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In this study, researchers will assess patient data from a hospital database in Japan.
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The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.
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To learn about this, researchers will collect the following information:
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* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
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* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
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* The number of days between diagnosis of sepsis and the beginning of DIC
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Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.
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In this study, only available data from routine care are collected. conditions: Sepsis conditions: Disseminated Intravascular Coagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5740 type: ESTIMATED name: No study intervention measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up measure: Distribution of JAAM DIC score measure: Distribution of ISTH DIC score measure: Distribution of MHLW DIC score measure: Distribution of SOFA score measure: Days from sepsis diagnosis to the onset of DIC measure: Number of participants per clinical characteristics measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Tokyo zip: 100-8265 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False
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<|newrecord|> nctId: NCT06373146 id: 18750 id: I8F-MC-GPIV type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-04-18 date: 2024-04-23 name: Eli Lilly and Company class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: Tirzepatide name: Mibavademab name: Tirzepatide-Placebo name: Mibavademab-Placebo measure: Mean Percent Change from Baseline in Body Weight measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) measure: Mean Absolute Change from Baseline for Body Weight (kg) measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction measure: Mean Percent Change from Randomization 2 for Body Weight measure: Mean Change from Randomization 2 for Body Weight (kg) measure: Mean Absolute Change from Randomization 2 for Body Weight (kg) measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline in FCQ-T-r Scores measure: Change from Baseline in FCQ-T-r Scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research, Gardena city: Gardena state: California zip: 90247 country: United States name: Mark T. Leibowitz role: PRINCIPAL_INVESTIGATOR lat: 33.88835 lon: -118.30896 facility: Irvine Clinical Research city: Irvine state: California zip: 92614 country: United States name: Elly R Lee role: PRINCIPAL_INVESTIGATOR lat: 33.66946 lon: -117.82311 facility: National Research Institute - Wilshire city: Los Angeles state: California zip: 90057 country: United States name: Juan Pablo Frias role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research, North Hollywood city: North Hollywood state: California zip: 91606 country: United States name: Samuel Penziner role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: Velocity Clinical Research, Panorama City city: Panorama City state: California zip: 91402 country: United States name: Maricor Grio role: PRINCIPAL_INVESTIGATOR lat: 34.22473 lon: -118.44981 facility: Velocity Clinical Research, Santa Ana city: Santa Ana state: California zip: 92704 country: United States name: Julie Vu role: PRINCIPAL_INVESTIGATOR lat: 33.74557 lon: -117.86783 facility: Diablo Clinical Research, Inc. city: Walnut Creek state: California zip: 94598 country: United States name: Bonnie S. Kimmel role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: Solaris Clinical Research city: Meridian state: Idaho zip: 83646 country: United States name: David J. Butuk role: PRINCIPAL_INVESTIGATOR lat: 43.61211 lon: -116.39151 facility: Tandem Clinical Research city: Marrero state: Louisiana zip: 70072 country: United States name: Adil Fatakia role: PRINCIPAL_INVESTIGATOR lat: 29.89937 lon: -90.10035 facility: Velocity Clinical Research, Metairie city: Metairie state: Louisiana zip: 70006 country: United States name: Scott P Striplin role: PRINCIPAL_INVESTIGATOR lat: 29.98409 lon: -90.15285 facility: Velocity Clinical Research, Norfolk city: Norfolk state: Nebraska zip: 68701 country: United States name: Charles Harold Harper role: PRINCIPAL_INVESTIGATOR lat: 42.02834 lon: -97.417 facility: Lillestol Research city: Fargo state: North Dakota zip: 58104 country: United States name: Michael J Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 facility: South Texas Clinical Research city: Corpus Christi state: Texas zip: 78404 country: United States name: Lloyd Stegemann role: PRINCIPAL_INVESTIGATOR lat: 27.80058 lon: -97.39638 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Julio Rosenstock role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Northwest Clinical Research Center city: Bellevue state: Washington zip: 98007 country: United States name: Nazia Rahman role: PRINCIPAL_INVESTIGATOR lat: 47.61038 lon: -122.20068 facility: Centro de Investigacion en Artritis y Osteoporosis SC city: Mexicali state: Baja California zip: 21200 country: Mexico name: Francisco Fidencio Cons Molina role: PRINCIPAL_INVESTIGATOR lat: 32.62781 lon: -115.45446 facility: Clínicos Asociados BOCM city: Mexico City state: Distrito Federal zip: 03300 country: Mexico name: Israel Olvera-Alvarez role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Unidad biomedica avanzada monterrey city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Eduardo Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos city: Chihuahua zip: 31110 country: Mexico name: Luis Alejandro Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 hasResults: False
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<|newrecord|> nctId: NCT06373133 id: 2024 (82) briefTitle: SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-11-01 date: 2024-04-18 date: 2024-04-18 name: West China Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SHR-8068 name: Adebrelimab name: BP102 measure: Dose-limiting toxicity measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06373120 id: QX20231057-X-1 briefTitle: Interventional Ventricular Assist System for PCI in CHIP Patients acronym: REC-CHIPMCS overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-30 date: 2025-04-30 date: 2024-04-18 date: 2024-04-18 name: Xijing Hospital class: OTHER briefSummary: In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).
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During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.
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There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.
