OncoTrials - мониторинг клинических исследований

Описание

Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis

Критерии включения

• * Age between 18-60 years
• * Written informed consent of the patient
• * Spontaneous arterial and/or venous thrombosis
• * infection-associated arterial and/or venous thrombosis within 30 days of infection
• * Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
• * Recurrent arterial or venous thrombosis despite anticoagulant therapy

Критерии исключения

• * Lack of consent of the patient
• * Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
• * Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
• * Thromboses more than 120 days old at the time of blood sampling

Описание

The goal of the study is to learn about the safety of MK-2060 and if people tolerate it when MK-2060 is given in different forms.

Критерии включения

• The key inclusion criteria include but are not limited to the following:
• * Is in good health before randomization
• * Has a body mass index (BMI) between ≥18 and ≤32 kg/m/^2, inclusive

Критерии исключения

• The key exclusion criteria include but are not limited to the following:
• * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• * Has a history of cancer

Описание

This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study is divided into two parts, called the single ascending dose (SAD) part and multiple ascending dose (MAD) part, and each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot yet be prescribed by doctors. In the SAD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.

Критерии включения

• * Male
• * Age 18-45 years (both inclusive) at the time of signing informed consent
• * Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m/^2) (both inclusive)
• * Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
• * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Критерии исключения

• * Factor VIII activity greater than or equal to (≥) 150% at screening
• * Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis
• * Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
• * Any of the thrombophilia markers listed below:
• * Protein C, protein S or antithrombin below the lower normal laboratory range
• * Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening

Описание

This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.

Критерии включения

• 1. Age ≥ 18 years /< 80 years
• 2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
• 3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• 4. RV/LV ratio of /> 0.9 on CTA as assessed by investigator (site determined).
• 5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• 6. Subject or subject`s legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care Protocol-specific procedures
• 7. Subject is willing and able to comply with all Protocol-required follow-up visits

Критерии исключения

• 1. Thrombolytic use within 30 days of baseline CTA
• 2. Pulmonary hypertension with peak pulmonary artery pressure /> 70 mmHg by right heart catheterization (site determined)
• 3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• 4. Unstable heart rate /> 130 beats per minute prior to procedure
• 5. FiO2 requirement /> 40% or /> 6 LPM to keep oxygen saturation /> 90%
• 6. Hematocrit /< 28%
• 7. Platelets /< 100,000/μL
• 8. Serum baseline creatinine /> 1.8 mg/dL
• 9. International normalized ratio (INR) /> 3
• 10. Major trauma injury severity score (ISS) /> 15 within the past 14 days
• 11. Presence of intracardiac lead in the right ventricle or right atrium placed /<180 days prior to the index procedure
• 12. Cardiovascular or pulmonary surgery within last 30 days
• 13. Actively progressing cancer requiring chemotherapy
• 14. Known bleeding diathesis or coagulation disorder
• 15. Left bundle branch block
• 16. History of severe or chronic pulmonary arterial hypertension
• 17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• 18. History of decompensated heart failure
• 19. Patients on extracorporeal membrane oxygenation (ECMO)
• 20. History of underlying lung disease that is oxygen dependent
• 21. History of chest irradiation
• 22. History of heparin-induced thrombocytopenia (HIT)
• 23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants
• 24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention
• 26. Life expectancy of /< 365 days, as determined by Investigator
• 27. Female who is pregnant or nursing
• 28. Current participation in another investigational drug or device treatment study
• 29. Inability to lay flat for procedure
• 30. Known presence of right-to-left cardiac shunt
• 31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
• 32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Описание

The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.

Критерии включения

• 1. The patient voluntarily joined the study and signed an informed consent form;
• 2. ≥18 and ≤ 75 years old, both male and female;
• 3. Pathologically confirmed hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST or RECIST 1.1 requirements;
• 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
• 5. BCLC-C stage accompanied by tumor thrombosis-associated portal hypertension;
• 6. Newly diagnosed patients who have not received local or systemic therapy in the past;
• 7. Expected survival period ≥ 3 months;
• 8. The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration): the absolute count of neutrophils≥1.5×10/^9/L; Platelet ≥50×10/^9/L; Hemoglobin ≥60 g/L; Serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal, the levels of FT3 and FT4 should be examined at the same time, if the levels of FT3 and FT4 are normal, they can be included in the group); Bilirubin≤2×ULN (within 7 days before the first administration); ALT and AST ≤5×ULN (within 7 days before the first dose); Serum creatinine≤1.5×ULN;
• 9. Child-Pugh score ≤ 13 points;
• 10. Diagnosed with portal hypertension-related complications: Gastrointestinal bleeding; refractory or recurrent ascites; hepatic pleural effusion; portal vein tumor thrombus exceeds 50% of lumen area.
• 11. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptive, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo surgical sterilization must be negative in serum or urine HCG within 72 hours before enrollment in the study; and must be non-lactating; for male patients whose partners are women of childbearing age, at the last time use effective methods for contraception within 3 months.

Критерии исключения

• 1. The patient has any active autoimmune disease or a history of autoimmune disease;
• 2. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose/>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment;
• 3. Severe allergic reaction to any compositions of donafenib tablets or contrast media containing iodine ;
• 4. Central nervous system metastasis;
• 5. Patients who have received liver transplantation in the past;
• 6. Tumor thrombus beyond the portal vein range, such as hepatic vein, inferior vena cava, right atrium, splenic vein, superior mesenteric vein;
• 7. Suffer from high blood pressure and cannot be well controlled by anti-hypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• 8. Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention , QTc/>450ms (male); QTc/>470ms (female); Abnormal coagulation function (INR/>2.0, PT/>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin;
• 9. Child-Pugh score />13 points;
• 10. Arterial/venous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• 11. Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.);
• 12. Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content/> 1.0 g;
• 13. The patient has active infection, fever of unknown origin within 7 days before medication ≥38.5℃, or baseline white blood cell count />15×109/L;
• 14. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons);
• 15. Moderate to severe pulmonary hypertension, pulmonary artery pressure was assessed by ultrasound />40mmHg；
• 16. The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
• 17. The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received apatinib therapy;
• 18. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and other abnormalities which may affect the efficacy and/or safety of patients.

Описание

This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).

Критерии включения

• 1. Age between 18 and 75 years old;
• 2. Patients with clinical diagnosis of Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT) (refer to the diagnostic criteria of the Chinese Expert Consensus on Multidisciplinary Diagnosis and Treatment of HCC with BDTT (2020 Edition)), BCLC Stage B or Stage C, and unresectable HCC (decided after multidisciplinary discussion);
• 3. Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;
• 4. Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT/MRI scan length diameter ≥ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.);
• 5. ECOG score: 0-1;
• 6. liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin ≤50umol/L is required. If higher than 50umol/L, biliary drainage is recommended;
• 7. Blood routine: absolute neutrophil count ≥1.5×10/^9/L, Hb≥8.5g/L, PLT≥75×10/^9/L;
• 8. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance />40mL/min;
• 9. Expected survival time greater than 3 months.

Критерии исключения

• 1. The tumor with extrahepatic metastasis or invaded adjacent organs;
• 2. Patients received other anti-tumor treatments;
• 3. Existence of contraindications to TACE;
• 4. History of allergy to the components or excipients of Lenvatinib or Tislelizumab;
• 5. The patient has any active autoimmune disease or has an autoimmune disease with expected relapse. Patients are on immunosuppressive or systemic hormone therapy for immunosuppression;
• 6. Patients with proteinuria suggestive of ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 1 g of 24-hour urine protein;
• 7. Patients with co-morbidities of other malignant tumors;
• 8. Patients with co-morbid psychiatric disorders;
• 9. Patients with pregnant or lactating women;
• 10. Patients with organ transplant patients;
• 11. Patients with hypothyroidism or hyperthyroidism.

Описание

Pulmonary embolism (PE) results from embolization of venous thrombi in the branches of the pulmonary arteries.

Although anticoagulation is usually the preferred method of treatment, patients with high-risk and/or intermediate/high-risk pulmonary embolism may benefit from immediate reperfusion therapy, such as mechanical catheter thrombectomy. During this procedure, there may be an increase in pulmonary pressures caused by the introduction of pulmonary catheters, which may trigger hemodynamic instability. In addition, anesthesia performed during percutaneous mechanical thrombectomy may precipitate hemodynamic and respiratory compromise due to hypoxia, hypercapnia and increased airway pressure.

We will perform a retrospective, single-center study to determine the incidence and immediate causes of hemodynamic and/or respiratory deterioration, before, during and after (first 30 days) of percutaneous pulmonary thrombectomy, as well as the need for mechanical respiratory/circulatory support.

Критерии включения

• * Patients over 18 years of age
• * Patients with high/intermediate risk of pulmonary embolism who undergo pulmonary mechanical thrombectomy

Критерии исключения

• * Patients under 18 years of age
• * Low-risk pulmonary embolism patients
• * Patients who do not undergo pulmonary mechanical thrombectomy

Описание

Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world.

The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French.

Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases).

The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.

Критерии включения

• * Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship
• * Willing to complete the anonymous WAST self-questionnaire
• * able to read and understand French
• * Outpatient consultant at Nîmes University Hospital in one of the following departments:
• * Biological hematology consultation
• * Clinical hematology consultation
• * Vascular medicine consultation

Критерии исключения

• * Individuals under court protection, guardianship or curatorship
• * Individuals unable to read and understand French
• * Individuals who have already completed the WAST questionnaire during the study period
• * Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation

Описание

The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.

The exercise program used aims to improve joint mobility, muscle strength, static and dynamic balance, motor coordination.

The program is structured in 1 hour sessions of 2 days/week and lasts 6 months.

The primary endpoint is the change in functional capacity calculated as the difference between the baseline assessment and the 3 and 6 month assessment of the 6 Minutes Walking Test measured with the G-Walk (BTS Bioengineering S.p.A).

Критерии включения

• * Diagnosis of hemophilia A or B;
• * Signature of informed consent;
• * Availability of a medical certificate for non-competitive activities

Критерии исключения

• * Active bleeding
• * Severe joint deformities that prevent exercise
• * Insufficiency of communicative and/or sensory functions so severe that it is impossible to understand or carry out the trainer`s instructions (dementia, aphasia, blindness, deafness)
• * Heart failure (NYHA class /> 2)
• * Unstable angina
• * Lung disease requiring oxygen therapy
• * Symptomatic peripheral arterial disease
• * Myocardial infarction or hospitalization within the previous 6 months
• * Symptomatic orthostatic hypotension
• * Hypertension in poor pharmacological control (diastolic/> 95 mmHg, systolic/> 160 mmHg)
• * Significant neurological conditions that impair motor or cognitive function

Описание

Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis.

