OncoTrials - мониторинг клинических исследований

Описание

International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves hemodynamics and overall survival but is also associated with a significant risk of severe bleeding. Catheter-directed intervention (CDI) is recommended as an alternative reperfusion therapy in high-risk PE when ST is contraindicated or has failed, as well as in patients who deteriorate or fail to improve during anticoagulation (AC) treatment. Despite lack of high-quality evidence and randomized studies between CDI and standard care, the use of CDI is spreading rapidly in high-risk PE and in less severe PE not fulfilling current treatment criteria.

Критерии включения

• * All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute pulmonary embolism who are planned for, or have received, treatment with catheter directed intervention or systemic thrombolysis
• * Informed consent (for patients who do not survive before informed consent can be obtained, a waiver of consent applies)

Критерии исключения

• * Ongoing enrolment in interventional catheter directed intervention trial
• * Surgical embolectomy as primary reperfusion treatment

Описание

The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).

Критерии включения

• * Age ≥18 years
• * Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
• * Acute occlusion with symptom duration of 14 days or less at presentation
• * ALI Rutherford Category I, IIa or IIb
• * First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
• * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
• * Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure

Критерии исключения

• * Life expectancy /<1 year
• * Target vessel size /<2 mm
• * Target thrombus is in the aorta or isolated profunda artery
• * Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
• * Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
• * LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb
• * Target thrombus in a saphenous vein bypass graft
• * Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
• * Pregnancy
• * Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
• * Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient`s ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• * Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become

Описание

The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful.

There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.

Критерии включения

• * Age 18-70 years
• * Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus)
• * ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
• * Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well.
• * Glasgow Coma Score (GCS) 5 - 14
• * Historical Modified Rankin Score 0 or 1

Критерии исключения

• * Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (less than 1 year) ICH, as diagnosed with radiographic imaging
• * NIH Stroke Scale (NIHSS) less than or equal to 5
• * Bilateral fixed dilated pupils
• * Extensor motor posturing
• * Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles
• * Primary thalamic ICH or basal ganglia hemorrhage with involvement /> 25% of thalamus
• * Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
• * Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction)
• * Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
• * Uncorrected coagulopathy or known clotting disorder
• * Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction
• * Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH
• * End-stage renal disease
• * Patients with a mechanical heart valve
• * End-stage liver disease
• * History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• * Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
• * Known life expectancy of less than 6 months before ICH
• * No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
• * Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible
• * Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
• * Homelessness or inability to meet follow-up requirements

Описание

Study Objective The goal of this clinical trial is to evaluate whether viewing a procedural video can improve the patient experience and reduce the incidence and severity of subconjunctival hemorrhage in individuals undergoing intravitreal anti-VEGF injections.

Key Research Questions

1. Can viewing the procedural video prior to treatment reduce the rate and/or area of subconjunctival hemorrhage?
2. Can the video improve the patient experience, specifically by reducing anxiety levels and increasing satisfaction with the treatment process?

Study Design Participants will be randomly assigned to either an intervention group, who will watch an educational video explaining the injection procedure, or a control group, who will not view the video.

All participants will complete the State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels.

Критерии включения

• * Patients who are receiving their first intravitreal injection of anti-VEGF medication due to retinal diseases
• * Mentally competent, and able to communicate without barriers
• * Willing to voluntarily sign an informed consent form.

Критерии исключения

• * History of previous eye surgery
• * Best-corrected visual acuity in the better eye worse than 0.3
• * The target eye is complicated with neovascular glaucoma.

Описание

Anticoagulants are classified as high-risk medications, with their main adverse drug events (ADEs) being recurrent venous thromboembolism (VTE) and bleeding events.Postoperative colorectal cancer (CRC) patients exhibit a high probability of recurrent VTE and bleeding during anticoagulation therapy.The Medication Therapy Management (MTM) model will contribute to reducing ADEs associated with anticoagulants in CRC patients.

Критерии включения

• 1. Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
• 2. CRC patients with VTE treated with an anticoagulant for at least 3 moths.

Критерии исключения

• 1.Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.

Описание

The purpose of the study is to learn about safety, how the body processes marstacimab and how it works in patients with severe hemophilia A. A rare bleeding disorder where the blood doesn`t clot normally. This causes a person to bleed a lot, even from a small cut.

These patients can be with or without inhibitors who are on emicizumab medicine for routine prophylaxis for at least 6 months, and desire to switch to marstacimab medicine. Inhibitors are antibodies that the immune system develops because it sees the infused clotting factor as a foreign substance that needs to be destroyed. Antibodies are proteins that eat up the activated factor before it has time to stop the bleeding. Prophylaxis are preventive medicines.

This study is seeking for participants:

* with severe Hemophilia A who are on emicizumab treatment for at least 6 months.
* must be 12 to less than 75 years old
* must have a body weight of at least 35 kilograms. The results from this study will serve as a guide to doctors and their hemophilia A patients who will change their medicines in the real-world clinical setting. Patients who can take part in the study will receive marstacimab medicine as weekly injections under the skin of 150 milligrams for 4 months. Study treatment with marstacimab will be initiated no earlier than 14 days after last dose of emicizumab. The study can last up to 6 months. The sponsor will provide marstacimab. Patients will continue their usual treatment with the infused clotting factor for their bleeds when taking part in the study.

Критерии включения

• 1. Male and 12 to /<75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent.
• 2. Diagnosis of severe hemophilia A (FVIII activity /<1%) with or without inhibitors.
• 3. On emicizumab therapy at a standard clinical dose for ≥6 months.

Критерии исключения

• 1. Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
• 2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator`s judgment, make the participant inappropriate for the study.
• 3. Known hemostatic defect other than hemophilia A.
• 4. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• 5. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
• 6. Platelet count /<100,000/μl or hemoglobin /<10 g/dL.
• 7. Clinically significant renal or hepatic function abnormality based on laboratory results at screening, or known kidney or liver disease.
• 8. CD4 cell count ≤200/μl if HIV positive.
• 9. Screening 12-lead ECG that demonstrates clinically significant abnormalities that, in the opinion of the investigator, may affect participant safety or interpretation of study results.
• 10. Known planned surgical procedure.
• 11. Hypersensitivity or allergic reaction to hamster protein or other components of the study intervention.
• 12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor-delegate employees directly involved in the conduct of the study and their family members.

Описание

This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.

Критерии включения

• * A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
• * Subject has not previously participated in the Cook MDR-2126 study.

Критерии исключения

• * Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.

Описание

Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths.

Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries.

We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient`s preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.

Критерии включения

• * Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTE based on a validated prediction model/* or International guidelines (ACCP 2012).
• * Age over 18 years
• * Delivery between 6 hours and /< 36 hours
• * Written informed consent
• * Definition: Intermediate risk is defined as ≥ 3%, based on risk prediction model developed by Sultan et al taking in account: smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, post-partum hemorrhage, postpartum infection, emergency or elective section or following ACCP guidelines: one major risk factor or two minor risk factors.

Критерии исключения

• * Previous personal history of VTE
• * LMWH started during antenatal period
• * Need for anticoagulation at curative dose
• * Contraindication to LMWH (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency)
• * Women who received more than two doses of LMWH since delivery
• * Unable or refusal to give informed consent
• * Aspirin at a daily dose 100 mg or dual antiplatelet therapy
• * Previous inclusion in Mum-VTE study
• * Concomitant participation in another therapeutic study

Описание

The purpose of this research is to evaluate a new technique, quantitative digital subtraction angiography (qDSA), to measure blood flow during liver embolization procedures. Liver transarterial embolization is a way of treating liver tumors by blocking blood flow to it. The qDSA technique could help doctors ensure the blood flow to the tumor is decreased by the right amount by calculating blood flow before, during, and after the procedure. Up to 20 participants will be enrolled for 1 study visit and data collection for up to 6 months.

Критерии включения

• * Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule

Критерии исключения

• * Pregnancy or breastfeeding
• * Patients with an acute kidney injury or stage IV or V chronic kidney disease (Cr greater than 2.4 or estimated glomerular filtration rate (eGFR) less than 30), unless anuric and on dialysis without expected return of renal function.
• * Patients with an iodinated contrast allergy who cannot be adequately premedicated to receive contrast as part of the embolization procedure.
• * Patients with a physical or psychological condition that would impair study participation.
• * The patient is judged unsuitable for study participation by the Investigator for any other reason

Описание

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks` gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks` postmenstrual age (PMA).

Критерии включения

• * Gestational age of 23 0/7 to 26 6/7 weeks
• * Postnatal age of /< 48 hours

Критерии исключения

• * Comfort care or withdrawal of care planned
• * Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
• * Receipt of platelet transfusion
• * No receipt of Vitamin K
• * Parents/guardian decline consent

Описание

In recent years, with an increase in the frequency of CT examinations, there has also been an increase in the random discovery of pulmonary emboli, often small, as part of examinations performed for other indications. Most of the literature so far deals with the discovery of such findings mainly in oncological patients, and there is relatively little information regarding the frequency of such random discovery in other patient populations. Specifically in the intensive care patient population, we have not yet found any study that examined the detection rates of these findings. Also, there is no consensus regarding how these random findings should be treated from a therapeutic point of view (whether to start treatment with full anticoagulation, and if so, for what period of time).

Random pulmonary embolism is often discovered as part of a CT scan done to assess acute lung disease or lung cancer staging. In a study done in oncology patients, 385 chest CT examinations were examined, with a random discovery of pulmonary emboli at a rate of 2.6% . A larger analysis of 8 studies involving 8491 cancer patients found a slightly higher incidence of 3.6%.

We would like to check the rate of pulmonary emboli that were randomly discovered in chest CT examinations performed in the intensive care unit for other indications, and the consequences of discoveries - ie starting anti-coagulant treatment and whether there were any complications for starting such treatment (bleeding).

Критерии включения

• All patients who were admitted to the ICU between 8/2020 and 8/2024 and underwent chest CT during ICU stay -

Критерии исключения

• Missing information
• -

Описание

The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:

* Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?
* Does intracoronary rhTNK-tPA increase the incidence of bleeding events?

This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.