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The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI. conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI) conditions: Left Ventricular Assist Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of CorVad compared to VA-ECMO in complicated and high-risk patient with indications for PCI primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: CorVad name: VA-ECMO measure: Major adverse event measure: All-cause death measure: Stroke measure: Myocardial infarction measure: Revascularization measure: Cardiovascular hospitalization measure: MCS-ARC defined type 3, 4, 5 bleeding measure: Acute kidney injury measure: Serious device-related adverse events measure: Cardiopulmonary resuscitation measure: Hospitalization time measure: Intensive care unit (ICU/CCU) stay time measure: ECMO/Corvad utilization time measure: Hemodynamic disorder measure: Transfusion rate measure: Units of transfusion measure: Device-related composite endpoint (DoCE) measure: Patient-related composite endpoint (PoCE) measure: Net adverse clinical events measure: Cardiac death measure: Ischemic stroke measure: Hemorrhagic stroke measure: Transient ischemic attack measure: Target vessel myocardial infarction measure: Target lesion revascularization measure: Target vessel revascularization measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR) measure: Rehospitalization measure: MCS-ARC type 2 bleeding measure: Puncture complications measure: Aortic valve injury measure: Active Infection measure: ECMO/Corvad setup time measure: Complete revascularization rate measure: Change in left ventricular ejection fraction (LVEF) from baseline measure: Change in New York Heart Association (NYHA) classification from baseline measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline measure: Change in creatinine clearance rate from baseline measure: Stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ling Tao status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Chao Gao, M.D., Ph.D. role: CONTACT phone: 86-18629551066 email: woshigaochao@gmail.com lat: 34.25833 lon: 108.92861 hasResults: False
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<|newrecord|> nctId: NCT06373107 id: 2117651-2 briefTitle: Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-10-30 date: 2026-01-31 date: 2024-04-18 date: 2024-04-18 name: Alvernia University class: OTHER name: Lehigh Valley Health Network briefSummary: The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: High intensity gait training measure: 3-meter backwards walk test measure: 6-minute walk test measure: 10-meter walk test measure: Surface electromyography (EMG) measure: Berg Balance Scale measure: Functional Gait Assessment measure: Borg Rating Scale of Perceived Exertion (RPE) measure: Patient Health Questionnaire (PHQ-9) measure: Rate of patient attendance (Compliance) to physical therapy measure: Newest Vital Sign measure: Multidimensional Scale of Perceived Social Support (MSPSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lehigh Valley Health Network Outpatient Neurologic Rehab city: Allentown state: Pennsylvania zip: 18104-2310 country: United States name: Sandra M Tremblay, DPT role: CONTACT lat: 40.60843 lon: -75.49018 hasResults: False
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<|newrecord|> nctId: NCT06373094 id: DON102-CTP briefTitle: A Single Dose Escalation Study of HHT201 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Donepezil Dihydroxynaphthalate for Injection measure: Adverse events measure: Number of Participants With Abnormal Laboratory Values measure: Number of Participants With Abnormal ECG QT Interval measure: Number of Participants With Abnormal Vital signs measure: Number of Participants With Abnormal Physical examination measure: VAS measure: Cmax of Donepezil measure: Tmax of Donepezil measure: AUC0-t of Donepezil measure: AUC0-∞ of Donepezil measure: t1/2z of Donepezil measure: Vz/F measure: CLz/F sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center) city: Taizhou state: Zhe Jiang zip: 318000 country: China name: Donqing Lv role: CONTACT phone: 86-0576-85199816 email: lvdq@enzemed.com name: Zhanrong Ye role: CONTACT phone: 86-0576-85199816 email: Zoe.Ye@enzemed-crc.com lat: 32.49069 lon: 119.90812 hasResults: False
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<|newrecord|> nctId: NCT06373081 id: CD19-CD3E-CN-A1 briefTitle: Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease overallStatus: RECRUITING date: 2024-04-20 date: 2025-04-15 date: 2026-04-15 date: 2024-04-18 date: 2024-04-18 name: Shanghai Changzheng Hospital class: OTHER briefSummary: This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases. conditions: Systemic Lupus Erythematosus (SLE) conditions: Sjogren's Syndrome conditions: Systemic Sclerosis conditions: Inflammatory Myopathy conditions: ANCA Associated Vasculitis conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Anti-CD19-CD3E-CAR-T cells measure: The incidence of dose-limiting toxicities (DLTs) (Safety) measure: Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured measure: Clinical response for relapsed/Refractory SLE measure: Clinical response for Sjögren's Syndrome measure: Clinical response for relapsed/refractory/progressive systemic sclerosis measure: Clinical response for relapsed/refractory/progressive inflammatory myopathy measure: Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: measure: Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ChangZheng hospital status: RECRUITING city: Shanghai zip: 200003 country: China name: Huji Xu role: CONTACT phone: 86021-81885514 email: xuhuji@smmu.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06373068 id: Resuscitation Orders ICU briefTitle: Association Between Resuscitation Orders and Mortality in ICU Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-03 date: 2024-04-18 date: 2024-04-24 name: Karolinska Institutet class: OTHER briefSummary: The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained. conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Resuscitation orders measure: Mortality sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06373055 id: 4-2023-1232 briefTitle: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics overallStatus: RECRUITING date: 2024-05-01 date: 2033-11 date: 2033-11 date: 2024-04-18 date: 2024-04-18 name: Yonsei University class: OTHER briefSummary: Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection. conditions: Muscle-invasive Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: neoadjuvant chemotherapy followed by radical cystectomy measure: Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles measure: overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Won Sik Ham role: CONTACT phone: 02-2228-2310 email: uroham@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06373042 id: ADJUVANT-2 briefTitle: Tirofiban for Successful Endovascular Stroke Thrombectomy acronym: ADJUVANT-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-31 date: 2026-10-31 date: 2024-04-18 date: 2024-04-18 name: Zhongming Qiu class: OTHER name: The Second Affiliated Hospital of Chongqing Medical University name: Mianyang Central Hospital name: The Second Hospital of Jiaozuo name: Chongzhou People's Hospital name: Xihua People's Hospital name: Xingguo People's Hospital briefSummary: Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy.
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Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate.
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Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear. conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 712 type: ESTIMATED name: Intraarterial and intravenous tirofiban name: Intraarterial and intravenous placebo measure: Functional independence measure: Recanalization on follow-up CTA or MRA measure: Early neurologic improvement measure: Level of disability measure: Excellent outcome measure: Independent ambulation measure: Health-related quality of life measure: Long-term of disability level measure: Health-related quality of life (long-term) measure: Incidence of symptomatic intracranial hemorrhage (SICH) measure: Radiologic intracranial hemorrhage rate measure: Mortality measure: Incidence of non-hemorrhagic serious adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06373029 id: 2023PHB211-001(2) briefTitle: Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-30 date: 2025-12-30 date: 2024-04-18 date: 2024-04-18 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy. conditions: Ultrasound conditions: Anterior Talofibular Ligament conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Ultrasound examination measure: classification of ATFL injury sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06373016 id: 2015P000652 id: 2023005 type: OTHER_GRANT domain: Baszucki Foundation briefTitle: Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder overallStatus: RECRUITING date: 2024-01-26 date: 2027-02-01 date: 2027-02-01 date: 2024-04-18 date: 2024-04-18 name: Stony Brook University class: OTHER name: Massachusetts General Hospital name: Mclean Hospital briefSummary: The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior. conditions: Bipolar Disorder conditions: Bipolar Disorder Type 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: Glucose name: Ketones measure: Stabilization of brain networks (general brain functioning) measure: Relative stabilization or destabilization of brain networks in response to metabolic bolus measure: Prefrontal-limbic circuit regulation measure: Cortico-striatal circuit regulation measure: Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: McLean Hospital status: RECRUITING city: Belmont state: Massachusetts zip: 02478 country: United States name: Dost Ongur, MD PhD role: CONTACT phone: 617-855-3922 email: dongur@mgb.org name: Virginie-Anne Chouinard, MD role: CONTACT phone: 617-855-3034 email: vchouinard@mgb.org name: Dost Ongur, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 42.39593 lon: -71.17867 facility: Martinos Center for Biomedical Research, Building 149, 13th Street status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Lilianne Mujica-Parodi, PhD role: CONTACT phone: 631-428-8461 email: lstrey@mgh.harvard.edu name: Eva-Maria Ratai, PhD role: CONTACT phone: 781-521-4436 email: eratai@mgh.harvard.edu name: Eva-Maria Ratai, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 facility: Laufer Center for Physical and Quantitative Biology , Stony Brook University status: ACTIVE_NOT_RECRUITING city: Stony Brook state: New York zip: 11794 country: United States lat: 40.92565 lon: -73.14094 hasResults: False
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<|newrecord|> nctId: NCT06373003 id: SNAPSITA briefTitle: Negative Antiphospholipid Syndrome: a Multicentric Study acronym: SNAPSITA overallStatus: RECRUITING date: 2024-03-31 date: 2026-03-31 date: 2026-03-31 date: 2024-04-18 date: 2024-04-18 name: Italian Society for Rheumatology class: OTHER briefSummary: Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.