Критерии включения

• * Patients aged 18 years and older
• * Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level /> 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation
• * Requiring renal replacement therapy according to consensus indications:
• * KDIGO stage 3 acute kidney injury with oliguria or anuria persisting for more than 72 hours
• * Urea /> 40 mmol/L
• * Plasma potassium /> 5.5 mmol/L despite medical treatment
• * pH /< 7.15 (pure metabolic acidosis with PaCO2 /< 30 mmHg or mixed acidosis with PaCO2 /> 50 mmHg without the possibility of improving alveolar ventilation)
• * Acute pulmonary edema secondary to hydrosaline overload resulting in severe hypoxemia (oxygen flow /> 5 L/min or FiO2 /> 50% during mechanical ventilation to maintain SaO2 /> 95%) despite diuretic therapy
• * Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane)

Критерии исключения

• * Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmann thrombasthenia, Gray`s syndrome or dense granule disease)
• * Myelodysplastic or myeloproliferative syndrome
• * Autoimmune thrombocytopenic purpura
• * Acute leukemia
• * Hemorrhagic shock
• * Platelet transfusion within 7 days prior to inclusion
• * Antiplatelet therapy with clopidogrel or ticagrelor within 5 days prior to inclusion, prasugrel or dipyridamole within 7 days prior to inclusion
• * Active HIV infection or hepatitis B or C
• * Pregnant woman
• * Not affiliated to a social security system or not benefiting from such a system

Описание

This project aims to identify catheter-related thrombosis (CRT) and determine its incidence, associated factors, and outcomes. The eligible patients will undergo daily ultrasound just distal to the central venous catheter insertion site for CRT. A staff radiologist will review all positive cases. These cases will be monitored by daily ultrasound examination till three days after the removal of the catheter or till the patient stays in the intensive care unit (ICU). The patient demographics, ICU treatment details, and outcomes will be noted. The data will be then analyzed. A preventive strategy will be prepared and disseminated to the department personnel to improve the quality of care.

Критерии включения

• * Adult patients (/>18 years of age) undergoing Central Venous Catheter (CVC) placements in the ICU or emergency department while waiting for admission to the ICU.

Критерии исключения

• * Pre-existing deep vein thrombosis (DVT),
• * Pre-existing CVC at ICU admission (other than placement in the emergency department)
• * Refusal to consent.

Описание

While blood clots after major cancer surgery are common and harmful to patients, the medications to decrease blood clot risk are seldom used after patients leave the hospital despite the recommendation of multiple professional medical societies. The reason why these medications are seldom prescribed is not well understood. The main questions this study aims to answer are:

* Does surgeon education paired with an electronic medical record based decision support tool improve the guideline concordant prescription of pharmacologic venous thromboembolism after abdominopelvic cancer surgery?
* Does dedicated patient education regarding blood clots at the time of hospital discharge after abdominopelvic cancer surgery improve understanding of the risk of venous thromboembolism and adherence to pharmacologic prophylaxis?

The investigators will study these questions using a stepped-wedge randomized trial where groups of surgeons will use a tool integrated to the electronic medical record to educate them on the individualized patient risks of blood clots after major cancer surgery and inform them regarding guidelines for preventative medicines. Utilization of the medications before and after using the tool will be compared.

Patients will be administered a questionnaire assessing their awareness of blood clots as a risk after cancer surgery. For those prescribed medications to reduce blood clot risk after leaving the hospital, the questionnaire will evaluate whether they took the medications as prescribed. Survey results will be evaluated before and after implementation of education on blood clot risk at the time of hospital discharge.

Критерии включения

• SURGEON CLUSTER
• Inclusion Criteria:
• * Surgeons performing cancer surgery within the Medical University of South Carolina (MUSC) system will be identified. Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/exclusion criteria as follows. "Abdominopelvic cancer surgery" includes esophagectomy, gastrectomy, pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / oophorectomy performed for a diagnosis of cancer as identified by Current Procedural Terminology (CPT) code and International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code.

Критерии исключения

• * We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as ePpx duration is for 30 days postoperative.
• PATIENT SURVEY
• Inclusion Criteria:
• * Patients undergoing surgery for included cancers in the three hospitals will be identified using inclusion/exclusion criteria as follows. "Abdominopelvic cancer surgery" includes esophagectomy, gastrectomy, pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / oophorectomy performed for a diagnosis of cancer as identified by Current Procedural Terminology (CPT) code and International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code.
• Exclusion Criteria:
• * We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as extended pharmacologic venous thromboembolism duration is for 30 days postoperative.
• * Lack of survey response.

Описание

The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.

Критерии включения

• 1. Age ≥18 years on the date of consent
• 2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
• 3. Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
• * Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors)
• * Renal embolization
• * Portal vein branches
• 4. Informed consent granted by the patient or legally authorized representative
• 5. Willing and able to comply with the protocol-specified procedures and assessments

Критерии исключения

• 1. Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
• 2. Has undergone an embolization procedure within 30 days prior to consent
• 3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
• 4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
• 5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
• 6. Pregnant, planning to become pregnant during the study period, or breastfeeding
• 7. Unresolved systemic infection or localized infection in the targeted region
• 8. Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
• 9. Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
• 10. Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
• 11. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
• Intra-procedural exclusion criteria:
• 13. Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions 14. Presence of collateral pathways potentially endangering normal territories during embolization 15. Blood flow precludes safe delivery of embolic material (e.g., arteriovenous shunting or high, unpredictable flow exists) 16. Anatomy that precludes advancement of the delivery device to target vessel embolization site or delivery of embolic material 17. Dissection in the target vessel 18. The delivery device has already been used with an ionic contrast agent (e.g., Conray® (iothalamate meglumine injection USP 60%), Guerbet)

Описание

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after unilateral total knee replacement surgery.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Критерии включения

• 1. Undergoing a primary elective unilateral TKA
• 2. Has a body weight ≤130 kg at screening visit
• 3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECG`s) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
• 4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Критерии исключения

• 1. History of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis
• 2. History of thromboembolic disease or thrombophilia
• 3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months
• 4. History of major trauma within approximately the past 6 months prior to dosing
• 5. Hospitalized (/>24 hours) for any reason within 30 days of the screening visit
• 6. Has an estimated glomerular filtration rate (GFR) of /<45 mL/min/1.73m/^2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation
• Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Описание

Major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (PE). These improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of Chronic Thrombo-embolic Disease (CTED). In most of the situations, it is due to a residual pulmonary vascular obstruction (RPVO) which can be assessed by pulmonary scintigraphy.

Критерии включения

• * Patient addressed to nuclear medicine department of Saint-Etienne public hospital for V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, admitted for a suspicion of pulmonary hypertension (PH), or a persistent dyspnea after PE
• * Patient affiliated ou beneficiary of social security.

Критерии исключения

• * Pregnant patient.
• * Patient addressed to nuclear medicine department for acute pulmonary embolism.
• * Impossibility of the entire protocol acquisitions realization.

Описание

The ARTS trial is a pragmatic, international, multicenter, randomized controlled open label trial comparing a DOAC - oral factor Xa inhibitor apixaban - to no anticoagulant among 5,436 patients undergoing abdominal or pelvic surgery at sufficiently similar (and not high) risk of VTE and bleeding that the net impact - benefit or harm - of thromboprophylaxis remains in doubt.

Критерии включения

• * Informed consent provided
• * Adult patients (≥18 years);
• * Undergoing elective abdominal or pelvic surgery at similar (and not high) risk of VTE and bleeding

Критерии исключения

• * Inability to provide informed consent
• * Patient with active bleeding/hemorrhage during the last 6 months if not expected to be treated by surgery planned
• * Lesion or condition if considered a significant risk factor for major bleeding
• a. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• * Anticoagulant treatment, antiplatelet treatment or omega-3 dietary supplement during previous 7 days preceding surgery and/or requiring within 30 days post-surgery
• * Patient who had during previous 6 months or are expected require within 30 days post-surgery chemotherapy/radiation or hormone therapy for cancer
• * Known thrombophilia
• * Known bleeding disorder
• * Substantial liver impairment (for instance INR 1.4 or more during last 60 days)
• * eGRF /<30 mL/min/1.73 m2
• * Platelet count /<100 × 109/L (that is, 100 000 mg/L)
• * Hb /<90 g/L (that is, /<9 g/dL)
• * ALT />2 × upper limit of normal
• * Known allergy to apixaban
• * Taking strong inhibitors or inductors of both CYP 3A4 and P-glycoprotein, such as anti-seizure medications (e.g. phenytoin, fosphenytoin, carbamazepine), azole-antimycotics (e.g. ketoconazole, itraconazole), HIV-protease inhibitors (e.g. ritonavir, indinavir) and rifampicin
• * Concomitant procedures with high risk of VTE/bleeding
• * Previous VTE
• * Pregnant or breast-feeding female patients
• * Female participants who have had periods in the last 12 months and who are not using highly reliable contraception: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); ii) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); iii) intrauterine device (IUD); iv) intrauterine hormone-releasing system (IUS); v) bilateral tubal occlusion; vi) vasectomized partner; and vii) sexual abstinence from heterosexual intercourse during the entire period of risk associated with the study treatments
• * Previous randomization in this trial
• * Any reason why, in the opinion of the investigator(s), the patient should not participate

Описание

The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.

Критерии включения

• 1. Age ≥ 18 years
• 2. Patients with stent age /> 6 weeks
• 3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
• 4. RevCore Thrombectomy Catheter must enter vasculature
• 5. Willing and able to provide informed consent

Критерии исключения

• 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
• 2. Stents not wall apposed
• 3. Stents compressed to /<10mm
• 4. Bilateral in-stent thrombosis
• 5. Congenital anatomic anomalies of the iliac veins
• 6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
• 7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• 8. Chronic non-ambulatory status
• 9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• 10. Inability to secure venous access
• 11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• 12. Current participation in another investigational drug or device treatment study

Описание

The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are:

1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases.
2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.

Критерии включения

• * Males or females, age must be 18 years old or above.
• * Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data.
• * Patients must have a clear clinical diagnosis.
• * All participants must sign a written informed consent form.

Критерии исключения

• * Pregnant women.
• * Individuals with a history of cancer other than lung disease.
• * Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants.
• * Individuals with other severe organic diseases or mental illnesses.
• * Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc.
• * Any other condition that researchers deem unsuitable for participation in this clinical trial.

Описание

The aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.

Критерии включения

• * over 20 years old and diagnosed with severe hemophilia
• * those who receive prophylaxis regularly
• * there are more than 2 target joints (hemophilic arthropathy)

Критерии исключения

• * unwilling to sign the informed consent
• * any neurological disease or specific musculoskeletal condition (such as fracture) one year ago
• * more than 3 (excluding 3) joint replacement surgeries (different joints)
• * unable to walk due to hemophilia joint disease or any other diseases
• * major bleeding events that pose risks or hinder research
• * unable to follow instructions due to cognitive impairment

Описание

Pulmonary embolism (PE) is a highly morbid and fatal cardiovascular disease. Right ventricular dysfunction (RVD) secondary to PE indicates a poor prognosis and serves as a critical basis for risk stratification. Recent studies have shown that over one-third of patients continue to experience RVD one year after PE, with the mechanisms and regression remaining unclear. Although electrocardiography (ECG) is the most commonly used test for cardiac disease, its diagnostic specificity for PE is limited.