Критерии включения

• * Age 18-75 years old;
• * STEMI within 12 hours of onset;
• * TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
• * Radial artery access

Критерии исключения

• * A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
• * Known or suspected old myocardial infarction of target vessels
• * Rescue PCI
• * Cardiogenic shock
• * Contraindications to Tirofiban or rhTNK-tPA
• * Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate /<30ml/min/1.73m2, or on dialysis)
• * Prolonged (/> 10 minutes) cardiopulmonary resuscitation
• * Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
• * Severe chronic obstructive pulmonary disease or respiratory failure
• * Severe infection
• * Neurological disorders
• * Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
• * Pregnant or lactating women

Описание

This study is a multicenter, randomized, open-label, positive-controlled Phase II clinical study to evaluate the efficacy and safety of H001 capsules in the prevention of venous thromboembolism (VTE) in subjects undergoing Total Knee Arthroplasty.

Критерии включения

• 1. Patients scheduled to undergo elective primary unilateral total knee arthroplasty (TKA);
• 2. Aged 18-74 years (inclusive) on the day of signing the informed consent form, regardless of gender;
• 3. Willing and able to voluntarily sign the informed consent form and comply with the study protocol;
• 4. Women of childbearing potential or subjects whose partners are women of childbearing potential must agree to use effective contraception throughout the study period. Acceptable methods include oral, implantable, or injectable hormonal contraceptives; mechanical products (e.g., intrauterine devices, diaphragms, condoms, spermicides); abstinence; or confirmed sterilization (e.g., vasectomy, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).

Критерии исключения

• 1. Pregnant or breastfeeding female subjects;
• 2. Body weight /<40 kg at screening;
• 3. History of allergy to contrast agents or inability to undergo bilateral lower limb venography; history of hypersensitivity to the study drug or drugs of the same class; known allergy to enoxaparin or any component listed in the enoxaparin prescribing information;
• 4. High bleeding risk or contraindications to enoxaparin (e.g., known or suspected heparin-induced thrombocytopenia, severe hematologic disorders, severe coagulation abnormalities);
• 5. History of deep vein thrombosis (DVT) or DVT confirmed during screening;
• 6. Clinically significant medical history, including
• 1. Hemorrhagic stroke or intracranial conditions (e.g., hemorrhage, tumor, arteriovenous malformation, or aneurysm);
• 2. Recurrent upper gastrointestinal or genital/urinary tract ulcers/bleeding, intraocular bleeding, or clinical bleeding within 6 months prior to screening (as judged by the investigator to increase bleeding risk);
• 3. Acute hepatitis within 1 year prior to screening or persistent severe liver disease (e.g., chronic active hepatitis, cirrhosis, or chronic hepatic insufficiency);
• 4. Myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism, or coronary revascularization within 6 months prior to screening; transient ischemic attack or ischemic stroke;
• 5. Chronic congestive heart failure with NYHA Class IV cardiac function;
• 6. Severe arrhythmias requiring Class Ia or III antiarrhythmic drugs; sinus node dysfunction, Type II Mobitz or third-degree atrioventricular block without pacemaker implantation;
• 7. History of QTc interval prolongation or QTc interval ≥480 ms during screening;
• 7. Poorly controlled hypertension within 3 months prior to screening (defined as failure to achieve target blood pressure despite ≥3 antihypertensive medications) or systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg confirmed during screening;
• 8. Major surgery or trauma within 3 months prior to screening, particularly involving the brain, spine, or eyes;
• 9. Use of the following treatments:
• 1. Ongoing or recent (within 7 days pre-surgery) anticoagulant therapy (e.g., after mechanical heart valve replacement) or plans to continue such therapy during the study;
• 2. Oral antiplatelet therapy (e.g., aspirin />165 mg/day, clopidogrel, ticlopidine, dipyridamole) within 7 days pre-surgery or plans to continue during the study;
• 3. Long-acting NSAIDs within 7 days or 5 half-lives (whichever is longer) prior to surgery;
• 4. Thrombolytic therapy for ischemic disease within 6 months prior to screening;
• 10. Planned or ongoing use of epidural analgesia post-surgery; planned or ongoing use of intermittent pneumatic compression devices, electrical/mechanical muscle stimulators post-surgery; intraoperative complications (e.g., hemorrhage or severe trauma) during spinal/epidural anesthesia;
• 11. Laboratory abnormalities at screening:
• 1. Total bilirubin />1.5×ULN, ALT or AST />3×ULN;
• 2. Serum creatinine />1.5×ULN; chronic kidney disease with eGFR /<30 mL/min/1.73 m²;
• 3. Hemoglobin /<100 g/L;
• 4. Platelet count /<100×10⁹/L;
• 5. APTT, PT, or INR />ULN with clinical significance (investigator judgment);
• 12. History of malignancy within 5 years prior to screening (excluding basal cell carcinoma or Stage I squamous cell carcinoma);
• 13. Positive serum pregnancy test (hCG) during screening;
• 14. Participation in another drug/device clinical trial within 1 month prior to screening or within 5 half-lives of the investigational drug (whichever is longer);
• 15. History of drug abuse or psychiatric disorders;
• 16. Other conditions deemed unsuitable for study participation by the investigator.

Описание

The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients.

Researchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT.

Participants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).

Критерии включения

• * Male or female patients older than 18 years.
• * Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy).

Критерии исключения

• * Prior locoregional therapy or liver transplantation.
• * Patients on vitamin K, vitamin K antagonists or antibiotics.
• * Patients with cholestasis.
• * Patients with renal insufficiency.
• * Patients with other malignancies.
• * Unwilling to participate in our study.

Описание

Venous thromboembolism (VTE) is frequent in patients in the intensive care unit (ICU). Pharmacologic prophylaxis is sometimes contraindicated, and mechanical prophylaxis is used. The primary objective of the study is to compare Pulsed Electromagnetic Field Therapy (PEMF) with conventional mechanical prophylaxis for the prevention of VTE in patients in the ICU.

Критерии включения

• 1. Patients /> 18 years old in ICU
• 2. PADUA score/> 4 (medical patients) and/or Caprini score/> 3 (surgical patients)
• 3. Contraindication to pharmacological prophylaxis or indication to combined (pharmacological and mechanical VTE prophylaxis)

Критерии исключения

• 1. Patients /< 18 years old in ICU
• 2. Unable to use mechanical prophylaxis due to trauma, burns, fracture, or problems in inferior members that prevent the use of mechanical prophylaxis
• 3. Life expectations less than 24 hours

Описание

This non-interventional study (NIS) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of life (HRQoL) of participants with Type 3 von Willebrand disease (VWD) receiving prophylactic therapy per local standard of care (SOC) over an observation period of at least 24 weeks.

Критерии включения

• * Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records
• * Adequate hematologic, hepatic, and renal function
• * Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study
• * For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements

Критерии исключения

• * Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
• * History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia
• * History of intracranial hemorrhage
• * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
• * Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
• * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
• * Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy

Описание

This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Критерии включения

• All patients admitted in the Unit of Vascular Surgery with proximal DVT (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to ESVS guidelines (2022).

Критерии исключения

• * Patient treated with thrombolysis drugs within 48 hours prior to the index procedure
• * Active bleeding, recent (/<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis
• * Impossibility or refusal to give informed consent

Описание

This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (/> 7cm) with portal vein tumor thrombosis (PVTT).

Критерии включения

• * a confirmed diagnosis of HCC
• * the largest intrahepatic lesion />7 cm
• * presence of PVTT on imaging
• * tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
• * Eastern Cooperative Oncology Group performance status ≤1
• * Child-Pugh class A/B
• * adequate hematologic and organ function, with leukocyte count/>3.0×10/^9/L, neutrophil count/>1.5×10/^9/L, platelet count≥75×10/^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
• * life expectancy of at least 3 months

Критерии исключения

• * accompanied with vena cava tumor thrombus
• * central nervous system involvement
• * previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
• * organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
• * history of other malignancies
• * uncontrollable infection
• * history of HIV
• * history of organ or cells transplantation

Описание

The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are:

* Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban?
* Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban?

The main tasks participants will be asked to do:

* Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage.
* Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.

Критерии включения

• 1. Patient aged from 18 to 80 years and no gender preference;
• 2. Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
• 3. Acute or subacute CVT from onset to door within 4 weeks;
• 4. The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
• 5. Patient or legally authorized representative is able to give written informed consent.

Критерии исключения

• 1. Patient refuse to take edoxaban or rivaroxaban to treat CVT;
• 2. Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
• 3. Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
• 4. CVT secondary to central nervous system infection or severe head trauma;
• 5. It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
• 6. Bleeding diathesis or other contraindication to anticoagulation;
• 7. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;
• 8. Concomitant use of strong CYP3A4 or P-gp inhibitors;
• 9. Impaired renal function (CrCl/<30 mL/min using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL/min during study;
• 10. Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;
• 11. Patient is unable to swallow due to depressed level of consciousness or other reasons;
• 12. Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;
• 13. Patient with severe hypertension (SBP≥180mmHg and/or DBP≥110mmHg);
• 14. Patient is known to be allergic to edoxaban or rivaroxaban.

Описание

The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.

Критерии включения

• * 18≤Age≤85
• * Clinical symptoms and presentation consistent with pulmonary embolism (PE).
• * PE symptoms duration ≤ 14 days.
• * High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
• * Intermediate-high risk PE patients with right ventricle dysfunction (right ventricle/ left ventricle />0.9) confirmed by computed tomography pulmonary angiography or transthoracic echocardiography.

Критерии исключения

• * Pregnancy.
• * Refusal to sign the informed consent form.
• * Presence of intracardiac thrombus.
• * Presence of chronic left heart failure with an ejection fraction lower than 30% Diagnosed thrombophilia.
• * History of severe or chronic pulmonary hypertension.
• * Serum creatinine level higher than 1.8 mg/dl.
• * Known serious and uncontrolled sensitivity to radiographic agents.

Описание

The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are:

* Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days)
* Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding)
* Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism)

Researchers will compare preoperative TXA to no TXA to answer the above questions.

Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.

Критерии включения

• 1. Adults 18 years or older
• 2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Критерии исключения

• 1. Creatinine clearance less than 30 mL/minute
• 2. Long-term dialysis
• 3. Known defective color vision (color blind)
• 4. Pregnancy
• 5. History of venous or arterial thromboembolism, or active thromboembolic disease
• 6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.

Описание

This study is a single-arm, open-label, multicenter study evaluating the efficacy and safety of GS1191-0445 injection as a single dose in Chinese subjects with hemophilia A.