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The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.
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The recruited patients have the following criteria:
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(i)Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) or patients with seronegative APS (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS; (ii) Age \<65 years; (iii) less than 5 years from the first event to the beginning of the study. conditions: Antiphospholipid Syndrome conditions: Seronegative Antiphospholipid Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 105 type: ESTIMATED name: Diagnostic accuracy measure: Primary endpoint measure: Secondary endpoint_1 measure: Secondary endpoint_2 measure: Secondary endpoint_3 measure: Exploratory Endpoint sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Reumatologia - AOU Policlinico Umberto I, "Sapienza" Università di Roma status: RECRUITING city: Roma state: Rome zip: 00185 country: Italy name: Simona Truglia, MD role: CONTACT phone: 06 49974631 email: simona.truglia@uniroma1.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06372990 id: 0015338 briefTitle: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease acronym: BDTc overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-30 date: 2026-09-30 date: 2024-04-18 date: 2024-04-18 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Duke-NUS Medical School (Singapore) briefSummary: Prospective, non-pharmacological, single-center, non-profit observational study.
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The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.
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The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.
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The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:
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* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)
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* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)
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The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay. conditions: HBV conditions: HBV/HDV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay measure: Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV measure: Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies measure: Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. city: Milano state: MI zip: 20122 country: Italy name: Pietro Lampertico, MD role: CONTACT phone: 0255035432 email: pietro.lampertico@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06372977 id: kappa index in ms briefTitle: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: To:
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1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
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2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis) conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 140 type: ESTIMATED name: kappa index measure: Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the role of k FLC in predicting disease activity (conversion from CIS to MS) measure: Assess the role of OCBs in predicting disease activity (conversion from CIS to MS) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06372964 id: ITI-007-421 briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-04-18 date: 2024-04-23 name: Intra-Cellular Therapies, Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). conditions: Bipolar Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 384 type: ESTIMATED name: Lumateperone name: Placebo measure: Children's Depression Rating Scale-Revised (CDRS-R) measure: Clinical Global Impression Scale-Severity (CGI-S) sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Clinical Site status: NOT_YET_RECRUITING city: Anaheim state: California zip: 92805 country: United States lat: 33.83529 lon: -117.9145 facility: Clinical Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95817 country: United States lat: 38.58157 lon: -121.4944 facility: Clinical Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Clinical Site status: NOT_YET_RECRUITING city: Colorado Springs state: Colorado zip: 80910 country: United States lat: 38.83388 lon: -104.82136 facility: Clinical Site status: NOT_YET_RECRUITING city: Gainesville state: Florida zip: 32607 country: United States lat: 29.65163 lon: -82.32483 facility: Clinical Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: RECRUITING city: Miami Springs state: Florida zip: 33166 country: United States lat: 25.82232 lon: -80.2895 facility: Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Clinical Site status: RECRUITING city: Lawrenceville state: Georgia zip: 30046 country: United States lat: 33.95621 lon: -83.98796 facility: Clinical Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Clinical Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Site status: NOT_YET_RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States lat: 39.29038 lon: -76.61219 facility: Clinical Site status: NOT_YET_RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Site status: NOT_YET_RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States lat: 40.8 lon: -96.66696 facility: Clinical Site status: NOT_YET_RECRUITING city: Kinston state: North Carolina zip: 28504 country: United States lat: 35.26266 lon: -77.58164 facility: Clinical Site status: NOT_YET_RECRUITING city: Avon Lake state: Ohio zip: 44012 country: United States lat: 41.50532 lon: -82.0282 facility: Clinical Site status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Clinical Site status: NOT_YET_RECRUITING city: Garfield state: Ohio zip: 44125 country: United States facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73116 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Clinical Site status: NOT_YET_RECRUITING city: Frisco state: Texas zip: 75034 country: United States lat: 33.15067 lon: -96.82361 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77089 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77090 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Bellevue state: Washington zip: 98007 country: United States lat: 47.61038 lon: -122.20068 hasResults: False
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<|newrecord|> nctId: NCT06372951 id: Lung ultrasound in neonate briefTitle: Lung Ultrasound in Neonatal Intensive Care Units overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray . conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 132 type: ESTIMATED name: Ultrasound measure: Identifying causes of neonatal respiratory distress sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06372938 id: AEŞH-BADEK-2024-43 briefTitle: Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-30 date: 2024-04-30 date: 2024-04-18 date: 2024-04-18 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges. conditions: Fetal Growth Restriction conditions: Inflammatory Response studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Ultrasound measurement name: Laboratory Tests and Inflammatory Markers measure: Evaluation of data measure: Machine learning modeling sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Etlik City Hospital city: Ankara state: Yenimahalle zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06372925 id: CKJX839A1CN04 id: CKJX839A1CN04 type: OTHER domain: Novartis briefTitle: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction acronym: V-ACCELERATE overallStatus: NOT_YET_RECRUITING date: 2024-07-23 date: 2026-06-24 date: 2026-06-24 date: 2024-04-18 date: 2024-04-18 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C). conditions: Plaque, Atherosclerotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC). whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: atorvastatin name: IVUS/OCT name: inclisiran measure: Change in percent atheroma volume (PAV) measure: Change in minimum fibrous cap thickness (FCT) measure: Change in mean minimum FCT of all images measure: Change in normalized total atheroma volume (NTAV) measure: Proportion of participants with progression, regression, or no change in PAV measure: Change in LDL-C measure: Change in TC measure: Change in HDL-C measure: Change in non-HDL-C measure: Change in ApoB measure: Change in ApoA1 measure: Change in Lp(a) measure: Change in TG measure: Proportion of participants with LDL-C target attainment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372912 id: Complications-Bariatric-TJ briefTitle: Early Postoperative Complications in Patients Undergoing Bariatric Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery. conditions: Bariatric Surgery Candidate conditions: Complication,Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. measure: Rate of Postoperative Complications measure: Long-term Weight Loss Efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico. status: RECRUITING city: Tijuana state: Baja California zip: 22046 country: Mexico name: José a Guzmán Barba, MD, PhD role: CONTACT phone: 3471043237 email: • aldogbarba@hotmail.com lat: 32.5027 lon: -117.00371 hasResults: False