In recent years, artificial intelligence (AI) has successfully extracted hundreds of features from data that are difficult for the human eye to recognize. The correlation between daily vital signs monitored by wearable devices and functional signs of chronic cardiovascular disease suggests the potential of AI in detecting disease progression. There is a lack of specific markers for right ventricular function post-PE, and the significance and changes of these markers in disease progression have not yet been explored.

This study aims to develop a predictive model for the progression of RVD after PE using AI, combining electromyography, wearable devices, and vitality markers. In this prospective cohort study, 500 patients with acute PE at intermediate or higher risk were enrolled. Approximately 200 patients with RVD at discharge were followed for one year, with daily electromyographic data collected using portable electromyographs. Biospecimens were collected at the following time points: admission, discharge, and follow-up at 3, 6, and 12 months and a variety of inflammatory markers were measured using a multifactorial assay on liquid suspension cores. These data were integrated into a continuous disease diagnostic model based on a deep learning restrictive updating strategy.

Ultimately, a continuous disease diagnosis and prognosis algorithm was developed, yielding a model for predicting the progression of RVD after PE using multifactorial assays on liquid suspension cores to measure various inflammatory markers.

Критерии включения

• 1. Age ≥18 years;
• 2. Patients with confirmed diagnosis of PE (refer to the 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism);
• 3. Onset ≤14 days from diagnosis; (4) Risk stratification of intermediate-low risk, intermediate-high risk, and high-risk according to the 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism;
• 5) Patients agree to sign informed consent.

Критерии исключения

• 1. A previous diagnosis of VTE with no evidence of recurrence, re-hospitalisation or treatment.
• 2. Unable to attach the cardiac acquisition system due to chest surgery, localised damage, allergy, etc.
• 3. Unable to complete the 1-year follow-up.
• 4. Unable to operate portable mapping due to cognitive impairment, lack of a smartphone, etc.

Описание

Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.

The displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.

Meniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.

Utilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.

The purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.

Критерии включения

• * Presenting with a painful meniscus (lateral or medial) longitudinal tear
• * Being between the ages of 18 and 50
• * Not having undergone surgery on the same knee before
• * Having an MRI taken at the end of the 1st year post-surgery

Критерии исключения

• * Having additional collateral ligamentous damage along with the meniscus tear (such as MCL or LCL)
• * Incomplete clinical scores at the end of the study
• * A history of previous surgery on the same knee
• * Having an active infection
• * Not having a control MRI at the end of the 1st year

Описание

Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body`s joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients.

This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. Study participants will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. Participants will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months.

Критерии включения

• * Patients of any adult age with symptomatic hemarthropathy of the ankle, knee, or elbow, based on radiographs within the last 24 months.
• * Patients must have failed at least six weeks of conventional conservative treatments (such as medication or physical therapy).

Критерии исключения

• * Exclusion criteria will include recent (last two years) surgery to the affected joint, prior joint replacement.
• * Prior orthobiologic injection into the affected joint.
• * Thrombocytopenia
• * Inability to receive factor prior to PRP injection.
• * Active systemic or local infection at the site of injection,
• * Non-ambulatory patients
• * Body mass index (BMI) over 50
• * Recent (six month) or current corticosteroid injection/intake.
• Patients with hemarthropathy in multiple joints will be eligible for up to 2 joints if multiple fit the criteria.

Описание

Along with the current clinical trial, the efficacy and safety of a 150 mg Bid dabigatran administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to 20 mg rivaroxaban were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral hemorrhagic complications

Критерии включения

• * 1-Patients aged 18 and above 2-New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT/CT venogram or MRI/MR venogram 3-Ability to randomize within 14 days of neuroimaging-confirmed diagnosis 4-The treating clinician thinks that the patient is appropriate for oral anticoagulation as per the standard of care 5-The patient or legally authorized representative can give written informed consent

Критерии исключения

• 1. The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis
• 2. The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation
• 3. Patient is unable to swallow due to depressed level of consciousness
• 4. Impaired renal function (i.e., CrCl /< 30 mL/min using CockroftGault equation)
• 5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive
• 6. Breastfeeding at the time of randomization
• 7. Bleeding diathesis or other contraindication to anticoagulation
• 8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
• 9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
• 10. Patient has a severe or fatal comorbid illness that will prevent improvement

Описание

To Evaluate the Safety and Efficacy of the Super-Bore 8F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.

Критерии включения

• 1. Age ≥18 years.
• 2. The clinical manifestations are consistent with acute cerebral infarction.
• 3. Patients can receive mechanical thrombectomy within 24 hours of onset .
• 4. The mRS score before onset was 0 or 1.
• 5. The NIHSS score at the time of onset was 6 or above.
• 6. Patients with eTICI 0-1 blood flow confirmed by angiography who can undergo intravascular thrombectomy, the occlusion includes the following locations: the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), the vertebral artery, or the basilar artery with vessel diameter ≥2.7 mm at the occlusion site.
• 7. ASPECTS or PC-ASPECTS score of 6-10 on NCCT or DWI-MRI .
• 8. Written informed consent obtained from patient or patient`s legally authorized representative.

Критерии исключения

• 1. Pregnant or lactating or positive pregnancy test on admission.
• 2. Patients with severe allergic reactions to contrast agent.
• 3. Current participation in another drug or device research that may affect the results of this study.
• 4. Patients with known hereditary or acquired bleeding disorders or coagulation factor deficiencies.
• 5. Patients with severely impaired renal function.
• 6. Patients whose expected survival is less than 90 days.
• 7. Clinical manifestations suggest subarachnoid hemorrhage, even if the CT or MRI scan is normal.
• 8. Patients with suspected aortic dissection.
• 9. Patients whose arterial conditions prevent the thrombectomy device from reaching the target vessel or impair safe retrieval.
• 10. Patients with angiographic findings of carotid artery dissection.
• 11. Patients with CT or MRI suggesting intracranial hemorrhage.
• 12. Patients with CT or MRI suggesting intracranial mass effect or tumors (except small meningiomas).
• 13. Patients with evidence of cerebral vasculitis on CT or MRI.
• 14. Patients with excessive infarct core volume revealed by CT or MRI.
• 15. The researchers believe that patients with imaging evidence suggest that they are not suitable for mechanical thrombectomy intervention.

Описание

Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels.

The study treatment BAY3018250 is under development to treat acute venous and arterial thrombotic and thromboembolic events. It aims to work by dissolving blood clots in the blood vessels.

In this study, participants will be healthy and will not benefit from receiving BAY3018250. However, the study will provide information on how to test BAY3018250 in future studies in people with acute venous and arterial thrombotic and thromboembolic events.

During the study, researchers will use two different methods of giving BAY3018250 to participants. This may help in developing a faster method of giving this treatment in case of emergencies.

The main purpose of this study is to check how safe BAY3018250 is and if it is well tolerated by participants. For this, researchers will study the number and severity of medical problems in:

* healthy Japanese men after receiving different doses of BAY3018250 as an infusion into a vein.
* healthy adult participants after receiving a certain dose of BAY3018250 by an injection.

These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatment.

This study will have two parts: Part A and Part B:

- Only healthy Japanese men can join Part A of the study, which will have two groups. In the first group, participants will receive a low dose of BAY3018250. If researchers consider this dose to be safe, the next group will receive a higher dose.

In each group, participants will be randomly assigned to receive BAY3018250 or placebo as an infusion into a vein once during the study. A placebo looks like a study drug but does not have any medicine in it.

- Healthy men and women can join Part B of the study. Participants will be randomly assigned to receive a certain dose of BAY3018250 or placebo by an injection once during the study.

Each participant will be in the study for around 14 weeks, which includes:

* a visit to the hospital within 3 weeks of taking any treatment to confirm if the participant can take part in the study
* a hospital stay of 1 week, during which participants will receive their assigned treatment, have blood and urine tests and complete health check-ups
* six follow-up visits to the hospital until about 11 weeks after receiving the study treatments During the study, the doctors and their study team will check participants` health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) As this study is conducted in healthy participants who will not benefit from the treatment, access to the treatment after the study is not planned.

Критерии включения

• Inclusion:
• Part A:
• * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and electrocardiogram (ECG).
• * Japanese who was born in Japan and whose parents and grandparents must have been Japanese and who has not lived outside of Japan for more than 10 years and has not significantly modified their diets since leaving Japan.
• * Male
• Part B:
• * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and ECG.
• * Male or female (postmenopausal or hysterectomized only)

Критерии исключения

• * Medical disorder, condition (e.g., after surgical procedure), or history of such that would impair the participant`s ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
• * Increased bleeding risk: known coagulation disorders (e.g., von Willebrand´s disease, hemophilia), periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, or similar diseases with tendency to lead to bleedings, known sensitivity to common causes of bleeding (e.g., nasal, etc.), or history of hemorrhage and gastrointestinal ulceration within 6 months prior to the screening visit.
• * Family history of hereditary or not explainable bleeding disorders.
• * History of thrombosis or family history of hereditary or not explainable diseases with increased risk for thrombosis or thromboembolic events.
• * Tendency of easy bruising.
• * Platelets out of reference range.
• * Activated partial thromboplastin time (aPTT) or prothrombin time (PT) out of reference range.

Описание

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia

Критерии включения

• * Male participants greater than or equal to (/>=) 12 and less than or equal to (/<=) 65 years of age at the time of informed consent
• * Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.
• * Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation

Критерии исключения

• * Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
• * Participation in another interventional clinical trial, except for SerpinPC trials
• * Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study
• * Treatment with anticoagulant or antiplatelet drugs

Описание

This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.

Критерии включения

• 1. Age ≥ 18 years /< 80 years
• 2. Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
• 3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• 4. RV/LV ratio of /> 0.9 on CTA as assessed by investigator (site determined).
• 5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• 6. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care clinical investigation plan specific procedures
• 7. Subject is willing and able to comply with all clinical investigation plan required follow-up visits

Критерии исключения

• 1. Thrombolytic use within 30 days of baseline CTA
• 2. Pulmonary hypertension with peak pulmonary artery pressure /> 70 mmHg by right heart catheterization (site determined)
• 3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• 4. Unstable heart rate /> 130 beats per minute prior to procedure
• 5. FiO2 requirement /> 40% or /> 6 LPM to keep oxygen saturation /> 90%
• 6. Hematocrit /< 28%
• 7. Platelets /< 100,000/µL
• 8. Serum baseline creatinine /> 1.8 mg/dL
• 9. International normalized ratio (INR) /> 3
• 10. Major trauma injury severity score (ISS) /> 15 within the past 14 days
• 11. Presence of intracardiac lead in the right ventricle or right atrium placed /<180 days prior to the index procedure
• 12. Cardiovascular or pulmonary surgery within last 30 days
• 13. Actively progressing cancer requiring chemotherapy
• 14. Known bleeding diathesis or coagulation disorder
• 15. Left bundle branch block
• 16. History of severe or chronic pulmonary arterial hypertension
• 17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• 18. History of decompensated heart failure
• 19. Patients on extracorporeal membrane oxygenation (ECMO)
• 20. History of underlying lung disease that is oxygen dependent
• 21. History of chest irradiation
• 22. History of heparin-induced thrombocytopenia (HIT)
• 23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants
• 24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention
• 26. Life expectancy of /< 365 days, as determined by Investigator
• 27. Female who is pregnant or nursing
• 28. Current participation in another investigational drug or device treatment study
• 29. Inability to lay flat for procedure
• 30. Known presence of right-to-left cardiac shunt
• 31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
• 32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Описание

With the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antiplatelet therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients. Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation.

