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* Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications?
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* Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery?
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* Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?
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Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.
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QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.
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In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction. conditions: Other Specified Disorders of Kidney and Ureter conditions: Benign Neoplasm of Ureter conditions: Calculus of Kidney and Ureter conditions: Ureter Cancer conditions: Ureteric Reflux conditions: Congenital Ureteric Anomaly conditions: Benign Renal Neoplasm conditions: Renal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: spinal analgesia with morphine and bupivacaine name: lidocaine infusion measure: QoR-15 score at postoperative day 1 measure: QoR-15 score preoperatively measure: QoR-15 score at postoperative day 7 measure: Pain (NRS) in rest and during motion 2hrs after arrival to the PACU measure: Pain (NRS) on POD 1-3 measure: Pain (NRS) in rest and during motion at POD 7 measure: Time from arrival in the OR to start of surgery measure: Time from end of surgery until leaving the OR measure: Incidence of unplanned termination of the lidocaine infusion measure: Amount of remifentanil in patients given remifentanil measure: Amount of intraoperative opioids in patients not receiving remifentanil measure: Length of stay at the PACU measure: Amount of opioids administred at the PACU measure: Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay measure: "Time out-of-bed" on POD 1-3 measure: Amount of opioids administered during the first 24 hours at the ward measure: First POD passing gases measure: First POD passing stool measure: Incidence of pruritus measure: Length of stay measure: DAOH30 measure: Postoperative complications untill POD 30 measure: Requirement for opioids after discharge measure: Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia measure: Intraoperative fluid balance measure: Time with low blood pressure during anesthesia measure: Lowest MAP within 10 minutes after induction of anesthesia measure: Highest MAP within 10 minutes of abdominal insufflation measure: Fraction of patients needing norepinephrine before start of surgery measure: Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery) measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery measure: Intraoperative Cardiac Index measure: Intraoperative Stroke Volume Index measure: Intraoperative Cardiac Power Index measure: Intraoperative dPmx measure: Intraoperative Pulse Pressure Variation measure: Intraoperative Stroke Volume Variation measure: Intraoperative Systemic Vascular Resistance Index measure: Intraoperative heart rate measure: Biochemical markers of inflammation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Linköping status: RECRUITING city: Linköping country: Sweden name: Martin Holmberg, MD role: CONTACT phone: +46101033932 email: [email protected] lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06349655 id: 2023-KY-0865-001 briefTitle: The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19 overallStatus: COMPLETED date: 2023-12-05 date: 2024-01-15 date: 2024-03-10 date: 2024-04-05 date: 2024-04-05 name: The First Affiliated Hospital of Zhengzhou University class: OTHER name: Henan Provincial Chest Hospital name: The Affiliated Infectious Disease Hospital of Zhengzhou University name: The Fifth People's Hospital of Anyang name: Shangqiu Municipal Hospital name: Nanyang Central Hospital name: Luoyang Central Hospital name: Guangshan County People's Hospital name: Fengqiu County People's Hospital briefSummary: To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection. conditions: COVID-19 conditions: Azvudine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 32864 type: ACTUAL name: Azvudine name: Paxlovid measure: All-cause death measure: Composite disease progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06349642 id: MC230901 id: 23-008413 type: OTHER domain: Mayo Clinic Institutional Review Board id: NCI-2024-02979 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) briefTitle: Predicting Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform acronym: CYBRID-04 overallStatus: RECRUITING date: 2024-04-24 date: 2027-05 date: 2027-05 date: 2024-04-05 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The primary purpose of this study is to determine the sensitivity of CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. The secondary purposes is to determine the sensitivity of the CYBRID Score for predicting in-vivo clinical response based on surgical response or RECIST 1.1 for neoadjuvant and locally advanced/metastatic patients, respectively. conditions: Early Stage Triple-Negative Breast Carcinoma conditions: Locally Advanced Bladder Urothelial Carcinoma conditions: Locally Advanced Cervical Carcinoma conditions: Locally Advanced Clear Cell Renal Cell Carcinoma conditions: Locally Advanced Colorectal Carcinoma conditions: Locally Advanced Endometrial Carcinoma conditions: Locally Advanced Esophageal Carcinoma conditions: Locally Advanced Liver Carcinoma conditions: Locally Advanced Lung Non-Small Cell Carcinoma conditions: Locally Advanced Malignant Skin Neoplasm conditions: Locally Advanced Triple-Negative Breast Carcinoma conditions: Metastatic Bladder Urothelial Carcinoma conditions: Metastatic Cervical Carcinoma conditions: Metastatic Clear Cell Renal Cell Carcinoma conditions: Metastatic Colorectal Carcinoma conditions: Metastatic Endometrial Carcinoma conditions: Metastatic Esophageal Carcinoma conditions: Metastatic Liver Carcinoma conditions: Metastatic Lung Non-Small Cell Carcinoma conditions: Metastatic Malignant Skin Neoplasm conditions: Metastatic Malignant Solid Neoplasm conditions: Metastatic Triple-Negative Breast Carcinoma conditions: Resectable Bladder Urothelial Carcinoma conditions: Resectable Colorectal Carcinoma conditions: Resectable Lung Non-Small Cell Carcinoma conditions: Resectable Malignant Liver Neoplasm conditions: Resectable Skin Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 324 type: ESTIMATED name: Biospecimen Collection name: Tissue Collection measure: Accuracy of cytoplasmic hybrid (Cybrid) Score for predicting in-vivo clinical response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Dev Mukhopadhyay, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06349629 id: 20240401 briefTitle: The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2027-01-01 date: 2024-04-05 date: 2024-04-05 name: Peking University Third Hospital class: OTHER briefSummary: Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: 3D printed WE43 magnesium alloy measure: Detection of Magnesium alloy metabolism measure: Degradation of 3D printed magnesium alloy prosthesis measure: New bone regeneration measure: Evaluation of shoulder joint function measure: Evaluation of wrist joint function measure: Evaluation of knee joint function sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Haidian country: China name: Bingchuan Liu role: CONTACT phone: +86 18310188678 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospita status: RECRUITING city: Beijing zip: 100083 country: China name: Yun Tian, M.D role: CONTACT phone: +8613701053505 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06349616 id: STUDY24458 briefTitle: Cooling Strategies for Older Adults in the Heat overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-05 date: 2024-04-05 name: Penn State University class: OTHER briefSummary: The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.