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<|newrecord|> nctId: NCT06372899 id: 855140 id: R01CA290541-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA290541-01A1 briefTitle: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2028-03-31 date: 2024-04-18 date: 2024-04-19 name: University of Pennsylvania class: OTHER name: National Cancer Institute (NCI) briefSummary: This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms. conditions: E-cigarette Use conditions: Cigarette Smoking conditions: Harm Reduction conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: E-cigarettes name: Oral nicotine pouches measure: Cigarette Consumption measure: Cigarette Smoking Across Follow-Up measure: Biomarkers of Exposure: Carbon Monoxide (CO) measure: Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%) measure: Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) measure: Biomarkers of Exposure:1-hydroxypyrene (1-HOP) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372886 id: 2402-147-1516 briefTitle: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment overallStatus: COMPLETED date: 2012-01-01 date: 2022-01-01 date: 2024-03-01 date: 2024-04-18 date: 2024-04-18 name: Seoul National University Hospital class: OTHER briefSummary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
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2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
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3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
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4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement. conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 264 type: ACTUAL name: portal/superior vein resection measure: 5-year overall survival measure: 5-year portal/superior mesenteric vein stenosis free survival sex: ALL maximumAge: 79 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372873 id: 2023PHB211-001 briefTitle: Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-04-30 date: 2025-05-30 date: 2024-04-18 date: 2024-04-23 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.
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The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise. conditions: Deep Learning conditions: Ultrasound conditions: Anterior Talofibular Ligament studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: re-evaluate by two senior radiologists in our medical center measure: To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06372860 id: RKS2018350 id: 3P20GM144269-02S2 type: NIH link: https://reporter.nih.gov/quickSearch/3P20GM144269-02S2 briefTitle: DPP Feasibility Study of Breastfeeding - eMOMS 2.0 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: University of Kansas Medical Center class: OTHER name: Ascension Health name: National Institute of General Medical Sciences (NIGMS) briefSummary: The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application. conditions: Overweight or Obesity conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Diabetes Prevention Program name: Breastfeeding name: Usual Care measure: Maternal weight measure: Maternal body mass index (BMI) measure: Initiation of Lactation measure: Duration of Lactation measure: Type of Infant Feeding measure: Recruitment Rate measure: Retention Rate measure: Research Engagement measure: Mobile Application Usage measure: Health Coach Interaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-04-09T16:15 filename: Prot_SAP_000.pdf size: 1164859 hasResults: False
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<|newrecord|> nctId: NCT06372847 id: Project ID 6214 briefTitle: DISE-HNS Effect Study acronym: DISE-HNS overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2028-03-31 date: 2028-03-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Antwerp class: OTHER briefSummary: The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.
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Furthermore, outcomes will be compared between responders and non-responders. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-and-after study primaryPurpose: BASIC_SCIENCE masking: NONE count: 58 type: ESTIMATED name: Hypoglossal nerve stimulation implant name: Polysomnography name: Drug-induced sleep endoscopy (DISE) measure: Δ%area-of-collapse at the level of the lateral walls measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders measure: DISE-score during baseline DISE and during one-year follow-up DISE. measure: Non-invasive site and pattern of collapse sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: Prot_SAP_000.pdf size: 425782 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: ICF_001.pdf size: 336420 hasResults: False
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<|newrecord|> nctId: NCT06372834 id: B202205178 briefTitle: Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial overallStatus: RECRUITING date: 2022-11-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Tri-Service General Hospital class: OTHER briefSummary: In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition. conditions: Major Depressive Disorder conditions: Treatment-Resistant Depression conditions: Suicide Ideations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: piTBS being delivered using the Magstim Rapid2 stimulator measure: The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session. measure: The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS). measure: The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS). measure: The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS). sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tri-service general hospital status: RECRUITING city: Taipei zip: 114 country: Taiwan name: Hsin-An Chang, M.D. role: CONTACT phone: 011-886-2-8792-3311 phoneExt: 17389 email: chang.ha@mail.ndmctsgh.edu.tw name: Hsin-An Chang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06372821 id: 158160 briefTitle: A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK acronym: NIO-SILK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-08 date: 2024-04-18 date: 2024-04-18 name: University College, London class: OTHER name: Washington University School of Medicine name: University of Washington name: Alzheimer's Association name: Sigrid Rausing Trust briefSummary: This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau. conditions: Alzheimer Disease conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: NIO752 name: Placebo measure: Tau synthesis rate inhibition in individuals with sporadic AD and ADAD measure: Compare efficacy of knockdown of tau production in sporadic AD and ADAD by measuring the synthesis rate of tau by determining the ratio of labelled to unlabeled tau (tracer to tracee ratio) in serial cerebrospinal fluid samples. measure: Number of participants with adverse events [safety and tolerability] measure: Comparison of number of Adverse Events reported between participants receiving one dose of NIO752 versus those receiving two doses of NIO752. measure: Compare rates of tau synthesis and clearance in sporadic AD and ADAD measure: Determine CSF tau concentration to tau production relationships in humans sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372808 id: 2022/118 briefTitle: The Effect of Plyometric Training in Freestyle Adolescent Wrestlers overallStatus: RECRUITING date: 2023-10-01 date: 2024-06-18 date: 2024-09-15 date: 2024-04-18 date: 2024-04-19 name: Hasan Kalyoncu University class: OTHER briefSummary: This study aims to determine the effect of plyometric exercises on physical fitness parameters in freestyle adolescent wrestlers. conditions: Physical Fitness conditions: Power studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: The Plyometric Exercise name: The Regular Training measure: Change from Baseline in Strength at 8 weeks measure: Change from Baseline in Endurance at 8 weeks measure: Change from Baseline in Agility at 8 weeks measure: Change from Baseline in Wrestling Performance at 8 weeks sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: Batipark Sports Hall status: RECRUITING city: Kahramanmaraş zip: 46050 country: Turkey name: Talha Gökçe, PT role: CONTACT phone: +905065624802 email: talhagokce89@gmail.com lat: 37.5847 lon: 36.92641 hasResults: False
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<|newrecord|> nctId: NCT06372795 id: KY2023635 briefTitle: Resistance Swallowing Training in Patients With Tracheotomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:
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* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
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* What medical problems do participants have when taking swallowing training?