Критерии включения

• 1. male or non-pregnant women aged 18-75 years;
• 2. IA confirmed by CTA, MRA or DSA;
• 3. IA size ranged from 3 mm to 25mm;
• 4. Patients and/or their authorized persons can understand the purpose of the study, voluntarily participate in and sign informed consent;
• 5. patients who were considered by the investigators to be suitable for stent treatment;
• 6. patients who were willing to be followed up and evaluated according to the clinical research protocol.

Критерии исключения

• 1. Patients with contraindications to atorvastatin treatment or patients sensitive to atorvastatin; "Female patients who are preparing for pregnancy, pregnant, or lactating."
• 2. patients with intracranial aneurysm (excluding other cardiovascular and cerebrovascular diseases).
• 3. patients with indications for atorvastatin treatment (according to the Chinese Guidelines for Lipid Management (2023)).
• 4. patients with ruptured aneurysms.
• 5. taking transport protein inhibitors, cyclosporine, protease inhibitors, other lipid-lowering products (fibrates, ezetimibe, evolocumab), antacids, erythromycin, cytochrome P450 enzymes, colchicine and other concomitant drugs that interact with atorvastatin metabolism.
• 6. patients who did not understand or were unwilling to follow up and evaluate according to the clinical research protocol.
• 7. life expectancy /<3 years.

Описание

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Критерии включения

• 1. Women/girls with haemophilia A (FVIII:C ≥1-/<40%) according to medical history
• 2. At least 12 years of age
• 3. Scheduled to undergo major elective surgery requiring FVIII treatment
• 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Критерии исключения

• 1. Coagulation disorder other than haemophilia A
• 2. Present or past FVIII inhibitor (≥0.6 Bethesda units /[BU/]/mL)
• 3. Severe liver or kidney disease (alanine aminotransferase /[ALT/] and/or aspartate aminotransferase /[AST/] levels />5 times the upper limit of normal; or creatinine />120 μmol/L)
• 4. Known hypersensitivity to Nuwiq`s active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
• 5. Pregnancy
• 6. Already had surgery in this study
• 7. Current participation in another interventional clinical trial
• 8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Описание

Hemophilia is a rare X-linked congenital bleeding disorder characterized by deficiency of clotting factor VIII (hemophilia A) or deficiency of factor IX (hemophilia B) with complex diagnosis and management. Participation in physical activity is still limited in children with hemophilia, probably due to protective attitudes of families/patients and avoidance of activity, and possibly also as a result of chronic pain. Exercise capacity has been identified as a protective factor against joint problems in hemophilia. Aerobic fitness is associated with better pulmonary function in children. Chronic pain and decreased range of motion due to recurrent bleeding in joints and muscles in hemophilia may indirectly affect posture and respiratory mechanics, leading to impaired pulmonary function. This study aims to compare pulmonary function, exercise capacity, posture, and physical activity level between children with hemophilia and healthy controls and to investigate the relationship between these parameters.

Критерии включения

• Hemophilia group
• Inclusion criteria:
• * Having been diagnosed with hemophilia and being clinically stable,
• * Being between the ages of 8-18,
• * Being on prophylaxis treatment (a routine treatment),
• * Being 125 cm or taller,
• * Being inhibitor negative at the time of enrollment,
• * To be able to cooperate with the tests to be performed,
• * Being willing to participate in the study.

Критерии исключения

• * Being inhibitor positive at the time of enrollment,
• * Having a history of acute joint bleeding,
• * Being unable to bear weight on the extremities,
• * Having a history of acute intramuscular bleeding,
• * Having undergone radionuclide synovectomy,
• * Having a history of surgery on any of the lower extremity joints,
• * Having a severe cardiovascular, orthopedic or neurological problem that may affect the assessments.
• Control group
• Inclusion criteria:
• * Not having any known internal or chronic disease
• * Being male between the ages of 8-18
• * Having full range of motion in the upper extremity
• * Having full range of motion in the lower extremity
• * Not having any history of injury or surgery in the lower extremity
• * Being 125 cm or taller
• * Being willing to participate in the study
• Exclusion criteria:
• * Having any problem that may affect the tests
• * Not having full range of motion in the upper extremity
• * Having a history of injury or surgery in any of the lower extremity joints
• * Having a neurological deficit
• * Having pain or movement limitation in the lower extremity

Описание

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Критерии включения

• 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
• 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
• 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
• 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
• 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
• 6. Received at least 2 cycles of HAIC or PD-1 inhibitors treatments；
• 7. Has repeated measurable intrahepatic lesions;
• 8. With a high tumor burden of up to 7 out;
• 9. Child-Pugh class A or B.

Критерии исключения

• 1. Patients who took anti-tumor treatments before the combination therapy;
• 2. With other malignant tumors;
• 3. Unable to meet criteria of combination timeframe described above.

Описание

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Критерии включения

• 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
• 2. presence of PVTT with III-IV grade by Cheng`s criteria;
• 3. having PVTT induced portal hypertension;
• 4. TIPS was performed within 72 hours after the endoscopic hemostasis;
• 5. metastases with limited five sites and no more two organs involved;
• 6. number of Intrahepatic tumors were no more than five;
• 7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
• 8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
• 9. no history of other malignancies;
• 10. agreed to participated in this clinical trial;
• 11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Критерии исключения

• 1. recurrent HCC;
• 2. PVTT at I-II grade by Cheng`s criteria;
• 3. age /< 18 years or /> 75 years;
• 4. advanced HCC with more than five metastases;
• 5. Number of Intrahepatic tumors were more than five;
• 6. no response to Lenvatinib;
• 7. life expectancy less than 3 months.

Описание

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

Критерии включения

• * At least 18 years of age at the time of consent
• * Clinical signs, symptoms, and presentation consistent with acute PE
• * Onset of PE symptoms occurred within 14 days of presentation
• * Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
• * RV dysfunction on CTA or echocardiography defined as RV/LV ratio />0.9

Критерии исключения

• * tPA use within 14 days prior to baseline CTA
• * Systolic BP /<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
• * Diagnosis of pulmonary hypertension or suspected undiagnosed pulmonary hypertension with peak PA />70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A)
• * History of severe or chronic pulmonary hypertension
• * FiO2 requirement />40% or />6 LPM to keep oxygen saturations />90%
• * Hematocrit /<28%
• * Platelets /<100,000/µL
• * Serum creatinine />1.8 mg/dL
• * INR />3
• * aPTT (or PTT) />50 seconds on no anticoagulation
• * History of heparin-induced thrombocytopenia (HIT)
• * Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
• * Recent (within one month) history of active bleeding from a major organ
• * Absolute contraindication to anticoagulation
• * Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
• * Morbidly obese (BMI />45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding
• * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• * Cardiovascular or pulmonary surgery within last 7 days
• * Cancer which requires active chemotherapy
• * Known serious, uncontrolled sensitivity to radiographic agents
• * Life expectancy /<90 days, as determined by investigator
• * Female who is pregnant
• * Intracardiac thrombus
• * Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
• * Simultaneous participation in another investigational study
• * Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
• * Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization

Описание

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure.

Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death.

The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding.

A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients.

To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.

The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person`s health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person`s health if not treated.

The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years.

In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.

Критерии включения

• * Patients under the age of 18 years
• * Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice
• * Informed consent form obtained from a legal representative

Критерии исключения

• * Participation in an investigational program with interventions outside of routine clinical practice
• * Contraindications according to the local marketing authorization
• * Previous treatment with rivaroxaban

Описание

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score /<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients` quality of life as well as being effective in medico-economic terms.

The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

Критерии включения

• * Patient aged 18 or over ;
• * Consultation in an emergency department of a participating centre;
• * Trauma to the lower limb requiring rigid or semi-rigid orthopaedic immobilisation;
• * Expected duration of orthopaedic immobilisation of at least 2 weeks;
• * Expected hospital stay of less than or equal to 72 hours;
• * TRiP(cast) score ≥ 7 ;
• * Patient affiliated to or benefiting from a social security scheme;
• * Patient with prior informed consent.

Критерии исключения

• * Active bleeding or high risk of bleeding,
• * Known contraindication to rivaroxaban or LMWH;
• * Taking any anticoagulant or antiplatelet agent before the trauma (only antithrombotic authorised: aspirin /< 325mg/d);
• * Pregnant or breastfeeding woman;
• * Any factor making 3-month follow-up impossible; 6. Patient subject to a legal protection measure, Imprisonment 7. Participation in any interventional study which modifies patient care or could influence study evaluation criteria

Описание

A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal.

The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low.

The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.

Критерии включения

• * Discharging clinician must be in one of the following iCentra electronic health record (Cerner, Kansas City, MO) positions:
• * Physician, nurse practitioner, or physician assistant hospitalist
• * Physician internal medicine
• * Physician family medicine
• * Patient age ≥ 18 years.
• * The encounter must be inpatient.
• * A signed hospital discharge order must be present.
• * eVTE target population criteria (increased venous thromboembolism risk, low bleeding risk) must be met

Критерии исключения

• * Pregnant during encounter
• * Discharge order completed by ineligible clinician type
• * Exclude all cases where the patient is being actively prescribed and intended to be discharged on the following qualifying anticoagulant medications, regardless of dose form or dosing regimen (i.e., they have an active prescription for one of these medications):
• * Apixaban
• * Dabigatran
• * Dalteparin
• * Enoxaparin
• * Edoxaban
• * Betrixaban
• * Fondaparinux
• * Rivaroxaban
• * Warfarin
• * Creatinine clearance /<30 milliliters/minute based on last-available eligible serum creatinine value preceding discharge
• * Estimated creatine clearance based on actual body weight (preferred) ((140 - age years) /* measured weight kilograms) / (72.0 /* serum creatine milligrams/deciliter) (/*0.85 if female)) = milliliters/minute
• * If measured body weight not available, then based on ideal body weight ((140 - age years) /* ideal body weight kilograms) / (72.0 /* serum creatine milligrams/deciliter) (/*0.85 if female)) = milliliters/minute

Описание

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.

Критерии включения

• 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
• 2. presence of PVTT with III-IV grade by Cheng`s criteria;
• 3. having PVTT induced portal hypertension;
• 4. with or without PVTT induced acute variceal bleeding;
• 5. metastases with limited five sites and no more two organs involved;
• 6. Number of Intrahepatic tumors were no more than five;
• 7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
• 8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
• 9. no history of other malignancies;
• 10. agreed to participated in this clinical trial;
• 11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Критерии исключения

• 1. recurrent HCC;
• 2. PVTT at I-II grade by Cheng`s criteria;
• 3. age /< 18 years or /> 75 years;
• 4. advanced HCC with more than five metastases;
• 5. Number of Intrahepatic tumors were more than five;
• 6. no response to Lenvatinib;
• 7. life expectancy less than 3 months.