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There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Subjects participate in 4 experiments, 2 for each treatment (folic acid supplementation and placebo). The order of treatment is random. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Intermittent cold-water hand and forearm immersion name: No intermittent cold-water hand and forearm immersion measure: Core temperature measure: Heart rate measure: Blood Pressure measure: Body Mass measure: Skin Temperature sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Noll Laboratory city: University Park state: Pennsylvania zip: 16802 country: United States name: W. Larry Kenney, Ph.D. role: CONTACT phone: 814-863-1672 email: [email protected] name: Rachel Cottle, MS role: CONTACT email: [email protected] lat: 40.80201 lon: -77.85639 hasResults: False
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<|newrecord|> nctId: NCT06349603 id: S2023 briefTitle: Physiotherapy Approach for Susac Syndrome overallStatus: COMPLETED date: 2023-02-13 date: 2023-04-01 date: 2023-04-06 date: 2024-04-05 date: 2024-04-05 name: Rehabilitation Centre Zivot class: OTHER briefSummary: Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales. conditions: Susac Syndrome studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 1 type: ACTUAL measure: Mobility and Muscle Strength Improvement measure: Muscle Strength Improvement Outcome Measure measure: Pain Intensity Outcome Measure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rehabilitation centre Život city: Mostar zip: 88000 country: Bosnia and Herzegovina lat: 43.34333 lon: 17.80806 hasResults: False
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<|newrecord|> nctId: NCT06349590 id: IRB24-0373 briefTitle: Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery acronym: DIET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2029-04 date: 2024-04-05 date: 2024-04-05 name: University of Chicago class: OTHER briefSummary: A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Plant-Based Meals measure: Change of the presence of active-urokinase-type plasminogen activation (uPA) stool samples before and after diet intervention using western blot and zymography. measure: Change of the presence of active- Matrix Metalloproteinase-9 (MMP9) in stool samples before and after diet intervention using western blot and zymography. measure: Change of the presence of plasminogen in stool samples before and after diet intervention using western blot and zymography. measure: Change of the stool associated metagenomics in subjects before and after intervention. measure: Change of the levels of short-chain fatty acids and bile acids between pre- and post- intervention stool samples. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Benjamin Shogan, MD role: CONTACT phone: 773-732-2260 email: [email protected] name: Leila Yazdanbakhsh role: CONTACT phone: 773-834-6087 email: [email protected] name: Benjamin Shogan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06349577 id: 23-0921 id: 5K23HL151882 type: NIH link: https://reporter.nih.gov/quickSearch/5K23HL151882 briefTitle: Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-10 date: 2024-04-05 date: 2024-04-05 name: University of Colorado, Denver class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass. conditions: Acute Kidney Injury conditions: Hemolysis conditions: Thrombocytopenia conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1100 type: ESTIMATED name: Non-pulsatile blood flow name: Pulsatile blood flow measure: Acute kidney injury measure: Acute kidney injury risk score measure: Red blood cell units transfused measure: Platelet nadir measure: Discontinuation rate of cardiopulmonary bypass mode measure: 30-day mortality measure: Myocardial infarction measure: Stroke measure: Renal failure requiring renal replacement therapy measure: Re-exploration for bleeding measure: Sepsis measure: New onset atrial fibrillation measure: Duration of mechanical ventilation measure: Post-operative delirium measure: Post-operative hospital length of stay measure: New requirement for mechanical circulatory support measure: Intra-operative red blood cell transfusion in units measure: Post-operative red blood cell transfusion in units measure: Post-operative platelet transfusion in units measure: Post-operative plasma transfusion in units measure: Post-operative cryoprecipitate transfusion in units measure: Intra-operative platelet transfusion in units measure: Intra-operative plasma transfusion in units measure: Intra-operative cryoprecipitate transfusion in units measure: New onset of acute lung injury measure: New onset of left ventricular systolic dysfunction measure: New onset of right ventricular systolic dysfunction sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06349564 id: 23-01443 briefTitle: Implementing Virtual Reality (VR) to Reduce Sedation overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-05 date: 2024-04-05 name: NYU Langone Health class: OTHER briefSummary: The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time. conditions: Sedative During Endoscopy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Pico 4 Enterprise headset with noise cancelling headphones measure: Total amount of sedative drugs administered during the procedure measure: Patient-reported discomfort or pain (using 0-10 pain scale) measure: Duration of the procedure measure: Overall patient satisfaction scores measure: Number of events of complications from VR measure: Number of technical failures measure: Troubleshooting time measure: PACU length of stay sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Brooklyn city: Brooklyn state: New York zip: 11220 country: United States lat: 40.6501 lon: -73.94958 hasResults: False
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<|newrecord|> nctId: NCT06349551 id: RC23_0586 briefTitle: Clot Formation and Coagulation Factors Consumption in the Clearing Fluid After Arterial Catheter Blood Sampling. acronym: SECU-BIO2 overallStatus: RECRUITING date: 2024-04-17 date: 2025-03-20 date: 2025-03-20 date: 2024-04-05 date: 2024-04-18 name: Nantes University Hospital class: OTHER briefSummary: After blood sampling from an arterial catheter, the reinjection of the clearing fluid (a mixture of saline solution and blood) is proposed to limit blood loss. However, the status of coagulation in this clearing liquid remains poorly documented. conditions: Intensive Care Units conditions: Arterial Lines studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 211 type: ESTIMATED name: Patients of intensive care unit measure: Composite score of the coagulation activation over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of prothrombin over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of factor II over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of factor V over time in the clearing fluid during blood sampling from an arterial catheter measure: Concentration of fibrin monomer over time in the clearing fluid during blood sampling from an arterial catheter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes university hospital status: RECRUITING city: Nantes state: Loire-atlantique zip: 44093 country: France name: Jerôme Dauvergne role: CONTACT phone: +33240165289 email: [email protected] lat: 47.21725 lon: -1.55336 facility: Hospital center status: NOT_YET_RECRUITING city: Saint-Nazaire zip: 44606 country: France name: Damien Muller, Dr role: CONTACT phone: 02 72 27 89 89 email: [email protected] lat: 47.28333 lon: -2.2 hasResults: False
