIGATOR lat: 38.83388 lon: -104.82136 facility: Florida Center For Allergy & Asthma Care Aventura city: Aventura state: Florida zip: 33180 country: United States role: CONTACT phone: 305-931-7583 name: Jaime Landman role: PRINCIPAL_INVESTIGATOR lat: 25.95648 lon: -80.13921 facility: Bluegrass Allergy Research city: Lexington state: Kentucky zip: 40509 country: United States role: CONTACT phone: 859-303-7191 name: William Greisner role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: Allergy, Asthma & Sinus Center city: Greenfield state: Massachusetts zip: 53228 country: United States role: CONTACT phone: 414-529-8519 name: Gary Steven role: PRINCIPAL_INVESTIGATOR lat: 42.58759 lon: -72.59953 facility: Respiratory Medicine Research Institute of Michigan, PLC city: Ypsilanti state: Michigan zip: 48197 country: United States role: CONTACT phone: 734-528-0477 name: Jeffrey Leflein role: PRINCIPAL_INVESTIGATOR lat: 42.24115 lon: -83.61299 facility: Clinical Research Institute city: Minneapolis state: Minnesota zip: 55402 country: United States role: CONTACT phone: 612-333-2200 phoneExt: 378 name: Gary Berman role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Allergy and Asthma Consultants city: Saint Louis state: Missouri zip: 63141 country: United States role: CONTACT phone: 314-991-5117 name: Robert Onder role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Dr. Patrick Perin city: Teaneck state: New Jersey zip: 07666 country: United States name: Patrick Perin role: PRINCIPAL_INVESTIGATOR lat: 40.8976 lon: -74.01597 facility: Bernstein Clinical Research Center, LLC city: Cincinnati state: Ohio zip: 45236 country: United States role: CONTACT phone: 314-991-5117 name: David Bernstein role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Northwest Research Center city: Portland state: Oregon zip: 97202 country: United States role: CONTACT phone: 503-238-6233 name: Anthony Montanaro role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Allergy and Clinical Immunology Associates city: Pittsburgh state: Pennsylvania zip: 15241 country: United States role: CONTACT phone: 412-833-4051 phoneExt: 116 name: Michael Palumbo role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Kerrville Allergy and Asthma Associates city: Kerrville state: Texas zip: 78028 country: United States role: CONTACT phone: 830-896-1433 name: Dale Mohar role: PRINCIPAL_INVESTIGATOR lat: 30.04743 lon: -99.14032 facility: Allergy Asthma Research Institute city: Waco state: Texas zip: 76712 country: United States role: CONTACT phone: 254-741-8151 name: Niran Amar role: PRINCIPAL_INVESTIGATOR lat: 31.54933 lon: -97.14667 hasResults: False
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<|newrecord|> nctId: NCT06338995 id: 18790 id: J2T-MC-KGBU type: OTHER domain: Eli Lilly and Company 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) overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-11-22 date: 2026-10-25 date: 2024-04-01 date: 2024-04-01 name: Eli Lilly and Company class: INDUSTRY 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. conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: LY3650150 name: Placebo name: Standard therapy for INCS measure: Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity measure: Mean CFBL in Endoscopic Nasal Polyp Score (NPS) measure: Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) measure: Mean change in Forced Expiratory Volume in 1 Second (FEV1) measure: Mean CFBL in Severity of Loss of Smell measure: Mean CFBL in Postnasal Drip sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS city: Mandeville state: Louisiana zip: 70448 country: United States name: James Connolly role: PRINCIPAL_INVESTIGATOR lat: 30.35825 lon: -90.06563 facility: Ear Nose and Throat Associates of Texas PA city: McKinney state: Texas zip: 75070-5735 country: United States name: Dale Ehmer, Jr. role: PRINCIPAL_INVESTIGATOR lat: 33.19762 lon: -96.61527 facility: Alamo ENT Associates city: San Antonio state: Texas zip: 78258-3227 country: United States role: CONTACT phone: 210-545-0404 name: Jeffrey Rosenbloom role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: Richmond Ear Nose and Throat city: Richmond state: Virginia zip: 23235 country: United States role: CONTACT phone: 804-622-3768 name: Michael Armstrong role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False
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<|newrecord|> nctId: NCT06338982 id: N-20230059 briefTitle: Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2029-10-31 date: 2030-10-31 date: 2024-04-01 date: 2024-04-01 name: Kimie Bols Østergaard class: OTHER 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:
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• 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.