GS1191-0445 is an AAV8-based gene therapy vector designed to express B-domain deleted human factor VIII (FVIII) under the regulation of a human liver-specific promoter. Following a single intravenous administration, AAV8 targets hepatocytes and facilitates the specific expression and secretion of FVIII into the bloodstream.

Критерии включения

• 1. Understand the purpose and risks of the study and provide informed consent in accordance with national and local privacy laws:
• 2. Subject must be male, aged />18 years old at the time of signing informed consent, and ≤65 years old:
• 3. Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ;
• 4. Subjects had used FVII products for at least 150 exposure days (ED) before enrollment;
• 5. Subject has no prior history of FVIII inhibitors;
• 6. Subjects agree to use a reliable barrier contraceptive method from the date of signing the informed consent
• 7. Subject is willing and able to follow planned visits, treatment plans, and other study procedures.

Критерии исключения

• 1. The subject has any hemorrhagic disorder not related to hemophilia A,
• 2. Abnormal liver function test results of subjects during screening.
• 3. Abnormal laboratory examination of subjects during screening
• 4. The subject has acute or chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment for hepatitis B and C;
• 5. Active systemic immune disease.

Описание

The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.

Критерии включения

• Acute intermediate-risk PE, defined as:
• * Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
• * Evidence of right ventricular enlargement by computed tomography (RV to LV ratio />1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition.
• Acute high-risk PE, defined as:
• * Intraluminal filling defect in segmental or larger vessels on computed tomography pulmonary angiography or high-probability ventilation/perfusion scan AND
• * Evidence of right ventricular enlargement by computed tomography (RV to LV ratio />1) or echocardiography; and/or right ventricular dysfunction by transthoracic echocardiography. These imaging characteristics must be in the setting of acute PE rather than explained by a prior chronic condition; AND
• * Hypotension (systolic blood pressure /< 90 mm Hg sustained for more than 15 minutes; or requiring vasopressors) or cardiogenic shock due to acute pulmonary embolism.

Критерии исключения

• * Inability to ambulate independently, which is necessary to perform 6MWD (may be self-reported or as deemed by physical therapy during inpatient evaluation).
• * If patient requires supplemental oxygen during ambulation, this does not exclude patient from participation and will be noted during eCRF.
• * Prior history of pulmonary embolism
• * History of CTEPH or pulmonary arterial hypertension
• * Unable to read a questionnaire in English
• * Unable to return for baseline, 3- or 6-month follow-up visit
• * Pregnancy-associated pulmonary embolism
• * Life expectancy /<1 year based on comorbidities
• * Unable/unwilling to provide informed written consent

Описание

Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients` arms using a needle to allow easy access to veins. They are the most commonly-used medical devices in the world, with almost 10 million placed each year in Australia alone. Approximately 40% (almost 4 million) of these devices stop working (i.e. fail) prior to completion of therapy.

The main goal of this study is to learn if softer, more flexible PIVC tip materials reduce the angle of the catheter tip on the vein surface compared to less flexible materials. Reducing the angle of the tip is believed to reduce rubbing on the inner vein surface and causing irritation, extending the life of the catheter. Other goals of this study are to learn if softer materials affect: volume of oedema (i.e. fluid leakage around the vein); time until catheter failure; clot volume in the vein; changes in vein size in response to catheter insertion; adverse event rates (i.e. changes in rates of specific, reportable symptoms); and determining if certain catheters are better for some people than others. This study is recruiting participants of all genders aged 18 - 75 years old who:

* Are not pregnant
* Have a Body Mass Index (BMI) between 18.5 - 35 kg/m2
* Have a current Australian Medicare card
* Do not have a history of chronic/infectious disease or clotting disorders
* Do not have a history of recreational drug use or alcohol abuse within the past 2 years

Participants will:

* Spend two hours in the clinic for screening blood collection, medical questionnaire and ultrasound imaging of veins
* Have one more flexible catheter and one less flexible catheter placed in opposite arms (i.e. participants will have a total of two catheters placed) which will remain in place either (i) until they fail or (ii) for 72 hours, whichever is earlier
* Spend eight hours per day in the clinic on the day the catheters are placed and the two days following for observation and ultrasound imaging
* Spend four hours in the clinic on the third day following placement of the catheters for observation, ultrasound imaging and catheter removal
* Spend one hour in the clinic 24-96 hours after catheter removal for a follow-up assessment and questionnaire

Критерии включения

• * Adult aged 18-75 years.
• * Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported)
• * Normal haematology results as per reference range determined by the laboratory.
• * Normal coagulation results as per reference range determined by the laboratory.
• * Target cephalic veins readily cannulatable (i.e., /> 2 mm)
• * Able and willing to provide verbal and written consent
• * Must be an Australian citizen with current Medicare card

Критерии исключения

• * History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
• * Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however are not exclusionary.
• * Haemophilia or any current or history of bleeding disorder or tendency
• * Presence or report of current blood borne disease/infection (e.g., hepatitis, HIV, leukemia, lymphoma)
• * History of difficult vascular access
• * Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives
• * BMI /< 18.5 kg/m2 or ≥ 35 kg/m2
• * Positive results for the urine drug screen at screening or check-in (including opiates, methadone, cocaine, amphetamines)
• * History or presence of alcoholism (self-reported) or drug abuse within the past 2 years
• * A current or previous medical, physical, mental / cognitive disorder or anatomical conditions that, in the opinion of the chief or sub-investigator, would place the patient at risk, would make them unable to perform study procedures or has the potential to confound interpretation of the study results. (e.g., musculo-skeletal injury, chronic back pain)
• * Employed by Terumo, Becton Dickinson, Teleflex Medical, ICUMedical or BBraun (conflict of interest)

Описание

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor

Критерии включения

• 1. 12 ≤age≤70 years of age.
• 2. Hemophilia A or B patients.
• 3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• 4. Establish proper venous access.
• 5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
• 6. Agree to use adequate contraception to avoid pregnancy.
• 7. Provide signed informed consent.

Критерии исключения

• 1. Have any coagulation disorder other than hemophilia.
• 2. Plan to receive prophylactic treatment of coagulation factor during the trail.
• 3. Patients plan to receive Emicizumab during the trial.
• 4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
• 5. Have a history of arterial and/or venous thrombotic events.
• 6. Platelet /<100×109/L.
• 7. Hemoglobin/<90g/L.
• 8. Severe liver or kidney disease.
• 9. Severe bleeding event occurred within 4 weeks before the first administration.
• 10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
• 11. Have a known allergy to STSP-0601.
• 12. Pregnant, lactating, or blood pregnancy test positive female subjects
• 13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
• 14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
• 15. Patients not suitable for the trail according to the judgment of the investigators.

Описание

This is a multinational, prospective, open-label, roll-over study in patients with severe haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), or PK comparison study (Sobi.BIVV001-003). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient`s respective country (or until March 2027, whichever comes first).

The study starts with the Baseline Visit, which will be done in connection to the End of Study visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.

Критерии включения

• * Capable of giving signed informed consent. Parents or legally designated representatives` consent is required for patients who are below 18 years of age or unable to give consent. Patients who are below 18 years of age may provide assent in addition to the parents`/legally designated representatives` consent, if appropriate.
• * Must have completed one of the required parent studies: Sobi.BIVV001-001, Sobi.BIVV001-003, or LTS16294, and be receiving a clinical benefit from the efanesoctocog alfa treatment, as judged by the Investigator.
• * Willingness and ability of patient or their parent or legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study.

Критерии исключения

• * Positive inhibitor result (assessed by central laboratory), defined as ≥0.6 Bethesda units (BU)/mL, at Baseline Visit.
• * Ongoing or planned participation in any interventional clinical study at Baseline Visit.
• * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.

Описание

Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) is a frequent disease and the third most common cause of cardiovascular death in the world after myocardial infarction and stroke. Anticoagulant therapy drastically reduces the risk of early VTE recurrence and death, but it exposes patients to a substantial risk of bleeding. Hence, determining the optimal duration of anticoagulant treatment for VTE is a major public health issue.

When major transient risk factors for VTE are identified (major surgery, immobilization...), patients generally do not need to extend anticoagulation beyond 3 months, whereas for VTE diagnosed in the context of cancer, therapeutic anticoagulation is required for as long as the cancer is considered "active".

However, in more than 50% of cases, venous thromboembolic disease occurs spontaneously, i.e. without any significant clinically detectable circumstance (known as unprovoked venous thromboembolic disease). In such patients, the risk of recurrence is high (35% recurrence rate at 5 years, with a 10% risk of death per recurrence). Scientific societies therefore recommend continuing anticoagulant treatment "indefinitely" (i.e. without programming a stop date or long-term treatment). However, this practice exposes these patients to an ongoing, non-negligible increase in the risk of bleeding, which could ultimately exceed the risk of recurrence of venous thrombo-embolic disease.

Optimizing anticoagulant therapy beyond the first three to six months of treatment is therefore a crucial and challenging issue, which could improve the long-term prognosis of patients with unprovoked thromboembolic venous disease.

Based on the quantitative and qualitative approaches implemented in MORPHEUS project granted by European Commission (HORIZON-HLTH-2022-TOOL-11-01 call), the investigators have combined predictive personalized medicine, through the use of risk biomarkers, with a patient-centered model of medicine, which, while based on an understanding of the patient`s experience, leading to develop Time-Dependent Multicomponent risk prediction scores and socIo-anthropological scales (TDMI) integrated in a shared decision-making process regarding anticoagulant treatment duration in patients with a first episode of unprovoked VTE.

The aim of this study is to demonstrate that this strategy, based on a medical decision-making process shared between patients and physicians and including TDMI, reduces the risk of recurrence of thromboembolic venous disease (fatal or non-fatal), the risk of bleeding and all-cause mortality, and is associated with greater patient satisfaction after a first episode of unprovoked thromboembolic venous disease.

Критерии включения

• * Patient /> or = 18 years,
• * Patient with a first episode of symptomatic unprovoked pulmonary embolism (PE) and/or proximal deep vein thrombosis (DVT) treated for 3 to 6 uninterrupted months with full dose anticoagulant therapy,
• * Signed informed consent.