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<|newrecord|> nctId: NCT06349538 id: 35-435 ex 22/23 briefTitle: Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2026-04-30 date: 2034-04-30 date: 2024-04-05 date: 2024-04-16 name: Medical University of Graz class: OTHER briefSummary: The goal of this observational study is to learn about epidemiology, biologic markers, disease subtypes and possible prognostic factors in essential tremor (ET) patients. The main question\[s\] it aims to answer are:
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* The prevalence of ET-plus compared to ET in a prospectively collected ET population.
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* To assess in detail the heterogenous group of ET patients using comprehensive clinical (motor and non-motor scales, questionnaires), imaging \[magnetic resonance imaging (MRI), sonography of substantia nigra and cerebral vessels\], neurophysiological (tremor analysis, digital spiral drawing) and laboratory markers (sGFAP, sNfL, routine laboratory parameters).
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* To assess possible non-invasive markers of neurodegeneration in ET patients (optic coherence tomography, alpha-synuclein in olfactory mucosa)
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Participants will be asked to undergo the above mention evaluation at baseline and at follow-up approx. 5 years later.
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Researchers will compare the findings within the ET group to independently existing cohorts of healthy controls and/or patients with other movement disorders like Parkinson's disease. conditions: Essential Tremor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Clinical examination, blood draw, cerebral MRI, sonography, tremor analysis, OCT, olfactory mucosa swab. measure: Prevalence of ET-plus measure: Age of ET patients measure: Sex of ET patients measure: Family history measure: Symptom leading to ET-plus classification measure: current and former medication for essential tremor measure: subjective disease course of ET measure: responsivity to alcohol measure: presence of cardiovascular risk factors measure: MDS-UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) parts I-IV measure: modified Essential Tremor Rating Assessment Scale (mTETRAS) measure: Scale for the assessment and rating of ataxia (SARA) measure: Verbal fluency animals (part of the CERAD-plus test battery) measure: Boston Naming Test (part of the CERAD-plus test battery) measure: Mini Mental State Examination Test (MMSE; part of the CERAD-plus test battery) measure: word list learning (part of the CERAD-plus test battery) measure: constructive praxis (part of the CERAD-plus test battery) measure: word list recall (part of the CERAD-plus test battery) measure: word list recognition (part of the CERAD-plus test battery) measure: constructive praxis recall (part of the CERAD-plus test battery) measure: Trail Making Test A (part of the CERAD-plus test battery) measure: Trail Making Test B (part of the CERAD-plus test battery) measure: s-words (part of the CERAD-plus test battery) measure: Frontal Assessment Battery (FAB) measure: Geriatric Depression Scale (GDS) measure: Hospital Anxiety and Depression Scale (HADS) measure: Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) measure: RBD Screening Questionnaire measure: Global Physical Activity Questionnaire (GPAQ) measure: Quality of Life in Essential Tremor Questionnaire (QUEST) measure: University of Pennsylvania Smell Identification Test (UPSIT) measure: Montreal Cognitive Assessment (MOCA) measure: Auditory verbal learning test measure: Symbol Digit Modalities Test (SDMT) measure: Brief Visuospatial Memory Test measure: Comprehensive trail making test 4 measure: Comprehensive trail making test 5 measure: Regensburg word fluency test measure: EQ-5D measure: resilience scale (RS-13) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Digital Spiral Drawing measure: Schellong Test measure: serum glial fibrillary acidic protein (sGFAP) measure: serum neurofilament light (sNfL) measure: Transcranial sonography measure: tremor analysis measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: cerebral MRI measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: optic coherence tomography (OCT) measure: Olfactory mucosa swab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06349525 id: DU-2021-00103 briefTitle: Retention of Telescopic Versus Locator Attachments overallStatus: COMPLETED date: 2021-04-01 date: 2023-07-05 date: 2023-10-01 date: 2024-04-05 date: 2024-04-09 name: Delta University for Science and Technology class: OTHER briefSummary: Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD , while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis. conditions: Jaw, Edentulous studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: telescopic overdenture name: Locator overdenture measure: Retention measure: Marginal bone loss sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delta University for Science & Technology city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06349512 id: IC 2022-07 id: 2023-507860-37-00 type: CTIS briefTitle: 68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT) acronym: FAP-IT overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-07-30 date: 2027-07-30 date: 2024-04-05 date: 2024-04-05 name: Institut Curie class: OTHER briefSummary: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC. conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-FAPI-46 PET/CT imaging measure: Area under the ROC curve measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances measure: Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances measure: Evaluation of predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349499 id: CIIPCL-AMD-MAG-23 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-05 date: 2024-04-05 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06349486 id: KMUHIRB-F(II)-20230179 briefTitle: Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication overallStatus: RECRUITING date: 2023-11-28 date: 2026-12-31 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Kaohsiung Medical University class: OTHER briefSummary: 1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
