Kornimate/medical-research-clean huggingface dataset:
a study on the outcomes of recombinant von willebrand factor on demand treatment and prevention and treatment of bleeding during and after surgery in adults with inherited von willebrand disease in the united kingdom (uk)

Conditions: Von Willebrand Disease (VWD)

Summary: this study is a retrospective chart review study and will collect data on real world use of vonicog alfa (recombinant von willebrand factor \[rvwf\]). von willebrand disease (vwd) is the most common inherited bleeding disorder. rvwf is approved in europe and uk to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018. this study will review and collect information on the treatment and bleed prevention of adult persons with inherited vwd with rvwf in uk. these data were already collected as a part of the routine care. the main aims of this study are to describe the use of rvwf in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rvwf and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.).


Eligibility criteria:
inclusion criteria: * adults (aged 18 or over at time of first administration of rvwf) who have provided informed consent and used rvwf within its licensed indication. * participants who have been diagnosed with congenital von willebrand disease. * confirmed instance of * at least one bleed (either a new bleed or ongoing bleed treated under a treatment switch) treated on-demand with rvwf between 01-oct-2020 and 30-jun- 2022 and/or * treatment to prevent and treat surgical bleeds with rvwf between 01-oct-2020 and 30-jun-2022 exclusion criteria: * participants who were aged 17 years or less at the time of the first administration of rvwf. * participants who have been diagnosed with any other bleeding disorders or factor deficiencies including acquired von willebrand disease. * participants with neutralising antibodies/inhibitors to vwf. * participants participation in a clinical trial of an investigational medical product during the study period.

Keywords: drug therapy
safety study of autologous stem cell in liver cirrhosis

Conditions: Liver Cirrhosis

Summary: it is a fase i/ii clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (abmmc) in patients with liver cirrhosis. all the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low meld score. the abmmc are labeled with 99mtc and infused through the hepatic artery. scintigraphy is performed 2 and 24 hours after infusion. patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.

a one year clinical trial was conducted. patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low meld scores. hepatocellular carcinoma (hcc) and hepatic artery or portal vein thrombosis were excluded by color doppler ultrasonography (dus) and 3-phase computed tomography (ct). under local anesthesia, 100 ml of bone marrow were aspirated from the posterior iliac crest. abmmc were isolated by density gradient centrifugation in ficoll-hypaque gradient, 10% of the cells were labeled with sncl2-99mtc, and a small fraction was used for cell counting and viability analysis. abmmc were delivered preferentially in the common hepatic artery by celiac trunk catheterism. total body scintigraphy (tbs) was performed 3 hours after infusion. patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.

Eligibility criteria:
inclusion criteria: * liver cirrhosis of any origin * moderate liver disfunction (child-pugh score=7-10) exclusion criteria: * waiting time expectancy of liver transplant shorter than 12 months * ongoing hepatic encephalopathy * clinically detectable ascitis * severe coagulation disorder (inr\>2,0 or platelets count \< 40.000) * diagnosis or strong suspicion of cancer (except basocellular) * pregnancy or intention to become pregnant during the next 12 months * moderate or severe co-morbidity * current participation in another clinical trial

Keywords: stem cell liver cirrhosis cellular therapy autologous bone marrow
the use of venlafaxine in reducing pain in primary total knee replacement

Conditions: Acute Pain; Chronic Pain; Knee Pain Chronic; Neuropathic Pain

Summary: patients experience pain after their knee replacement surgery - and some may continue to experience persistent pain long after their knee replacement surgery. traditional pain management strategies reply on pain medication such as opioids for pain control. however, these drugs do not work well for pain associated with movement or the the nerve pain (tingling, electrical sensations) after surgery. in addition, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, depression, cognitive dysfunction and risk of persistent opioid use. neuropathic pain medications, such as venlafaxine are effective in managing nerve pain. recent studies also support its potential role in acute pain management. here, we propose a prospective randomized clinical trial 1) to evaluate the efficacy of venlafaxine in reducing pain intensity and opioid consumption at post-operative day 1 (pod1) and 1- week after surgery, and 2) to examine whether the use of venlafaxine will reduce the incidents of chronic postsurgical pain in tka patients at 3-month time point.

patients meeting the inclusion criteria will be randomized to receive either venlafaxine extended release (er) 37.5 mg/d or a placebo on the day of surgery and continue the treatment for 7 days after surgery. the primary outcomes include pain severity score (numeric rating scale, nrs) and consumption of morphine miligram equivalent (mme) at 24 hours. the secondary outcome will measure mme and nrs at postoperative day 7. in addition, the disability scale and perceived function 3 months after surgery will be compared to the baseline level by using promis (patient-reported outcomes measurement information system)10 global health, koos, jr. (knee injury and osteoarthritis outcome score short form), and vr-12 (veterans rand 12 item health survey) scale.