Описание

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a `PICC line`.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Критерии включения

• 1. PICC is anticipated to remain in place for at least 14 days
• 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
• 3. Body weight ≥50 kg and ≤130 kg during the screening period
• 4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
• 5. Platelet count ≥100 x 10/^9/L during the screening period as described in the protocol

Критерии исключения

• 1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
• 2. History of prior venous thrombosis in the arm in which the PICC is to be placed
• 3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
• 4. History of known thromboembolic disease or thrombophilia
• 5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol
• 6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
• 7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand`s disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)
• Note: Other protocol defined inclusion/exclusion criteria apply

Описание

In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab`)2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.

Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.

The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.

The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.

This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.

Критерии включения

• * Men or Women, at least 18 years old
• * Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital
• * Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative.
• * Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and/or moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and/or severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage)
• * Be able to receive and understand information related to the research
• * Be able to freely give verbal consent to participate in the proposed research
• * Be able to freely give written informed consent to participate in the plasmathèque
• * Be affiliated to the general social security system

Критерии исключения

• * Pregnant or breastfeeding woman
• * People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®.
• * Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors
• * Disseminated intravascular coagulation (DIC)
• * Constitutional and acquired Von Willebrand disease
• * Constitutional and acquired thrombopathies
• * Idiopathic thrombocytopenic purpura
• * Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty.

Описание

This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.

Критерии включения

• * Male Chinese subjects aged ≤ 70 years
• * Subjects with documented severe or moderately severe hemophilia B (FIX activity of ≤ 2%)
• * Subjects have received FIX products for ≥ 150 exposure days (EDs) (subjects aged ≥ 6 years) or ≥ 50 EDs (subjects aged /< 6 years)
• * Subjects have no confirmed prior history of FIX inhibitor formation

Критерии исключения

• * Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein.
• * Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
• * Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
• * Currently receiving a long-acting recombinant FIX treatment such as coagulation factor IX (recombinant), Fc fusion protein (Alprolix®).
• * Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the subject`s participation in the study.

Описание

The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT, periprocedural complications and development of PTS after tratment of iliofemoral DVT.

Критерии включения

• Acute IF DVT
• life expectancy more than 1 year

Критерии исключения

• * Recurrence of DVT Chronic DVT The catheter cannot be used in vessels smaller than 6mm. Patients have contraindications for endovascular procedures Patients cannot tolerate contrast media In patients with lesions that cannot be accessed with the guide wire Pregnancy History of pelvic surgery with left iliac vein injury or pelvic radioactive therapy

Описание

Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.

Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events./[12/] Given the low rate of adverse events while using TXA systemically, this protocol`s application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.

Критерии включения

• * Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
• * age 18 and older
• * English speaking.

Критерии исключения

• * younger than 18
• * previously had an adverse reaction to tranexamic acid
• * non-English speaking
• * patients who elect not to participate or withdraw from the study.

Описание

This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.

Критерии включения

• 1. Signed written informed consent and able to comply with scheduled visits and related procedures;
• 2. Age ≥18 and ≤75 years, regardless of gender;
• 3. Patients with HCC who meet the clinical diagnostic criteria of China`s "Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma" (2022 Edition) or are diagnosed by biopsy, and have at least one measurable lesion according to the mRECIST criteria;
• 4. Presence of portal vein tumor thrombus (PVTT) of Cheng`s type I/II/III, with the primary tumor being resectable;
• 5. Child-Pugh score of Class A;
• 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1;
• 7. No prior antitumor treatment (such as surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, or systemic therapy).
• 8. For patients with hepatitis B virus (HBV) infection, testing for HBV-DNA is required; direct treatment initiation is allowed if HBV-DNA ≤2000 IU/mL; if HBV-DNA />2000 IU/mL, antiviral therapy should be administered for one week before starting the treatment; all HBV positive patients will receive continuous antiviral treatment throughout the study; patients with hepatitis C virus (HCV) RNA positive must undergo antiviral treatment as per the guidelines;
• 9. Participants must provide a fresh tumor biopsy sample during the screening period (can be waived after discussion with the medical monitor) and blood samples for monitoring immune cells, cytokine levels, and other relevant immune status in the tumor microenvironment;
• 10. Expected survival of ≥12 weeks;
• 11. Adequate organ and marrow function, as defined by the following laboratory values:
• 1. Hematology: Absolute Neutrophil Count ≥1.5×109/L; Platelets ≥80×109/L; Hemoglobin ≥90g/L;
• 2. Liver function: Total bilirubin ≤3× upper limit of normal (ULN); Alanine Aminotransferase and Aspartate Aminotransferase ≤5×ULN; Serum albumin ≥30g/L;
• 3. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for patients with Cr />1.5×ULN, creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula); Urinalysis showing proteinuria /<2+; For participants with baseline proteinuria ≥2+, a 24-hour urine collection and quantitative protein /<1g is required;
• 4. Coagulation: International Normalized Ratio or APTT ≤1.5×ULN;
• 12. Females of childbearing potential must agree to abstain from heterosexual intercourse or use effective contraception from signing the informed consent until at least 120 days after the last dose of study medication. They must have a negative serum HCG test within 1 week before treatment and must not be breastfeeding. Females who have not reached menopause (≥12 months of amenorrhea without an alternative medical cause) and have not undergone sterilization (e.g., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are considered to be of childbearing potential;
• 13. Male participants with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraceptive methods from the time of signing the informed consent until at least 120 days after the last dose of study medication. During the same period, male participants must also agree not to donate sperm. Male subjects whose partners are pregnant must use condoms and do not need to use other contraceptive methods.

Критерии исключения

• 1. PVTT located in the portal vein branch opposite the tumor, or with inferior vena cava tumor thrombus, extrahepatic metastasis, or tumor invasion of adjacent organs;
• 2. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, and fibrolamellar carcinoma; active malignant tumors other than HCC within the past 5 years or concurrently, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, which are allowed;
• 3. Currently with interstitial pneumonia or interstitial lung disease, or history of interstitial lung disease requiring hormone treatment, or other conditions that may interfere with the judgement and management of immunotherapy-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or participants with active pneumonia or severe impairment of lung function shown on a chest CT during screening; active tuberculosis;
• 4. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controllable with hormone replacement therapy are allowed); Patients with skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, and alopecia, those with controlled Type I diabetes mellitus undergoing insulin therapy, or individuals whose childhood asthma has fully resolved with no need for intervention in adulthood, are allowed; patients requiring bronchodilators for medical intervention of asthma are not allowed;
• 5. Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (dose />10mg/day of prednisone or equivalent) within 2 weeks before the start of the study;
• 6. Active infection, fever of unknown origin ≥38.5°C within 1 week before the study start, or baseline white blood cell count />15×10/^9/L; therapeutic antibiotics orally or intravenously within 2 weeks before the study start (excluding prophylactic antibiotics given IV for no more than 48 hours);
• 7. Congenital or acquired immunodeficiency (e.g., HIV infection);
• 8. Receipt of live attenuated vaccines within 4 weeks before the study start or expectation of needing such vaccines during the camrelizumab treatment period or within 60 days after the last dose of camrelizuma;
• 9. Significant bleeding symptoms of clinical significance or a clear bleeding tendency within 6 months before the study start, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, or vasculitis; if baseline fecal occult blood is positive, retesting is allowed, and if still positive, gastroduodenoscopy is required;
• 10. Known genetic or acquired bleeding (e.g., coagulopathy) and thrombotic tendencies, such as hemophilia, coagulation mechanism disorders, thrombocytopenia, etc.; currently receiving full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, etc., is allowed);
• 11. Arterial thromboembolic events within 6 months before the study start, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc;
• 12. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) heart failure of NYHA class II or above or echocardiography showing LVEF /<50%; (2) unstable angina; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc /> 450ms for males and />470ms for females (QTc interval calculated using the Fridericia formula; if QTc is abnormal, continuous testing three times at 2-minute intervals is allowed, taking the average value);
• 13. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg based on the average of ≥2 blood pressure readings), allowing achievement of the above parameters through antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;
• 14. Major vascular diseases within 6 months before the study start (e.g., requiring surgical repair or recent peripheral arterial thrombosis of an aneurysm);
• 15. Severe, unhealed, or open wounds and active ulcers or untreated fractures;
• 16. Major surgery (excluding diagnostic) within 4 weeks before the study start;
• 17. Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
• 18. Intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction, including partial obstructions requiring parenteral hydration, parenteral nutrition, or tube feeding related to the underlying disease, within 6 months before the study start. Patients with incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at initial diagnosis who have undergone definitive (surgical) treatment to alleviate symptoms may be eligible for the study;
• 19. Use of strong CYP3A4/CYP2C19 inducers, including rifampin (and its analogs) and Hypericum perforatum, or strong CYP3A4/CYP2C19 inhibitors within 2 weeks before the study start;
• 20. Known allergy to any monoclonal antibody, antiangiogenic targeted drugs, or excipients;
• 21. Participation in other drug clinical studies within 12 weeks before the study start.

Описание

Rationale:

Cardiac CT acquired during the acute stroke imaging protocol (acute cardiac CT) has recently been shown to have a superior diagnostic yield than transthoracic echocardiography, which is currently the most commonly used method to screen for structural sources of cardioembolism in patients with acute ischemic stroke. The most common finding on acute cardiac CT are cardiac thrombi located in the left atrium (LA) and specifically the left atrial appendage (LAA). The higher diagnostic yield of acute cardiac CT compared to TTE is partially explained because CT allows for better visualization of the LAA, but also because cardiac thrombi may dissolve in the first days after stroke. Whether acute cardiac CT is the optimal diagnostic modality for LA thrombi in stroke patients is unknown, since data comparing it to transoesophageal echocardiography (TEE), which is the reference standard to detect LA thrombi, are lacking. The general hypothesis of this study is that acute cardiac CT is the optimal method to detect LA thrombi in ischemic stroke patients, since TEE can miss LA thrombi that dissolve in the first days after stroke.

Objectives:

1. Determine whether acute cardiac CT has a higher diagnostic probability of detecting LA thrombi compared to TEE or repeated cardiac CT in the subacute phase of ischemic stroke by assessing the rate at which LA thrombi dissolve in the first days after ischemic stroke occurrence.
2. Determine the positive predictive value of acute cardiac CT compared to TEE for the detection of LA thrombi. Study design: Prospective, single-centre, observational cohort Study population: 39 patients of 18 years or older with acute ischemic stroke and a LA thrombus detected on cardiac CT acquired during the acute stroke imaging.