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2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments. conditions: Helicobacter Pylori Eradication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. bismuth-amoxicillin-vonoprazan triple therapy
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2. vonoprazan-amoxicillin dual therapy
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3. proton pump inhibitor-based standard triple therapy primaryPurpose: TREATMENT masking: NONE count: 780 type: ESTIMATED name: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate name: vonoprazan, amoxicillin name: rabeprazole, amoxicillin, clarithromycin measure: the eradication rate of Helicobacter pylori measure: genotype analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Hospital status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan name: Deng-Chyang Wu, MD,PHD role: CONTACT phone: 886-7-3121101 phoneExt: 7451 email: [email protected] lat: 22.61626 lon: 120.31333 hasResults: False
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<|newrecord|> nctId: NCT06349473 id: SR604-1 briefTitle: A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B) overallStatus: RECRUITING date: 2024-04-15 date: 2025-09-27 date: 2025-09-27 date: 2024-04-05 date: 2024-04-23 name: Equilibra Bioscience LLC class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with severe Hemophilia A or Hemophilia B, with or without inhibitors (Part B). conditions: Healthy Participants conditions: Hemophilia A conditions: Hemophilia B studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: SR604 name: Placebo measure: Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) measure: Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers measure: Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t]) measure: Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf]) measure: Parts A and B: Maximum Concentration (Cmax) of SR604 measure: Parts A and B: Time to Maximum Concentration (tmax) of SR604 measure: Parts A and B: Terminal Half-life (T1/2) of SR604 measure: Part A: Clearance Following Extravascular Administration (CL/F) of SR604 measure: Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604 measure: Parts B: Concentration before the next dose administration (Ctrough) measure: Parts B: Area Under the Serum Concentration-time Curve within One Dosing Interval (AUCtau) measure: Parts B: Accumulation Ratio (R) of SR604 measure: Parts B: Number of Bleeding Events measure: Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints measure: Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs) sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: California Clinical Trials Medical Group (CCTMG) status: RECRUITING city: Glendale state: California zip: 91206 country: United States name: Esther Yoon, M.D. role: PRINCIPAL_INVESTIGATOR lat: 34.14251 lon: -118.25508 hasResults: False
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<|newrecord|> nctId: NCT06349460 id: STU00216998 id: R01DK133300 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK133300 briefTitle: A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors overallStatus: RECRUITING date: 2024-03-21 date: 2026-09-30 date: 2026-12-31 date: 2024-04-05 date: 2024-04-05 name: Northwestern University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence. conditions: Binge Eating conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization. primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: FoodSteps behavioral intervention measure: Weekly change in binge eating sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University Feinberg School of Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Andrea K Graham, PhD role: CONTACT phone: 312-503-5266 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06349447 id: KY2021-771 briefTitle: Pilot Study of LED for PIE and PIH overallStatus: RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-01 date: 2024-04-05 date: 2024-04-05 name: Yanjun Dan class: OTHER briefSummary: The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH. conditions: Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 308 nm LED light was utilized to induce an vivo PIE/PIH model on the thigh of subjects. The irradiation dose was 1.5 MED. Five circular experimental lesions measuring 1.5 × 1.5 cm were selected on the thighs, categorizing into five groups: control group, 830 nm LED treatment group, 590 nm LED treatment group, 830 nm LED prevention group and 590 nm LED prevention group. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: LED name: without any LED exposition measure: melanin index measure: erythema index measure: transepidermal water loss (TEWL) measure: elasticity sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital status: RECRUITING city: Shanghai country: China name: Yanjun Dan role: CONTACT phone: +86 159 0194 0897 email: [email protected] name: Leihong Xiang role: CONTACT phone: +86 13818252671 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06349434 id: R-1215-23 briefTitle: The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI overallStatus: RECRUITING date: 2023-10-15 date: 2028-10-01 date: 2028-10-01 date: 2024-04-05 date: 2024-04-15 name: Kessler Foundation class: OTHER briefSummary: To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study. conditions: SCI - Spinal Cord Injury conditions: Upper Extremity Dysfunction conditions: Upper Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized Clinical Trial primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MyoMo name: conventional therapy measure: GRASSP measure: Range of motion of hands and arms measure: Muscle strength measurement measure: Spasticity measurement measure: Brain signals measurement measure: CUE-Q sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kessler Foundation status: RECRUITING city: West Orange state: New Jersey zip: 07052 country: United States name: Ghaith J Androwis, Ph.D. role: CONTACT phone: 201-968-6110 email: [email protected] lat: 40.79871 lon: -74.23904 hasResults: False
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<|newrecord|> nctId: NCT06349421 id: 202401078RINE briefTitle: Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-05-31 date: 2024-10-31 date: 2024-04-05 date: 2024-04-05 name: National Taiwan University Hospital class: OTHER briefSummary: Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.