Критерии исключения

• * Unable or refusal to give informed consent,
• * Isolated distal DVT,
• * Isolated sub-segmental PE
• * Previous unprovoked VTE
• * Known CTEPH
• * Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves...),
• * Interruption of anticoagulation for 14 days or more before the inclusion,
• * Active cancer of less than 24 months,
• * Current pregnancy,
• * Life expectancy /<18 months (e.g.; patients with an end-stage chronic disease)
• * Not affiliated to national insurance, social security (only for France)

Описание

The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty.

Критерии включения

• 1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
• 2. Planned elective schedule total knee arthroplasty (TKA) patients;
• 3. Men or women who are ≥ 18 years old and /< 80 years old on the day of signing the informed consent form.

Критерии исключения

• 1. Unable to receive CT angiography of both lower limbs;
• 2. Malignant tumor within one year of the screening;
• 3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
• 4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
• 5. History of drug abuse;
• 6. Pregnant or lactating women.

Описание

Background:

Long COVID, characterized by persistent symptoms following acute COVID-19 infection, has emerged as a significant public health concern. Symptoms range from fatigue, cognitive impairments, to respiratory difficulties, affecting patients/' quality of life. Dietary interventions, particularly fasting, have historically been used to modulate immune responses and improve health outcomes in various conditions. The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach. Given the inflammatory nature of long COVID, fasting may offer therapeutic benefits by modulating the immune response, enhancing cellular repair mechanisms, and resetting metabolic processes.

Objectives:

This clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective. As secondary objectives, the study will investigate the potential beneficial impact of fasting on clinical, biological, and psychological parameters over a period of 4 weeks, offering insights into potential therapeutic avenues for long COVID management.

Study timeline:

The research will span a period of 4 weeks

Study population:

This study aims to recruit around 20 participants, who will all receive a fasting intervention using the Buchinger-Wilhelmi method.

Biological sample and data collection:

Participants will undergo various data and sample collection procedures, including blood draws of up to 90 42 ml per visit, collection of peripheral mononuclear cells, stool samples, and completion of questionnaires in a smartphone-based Application (MyCap).

Sample analysis:

The collected samples will be subjected to a range of analyses, including the assessment of serological markers for routine blood chemistry, evaluation of inflammation markers, and examination of stool samples.

Критерии включения

• * Age 18-64
• * Diagnosis Long Covid Syndrome (post-acute COVID-19 symptoms persisting ≥12 weeks)
• * Normal body Mass Index (18.5 to 25 kg/m2)
• * Marginal Iron status ( PF/< 25 ng/ml)
• * Able to communicate in and comprehend English and/or German and/or French language
• * Present written / signed declaration of consent
• * Ability to understand the patient information and willingness to sign the consent form
• * Consent to specimen collection and specimen use

Критерии исключения

• * Current underweight condition (body mass index less than 18.5 kg/m2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.
• * Existing / current eating disorder within the past five years (e.g., anorexia, bulimia).
• * Psychiatric condition that limits understanding of the examination protocol (unable to consent)
• * Severe internal disease (e.g. kidney deficiency with creatinine /> 2mg/dl), chronic inflammatory illness other than LCS
• * Participation in another intervention study.
• * Existing vegan diet or fasting during the last six months
• * Pregnancy or breastfeeding status.
• * Presence or suspicion of pre-existing ME/CFS or early autonomous dysfunction
• * Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the German Society of Gastroenterology
• * Use of anti-psychotic drugs
• * Antibiotic use during the previous 12 months
• * Start of novel drug therapy
• * Contraindication for additional blood draws (e.g. hemoglobin /<10)

Описание

This registry is a global prospective, non-randomized, multicenter, observational, active post-market data collection of Inari Medical devices and products.

Критерии включения

• 1. Willing and able to provide informed consent per institution and geographical requirements
• 2. Has received treatment with an eligible Inari Medical device. NOTE: If patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure.
• 3. Currently within enrollment window relative to their procedure
• 4. Age ≥ 18 years

Критерии исключения

• 1. Is or will be inaccessible for registry follow-up
• 2. Meets exclusion criteria required by local requirements
• 3. Current or planned participation in another drug or device study that, in the investigator`s opinion, would interfere with participation in this registry
• 4. Is pregnant or breastfeeding at the time of enrollment

Описание

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.

The name of the study drug involved in this study is:

-Apixiban (a type of anticoagulant)

Критерии включения

• * Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months.
• * Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated thrombosis will be included, as will distal lower extremity DVTs.
• * Platelet count /< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis.
• * Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3 transfusions.
• * No evidence of active hemorrhage.
• * No recent history of major hemorrhage (requiring transfusion, hospitalization or intervention) within the last 12 months.
• * No known brain metastases.
• * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of apixaban in participants /<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
• * ECOG performance status ≤2
• * Participants must have adequate organ and marrow function as defined below:
• * Total bilirubin ≤ institutional upper limit of normal (ULN)
• * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
• * Glomerular filtration rate (GFR) ≥25 mL/min/1.73/m2
• * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• * The effects of apixaban on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of apixaban administration.
• * Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• * Participants who are receiving any other investigational agents.
• * Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent.
• * Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or pulmonary embolism with hemodynamic compromise.
• * Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant.
• * Participants with luminal gastrointestinal malignancy or genitourinary cancer.
• * Presence of known or prior brain metastasis, given the increased risk of life-threatening intracranial hemorrhage with anticoagulant use. While screening for brain metastases is not standard of care in this population, investigators may obtain brain imaging if clinically indicated prior to initiation of anticoagulation. Imaging is not mandated in order to participate in this study.
• * History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban.
• * Participants receiving any medications or substances that are inhibitors or inducers of CYP3A/P-gp are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
• * Participants on aspirin (/>100 mg/day), dual antiplatelet therapy, or receiving chronic treatment with NSAIDS
• * Participants with uncontrolled intercurrent illness.
• * Participants at high risk of bleeding such as:
• * Unresected luminal/mucosal GI and GU cancers
• * Active gastric or duodenal cancer
• * History of major bleeding (based on ISTH criteria) in the past 12 months
• * Any prior history of Intracranial hemorrhage (microhemorrhage is not included)
• * Clinical or laboratory concern for ongoing DIC (prolonged PT/APTT or low fibrinogen)
• * Severe renal disease (CKD Stage IV or higher) or liver disease (Child Pugh B/C)
• * Participants with pre-planned major surgery within the study period
• * Participants with psychiatric illness/social situations that would limit compliance with study requirements.
• * Pregnant women are excluded from this study because apixaban has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with apixaban, breastfeeding should be discontinued if the mother is treated with apixaban.
• * Participant must be able to swallow pills.

Описание

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

Критерии включения

• Subjects are eligible if they meet all of the following criteria:
• * Male or female volunteers older than 18 years old.
• * Disease-free as assessed by medical history and physical examination.
• * Ability to provide signed informed consent.

Критерии исключения

• Subjects will be excluded if they meet any of the following criteria:
• * Pregnant or lactating women
• * History of clinically relevant cardiovascular, pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness.
• * Use of medication within one month prior to study drug administration or within six times the elimination half-life (whichever is longer), except for oral contraceptives or occasional use of acetaminophen or an antihistamine.
• * History of drug abuse or alcohol consumption />20 g/day /[125 ml (30ml=1oz) glass of 10% wine = 12.5 g, 40 mL aperitif of 40% = 17 g, 250 mL glass of 6% beer = 15g/]
• * Loss of />400 mL blood or blood donation within 3 months.
• * Conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.

Описание

The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.

Критерии включения

• * Aged />18
• * PCI with mini-crush or controlled balloon-crush
• * Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)

Критерии исключения

• * Non-complex bifurcation anatomy
• * Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
• * ST-elevation myocardial infarction
• * Cardiogenic shock status
• * In-stent restenosis
• * A history of coronary artery bypass grafting
• * Implantation of bare-metal stent
• * End-stage hepatic or renal disease
• * /<1-year life expectancy

Описание

This study aims to assess physiotherapists` knowledge levels, awareness, perceived roles, adequacy of education received, learning preferences, and external barriers regarding exercise and physical activity in individuals with hemophilia. The findings will help identify physiotherapists` educational needs and contribute to the development of strategies to enhance their effectiveness in hemophilia management.

Критерии включения

• * Profession Group: Participants must be physiotherapists.

Критерии исключения

• * Non-Physiotherapists: Individuals who are not licensed physiotherapists will be excluded from the study.

Описание

The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).

Критерии включения

• 1. Age equal to or greater than 18 years of age.
• 2. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group
• 3. First active treatment for MM started after recruitment in the study
• 4. Signed informed consent

Критерии исключения

• 1. Patients having had thrombosis within 6 months before diagnosis of MM
• 2. Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)
• 3. Ongoing first active treatment for MM initiated before the starting of the study.

Описание

We now have very sensitive blood tests that can pick up damage to the heart and find patients who have had a heart attack. However, whilst this is welcome, it does not identify what causes the heart attack and can sometimes pick up other conditions that cause a strain on the heart.

The classic cause of a heart attack is when a blood clot forms on fatty deposits within the heart arteries. This leads to treating patients with blood thinning medication, and this is very effective and saves lives. However, many apparent heart attacks are not caused by blood clots and some may be caused by blood clots but pass unrecognised.

In this proposal, we will test an exciting new imaging test that can `see` from outside the body whether there is a blood clot in the heart arteries. This could provide a major new way of assessing patients to ensure they get the right diagnosis and the right treatment. This could ultimately improve the outcomes of or patients with heart attacks.

We will recruit 80 patients in total who have recently been diagnosed with a heart attack from the cardiology department at the Royal Infirmary of Edinburgh. The research team will review patient`s medical records to determine eligibility for the study.