Main study parameters/endpoints:

1. Rate at which LA thrombi visualized on acute cardiac CT dissolve in the first days after ischemic stroke.
2. False-positive rate for detection of left atrial thrombi on acute cardiac CT compared to TEE. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Clinical and imaging patient data which are obtained as part of standard care will be prospectively collected after written informed consent. Patient with a LA thrombus on acute cardiac CT will undergo TEE for research purposes after obtaining written informed consent. TEE is semi-invasive and associated with a small risk of major complications (/<0.2%). Patients will also be exposed to additional radiation (1.4 mSV) due to sequential cardiac CT after TEE. The Radiation Dose Committee deemed this to be an intermediate risk. In a small minority of patients (/<10%), another cardiac CT will be acquired 2 minutes after this sequential cardiac CT to ensure a clear, final assessment of the presence of an atrial appendage thrombus. This will result in a total additional radiation of 3 mSV for the two additional cardiac CT`s. The Radiation Dose Committee deemed this to be an intermediate risk. As part of standard care, patients will be contacted for follow-up evaluation by a trained stroke nurse at 90 days. As a result of ischemic stroke, some patients become incapacitated to an extent they are unable to give informed consent. In these cases, the legal representative will be asked for informed consent. Decreased leveI of consciousness or aphasia are typical clinical characteristics of cardioembolic stroke. Therefore, it is pivotal to also include incapacitated acute ischemic stroke patients. Excluding these patients from the study would render the study non-representative of the study`s target population (acute ischemic stroke patients with cardioembolic stroke due to LA thrombus).

Критерии включения

• * Age 18 years or older
• * Clinical diagnosis of acute ischemic stroke
• * Written informed consent from patient or representative
• * Radiological diagnosis of cardiac thrombus in the LA, including the LAA, on cardiac CT acquired during the initial stroke imaging protocol.

Критерии исключения

• * Patients with a diagnosis other than acute ischemic stroke, such as: transient ischemic attack, intracerebral haemorrhage, subarachnoid haemorrhage, epilepsy, tumor.
• * Absolute contraindication for TEE:
• * Perforated viscus
• * Esophageal stricture
• * Esophageal tumor
• * Esophageal perforation, laceration
• * Esophageal diverticulum
• * Active upper GI bleed
• * Absolute contraindication for repeat cardiac CT
• * Documented previous severe reaction to iodinated contrast media, including anaphylaxis, angioedema and bronchospasm.
• * Severely impaired kidney function defined as estimated glomerular filtration rate of 30 mL/min/1.73 m2.

Описание

Background: It has not been extensively studied in differing populations that endovascular treatment (EVT) for acute and subacute CVST with multimodal imaging selection improves the functional outcome better than standard medical care based on the guidelines. Published experience with endovascular treatment is promising. However, its efficacy has not been confirmed and early selection criteria for EVT are unknown.

Objective:The main objective of the Endovascular treatment or Standard medical Care for Cerebral Venous Sinus Thrombosis (ESCORT) trial is to determine if EVT improves the functional outcome of acute and subacute CVST patients with multimodal imaging selection.

Study Design:The ESCORT trial is a multicenter, prospective, randomized, open-label, blinded endpoint trial.

Study population: Patients are eligible if they have a radiologically criteria proven acute and subacute CVST, obvious symptoms of intracranial hypertension(lumbar puncture pressure≥250mmH2O).

Intervention: Patients will be randomized to receive either EVT or standard medical care (therapeutic doses of heparin). EVT consists of local application of alteplase or urokinase within the thrombosed sinuses, balloon angioplasty, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale, ophthalmologic examination, Headache Impact Test-6(HIT-6), EuroQol-5 dimension-5 level(EQ-5D-5L) scale score, multimodal imaging and relevant laboratory parameters will be assessed at baseline.

Endpoints: The primary endpoint is the proportion with good prognosis at 3 months (definition: a. mRS≤1; b. headache score (/<50, HIT-6); c. Frisén=0 grade for papilledema; d. defect of field vision PMD/>-2dB). Secondary outcomes are three-months mRS, HIT-6,Frisén grade for papilledema, situation of EQ-5D-5L, mortality and recanalization rate. Major intracranial and extracranial hemorrhagic complications within one-week after the intervention are the principal safety outcomes. Results will be analyzed according to the`intention-to-treat` principle. Blinded assessors not involved in the treatment of the patient will assess endpoints with standardized questionnaires.

Study size: To detect a 20% relative increase of good prognosis (from 65 to 85%), 224 patients (112 in each treatment arm) have to be included (two-sided alpha, 80% power).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from EVT. Complications of EVT, most notably intracranial hemorrhages, constitute the most important risk of the study.

Критерии включения

• General inclusion criteria
• 1. age between 18 years and 60 years
• 2. Cerebral venous sinus thrombosis (CVST), confirmed by computed tomographic and magnetic resonance imaging (T1, T2, SWI, DWI, FLAIR), magnetic resonance venography, computed tomographic venography or digital subtraction angiography.
• 3. Patients with CVST who meet the following conditions (1) Within 3 weeks of acute onset (2) There are one of the obvious clinical symptoms: A. symptoms of intracranial hypertension: headache, papilledema, visual acuity and visual field damage; B. Neurological impairment symptoms; C. Seizure; D. Disturbance of consciousness (GCS score≥9)
• 4. Lumbar puncture pressure≥250mmH2O
• 5. Patients or their relatives can sign written informed consent
• Image inclusion criteria
• 1.CT and MRI (T1, T2, MRV, SWI, DWI) are used to screen CVST as acute phase (T1 low signal, T2 equal signal or slightly high signal; CT showed that the corresponding area is high signal) or subacute phase (T1 and T2 high signal) 2.3D-TOF or CE-MRA or CTV are used to screen the types of venous sinus thrombosis occlusion of main drainage which is prone to intracranial hypertension due to venous sinus thrombosis as follows: A.Superior sagittal sinus occlusion: thrombus obliterates the posterior 1/2 segment of superior sagittal sinus
• B.Transverse sinus occlusive type:
• 1. complete thrombosis of the bilateral transverse sinus with or without the corresponding sigmoid sinus involvement
• 2. complete thrombosis of the superior transverse sinus with or without the corresponding sigmoid sinus involvement C.complete thrombosis of the superior sagittal sinus and unilateral transverse sinus with or without the corresponding sigmoid sinus involvement D.complete thrombosis of the superior sagittal sinus and bilateral transverse sinus with the corresponding sigmoid sinus is occluded

Критерии исключения

• 1. Received any thrombolytic therapy within 7 days
• 2. Patients who cannot cooperate or accept MRI examination
• 3. Patients with dementia or mental illness are known to be unable to complete neurological function assessment and follow-up
• 4. Patients with high myopia and eye diseases affecting fundus examination and visual field examination
• 5. The patient has a clear history of primary headache such as migraine, tension headache and cluster headache, and a clear history of secondary headache
• 6. Patients who receive major surgery (excluding lumbar puncture) or a history of severe brain injury within 2 weeks
• 7. Known history of severe allergy to contrast media (excluding rash)
• 8. Gastrointestinal bleeding occurred within 3 months (excluding bleeding from recto anal hemorrhoids)
• 9. Serious liver function or renal dysfunction with written records and affecting normal coagulation function
• 10. Hemorrhagic disease (hemorrhagic disease history) with written records
• 11. Excepting for CVST, patients with any life expectancy less than 1 year (such as advanced cancer)
• 12. Pregnant women (puerperal women can be enrolled)
• 13. Patients with contraindications to anticoagulation or thrombolysis
• 14. Intracranial infectious or malignant tumor secondary to cerebrospinal fluid
• 15. CVST secondary to autoimmune diseases and hematological diseases (such as primary thrombocytosis, myelodysplastic syndrome, leukemia, etc.) and genetic factors
• 16. Concurrent thrombocytopenia (/<100×109/L)
• 17. MRI features showed that the occluded vessels of venous sinus were in chronic phase (T1 and T2 images showed equal signal)
• 18. Severe brain tissue injury symptoms such as obvious space occupying effect due to massive cerebral edema, cerebral infarction or cerebral hemorrhage
• 19. Patients with CVST accompanied by ventricular compression and hydrocephalus requiring surgery
• 20. Participating in clinical trials of any other drugs or medical devices, or may participate in clinical trials of any other drugs or medical devices within 6 months after being enrolled in this clinical trial
• 21. The researchers judge that there are other situations that are not suitable for enrollment

Описание

Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.

The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it.

The study is looking at several other research questions including:

* How much study drug is in the blood at different times
* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body`s immune system in response to a foreign substance
* Whether the body makes antibodies against the clotting factor replacement therapy
* How quality of life is affected by hemophilia B and if it changes after taking study drug
* How joint health is affected by hemophilia B and if it changes after taking study drug
* How often visits are required for the emergency room, urgent care center, physician`s office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug
* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug)
* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood

Критерии включения

• 1. Confirmed diagnosis of severe or moderately severe hemophilia B with medical history of FIX functional activity (≤2% or /<0.02 IU/mL) or documented genotype known to produce severe hemophilia B
• 2. Currently taking FIX prophylaxis and previous experience with FIX therapy, as defined in the protocol
• 3. Participation in the lead-in period of this interventional study OR a separate lead-in study (R0000-HEMB-2187 /[NCT05568459/]) for at least 6 months for ABR data while taking FIX prophylaxis, as defined in the protocol

Критерии исключения

• 1. History of FIX inhibitor (clinical or laboratory-based assessment) on 2 or more occasions
• 2. Bethesda inhibitor titer greater than the upper limit of normal (ULN) at screening
• 3. Detectable pre-existing antibodies to the adeno-associated virus serotype 8 (AAV8) capsid; as measured by enzyme-linked immunosorbent assay (ELISA) at prescreening (or final lead-in visit, if applicable).
• 4. Any significant underlying liver disease such as: cholestatic liver disease, liver cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy
• 5. Evidence of advanced liver fibrosis, as defined in the protocol
• 6. Evidence of cirrhosis and/or portal hypertension as assessed by abdominal ultrasound at screening or measured within 6 months prior to the screening visit
• 7. History of arterial or venous thrombo-embolic events, as defined in the protocol
• 8. History of hypersensitivity to corticosteroids or known medical condition that requires chronic administration of corticosteroids
• 9. Previously received any AAV gene-based therapy or intends to receive approved or investigational AAV-based gene therapy other than REGV131-LNP1265 during the study period
• NOTE: Other Inclusion/Exclusion Protocol Defined Criteria Apply

Описание

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

Критерии включения

• * Men and women aged 18 and over.
• * Verified diagnosis of intermediate high-risk PE using CTPA, no more than two weeks from the symptoms onset.
• * RV dysfunction, defined as a RV/LV ventricular end-diastolic diameter ratio more than 1.0 assessed by echocardiography.
• * Increased risk of early death or hemodynamic collapse, defined by one of the following criteria:
• 1. systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;
• 2. respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;
• 3. chronic heart failure with left ventricular ejection fraction less than 40%.
• * Serum troponin I level more than 14 pg/mL in patients under 75 years, and more than 45 pg/mL in patients aged 75 years or older.
• * Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
• * women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
• * men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility).
• * Availability of signed and dated informed consent of the patient to participate in the study.