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Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.
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This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment. conditions: Dentistry conditions: Education studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: VAS scale at the same density of sawbone sex: ALL minimumAge: 24 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06349408 id: CIBI3001A101 briefTitle: IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-05-30 date: 2027-05-30 date: 2024-04-05 date: 2024-04-05 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: This is a Phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. It includes a Phase 1 section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3001, and a Phase 2 section to explore and confirm the efficacy, safety and tolerability of IBI3001 at its RP2D. conditions: Locally Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: IBI3001 measure: Number of subjects with adverse events measure: Number of subjects with clinically significant changes in physical examination results measure: Number of subjects with clinically significant changes in vital signs measure: MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) measure: Plasma concentration (Cmax) of IBI3001 measure: Area under the curve (AUC) of IBI3001 measure: Time to maximum concentration (Tmax) of IBI3001 measure: Clearance (CL) of IBI3001 measure: Volume of distribution (V) of IBI3001 measure: Half-life (T1/2) of IBI3001 measure: Immunogenicity of IBI3001 measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: Time to response (TTR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wollongong Public city: Wollongong state: New South Wales zip: 2500 country: Australia name: Daniel Brungs role: CONTACT email: [email protected] lat: -34.424 lon: 150.89345 hasResults: False
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<|newrecord|> nctId: NCT06349395 id: NisantasiU briefTitle: The Effect of Mindfulness-Based Stress Reduction Training Before Mastectomy on Postoperative Pain in Early Period overallStatus: RECRUITING date: 2023-05-01 date: 2024-06-29 date: 2024-07-29 date: 2024-04-05 date: 2024-04-05 name: Istanbul Nisantasi University class: OTHER briefSummary: This research aims to investigate the effect of mindfulness-based stress reduction training given before mastectomy on postoperative early period pain and the fear of movement caused by pain. According to the World Health Organization, 18.1 million new cancer diagnoses are made each year, with breast cancer being the most common type among women, accounting for 24.2% of all cancers diagnosed. In Turkey, the incidence of breast cancer was determined as 22,345 in 2018. Breast cancer significantly affects women's quality and length of life. Surgical intervention is the most commonly chosen treatment method for cases of localized breast cancer. Pain and limited movement are among the most common problems encountered after surgery. Non-pharmacological methods have been shown to be effective in pain management, with the mindfulness-based stress reduction technique being one of these methods. This technique is described as an effective treatment for conditions such as pain, depression, and addiction, with high levels of mindfulness being associated with greater self-esteem, optimism, and empathy, whereas low levels of mindfulness are linked to depression, anxiety, chronic pain, and acute pain. conditions: Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 parallel groups randomized controlled study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: MBSR surgical nursing care measure: Visual analog scale measure: The Tampa Scale of Kinesiophobia sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa status: RECRUITING city: Istanbul zip: 34160 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06349382 id: CALAS briefTitle: CArbohydrate Loading in Aortic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-05 date: 2024-04-08 name: University of Belgrade class: OTHER briefSummary: The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery. conditions: Abdominal Aortic Aneurysm conditions: Leriche Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to receive preoperative OCHL (the experimental group) or no intervention (the control group) in a 1:1 ratio. Randomization will be performed using computer-generated randomization codes, which will be held in sealed envelopes. Patients in the experimental group (OCHL group) will receive a high-carbohydrate beverage (12.6% carbohydrates, 50 kcal/100 mL, 285 mOsm/kg; PreOp®, Nutricia, Zoetermeer, The Netherlands) 800 mL on the evening before surgery (between 9 p.m. and 11 p.m.), and 400 mL 2 hours before the induction of anesthesia. Participants in the no-intervention (control) group will be fasted from midnight until surgery. All other aspects of perioperative patient care will be the same for all participants, as per the standardized Institutional protocol for the treatment of abdominal aortic aneurysms and Leriche Syndrome. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: carbohydrate-rich beverage measure: The ICU length of stay measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measure: Insulin sensitivity index (HOMA-ISI) measure: Homeostasis model assessment of β-cell function (HOMA-β) measure: Six aspects of subjective well-being according to the visual analog scale measure: Length of hospital stay measure: 30-day mortality rate measure: The incidence of local wound infections measure: The incidence of postoperative surgical complications measure: The incidence of postoperative non-surgical complications sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia city: Belgrade zip: 11000 country: Serbia name: Igor Koncar, MD, Ph.D. role: CONTACT phone: +381668300290 email: [email protected] name: Igor Koncar, MD, Ph.D. role: SUB_INVESTIGATOR name: Ksenija Jovanovic, MD, Ph.D. role: SUB_INVESTIGATOR name: Ranko Trailovic, MD role: SUB_INVESTIGATOR lat: 44.80401 lon: 20.46513 hasResults: False