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Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.
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Participants will:
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-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week. conditions: Swallowing Training on Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 66 type: ESTIMATED name: pure effortful swallowing name: progressive resistance swallowing training measure: Forced swallowing tongue pressure sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372782 id: 43CH2305 briefTitle: Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-18 date: 2024-04-18 name: Galderma R&D class: INDUSTRY briefSummary: This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects. conditions: Skin Aging of Dorsal Hands studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Restylane Skinboosters Vital Lidocaine name: Restylane Vital measure: The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Galderma Research Site 01 city: Shanghai state: Shanghai country: China name: Principle Investigator role: CONTACT lat: 31.22222 lon: 121.45806 facility: Galderma Research Site 02 city: Hangzhou state: Zhejiang country: China name: Principle Investigator role: CONTACT lat: 30.29365 lon: 120.16142 facility: Galderma Research Site 03 city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06372769 id: 20240304 briefTitle: Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder overallStatus: COMPLETED date: 2022-02-01 date: 2022-07-15 date: 2023-02-10 date: 2024-04-18 date: 2024-04-18 name: Stomatological Hospital Affiliated with Fujian Medical University class: OTHER briefSummary: This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices. conditions: Temporomandibular Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: electromyograph and kinesiograph measure: Surface electromyography (μV) measure: Mandibular kinematics (mm, mm/s) sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: The Affiliated Stomatological Hospital of Fujian Medical University city: Fuzhou state: Fujian zip: 350002 country: China lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06372756 id: 102122 briefTitle: Deep Learning Reconstruction Algorithms in Dual Low-dose CTA overallStatus: RECRUITING date: 2023-06-01 date: 2025-12 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Hao Tang class: OTHER briefSummary: The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: Deep learning image reconstruction measure: The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve. measure: The signal-to-noise ratio calculated from image CT values and noise sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Youfa M Tang role: CONTACT phone: +8613554101223 email: 1525573397@qq.com lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06372743 id: Alex Hospital briefTitle: Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity acronym: INTEGREATCKD overallStatus: RECRUITING date: 2023-11-01 date: 2025-05-31 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Alexandra Hospital class: OTHER name: National University Hospital, Singapore briefSummary: Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community.
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A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a dual-centre two-arm, open-label randomized controlled trial (RCT). Patients are randomized with a one-to-one allocation into two parallel groups. primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: INTEGREAT-CKD Intervention measure: Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire measure: Secondary outcome sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wei Zhen Hong status: RECRUITING city: Singapore zip: 119228 country: Singapore name: Wei Zhen Hong role: CONTACT phone: 97330789 email: wei_zhen_hong@nuhs.edu.sg name: Priyanka Khatri, MBBS role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06372730 id: 29BRC23.0161 id: 2023-A01566-39 type: OTHER domain: IDRCB briefTitle: Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT) acronym: PRONOSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-10 date: 2029-01 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.
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Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.
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Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.
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In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.
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In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.
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Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.
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The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence. conditions: Pulmonary Embolism conditions: Venous Thromboembolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort study primaryPurpose: PREVENTION masking: NONE count: 665 type: ESTIMATED name: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) measure: Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period. measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study. measure: Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old) measure: Potential predictors of RPVO including : demographics measure: Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council) measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life) measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH). measure: Mortality of all causes. measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton. measure: The following score will be computed : PADIS-PE score. measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens city: Amiens zip: 80054 country: France name: Marie-Antoinette SEVESTRE, Pr role: CONTACT phone: +33322087306 email: sevestre.marie-antoinette@chu-amiens.fr lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers zip: 49933 country: France name: Jeanne HERSANT, Pr role: CONTACT phone: +33661392285 email: Jeanne.hersant@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest zip: 29609 country: France name: Pierre-Yves LE ROUX, Pr role: CONTACT phone: +33298223327 email: pierre-yves.leroux@chu-brest.fr name: Francis COUTURAUD, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Hôpital Louis MourierAP-HP city: Colombes zip: 92700 country: France name: Isabelle MAHE, Pr role: CONTACT phone: +33147606490 email: isabelle.mahe@lmr.aphp.fr lat: 48.91882 lon: 2.25404 facility: CHD Vendée - La Roche sur Yon city: La Roche-sur-Yon zip: 85925 country: France name: Jean-Manuel KUBINA, Dr role: CONTACT phone: +33251446301 email: jean-manuel.kubina@ght85.fr lat: 46.66667 lon: -1.43333 facility: Kremlin-Bicêtre AP-HP city: Le Kremlin-Bicêtre zip: 94270 country: France name: David MONTANI, Pr role: CONTACT phone: +33145217976 email: david.montani@aphp.fr lat: 48.81471 lon: 2.36073 facility: CH Les Sables d'Olonne city: Les Sables-d'Olonne zip: 85340 country: France name: Nicolas BREBION role: CONTACT phone: +33251218824 email: nicolas.brebion@ght85.fr lat: 46.5 lon: -1.78333 facility: Hegp Ap-Hp city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: CH Quimper city: Quimper zip: 29000 country: France name: Charles ORIONE, Dr role: CONTACT phone: +33298526096 email: charles.orione@ch-cornouaille.fr lat: 48.0 lon: -4.1 facility: CHU St-Etienne city: Saint-Étienne zip: 42055 country: France name: Laurent BERTOLETTI, Pr role: CONTACT phone: +33477127770 email: laurent.bertoletti@chu-st-etienne.fr lat: 45.43389 lon: 4.39 facility: CHIC Toulon city: Toulon zip: 83056 country: France name: Jean-Noël POGGI, Dr role: CONTACT phone: +33494145787 email: jean-noel.poggi@ch-toulon.fr lat: 43.12442 lon: 5.92836 facility: HIA Toulon city: Toulon zip: 83800 country: France name: Antoine-Raphaël BRONSTEIN, Dr role: CONTACT phone: +33483162553 email: antoine-raphael.bronstein@intradef.gouv.fr lat: 43.12442 lon: 5.92836 facility: CHU Toulouse city: Toulouse zip: 31059 country: France name: Alessandra BURA-RIVIERE, Pr role: CONTACT phone: +33561322438 email: bura-riviere.a@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06372717 id: AP30CP01 briefTitle: A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-01 date: 2027-04-01 date: 2024-04-18 date: 2024-04-18 name: Apollo Therapeutics Ltd class: INDUSTRY briefSummary: This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only. conditions: Acute Myeloid Leukemia Refractory conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome With Excess Blasts conditions: Acute Myeloid Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: APL-4098 name: Azacitidine and APL-4098 measure: Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1) measure: Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1) measure: Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2) measure: Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372704 id: 2024/72 