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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. conditions: Impacted Third Molar Tooth conditions: Osteotomy conditions: Orthognathic Surgery conditions: Mandibular Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial with a test group and a control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: Interoperative wisdom tooth removal in conjunction with BSSO measure: Fracture pattern following BSSO with or without impacted third molars measure: Condylar segment position following BSSO with or without impacted third molars measure: Oral Health Impact Profile-14 (OHIP-14) measure: The Modified Dental Anxiety Scale (MDAS) measure: Short Form-36 (SF-36) measure: PROMs measure: Length of the surgical procedure measure: Intraoperative bleeding measure: Frequency of intra- and postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aalborg universitets hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False
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<|newrecord|> nctId: NCT06338969 id: PostBariKetosis briefTitle: The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis overallStatus: RECRUITING date: 2024-03-25 date: 2025-04-01 date: 2025-08-01 date: 2024-04-01 date: 2024-04-03 name: The Society of Bariatric and Metabolic Surgeons of Kazakhstan class: OTHER briefSummary: Background:
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Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.
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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).
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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.
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Objectives:
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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. conditions: Obesity, Morbid conditions: NASH conditions: Ketosis conditions: Keto Acidosis conditions: Carbohydrate Metabolism Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Carbohydrate Restriction after a Gastric Bypass measure: Cases of ketosis and incidence of ketoacidosis measure: Cases of liver failure measure: Change in body mass index (Δ BMI) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Oral Ospanov status: RECRUITING city: Astana state: Aqmola zip: 010000 country: Kazakhstan name: Oral Ospanov, PhD role: CONTACT phone: 7015287734 phoneExt: +7 email: bariatric.kz@gmail.com lat: 51.1801 lon: 71.44598 hasResults: False
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<|newrecord|> nctId: NCT06338956 id: Lipid-PCI briefTitle: Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI acronym: Lipid-PCI overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-01 date: 2024-04-01 name: Samsung Medical Center class: OTHER 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. conditions: Coronary Artery Disease conditions: Hyperlipidemias studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 94189 type: ESTIMATED name: LDL reduction therapy measure: MACCE measure: Cardiovascular death measure: Spontaneous myocardial infarction measure: Repeat revascularization measure: Ischemic stroke sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Ki Hong Choi, MD role: CONTACT phone: 82-2-3410-3419 email: cardiokh@gmail.com lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06338943 id: 02-02/24 briefTitle: Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction acronym: MAPO-HF overallStatus: RECRUITING date: 2024-03-18 date: 2025-01 date: 2025-01 date: 2024-04-01 date: 2024-04-01 name: National Medical Research Center for Therapy and Preventive Medicine class: OTHER_GOV 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.
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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.
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Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?
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Objectives
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1. 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.
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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.
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3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.
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4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.
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Study population - 45-60 year-old women with the history of pregnancy (\>20 weeks) in the absence of low left ventricle ejection fraction (\<50%)
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Primary endpoint: The prevalence of HFpEF in patients with the history of APOs. conditions: Heart Failure Preserved Ejection Fraction conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Echocardiography name: Questionnaire measure: HFpEF incidence measure: APOs incidence sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT facility: National Medical Research Center for Therapy and Preventive Medicine status: RECRUITING city: Moscow country: Russian Federation name: Olga Dzhioeva, MD, PhD role: CONTACT phone: +79166141821 email: odzhioeva@gnicpm.ru name: Max Shperling, MD role: PRINCIPAL_INVESTIGATOR name: Alexandr Mols role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
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<|newrecord|> nctId: NCT06338930 id: ROADMAP briefTitle: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy acronym: ROADMAP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-03-02 date: 2027-03-30 date: 2024-04-01 date: 2024-04-01 name: Universitaire Ziekenhuizen KU Leuven class: OTHER 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.
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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.
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