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<|newrecord|> nctId: NCT06349369 id: PG Thesis/2023-24/105 briefTitle: Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia acronym: tDCS overallStatus: RECRUITING date: 2024-04-08 date: 2025-12-09 date: 2026-04-09 date: 2024-04-05 date: 2024-04-25 name: All India Institute of Medical Sciences, Bhubaneswar class: OTHER briefSummary: The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes. conditions: Chronic Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: transcranial direct current stimulation measure: Change in the IL-6 levels measure: Change in the TNF alpha levels. measure: Change in the Positive and Negative syndrome Scale measure: Change in the Auditory hallucination rating scale measure: Change in the Clinical global impression- Schizophrenia scale measure: Change in the Global Assessment of Functioning scale measure: To compare the adverse events reported in both control and intervention groups. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: AIIMS Bhubaneswar status: RECRUITING city: Bhubaneswar state: Odisha zip: 751019 country: India name: Ashutosh Biswas role: CONTACT lat: 20.27241 lon: 85.83385 hasResults: False
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<|newrecord|> nctId: NCT06349356 id: FDACSTIM0012023 id: IRB00000533 type: OTHER domain: WCG IRB briefTitle: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease" overallStatus: RECRUITING date: 2023-03-28 date: 2024-09-30 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Quantel Medical class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:
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• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).
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Researchers will compare treated group and placebo to respond to the main question.
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Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose). conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Intense pulsed light with C.STIM device measure: Tear Break-Up Time evolution measure: dry eye signs and symptoms measure: dry eye signs and symptoms measure: dry eye signs and symptoms measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Meibum quality measure: Meibum Expressibility measure: Use of artificial tear drops measure: Use of artificial tear drops measure: Glaucoma sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Visionary Consultants Inc. status: RECRUITING city: Lexington state: Kentucky zip: 40517 country: United States name: Dr. KARPECKI role: CONTACT phone: 463-210-6618 email: [email protected] lat: 37.98869 lon: -84.47772 facility: Triangle Eye Consultants status: ACTIVE_NOT_RECRUITING city: Raleigh state: North Carolina zip: 27617 country: United States lat: 35.7721 lon: -78.63861 facility: Toyos Clinic status: RECRUITING city: Nashville state: Tennessee zip: 37215 country: United States name: Dr. TOYOS role: CONTACT phone: 615-327-4015 email: [email protected] lat: 36.16589 lon: -86.78444 facility: Eye Centers of Racine & Kenosha status: RECRUITING city: Kenosha state: Wisconsin zip: 53142 country: United States name: Dr SINGH role: CONTACT phone: 312-371-4335 email: [email protected] lat: 42.58474 lon: -87.82119 hasResults: False
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<|newrecord|> nctId: NCT06349343 id: UHCT230949 briefTitle: CD19/BCMA HLA-independent TCR-T Cell Therapy for Refractory/Moderate-to-severe Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2026-01 date: 2024-04-05 date: 2024-04-05 name: Wuhan Union Hospital, China class: OTHER briefSummary: The purpose of the study is to explore the safety and efficacy of cluster of differentiation 19 (CD19)/B cell maturation antigen (BCMA) human leukocyte antigen (HLA)-independent T cell receptor (TCR) -T therapy in refractory/moderate-to-severe systemic lupus erythematosus(SLE). conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: CD19/BCMA Hi-TCR-T cell therapy measure: Safety and tolerability measure: Proportion of subjects with SRI-4 response measure: Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline measure: Changes in the BILAG-2004 score from baseline measure: Changes in the Physician Global Assessment (PGA) score from baseline measure: Pharmacokinetics (PK) measure: Pharmacodynamics (PD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349330 id: 2022/00908 briefTitle: The Immediate Effectiveness of a 3D Intraoral Scanner as an Oral Hygiene Educational Tool acronym: 3D scanner overallStatus: RECRUITING date: 2023-11-07 date: 2024-07-31 date: 2024-07-31 date: 2024-04-05 date: 2024-04-24 name: National University Hospital, Singapore class: OTHER briefSummary: The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question\[s\] it aims to answer are:
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* Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?
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* Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects?
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Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention.
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Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group.
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A questionnaire will be given to subjects in the test and control group for qualitative analysis.
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The study will require 1 visit. conditions: Periodontal Diseases conditions: Plaque Induced Gingival Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a parallel-arm randomized controlled trial and subjects are randomized into test and control groups via block randomization.