The research study involves participants undertaking the following research procedures and assessments:

1. A combined Positron Emission Tomography and Computed Tomography (PET-CT) scan of the heart
2. Ultrasound scan of the heart (Echocardiogram)
3. MRI scan of the heart
4. A blood test - a total of up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remaining blood will be stored for future ethically approved studies
5. A follow up questionnaire 6 -12 months following the heart attack

Критерии включения

• * Males and females ≥ 18 years of age
• * Clinical presentation of chest pain, ST-segment deviation within a coronary artery territory on the electrocardiogram, raised cardiac troponin and non-obstructive coronary arteries on invasive coronary angiography as per international societal diagnostic criteria

Критерии исключения

• * /<18 years of age
• * Takatsubo cardiomyopathy
• * Myocarditis
• * Renal failure (estimated glomerular filtration rate /<30 mL/min/1.73 m2)
• * Woman of child-bearing potential who are pregnant or breastfeeding
• * Known allergy or contraindication to iodinated contrast or radiotracer
• * Patients unable to tolerate the supine position
• * Patients unable to provide informed consent

Описание

The investigators will use state-of-the-art imaging to look at heart disease in people with haemophilia. Haemophilia is an inherited disorder in which blood does not clot properly because of lack of a key `glue` blood component (chemicals known as factor VIII or IX). People with haemophilia are 40% less likely to die of heart disease, but it is not known exactly why this is. Understanding heart disease in people with haemophilia is important because better treatments for haemophilia mean that these patients are now living longer, but doctors still don`t know if the risk for heart disease in these patients as they age is the same as that for the general population. If these processes are better understand (perhaps less blood clotting is actually protecting the heart from blockage-causing clots), scientists might be able to reduce the risk of heart attacks for everybody.

The UK`s first photon-counting detector cardiac CT scanner generates detailed images of the heart and its blood vessels by counting individual X-ray photons. Together with artificial intelligence tools, it is possible to extract a lot of information from these images. As people age, fat is deposited in the vessels which supply blood to the heart which forms plaques. Plaques cause narrowing of the vessels, reducing blood flow to the heart, and can also burst (rupture), leading to a blood clot and heart attack. The new CT scan will show the type and amount of plaques, and quantify the risk of plaque rupture, in people with haemophilia; and the investigators will compare this to people without haemophilia.

Understanding the role of factor VIII/IX in heart attacks will improve management of heart disease in people with haemophilia, and may also lead to new prevention and treatment strategies that benefit heart health for everyone.

Критерии включения

• * Be willing and able to give informed consent for participation in the study.
• * Male, aged 45 years or above (no upper age limit).
• * Haemophilia A or B with Factor VIII/IX less than 40% (0.40 IU/ml).

Критерии исключения

• * Participants unable or unwilling to give informed consent.
• * Participants unable to understand the English language.
• * Participants unable or unwilling to attend for the necessary scans and investigations.
• * Patients with absolute contra-indications to CT imaging will be excluded from the study. This includes:
• * Any known contraindications to CT iodinated Contrast.
• * Significant renal impairment (eGFR /<30 ml/min).
• * Any other medical conditions which would influence the reliability of the study results determined by the investigators.

Описание

The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.

Критерии включения

• 1. Age ≥ 18 years
• 2. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
• 1. Bilateral iliofemoral DVT
• 2. Clot extending into or located in the IVC
• 3. In-stent thrombosis
• 4. Presence of thrombosed IVC filter
• 5. Other features that the investigator deems put the subject at elevated risk for thromboembolism
• 3. Willing and able to provide informed consent

Критерии исключения

• 1. Current symptomatic PE
• 2. Known anatomic inability to place Protrieve device via jugular vein access site
• 3. Presence of clot extending to the IVC-Right Atrial junction or in the SVC
• 4. Subject is pregnant
• 5. Severe allergy to iodinated contrast agents that cannot be mitigated
• 6. INR /> 1.7 if not currently on anticoagulation therapy, platelets /< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin /< 8.0 g/dL
• 7. Severe renal impairment in patients who are not yet on dialysis that in the Investigator`s discretion would pose risk to the patient with the use of marketed contrast agents
• 8. Subject is participating in another study that may interfere with this study
• 9. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
• 10. Subject has previously completed or withdrawn from this study
• 11. Limb-threatening circulatory compromise (e.g., phlegmasia)
• 12. Uncontrolled severe hypertension on repeated readings (systolic /> 180mmHg or diastolic /> 105mmHg)
• 13. Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• 14. Inability to provide therapeutic anticoagulation per Investigator discretion
• 15. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
• 16. Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

Описание

Hemophilia A is a blood coagulation disorder caused by deficient or dysfunctional clotting factor VIII (FVIII) leading to incomplete haemostasis. Patients with severe Hemophilia A are predisposed to recurrent bleeding episodes (BEs) in joints and soft tissues that culminate in debiltating arthropathy and long-term morbidity. Prophylaxis with plasma-derived or recombinant FVIII concentrates effectively restores FVIII levels in patients with Hemophilia A, and significantly reduces the risk of bleeding. A critical concern for patients receiving FVIII replacement therapy is the development of neutralising antibodies (inhibitors) against the treatment. Inhibitors develop in up to 40% of patients with severe Hemophilia A when first exposed to FVIII treatment, typically within the first 20-30 exposure days (EDs) although a residual risk remains until after 75 EDs. Inhibitors preclude the use of FVIII replacement therapy for prevention and treatment of bleeding.

Eradication of inhibitors therefore remains an important objective for Hemophilia A patients with inhibitors. Immune tolerance induction (ITI) therapy is the only clinically proven strategy for inhibitor eradication, and at least one attempt should be offered to patients with inhibitors. However, while ITI is well-studied and has a 60- 80% success rate, treatment regimens can be expensive and burdensome to patients.

There are limited data on the use of different dose regimen of FVIII ITI in China. The INITIATE Study was designed to observe treatment strategies in patients with hemophilia A with inhibitors, with a focus on evaluating the safety and effectiveness of different dose regimens of ITI. The INITIATE Study includes multiple groups to explore factors that may affect ITI outcomes, and to explore the effects of different treatment methods on patient ITI biomarkers (genomics, transcriptomics, proteins (antibodies).

Критерии включения

• * Severe hemophilia A (FⅧ:C /<2%);
• * Positive for FVIII inhibitors;
• * No allergic reactions to FVIII concentrates.

Критерии исключения

• * Presence of other coagulation-related diseases,
• * Hematological disorders,
• * autoimmune diseases
• * malignancies

Описание

This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).

Критерии включения

• 1. Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
• 2. Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
• 3. Able and willing to provide informed consent.

Критерии исключения

• 1. Active bleeding or other reasons for which anticoagulation is contraindicated.
• 2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
• 3. Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .
• 4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.
• 5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.

Описание

This is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study of HMB-002 in participants with VWD. Part A of the study involves a single ascending dose (SAD) design to establish safety, tolerability, PK, and PD effect. In Part B of the study, the safety and tolerability of repeat dosing will be established prior to cohort expansion to explore efficacy.

Критерии включения

• 1. Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations.
• 2. Has an understanding, ability, and willingness to comply with study procedures and restrictions.
• 3. ≥18 and /<65 years.
• 4. Weight 60 to 110 kg, inclusive.
• 5. Congenital Type 1 VWD diagnosis as documented by laboratory results for VWF antigen and activity.
• 6. Vital signs are within the following ranges at Screening:
• 1. Resting pulse rate ≤105 bpm
• 2. Blood pressure (BP):
• * Systolic blood pressure: 90 - 140 mmHg
• * Diastolic blood pressure: 40 - 90 mmHg
• 7. Participants assigned female at birth and of child-bearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of HMB-002.
• 8. Women of childbearing potential (CBP) and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study.
• 9. Participants must meet the following baseline organ function, indicated by laboratory criteria as Screening:
• 1. Renal: Estimated glomerular filtration rate (eGFR) of ≥45 ml/min/1.73m/^2.
• 2. Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin ≤1.5 upper limit of normal (ULN) range at Screening. For participants with a history of Gilbert`s Syndrome, total bilirubin ≤2 × ULN.
• 3. Hematology: Hemoglobin />85 g/L and platelet count />120 x 10/^9/L.
• 10. PART B ONLY- Participants must be symptomatic as defined by a history of bleeding events. They must have participated in the observational study HMB-002-101_SCR and have recorded bleeding events within this observational study.

Критерии исключения

• 1. History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
• 2. Personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated, superficial venous thrombosis.
• 3. High risk thrombophilia: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/Prothrombin gene mutation, Antithrombin /<50%. Congenital Protein C and Protein S deficiency with levels /<50%.
• 4. Requires ongoing bleed prophylaxis with IV factor concentrates.
• 5. Has a positive test for Hepatitis B surface antigen (HbsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening with RNA level above the lower limit of detection.
• 6. Has received any live vaccine within 28 days prior to signing of informed consent and/or is planning to have a live vaccine during the study period.
• 7. Planned major surgery during the course of the study.
• 8. Body mass index (BMI) />35 kg/m/^2 (obese, adjusted for ethnicity).
• 9. Other conditions that substantially increase risk of thrombosis by the discretion of the Investigator.
• 10. Participants who are pregnant or breastfeeding.
• 11. Clinically significant cardiovascular disease.
• 12. Other conditions that substantially increase the risk of cardiovascular events by the discretion of the Investigator.
• 13. Congenital or acquired bleeding disorders other than Type 1 VWD.
• 14. Concurrent disease, treatment, medication, or abnormality in clinical laboratory tests may pose additional risk in the opinion of the investigator.
• 15. Hypersensitivity to study drug or any of the excipients.
• 16. Received investigational medication in another clinical study within 5 half-lives before administration of HMB-002.
• 17. PART A only: Type 1C VWD.

Описание

The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.

Критерии включения

• 1. English speaking (/>18 years old). Daily messages will be sent in English.
• 2. Acute PE with at least one of the following:
• 1. any right ventricular enlargement or dysfunction on echocardiogram;
• 2. CT Angiogram reporting any right ventricular enlargement; or
• 3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
• 3. Rate controlled atrial arrythmias (resting heart rate /<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
• 4. Subjects do need to take prescribed anticoagulation.

Критерии исключения

• 1. Pregnancy.
• 2. Cardiac Effort />3.5 beats/m during 6MWT.
• 3. Resting tachycardia />110 beats/m at hospital discharge.
• 4. Chronic Thromboembolic Pulmonary Hypertension
• 5. Systolic blood pressure />180 mmHg at hospital discharge.
• 6. Inability to walk.
• 7. Estimated prognosis /<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
• 8. Advanced neurologic disease and would not be able to comply with the messages.
• 9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.

Описание

Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis, thrombotic and bleeding events.

Previous studies in patients on durable MCS suggest that device-induced platelet dysfunction plays a major contributory role in the development of such events and that selected markers of platelet function have the potential to stratify patients according to an elevated risk of adverse events. To date, the potential clinical utility of markers of altered platelet function in patients supported with an Impella pump is unexplored.