briefTitle: Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence? acronym: HIFEM for PPI overallStatus: COMPLETED date: 2024-02-01 date: 2024-04-01 date: 2024-04-05 date: 2024-04-18 date: 2024-04-24 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy. conditions: Prostate Cancer conditions: Incontinence conditions: Pelvic Floor Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 27 type: ACTUAL name: HIFEM measure: This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients. sex: MALE minimumAge: 63 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İbrahim Üntan city: Kirşehi̇r country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06372691 id: PoplitealApproach SciaticBlock briefTitle: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-18 date: 2024-04-18 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks. conditions: Adult conditions: Regional Anesthesia Morbidity conditions: Anesthesia Injection Site studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 809 type: ESTIMATED name: Subparaneural Injection (Grup S), Block name: Interneural Injection (Grup I), Block measure: Onset Time measure: Block Execution Times measure: Need for Multiple Injections Owing to Insufficient Anesthesia measure: Additional Rescue Analgesic measure: Adverse Effects to Anesthesia measure: Hemodynamic Effects Of The Block measure: Effects Of The Block On Heart Rate measure: Effects Of The Block On Peripheral Pulse Oximetry measure: Regression Time Of Sensory and Motor Block measure: Total Block Times sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372678 id: CM326-102102 briefTitle: Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-06-30 date: 2026-06-30 date: 2024-04-18 date: 2024-04-18 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). conditions: Chronic Rhinosinusitis With Nasal Polyps studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: CM326 name: Placebo measure: Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital, CMU city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06372665 id: CDB-IV-JE-025202301 briefTitle: Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-31 date: 2025-06-30 date: 2024-04-18 date: 2024-04-18 name: Liaoning Chengda Biotechnology CO., LTD class: INDUSTRY briefSummary: This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older. conditions: Japanese Encephalitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 28547 type: ESTIMATED measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events sex: ALL minimumAge: 8 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Provincial Center for Disease Control and Prevention status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Zhiguo Wang, Master role: CONTACT email: 120714991@QQ.com name: Zhiguo Wang, Master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06372652 id: TE-8214-001 briefTitle: A Phase 1 Study of TE-8214 Solution in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-10-10 date: 2024-12-26 date: 2024-04-18 date: 2024-04-19 name: Immunwork, Inc. class: INDUSTRY briefSummary: This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214. conditions: Acromegaly studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: TE-8214 - SAD name: Placebo measure: Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) measure: Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events measure: Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs) measure: Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings measure: Safety and tolerability of TE-8214 by the changes in physical examination findings measure: Safety and tolerability of TE-8214 by the changes in ECG findings measure: PK Parameters: Maximum observed concentration (Cmax) measure: PK Parameters: Time to maximum observed concentration (Tmax) measure: PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: CMAX Clinical Research city: Adelaide state: South Australia zip: 5000 country: Australia name: Jessica Gehlert, Dr role: CONTACT lat: -34.92866 lon: 138.59863 hasResults: False
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<|newrecord|> nctId: NCT06372639 id: TAU-PTSD-TMS briefTitle: Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS overallStatus: RECRUITING date: 2022-02-23 date: 2024-11-24 date: 2024-11-24 date: 2024-04-18 date: 2024-04-18 name: Tel Aviv University class: OTHER briefSummary: Characterization and modulation of traumatic memories in PTSD patients using TMS. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Trans-Cranial Magnetic Stimulation measure: CAPS-5 score measure: Neurological measures of functional connectivity measure: Intrusive memories sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tel Aviv University status: RECRUITING city: Tel Aviv zip: 69978 country: Israel name: Yair Bar-Haim, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 hasResults: False
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<|newrecord|> nctId: NCT06372626 id: ZG005-004 briefTitle: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-07 date: 2026-08 date: 2024-04-18 date: 2024-04-18 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment. conditions: Neuroendocrine Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 93 type: ESTIMATED name: ZG005 name: Etoposide name: Cisplatin name: Placebo measure: Dose Limiting Toxicity (DLT) measure: Objective Response Rate (ORR) measure: Adverse Event (AE) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China name: Jianming Xu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06372613 id: LRG&UC briefTitle: Association Between LRG and Endoscopic Remission in Ulcerative Colitis overallStatus: RECRUITING date: 2024-02-25 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Showa Inan General Hospital class: OTHER briefSummary: We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which predicts endoscopic remission in ulcerative colitis patients in this study. Colonoscopy with histology is performed when endoscopic remission will be predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were analyzed by an enzyme-linked immunosorbent assay. conditions: Ulcerative Colitis in Remission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Endoscopic remission of UC sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Showa Inan General Hospital status: RECRUITING city: Komagane country: Japan name: Akira Horiuchi role: CONTACT lat: 35.71657 lon: 137.93745 hasResults: False
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<|newrecord|> nctId: NCT06372600 id: 2023-181 briefTitle: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2025-12-31 date: 2026-02-20 date: 2024-04-18 date: 2024-04-18 name: Xiali Xue class: OTHER briefSummary: The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible. conditions: Rotator Cuff Tendinitis conditions: Rotator Cuff Tendinosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Extracorporeal shock wave therapy device name: Platelet-rich plasma measure: Visual Analogue Scale,VAS measure: American Shoulder and Elbow Surgeon's Form,ASES measure: the university of California at Los Angeles shoulder rating scale, UCLA measure: The location and size of the calcifications were examined by ultrasound sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06372587 id: 5502 briefTitle: Next-Generation alzheImer'S Therapeutics acronym: ENERGISE overallStatus: RECRUITING date: 2023-12-19 date: 2024-12-30 date: 2027-02-28 date: 2024-04-18 date: 2024-04-18 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Is this the right time to use next-generation approaches in Alzheimer's disease (AD)? In recent years, several large clinical trials testing treatments for AD have failed, putting the entire field on a reset. AD drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. Of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of AD. On the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of AD with multiple underlying hypotheses and multifactorial pathology. The idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. Thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in AD. By overcoming the limits of traditional AD therapeutic approaches, the investigators will use genetically encoded engineered proteins (GEEPs), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. Indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. The investigators designed GEEPs to address some of the leading causes of synaptic plasticity failures documented in AD. Thus, GEEPs will be tested in human induced pluripotent stem cells (hiPSCs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with Alzheimer's diseases. hiPSCs will be obtained from fibroblast-derived from a skin biopsy of participants with AD and controls performed in local anesthesia using a 4 mm punch. The findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on AD-related cognitive decline. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: genetically encoded engineered proteins measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons preventing dendritic spines loss measure: To leverage genetically encoded engineered proteins to prevent alterations in the morphology of dendritic spines in living human neurons measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons promoting functional synaptic plasticity measure: To use genetically encoded engineered proteins to obtain evaluate neuronal excitability in living human neurons sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: CRISTIAN RIPOLI role: CONTACT phone: +390630154966 email: cristian.ripoli@policlinicogemelli.it name: CRISTIAN RIPOLI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06372574 id: GO44669 briefTitle: A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-02-01 date: 2028-02-01 date: 2024-04-18 date: 2024-04-18 name: Genentech, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors. conditions: Refractory Cancer conditions: Recurrent Cancer conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: RO7617991 name: Tocilizumab measure: Incidence and Severity of Adverse Events measure: Number of Participants with Abnormal Values in Targeted Vital Signs measure: Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters measure: Serum Concentration of RO7617991 at Specific Timepoints measure: Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 measure: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1 measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 measure: Overall Survival (OS) measure: Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372561 id: Melatonin- vital pulp therapy briefTitle: Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study overallStatus: RECRUITING date: 2023-05-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-18 date: 2024-04-18 name: Suez Canal University class: OTHER briefSummary: The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts. conditions: Dental Caries in Children conditions: Vital Pulp Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: Mineral trioxide aggregate (dressing material) name: Melatonin (dressing material) measure: Clinically assessment (Modified visual analogue scale) measure: Clinically assessment (Millar's index) measure: Clinically assessment (presence or abscence) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Faculty of Medicine, Suez canal university status: RECRUITING city: Ismailia zip: 41522 country: Egypt name: Ismail Dahshan, PHD role: CONTACT phone: 01012715799 email: dahshan1633@gmail.com lat: 30.60427 lon: 32.27225 hasResults: False
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<|newrecord|> nctId: NCT06372548 id: NEADS0004 briefTitle: Rehabilitation Training Games for Children With Amblyopia overallStatus: RECRUITING date: 2023-03-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-18 date: 2024-04-18 name: Zhu Dian class: OTHER briefSummary: A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game. conditions: Amblyopia conditions: Amblyopia Occlusion conditions: Child Behavior conditions: Adherence, Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Find You! Cure My Animal Friends name: DuoBao Vision Training System measure: 8-Item Morisky Medication Adherence Scale (MMAS-8): measure: User Experience Questionnaire (UEQ) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD facility: Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200240 country: China name: Zhao Liu role: CONTACT phone: +8618901626266 email: hotlz@sjtu.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06372535 id: FujianUTCM-1 briefTitle: Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-15 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 540 type: ESTIMATED name: Tai Chi Chuan （dose 1） name: Tai Chi Chuan （dose 2） name: Tai Chi Chuan （dose 3） name: Tai Chi Chuan （dose 4） name: Tai Chi Chuan （dose 5） name: Tai Chi Chuan （dose 6） name: Tai Chi Chuan （dose 7） name: Tai Chi Chuan （dose 8） name: Tai Chi Chuan （dose 9） measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digital Symbol test measure: Trial Making Test part B measure: Stroop color word test measure: Boston naming test measure: Rey-Osterrieth complex graphics test measure: Rey Auditory Verbal Learning Test measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: Functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora measure: Sleep Quality measure: General health sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372522 id: RMB-0517-23 briefTitle: Oxytocin in Multiparous Women overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Rambam Health Care Campus class: OTHER briefSummary: This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 166 type: ESTIMATED name: Pitocin Injectable Product measure: The rate of women delivering within 24 hours. measure: Length of latent and active phases of labor. measure: The rate of instrumental and caesarean deliveries. measure: chorioamnionitis measure: obstetric anal sphincter injuries (OASIS) measure: hyponatremia measure: post-partum hemorrhage (PPH) measure: neonatal outcome - 1 and 5-minute Apgar score measure: umbilical artery pH measure: NICU admission measure: Women's satisfaction. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372509 id: L2-070 briefTitle: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease acronym: PMCD overallStatus: RECRUITING date: 2024-04-03 date: 2025-10-30 date: 2025-10-30 date: 2024-04-18 date: 2024-04-18 name: Centro Cardiologico Monzino class: OTHER name: IRCCS Policlinico S. Donato briefSummary: This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and CV risk factors. conditions: Coronary Artery Disease conditions: Migraine conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Correlation between migraine and proteomic profiling of plasma sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milano state: Milan zip: 20131 country: Italy name: Daniela Trabattoni, MD role: CONTACT phone: 0258002780 email: daniela.trabattoni@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06372496 id: 219912 briefTitle: Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2026-03-11 date: 2026-03-11 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY briefSummary: The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma conditions: Asthma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1136 type: ESTIMATED name: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate name: Inhaled corticosteroids/long-acting beta-2 agonists measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment measure: Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment measure: Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment measure: Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization measure: Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization. measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization. measure: Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Little Rock state: Arkansas zip: 72205 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Karl V Sitz role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site city: Newport Beach state: California zip: 92663 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ryan Mitchell Klein role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: GSK Investigational Site city: Miami state: Florida zip: 33135 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Enrique Villa role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ileana C. Rodicio role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Jaime Landman role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32819 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Marvin Heuer role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Port Charlotte state: Florida zip: 33952 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Joseph Ravid role: PRINCIPAL_INVESTIGATOR lat: 26.97617 lon: -82.09064 facility: GSK Investigational Site city: Tallahassee state: Florida zip: 32308 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Ronald H. Saff role: PRINCIPAL_INVESTIGATOR lat: 30.43826 lon: -84.28073 facility: GSK Investigational Site city: Columbus state: Georgia zip: 31904 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Robert R Chrzanowski role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: GSK Investigational Site city: Normal state: Illinois zip: 61761 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Dareen Siri role: PRINCIPAL_INVESTIGATOR lat: 40.5142 lon: -88.99063 facility: GSK Investigational Site city: Bangor state: Maine zip: 04401 country: United States name: US GSK Clinical 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hasResults: False
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<|newrecord|> nctId: NCT06372483 id: VMX-C001-03 id: 2023-507059-32-00 type: CTIS briefTitle: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant overallStatus: RECRUITING date: 2024-02-21 date: 2024-09 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: VarmX B.V. class: INDUSTRY briefSummary: A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:
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Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.