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To investigate the immediate effectiveness on the use of 3D intraoral scanner in the improvement of oral hygiene in two (2) parallel arm study with 52 subjects (n=52). The study will take place over 1 visit. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Test: 3D intra-oral scanner name: Control: Standard oral hygiene measure: Full mouth plaque score (%) measure: Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital, Singapore status: RECRUITING city: Singapore country: Singapore name: Xiao Tong, Jacinta Lu, BDS role: CONTACT phone: 6716 2233 email: [email protected] name: Xiao Tong, Jacinta Lu, MDS role: PRINCIPAL_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06349317 id: 2024-005 briefTitle: Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: Yongyi Zeng class: OTHER briefSummary: This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib measure: 1-year Event-Free Survival (EFS) rate measure: Event-Free Survival (EFS) measure: Overall Survival (OS) measure: Disease-Free Survival (DFS) measure: R0 resection rate measure: Overall Objective Response of primary liver tumor and PVTT measure: Surgical safety measure: Safety of radiotherapy, camrelizumab and apatinib treatment measure: Exploratory Endpoints sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349304 id: S25 briefTitle: Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-05 date: 2024-04-05 name: National University of Singapore class: OTHER name: California Table Grape Commission briefSummary: The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults. The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group. conditions: Macula; Degeneration conditions: Aging conditions: Advanced Glycation End Products studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Freeze-dried table grape powder name: Placebo grape powder measure: Macular pigment optical density measure: Visual acuity measure: Photostress recovery time measure: Visual function questionnaire 25 measure: Skin advanced glycation end products levels measure: Dietary advanced glycation end products level measure: Blood advanced glycation end products levels measure: Contrast sensitivity measure: Concentration of tumour necrosis factor-α measure: Concentration of interleukin-6 measure: Concentration of high-sensitivity C-reactive protein measure: Concentration of fasting blood glucose measure: Concentration of malondialdehyde measure: Concentration of 8-isoprostaglandin-F2α measure: Skin carotenoid status measure: Concentration of insulin measure: Percentage of glycated hemoglobin measure: Measurement of height measure: Measurement of blood pressure measure: Measurement of weight measure: Measurement of waist circumference sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349291 id: 0074-24-MMC briefTitle: Venous Thrombosis After Removal of Central Venous Catheter overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08-01 date: 2025-08-01 date: 2024-04-05 date: 2024-04-05 name: Meir Medical Center class: OTHER briefSummary: Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.
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In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis. conditions: Thrombosis, Venous studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Detection of venous thrombosis via US measure: Rate of DVT after removal of central venous catheter sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False
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<|newrecord|> nctId: NCT06349278 id: 2024-7276 briefTitle: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX acronym: PDAC-LIV overallStatus: RECRUITING date: 2024-01-16 date: 2026-01-16 date: 2029-01-16 date: 2024-04-05 date: 2024-04-16 name: Laval University class: OTHER briefSummary: This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued. conditions: Pancreas Adenocarcinoma conditions: Pancreas Metastases conditions: Pancreas Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will undergo intervention prospectively. primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Pancreatic resection and non-anatomic liver resections. measure: Morbidity and mortality measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Québec status: RECRUITING city: Quebec City state: Quebec zip: G1R 2J6 country: Canada name: Alexandre Brind'Amour role: CONTACT phone: +14185254444 phoneExt: 15925 email: [email protected] name: Jean-François Ouellet, MD role: SUB_INVESTIGATOR name: Jean-François Berthin Ouellet, MD role: SUB_INVESTIGATOR name: Isabelle Deshaies, MD role: SUB_INVESTIGATOR name: Carl Daigle, MD role: SUB_INVESTIGATOR name: Félix Couture, MD role: SUB_INVESTIGATOR name: Maxime Chénard-Poirier, MD role: SUB_INVESTIGATOR name: Anne-Julie Simard role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False
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<|newrecord|> nctId: NCT06349265 id: 02 briefTitle: Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome overallStatus: COMPLETED date: 2023-10-02 date: 2024-02-02 date: 2024-03-02 date: 2024-04-05 date: 2024-04-05 name: Kastamonu University class: OTHER briefSummary: This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 33 type: ACTUAL name: Carpal Tunnel Hydrodissection with %5 dextrose in water injection measure: Visual Analogue Scale(VAS) measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) measure: Dolour Neuropathique en 4 Questions (DN4) questionnaire sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gamze Gül Güleç city: Kastamonu zip: 37150 country: Turkey lat: 41.37805 lon: 33.77528 hasResults: False
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<|newrecord|> nctId: NCT06349252 id: LUNGTNM briefTitle: Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer overallStatus: RECRUITING date: 2021-01-01 date: 2024-08-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Fudan University class: OTHER briefSummary: The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system. conditions: Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1263 type: ESTIMATED name: Radical resection measure: Overall Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Chen Haiquan, MD role: CONTACT phone: +86-21 64175590 phoneExt: 1707 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06349239 id: 24Hemato01 briefTitle: Oral Azacitidine Maintenance Post-CPX 351 acronym: ORAZ-351 overallStatus: RECRUITING date: 2020-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.
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Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).
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The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.