The proposed study will analyze changes in platelet function in the setting of Impella support (primary aim) and possibly identify a platelet function "profile" indicative of patients at high-risk to develop adverse events (secondary aim).

The study is a prospective observational study. Changes in the expression levels of markers of both platelet activation and aggregation in patients supported with an Impella pump will be measured. Data will be longitudinally measured: pre-implant (before Impella implantation) and then after 24, 48 and 72h of Impella support. Markers that will be analyzed include surface platelet receptors and platelet microRNAs. Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events.

This study will provide mechanistic insights into the effect of Impella support on the protein and miRNA expression of platelets. The intention is to get a better understanding of distinct pathways of platelet function related to Impella support and their relationship to adverse events. Our data might open the perspective for the future clinical use of markers of platelet function to enhance the early recognition of patients at high risk of developing an adverse event and the definition of novel, personalized therapeutic strategies targeted to platelet biology to prevent their occurrence.

Критерии включения

• * Patients />18yrs-old and /<75yrs-old
• * Cardiogenic shock SCAI class C-D-E
• * primary tMCS with an Impella device (all Impella pumps)
• * Informed consent

Критерии исключения

• * Patients /<18yrs-old or />75yrs-old
• * Refusal to participate to the study

Описание

This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy 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
• 3. PE symptom duration ≤ 14 days
• 4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator)
• 5. CTA evidence of RV/LV ratio /> 0.9 note: based on Investigator`s interpretation of RV/LV ratio at baseline;
• 6. Systolic BP ≥ 90 mmHg note: initial SBP may be /< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation
• 7. Stable heart rate (HR) /< 130 BPM prior to procedure
• 8. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment.
• 9. 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 /< 48 hours prior to baseline CTA
• 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) />70 mmHg by right heart catheterization
• 4. Vasopressor requirement after fluids to keep pressure at ≥90 mmHg
• 5. FiO2 requirement />40% or />6 LPM to keep oxygen saturation />90%
• 6. Hematocrit /<28% (Note: hematocrit required within 6 hrs. of index procedure)
• 7. Platelets count /<100,000/µL
• 8. eGFR /<30 ml/min per 1.73 m2
• 9. International normalized ratio (INR) />3
• 10. Major trauma injury severity score (ISS) /> 15
• 11. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
• 12. Cardiovascular or pulmonary surgery within 7 days of index procedure
• 13. Actively progressing cancer treated by chemotherapeutics
• 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. History of underlying lung disease that is oxygen dependent
• 20. History of chest irradiation
• 21. History of heparin-induced thrombocytopenia (HIT)
• 22. Contraindication to systemic or therapeutic doses of anticoagulants
• 23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 24. Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle).
• 25. CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus)
• 26. Life expectancy /<90 days, as determined by investigator
• 27. Female who is pregnant or nursing
• 28. Current participation in another investigational drug or device treatment study Note: observational or registry studies may be permitted with Sponsor approval

Описание

The goal of this clinical trial is to compare the use of a machine learning-based algorithm and point-of-care D-dimer to laboratory D-dimer and compression ultrasound to exclude deep vein thrombosis in the under extremities in patients referred to a medical department suspected of having deep vein thrombosis. The main aim is to answer are if a machine learning algorithm and point of care D-dimer can exclude deep vein thrombosis in more patients than clinical assessment and D-dimer alone.

Критерии включения

• * Patients referred to the ED due to suspicion of DVT
• * Age ≥ 18 years
• * Able to give informed consent

Критерии исключения

• * Ongoing use of anticoagulation for more than 72 hours
• * Previous participation in the study
• * Life expectancy of less than three months.

Описание

Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.

Критерии включения

• * Inclusion criteria common to both groups :
• * Patients who have given written informed consent.
• * Patients who are affiliated to or beneficiaries of a social security scheme.
• Inclusion criteria specific to the Patient Group:
• * Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
• Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
• * First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
• * Hormonal stimulation for oocyte retrieval
• * Pregnancy and 6 weeks post-partum
• * Surgery
• * Trauma
• * Immobilisation in plaster or splint
• * Outbreak of acute infectious disease
• * Acute flare-up of inflammatory disease
• * Prolonged air travel lasting at least 4 hours
• * Prolonged strict bed rest lasting at least 3 consecutive days.
• Inclusion criteria specific to the Control Group:
• * Subjects with no personal history of venous thromboembolism
• * Subjects with no family history of venous thromboembolism in first-degree relatives
• * Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.

Критерии исключения

• * Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure /> 200/110 mmHg, recent stroke or transient ischemic attack).
• * Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
• * Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
• * Last surgery dating back to less than 3 months.
• * Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
• * For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
• * Pregnancy within the last year.
• * Difficult venous access.
• * Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.

Описание

TORPEDO-NL will be an investigator-initiated, academically sponsored, multicentre, open-label, randomized controlled trial (RCT).

Patients with high-risk pulmonary embolism (PE) require immediate reperfusion therapy on top of anticoagulation. The standard reperfusion treatment in these patients is full-dose systemic thrombolysis. This carries a significant risk of major bleeding (10-25%) and intracranial haemorrhage (ICH, 3%). Catheter-directed thrombectomy (CDT) is a promising alternative to systemic thrombolysis with a more direct effect on reducing pulmonary artery clot burden and very likely a better safety profile. Randomized trials evaluating the safety and efficacy of CDT in high-risk patients are currently unavailable. The investigators hypothesize that in high-risk PE patients, CDT is superior to the current standard of systemic thrombolysis in terms of mortality and adverse events, i.e., is associated with a lower composite incidence of all-cause mortality, treatment failure, major bleeding and all-cause stroke. The investigators also hypothesize that CDT will lead to a shorter length of stay (LOS) at the intensive care unit (ICU) and in-hospital, faster recovery, and better long-term quality of life (QoL).

Objective: To determine whether CDT in high-risk PE relative to systemic thrombolysis is:

* more effective and safer in terms of a reduction of the composite endpoint on all-cause mortality and adverse events defined as treatment failure, major bleeding and all-cause stroke at day 30 (primary outcome)
* leads to a better Desirability of Outcome Ranking (DOOR) at day 7
* associated with a lower level of oxygen supplementation at 48 hours
* associated with shorter length of stay (LOS) at the intensive care unit (ICU) and in the hospital
* associated with better functional recovery as well as better patient-reported outcomes such as QoL at one year
* cost-effective after a time horizon of one year

Критерии включения

• 1. Adult patients with confirmed acute PE, i.e. contrast filling defect in a lobar or more proximal pulmonary artery on computed tomography pulmonary angiography (CTPA), and/or obstructive shock with echocardiographic confirmed dilatation of the right ventricle and a congested vena cava inferior, both with/without echocardiographic signs of clot in transit or deep vein thrombosis of the leg.
• 2. High risk for mortality, i.e.
• 1. post cardiac arrest (after temporary need for cardiopulmonary resuscitation), OR
• 2. obstructive shock (systolic blood pressure /<90 mmHg and signs of end-organ hypoperfusion (e.g. elevated lactate levels />2 mmol/l) or the need for vasopressors (adrenalin or noradrenalin) to maintain an adequate blood pressure), OR
• 3. persistent hypotension (systolic blood pressure /<90 mmHg or systolic blood pressure drop ≥40 mmHg for at least 15 minutes) not caused by new onset arrhythmia, hypovolemia, or sepsis, OR
• 4. abnormal RV function on transthoracic echocardiography or CTPA AND elevated cardiac troponin levels AND respiratory failure defined as hypoxemia (SaO2 /<90%) refractory to O2 supplementation by nasal cannula or Venturi mask, requiring full face mask O2 supplementation (100% FiO2), high-flow nasal O2, or (non-)invasive mechanical ventilation.
• 3. CDT available and technically feasible so as to allow for a randomization-to-needle time of 60 minutes or less.

Критерии исключения

• 1. "Catastrophic PE", i.e. ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation (ECPR) and/or immediate indication for venoarterial extracorporeal membrane oxygenation (VA-ECMO) as judged by the responsible physician(s)
• 2. Glascow Coma Scale /<8 following resuscitation for cardiac arrest
• 3. Alternative diagnosis than acute PE contributing largely to the acute hemodynamic and/or respiratory failure, e.g. sepsis, COPD GOLD 3 or 4, or known heart failure with NYHA Functional Classification of 4, as judged by the treating physician.
• 4. A known "do not admit to the ICU" or "do not resuscitate" directive
• 5. An absolute contraindication to systemic thrombolysis, i.e.
• * History of hemorrhagic stroke
• * Ischemic stroke in past 6 months
• * Central nervous system neoplasm
• * Major trauma, major surgery or major head injury in past 3 weeks (note: mild external laceration of the head after, e.g. syncope, does not count as major head injury, especially when a CT scan of the head shows no hematoma)
• * Active bleeding, life-threatening or into a critically organ/area; OR known severe bleeding diathesis with previous bleeding fulfilling these criteria
• 6. Reperfusion therapy (systemic thrombolysis, surgical thrombectomy or CDT/other catheter directed therapy), or placement of a non-retrieved inferior vena cava filter for acute pulmonary embolism in the past 3 months
• 7. Thrombus in transit through a patent foramen ovale.
• 8. Known chronic thromboembolic pulmonary hypertension (CTEPH), or strong suspicion of CTEPH based on pre-existing clinical findings and combinations of signs of PE chronicity on echocardiography and/or CTPA.
• 9. Known hypersensitivity to systemic thrombolysis, heparin, or to any of the excipients
• 10. If, in the Investigator`s opinion, or after consultation with the local PERT-team or EC-members, the patient is not appropriate for thrombectomy
• 11. Chronic use of full-dose oral or parenteral anticoagulation before presentation.
• 12. Pregnancy
• 13. Current participation in another study that would interfere with participation in this study
• 14. Previous enrolment in this study
• 15. Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.

Описание

Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy.

Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia.

Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.

Критерии включения

• * Patients diagnosed with haemophilia A and B
• * With severe haemophilia phenotype (/<1% FVIII/FIX)
• * Over 18 years of age
• * With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
• * On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates

Критерии исключения

• * Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
• * Failure to sign the informed consent document

Описание

The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.

Критерии включения

• 1. Age ≥ 18 years
• 2. Ability to provide written informed consent,
• 3. Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
• 4. Baseline score ≥55 on the FACIT-Fatigue scale,
• 5. Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
• 6. Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline
• 7. Currently owns and operates an iOS or Android smart phone regularly
• 8. Ability to comply with the clinical visits schedule and the study-related procedures.