Критерии исключения

• * High-risk PE with hemodynamic instability.
• * Increased risk of bleeding:
• * extensive bleeding at present or within the previous 6 months;
• * intracranial (including subarachnoid) hemorrhage at present or in history;
• * hemorrhagic stroke within the last 6 months;
• * a history of diseases of the central nervous system (including neoplasms, aneurysms);
• * intracranial or spinal surgical interventions within the last 2 months;
• * major surgery or major trauma within the previous 4 weeks;
• * recent puncture of an incompressible blood vessel (eg, subclavian or jugular vein);
• * severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
• * confirmed gastric or duodenal ulcer within the last 3 months;
• * neoplasm with an increased risk of bleeding;
• * simultaneous administration of Dabigatran without prior administration of idarucizumab;
• * arterial aneurysms, developmental defects of arteries / veins;
• * acute pancreatitis;
• * bacterial endocarditis, pericarditis;
• * suspicion of aortic dissecting aneurysm;
• * any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.
• * Lactation, pregnancy.
• * Known hypersensitivity to mon-immunogenic recombinant staphylokinase.

Описание

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.

Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.

The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.

This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months.

Критерии включения

• 1. Age ≥ 18 years
• 2. Outpatients with acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus
• 3. Affiliates or beneficiaries of a social security scheme.

Критерии исключения

• 1. Pregnant women, women in labour or breastfeeding mothers.
• 2. Suspected or confirmed pulmonary embolism.
• 3. Asymptomatic venous thrombosis.
• 4. Bilateral venous thrombosis.
• 5. History of ipsilateral or contralateral venous thrombosis of the lower limb.
• 6. DVT caused by a major transient risk factor (surgery with general anaesthetic /> 30 minutes in the last 3 months; fracture of the lower limbs in the last 3 months; immobilisation /> 3 days for acute medical reasons in the last 3 months; oestroprogestogenic contraception, pregnancy, post-partum, menopausal hormone treatment).
• 7. DVT caused by a minor risk factor (Surgery with general anaesthetic /< 30 minutes in the last 2 months; Trauma to a non-plastered lower limb with reduced mobility ≥ 3 days; Immobilisation /< 3 days for acute medical reason in the last 2 months; Travel /> 6 hours in the last 2 months).
• 8. Active cancer defined as cancer for which treatment is ongoing, treatment has not been effective (recurrence or progression) or treatment is palliative.
• 9. Chronic inflammatory bowel disease.
• 10. Time between onset of symptoms and diagnosis /> 14 days.
• 11. Prophylactic or therapeutic anticoagulant treatment /> 48 hours.
• 12. Expected duration of anticoagulant treatment /< 3 months (all patients must have a minimum treatment of 3 months).
• 13. Known contraindication to anticoagulant treatment (chronic renal insufficiency defined by creatinine clearance /< 30 ml/min according to the Cockcroft-Gault formula; platelets /< 100,000/mm3; active bleeding or high risk of bleeding (gastric ulcer, recent haemorrhagic stroke, etc.); known liver disease (Child Pugh class B and class C)).
• 14. Treatment with antiplatelet agents other than Aspirin ≤ 160 mg/ 24H or Clopidogrel ≤ 75 mg, non-steroidal anti-inflammatory drugs.
• 15. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
• 16. Refusal or inability to give written informed consent to participate in the study.
• 17. Life expectancy /< 6 months.
• 18. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
• 19. Patients taking part in a therapeutic trial for venous thromboembolism.

Описание

This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.

During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic`s standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).

Критерии включения

• - All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).

Критерии исключения

• - None

Описание

The aim is to improve the diagnosis of chronic lower limb venous thrombosis before a lower limb venous recanalization procedure. Additionally, if the MRI scores are comparable to those of the CT, MRI would reduce radiation exposure and limit the need for foot vein punctures that accompany CT use.

Критерии включения

• * Men and women aged more than 18 years old,
• * patient`s oral consent,
• * affiliated or beneficiary of health insurance

Критерии исключения

• * inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
• * patient under legal protection

Описание

A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy

Критерии включения

• * either
• * require ECMO support or
• * have been started on ECMO therapy within the last 12 hours

Критерии исключения

• * Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances
• * Patients who are pregnant
• * Patients suffering from a clinically relevant pre-existing coagulopathy
• * Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation
• * Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)
• * Patients whose total duration of ECMO support lasts less than 24 hours
• * Patients with start of ECMO support during CPR (eCPR)
• * Patients with passive decarboxylation, without an active pumping system
• * Patients, who have been weaned off ECMO support within the last 30 days
• * Patients with central ECMO cannulation and/or after cardiopulmonary bypass

Описание

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.

Критерии включения

• 1. Have signed the informed consent
• 2. Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
• 3. ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
• 4. Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
• 5. Patients have received at least one faricimab treatment (the first dose) in the study eye

Критерии исключения

• 1. Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
• 2. Active ocular inflammation or suspected / active ocular infection in either eye
• 3. Received any other anti-VEGF treatment after faricimab
• 4. Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
• 5. Any participation in any other clinical trials currently
• 6. Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection

Описание

Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.

Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.

Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables

Критерии включения

• * Patients diagnosed with hemophilia A or B.
• * Patients over 18 years of age.
• * Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
• * Patients with clinical assessment by Hemophilia Joint Health Score (/>4 points).
• * Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
• * Have signed the informed consent document.

Критерии исключения

• * Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
• * Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
• * Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
• * Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.

Описание

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).

Критерии включения

• 1. Patient is ≥ 18 and ≤ 90 years old
• 2. Clinical signs and symptoms consistent with acute PE for /< 14 days
• 3. CTA evidence of proximal PE
• 4. RV/LV ratio /> 0.9
• 5. Systolic BP ≥90 mmHg without the need for vasopressors
• 6. Stable heart rate (HR) /< 130 BPM prior to procedure
• 7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• 8. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures

Критерии исключения

• 1. Prior PE /< 180 days from index procedure
• 2. Thrombolytic use /< 30 days prior to baseline CTA
• 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) />70 mmHg by right heart catheterization
• 4. FiO2 requirement />40% or />6 LPM to keep oxygen saturation />90%
• 5. Hematocrit /<28%
• 6. Platelets count /<100,000/µL
• 7. Serum creatinine />1.8 mg/dL
• 8. International normalized ratio (INR) />3
• 9. Major trauma injury severity score (ISS) />15 prior to screening assessment
• 10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
• 11. Cardiovascular or pulmonary surgery within 7 days of index procedure
• 12. Actively progressing cancer treated by chemotherapeutics
• 13. Known bleeding diathesis or coagulation disorder
• 14. Left bundle branch block
• 15. History of severe or chronic pulmonary arterial hypertension
• 16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• 17. History of decompensated heart failure
• 18. History of underlying lung disease that is oxygen dependent
• 19. History of chest irradiation
• 20. History of heparin-induced thrombocytopenia (HIT)
• 21. Contraindication to systemic or therapeutic doses of anticoagulants
• 22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
• 24. Life expectancy /<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
• 25. Female who is pregnant or nursing
• 26. Current participation in another investigational drug or device treatment study.

Описание

The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.

Критерии включения

• * adult patients (/>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion

Критерии исключения

• * patients with Chronic Kidney Disease, whether dialytic or not;
• * patients in critical or unstable condition characterized by the need for intubation, respiratory rate /<8 or />35 breaths per minute, oxygen saturation /<90%, heart rate /<40 or />140 beats per minute, systolic blood pressure /<90mmHg, decreased Glasgow Coma Scale />2 points, or prolonged (/>5 minutes) or repeated seizures;
• * patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.

Описание

The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians` assessment using the physician`s implicit probability (gestalt) compared with the use of the TRiP(cast) score.

Критерии включения

• * Consultation in one of the emergency departments participating in the study,
• * Isolated trauma to a lower limb,
• * Rigid immobilisation (plaster or resin) or semi-rigid immobilisation for an expected duration of at least 7 days,
• * Patient over 18 years of age,
• * Patient affiliated to or benefiting from a social security scheme,
• * Patients who have signed a prior informed consent form

Критерии исключения

• * Patient taking anticoagulant treatment at the time of the trauma,
• * Trauma requiring hospitalisation for more than 48 hours,
• * Pregnant, breast-feeding or parturient patients,
• * Patient deprived of liberty by judicial or administrative decision,
• * Patient under compulsory psychiatric care,
• * Patient under legal protection,
• * Patients unable to give their free and informed consent

Описание

The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:

* What is the association between antiXa and VTE?
* What is the association between antiXa and symptomatic, respectively incidental, VTE?
* How is pharmacological anticoagulation with enoxaparin related to measured antiXa?
* What is the association between antiXa and bleeding complications.
* What is the incidence of venous thromboembolism in patients treated at an intensive care unit?
* How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.

Критерии включения

• * Age over 18 years at the time of intensive care unit admission
• * Admission to a participating intensive care unit within the last 24 hours
• * Expected discharge is later than 48 hours after enrolment

Критерии исключения

• * Therapeutic anticoagulation, defined as enoxaparin dose of at least 100 IE/kg when given twice daily or of at least 150 IE/kg when given once daily
• * Extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment
• * Planned regular administration of vitamin K antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor X inhibitors within the observation period
• * Estimated life expectancy below 48 hours or comfort terminal care order in place
• * Previously diagnosed heparin-induced thrombocytopenia
• * Pre-operative admission for elective surgery
• * Previous enrolment in the study

Описание

Individuals attending the hospital to undergo operations are at risk of developing blood clots in the legs, known as deep vein thrombosis (DVT). A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs` ability to move oxygen from the air into the blood and may be life-threatening. This is known as pulmonary embolism (PE). DVT and PE are known collectively as venous thromboembolism or VTE.

The importance of preventing VTE in surgical patients is widely recognised, with two main strategies used: thinning the blood with regular injections and/or tablets and wearing elastic stockings to help stop blood from sitting in the leg veins where it can clot.

Evidence for using elastic stockings to prevent VTE has recently been challenged. Additionally, there is a lack of evidence for the additional benefit of stockings over and above that of blood thinning medications. If stockings were to reduce VTE over and above blood thinning medication, these benefits need to be weighed against the risks and disadvantages of stockings, including discomfort, restricting blood flow to the leg causing blisters and wounds in addition to the cost. If stockings were found not to reduce the risk of clots, they would no longer need to be used in these patients, thus reducing the disadvantages of stockings, and saving the NHS millions of pounds per year.

Certain types of operations (300,000 per year in the UK) are linked with a particularly high risk of VTE, including cancer surgery, surgery in the abdomen and pelvis, and bone (orthopaedic) surgery. In these cases, patients are offered blood thinning medications both during their hospital stay and for a period after they have left the hospital. Furthermore, these patients are offered stockings to wear while in the hospital.

It is not known if, in patients who receive blood thinning medications both in hospital and after discharge, the addition of wearing stockings whilst in hospital reduces their risk of VTE any further.

The purpose of this study is to investigate if it is worthwhile using stockings, in addition to blood thinning medication, to reduce blood clots after surgery. People enrolled in the study will be those at the highest risk of VTE and require an extended period of medication to reduce the risk of a blood clot.