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But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: overall survival measure: Safety and tolerance sex: ALL minimumAge: 64 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nice status: RECRUITING city: Nice country: France name: CLUZEAU thomas role: CONTACT lat: 43.70313 lon: 7.26608 hasResults: False
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<|newrecord|> nctId: NCT06349226 id: DISCOLAB briefTitle: Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain overallStatus: RECRUITING date: 2018-05-22 date: 2025-05-21 date: 2025-05-21 date: 2024-04-05 date: 2024-04-05 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Low back pain, associated with intrinsic disorders of the spine, is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects, and health care system. It occurs in approximately 80% of the population throughout their lives. Most low back pain is associated with intervertebral disc degeneration (IDD) associated with neuroinflammation and pain. In this context, the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process. Sphingolipids, in fact, are a class of molecules that are implicated in multiple signal pathways, such as proliferation, degradation of the extracellular matrix, inflammatory state, apoptosis and migration. In particular, sphingosine-1-phosphate (S1P), an intermediate of sphingolipid metabolism, acts as a pro-inflammatory mediator, predominantly in the extracellular environment, regulating important cellular properties related to inflammatory potential and pain. The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes, including sphingolipid signaling pathway. conditions: Intervertebral Disc Degeneration conditions: Discogenic Pain conditions: Discogenic Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: cell isolation from intervertebral disc tissue and biomarker investigation measure: Characterization of degenerated intervertebral disc cells measure: Development of cellular model platform sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: RECRUITING city: Milan zip: 20122 country: Italy name: Giovanni Marfia, MD, Phd role: CONTACT phone: 0255035502 phoneExt: +39 email: [email protected] name: Stefania E Navone, PhD role: CONTACT phone: 0255034268 phoneExt: +39 email: [email protected] name: Mauro Pluderi, MD role: PRINCIPAL_INVESTIGATOR name: Giovanni Marfia, MD, PhD role: SUB_INVESTIGATOR name: Stefania E Navone, PhD role: SUB_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR name: Marco Locatelli, MD, PhD role: SUB_INVESTIGATOR name: Stefano Borsa, MD role: SUB_INVESTIGATOR name: Giulio Bertani, MD role: SUB_INVESTIGATOR name: Claudia Fanizzi, MD role: SUB_INVESTIGATOR name: Giorgio Fiore, MD role: SUB_INVESTIGATOR name: Luigi Schisano, MD role: SUB_INVESTIGATOR name: Manuela Caroli, MD role: SUB_INVESTIGATOR name: Antonella Ampollini, MD role: SUB_INVESTIGATOR name: Elena Pirola, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06349213 id: C23-19 id: 2023-A02263-42 type: OTHER domain: Secondary ID briefTitle: Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time acronym: TIMES overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-11-01 date: 2030-11-01 date: 2024-04-05 date: 2024-04-10 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV briefSummary: Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments. conditions: Healthy Aging studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: FDOPA injection before PET imaging name: Time perception tasks name: fMRI imaging name: EEG imaging name: 3 year follow-up measure: EEG phase lag index differences between group sex: ALL minimumAge: 20 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349200 id: 3197 briefTitle: Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients overallStatus: RECRUITING date: 2024-03-27 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-12 name: Dow University of Health Sciences class: OTHER briefSummary: Many patients suffer from dental anxiety and don't go to dentists for regular checkups. This can lead to the initiation and progression of dental caries, which, if not controlled at the right time, can lead to the loss of the tooth itself. Many forms of distraction have been used to overcome this; music is also one of them. The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital. The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital. A total of three groups will be a part of this study, with a total sample size of 99 participants (33 participants in each group). Group A will listen to 432 Hz music for 10 minutes before the procedure, Group B will listen to binaural beats for 10 minutes before the procedure; and Group C (active control group) will listen to white noise for 10 minutes before the procedure. The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration, after local anesthesia administration, and 10 minutes after listening to sounds. Then root canal treatment will be completed as a routine procedure. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 99 type: ESTIMATED name: 432 Hz music name: Binaural beats name: White noise measure: Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Dow University of Health Sciences status: RECRUITING city: Karachi state: Sindh zip: 74200 country: Pakistan name: Dr. Hafsa Zaki role: CONTACT phone: +923462746052 email: [email protected] name: Dr. Shahbaz Ahmed role: CONTACT phone: +923212000873 email: [email protected] lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06349187 id: dsc002 briefTitle: Digital Competencies of the Doctors overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-10 date: 2024-04-05 date: 2024-04-05 name: Limited Liability Company "Docstarclub" class: OTHER briefSummary: The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[Aungst, Patel, 2020\]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA \[Adler-Milstein, et al., 2014\], Europe \[Schreiweis, et al., 2019\], Australia \[Evolution of eHealth in Australia, 2016\].
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The most common methodologies for determining a doctor's digital literacy level are HITCOMP and TIGER. In particular, HITCOMP includes 5 areas of expertise: administration, research/biomedicine, direct patient care, computer science, engineering/information systems/information and communication technologies, as well as several levels: basic, basic, intermediate, advanced, expert \[EU\*US eHealth Work Project, 2020\].
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However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes.
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It all starts with digital trust, that is, with people's confidence in the reliability and security of digital systems, processes and technologies. Without the conviction that the implementation and active use of certain IT services will be useful and will not bring harm, the successful launch of such technologies will be impossible.
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Provided that there is digital trust, a person in his daily life gradually gets experience using various technologies: payments, appointments with specialists, purchases, etc. Thus, basic digital literacy appears in conjunction with the rules of behavior in the online space (digital culture). And only after that, having skills positively supported by experience, the doctor begins to master digital competencies in his workplace.
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Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks.
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