Критерии исключения

• 1. History of sympathectomy or stellate ganglion block
• 2. History of Botox injections to the digits within the last 3 months
• 3. Diabetes mellitus
• 4. Major surgery within 8 weeks
• 5. Hospitalization for any reason within four weeks of the study baseline visit
• 6. Active malignancy
• 7. Pregnant or breastfeeding women,
• 8. End-stage renal disease (estimated glomerular filtration rate /< 15 mL/min/1.73m2) or on dialysis,
• 9. Hepatic insufficiency as defined by function worse than Child-Pugh Class B
• 10. Medication exclusions:
• 1. actively prescribed standing doses of beta-blockers,
• 2. actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.

Описание

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

Критерии включения

• * The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
• * Clinical signs, symptoms and presentation consistent with acute PE
• * PE symptom duration ≤ 14 days
• * CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• * CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator`s interpretation of RV/LV ratio at baseline)
• * Systolic BP ≥ 90 mmHg (initial SBP may be /< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
• * Stable HR /< 130 BPM prior to the procedure

Критерии исключения

• * Prior PE /<180 days from index procedure
• * Thrombolytic use within 30 days prior to baseline CTA
• * Pulmonary hypertension with peak pulmonary arterial pressure (PAP) /> 70 mmHg by right heart catheterization
• * Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
• * FiO2 requirement /> 40% or /> 6 LPM (to keep oxygen saturation /> 90%)
• * Hematocrit /< 28% (Note: hematocrit required within 6 hrs. of index procedure)
• * Platelets /< 100,000/μL
• * eGFR /<30 ml/min per 1.73 m2
• * International normalized ratio (INR) /> 3
• * Major trauma injury severity score (ISS) /> 15
• * Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
• * Cardiovascular or pulmonary surgery within the last 7 days
• * Actively progressing cancer treated by chemotherapeutics
• * Known bleeding diathesis or coagulation disorder
• * Left bundle branch block
• * History of severe or chronic pulmonary arterial hypertension
• * History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• * History of uncompensated heart failure.
• * History of underlying lung disease that is oxygen dependent
• * History of chest irradiation
• * History of heparin-induced thrombocytopenia (HIT)
• * Contraindication to systemic or therapeutic doses of anticoagulants
• * Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• * Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
• * CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
• * Life expectancy /< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
• * Female who is pregnant or nursing
• * Current participation in another investigational drug or device treatment study

Описание

The goal of this observational study is to evaluate the predictive efficacy of the Modified Caprini Risk Assessment Score and D-Dimer in identifying and managing lower extremity venous thrombosis (LEVT) among cardiothoracic surgery patients in Baghdad. The main questions it aims to answer are:

Does combining the Modified Caprini Score with D-Dimer improve the accuracy of predicting lower extremity venous thrombosis (LEVT) compared to using each tool independently? Can these tools effectively guide clinical decisions for lower extremity venous thrombosis (LEVT) prevention and management in this patient population?

Participants will:

Undergo risk assessment for lower extremity venous thrombosis (LEVT) using the Modified Caprini Score and have their D-Dimer levels measured during their hospital stay.

Be monitored for clinical outcomes, including confirmed lower extremity venous thrombosis (LEVT) incidence, need for anticoagulation therapy, and complications such as pulmonary embolism or recurrent thrombosis.

Критерии включения

• * Inpatients with a hospital stay over 3 days
• * Written informed consent obtained from patients or their legal guardians.
• * Availability for postoperative follow-up to assess outcomes like LEVT development or related complications.

Критерии исключения

• * Preexisting LEVT or Pulmonary Embolism: Diagnosed before the index surgery.
• * Severe Coagulopathy: Patients with inherited or acquired bleeding disorders (e.g., hemophilia, advanced liver disease).
• * receiving any anticoagulation therapy for any reason.
• * patients who did not undergo a postoperative D-dimer test.
• * Incomplete Data: missing essential clinical or laboratory data for Modified Caprini Score calculation or D-Dimer measurement.
• * Pregnancy: pregnant women or those within six weeks postpartum.
• * Noncompliance: Patients unwilling or unable to adhere to study follow-up protocols.

Описание

For bridging the available global clinical data of rVIII-SingleChain, with the Chinese population, the aim of this study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than /[/</] 1%).

Критерии включения

• * Male Chinese participants /<= 65 years of age.
• * Participants with severe hemophilia A (FVIII activity /< 1%).
• * Participants who have received FVIII products for />= 150 EDs (/>= 6 years of age) or />= 50 EDs (/< 6 years of age).

Критерии исключения

• * Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein.
• * Known congenital or acquired coagulation disorder other than congenital FVIII deficiency.
• * Currently receiving intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
• * Receiving any cryoprecipitate, whole blood, or plasma within 30 days before administration of rVIII-SingleChain.
• * 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 participant`s participation in the study.

Описание

Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia A.

Participants who are receiving treatment with damoctocog alfa pegol (n/~12) or turoctocog alfa pegol (n/~12) will be enrolled in the study. The study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period.

During the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant`s pre-study treatment) will be administered. A PK sampling period will follow over 7 visits. Following completion of the PK sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new PK sampling period will follow (visit 8-15).

The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections.

Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.

Критерии включения

• * Participant must be male, 18 to 65 years of age, inclusive, at the time of signing the informed consent form (ICF).
• * Severe haemophilia A, defined as /<1 IU/dL (/<1%) endogenous FVIII activity, as documented in historical medical records from a clinical laboratory demonstrating /<1% FVIII coagulant activitiy or a documented genotype known to produce severe haemophilia A.
• * Previous treatment for haemophilia A with any marketed recombinant and/or plasma derived FVIII for at least 150 exposure days.
• * Currently receiving treatment with damoctocog alfa pegol or turoctocog alfa pegol at Screening.

Критерии исключения

• * Any history of a positive inhibitor test, defined as />0.6 Bethesda units (BU)/mL in at least two consecutive Bethesda inhibitor assays, or any value greated than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL. Family history of inhibitors will not exclude the participant.
• * Positive FVIII inhibitor result (assessed by central laboratory), defined as ≥0.6 BU/mL at Screening.

Описание

Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared.

In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported.

Критерии включения

• Substudy 1
• Inclusion Criteria:
• * Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy
• * Informed and signed consent from next of kind

Критерии исключения

• * None
• Substudy 2 Inclusion Criteria
• * Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast
• * Informed and signed consent from the patient
• Exclusion Criteria
• - GFR /<15 mL/min/1.73 m2

Описание

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism

Критерии включения

• 1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
• a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP /<90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
• 2. Age ≥18 years

Критерии исключения

• 1. Contraindications for catheter-based treatment
• 2. Contraindications to systemic fibrinolytic treatment or anticoagulation/*
• 1. Active, potentially life-threatening bleeding
• 2. Surgery within 24h before screening
• 3. Cranial or spinal surgery within 14d before screening
• 4. Stroke within 14d before screening
• 5. Intracranial tumor
• 6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
• 3. Pregnancy
• * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

Описание

A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the treatment of Schimke immuno-osseous dysplasia

Критерии включения

• * 1. Diagnosed as SIOD and was in stage 5 of chronic kidney disease
• * 2. Having allogeneic HSCT indications, at least suitable donors (relatives) for haploidentical allogeneic transplantation and kidneys from stem cell transplantation donors;
• * 3. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range.
• * 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• * 5. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%；
• * 6. Estimated survival time ≥ 3 months;
• * 7. ECOG performance status 0 to 1;
• * 8. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• * 9. Those who voluntarily participated in this trial and provided informed consent

Критерии исключения

• * 1. Allergic to pretreatment measures
• * 2. received any containing ATG/ALG such IST、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received CsA treatment within 6 months, or used thrombopoietin receptor (tpo-r) agonists in the past;
• * 3. Patients with the history of epilepsy or other CNS disease;
• * 4. Patients with prolonged QT interval time or severe heart disease;
• * 5. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation
• * 6. People infected with HIV, active hepatitis B or hepatitis C virus, and patients with active infection who are not cured;
• * 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• * 8. Patients with malignant tumor;
• * 9. People with other genetic diseases；
• * 10. After receiving CD7 car-t treatment, patients who were unable to accept subsequent kidney transplantation due to severe infection or poor amplification of car-t in vivo.
• * 11. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Описание

The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.

Критерии включения

• 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Parents` or legally designated representatives` consent is required for patients who are /<18 years of age or unable to give consent, or as applicable per local laws. Patients who are /<18 years of age should provide assent in addition to the parents`/legally designated representatives` consent, if appropriate.
• 2. Male or female patients who are ≥12 years of age and diagnosed with moderate or severe haemophilia A (defined as ≤5% of normal FVIII clotting activity) at the time of signing the ICF.
• 3. A female patient is eligible to participate if she is not pregnant at enrolment and does not plan to become pregnant during the study. A woman of child-bearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at the Screening Visit.
• 4. Must have received prophylactic treatment per local label with any marketed FVIII product or emicizumab for ≥12 months prior to the Baseline Visit.
• 5. Have at least one eligible index joint (ankle, elbow, knee).
• 6. Have 12 months of documented pre-study treatment data on haemophilia prescriptions and on treated bleeding episodes prior to the Baseline Visit.
• 7. Willingness and the ability of the patient or their legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study.

Критерии исключения

• 1. Blood clotting disorders other than haemophilia A
• 2. Already on efanesoctocog alfa treatment
• 3. Positive inhibitor result (assessed by local laboratory) from the Screening Visit, defined as ≥0.6 Bethesda units (BU)/mL.
• 4. History of inhibitors without successful immune tolerance induction (ITI)
• * Successful ITI is defined as:
• * Negative inhibitor titer (/<0.6 BU/mL)
• * FVIII recovery /> 66% of expected
• * FVIII half-life ≥ 6 hours
• 5. ITI performed within the last 2 years prior to the Baseline Visit.
• 6. Currently receiving treatment with any of the prohibited concomitant medications, as specified by the protocol.
• 7. Planned major orthopaedic procedure in any eligible index joint during the course of the study.
• 8. Patients are not eligible for participation in the study if they cannot undergo MRI assessments at the Baseline Visit.
• 9. Patients with known hypersensitivity to the active substance or to any of the excipients.
• 10. Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
• 11. Enrolment in a concurrent clinical interventional study, or intake of an investigational medicinal product (IMP), within 3 months prior to inclusion in the study.