A computer will randomly choose one of the below treatments by chance to make the trial fair:

A) Extended duration clot-reducing medicine in addition to stockings B) Extended duration clot-reducing medicine alone

The surgery and all the other medical care will continue as normal. Everyone in the study will get an ultrasound scan at 21 - 35 days after their operation to check if they have developed a blood clot. This is an additional scan, not routinely performed in the NHS, to make sure that all blood clots are detected at an early stage. Participants will receive a phone call at 7, 21-35 and 90 days after their treatment to see if they have developed a blood clot or had any problems with the treatment.

Критерии включения

• * Adults (≥18 years of age)
• * Participants undergoing elective surgery; risk assessed as requiring EDPTP

Критерии исключения

• * Contraindications to EDPTP or GCS
• * Individuals requiring therapeutic anticoagulation e.g., anticoagulation for previous DVT
• * Known thrombophilia or thrombogenic disorder

Описание

The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure.

Критерии включения

• 1. Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by investigator, in the lower extremity peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
• 2. Subject or legally authorized representative must provide written informed consent
• 3. Subject must be ≥ 18 years of age.

Критерии исключения

• 1. Subject has previously been registered in the JETi Hong Kong PMS in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study.
• 2. Subject is currently participating in another drug or device clinical investigation.
• 3. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading infectious agent within the past 20 days.
• 4. Subject with hemodialysis access thrombosis or bypass graft thrombosis

Описание

The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, and sleep habits, relates to how participants feel. During the course of the treatment, the symptoms participants experience change, and whether the Apple watch can detect these changes. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.

Критерии включения

• * newly-diagnosed or recurrent glioblastoma undergoing treatment or active surveillance
• * at least 18 years of age at the time of study enrolment
• * Karnofsky Performance Status (KPS) ≥ 70% at time of study enrolment
• * able to comprehend informed consent form and provide informed consent
• * access to patient or caregiver`s own Apple iPhone to interface with watch application for documentation of symptoms

Критерии исключения

• * under 18 years of age at the time of study enrolment
• * inability to give informed consent due to aphasia or other language barrier
• * tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed or other skin conditions preventing adequate sensor function
• * inability to tolerate Apple Watch for at least 12 hours per day on at least 50% of days in a four-week period
• * no access to patient or caregiver Apple iPhone to document symptoms

Описание

This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume /< 700ml or estimated liver-GTV V5 /< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.

Критерии включения

• 1. Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;
• 2. Age 18-90 years;
• 3. Liver-GTV volume/<700ml or the estimated volume of Liver-GTV receiving less than 5 Gy of irradiation/<300ml but the average dose of Liver-GTV needs to be /<18Gy;
• 4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies;
• 5. ECOG performance status 0-2, expected survival greater than 1 month;
• 6. Allowing patients with distant metastases;
• 7. Child-Pugh A5, A6, B7 and B8;
• 8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL /<60umol/L.
• 9. No significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment;
• 10. CRE, BUN within 2.5 times the normal upper limit;
• 11. Hb ≥ 50g/L, ANC ≥ 0.5 × 10/^9 /L, PLT ≥ 30 × 10/^9 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L and a significant rising trend;
• 12. Patients voluntarily participate in this clinical trial and sign an informed consent form.

Критерии исключения

• 1. Currently participating in other clinical trials;
• 2. Previously received abdominal radiotherapy or liver transplantation;
• 3. Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;
• 4. Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.
• 5. Suspected or confirmed drug addiction, medicine abuse,or alcoholism
• 6. Pregnant or lactating women;
• 7. Severe mental or neurological disorders
• 8. Presence of other life-threatening malignancy within the last 3 years before the start of the study (excluding superficial skin cancer, localized low-grade malignant tumor and in situ carcinoma).

Описание

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

Критерии включения

• * Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
• 1. Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA /< 200 copies/mL and CD4 positive T lymphocyte count />= 200 cells/µL at screening).
• 2. Regarding HCV, patients who had passed />= 12 months after achieving SVR at registration.
• * Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
• * Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
• 1. Liver stiffness measurement by FibroScan is />= 12.5 kPa (Fibrosis stage F4) at screening.
• 2. Abdominal CT scan shows changes in liver shape and/or portal hypertension.
• * Patients with Performance Status 0-2.

Критерии исключения

• * Patients with liver cirrhosis of which cause is not HCV or unknown.
• * Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
• * Patients with complication or history of malignant tumor (within 3 years before registration).
• * Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
• * Patients with active AIDS-indicator disease that require treatment.

Описание

This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.

Критерии включения

• Each patient must meet the following criteria to be enrolled in this study:
• 1. be male with a diagnosis of congenital hemophilia A or B of any severity
• 2. have one of the following:
• 1. positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) OR
• 2. an inhibitor test BU /<5 (as confirmed at screening by the institutional lab) but expected to have an anamnestic response to FVIII or FIX, as demonstrated by a history of a high-responding inhibitor manifested by a previous anamnestic response, defined as a peak inhibitor titer />5 BU after re-exposure to factor concentrates, precluding the use of FVIII or FIX products to treat or prevent bleeding OR
• 3. an inhibitor test BU /<5 (as confirmed at screening by the institutional lab) but expected to be refractory to FVIII or FIX, as demonstrated by the patient`s history of previous failure to respond to FVIII or FIX concentrates, even in the absence of a documented anamnestic response, precluding the use of FVIII or FIX products to treat or prevent bleeding episodes.
• 3. be ≥12 years to ≤65 years of age on the day of informed consent
• 4. be scheduled for an elective major surgical procedure as defined in the study protocol (see Table ``Definitions for the specific purpose of Study F7TG2202``)
• 5. have Hb ≥ 12 g/dL
• 6. be capable of understanding and willing to comply with the conditions of the protocol OR in the case of a patient under the age of legal majority, parent(s)/legal guardian(s) must be capable of understanding and willing to comply with the conditions of the protocol
• 7. have read, understood, and provided written informed consent (patient or parent(s)/legal guardian(s) if the patient is minor according to local regulation) and, where applicable according to local regulation, patient`s assent if the patient is minor -

Критерии исключения

• Patients who meet any of the following criteria will be excluded from the study.
• 1. have any coagulation disorder other than hemophilia A or B
• 2. be immunosuppressed (i.e. the patient should not be receiving systemic immunosuppressive medication; CD4+ cell counts at screening should be />200/μL)
• 3. known intolerance to LR769 or any of its excipients
• 4. currently receiving immune tolerance induction (ITI) therapy
• 5. have a known or suspected allergy or hypersensitivity to rabbits or rabbit proteins
• 6. have platelet count /<100,000/μL
• 7. have received an investigational drug within 30 days or within 5 half-lives of that investigational drug, whichever is longer, of the planned first LR769 administration, or be expected to receive such drug during participation in this study. Patients who have received fitusiran in a clinical study may not participate in this clinical study for 6 months since the last dose and if they have an antithrombin III level not in the normal range at screening.
• 8. for patients using emicizumab, have received during the last 6 months or currently receiving a maintenance dosing regimen of emicizumab different from the indicated one ± 10% of approved dose), i.e. different from 1.5 mg/kg once weekly (±10%), 3 mg/kg (±10%) every two weeks or 6 mg/kg (±10%) every four weeks
• 9. for patients using emicizumab, currently be any plans, or notes in the patient`s medical records that would suggest the need to increase or decrease emicizumab dosing due to antidrug antibodies (ADAs), reduced PK, or coagulation/safety-related issues (e.g. lack of response, or potential/actual thromboembolic concerns, etc)
• 10. have a clinically relevant hepatic (aspartate aminotransferase /[AST/] and/or alanine aminotransferase /[ALT/] />3 times the upper limit of normal /[ULN/]) and/or renal impairment (creatinine />2 times the ULN)
• 11. have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, DVT, or PE) within 2 years prior to the planned first dose of LR769, uncontrolled arrhythmia, or current New York Heart Association (NYHA) functional classification score of stages II - IV
• 12. have an active malignancy (those with non-melanoma skin cancer are allowed)
• 13. have any life-threatening disease or other disease or condition which, according to the investigator`s judgment, could imply a potential hazard to the patient, or interfere with the study participation or study outcome (e.g. chronic, unmanaged hepatitis infection)
• 14. be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitory properties within one week prior to surgery and for the duration of treatment with LR769
• 15. have active gastric or duodenal ulcer disease
• 16. have received a FVII- or FVIIa-containing product (either plasma derived or recombinant) within 24 hours prior to administration of LR769
• 17. have a contraindication to antifibrinolytics
• 18. have planned combined major surgeries at the same time
• 19. be administered pharmacologic thromboprophylaxis within 5 half-lives of that medication before surgery or for the duration of treatment with LR769 -

Описание

We have developed a questionnaire to elucidate the dosing, frequency and indication for the use of emicizumab in patients with Hemophilia A (mild, moderate or severe) ages 0-3 years. We are also collecting data on any pre-, peri and post surgical practices while on emicizumab. More importantly, we are asking if pediatricians are planning to introduce factor 8 to children who are already on emicizumab for primary prophylaxis as well as how and when they are planning to do so. We hope that this data will help inform understanding of current use of emicizumab in infants and young children as a form of primary prophylaxis, especially when venous access has historically been a limiting factor.

Критерии включения

• Patients must meet the following criteria for study entry:
• * Patients who have been prescribed Emicizumab
• * Patients who are 0-36 months of age at the time of starting treatment with Emicizumab
• * Diagnosis of congenital mild, moderate or severe hemophilia with or without an inhibitor

Критерии исключения

• * Patients with acquired Hemophilia A
• * Patients with Hemophilia A and another congenital or acquired bleeding disorder.

Описание

The purpose of the aPCC-emicizumab safety study is to prospectively investigate the safety and hemostatic efficacy of a personalized dose of aPCC in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis during acute bleeding events or prior to procedures.

Критерии включения

• * Moderately severe hemophilia A, defined as FVIII level /<0.02 IU/mL in the central laboratory prior to development of an inhibitor
• * Age ≥6 years of age at time of informed consent
• * Documented on 2 occasions a high titer inhibitor (/>5 BU/mL) with a 72-hour washout within 2 years of enrollment
• * Parent/guardian (caregiver henceforth) or patient has provided written informed consent
• * Adequate hematologic function (Hgb />8 g/dL and platelet count />100,000 µL)
• * Adequate hepatic function (total bilirubin ≤1.5 x ULN and both AST/ALT ≤3x ULN at screening (excluding known Gilbert`s)
• * Adequate renal function (≤2.5 x ULN and CrCl ≥30 mL/min)

Критерии исключения

• * Inherited or acquired bleeding disorder other than hemophilia A excluding low VWF (/>30% VWF:RCo or VWF:GP1bm)
• * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease (excluding previous resolved line associated thrombosis)
• * Conditions that may increase risk of bleeding or thrombosis
• * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
• * Known HIV infection with CD4 count /<200 cells/µL within 24 weeks prior to screening. Testing not required if /<35 years of age.
• * Use of systemic immunomodulators at enrollment or planned use during the study
• * Participants who are at high risk for TMA (for example, have a previous medical/family history of TMA), in the investigator`s judgment
• * Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the investigator, preclude the participant`s safe participation in and completion of the study
• * Every effort will be made to include participants that are considering minor and major procedures over the next 2 years to capture this important data with the goal of 10 procedures.