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Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects. conditions: Coagulation Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Placebo controlled, single dose. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: VMX-C001 name: Placebo name: Rivaroxaban 20 mg Oral Tablet name: Apixaban 5 mg Oral Tablet name: Edoxaban 60 mg Oral Tablet measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2) measure: PK of VMX-C001 in plasma - Cmax measure: PK of VMX-C001 in plasma - tmax measure: PK of VMX-C001 in plasma - t1/2 measure: PK of VMX-C001 in plasma - AUC0-last measure: PK of VMX-C001 in plasma - AUC0-inf measure: PK of VMX-C001 in plasma - Lambda z measure: PK of VMX-C001 in plasma - CL measure: PK of VMX-C001 in plasma - Vz measure: DOAC plasma concentrations (Part 2) measure: Change in Prothrombin time (PT) following dosing with VMX-C001 measure: Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001 measure: Change in D-dimer following dosing with VMX-C001 measure: Change in prothrombin fragments F1 and 2 following dosing with VMX-C001 measure: Change in thrombin generation, measured by lag time, following dosing with VMX-C001 measure: Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001 measure: Change in thrombin generation, measured by peak height, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to peak, following dosing with VMX-C001 measure: Change in thrombin generation, measured by velocity index, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to tail, following dosing with VMX-C001 measure: Change in diluted prothrombin time (dPT) following dosing with VMX-C001 measure: Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001 measure: Change in real time activated clotting time (ACT) following dosing with VMX-C001 measure: Antibodies against VMX-C001 in plasma measure: Antibodies against human coagulation FX in plasma sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON status: RECRUITING city: Groningen zip: 9728 NZ country: Netherlands name: Salah Hadi, MD role: CONTACT phone: +31 50 8505 798 email: info@iconclinicaltrials.com lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06372470 id: CLM-HTN-005 briefTitle: Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment acronym: OptiZest overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-18 date: 2024-04-23 name: Closed Loop Medicine class: INDUSTRY name: Pharmanovia briefSummary: A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation conditions: Uncomplicated Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Zestril measure: Achieving target Home Blood Pressure measure: Reduction in systolic blood pressure (SBP) measure: Reduction in diastolic blood pressure (DBP) measure: The time to achieve BP Control (BPC) measure: Patient daily adherence to prescribed medication measure: Adherence to collecting data using the electronic BP diary measure: Patients' thoughts and feelings about BP/treatment measure: Discontinuation of Zestril due to unwanted side effects measure: Number and type of spontaneously reported unwanted side effects measure: User experience and feasibility of the blood pressure digital diary sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norwich Health Centre status: RECRUITING city: Norwich country: United Kingdom name: Serge Engamba, MD role: CONTACT phone: 01603987074 email: serge.engamba@nhs.net name: Marc Buckingham role: CONTACT email: marc.buckingham@nhs.net lat: 52.62783 lon: 1.29834 hasResults: False
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<|newrecord|> nctId: NCT06372457 id: CV027-1107 briefTitle: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) acronym: COLLIGO-HCM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-01 date: 2025-03-01 date: 2025-06-15 date: 2024-04-18 date: 2024-04-18 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice. conditions: Hypertrophic Cardiomyopathy (HCM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Approved Hypertrophic Cardiomyopathy drug treatments name: Mavacamten measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant age at mavacamten treatment initiation measure: Participant sex measure: Participant race/ethnicity measure: Participant insurance coverage measure: Participant employment status measure: Participant educational level measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant height measure: Participant weight measure: Participant blood pressure measure: Participant heart rate measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms measure: European participant CYP2C19 genotype measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM) measure: Participant family history of sudden cardiac death (SCD) measure: Participant smoking status measure: Participant alcohol use measure: Participant recreational drug use measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT) measure: Participant cardiovascular (CV) and CV-related comorbidities measure: Participant non-cardiovascular (CV)-related comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant cardiac magnetic resonance imaging (MRI) results measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results measure: Participant cardiac troponin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Participant blood creatine levels measure: Participant cardiovascular (CV) events measure: Type of procedures received by participants measure: Cardiovascular treatments prescribed to participants measure: Date of mavacamten prescription measure: Date of mavacamten treatment initiation measure: Date of mavacamten dosage change measure: Reason for mavacamten dosage change measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose) measure: Dates of follow-up after mavacamten treatment initiation measure: Date of mavacamten treatment interuption or discontinuation measure: Reason for mavacamten treatment interuption or discontinuation measure: Supportive care provided to participants measure: Heath care resource utilization (HCRU) measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM) measure: Participant family history of sudden cardiac death (SCD) measure: Cardiovascular (CV) and CV-related comorbidities measure: Non-cardiovascular (non-CV) comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant echocardiogram (ECHO) results measure: Participant cardiac MRI results measure: Participant NT-proBNP results measure: Participant cardiac tropin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Hypertrophic Cardiomyopathy (HCM) subtype measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM) measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IQVIA city: Durham state: North Carolina zip: 27703 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06372444 id: 995725 briefTitle: Mechanisms of Acute Kidney Injury in Severe Infections acronym: PET-AKI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-03 date: 2026-06-30 date: 2024-04-18 date: 2024-04-19 name: Uppsala University Hospital class: OTHER briefSummary: Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations. conditions: Sepsis conditions: AKI - Acute Kidney Injury conditions: Positron Emission Tomography (PET) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Positron emission tomography (PET) measure: Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET) measure: Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET) sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06372431 id: D1843R00360 briefTitle: PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia acronym: PRIORITY-CKD overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2025-10-31 date: 2025-10-31 date: 2024-04-18 date: 2024-04-18 name: AstraZeneca class: INDUSTRY briefSummary: This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia.
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This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice. conditions: Arterial Hypertension, Chronic Kidney Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 10000 type: ESTIMATED measure: To describe the rate of CKD diagnosis in patients with AH and CKD markers. measure: To describe demographic and clinical characteristics of patients with AH and CKD markers measure: To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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