Описание

Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.

In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.

Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.

As a control cohort, blood samples are obtained from patients undergoing resection for glioma.

Критерии включения

• * Patients undergoing resection for meningioma or
• * Patients undergoing resection for glioma or
• * Healthy controls
• * written consent for study participation

Критерии исключения

• -

Описание

This study will be conducted as a randomized controlled trial with a parallel design to determine the impact of an interactive video developed for the care of surgical patients wearing anti-embolism stockings on nursing students` learning outcomes. The research hypotheses are as follows: H0a: There is no significant difference in knowledge levels related to anti-embolism stocking care between the experimental and control groups. H0b: There is no significant difference in skill levels related to anti-embolism stocking care between the experimental and control groups.

Критерии включения

• * The student`s academic average must be above 2.00.
• * The student must own a smartphone, tablet, or laptop/desktop computer capable of downloading the video.
• * The student must have internet access.
• * The student must be willing to participate in the study voluntarily.

Критерии исключения

• * Graduates of health vocational high schools.
• * Students who have failed the Surgical Diseases Nursing course.
• * Students who have not participated in any of the stages of the study.
• * Students who voluntarily decide to withdraw from the study.

Описание

In France, venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep-vein thrombosis (DVT), is the 3rd leading cause of cardiovascular disease, leading to major public health problems. Despite current monitoring and treatment, the recurrence rate and the rate of haemorrhagic complications remain high, at 18.5% and 12% respectively in the year following the thrombotic event.

Patients with PE diagnosed in the emergency department are very often admitted to hospital.

However, according to international recommendations on the treatment of PE, outpatient management with early discharge could be envisaged but is rarely carried out in practice, particularly for non-severe PE (spESI = 0).

Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital, with follow-up at 1, 3 and 6 months. The aim is to evaluate anticoagulant treatment (high-risk medication), investigate the causes of PE, monitor the patient and decide whether or not to continue anticoagulant treatment 6 months after diagnosis.

Patients diagnosed with non-severe PE can only be monitored as soon as they are discharged from hospital, thanks to an organised and specific care pathway involving healthcare professionals working in towns and cities as well as in hospitals.

In 2018, the French authorities created a new healthcare profession, the advanced practice nurse (APN). They are said to be one of the /'answers/' to making care pathways, including PE, even more relevant by improving the quality of patient care and strengthening the town-hospital link.

Thanks to their training and expertise, IPAs can carry out the following activities:

* Observation, collection and interpretation of data in the context of patient monitoring in his/her area of expertise;
* Prescribing, renewing prescriptions and carrying out technical procedures as part of patient follow-up in their area of expertise;
* Designing, implementing and evaluating preventive and therapeutic education measures.

Thus, by intervening at specific times throughout the course of a patient/'s diagnosis of a non-severe PE, the involvement of the IPA in the patient/'s follow-up, in addition to current recommendations, would make it possible to reduce the risk of haemorrhagic complications associated with the use of anticoagulants.

Критерии включения

• * Person who has given oral consent
• * Person affiliated to the social security system
• * Over 18 years of age
• * Resident in the 21-52 region
• * Emergency care at Dijon University Hospital or Langres University Hospital less than 24 hours after diagnosis of non-severe pulmonary embolism (spESI = 0)
• Symptomatic PE is confirmed if there is :
• * a high pre-test clinical probability and a high probability ventilation-perfusion (V/Q) lung scan according to the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria
• * a proximal DVT diagnosed by ultrasound in a patient with symptoms of PE;
• * a positive CT pulmonary angiogram (PA) showing a central filling defect highlighted by contrast material or a complete occlusion in a segmental or more proximal pulmonary artery.
• * No contraindication to anticoagulant treatment

Критерии исключения

• * Person not affiliated to or not benefiting from a social security scheme
• * Person subject to a legal protection measure (curatorship, guardianship)
• * Person subject to a legal protection measure
• * Pregnant women, women in labour or breastfeeding mothers
• * An adult who is incapable or unable to give consent
• * Minors
• * Contraindication to anticoagulant treatment

Описание

RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Критерии включения

• 1. Age at enrollment ≥18 years
• 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
• 3. High-risk class of acute PE
• 4. RV dysfunction, as defined RV/LV ratio ≥1.0
• 5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

Критерии исключения

• 1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
• 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
• 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
• 4. Recent stroke (/<14 days)
• 5. Recent cranial or spinal surgery (/<14 days)
• 6. Life-threatening active bleeding or hemorrhage into a critical area
• 7. Known intracranial tumor
• 8. End-stage medical condition with life expectancy /<3 months (irrespective of the severity of acute PE), as determined by the Investigator
• 9. Known sensitivity to radiographic contrast agents that, in the Investigator`s opinion, cannot be adequately pre-treated
• 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
• 11. Current participation in another drug or device study that may interfere with the conduct of this trial
• 12. Ventricular arrhythmias refractory to treatment at the time of enrollment
• 13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
• 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
• 15. Subject was previously enrolled in this study
• 16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization

Описание

To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.

Критерии включения

• 1. Aged 18 years or older;
• 2. Clinical presentation consistent with acute ischemic stroke (AIS);
• 3. Able to receive mechanical thrombectomy within 24 hours of onset;
• 4. Pre-morbid mRS score of 0 or 1;
• 5. Baseline NIHSS score of 6 or greater;
• 6. Complete or near-complete occlusion (eTICI 0-1) of the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or the basilar artery (with or without involvement of the intracranial vertebral artery) confirmed by angiography who can undergo intravascular thrombectomy;
• 7. Vessel diameter ≥2.2 mm at the occlusion site;
• 8. ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;
• 9. Written informed consent obtained from the patient or the patient`s qualified representative.

Критерии исключения

• 1. Pregnant or lactating women;
• 2. Severe allergic reactions to contrast agents;
• 3. Current participation in other clinical studies;
• 4. Known hereditary or acquired bleeding disorders, platelet count /<50,000/µL, or coagulation factor deficiencies;
• 5. Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) /<30 mL/min;
• 6. Expected survival /< 6 months or known cancer with metastases;
• 7. Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
• 8. Suspected aortic dissection;
• 9. Known arterial condition in a proximal vessel that requires treatment or prevents access to the site of occlusion or safe recovery of the investigational device (for example, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion);
• 10. High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD on CTA, MRA, or DSA, or any other finding that is highly suggestive of ICAD as the underlying etiology of the occlusion;
• 11. Evidence of dissection in the extracranial or intracranial cerebral arteries;
• 12. Intracranial hemorrhage on CT or MRI;
• 13. Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;
• 14. Suspicious of cerebral vasculitis or infectious endocarditis;
• 15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;
• 16. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic;
• 17. Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Super-Bore Aspiration Catheters;
• 18. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices;
• 19. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician;
• 20. Known aneurysm at or near the target treatment segment;
• 21. Known glucose level/< 50 mg/dl (2.78 mmol/L) or /> 400 mg/dl (22.20 mmol/L)；
• 22. Patients who, in the opinion of the investigator, are unsuitable for mechanical thrombectomy as evidenced by imaging findings.

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

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 />50 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

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

The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on emicizumab prophylaxis.

Критерии включения

• * Moderately severe hemophilia A, defined as FVIII level /<0.05 IU/mL before 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 (Legally Authorized Representative) or the 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)
• * Had an active bleed requiring factor therapy at screening
• * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease (excluding previously resolved line-associated thrombosis)
• * Had a surgical procedure 14 days before screening
• * Conditions that may increase the risk of bleeding or thrombosis
• * If the patient is treated with rFVIIa or aPCC seven days before screening
• * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
• * Had current use of any medication other than emicizumab that could affect the coagulation system.
• * Known HIV infection with CD4 count /<200 cells/µL within 24 weeks before screening. Testing is 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 an additional risk, or would, in the opinion of the investigator, preclude the participant`s safe participation in and completion of the study

Описание

The human immune system is designed to protect individuals from external sources of infection and internal cell mutation. It works effectively and efficiently until inflammation disturbs its functioning. Once compromised by inflammation, the immune system loses its capacity to recognize antigens and dependably defend the body against disease and illness.

When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body`s over immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual`s organ(s)` structure, leaving the body without sufficient strength or time to fight back. When the medical herbs join the body, it can slow down the immune reaction. Medical herbs benefit the physical body; they protect the cells and organism structure and mediate the immune response, allowing the T cells to kill the virus (mutated or not) internally. Such success has been achieved by the All Natural Medicine Clinic during pre-clinical trials.

This clinical study`s goal is to demonstrate that the immune system can be rebuilt and retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing the immune storm, and to explore the mechanism by which these medical herbs, which have been used for thousands of years for healing, achieve results.

Критерии включения

• A subject will be eligible for inclusion in this study if any of the following criteria apply:
• * Individuals diagnosed with COVID-19 virus infection in the past 1-20 days must submit the proved metrics of COVID-19 virus marks positive during the registration;
• * The age of participants is between 10-70 years old;
• * The participants are received or not received conventional medication treatment, and continuing the treatment patients, could be enrolled in this clinical study;
• * This clinical study is not restricted to gender, age, sex, race, and nationality;
• * The participants must have reports of CBC, C3, C4, IgM, IgG, CD4/CD8, and lungs` images ready before the clinical study;
• * The Participants must repeat the evaluation experiment during and at the end of the clinical study.

Критерии исключения

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• * Individuals with a prior COVID-19 virus infection that no longer shows up from COVID-19 testing;
• * Children who are younger than 10-year-old, cannot control themselves to take the medical herbs on time;
• * Elders whose age beyond 70-year-old, with severe underline illness;
• * COVID-19 virus-infected patients who do not feel willing to take medical herbs;
• * Patients diagnosed with COVID-19 virus infection cannot consistently finish the treatment courses for a specific reason;
• * Patients diagnosed with COVID-19 virus infection but do not willing to share their information with the public;
• * Current or past participation within a specified timeframe in another clinical trial, as warranted by this intervention`s administration;
• * Severe patients, when there have insufficient normal cells, can be adjusted, with pre-list diseases life-threatening.