Eligibility criteria:
inclusion criteria: * adult (male and female) subjects aged 18 to 75, * english speaking, * are scheduled for primary total knee arthroplasty with planned spinal anesthesia with saphenous peripheral nerve block at the adductor canal. exclusion criteria: * general anesthesia, * hepatic \& renal failure, * history of diabetic peripheral neuropathic pain, * chronic opioid use, * concurrent use of antidepressants, triptans, and/or linezolid, * allergy to the study medications, * prior knee surgery, * bmi \> 40, * bleeding disorders, * history of recent falls, * concurrent benzodiazepine use.
resynchronization for ambulatory heart failure trial in patients with preserved lv function

Conditions: Heart Failure

Summary: this trial will compare two management strategies for hf patients with preserved lv function in sinus rhythm and lbbb. the control group will be treated with practice guideline optimal medical therapy for hf. the experimental group will be treated with crt in addition to optimal medical therapy for hf. in addition, the trial will further compare two methods of delivering crt. one experimental group will receive biv-crt, while the second experimental group will receive cs-crt.


Eligibility criteria:
inclusion criteria: * patients with nyha class ii-iva hf symptoms and are on diuretic therapy * lvef \> 35% (stratify by lvef 36-49% and lvef ≥ 50%), and recovered lvef (previously lvef ≤ 35%, but improved to lvef \> 35% with medical therapy) * patients with lvef ≥ 50% must also have either left atrial enlargement (any of the following: la diameter ≥3.8 cm, la length ≥5.0 cm, la volume ≥55 ml, la volume index (lavi) ≥29 ml/m2) or lv hypertrophy (lv mass index (lvmi) ≥115 g/m2 for males and ≥ 95g/m2 for females) * lbbb and qrs duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-qrs notching or slurring in ≥ 2 leads * patients may have permanent rv pacing with a qrs duration ≥180ms * patients may have permanent atrial fibrillation with good rate control defined as a resting heart rate of ≤80 bpm at rest and ≤110 bpm with 6-minute walk test * nt-probnp ≥ 600 pg/ml on stable medical therapy without previous heart failure hospitalization in the last 12 months, or ≥400 pg/ml on stable medical therapy if there was a heart failure hospitalization within the previous 12 months * appropriate pharmacological treatment of hf and co-morbidities. * stable diuretic and other hf medications for at least four weeks exclusion criteria: * serum creatinine \>180 μmol/l; or estimated glomerular filtration rate \[egfr\] ≤30 ml/min/1.73 m2, calculated using the modification of diet in renal disease formula * in-hospital patients with acute cardiac or non-cardiac illness that requires intensive care * acute coronary syndrome (including mi) \<4 weeks * coronary revascularization (cabg or pci) \< 3 months * uncorrected or uncorrectable primary valvular disease * tavi \< 3 months * restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis * severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm hg) * expected to undergo cardiac transplantation within one year (status i) * patients with a life expectancy of less than one year from non-cardiac cause. * patients included in other clinical trials that will affect the objectives of this study * patients who are pregnant/intend to get pregnant * those unable or unwilling to provide informed consent

Keywords: lbbb medical therapy sinus rhythm preserved lv function
msc-based therapy in covid-19-associated acute respiratory distress syndrome

Conditions: Covid19; ARDS, Human

Summary: considering the potential of mesenchymal stromal cells (mscs) in the treatment of lung injuries by covid-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with covid-19-associated acute respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of covid-19 confirmed by rt-pcr; * thorax ct image suggestive of viral pneumonia; * respiratory failure (sao2 \<93% with o2 at 5l / min) * tracheal intubation (first 48 h); exclusion criteria: * pregnancy or breastfeeding; * patients with a history of cancer, chemotherapy in the past 2 years; * life expectancy less than 6 months or in exclusive palliative care; * severe liver failure, with child-pugh score\> 12; * high probability of death in the following 48 h; * previous renal failure: patients who were already on dialysis or patients with rfg \<30ml / min / 1.73 m2; * clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
registry to gather long-time results after surgical aortic valve replacement with a "rapid deployment aortic valve prothesis (edwards intuity) combined with bypss surgery (cabg)

Conditions: Aortic Valve Stenosis; Coronary Artery Disease

Summary: this is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (cabg). the registry will collect patient specific baseline data and established risk scores (logistic euroscore i \& ii, sts-score, kba score) to enable us to make an estimate about the perioperative risks.

aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective. the advantage of rapid deployment aortic valve prostheses, like the edward intuity elite valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. in procedures where the aortic valve replacement (avr) is combined with a coronary artery bypass graft (cabg), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * patients with aortic valve stenosis and coronary heart disease with indication for avr and cabg * patients in who the edwards intuity elite valve is to be implanted * patients who are planned to receive at least one coronary bypass * patients who have signed an informed consent form exclusion criteria: * exclusion criteria: * emergency surgery * re-operation (i.e. any previous opening of pericardium) * additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection) * legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial * patients wanting a mechanical prosthesis * patients with contraindications for the edwards intuity elite valve * acute endocarditis or other systemic infections

Keywords: aortic valve stenosis rapid deployment valve cabg edwards intuity elite
french post-marketing surveillance survey

Conditions: Coronary Artery Disease

Summary: to assess the safety and effecacy of the cypher stent ™ \& cypher select ™ in the normal use of medical practices, within the labeled indications.

multi-center, retrospective and prospective french register. this register does not impose any constraint on the evaluated population, the procedure, or the required examinations. the local practice routines should be applied.

Eligibility criteria:
inclusion criteria: * patients with symptomatic ischemic heart disease due to de novo lesions (lesions \<30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries. exclusion criteria: * patients suffering from coronary heart disease. * patients for whom treatment antiplatelet and / or anticoagulant is against the state; * patients with injuries incompatible with the full inflation of a balloon angioplasty; * transplant patients ; * patients with known allergy to sirolimus, the stainless steel 316l, to polymethacrylates or copolymers polyolefins;
dep combine with pd-1 antibody as an treatment for ebv-hlh

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this study aimed to investigate the efficacy and safety of dep (liposomal doxorubicin, etoposide and methylprednisolone) together with pd-1 antibody as an treatment for ebv associated hemophagocytic lymphohistiocytosis.

pd-1 antibody added to the dep regimen （with or without asparaginases） in ebv-hlh,

Eligibility criteria:
inclusion criteria: 1. meet hemophagocytic lymphohistiocytosis (hlh)-04 diagnostic criteria; ebv-dna in peripheral blood or eber in tissue were positive, patients were diagnosed with ebv associated hlh (ebv-hlh). 2. . the expected survival time is more than 1 month. 3. age \>18 years old, gender is not limited. 4. serum creatinine ≤ 1.5 times normal； 5. serum human immunodeficiency virus(hiv) antigen or antibody negative； hepatitis c virus (hcv) antibody is negative, or hcv antibody is positive, but hcv rna is negative；hbv copies less than 1e+03 copies/ml. 6. no thyroid dysfunction. the left ventricular ejection fraction (lvef) was normal. 7. no uncontrollable infection. 8. contraception for both male or female. 8. informed consent obtained. exclusion criteria: 1. allergic to doxorubicin, etoposide and sintilimab injection 2. serious immunoreaction: myocardial damage, hepatitis, pneumonia 3. central nervous system symptoms 4. serious mental illness; 5. central nervous system symptoms 6. serious mental illness; 7. accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2； 8. pancreatitis history. patients unable to comply during the trial and/or follow-up phase; 9. participate in other clinical research at the same time.

Keywords: hemophagocytic lymphohistiocytosis dep pd-1 antibody
the effects of body mass i̇ndex on i̇ntraabdominal pressure and regional cerebral oxygen saturation i̇n prone position

Conditions: Cerebral Hypoxia During and/or Resulting From A Procedure

Summary: a total of 40 asa (american society of anesthesiology) physical status i-iii who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. a standard anesthesia protocol was performed in all patients. routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through nirs.patients' demographics such as age, gender, height, weight, bmi, smoking status and pre-existing medical conditions were recorded.the patients were allocated equally to two groups according to bmi as group i: bmi ≥30kg/m2,group ii \<30 kg/m2.

routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through nirs.frontal lobe oxygenation was monitored continuously and recorded every 5 minutes.before positioning patients on the operating table, a foley catheter was placed. iap was measured in the following positions in all patients: 1) in the supine position after intubation 2) in the prone position before the skin incision.all patients were placed into the prone position on the silicone pads after general anesthesia.before statistical analysis, the 40 patients were allocated equally to two groups according to the world health organization guideline of bmi: group i: bmi ≥30kg/m2, group ii \<30 kg/m2

Eligibility criteria:
inclusion criteria: * age 18-70 years * asa physical status i - iii patients undergoing lumbar disc hernia repair for two or less levels exclusion criteria: * age smaller than 18 or older than 70 years, * asa physical status more than iii, * patients with a history of carotid artery stenosis, prior neck surgery, cervical canal stenosis, stroke, neurological deficit, myocardial infarction, spinal cord injury and sudden vision loss

Keywords: cerebral oxygenation, prone position, obesity
intramyocellular fatty acid trafficking in insulin resistance states - effects of intestinal delivery of lipids

Conditions: Insulin Resistance

Summary: muscle insulin resistance is a hallmark of upper body obesity (ubo) and type 2 diabetes (t2dm). it is unknown whether muscle free fatty acid (ffa) availability or intramyocellular fatty acid trafficking is responsible for muscle insulin resistance, although it has been shown that raising ffa with intralipid can cause muscle insulin resistance within 4 hours. the investigators do not understand to what extent the incorporation of ffa into ceramides or diacylglycerols (dg) affect insulin signaling and muscle glucose uptake. the investigators propose to alter the profile and concentrations of ffa of healthy, non-obese adults using an overnight, intra-duodenal palm oil infusion vs. an overnight intra-duodenal intralipid infusion (both compared to saline control). the investigators will compare the muscle ffa storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates, providing the first measure of how different ffa profiles alter muscle ffa trafficking and insulin action at the whole body and cellular/molecular levels. by identifying which steps in the insulin signaling pathway are most affected, the investigators will determine the site-specific effect of ceramides and/or dg on different degrees of insulin resistance. hypothesis 1: palm oil infusion will result in abnormal ffa trafficking into intra-myocellular ceramides and abnormal insulin signaling. hypothesis 2: intralipid infusion will result in abnormal ffa trafficking into intra-myocellular saturated dg and abnormal insulin signaling.


Eligibility criteria:
inclusion criteria: * women and men (women premenopausal) * bmi 18-27 * weight stable * not pregnant/nursing exclusion criteria: * ischemic heart disease * atherosclerotic valvular disease * smokers (\> 20 cigarettes per week) * bilateral oophorectomy * concomitant use of medications that can alter serum lipid profile (high dose fish oil, statins, niacin, fibrates, thiazolinediones, beta-blockers, atypical antipsychotics) * lidocaine allergy
acceptability study of a new fixed combination of fenofibrate 80 mg bid and metformin 1000 mg bid in type 2 diabetes and dyslipidemia

Conditions: Diabetes Mellitus, Type 2; Dyslipidemia

Summary: the present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia


Eligibility criteria:
inclusion criteria: 1. male or female patients aged from 20 to 80 years (at inclusion visit). 2. type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent. 3. dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin. 4. and having signed a written informed consent.- exclusion criteria: 1. known type 1 diabetes, uncontrolled type 2 diabetes \[hba1c \> 9.5 %, fasting plasma glucose (fpg) \> 240 mg/dl (\> 13.4 mmol/l) on the last performed blood sample (within the last 3 months)\]. 2. tg \> 500 mg/dl (\> 5.65 mmol/l) on the last performed blood sample (within the last 3 months). 3. women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (\> 1 year since their last menstrual period). 4. pregnant or lactating women.

Keywords: type ii diabetes dyslipidemia metformin fenofibrate synordia
prostate cancer in firemen: early diagnosis because of increased diagnostic pressure?

Conditions: Prostate Cancer

Summary: firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. a possible explanation for this is that these four groups of employees need regular mandatory health-checkups. if these checkups increase the chances of having a psa or dre performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. if this is the case the four groups should have cancers that are lower grade and have better survival. the investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. this will be done by extracting data from the cancer registry of norway, coupled with employment data from statistics norway. this study is also a part of a project on cancer in firefighters. if the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.


Eligibility criteria:
inclusion criteria: * all cases of prostate cancer as registered by the cancer registry of norway exclusion criteria: * none